Hospital Medicine

A 67-year-old man presented to the emergency department with four days of nausea, vomiting, and chills. He was originally from the Philippines but lived in the United States for six years. His past medical history was notable for nephrolithiasis for which a ureteral stent had been placed and was subsequently removed three years prior. He reported no abdominal pain, diarrhea, dysuria, urinary frequency, hematuria, cough, headache, or fever. He was a retired high school teacher and a lifelong nonsmoker.

This patient presents with a nonspecific constellation of constitutional and gastrointestinal (GI) symptoms. A system-based approach may be helpful when considering the differential diagnosis. Chills most often suggest infection, especially in older patients. With regard to GI causes, acute gastroenteritis and other food-borne infections can cause nausea, vomiting, and chills, but these are typically accompanied by abdominal pain and diarrhea and often resolve in less than four days. Abdominal pain would also be expected with cholecystitis as well as more life-threatening causes of nausea such as acute pancreatitis, mesenteric ischemia, and bowel obstruction. In contrast, abdominal pain would not be expected with a central nervous system (CNS) infection such as a brain abscess, which may cause nausea from increased intracranial pressure. Headaches occur in a majority of these cases, making CNS etiologies of nausea less likely. Cardiovascular causes, including myocardial ischemia and infarction, may lead to nausea and vomiting, but these are less likely given the absence of chest pain. Genitourinary causes must be considered, especially given his history of both nephrolithiasis and instrumentation. A stricture or recurrence of nephrolithiasis could lead to acute pyelonephritis or perinephric abscess, although both commonly present with urinary tract symptoms. Uremia, possibly from obstructive uropathy given the patient’s history of nephrolithiasis, could also lead to this constellation of symptoms.

On examination, temperature was 101.6 °F, heart rate 126 beats per minute, respiratory rate 18 breaths per minute, blood pressure 120/76 mm Hg, and oxygen saturation 98% on room air. The oral mucosa was moist, heart sounds were normal without murmurs, lungs were clear to auscultation, and abdomen was soft, nontender, and nondistended. There was no flank tenderness, and penile, testicular, and prostate examination findings were normal.

Laboratory studies revealed a serum sodium of 126 mEq/L, potassium 5.0 mEq/L, chloride 98 mEq/L, bicarbonate 15 mEq/L, blood urea nitrogen 88 mg/dL, creatinine 9.0 mg/dL, calcium 8 mg/dL, glucose 110 mg/dL, and albumin 3.3 g/dL. One year prior, serum creatinine was 1.4 mg/dL. His white blood cell (WBC) count was 8.0 k/uL with normal differential, hemoglobin 11.4 g/dL with normal MCV, and platelet count was normal. Serum osmolality was 286 mOsm/kg and serum parathyroid hormone (PTH) level 63 pg/mL (normal, 10-65). The urinalysis revealed cloudy urine with a specific gravity 1.009, 54 red blood cells (RBC), 236 WBC, large leukocyte esterase, negative nitrite, trace protein, and no casts or dysmorphic RBCs. A random urine specimen revealed sodium of 86 mEq/L, potassium 16 mEq/L, chloride 80 mEq/L, and creatinine 70 mg/dL.

Fever and tachycardia support an infectious cause of his symptoms. Absent flank tenderness and a normal genitourinary examination have only moderate negative predictive values for acute pyelonephritis and prostatitis, respectively. The most striking laboratory finding is his azotemia. Acute kidney injury (AKI) is more likely than chronic kidney disease (CKD) given that the PTH level is normal and the serum creatinine from a year ago was near normal. The most useful finding to differentiate AKI from CKD is the presence of atrophic kidneys on imaging. The low bicarbonate level indicates a metabolic acidosis. His serum anion gap is 13 mEq/L, which falls above most normal ranges. A mildly elevated serum anion gap together with a “delta serum anion gap/delta serum bicarbonate” ratio less than one suggest concomitant anion gap metabolic acidosis and non anion gap metabolic acidosis. The latter, coupled with a history of nephrolithiasis, may point to the possibility of renal tubular acidosis and AKI caused by urinary tract obstruction. This could also account for the marked hyponatremia. Moreover, his high fractional excretion of sodium (9%) is not suggestive of prerenal injury, the most common acute renal injury among patients who present to the emergency department. Hematuria carries a broad differential diagnosis, but most common causes include nephrolithiasis, urinary tract infection (UTI), prostatitis, neoplasm, and glomerulonephritis (GN). The lack of casts and dysmorphic RBCs makes GN unlikely. Taken together, his vital signs, examination, and laboratory studies suggest a high likelihood of an upper UTI (acute obstructive pyelonephritis) in the context of AKI due to obstructive uropathy.

Despite both a normal serum WBC count (which has only a moderate negative predictive value) and his low risk of developing life-threating organ dysfunction from sepsis based on a quick Sequential Organ Failure Assessment (qSOFA) score of zero, it is appropriate to start antibiotics after drawing blood and doing urine cultures. The next step should include administration of a broad-spectrum regimen that is appropriately dose-adjusted for renal dysfunction, such as an antipseudomonal carbapenem and vancomycin to cover extended-spectrum beta-lactamase (ESBL)-producing organisms, Pseudomonas aeruginosa, and methicillin-resistant Staphylococcus aureus (MRSA). This broad coverage is indicated for empiric treatment of complicated obstructive pyelonephritis, a condition that may arise from significant urinary obstruction and that carries a high risk of rapid clinical deterioration. He should undergo a rapid bedside test to assess for urethral or bladder outlet obstruction: either a bladder ultrasound or temporary insertion of a bladder catheter. He should also have an urgent computed tomography (CT) of his abdomen and pelvis without intravenous (IV) contrast, looking for evidence of urinary tract obstruction. A CT is preferred over ultrasound of the kidneys and bladder as CT has higher sensitivity and specificity for nephrolithiasis and neoplasm.

A CT of the abdomen and pelvis without IV contrast revealed bilateral hydroureter and hydronephrosis with multiple punctate calcified stones within the right calyces and the distal right ureter (Figure 1, Figure 2). However, these appeared too small to cause the degree of obstruction visualized. There were no stones noted in the left ureter to account for the obstruction, though small stones were noted in the left calyces. The bladder appeared normal.

More commonly, bilateral hydroureter with bilateral hydronephrosis is caused by an obstruction of the bladder or urethra. CT scans can reveal prostatic hyperplasia (occasionally with protrusion into the bladder) and increased bladder wall thickness as a result of chronic bladder outlet obstruction, but the negative predictive value of either finding is modest. More revealing is that the patient reported neither an inability to pass urine (in fact, a “random” urine sample was obtained) nor suprapubic discomfort. Both symptoms would be pronounced with acute bladder obstruction but may be minimal with slowly progressive obstruction. In either case, a distended bladder would have been seen on the CT scan.

Regardless of the cause or whether the obstruction is in the upper or lower urinary tract, emergency intervention is needed to relieve the obstruction when AKI presents with bilateral hydronephrosis. A urology consultation should be sought urgently to determine the best strategy to relieve the obstruction. This may include bilateral percutaneous nephrostomy tubes given that the obstruction appears to be above the level of the bladder. Their findings will also direct additional diagnostic workup.

The patient received ceftriaxone and underwent cystoscopy, which revealed a stricture of the distal bulbar urethra. The ureters and bladder could not be completely visualized due to hematuria. The urethral stricture was dilated, and a Foley catheter was placed. In the operating room, the patient had a fever of 103 °F and developed severe hypotension unresponsive to 3 L of intravenous normal saline. Norepinephrine infusion was initiated for refractory hypotension.

Except for transurethral prostate resections, endoscopic urologic procedures rarely lead to a stricture of any segment of the urethra, suggesting that the previous ureteral stent placement and retrieval were not causal. Longstanding Mycobacterium tuberculosis or Schistosoma haematobium infection occasionally causes urethral strictures presenting as bilateral hydronephrosis. The multiple punctate calcified “stones” demonstrated on CT may suggest either diagnosis if they were actually calcified granulomas.

Regardless of the cause, most patients with a urethral stricture have chronic lower urinary tract symptoms such as decreased stream and the feeling of incomplete bladder emptying. Since this patient does not report these symptoms, it is important to consider if the stricture might be merely incidental. The absence of pain is more telling than the absence of chronic or recurrent symptoms. Lack of pain argues strongly against a pure de novo acute obstruction because abrupt stretching of the renal capsules and the walls of the collecting system is usually painful. Slow stretching caused by a progressive stricture may mask the pain of a superimposed acute obstruction. A blood clot, for example, may have precipitated an acute-on-chronic obstruction upon lodging at the urethral stricture.

The worsening systemic response to the procedure may be due to increased intravesical pressure by dilation and cystoscopy, which may have caused subsequent backflow of bacteria from the renal parenchyma into the circulation (pyelorenal backflow). The broad-spectrum antibiotic regimen suggested above and IV crystalloid infusion should be continued with close hemodynamic monitoring.

Treatment for severe sepsis was initiated with empiric piperacillin-tazobactam, ceftriaxone was discontinued, and the patient was transferred to the intensive care unit (ICU). Norepinephrine was discontinued after 24 hours. Despite the indwelling Foley catheter, his kidney function worsened (creatinine increased to 10.5 over the next 36 hours, and he remained oliguric). Therefore, bilateral percutaneous nephrostomy tubes were placed to relieve the ongoing obstruction. In the ICU, he remained febrile, despite receiving piperacillin-tazobactam, through hospital day 7. Serial blood and urine cultures all remained negative. HIV testing was negative. His chest radiograph was unremarkable, and transthoracic echocardiogram was normal. His creatinine improved but plateaued at 2.5 mg/dL by day 7.

Worsening renal function (alongside oliguria or anuria) despite a functioning Foley catheter suggests either intrinsic renal disease or bilateral ureteral obstructions. The initial attempt at relieving the obstruction with a Foley catheter did not take into consideration the bilateral ureteral strictures. As a result, soon thereafter, the insertion of percutaneous nephrostomy tubes was necessary. Given the severity of his illness, underlying obstructive uropathy, and persistent fever, suggesting an ongoing infection, one strategy would be to continue antibiotics with broader coverage than piperacillin-tazobactam. This approach may be reasonable, given the emergence of ESBL organisms and the possibility of MRSA due to instrumentation. However, it is important to note that only sterile pyuria has been identified to date, which raises the possibility of nonbacterial infections. Although chronic infection with Schistosoma haematobium can cause bilateral ureteral strictures, associated fever is limited to the acute phase of infection and not the chronic obstructive phase, unless there is a superimposed infection. Genitourinary Mycobacterium tuberculosis remains a likely possibility, regardless of the unrevealing chest radiograph. Urine nucleic acid amplification and acid-fast bacilli (AFB) smear and culture, the best initial diagnostic test, should be sent. Although less definitive, a tuberculin skin test and an interferon-gamma release assay should also be conducted. Histopathology of the ureters obtained by repeat cystoscopy may be diagnostic, but given the limited visualization during the last cystoscopy and the recent dilation of the urethra, this option should be kept in reserve for now.

Antibiotics were discontinued on day 7, but the patient continued to experience ongoing fever. Urine Histoplasma and serum cryptococcal antigens were negative. His urine AFB smear was 1+ positive. Liver function tests revealed a total protein of 7.0 g/dL, albumin 3.0 g/dL, total bilirubin 1.2 mg/dL, direct bilirubin 0.3 mg/dL, alkaline phosphatase 418 U/L, aspartate aminotransferase 65 U/L, alanine aminotransferase 88 U/L, gamma-glutamyltransferase (GGT) 609 U/L (normal, 3-60), and lactate dehydrogenase 284 U/L (normal, 85-210).

Acid-fast bacillus in the urine strongly suggests Mycobacterium tuberculosis (MTB) with several reports of likelihood ratios greater than 10. Nevertheless, confirmation is needed to rule out nontuberculous mycobacteria because of potential hepatotoxicity from treatment. Up to six urine samples should be sent for mycobacterium culture. However, false negative rates of up to 90% are reported, and final test results can take up to two months, so other methods of confirmation should be simultaneously sought. A nucleic acid amplification test of urine could rule in a pathogenic species within 24 hours. Alternatively, the probability of a nonpathogenic colonizing species would be negligible if a caseating granuloma was found. Biopsy could be obtained from the ureters, as suggested above. Liver biopsy should also be considered, especially if the moderate elevations in alkaline phosphatase and GGT (the most common liver enzyme abnormalities in hepatic tuberculosis) did not merely wax and wane with sepsis.

A CT of the thorax without IV contrast was done to evaluate for evidence of pulmonary disease given the positive urine AFB. This demonstrated bilateral fibrotic upper lobe opacities suggestive of prior granulomatous disease but no cavitary lung lesions (Figure 3). Three sputum smears were negative for AFB, but one sample showed Mycobacterium tuberculosis detected by a polymerase chain reaction (PCR) probe.

The two-month initiation phase of treatment with four antituberculosis drugs should begin while drug susceptibility tests are pending. Potential hepatotoxicity should be closely monitored, ideally by a clinician with experience treating tuberculosis in patients with existing liver disease. As a general precaution, alcohol should be avoided as should medications such as acetaminophen that are known to be hepatotoxic. Urology follow-up is also needed because about one-third of tuberculous ureteral strictures treated initially with percutaneous nephrostomy do not resolve with antituberculosis therapy.

The patient was started on weight-based antituberculosis treatment with four antimicrobial agents (rifampin, ethambutol, pyrazinamide, and isoniazid). He was seen in the infectious disease clinic two weeks later; his fever had resolved, and his liver function tests showed normalization of AST and LDH as well as a 45% reduction in his GGT and alkaline phosphatase levels. Two months following discharge, a nuclear medicine radionuclide angiogram renal flow scan showed normal right kidney function. The right nephrostomy tube was subsequently removed. He continued to have left kidney outflow obstruction due to a residual ureteral stricture (Figure 4). Repeat cystoscopy and attempted left ureteral stenting was unsuccessful. The left nephrostomy tube remained in place.

According to the Centers for Disease Control, in 2017, 10 million people became sick with TB, and there were 1.3 million TB-related deaths worldwide with 9,150 cases reported in the United States. Extrapulmonary TB (EPTB) constitutes 10% of all TB cases globally.^1-4 GUTB is the second most common form of EPTB after lymph node TB, and it occurs in up to 20% of all pulmonary TB cases.^2,3

Mycobacteria reach the genitourinary (GU) tract via hematogenous spread during primary infection or reactivation of TB. This leads to cortical and medullary lesions, which can heal spontaneously or eventually (average of 22 years) rupture into the tubules and onto the collecting system, ureters, and bladder.^5,6 Spread to the ureter and bladder leads to multiple ureteral strictures and contracture of the bladder with disruption of the ureterovesical junction (UVJ), which causes hydroureter and hydronephrosis.⁷ Unilateral kidney involvement is most common, but bilateral involvement can occur following exacerbated hematogenous spread, particularly in immune deficient patients. Bilateral kidney involvement is also possible from retrograde spread to the good kidney due to bladder contracture and UVJ disruption.^8,9 Distal infection can involve all aspects of the male and female genital tracts, but urethral strictures are extremely rare.^10,11

GUTB affects males more than females (2:1) and presents insidiously at 40 to 60 years of age.¹² Other risk factors for TB include birth in TB endemic areas, prior TB infection, immunosuppression, malnutrition, severe systemic disease, diabetes, and cirrhosis. It is crucial to assess these risk factors when creating and refining differential diagnoses. Many patients have hematuria and sterile pyuria as incidental initial findings. The most common symptoms arise from bladder involvement, including frequency, urgency, and dysuria. Low back pain and gross hematuria are also common, but fever and constitutional symptoms are uncommon.¹⁰ Bilateral ureteral strictures can lead to obstructive renal failure, and involvement of the genital tracts can lead to pelvic or scrotal pain, swelling, and fistula formation.¹⁰

Diagnosis involves the demonstration of TB bacilli in urine or GU tissue. The urinalysis reveals hematuria and sterile pyuria.¹³ Urine AFB stains are positive in 52% of cases but are not diagnostic as nontuberculous mycobacteria may also cause a positive test result.^13,14 Urine cultures for Mycobacterium tuberculosis are positive in up to 90% of cases after six to eight weeks. As many as three to six morning urine samples are required to achieve diagnostic accuracy.^10,14 Urine PCR for Mycobacterium tuberculosis has 96% sensitivity and up to 98% specificity,¹⁴ while PCR on GU tissue has a sensitivity of 88% and specificity of 87%.¹⁵ The rapid nucleic acid amplification assay Xpert MTB/RIF in urine has a sensitivity of 83%, and specificity of 98%.¹⁶ Imaging is required to evaluate for obstruction, and the CT scan is abnormal in up to 90% of cases, showing multiple ureteral stenoses, hydroureter and hydronephrosis, and a contracted bladder.^10,17

GUTB is treated with standard antituberculosis regimens.¹⁸ Patients with urinary obstruction benefit from ureteral stenting or percutaneous nephrostomy, bladder diversion, or ureteral reconstruction surgery. Unilateral nephrectomy for a nonfunctioning kidney with extensive disease is occasionally required.¹⁹ Following treatment, relapse occurs in up to 6% of patients over five years, and long-term follow-up with urine cultures and PCR every six months is recommended.^10,20 Appropriate screening and treatment for latent tuberculosis infection greatly reduces the risk of reactivation GUTB.

This patient presented with features of an infection, which, combined with his history of renal stones and his urinalysis, led to an appropriate suspicion of and empiric treatment for an upper UTI. Given the AKI and nephrolithiasis, imaging was done to exclude obstruction. The CT finding of bilateral hydroureters and hydronephrosis absent an obstructing stone or mass or abnormal bladder was the initial clue that this was not a typical bacterial infection and that there was likely an underlying infectious pathologic process such as TB involving the GU tract diffusely. The care team treated the patient as an individual with fever and sterile pyuria in the context of multiple urinary tract strictures and an initial unrevealing infectious diagnostic workup. They recognized that the clues to the ultimate diagnosis of GUTB were all in the stream.

• GUTB is a significant cause of sterile pyuria.
• In the presence of bilateral hydronephrosis, it is vital to determine the level of obstruction. If the bladder is not distended or contracted, then obstruction is likely at the level of the ureters and initial use of percutaneous nephrostomy tubes to relieve obstruction may be preferred.
• Imaging abnormalities such as multiple ureteral strictures, hydroureter and hydronephrosis (absent an obstructing stone or mass), and the finding of a contracted bladder are highly suggestive of GUTB.
• The mainstay of treatment for GUTB is standard antituberculosis treatment regimens in combination with the relief of urinary obstruction by ureteral stenting, percutaneous nephrostomy or open surgery.
• GUTB can relapse in up to 6% of treated cases over five years, and long-term follow-up and surveillance with urine culture and PCR every six months are recommended.

Disclosures

Benjamin Mba, Nathan Houchens, Marie Jennifer Seares, and Udit Joshi have no financial conflicts of interest and no disclosures.

Funding

Brian P. Lucas receives funding from the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, and National Center for Translational Science (UL1TR001086).

A 67-year-old man presented to the emergency department with four days of nausea, vomiting, and chills. He was originally from the Philippines but lived in the United States for six years. His past medical history was notable for nephrolithiasis for which a ureteral stent had been placed and was subsequently removed three years prior. He reported no abdominal pain, diarrhea, dysuria, urinary frequency, hematuria, cough, headache, or fever. He was a retired high school teacher and a lifelong nonsmoker.

This patient presents with a nonspecific constellation of constitutional and gastrointestinal (GI) symptoms. A system-based approach may be helpful when considering the differential diagnosis. Chills most often suggest infection, especially in older patients. With regard to GI causes, acute gastroenteritis and other food-borne infections can cause nausea, vomiting, and chills, but these are typically accompanied by abdominal pain and diarrhea and often resolve in less than four days. Abdominal pain would also be expected with cholecystitis as well as more life-threatening causes of nausea such as acute pancreatitis, mesenteric ischemia, and bowel obstruction. In contrast, abdominal pain would not be expected with a central nervous system (CNS) infection such as a brain abscess, which may cause nausea from increased intracranial pressure. Headaches occur in a majority of these cases, making CNS etiologies of nausea less likely. Cardiovascular causes, including myocardial ischemia and infarction, may lead to nausea and vomiting, but these are less likely given the absence of chest pain. Genitourinary causes must be considered, especially given his history of both nephrolithiasis and instrumentation. A stricture or recurrence of nephrolithiasis could lead to acute pyelonephritis or perinephric abscess, although both commonly present with urinary tract symptoms. Uremia, possibly from obstructive uropathy given the patient’s history of nephrolithiasis, could also lead to this constellation of symptoms.

On examination, temperature was 101.6 °F, heart rate 126 beats per minute, respiratory rate 18 breaths per minute, blood pressure 120/76 mm Hg, and oxygen saturation 98% on room air. The oral mucosa was moist, heart sounds were normal without murmurs, lungs were clear to auscultation, and abdomen was soft, nontender, and nondistended. There was no flank tenderness, and penile, testicular, and prostate examination findings were normal.

Laboratory studies revealed a serum sodium of 126 mEq/L, potassium 5.0 mEq/L, chloride 98 mEq/L, bicarbonate 15 mEq/L, blood urea nitrogen 88 mg/dL, creatinine 9.0 mg/dL, calcium 8 mg/dL, glucose 110 mg/dL, and albumin 3.3 g/dL. One year prior, serum creatinine was 1.4 mg/dL. His white blood cell (WBC) count was 8.0 k/uL with normal differential, hemoglobin 11.4 g/dL with normal MCV, and platelet count was normal. Serum osmolality was 286 mOsm/kg and serum parathyroid hormone (PTH) level 63 pg/mL (normal, 10-65). The urinalysis revealed cloudy urine with a specific gravity 1.009, 54 red blood cells (RBC), 236 WBC, large leukocyte esterase, negative nitrite, trace protein, and no casts or dysmorphic RBCs. A random urine specimen revealed sodium of 86 mEq/L, potassium 16 mEq/L, chloride 80 mEq/L, and creatinine 70 mg/dL.

Fever and tachycardia support an infectious cause of his symptoms. Absent flank tenderness and a normal genitourinary examination have only moderate negative predictive values for acute pyelonephritis and prostatitis, respectively. The most striking laboratory finding is his azotemia. Acute kidney injury (AKI) is more likely than chronic kidney disease (CKD) given that the PTH level is normal and the serum creatinine from a year ago was near normal. The most useful finding to differentiate AKI from CKD is the presence of atrophic kidneys on imaging. The low bicarbonate level indicates a metabolic acidosis. His serum anion gap is 13 mEq/L, which falls above most normal ranges. A mildly elevated serum anion gap together with a “delta serum anion gap/delta serum bicarbonate” ratio less than one suggest concomitant anion gap metabolic acidosis and non anion gap metabolic acidosis. The latter, coupled with a history of nephrolithiasis, may point to the possibility of renal tubular acidosis and AKI caused by urinary tract obstruction. This could also account for the marked hyponatremia. Moreover, his high fractional excretion of sodium (9%) is not suggestive of prerenal injury, the most common acute renal injury among patients who present to the emergency department. Hematuria carries a broad differential diagnosis, but most common causes include nephrolithiasis, urinary tract infection (UTI), prostatitis, neoplasm, and glomerulonephritis (GN). The lack of casts and dysmorphic RBCs makes GN unlikely. Taken together, his vital signs, examination, and laboratory studies suggest a high likelihood of an upper UTI (acute obstructive pyelonephritis) in the context of AKI due to obstructive uropathy.

Despite both a normal serum WBC count (which has only a moderate negative predictive value) and his low risk of developing life-threating organ dysfunction from sepsis based on a quick Sequential Organ Failure Assessment (qSOFA) score of zero, it is appropriate to start antibiotics after drawing blood and doing urine cultures. The next step should include administration of a broad-spectrum regimen that is appropriately dose-adjusted for renal dysfunction, such as an antipseudomonal carbapenem and vancomycin to cover extended-spectrum beta-lactamase (ESBL)-producing organisms, Pseudomonas aeruginosa, and methicillin-resistant Staphylococcus aureus (MRSA). This broad coverage is indicated for empiric treatment of complicated obstructive pyelonephritis, a condition that may arise from significant urinary obstruction and that carries a high risk of rapid clinical deterioration. He should undergo a rapid bedside test to assess for urethral or bladder outlet obstruction: either a bladder ultrasound or temporary insertion of a bladder catheter. He should also have an urgent computed tomography (CT) of his abdomen and pelvis without intravenous (IV) contrast, looking for evidence of urinary tract obstruction. A CT is preferred over ultrasound of the kidneys and bladder as CT has higher sensitivity and specificity for nephrolithiasis and neoplasm.

A CT of the abdomen and pelvis without IV contrast revealed bilateral hydroureter and hydronephrosis with multiple punctate calcified stones within the right calyces and the distal right ureter (Figure 1, Figure 2). However, these appeared too small to cause the degree of obstruction visualized. There were no stones noted in the left ureter to account for the obstruction, though small stones were noted in the left calyces. The bladder appeared normal.

More commonly, bilateral hydroureter with bilateral hydronephrosis is caused by an obstruction of the bladder or urethra. CT scans can reveal prostatic hyperplasia (occasionally with protrusion into the bladder) and increased bladder wall thickness as a result of chronic bladder outlet obstruction, but the negative predictive value of either finding is modest. More revealing is that the patient reported neither an inability to pass urine (in fact, a “random” urine sample was obtained) nor suprapubic discomfort. Both symptoms would be pronounced with acute bladder obstruction but may be minimal with slowly progressive obstruction. In either case, a distended bladder would have been seen on the CT scan.

Regardless of the cause or whether the obstruction is in the upper or lower urinary tract, emergency intervention is needed to relieve the obstruction when AKI presents with bilateral hydronephrosis. A urology consultation should be sought urgently to determine the best strategy to relieve the obstruction. This may include bilateral percutaneous nephrostomy tubes given that the obstruction appears to be above the level of the bladder. Their findings will also direct additional diagnostic workup.

The patient received ceftriaxone and underwent cystoscopy, which revealed a stricture of the distal bulbar urethra. The ureters and bladder could not be completely visualized due to hematuria. The urethral stricture was dilated, and a Foley catheter was placed. In the operating room, the patient had a fever of 103 °F and developed severe hypotension unresponsive to 3 L of intravenous normal saline. Norepinephrine infusion was initiated for refractory hypotension.

Except for transurethral prostate resections, endoscopic urologic procedures rarely lead to a stricture of any segment of the urethra, suggesting that the previous ureteral stent placement and retrieval were not causal. Longstanding Mycobacterium tuberculosis or Schistosoma haematobium infection occasionally causes urethral strictures presenting as bilateral hydronephrosis. The multiple punctate calcified “stones” demonstrated on CT may suggest either diagnosis if they were actually calcified granulomas.

Regardless of the cause, most patients with a urethral stricture have chronic lower urinary tract symptoms such as decreased stream and the feeling of incomplete bladder emptying. Since this patient does not report these symptoms, it is important to consider if the stricture might be merely incidental. The absence of pain is more telling than the absence of chronic or recurrent symptoms. Lack of pain argues strongly against a pure de novo acute obstruction because abrupt stretching of the renal capsules and the walls of the collecting system is usually painful. Slow stretching caused by a progressive stricture may mask the pain of a superimposed acute obstruction. A blood clot, for example, may have precipitated an acute-on-chronic obstruction upon lodging at the urethral stricture.

The worsening systemic response to the procedure may be due to increased intravesical pressure by dilation and cystoscopy, which may have caused subsequent backflow of bacteria from the renal parenchyma into the circulation (pyelorenal backflow). The broad-spectrum antibiotic regimen suggested above and IV crystalloid infusion should be continued with close hemodynamic monitoring.

Treatment for severe sepsis was initiated with empiric piperacillin-tazobactam, ceftriaxone was discontinued, and the patient was transferred to the intensive care unit (ICU). Norepinephrine was discontinued after 24 hours. Despite the indwelling Foley catheter, his kidney function worsened (creatinine increased to 10.5 over the next 36 hours, and he remained oliguric). Therefore, bilateral percutaneous nephrostomy tubes were placed to relieve the ongoing obstruction. In the ICU, he remained febrile, despite receiving piperacillin-tazobactam, through hospital day 7. Serial blood and urine cultures all remained negative. HIV testing was negative. His chest radiograph was unremarkable, and transthoracic echocardiogram was normal. His creatinine improved but plateaued at 2.5 mg/dL by day 7.

Worsening renal function (alongside oliguria or anuria) despite a functioning Foley catheter suggests either intrinsic renal disease or bilateral ureteral obstructions. The initial attempt at relieving the obstruction with a Foley catheter did not take into consideration the bilateral ureteral strictures. As a result, soon thereafter, the insertion of percutaneous nephrostomy tubes was necessary. Given the severity of his illness, underlying obstructive uropathy, and persistent fever, suggesting an ongoing infection, one strategy would be to continue antibiotics with broader coverage than piperacillin-tazobactam. This approach may be reasonable, given the emergence of ESBL organisms and the possibility of MRSA due to instrumentation. However, it is important to note that only sterile pyuria has been identified to date, which raises the possibility of nonbacterial infections. Although chronic infection with Schistosoma haematobium can cause bilateral ureteral strictures, associated fever is limited to the acute phase of infection and not the chronic obstructive phase, unless there is a superimposed infection. Genitourinary Mycobacterium tuberculosis remains a likely possibility, regardless of the unrevealing chest radiograph. Urine nucleic acid amplification and acid-fast bacilli (AFB) smear and culture, the best initial diagnostic test, should be sent. Although less definitive, a tuberculin skin test and an interferon-gamma release assay should also be conducted. Histopathology of the ureters obtained by repeat cystoscopy may be diagnostic, but given the limited visualization during the last cystoscopy and the recent dilation of the urethra, this option should be kept in reserve for now.

Antibiotics were discontinued on day 7, but the patient continued to experience ongoing fever. Urine Histoplasma and serum cryptococcal antigens were negative. His urine AFB smear was 1+ positive. Liver function tests revealed a total protein of 7.0 g/dL, albumin 3.0 g/dL, total bilirubin 1.2 mg/dL, direct bilirubin 0.3 mg/dL, alkaline phosphatase 418 U/L, aspartate aminotransferase 65 U/L, alanine aminotransferase 88 U/L, gamma-glutamyltransferase (GGT) 609 U/L (normal, 3-60), and lactate dehydrogenase 284 U/L (normal, 85-210).

Acid-fast bacillus in the urine strongly suggests Mycobacterium tuberculosis (MTB) with several reports of likelihood ratios greater than 10. Nevertheless, confirmation is needed to rule out nontuberculous mycobacteria because of potential hepatotoxicity from treatment. Up to six urine samples should be sent for mycobacterium culture. However, false negative rates of up to 90% are reported, and final test results can take up to two months, so other methods of confirmation should be simultaneously sought. A nucleic acid amplification test of urine could rule in a pathogenic species within 24 hours. Alternatively, the probability of a nonpathogenic colonizing species would be negligible if a caseating granuloma was found. Biopsy could be obtained from the ureters, as suggested above. Liver biopsy should also be considered, especially if the moderate elevations in alkaline phosphatase and GGT (the most common liver enzyme abnormalities in hepatic tuberculosis) did not merely wax and wane with sepsis.

A CT of the thorax without IV contrast was done to evaluate for evidence of pulmonary disease given the positive urine AFB. This demonstrated bilateral fibrotic upper lobe opacities suggestive of prior granulomatous disease but no cavitary lung lesions (Figure 3). Three sputum smears were negative for AFB, but one sample showed Mycobacterium tuberculosis detected by a polymerase chain reaction (PCR) probe.

The two-month initiation phase of treatment with four antituberculosis drugs should begin while drug susceptibility tests are pending. Potential hepatotoxicity should be closely monitored, ideally by a clinician with experience treating tuberculosis in patients with existing liver disease. As a general precaution, alcohol should be avoided as should medications such as acetaminophen that are known to be hepatotoxic. Urology follow-up is also needed because about one-third of tuberculous ureteral strictures treated initially with percutaneous nephrostomy do not resolve with antituberculosis therapy.

The patient was started on weight-based antituberculosis treatment with four antimicrobial agents (rifampin, ethambutol, pyrazinamide, and isoniazid). He was seen in the infectious disease clinic two weeks later; his fever had resolved, and his liver function tests showed normalization of AST and LDH as well as a 45% reduction in his GGT and alkaline phosphatase levels. Two months following discharge, a nuclear medicine radionuclide angiogram renal flow scan showed normal right kidney function. The right nephrostomy tube was subsequently removed. He continued to have left kidney outflow obstruction due to a residual ureteral stricture (Figure 4). Repeat cystoscopy and attempted left ureteral stenting was unsuccessful. The left nephrostomy tube remained in place.

According to the Centers for Disease Control, in 2017, 10 million people became sick with TB, and there were 1.3 million TB-related deaths worldwide with 9,150 cases reported in the United States. Extrapulmonary TB (EPTB) constitutes 10% of all TB cases globally.^1-4 GUTB is the second most common form of EPTB after lymph node TB, and it occurs in up to 20% of all pulmonary TB cases.^2,3

Mycobacteria reach the genitourinary (GU) tract via hematogenous spread during primary infection or reactivation of TB. This leads to cortical and medullary lesions, which can heal spontaneously or eventually (average of 22 years) rupture into the tubules and onto the collecting system, ureters, and bladder.^5,6 Spread to the ureter and bladder leads to multiple ureteral strictures and contracture of the bladder with disruption of the ureterovesical junction (UVJ), which causes hydroureter and hydronephrosis.⁷ Unilateral kidney involvement is most common, but bilateral involvement can occur following exacerbated hematogenous spread, particularly in immune deficient patients. Bilateral kidney involvement is also possible from retrograde spread to the good kidney due to bladder contracture and UVJ disruption.^8,9 Distal infection can involve all aspects of the male and female genital tracts, but urethral strictures are extremely rare.^10,11

GUTB affects males more than females (2:1) and presents insidiously at 40 to 60 years of age.¹² Other risk factors for TB include birth in TB endemic areas, prior TB infection, immunosuppression, malnutrition, severe systemic disease, diabetes, and cirrhosis. It is crucial to assess these risk factors when creating and refining differential diagnoses. Many patients have hematuria and sterile pyuria as incidental initial findings. The most common symptoms arise from bladder involvement, including frequency, urgency, and dysuria. Low back pain and gross hematuria are also common, but fever and constitutional symptoms are uncommon.¹⁰ Bilateral ureteral strictures can lead to obstructive renal failure, and involvement of the genital tracts can lead to pelvic or scrotal pain, swelling, and fistula formation.¹⁰

Diagnosis involves the demonstration of TB bacilli in urine or GU tissue. The urinalysis reveals hematuria and sterile pyuria.¹³ Urine AFB stains are positive in 52% of cases but are not diagnostic as nontuberculous mycobacteria may also cause a positive test result.^13,14 Urine cultures for Mycobacterium tuberculosis are positive in up to 90% of cases after six to eight weeks. As many as three to six morning urine samples are required to achieve diagnostic accuracy.^10,14 Urine PCR for Mycobacterium tuberculosis has 96% sensitivity and up to 98% specificity,¹⁴ while PCR on GU tissue has a sensitivity of 88% and specificity of 87%.¹⁵ The rapid nucleic acid amplification assay Xpert MTB/RIF in urine has a sensitivity of 83%, and specificity of 98%.¹⁶ Imaging is required to evaluate for obstruction, and the CT scan is abnormal in up to 90% of cases, showing multiple ureteral stenoses, hydroureter and hydronephrosis, and a contracted bladder.^10,17

GUTB is treated with standard antituberculosis regimens.¹⁸ Patients with urinary obstruction benefit from ureteral stenting or percutaneous nephrostomy, bladder diversion, or ureteral reconstruction surgery. Unilateral nephrectomy for a nonfunctioning kidney with extensive disease is occasionally required.¹⁹ Following treatment, relapse occurs in up to 6% of patients over five years, and long-term follow-up with urine cultures and PCR every six months is recommended.^10,20 Appropriate screening and treatment for latent tuberculosis infection greatly reduces the risk of reactivation GUTB.

This patient presented with features of an infection, which, combined with his history of renal stones and his urinalysis, led to an appropriate suspicion of and empiric treatment for an upper UTI. Given the AKI and nephrolithiasis, imaging was done to exclude obstruction. The CT finding of bilateral hydroureters and hydronephrosis absent an obstructing stone or mass or abnormal bladder was the initial clue that this was not a typical bacterial infection and that there was likely an underlying infectious pathologic process such as TB involving the GU tract diffusely. The care team treated the patient as an individual with fever and sterile pyuria in the context of multiple urinary tract strictures and an initial unrevealing infectious diagnostic workup. They recognized that the clues to the ultimate diagnosis of GUTB were all in the stream.

• GUTB is a significant cause of sterile pyuria.
• In the presence of bilateral hydronephrosis, it is vital to determine the level of obstruction. If the bladder is not distended or contracted, then obstruction is likely at the level of the ureters and initial use of percutaneous nephrostomy tubes to relieve obstruction may be preferred.
• Imaging abnormalities such as multiple ureteral strictures, hydroureter and hydronephrosis (absent an obstructing stone or mass), and the finding of a contracted bladder are highly suggestive of GUTB.
• The mainstay of treatment for GUTB is standard antituberculosis treatment regimens in combination with the relief of urinary obstruction by ureteral stenting, percutaneous nephrostomy or open surgery.
• GUTB can relapse in up to 6% of treated cases over five years, and long-term follow-up and surveillance with urine culture and PCR every six months are recommended.

Disclosures

Benjamin Mba, Nathan Houchens, Marie Jennifer Seares, and Udit Joshi have no financial conflicts of interest and no disclosures.

Funding

Brian P. Lucas receives funding from the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, and National Center for Translational Science (UL1TR001086).

A 67-year-old man presented to the emergency department with four days of nausea, vomiting, and chills. He was originally from the Philippines but lived in the United States for six years. His past medical history was notable for nephrolithiasis for which a ureteral stent had been placed and was subsequently removed three years prior. He reported no abdominal pain, diarrhea, dysuria, urinary frequency, hematuria, cough, headache, or fever. He was a retired high school teacher and a lifelong nonsmoker.

This patient presents with a nonspecific constellation of constitutional and gastrointestinal (GI) symptoms. A system-based approach may be helpful when considering the differential diagnosis. Chills most often suggest infection, especially in older patients. With regard to GI causes, acute gastroenteritis and other food-borne infections can cause nausea, vomiting, and chills, but these are typically accompanied by abdominal pain and diarrhea and often resolve in less than four days. Abdominal pain would also be expected with cholecystitis as well as more life-threatening causes of nausea such as acute pancreatitis, mesenteric ischemia, and bowel obstruction. In contrast, abdominal pain would not be expected with a central nervous system (CNS) infection such as a brain abscess, which may cause nausea from increased intracranial pressure. Headaches occur in a majority of these cases, making CNS etiologies of nausea less likely. Cardiovascular causes, including myocardial ischemia and infarction, may lead to nausea and vomiting, but these are less likely given the absence of chest pain. Genitourinary causes must be considered, especially given his history of both nephrolithiasis and instrumentation. A stricture or recurrence of nephrolithiasis could lead to acute pyelonephritis or perinephric abscess, although both commonly present with urinary tract symptoms. Uremia, possibly from obstructive uropathy given the patient’s history of nephrolithiasis, could also lead to this constellation of symptoms.

On examination, temperature was 101.6 °F, heart rate 126 beats per minute, respiratory rate 18 breaths per minute, blood pressure 120/76 mm Hg, and oxygen saturation 98% on room air. The oral mucosa was moist, heart sounds were normal without murmurs, lungs were clear to auscultation, and abdomen was soft, nontender, and nondistended. There was no flank tenderness, and penile, testicular, and prostate examination findings were normal.

Laboratory studies revealed a serum sodium of 126 mEq/L, potassium 5.0 mEq/L, chloride 98 mEq/L, bicarbonate 15 mEq/L, blood urea nitrogen 88 mg/dL, creatinine 9.0 mg/dL, calcium 8 mg/dL, glucose 110 mg/dL, and albumin 3.3 g/dL. One year prior, serum creatinine was 1.4 mg/dL. His white blood cell (WBC) count was 8.0 k/uL with normal differential, hemoglobin 11.4 g/dL with normal MCV, and platelet count was normal. Serum osmolality was 286 mOsm/kg and serum parathyroid hormone (PTH) level 63 pg/mL (normal, 10-65). The urinalysis revealed cloudy urine with a specific gravity 1.009, 54 red blood cells (RBC), 236 WBC, large leukocyte esterase, negative nitrite, trace protein, and no casts or dysmorphic RBCs. A random urine specimen revealed sodium of 86 mEq/L, potassium 16 mEq/L, chloride 80 mEq/L, and creatinine 70 mg/dL.

Fever and tachycardia support an infectious cause of his symptoms. Absent flank tenderness and a normal genitourinary examination have only moderate negative predictive values for acute pyelonephritis and prostatitis, respectively. The most striking laboratory finding is his azotemia. Acute kidney injury (AKI) is more likely than chronic kidney disease (CKD) given that the PTH level is normal and the serum creatinine from a year ago was near normal. The most useful finding to differentiate AKI from CKD is the presence of atrophic kidneys on imaging. The low bicarbonate level indicates a metabolic acidosis. His serum anion gap is 13 mEq/L, which falls above most normal ranges. A mildly elevated serum anion gap together with a “delta serum anion gap/delta serum bicarbonate” ratio less than one suggest concomitant anion gap metabolic acidosis and non anion gap metabolic acidosis. The latter, coupled with a history of nephrolithiasis, may point to the possibility of renal tubular acidosis and AKI caused by urinary tract obstruction. This could also account for the marked hyponatremia. Moreover, his high fractional excretion of sodium (9%) is not suggestive of prerenal injury, the most common acute renal injury among patients who present to the emergency department. Hematuria carries a broad differential diagnosis, but most common causes include nephrolithiasis, urinary tract infection (UTI), prostatitis, neoplasm, and glomerulonephritis (GN). The lack of casts and dysmorphic RBCs makes GN unlikely. Taken together, his vital signs, examination, and laboratory studies suggest a high likelihood of an upper UTI (acute obstructive pyelonephritis) in the context of AKI due to obstructive uropathy.

Despite both a normal serum WBC count (which has only a moderate negative predictive value) and his low risk of developing life-threating organ dysfunction from sepsis based on a quick Sequential Organ Failure Assessment (qSOFA) score of zero, it is appropriate to start antibiotics after drawing blood and doing urine cultures. The next step should include administration of a broad-spectrum regimen that is appropriately dose-adjusted for renal dysfunction, such as an antipseudomonal carbapenem and vancomycin to cover extended-spectrum beta-lactamase (ESBL)-producing organisms, Pseudomonas aeruginosa, and methicillin-resistant Staphylococcus aureus (MRSA). This broad coverage is indicated for empiric treatment of complicated obstructive pyelonephritis, a condition that may arise from significant urinary obstruction and that carries a high risk of rapid clinical deterioration. He should undergo a rapid bedside test to assess for urethral or bladder outlet obstruction: either a bladder ultrasound or temporary insertion of a bladder catheter. He should also have an urgent computed tomography (CT) of his abdomen and pelvis without intravenous (IV) contrast, looking for evidence of urinary tract obstruction. A CT is preferred over ultrasound of the kidneys and bladder as CT has higher sensitivity and specificity for nephrolithiasis and neoplasm.

A CT of the abdomen and pelvis without IV contrast revealed bilateral hydroureter and hydronephrosis with multiple punctate calcified stones within the right calyces and the distal right ureter (Figure 1, Figure 2). However, these appeared too small to cause the degree of obstruction visualized. There were no stones noted in the left ureter to account for the obstruction, though small stones were noted in the left calyces. The bladder appeared normal.

More commonly, bilateral hydroureter with bilateral hydronephrosis is caused by an obstruction of the bladder or urethra. CT scans can reveal prostatic hyperplasia (occasionally with protrusion into the bladder) and increased bladder wall thickness as a result of chronic bladder outlet obstruction, but the negative predictive value of either finding is modest. More revealing is that the patient reported neither an inability to pass urine (in fact, a “random” urine sample was obtained) nor suprapubic discomfort. Both symptoms would be pronounced with acute bladder obstruction but may be minimal with slowly progressive obstruction. In either case, a distended bladder would have been seen on the CT scan.

Regardless of the cause or whether the obstruction is in the upper or lower urinary tract, emergency intervention is needed to relieve the obstruction when AKI presents with bilateral hydronephrosis. A urology consultation should be sought urgently to determine the best strategy to relieve the obstruction. This may include bilateral percutaneous nephrostomy tubes given that the obstruction appears to be above the level of the bladder. Their findings will also direct additional diagnostic workup.

The patient received ceftriaxone and underwent cystoscopy, which revealed a stricture of the distal bulbar urethra. The ureters and bladder could not be completely visualized due to hematuria. The urethral stricture was dilated, and a Foley catheter was placed. In the operating room, the patient had a fever of 103 °F and developed severe hypotension unresponsive to 3 L of intravenous normal saline. Norepinephrine infusion was initiated for refractory hypotension.

Except for transurethral prostate resections, endoscopic urologic procedures rarely lead to a stricture of any segment of the urethra, suggesting that the previous ureteral stent placement and retrieval were not causal. Longstanding Mycobacterium tuberculosis or Schistosoma haematobium infection occasionally causes urethral strictures presenting as bilateral hydronephrosis. The multiple punctate calcified “stones” demonstrated on CT may suggest either diagnosis if they were actually calcified granulomas.

Regardless of the cause, most patients with a urethral stricture have chronic lower urinary tract symptoms such as decreased stream and the feeling of incomplete bladder emptying. Since this patient does not report these symptoms, it is important to consider if the stricture might be merely incidental. The absence of pain is more telling than the absence of chronic or recurrent symptoms. Lack of pain argues strongly against a pure de novo acute obstruction because abrupt stretching of the renal capsules and the walls of the collecting system is usually painful. Slow stretching caused by a progressive stricture may mask the pain of a superimposed acute obstruction. A blood clot, for example, may have precipitated an acute-on-chronic obstruction upon lodging at the urethral stricture.

The worsening systemic response to the procedure may be due to increased intravesical pressure by dilation and cystoscopy, which may have caused subsequent backflow of bacteria from the renal parenchyma into the circulation (pyelorenal backflow). The broad-spectrum antibiotic regimen suggested above and IV crystalloid infusion should be continued with close hemodynamic monitoring.

Treatment for severe sepsis was initiated with empiric piperacillin-tazobactam, ceftriaxone was discontinued, and the patient was transferred to the intensive care unit (ICU). Norepinephrine was discontinued after 24 hours. Despite the indwelling Foley catheter, his kidney function worsened (creatinine increased to 10.5 over the next 36 hours, and he remained oliguric). Therefore, bilateral percutaneous nephrostomy tubes were placed to relieve the ongoing obstruction. In the ICU, he remained febrile, despite receiving piperacillin-tazobactam, through hospital day 7. Serial blood and urine cultures all remained negative. HIV testing was negative. His chest radiograph was unremarkable, and transthoracic echocardiogram was normal. His creatinine improved but plateaued at 2.5 mg/dL by day 7.

Worsening renal function (alongside oliguria or anuria) despite a functioning Foley catheter suggests either intrinsic renal disease or bilateral ureteral obstructions. The initial attempt at relieving the obstruction with a Foley catheter did not take into consideration the bilateral ureteral strictures. As a result, soon thereafter, the insertion of percutaneous nephrostomy tubes was necessary. Given the severity of his illness, underlying obstructive uropathy, and persistent fever, suggesting an ongoing infection, one strategy would be to continue antibiotics with broader coverage than piperacillin-tazobactam. This approach may be reasonable, given the emergence of ESBL organisms and the possibility of MRSA due to instrumentation. However, it is important to note that only sterile pyuria has been identified to date, which raises the possibility of nonbacterial infections. Although chronic infection with Schistosoma haematobium can cause bilateral ureteral strictures, associated fever is limited to the acute phase of infection and not the chronic obstructive phase, unless there is a superimposed infection. Genitourinary Mycobacterium tuberculosis remains a likely possibility, regardless of the unrevealing chest radiograph. Urine nucleic acid amplification and acid-fast bacilli (AFB) smear and culture, the best initial diagnostic test, should be sent. Although less definitive, a tuberculin skin test and an interferon-gamma release assay should also be conducted. Histopathology of the ureters obtained by repeat cystoscopy may be diagnostic, but given the limited visualization during the last cystoscopy and the recent dilation of the urethra, this option should be kept in reserve for now.

Antibiotics were discontinued on day 7, but the patient continued to experience ongoing fever. Urine Histoplasma and serum cryptococcal antigens were negative. His urine AFB smear was 1+ positive. Liver function tests revealed a total protein of 7.0 g/dL, albumin 3.0 g/dL, total bilirubin 1.2 mg/dL, direct bilirubin 0.3 mg/dL, alkaline phosphatase 418 U/L, aspartate aminotransferase 65 U/L, alanine aminotransferase 88 U/L, gamma-glutamyltransferase (GGT) 609 U/L (normal, 3-60), and lactate dehydrogenase 284 U/L (normal, 85-210).

Acid-fast bacillus in the urine strongly suggests Mycobacterium tuberculosis (MTB) with several reports of likelihood ratios greater than 10. Nevertheless, confirmation is needed to rule out nontuberculous mycobacteria because of potential hepatotoxicity from treatment. Up to six urine samples should be sent for mycobacterium culture. However, false negative rates of up to 90% are reported, and final test results can take up to two months, so other methods of confirmation should be simultaneously sought. A nucleic acid amplification test of urine could rule in a pathogenic species within 24 hours. Alternatively, the probability of a nonpathogenic colonizing species would be negligible if a caseating granuloma was found. Biopsy could be obtained from the ureters, as suggested above. Liver biopsy should also be considered, especially if the moderate elevations in alkaline phosphatase and GGT (the most common liver enzyme abnormalities in hepatic tuberculosis) did not merely wax and wane with sepsis.

A CT of the thorax without IV contrast was done to evaluate for evidence of pulmonary disease given the positive urine AFB. This demonstrated bilateral fibrotic upper lobe opacities suggestive of prior granulomatous disease but no cavitary lung lesions (Figure 3). Three sputum smears were negative for AFB, but one sample showed Mycobacterium tuberculosis detected by a polymerase chain reaction (PCR) probe.

The two-month initiation phase of treatment with four antituberculosis drugs should begin while drug susceptibility tests are pending. Potential hepatotoxicity should be closely monitored, ideally by a clinician with experience treating tuberculosis in patients with existing liver disease. As a general precaution, alcohol should be avoided as should medications such as acetaminophen that are known to be hepatotoxic. Urology follow-up is also needed because about one-third of tuberculous ureteral strictures treated initially with percutaneous nephrostomy do not resolve with antituberculosis therapy.

The patient was started on weight-based antituberculosis treatment with four antimicrobial agents (rifampin, ethambutol, pyrazinamide, and isoniazid). He was seen in the infectious disease clinic two weeks later; his fever had resolved, and his liver function tests showed normalization of AST and LDH as well as a 45% reduction in his GGT and alkaline phosphatase levels. Two months following discharge, a nuclear medicine radionuclide angiogram renal flow scan showed normal right kidney function. The right nephrostomy tube was subsequently removed. He continued to have left kidney outflow obstruction due to a residual ureteral stricture (Figure 4). Repeat cystoscopy and attempted left ureteral stenting was unsuccessful. The left nephrostomy tube remained in place.

According to the Centers for Disease Control, in 2017, 10 million people became sick with TB, and there were 1.3 million TB-related deaths worldwide with 9,150 cases reported in the United States. Extrapulmonary TB (EPTB) constitutes 10% of all TB cases globally.^1-4 GUTB is the second most common form of EPTB after lymph node TB, and it occurs in up to 20% of all pulmonary TB cases.^2,3

Mycobacteria reach the genitourinary (GU) tract via hematogenous spread during primary infection or reactivation of TB. This leads to cortical and medullary lesions, which can heal spontaneously or eventually (average of 22 years) rupture into the tubules and onto the collecting system, ureters, and bladder.^5,6 Spread to the ureter and bladder leads to multiple ureteral strictures and contracture of the bladder with disruption of the ureterovesical junction (UVJ), which causes hydroureter and hydronephrosis.⁷ Unilateral kidney involvement is most common, but bilateral involvement can occur following exacerbated hematogenous spread, particularly in immune deficient patients. Bilateral kidney involvement is also possible from retrograde spread to the good kidney due to bladder contracture and UVJ disruption.^8,9 Distal infection can involve all aspects of the male and female genital tracts, but urethral strictures are extremely rare.^10,11

GUTB affects males more than females (2:1) and presents insidiously at 40 to 60 years of age.¹² Other risk factors for TB include birth in TB endemic areas, prior TB infection, immunosuppression, malnutrition, severe systemic disease, diabetes, and cirrhosis. It is crucial to assess these risk factors when creating and refining differential diagnoses. Many patients have hematuria and sterile pyuria as incidental initial findings. The most common symptoms arise from bladder involvement, including frequency, urgency, and dysuria. Low back pain and gross hematuria are also common, but fever and constitutional symptoms are uncommon.¹⁰ Bilateral ureteral strictures can lead to obstructive renal failure, and involvement of the genital tracts can lead to pelvic or scrotal pain, swelling, and fistula formation.¹⁰

Diagnosis involves the demonstration of TB bacilli in urine or GU tissue. The urinalysis reveals hematuria and sterile pyuria.¹³ Urine AFB stains are positive in 52% of cases but are not diagnostic as nontuberculous mycobacteria may also cause a positive test result.^13,14 Urine cultures for Mycobacterium tuberculosis are positive in up to 90% of cases after six to eight weeks. As many as three to six morning urine samples are required to achieve diagnostic accuracy.^10,14 Urine PCR for Mycobacterium tuberculosis has 96% sensitivity and up to 98% specificity,¹⁴ while PCR on GU tissue has a sensitivity of 88% and specificity of 87%.¹⁵ The rapid nucleic acid amplification assay Xpert MTB/RIF in urine has a sensitivity of 83%, and specificity of 98%.¹⁶ Imaging is required to evaluate for obstruction, and the CT scan is abnormal in up to 90% of cases, showing multiple ureteral stenoses, hydroureter and hydronephrosis, and a contracted bladder.^10,17

GUTB is treated with standard antituberculosis regimens.¹⁸ Patients with urinary obstruction benefit from ureteral stenting or percutaneous nephrostomy, bladder diversion, or ureteral reconstruction surgery. Unilateral nephrectomy for a nonfunctioning kidney with extensive disease is occasionally required.¹⁹ Following treatment, relapse occurs in up to 6% of patients over five years, and long-term follow-up with urine cultures and PCR every six months is recommended.^10,20 Appropriate screening and treatment for latent tuberculosis infection greatly reduces the risk of reactivation GUTB.

This patient presented with features of an infection, which, combined with his history of renal stones and his urinalysis, led to an appropriate suspicion of and empiric treatment for an upper UTI. Given the AKI and nephrolithiasis, imaging was done to exclude obstruction. The CT finding of bilateral hydroureters and hydronephrosis absent an obstructing stone or mass or abnormal bladder was the initial clue that this was not a typical bacterial infection and that there was likely an underlying infectious pathologic process such as TB involving the GU tract diffusely. The care team treated the patient as an individual with fever and sterile pyuria in the context of multiple urinary tract strictures and an initial unrevealing infectious diagnostic workup. They recognized that the clues to the ultimate diagnosis of GUTB were all in the stream.

• GUTB is a significant cause of sterile pyuria.
• In the presence of bilateral hydronephrosis, it is vital to determine the level of obstruction. If the bladder is not distended or contracted, then obstruction is likely at the level of the ureters and initial use of percutaneous nephrostomy tubes to relieve obstruction may be preferred.
• Imaging abnormalities such as multiple ureteral strictures, hydroureter and hydronephrosis (absent an obstructing stone or mass), and the finding of a contracted bladder are highly suggestive of GUTB.
• The mainstay of treatment for GUTB is standard antituberculosis treatment regimens in combination with the relief of urinary obstruction by ureteral stenting, percutaneous nephrostomy or open surgery.
• GUTB can relapse in up to 6% of treated cases over five years, and long-term follow-up and surveillance with urine culture and PCR every six months are recommended.

Disclosures

Benjamin Mba, Nathan Houchens, Marie Jennifer Seares, and Udit Joshi have no financial conflicts of interest and no disclosures.

Funding

Brian P. Lucas receives funding from the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, and National Center for Translational Science (UL1TR001086).

In recognizing the importance of Hospital Medicine (HM) and its practitioners, the Centers for Medicare and Medicaid Services (CMS) awarded the field a specialty designation in 2016. The code is self-selected by hospitalists and used by the CMS for programmatic and claims processing purposes. The HM code (“C6”), submitted to the CMS by the provider or their designee through the Provider Enrollment Chain and Ownership System (PECOS), in turn links to the National Provider Identification provider data.

The Society of Hospital Medicine^® sought the designation given the growth of hospitalists practicing nationally, their impact on the practice of medicine in the inpatient setting,¹ and their secondary effects on global care.² In fact, early efforts by the CMS to transition physician payments to the value-based payment used specialty designations to create benchmarks in cost metrics, heightening the importance for hospitalists to be able to assess their performance. The need to identify any shifts in resource utilization and workforce mix in the broader context of health reforms necessitated action. Essentially, to understand the “why’s” of hospital medicine, the field required an accounting of the “who’s” and “where’s.”

The CMS granted the C6 designation in 2016, and it went live in April 2017. Despite the code’s brief two-year tenure, calls for its creation long predated its existence. As such, the new modifier requires an initial look to help steer the role of HM in any future CMS and managed care organization (MCO) quality, payment, or practice improvement activities.

We analyzed publicly available 2017 Medicare Part B utilization data³ to explore the rates of Evaluation & Management (E&M) codes used across specialties, using the C6 designation to identify hospitalists.

To try to estimate the percentage of hospitalists who were likely billing under the C6 designation, we then compared the rates of C6 billing to expected rates of hospitalist E&M billing based on an analysis of hospitalist prevalence in the 2012 Medicare physician payment data. Prior work to identify hospitalists before the implementation of the C6 designation relied on thresholds of inpatient codes for various inpatient E&M services.^4,5 We used our previously published approach of a threshold of 60% of inpatient E&M hospital services to differentiate hospitalists from their parent specialties.⁶ We also calculated the expected rates of E&M billing for other select specialty services by applying the 2012 E&M coding trends to the 2017 data.

Table 1 shows the distribution of inpatient E&M codes billed by hospitalists using the C6 identification, as well as the use of those codes by other specialists. Hospitalists identified by the C6 designation billed only 2%-5% of inpatient and 6% of observation codes. As an example, in 2017, discharge CPT codes 99238 and 99239 were used 7,872,323 times. However, C6-identified hospitalists accounted for only 441,420 of these codes.

Table 2 compares the observed billing rates by specialty using the C6 designation to identify hospitalists with what would be the expected rates with the 2012 threshold-based specialty billing designation applied to the 2017 data. This comparison demonstrates that hospitalist billing based on the C6 modifier use is approximately one-tenth of what would have been their expected volume of E&M services.

We examined the patterns of hospitalist billing using the C6 hospital medicine specialty modifier, comparing billing patterns with what we would expect hospitalist activity to be if we had used a threshold-based approach. The difference between the C6 and the threshold-based approaches to assessing hospitalist activity suggests that as few as 10% of hospitalists have adopted the C6 code.

Why is the adoption of the C6 modifier so low? Although administrative data do not allow us to identify the reasons why providers chose to disregard the C6 designation, we can speculate on causes. There are, to date, low direct risks and recognized benefits with using the code. We hypothesize that several factors could be impeding whether providers use the modifier to bring about potential gains. The first may be knowledge-related; ie, hospitalists might not be familiar with the specialty code or unaware of the importance of accurately capturing hospitalist practice patterns. They may also wrongly assume that their practices are aware of the revision or have submitted the appropriate paperwork. Similarly, practice personnel may lack knowledge regarding the code or the importance of its use. The second factor may be logistical; ie, administrative barriers such as difficulty accessing the Provider Enrollment, Chain and Ownership System (PECOS) and out-of-date paper registration forms impede fast uptake. The final reason might be related to professionals whose tenures as hospitalists will be brief, and their unease of carrying an identifier into their next non-HM position prompts hesitation. Providers may have a misperception that using the C6 code may somehow impact or limit their future scope of practice, when, in fact, they may change their Medicare specialty designation at any time.

Changes in reimbursement models, including the Bundled Payments for Care Improvement Advanced (BPCI-A) and other value-based initiatives, heighten the need for a more accurate identification of the specialty. Classifying individual providers and groups to make valid performance comparisons is relevant for the same reasons. The CMS continues to advance cost and efficiency measures in its publicly accessible physiciancompare.gov website.⁷ Without an improved ability to identify services provided by hospitalists—by both CMS and commercial entities—the potential benefits delivered by hospitalists in terms of improved care quality, safety, or efficiency could go undetected by payers and policymakers. Moreover, C6 may be used in other ways by the CMS throughout its payment systems and programmatic efforts that use specialty to differentiate between Medicare providers.⁸ Finally, the C6 is an identifier for the Medicare fee-for-service system; state programs and MCOs may not identify hospitalists in the same manner, or at all. Therefore, it may make it more difficult for those groups and HM researchers to study the trends in care delivery changes. The specialty needs to engage with these other payers to assist in revising their information systems to better account for how hospitalists care for their insured populations.

Although we would expect a natural increase in C6 adoption over time, optimally meeting stakeholders’ data needs requires more rapid uptake. Our analysis is limited by our assumption that specialty patterns of code use remain similar from 2012 to 2017. Regardless, the magnitude of the difference between the estimate of hospitalists using the C6 versus billing thresholds strongly suggests underuse of the C6 designation. The CMS and MCOs have an increasing need for valid and representative data, and C6 can be used to assess “HM-adjusted” resource utilization, relative value units (RVUs), and performance evaluations. Therefore, hospitalists may see more incentives to use the C6 specialty code in a manner consistent with other recognized subspecialties. 

Disclaimer

The research reported here was supported by the Department of Veterans Affairs, Veterans Health Administration, and the Health Services Research and Development Service. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.

In recognizing the importance of Hospital Medicine (HM) and its practitioners, the Centers for Medicare and Medicaid Services (CMS) awarded the field a specialty designation in 2016. The code is self-selected by hospitalists and used by the CMS for programmatic and claims processing purposes. The HM code (“C6”), submitted to the CMS by the provider or their designee through the Provider Enrollment Chain and Ownership System (PECOS), in turn links to the National Provider Identification provider data.

The Society of Hospital Medicine^® sought the designation given the growth of hospitalists practicing nationally, their impact on the practice of medicine in the inpatient setting,¹ and their secondary effects on global care.² In fact, early efforts by the CMS to transition physician payments to the value-based payment used specialty designations to create benchmarks in cost metrics, heightening the importance for hospitalists to be able to assess their performance. The need to identify any shifts in resource utilization and workforce mix in the broader context of health reforms necessitated action. Essentially, to understand the “why’s” of hospital medicine, the field required an accounting of the “who’s” and “where’s.”

The CMS granted the C6 designation in 2016, and it went live in April 2017. Despite the code’s brief two-year tenure, calls for its creation long predated its existence. As such, the new modifier requires an initial look to help steer the role of HM in any future CMS and managed care organization (MCO) quality, payment, or practice improvement activities.

We analyzed publicly available 2017 Medicare Part B utilization data³ to explore the rates of Evaluation & Management (E&M) codes used across specialties, using the C6 designation to identify hospitalists.

To try to estimate the percentage of hospitalists who were likely billing under the C6 designation, we then compared the rates of C6 billing to expected rates of hospitalist E&M billing based on an analysis of hospitalist prevalence in the 2012 Medicare physician payment data. Prior work to identify hospitalists before the implementation of the C6 designation relied on thresholds of inpatient codes for various inpatient E&M services.^4,5 We used our previously published approach of a threshold of 60% of inpatient E&M hospital services to differentiate hospitalists from their parent specialties.⁶ We also calculated the expected rates of E&M billing for other select specialty services by applying the 2012 E&M coding trends to the 2017 data.

Table 1 shows the distribution of inpatient E&M codes billed by hospitalists using the C6 identification, as well as the use of those codes by other specialists. Hospitalists identified by the C6 designation billed only 2%-5% of inpatient and 6% of observation codes. As an example, in 2017, discharge CPT codes 99238 and 99239 were used 7,872,323 times. However, C6-identified hospitalists accounted for only 441,420 of these codes.

Table 2 compares the observed billing rates by specialty using the C6 designation to identify hospitalists with what would be the expected rates with the 2012 threshold-based specialty billing designation applied to the 2017 data. This comparison demonstrates that hospitalist billing based on the C6 modifier use is approximately one-tenth of what would have been their expected volume of E&M services.

We examined the patterns of hospitalist billing using the C6 hospital medicine specialty modifier, comparing billing patterns with what we would expect hospitalist activity to be if we had used a threshold-based approach. The difference between the C6 and the threshold-based approaches to assessing hospitalist activity suggests that as few as 10% of hospitalists have adopted the C6 code.

Why is the adoption of the C6 modifier so low? Although administrative data do not allow us to identify the reasons why providers chose to disregard the C6 designation, we can speculate on causes. There are, to date, low direct risks and recognized benefits with using the code. We hypothesize that several factors could be impeding whether providers use the modifier to bring about potential gains. The first may be knowledge-related; ie, hospitalists might not be familiar with the specialty code or unaware of the importance of accurately capturing hospitalist practice patterns. They may also wrongly assume that their practices are aware of the revision or have submitted the appropriate paperwork. Similarly, practice personnel may lack knowledge regarding the code or the importance of its use. The second factor may be logistical; ie, administrative barriers such as difficulty accessing the Provider Enrollment, Chain and Ownership System (PECOS) and out-of-date paper registration forms impede fast uptake. The final reason might be related to professionals whose tenures as hospitalists will be brief, and their unease of carrying an identifier into their next non-HM position prompts hesitation. Providers may have a misperception that using the C6 code may somehow impact or limit their future scope of practice, when, in fact, they may change their Medicare specialty designation at any time.

Changes in reimbursement models, including the Bundled Payments for Care Improvement Advanced (BPCI-A) and other value-based initiatives, heighten the need for a more accurate identification of the specialty. Classifying individual providers and groups to make valid performance comparisons is relevant for the same reasons. The CMS continues to advance cost and efficiency measures in its publicly accessible physiciancompare.gov website.⁷ Without an improved ability to identify services provided by hospitalists—by both CMS and commercial entities—the potential benefits delivered by hospitalists in terms of improved care quality, safety, or efficiency could go undetected by payers and policymakers. Moreover, C6 may be used in other ways by the CMS throughout its payment systems and programmatic efforts that use specialty to differentiate between Medicare providers.⁸ Finally, the C6 is an identifier for the Medicare fee-for-service system; state programs and MCOs may not identify hospitalists in the same manner, or at all. Therefore, it may make it more difficult for those groups and HM researchers to study the trends in care delivery changes. The specialty needs to engage with these other payers to assist in revising their information systems to better account for how hospitalists care for their insured populations.

Although we would expect a natural increase in C6 adoption over time, optimally meeting stakeholders’ data needs requires more rapid uptake. Our analysis is limited by our assumption that specialty patterns of code use remain similar from 2012 to 2017. Regardless, the magnitude of the difference between the estimate of hospitalists using the C6 versus billing thresholds strongly suggests underuse of the C6 designation. The CMS and MCOs have an increasing need for valid and representative data, and C6 can be used to assess “HM-adjusted” resource utilization, relative value units (RVUs), and performance evaluations. Therefore, hospitalists may see more incentives to use the C6 specialty code in a manner consistent with other recognized subspecialties. 

Disclaimer

The research reported here was supported by the Department of Veterans Affairs, Veterans Health Administration, and the Health Services Research and Development Service. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.

In recognizing the importance of Hospital Medicine (HM) and its practitioners, the Centers for Medicare and Medicaid Services (CMS) awarded the field a specialty designation in 2016. The code is self-selected by hospitalists and used by the CMS for programmatic and claims processing purposes. The HM code (“C6”), submitted to the CMS by the provider or their designee through the Provider Enrollment Chain and Ownership System (PECOS), in turn links to the National Provider Identification provider data.

The Society of Hospital Medicine^® sought the designation given the growth of hospitalists practicing nationally, their impact on the practice of medicine in the inpatient setting,¹ and their secondary effects on global care.² In fact, early efforts by the CMS to transition physician payments to the value-based payment used specialty designations to create benchmarks in cost metrics, heightening the importance for hospitalists to be able to assess their performance. The need to identify any shifts in resource utilization and workforce mix in the broader context of health reforms necessitated action. Essentially, to understand the “why’s” of hospital medicine, the field required an accounting of the “who’s” and “where’s.”

The CMS granted the C6 designation in 2016, and it went live in April 2017. Despite the code’s brief two-year tenure, calls for its creation long predated its existence. As such, the new modifier requires an initial look to help steer the role of HM in any future CMS and managed care organization (MCO) quality, payment, or practice improvement activities.

We analyzed publicly available 2017 Medicare Part B utilization data³ to explore the rates of Evaluation & Management (E&M) codes used across specialties, using the C6 designation to identify hospitalists.

To try to estimate the percentage of hospitalists who were likely billing under the C6 designation, we then compared the rates of C6 billing to expected rates of hospitalist E&M billing based on an analysis of hospitalist prevalence in the 2012 Medicare physician payment data. Prior work to identify hospitalists before the implementation of the C6 designation relied on thresholds of inpatient codes for various inpatient E&M services.^4,5 We used our previously published approach of a threshold of 60% of inpatient E&M hospital services to differentiate hospitalists from their parent specialties.⁶ We also calculated the expected rates of E&M billing for other select specialty services by applying the 2012 E&M coding trends to the 2017 data.

Table 1 shows the distribution of inpatient E&M codes billed by hospitalists using the C6 identification, as well as the use of those codes by other specialists. Hospitalists identified by the C6 designation billed only 2%-5% of inpatient and 6% of observation codes. As an example, in 2017, discharge CPT codes 99238 and 99239 were used 7,872,323 times. However, C6-identified hospitalists accounted for only 441,420 of these codes.

Table 2 compares the observed billing rates by specialty using the C6 designation to identify hospitalists with what would be the expected rates with the 2012 threshold-based specialty billing designation applied to the 2017 data. This comparison demonstrates that hospitalist billing based on the C6 modifier use is approximately one-tenth of what would have been their expected volume of E&M services.

We examined the patterns of hospitalist billing using the C6 hospital medicine specialty modifier, comparing billing patterns with what we would expect hospitalist activity to be if we had used a threshold-based approach. The difference between the C6 and the threshold-based approaches to assessing hospitalist activity suggests that as few as 10% of hospitalists have adopted the C6 code.

Why is the adoption of the C6 modifier so low? Although administrative data do not allow us to identify the reasons why providers chose to disregard the C6 designation, we can speculate on causes. There are, to date, low direct risks and recognized benefits with using the code. We hypothesize that several factors could be impeding whether providers use the modifier to bring about potential gains. The first may be knowledge-related; ie, hospitalists might not be familiar with the specialty code or unaware of the importance of accurately capturing hospitalist practice patterns. They may also wrongly assume that their practices are aware of the revision or have submitted the appropriate paperwork. Similarly, practice personnel may lack knowledge regarding the code or the importance of its use. The second factor may be logistical; ie, administrative barriers such as difficulty accessing the Provider Enrollment, Chain and Ownership System (PECOS) and out-of-date paper registration forms impede fast uptake. The final reason might be related to professionals whose tenures as hospitalists will be brief, and their unease of carrying an identifier into their next non-HM position prompts hesitation. Providers may have a misperception that using the C6 code may somehow impact or limit their future scope of practice, when, in fact, they may change their Medicare specialty designation at any time.

Changes in reimbursement models, including the Bundled Payments for Care Improvement Advanced (BPCI-A) and other value-based initiatives, heighten the need for a more accurate identification of the specialty. Classifying individual providers and groups to make valid performance comparisons is relevant for the same reasons. The CMS continues to advance cost and efficiency measures in its publicly accessible physiciancompare.gov website.⁷ Without an improved ability to identify services provided by hospitalists—by both CMS and commercial entities—the potential benefits delivered by hospitalists in terms of improved care quality, safety, or efficiency could go undetected by payers and policymakers. Moreover, C6 may be used in other ways by the CMS throughout its payment systems and programmatic efforts that use specialty to differentiate between Medicare providers.⁸ Finally, the C6 is an identifier for the Medicare fee-for-service system; state programs and MCOs may not identify hospitalists in the same manner, or at all. Therefore, it may make it more difficult for those groups and HM researchers to study the trends in care delivery changes. The specialty needs to engage with these other payers to assist in revising their information systems to better account for how hospitalists care for their insured populations.

Although we would expect a natural increase in C6 adoption over time, optimally meeting stakeholders’ data needs requires more rapid uptake. Our analysis is limited by our assumption that specialty patterns of code use remain similar from 2012 to 2017. Regardless, the magnitude of the difference between the estimate of hospitalists using the C6 versus billing thresholds strongly suggests underuse of the C6 designation. The CMS and MCOs have an increasing need for valid and representative data, and C6 can be used to assess “HM-adjusted” resource utilization, relative value units (RVUs), and performance evaluations. Therefore, hospitalists may see more incentives to use the C6 specialty code in a manner consistent with other recognized subspecialties. 

Disclaimer

The research reported here was supported by the Department of Veterans Affairs, Veterans Health Administration, and the Health Services Research and Development Service. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.

Approximately five million central venous catheters (CVCs) are inserted in the United States annually, with over 15 million catheter days documented in intensive care units alone.¹ Traditional CVC insertion techniques using landmarks are associated with a high risk of mechanical complications, particularly pneumothorax and arterial puncture, which occur in 5%-19% patients.^2,3

Since the 1990s, several randomized controlled studies and meta-analyses have demonstrated that the use of real-time ultrasound guidance for CVC insertion increases procedure success rates and decreases mechanical complications.^4,5 Use of real-time ultrasound guidance was recommended by the Agency for Healthcare Research and Quality, the Institute of Medicine, the National Institute for Health and Care Excellence, the Centers for Disease Control and Prevention, and several medical specialty societies in the early 2000s.^6-14 Despite these recommendations, ultrasound guidance has not been universally adopted. Currently, an estimated 20%-55% of CVC insertions in the internal jugular vein are performed without ultrasound guidance.^15-17

Following the emergence of literature supporting the use of ultrasound guidance for CVC insertion, observational and randomized controlled studies demonstrated improved procedural success rates with the use of ultrasound guidance for the insertion of peripheral intravenous lines (PIVs), arterial catheters, and peripherally inserted central catheters (PICCs).^18-23

The purpose of this position statement is to present evidence-based recommendations on the use of ultrasound guidance for the insertion of central and peripheral vascular access catheters in adult patients. This document presents consensus-based recommendations with supporting evidence for clinical outcomes, techniques, and training for the use of ultrasound guidance for vascular access. We have subdivided the recommendations on techniques for central venous access, peripheral venous access, and arterial access individually, as some providers may not perform all types of vascular access procedures.

These recommendations are intended for hospitalists and other healthcare providers that routinely place central and peripheral vascular access catheters in acutely ill patients. However, this position statement does not mandate that all hospitalists should place central or peripheral vascular access catheters given the diverse array of hospitalist practice settings. For training and competency assessments, we recognize that some of these recommendations may not be feasible in resource-limited settings, such as rural hospitals, where equipment and staffing for assessments are not available. Recommendations and frameworks for initial and ongoing credentialing of hospitalists in ultrasound-guided bedside procedures have been previously published in an Society of Hospital Medicine (SHM) position statement titled, “Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures.”²⁴

Detailed methods are described in Appendix 1. The SHM Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced practice providers with expertise in POCUS. Expert panel members were divided into working group members, external peer reviewers, and a methodologist. All Task Force members were required to disclose any potential conflicts of interest (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the vascular access working group members themselves. Key clinical questions and draft recommendations were then prepared. A systematic literature search was conducted by a medical librarian based on the findings of the initial literature search and draft recommendations. The Medline, Embase, CINAHL, and Cochrane medical databases were searched from 1975 to December 2015 initially. Google Scholar was also searched without limiters. An updated search was conducted in November 2017. The literature search strings are included in Appendix 3. All article abstracts were initially screened for relevance by at least two members of the vascular access working group. Full-text versions of screened articles were reviewed, and articles on the use of ultrasound to guide vascular access were selected. The following article types were excluded: non-English language, nonhuman, age <18 years, meeting abstracts, meeting posters, narrative reviews, case reports, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled studies, and observational studies of ultrasound-guided vascular access were screened and selected (Appendix 3, Figure 1). All full-text articles were shared electronically among the working group members, and final article selection was based on working group consensus. Selected articles were incorporated into the draft recommendations.

These recommendations were developed using the Research and Development (RAND) Appropriateness Method that required panel judgment and consensus.¹⁴ The 28 voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering five transforming factors: (1) Problem priority and importance, (2) Level of quality of evidence, (3) Benefit/harm balance, (4) Benefit/burden balance, and (5) Certainty/concerns about PEAF (Preferences/Equity/Acceptability/Feasibility). Using an internet-based electronic data collection tool (REDCap™), panel members participated in two rounds of electronic voting, one in August 2018 and the other in October 2018 (Appendix 4). Voting on appropriateness was conducted using a nine-point Likert scale. The three zones of the nine-point Likert scale were inappropriate (1-3 points), uncertain (4-6 points), and appropriate (7-9 points). The degree of consensus was assessed using the RAND algorithm (Appendix 1, Figure 1 and Table 1). Establishing a recommendation required at least 70% agreement that a recommendation was “appropriate.” Disagreement was defined as >30% of panelists voting outside of the zone of the median. A strong recommendation required at least 80% of the votes within one integer of the median per the RAND rules.

Literature Search

A total of 5,563 references were pooled from an initial search performed by a certified medical librarian in December 2015 (4,668 citations) which was updated in November 2017 (791 citations), and from the personal bibliographies and searches (104 citations) performed by working group members. A total of 514 full-text articles were reviewed. The final selection included 192 articles that were abstracted into a data table and incorporated into the draft recommendations. See Appendix 3 for details of the literature search strategy.

Four domains (technique, clinical outcomes, training, and knowledge gaps) with 31 draft recommendations were generated based on a review of the literature. Selected references were abstracted and assigned to each draft recommendation. Rationales for each recommendation cite supporting evidence. After two rounds of panel voting, 31 recommendations achieved agreement based on the RAND rules. During the peer review process, two of the recommendations were merged with other recommendations. Thus, a total of 29 recommendations received final approval. The degree of consensus based on the median score and the dispersion of voting around the median are shown in Appendix 5. Twenty-seven statements were approved as strong recommendations, and two were approved as weak/conditional recommendations. The strength of each recommendation and degree of consensus are summarized in Table 3.

Terminology
Central Venous Catheterization

Central venous catheterization refers to insertion of tunneled or nontunneled large bore vascular catheters that are most commonly inserted into the internal jugular, subclavian, or femoral veins with the catheter tip located in a central vein. These vascular access catheters are synonymously referred to as central lines or central venous catheters (CVCs). Nontunneled catheters are designed for short-term use and should be removed promptly when no longer clinically indicated or after a maximum of 14 days.²⁵

Peripherally Inserted Central Catheter (PICC)

Peripherally inserted central catheters, or PICC lines, are inserted most commonly in the basilic or brachial veins in adult patients, and the catheter tip terminates in the distal superior vena cava or cavo-atrial junction. These catheters are designed to remain in place for a duration of several weeks, as long as it is clinically indicated.

Midline Catheterization

Midline catheters are a type of peripheral venous catheter that are an intermediary between a peripheral intravenous catheter and PICC line. Midline catheters are most commonly inserted in the brachial or basilic veins, but unlike PICC lines, the tips of these catheters terminate in the axillary or subclavian vein. Midline catheters are typically 8 cm to 20 cm in length and inserted for a duration <30 days.

Peripheral Intravenous Catheterization

Peripheral intravenous lines (PIV) refer to small bore venous catheters that are most commonly 14G to 24G and inserted into patients for short-term peripheral venous access. Common sites of ultrasound-guided PIV insertion include the superficial and deep veins of the hand, forearm, and arm.

Arterial Catheterization

Arterial catheters are commonly used for reliable blood pressure monitoring, frequent arterial blood sampling, and cardiac output monitoring. The most common arterial access sites are the femoral and radial arteries.

1. We recommend that providers should be familiar with the operation of their specific ultrasound machine prior to initiation of a vascular access procedure.

Rationale: There is strong consensus that providers must be familiar with the knobs and functions of the specific make and model of ultrasound machine that will be utilized for a vascular access procedure. Minimizing adjustments to the ultrasound machine during the procedure may reduce the risk of contaminating the sterile field.

2. We recommend that providers should use a high-frequency linear transducer with a sterile sheath and sterile gel to perform vascular access procedures.

Rationale: High-frequency linear-array transducers are recommended for the vast majority of vascular access procedures due to their superior resolution compared to other transducer types. Both central and peripheral vascular access procedures, including PIV, PICC, and arterial line placement, should be performed using sterile technique. A sterile transducer cover and sterile gel must be utilized, and providers must be trained in sterile preparation of the ultrasound transducer.^13,26,27

The depth of femoral vessels correlates with body mass index (BMI). When accessing these vessels in a morbidly obese patient with a thigh circumference >60 cm and vessel depth >8 cm, a curvilinear transducer may be preferred for its deeper penetration.²⁸ For patients who are poor candidates for bedside insertion of vascular access catheters, such as uncooperative patients, patients with atypical vascular anatomy or poorly visualized target vessels, we recommend consultation with a vascular access specialist prior to attempting the procedure.

3. We recommend that providers should use two-dimensional ultrasound to evaluate for anatomical variations and absence of vascular thrombosis during preprocedural site selection.

Rationale: A thorough ultrasound examination of the target vessel is warranted prior to catheter placement. Anatomical variations that may affect procedural decision-making are easily detected with ultrasound. A focused vascular ultrasound examination is particularly important in patients who have had temporary or tunneled venous catheters, which can cause stenosis or thrombosis of the target vein.

For internal jugular vein (IJV) CVCs, ultrasound is useful for visualizing the relationship between the IJV and common carotid artery (CCA), particularly in terms of vessel overlap. Furthermore, ultrasound allows for immediate revisualization upon changes in head position.^29-32 Troianos et al. found >75% overlap of the IJV and CCA in 54% of all patients and in 64% of older patients (age >60 years) whose heads were rotated to the contralateral side.³⁰ In one study of IJV CVC insertion, inadvertent carotid artery punctures were reduced (3% vs 10%) with the use of ultrasound guidance vs landmarks alone.³³ In a cohort of 64 high-risk neurosurgical patients, cannulation success was 100% with the use of ultrasound guidance, and there were no injuries to the carotid artery, even though the procedure was performed with a 30-degree head elevation and anomalous IJV anatomy in 39% of patients.³⁴ In a prospective, randomized controlled study of 1,332 patients, ultrasound-guided cannulation in a neutral position was demonstrated to be as safe as the 45-degree rotated position.³⁵

Ultrasound allows for the recognition of anatomical variations which may influence the selection of the vascular access site or technique. Benter et al. found that 36% of patients showed anatomical variations in the IJV and surrounding tissue.³⁶ Similarly Caridi showed the anatomy of the right IJV to be atypical in 29% of patients,³⁷ and Brusasco found that 37% of bariatric patients had anatomical variations of the IJV.³⁸ In a study of 58 patients, there was significant variability in the IJV position and IJV diameter, ranging from 0.5 cm to >2 cm.³⁹ In a study of hemodialysis patients, 75% of patients had sonographic venous abnormalities that led to a change in venous access approach.⁴⁰

To detect acute or chronic upper extremity deep venous thrombosis or stenosis, two-dimensional visualization with compression should be part of the ultrasound examination prior to central venous catheterization. In a study of patients that had undergone CVC insertion 9-19 weeks earlier, 50% of patients had an IJV thrombosis or stenosis leading to selection of an alternative site. In this study, use of ultrasound for a preprocedural site evaluation reduced unnecessary attempts at catheterizing an occluded vein.⁴¹ At least two other studies demonstrated an appreciable likelihood of thrombosis. In a study of bariatric patients, 8% of patients had asymptomatic thrombosis³⁸ and in another study, 9% of patients being evaluated for hemodialysis catheter placement had asymptomatic IJV thrombosis.³⁷

4. We recommend that providers should evaluate the target blood vessel size and depth during a preprocedural ultrasound evaluation.

Rationale: The size, depth, and anatomic location of central veins can vary considerably. These features are easily discernable using ultrasound. Contrary to traditional teaching, the IJV is located 1 cm anterolateral to the CCA in only about two-thirds of patients.^37,39,42,43 Furthermore, the diameter of the IJV can vary significantly, ranging from 0.5 cm to >2 cm.³⁹ The laterality of blood vessels may vary considerably as well. A preprocedural ultrasound evaluation of contralateral subclavian and axillary veins showed a significant absolute difference in cross-sectional area of 26.7 mm² (P < .001).⁴²

Blood vessels can also shift considerably when a patient is in the Trendelenburg position. In one study, the IJV diameter changed from 11.2 (± 1.5) mm to 15.4 (± 1.5) mm in the supine versus the Trendelenburg position at 15 degrees.³³ An observational study demonstrated a frog-legged position with reverse Trendelenburg increased the femoral vein size and reduced the common surface area with the common femoral artery compared to a neutral position. Thus, a frog-legged position with reverse Trendelenburg position may be preferred, since overall catheterization success rates are higher in this position.⁴⁴

General Techniques

5. We recommend that providers should avoid using static ultrasound alone to mark the needle insertion site for vascular access procedures.

Rationale: The use of static ultrasound guidance to mark a needle insertion site is not recommended because normal anatomical relationships of vessels vary, and site marking can be inaccurate with minimal changes in patient position, especially of the neck.^43,45,46 Benefits of using ultrasound guidance for vascular access are attained when ultrasound is used to track the needle tip in real-time as it is advanced toward the target vessel.

Although continuous-wave Doppler ultrasound without two-dimensional visualization was used in the past, it is no longer recommended for IJV CVC insertion.⁴⁷ In a study that randomized patients to IJV CVC insertion with continuous-wave Doppler alone vs two-dimensional ultrasound guidance, the use of two-dimensional ultrasound guidance showed significant improvement in first-pass success rates (97% vs 91%, P = .045), particularly in patients with BMI >30 (97% vs 77%, P = .011).⁴⁸

A randomized study comparing real-time ultrasound-guided, landmark-based, and ultrasound-marked techniques found higher success rates in the real-time ultrasound-guided group than the other two groups (100% vs 74% vs 73%, respectively; P = .01). The total number of mechanical complications was higher in the landmark-based and ultrasound-marked groups than in the real-time ultrasound-guided group (24% and 36% versus 0%, respectively; P = .01).⁴⁹ Another randomized controlled study found higher success rates with real-time ultrasound guidance (98%) versus an ultrasound-marked (82%) or landmark-based (64%) approach for central line placement.⁵⁰

6. We recommend that providers should use real-time (dynamic), two-dimensional ultrasound guidance with a high-frequency linear transducer for CVC insertion, regardless of the provider’s level of experience.

7. We suggest using either a transverse (short-axis) or longitudinal (long-axis) approach when performing real-time ultrasound-guided vascular access procedures.

Rationale: In clinical practice, the phrases transverse, short-axis, or out-of-plane approach are synonymous, as are longitudinal, long-axis, and in-plane approach. The short-axis approach involves tracking the needle tip as it approximates the target vessel with the ultrasound beam oriented in a transverse plane perpendicular to the target vessel. The target vessel is seen as a circular structure on the ultrasound screen as the needle tip approaches the target vessel from above. This approach is also called the out-of-plane technique since the needle passes through the ultrasound plane. The advantages of the short-axis approach include better visualization of adjacent vessels or nerves and the relative ease of skill acquisition for novice operators.⁹ When using the short-axis approach, extra care must be taken to track the needle tip from the point of insertion on the skin to the target vessel. A disadvantage of the short-axis approach is unintended posterior wall puncture of the target vessel.⁵⁵

In contrast to a short-axis approach, a long-axis approach is performed with the ultrasound beam aligned parallel to the vessel. The vessel appears as a long tubular structure and the entire needle is visualized as it traverses across the ultrasound screen to approach the target vessel. The long-axis approach is also called an in-plane technique because the needle is maintained within the plane of the ultrasound beam. The advantage of a long-axis approach is the ability to visualize the entire needle as it is inserted into the vessel.¹⁴ A randomized crossover study with simulation models compared a long-axis versus short-axis approach for both IJV and subclavian vein catheterization. This study showed decreased number of needle redirections (relative risk (RR) 0.5, 95% confidence interval (CI) 0.3 to 0.7), and posterior wall penetrations (OR 0.3, 95% CI 0.1 to 0.9) using a long-axis versus short-axis approach for subclavian vein catheterization.⁵⁶

A randomized controlled study comparing a long-axis or short-axis approach with ultrasound versus a landmark-based approach for IJV CVC insertion showed higher success rates (100% vs 90%; P < .001), lower insertion time (53 vs 116 seconds; P < .001), and fewer attempts to obtain access (2.5 vs 1.2 attempts, P < .001) with either the long- or short-axis ultrasound approach. The average time to obtain access and number of attempts were comparable between the short-axis and long-axis approaches with ultrasound. The incidence of carotid puncture and hematoma was significantly higher with the landmark-based approach versus either the long- or short-axis ultrasound approach (carotid puncture 17% vs 3%, P = .024; hematoma 23% vs 3%, P = .003).⁵⁷

High success rates have been reported using a short-axis approach for insertion of PIV lines.⁵⁸ A prospective, randomized trial compared the short-axis and long-axis approach in patients who had had ≥2 failed PIV insertion attempts. Success rate was 95% (95% CI, 0.85 to 1.00) in the short-axis group compared with 85% (95% CI, 0.69 to 1.00) in the long-axis group. All three subjects with failed PIV placement in the long-axis group had successful rescue placement using a short-axis approach. Furthermore, the short-axis approach was faster than the long-axis approach.⁵⁹

For radial artery cannulation, limited data exist comparing the short- and long-axis approaches. A randomized controlled study compared a long-axis vs short-axis ultrasound approach for radial artery cannulation. Although the overall procedure success rate was 100% in both groups, the long-axis approach had higher first-pass success rates (1.27 ± 0.4 vs 1.5 ± 0.5, P < .05), shorter cannulation times (24 ± 17 vs 47 ± 34 seconds, P < .05), fewer hematomas (4% vs 43%, P < .05) and fewer posterior wall penetrations (20% vs 56%, P < .05).⁶⁰

Another technique that has been described for IJV CVC insertion is an oblique-axis approach, a hybrid between the long- and short-axis approaches. In this approach, the transducer is aligned obliquely over the IJV and the needle is inserted using a long-axis or in-plane approach. A prospective randomized trial compared the short-axis, long-axis, and oblique-axis approaches during IJV cannulation. First-pass success rates were 70%, 52%, and 74% with the short-axis, long-axis, and oblique-axis approaches, respectively, and a statistically significant difference was found between the long- and oblique-axis approaches (P = .002). A higher rate of posterior wall puncture was observed with a short-axis approach (15%) compared with the oblique-axis (7%) and long-axis (4%) approaches (P = .047).⁶¹

8. We recommend that providers should visualize the needle tip and guidewire in the target vein prior to vessel dilatation.

Rationale: When real-time ultrasound guidance is used, visualization of the needle tip within the vein is the first step to confirm cannulation of the vein and not the artery. After the guidewire is advanced, the provider can use transverse and longitudinal views to reconfirm cannulation of the vein. In a longitudinal view, the guidewire is readily seen positioned within the vein, entering the anterior wall and lying along the posterior wall of the vein. Unintentional perforation of the posterior wall of the vein with entry into the underlying artery can be detected by ultrasound, allowing prompt removal of the needle and guidewire before proceeding with dilation of the vessel. In a prospective observational study that reviewed ultrasound-guided IJV CVC insertions, physicians were able to more readily visualize the guidewire than the needle in the vein.⁶² A prospective observational study determined that novice operators can visualize intravascular guidewires in simulation models with an overall accuracy of 97%.⁶³

In a retrospective review of CVC insertions where the guidewire position was routinely confirmed in the target vessel prior to dilation, there were no cases of arterial dilation, suggesting confirmation of guidewire position can potentially eliminate the morbidity and mortality associated with arterial dilation during CVC insertion.⁶⁴

9. To increase the success rate of ultrasound-guided vascular access procedures, we recommend that providers should utilize echogenic needles, plastic needle guides, and/or ultrasound beam steering when available.

Rationale: Echogenic needles have ridged tips that appear brighter on the screen, allowing for better visualization of the needle tip. Plastic needle guides help stabilize the needle alongside the transducer when using either a transverse or longitudinal approach. Although evidence is limited, some studies have reported higher procedural success rates when using echogenic needles, plastic needle guides, and ultrasound beam steering software. In a prospective observational study, Augustides et al. showed significantly higher IJV cannulation rates with versus without use of a needle guide after first (81% vs 69%, P = .0054) and second (93% vs 80%. P = .0001) needle passes.⁶⁵ A randomized study by Maecken et al. compared subclavian vein CVC insertion with or without use of a needle guide, and found higher procedure success rates within the first and second attempts, reduced time to obtain access (16 seconds vs 30 seconds; P = .0001) and increased needle visibility (86% vs 32%; P < .0001) with the use of a needle guide.⁶⁶ Another study comparing a short-axis versus long-axis approach with a needle guide showed improved needle visualization using a long-axis approach with a needle guide.⁶⁷ A randomized study comparing use of a novel, sled-mounted needle guide to a free-hand approach for venous cannulation in simulation models showed the novel, sled-mounted needle guide improved overall success rates and efficiency of cannulation.⁶⁸

10. We recommend that providers should use a standardized procedure checklist that includes use of real-time ultrasound guidance to reduce the risk of central line-associated bloodstream infection (CLABSI) from CVC insertion.

 

Rationale: A standardized checklist or protocol should be developed to ensure compliance with all recommendations for insertion of CVCs. Evidence-based protocols address periprocedural issues, such as indications for CVC, and procedural techniques, such as use of maximal sterile barrier precautions to reduce the risk of infection. Protocols and checklists that follow established guidelines for CVC insertion have been shown to decrease CLABSI rates.^69,70 Similarly, development of checklists and protocols for maintenance of central venous catheters have been effective in reducing CLABSIs.⁷¹ Although no externally-validated checklist has been universally accepted or endorsed by national safety organizations, a few internally-validated checklists are available through peer-reviewed publications.^72,73 An observational educational cohort of internal medicine residents who received training using simulation of the entire CVC insertion process was able to demonstrate fewer CLABSIs after the simulator-trained residents rotated in the intensive care unit (ICU) (0.50 vs 3.2 infections per 1,000 catheter days, P = .001).⁷⁴

11. We recommend that providers should use real-time ultrasound guidance, combined with aseptic technique and maximal sterile barrier precautions, to reduce the incidence of infectious complications from CVC insertion.

Rationale: The use of real-time ultrasound guidance for CVC placement has demonstrated a statistically significant reduction in CLABSIs compared to landmark-based techniques.⁷⁵ The Centers for Disease Control and Prevention (CDC) guidelines for the prevention of intravascular catheter-related infections recommend the use of ultrasound guidance to reduce the number of cannulation attempts and risk of mechanical complications.⁶⁹ A prospective, three-arm study comparing ultrasound-guided long-axis, short-axis, and landmark-based approaches showed a CLABSI rate of 20% in the landmark-based group versus 10% in each of the ultrasound groups.⁵⁷ Another randomized study comparing use of ultrasound guidance to a landmark-based technique for IJV CVC insertion demonstrated significantly lower CLABSI rates with the use of ultrasound (2% vs 10%; P < .05).⁷²

Studies have shown that a systems-based intervention featuring a standardized catheter kit or catheter bundle significantly reduced CLABSI rates.^76-78 A complete review of all preventive measures to reduce the risk of CLABSI is beyond the scope of this review, but a few key points will be mentioned. First, aseptic technique includes proper hand hygiene and skin sterilization, which are essential measures to reduce cutaneous colonization of the insertion site and reduce the risk of CLABSIs.⁷⁹ In a systematic review and meta-analysis of eight studies including over 4,000 catheter insertions, skin antisepsis with chlorhexidine was associated with a 50% reduction in CLABSIs compared with povidone iodine.¹¹ Therefore, a chlorhexidine-containing solution is recommended for skin preparation prior to CVC insertion per guidelines by Healthcare Infection Control Practices Advisory Committee/CDC, Society for Healthcare Epidemiology of America/Infectious Diseases Society of America, and American Society of Anesthesiologists.^11,69,80,81 Second, maximal sterile barrier precautions refer to the use of sterile gowns, sterile gloves, caps, masks covering both the mouth and nose, and sterile full-body patient drapes. Use of maximal sterile barrier precautions during CVC insertion has been shown to reduce the incidence of CLABSIs compared to standard precautions.^26,79,82-84 Third, catheters containing antimicrobial agents may be considered for hospital units with higher CLABSI rates than institutional goals, despite a comprehensive preventive strategy, and may be considered in specific patient populations at high risk of severe complications from a CLABSI.^11,69,80 Finally, providers should use a standardized procedure set-up when inserting CVCs to reduce the risk of CLABSIs. The operator should confirm availability and proper functioning of ultrasound equipment prior to commencing a vascular access procedure. Use of all-inclusive procedure carts or kits with sterile ultrasound probe covers, sterile gel, catheter kits, and other necessary supplies is recommended to minimize interruptions during the procedure, and can ultimately reduce the risk of CLABSIs by ensuring maintenance of a sterile field during the procedure.¹³

12. We recommend that providers should use real-time ultrasound guidance for internal jugular vein catheterization, which reduces the risk of mechanical and infectious complications, the number of needle passes, and time to cannulation and increases overall procedure success rates.

Rationale: The use of real-time ultrasound guidance for CVC insertion has repeatedly demonstrated better outcomes compared to a landmark-based approach in adults.¹³ Several randomized controlled studies have demonstrated that real-time ultrasound guidance for IJV cannulation reduces the risk of procedure-related mechanical and infectious complications, and improves first-pass and overall success rates in diverse care settings.^{27,29,45,50,53,65,75,85-90} Mechanical complications that are reduced with ultrasound guidance include pneumothorax and carotid artery puncture.^{4,5,45,46,53,62,75,86-93} Currently, several medical societies strongly recommend the use of ultrasound guidance during insertion of IJV CVCs.^{10-12,14,94-96}

A meta-analysis by Hind et al. that included 18 randomized controlled studies demonstrated use of real-time ultrasound guidance reduced failure rates (RR 0.14, 95% CI 0.06 to 0.33; P < .0001), increased first-attempt success rates (RR 0.59, 95% CI 0.39 to 0.88; P = .009), reduced complication rates (RR 0.43, 95% CI 0.22 to 0.87; P = .02) and reduced procedure time (P < .0001), compared to a traditional landmark-based approach when inserting IJV CVCs.⁵

A Cochrane systematic review compared ultrasound-guided versus landmark-based approaches for IJV CVC insertion and found use of real-time ultrasound guidance reduced total complication rates by 71% (RR 0.29, 95% CI 0.17 to 0.52; P < .0001), arterial puncture rates by 72% (RR 0.28, 95% CI 0.18 to 0.44; P < .00001), and rates of hematoma formation by 73% (RR 0.27, 95% CI 0.13 to 0.55; P = .0004). Furthermore, the number of attempts for successful cannulation was reduced (mean difference -1.19 attempts, 95% CI -1.45 to -0.92; P < .00001), the chance of successful insertion on the first attempt was increased by 57% (RR 1.57, 95% CI 1.36 to 1.82; P < .00001), and overall procedure success rates were modestly increased in all groups by 12% (RR 1.12, 95% CI 1.08 to 1.17; P < .00001).⁴⁶

An important consideration in performing ultrasound guidance is provider experience. A prospective observational study of patients undergoing elective CVC insertion demonstrated higher complication rates for operators that were inexperienced (25.2%) versus experienced (13.6%).⁵⁴ A randomized controlled study comparing experts and novices with or without the use of ultrasound guidance for IJV CVC insertion demonstrated higher success rates among expert operators and with the use of ultrasound guidance. Among novice operators, the complication rates were lower with the use of ultrasound guidance.⁹⁷ One study evaluated the procedural success and complication rates of a two-physician technique with one physician manipulating the transducer and another inserting the needle for IJV CVC insertion. This study concluded that procedural success rates and frequency of complications were directly affected by the experience of the physician manipulating the transducer and not by the experience of the physician inserting the needle.⁹⁸

The impact of ultrasound guidance on improving procedural success rates and reducing complication rates is greatest in patients that are obese, short necked, hypovolemic, or uncooperative.⁹³ Several studies have demonstrated fewer needle passes and decreased time to cannulation compared to the landmark technique in these populations.^{46,49,53,86-88,92,93}

Ultrasound-guided placement of IJV catheters can safely be performed in patients with disorders of hemostasis and those with multiple previous catheter insertions in the same vein.⁹ Ultrasound-guided placement of CVCs in patients with disorders of hemostasis is safe with high success and low complication rates. In a case series of liver patients with coagulopathy (mean INR 2.17 ± 1.16, median platelet count 150K), the use of ultrasound guidance for CVC insertion was highly successful with no major bleeding complications.⁹⁹

A study of renal failure patients found high success rates and low complication rates in the patients with a history of multiple previous catheterizations, poor compliance, skeletal deformities, previous failed cannulations, morbid obesity, and disorders of hemostasis.¹⁰⁰ A prospective observational study of 200 ultrasound-guided CVC insertions for apheresis showed a 100% success rate with a 92% first-pass success rate.¹⁰¹

The use of real-time ultrasound guidance for IJV CVC insertion has been shown to be cost effective by reducing procedure-related mechanical complications and improving procedural success rates. A companion cost-effectiveness analysis estimated that for every 1,000 patients, 90 complications would be avoided, with a net cost savings of approximately $3,200 using 2002 prices.¹⁰²

13. We recommend that providers who routinely insert subclavian vein CVCs should use real-time ultrasound guidance, which has been shown to reduce the risk of mechanical complications and number of needle passes and increase overall procedure success rates compared with landmark-based techniques.

Rationale: In clinical practice, the term ultrasound-guided subclavian vein CVC insertion is commonly used. However, the needle insertion site is often lateral to the first rib and providers are technically inserting the CVC in the axillary vein. The subclavian vein becomes the axillary vein at the lateral border of the first rib where the cephalic vein branches from the subclavian vein. To be consistent with common medical parlance, we use the phrase ultrasound-guided subclavian vein CVC insertion in this document.

Advantages of inserting CVCs in the subclavian vein include reliable surface anatomical landmarks for vein location, patient comfort, and lower risk of infection.¹⁰³ Several observational studies have demonstrated the technique for ultrasound-guided subclavian vein CVC insertion is feasible and safe.^104-107 In a large retrospective observational study of ultrasound-guided central venous access among a complex patient group, the majority of patients were cannulated successfully and safely. The subset of patients undergoing axillary vein CVC insertion (n = 1,923) demonstrated a low rate of complications (0.7%), proving it is a safe and effective alternative to the IJV CVC insertion.¹⁰⁷

A Cochrane review of ultrasound-guided subclavian vein cannulation (nine studies, 2,030 participants, 2,049 procedures), demonstrated that real-time two-dimensional ultrasound guidance reduced the risk of inadvertent arterial punctures (three studies, 498 participants, RR 0.21, 95% CI 0.06 to 0.82; P = .02) and hematoma formation (three studies, 498 participants, RR 0.26, 95% CI 0.09 to 0.76; P = .01).⁴⁶ A systematic review and meta-analysis of 10 randomized controlled studies comparing ultrasound-guided versus landmark-based subclavian vein CVC insertion demonstrated a reduction in the risk of arterial punctures, hematoma formation, pneumothorax, and failed catheterization with the use of ultrasound guidance.¹⁰⁵

A randomized controlled study comparing ultrasound-guided vs landmark-based approaches to subclavian vein cannulation found that use of ultrasound guidance had a higher success rate (92% vs 44%, P = .0003), fewer minor complications (1 vs 11, P = .002), fewer attempts (1.4 vs 2.5, P = .007) and fewer catheter kits used (1.0 vs 1.4, P = .0003) per cannulation.¹⁰⁸

Fragou et al. randomized patients undergoing subclavian vein CVC insertion to a long-axis approach versus a landmark-based approach and found a significantly higher success rate (100% vs 87.5%, P < .05) and lower rates of mechanical complications: artery puncture (0.5% vs 5.4%), hematoma (1.5% vs 5.4%), hemothorax (0% vs 4.4%), pneumothorax (0% vs 4.9%), brachial plexus injury (0% vs 2.9%), phrenic nerve injury (0% vs 1.5%), and cardiac tamponade (0% vs 0.5%).¹⁰⁹ The average time to obtain access and the average number of insertion attempts (1.1 ± 0.3 vs 1.9 ± 0.7, P < .05) were significantly reduced in the ultrasound group compared to the landmark-based group.⁹⁵

A retrospective review of subclavian vein CVC insertions using a supraclavicular approach found no reported complications with the use of ultrasound guidance vs 23 mechanical complications (8 pneumothorax, 15 arterial punctures) with a landmark-based approach.¹⁰⁶ However, it is important to note that a supraclavicular approach is not commonly used in clinical practice.

14. We recommend that providers should use real-time ultrasound guidance for femoral venous access, which has been shown to reduce the risk of arterial punctures and total procedure time and increase overall procedure success rates.

Rationale: Anatomy of the femoral region varies, and close proximity or overlap of the femoral vein and artery is common.⁵¹ Early studies showed that ultrasound guidance for femoral vein CVC insertion reduced arterial punctures compared with a landmark-based approach (7% vs 16%), reduced total procedure time (55 ± 19 vs 79 ± 62 seconds), and increased procedure success rates (100% vs 90%).⁵² A Cochrane review that pooled data from four randomized studies comparing ultrasound-guided vs landmark-based femoral vein CVC insertion found higher first-attempt success rates with the use of ultrasound guidance (RR 1.73, 95% CI 1.34 to 2.22; P < .0001) and a small increase in the overall procedure success rates (RR 1.11, 95% CI 1.00 to 1.23; P = .06). There was no difference in inadvertent arterial punctures or other complications.¹¹⁰

15. We recommend that providers should use real-time ultrasound guidance for the insertion of peripherally inserted central catheters (PICCs), which is associated with higher procedure success rates and may be more cost effective compared with landmark-based techniques.

Rationale: Several studies have demonstrated that providers who use ultrasound guidance vs landmarks for PICC insertion have higher procedural success rates, lower complication rates, and lower total placement costs. A prospective observational report of 350 PICC insertions using ultrasound guidance reported a 99% success rate with an average of 1.2 punctures per insertion and lower total costs.²⁰ A retrospective observational study of 500 PICC insertions by designated specialty nurses revealed an overall success rate of 95%, no evidence of phlebitis, and only one CLABSI among the catheters removed.²¹ A retrospective observational study comparing several PICC variables found higher success rates (99% vs 77%) and lower thrombosis rates (2% vs 9%) using ultrasound guidance vs landmarks alone.²² A study by Robinson et al. demonstrated that having a dedicated PICC team equipped with ultrasound increased their institutional insertion success rates from 73% to 94%.¹¹¹

A randomized controlled study comparing ultrasound-guided versus landmark-based PICC insertion found high success rates with both techniques (100% vs 96%). However, there was a reduction in the rate of unplanned catheter removals (4.0% vs 18.7%; P = .02), mechanical phlebitis (0% vs 22.9%; P < .001), and venous thrombosis (0% vs 8.3%; P = .037), but a higher rate of catheter migration (32% vs 2.1%; P < .001). Compared with the landmark-based group, the ultrasound-guided group had significantly lower incidence of severe contact dermatitis (P = .038), and improved comfort and costs up to 3 months after PICC placement (P < .05).¹¹²

Routine postprocedure chest x-ray (CXR) is generally considered unnecessary if the PICC is inserted with real-time ultrasound guidance along with use of a newer tracking devices, like the magnetic navigation system with intracardiac electrodes.⁹ Ultrasound can also be used to detect malpositioning of a PICC immediately after completing the procedure. A randomized controlled study comparing ultrasound versus postprocedure CXR detected one malpositioned PICC in the ultrasound group versus 11 in the control group. This study suggested that ultrasound can detect malpositioning immediately postprocedure and reduce the need for a CXR and the possibility of an additional procedure to reposition a catheter.¹¹³

16. We recommend that providers should use real-time ultrasound guidance for the placement of peripheral intravenous lines (PIV) in patients with difficult peripheral venous access to reduce the total procedure time, needle insertion attempts, and needle redirections. Ultrasound-guided PIV insertion is also an effective alternative to CVC insertion in patients with difficult venous access.

Rationale: Difficult venous access refers to patients that have had two unsuccessful attempts at PIV insertion using landmarks or a history of difficult access (i.e. edema, obesity, intravenous drug use, chemotherapy, diabetes, hypovolemia, chronic illness, vasculopathy, multiple prior hospitalizations). A meta-analysis of seven randomized controlled studies concluded that ultrasound guidance increases the likelihood of successful PIV insertion (pooled OR 2.42, 95% CI 1.26 to 4.68; P < .008).18 A second meta-analysis that pooled data from seven studies (six randomized controlled studies) confirmed that ultrasound guidance improves success rates of PIV insertion (OR 3.96, 95% CI 1.75 to 8.94).19 Approximately half of these studies had physician operators while the other half had nurse operators.

In one prospective observational study of emergency department patients with two failed attempts of landmark-based PIV insertion, ultrasound guidance with a modified-Seldinger technique showed a relatively high success rate (96%), fewer needle sticks (mean 1.32 sticks, 95% CI 1.12 to 1.52), and shorter time to obtain access (median time 68 seconds).¹¹⁴ Other prospective observational studies have demonstrated that ultrasound guidance for PIV insertion has a high success rate (87%),¹¹⁵ particularly with brachial or basilic veins PIV insertion, among patients with difficult PIV access, defined as having had ≥2 failed attempts.⁵⁸

Since insertion of PIVs with ultrasound guidance has a high success rate, there is potential to reduce the reliance on CVC insertion for venous access only. In a study of patients that had had two failed attempts at PIV insertion based on landmarks, a PIV was successfully inserted with ultrasound guidance in 84% of patients, obviating the need for CVC placement for venous access.¹¹⁶ A prospective observational study showed ultrasound-guided PIV insertion was an effective alternative to CVC placement in ED patients with difficult venous access with only 1% of patients requiring a CVC.¹¹⁷ Use of ultrasound by nurses for PIV placement has also been shown to reduce the time to obtain venous access, improve patient satisfaction, and reduce the need for physician intervention.¹¹⁸ In a prospective observational study of patients with difficult access, the majority of patients reported a better experience with ultrasound-guided PIV insertion compared to previous landmark-based attempts with an average satisfaction score of 9.2/10 with 76% of patients rating the experience a 10.¹¹⁹ A strong recommendation has been made for use of ultrasound guidance in patients with difficult PIV placement by la Société Française d’Anesthésie et de Réanimation (The French Society of Anesthesia and Resuscitation).⁹⁵

17. We suggest using real-time ultrasound guidance to reduce the risk of vascular, infectious, and neurological complications during PIV insertion, particularly in patients with difficult venous access.

Rationale: The incidence of complications from PIV insertion is often underestimated. Vascular complications include arterial puncture, hematoma formation, local infiltration or extravasation of fluid, and superficial or deep venous thrombosis. The most common infectious complications with PIV insertion are phlebitis and cellulitis.¹²⁰ One observational study reported PIV complications occurring in approximately half of all patients with the most common complications being phlebitis, hematoma formation, and fluid/blood leakage.¹²¹

A retrospective review of ICU patients who underwent ultrasound-guided PIV insertion by a single physician showed high success rates (99%) with low rates of phlebitis/cellulitis (0.7%).There was an assumed benefit of risk reduction due to the patients no longer requiring a CVC after successful PIV placement.¹²² Another study found very low rates of infection with both landmark-based and ultrasound-guided PIV placement performed by emergency department nurses, suggesting that there is no increased risk of infection with the use of ultrasound.¹²³ To reduce the risk of infection from PIV insertion, we recommend the use of sterile gel and sterile transducer cover (See Recommendation 2).

18. We recommend that providers should use real-time ultrasound guidance for arterial access, which has been shown to increase first-pass success rates, reduce the time to cannulation, and reduce the risk of hematoma development compared with landmark-based techniques.

Rationale: Several randomized controlled studies have assessed the value of ultrasound in arterial catheter insertion. Shiver et al. randomized 60 patients admitted to a tertiary center emergency department to either palpation or ultrasound-guided arterial cannulation. They demonstrated a first-pass success rate of 87% in the ultrasound group compared with 50% in the landmark technique group. In the same study, the use of ultrasound was also associated with reduced time needed to establish arterial access and a 43% reduction in the development of hematoma at the insertion site.¹²⁴ Levin et al. demonstrated a first-pass success rate of 62% using ultrasound versus 34% by palpation alone in 69 patients requiring intraoperative invasive hemodynamic monitoring.¹²⁵ Additional randomized controlled studies have demonstrated that ultrasound guidance increases first-attempt success rates compared to traditional palpation.^23,126,127

19. We recommend that providers should use real-time ultrasound guidance for femoral arterial access, which has been shown to increase first-pass success rates and reduce the risk of vascular complications.

Rationale: Although it is a less frequently used site, the femoral artery may be accessed for arterial blood sampling or invasive hemodynamic monitoring, and use of ultrasound guidance has been shown to improve the first-pass success rates of femoral artery cannulation. It is important to note that most of these studies comparing ultrasound-guided vs landmark-based femoral artery cannulation were performed in patients undergoing diagnostic or interventional vascular procedures.

A meta-analysis of randomized controlled studies comparing ultrasound-guided vs landmark-based femoral artery catheterization found use of ultrasound guidance was associated with a 49% reduction in overall complications (RR 0.51, 95% CI 0.28 to 0.91; P > .05) and 42% improvement in first-pass success rates.¹²⁸ In another study, precise site selection with ultrasound was associated with fewer pseudoaneurysms in patients undergoing femoral artery cannulation by ultrasound guidance vs palpation for cardiac catheterization (3% vs 5%, P < .05).¹²⁹

A multicenter randomized controlled study comparing ultrasound vs fluoroscopic guidance for femoral artery catheterization demonstrated ultrasound guidance improved rates of common femoral artery (CFA) cannulation in patients with high CFA bifurcations (83% vs 70%, P < .01).¹³⁰ Furthermore, ultrasound guidance improved first-pass success rates (83% vs 46%, P < .0001), reduced number of attempts (1.3 vs 3.0, P < .0001), reduced risk of venipuncture (2.4% vs 15.8%, P < .0001), and reduced median time to obtain access (136 seconds vs148 seconds, P = .003). Vascular complications occurred in fewer patients in the ultrasound vs fluoroscopy groups (1.4% vs 3.4% P = .04). Reduced risk of hematoma formation with routine use of ultrasound guidance was demonstrated in one retrospective observational study (RR 0.62, 95% CI 0.46 to 0.84; P < .01).¹³¹

20. We recommend that providers should use real-time ultrasound guidance for radial arterial access, which has been shown to increase first-pass success rates, reduce the time to successful cannulation, and reduce the risk of complications compared with landmark-based techniques.

Rationale: Ultrasound guidance is particularly useful for radial artery cannulation in patients with altered anatomy, obesity, nonpulsatile blood flow, low perfusion, and previously unsuccessful cannulation attempts using a landmark-guided approach.¹³² A meta-analysis of six randomized controlled studies in adults showed that use of ultrasound guidance significantly increased first-attempt success rate of radial artery catheterization by 14-37% (RR 1.4, 95% CI 1.28 to 1.64; P < .00001), reduced mean number of attempts (weighted mean difference (WMD) -1.17; 95% CI -2.21 to -0.13; P = .03), and mean time to successful cannulation (WMD -46 seconds; 95% CI -86.66 to -5.96, P = .02).¹³³ Other meta-analyses of randomized studies have demonstrated similar benefits of using ultrasound guidance for radial artery cannulation.^126,127,134

A multicenter randomized controlled study that was not included in the abovementioned meta-analyses showed similar benefits of using ultrasound guidance vs landmarks for radial artery catheterization: a reduction in the number of attempts with ultrasound guidance (1.65 ± 1.2 vs 3.05 ± 3.4, P < .0001) and time to obtain access (88 ± 78 vs 108 ± 112 seconds, P = .006), and increased first-pass success rates (65% vs 44%, P < .0001). The use of ultrasound guidance was found to be particularly useful in patients with difficult access by palpation alone.¹³⁵

Regarding the level of expertise required to use ultrasound guidance, a prospective observational study demonstrated that physicians with little previous ultrasound experience were able to improve their first-attempt success rates and procedure time for radial artery cannulation compared to historical data of landmark-based insertions.¹³⁶

21. We recommend that post-procedure pneumothorax should be ruled out by the detection of bilateral lung sliding using a high-frequency linear transducer before and after insertion of internal jugular and subclavian vein CVCs.

Rationale: Detection of lung sliding with two-dimensional ultrasound rules out pneumothorax, and disappearance of lung sliding in an area where it was previously seen is a strong predictor of postprocedure pneumothorax. In a study of critically ill patients, the disappearance of lung sliding was observed in 100% of patients with pneumothorax vs 8.8% of patients without pneumothorax. For detection of pneumothorax, lung sliding showed a sensitivity of 95%, specificity of 91%, and negative predictive value of 100% (P < .001).¹³⁷ Another study by the same author showed that the combination of horizontal artifacts (absence of comet-tail artifact) and absence of lung sliding had a sensitivity of 100%, specificity of 96.5%, and negative predictive value of 100% for the detection of pneumothorax.¹³⁸ A meta-analysis of 10 studies on the diagnostic accuracy of CVC confirmation with bedside ultrasound vs chest radiography reported detection of all 12 pneumothoraces with ultrasound, whereas chest radiography missed two pneumothoraces. The pooled sensitivity and specificity of ultrasound for the detection of pneumothorax was 100%, although an imperfect gold standard bias likely affected the results. An important advantage of bedside ultrasound is the ability to rule out pneumothorax immediately after the procedure while at the bedside. The mean time for confirmation of CVC placement with bedside ultrasound was 6 minutes versus 64 minutes and 143 minutes for completion and interpretation of a chest radiograph, respectively.¹³⁹

22. We recommend that providers should use ultrasound with rapid infusion of agitated saline to visualize a right atrial swirl sign (RASS) for detecting catheter tip misplacement during CVC insertion. The use of RASS to detect the catheter tip may be considered an advanced skill that requires specific training and expertise.

Rationale: Bedside echocardiography is a reliable tool to detect catheter tip misplacement during CVC insertion. In one study, catheter misplacement was detected by bedside echocardiography with a sensitivity of 96% and specificity of 83% (positive predictive value 98%, negative predictive value 55%) and prevented distal positioning of the catheter tip.¹⁴⁰ A prospective observational study assessed for RASS, which is turbulent flow in the right atrium after a rapid saline flush of the distal CVC port, to exclude catheter malposition. In this study with 135 CVC placements, visualization of RASS with ultrasound was able to identify all correct CVC placements and three of four catheter misplacements. Median times to complete the ultrasound exam vs CXR were 1 vs 20 minutes, respectively, with a median difference of 24 minutes (95% CI 19.6 to 29.3, P < .0001) between the two techniques.¹⁴¹

A prospective observational study assessed the ability of bedside transthoracic echocardiography to detect the guidewire, microbubbles, or both, in the right atrium compared to transesophageal echocardiography as the gold standard. Bedside transthoracic echocardiography allowed visualization of the right atrium in 94% of patients, and both microbubbles plus guidewire in 91% of patients.¹⁴² Hence, bedside transthoracic echocardiography allows adequate visualization of the right atrium. Another prospective observational study combining ultrasonography and contrast enhanced RASS resulted in 96% sensitivity and 93% specificity for the detection of a misplaced catheter, and the concordance with chest radiography was 96%.¹⁴³

23. To reduce the risk of mechanical and infectious complications, we recommend that novice providers should complete a systematic training program that includes a combination of simulation-based practice, supervised insertion on patients, and evaluation by an expert operator before attempting ultrasound-guided CVC insertion independently on patients.

Rationale: Cumulative experience has been recognized to not be a proxy for mastery of a clinical skill.¹⁴⁴ The National Institute for Clinical Excellence (NICE) has recommended that providers performing ultrasound-guided CVC insertion should receive appropriate training to achieve competence before performing the procedure independently.⁷ Surveys have demonstrated that lack of training is a commonly reported barrier for not using ultrasound.^145,146

Structured training programs on CVC insertion have been shown to reduce the occurrence of infectious and mechanical complications.^{74,143,147-149} The use of ultrasound and checklists, bundling of supplies, and practice with simulation models, as a part of a structured training program, can improve patient safety related to CVC insertion.^{9,140,150-154}

Simulation-based practice has been used in medical education to provide deliberate practice and foster skill development in a controlled learning environment.^155-158 Studies have shown transfer of skills demonstrated in a simulated environment to clinical practice, which can improve CVC insertion practices.^159,160 Simulation accelerates learning of all trainees, especially novice trainees, and mitigates risks to patients by allowing trainees to achieve a minimal level of competence before attempting the procedure on real patients.^152,161,162 Residents that have been trained using simulation preferentially select the IJV site,¹⁴⁷ and more reliably use ultrasound to guide their CVC insertions.^160,163

Additionally, simulation-based practice allows exposure to procedures and scenarios that may occur infrequently in clinical practice.

Although there is evidence on efficacy of simulation-based CVC training programs, there is no broadly accepted consensus on timing, duration, and content of CVC training programs for trainees or physicians in practice. The minimum recommended technical skills a trainee must master include the ability to (1) manipulate the ultrasound machine to produce a high-quality image to identify the target vessel, (2) advance the needle under direct visualization to the desired target site and depth, (3) deploy the catheter into the target vessel and confirm catheter placement in the target vessel using ultrasound, and (4) ensure the catheter has not been inadvertently placed in an unintended vessel or structure.¹⁵³

A variety of simulation models are currently used to practice CVC insertion at the most common sites: the internal jugular, subclavian, basilic, and brachial veins.^164,165 Effective simulation models should contain vessels that mimic normal anatomy with muscles, soft tissues, and bones. Animal tissue models, such as turkey or chicken breasts, may be effective for simulated practice of ultrasound-guided CVC insertion.^166,167 Ultrasound-guided CVC training using human cadavers has also been shown to be effective.¹⁶⁸

24. We recommend that cognitive training in ultrasound-guided CVC insertion should include basic anatomy, ultrasound physics, ultrasound machine knobology, fundamentals of image acquisition and interpretation, detection and management of procedural complications, infection prevention strategies, and pathways to attain competency.

Rationale: After receiving training in ultrasound-guided CVC insertion, physicians report significantly higher comfort with the use of ultrasound compared to those who have not received such training.¹⁴⁵ Learners find training sessions worthwhile to increase skill levels,¹⁶⁷ and skills learned from simulation-based mastery learning programs have been retained up to one year.¹⁵⁸

Several commonalities have been noted across training curricula. Anatomy and physiology didactics should include vessel anatomy (location, size, and course);⁹ vessel differentiation by ultrasound;^9,69 blood flow dynamics;⁶⁹ Virchow’s triad;⁶⁹ skin integrity and colonization;¹⁵⁰ peripheral nerve identification and distribution;⁹ respiratory anatomy;^9,69 upper and lower extremity, axillary, neck, and chest anatomy.^9,69 Vascular anatomy is an essential curricular component that may help avoid preventable CVC insertion complications, such as inadvertent nerve, artery, or lung puncture.^150,169 Training curricula should also include ultrasound physics (piezoelectric effect, frequency, resolution, attenuation, echogenicity, Doppler ultrasound, arterial and venous flow characteristics), image acquisition and optimization (imaging mode, focus, dynamic range, probe types), and artifacts (reverberation, mirror, shadowing, enhancement).

CVC-related infections are an important cause of morbidity and mortality in the acute and long-term care environment.⁶⁹ Infection and thrombosis can both be impacted by the insertion site selection, skin integrity, and catheter–vein ratio.^2,3,84 Inexperience generally leads to more insertion attempts that can increase trauma during CVC insertion and potentially increase the risk of infections.¹⁷⁰ To reduce the risk of infectious complications, training should include important factors to consider in site selection and maintenance of a sterile environment during CVC insertion, including use of maximal sterile barrier precautions, hand hygiene, and appropriate use of skin antiseptic solutions.

Professional society guidelines have been published with recommendations of appropriate techniques for ultrasound-guided vascular access that include training recommendations.^9,154 Training should deconstruct the insertion procedure into readily understood individual steps, and can be aided by demonstration of CVC insertion techniques using video clips. An alternative to face-to-face training is internet-based training that has been shown to be as effective as traditional teaching methods in some medical centers.¹⁷¹ Additional methods to deliver cognitive instruction include textbooks, continuing medical education courses, and digital videos.^164,172

25. We recommend that trainees should demonstrate minimal competence before placing ultrasound-guided CVCs independently. A minimum number of CVC insertions may inform this determination, but a proctored assessment of competence is most important.

Rationale: CVC catheter placement carries the risk of serious complications including arterial injury or dissection, pneumothorax, or damage to other local structures; arrhythmias; catheter malposition; infection; and thrombosis. Although there is a lack of consensus and high-quality evidence for the certification of skills to perform ultrasound-guided CVC insertion, recommendations have been published advocating for formal and comprehensive training programs in ultrasound-guided CVC insertion with an emphasis on expert supervision prior to independent practice.^9,153,154 Two groups of expert operators have recommended that training should include at least 8-10 supervised ultrasound-guided CVC insertions.^154,173,174 A consensus task force from the World Congress of Vascular Access has recommended a minimum of six to eight hours of didactic education, four hours of hands-on training on simulation models, and six hours of hands-on ultrasound training on human volunteers to assess normal anatomy.¹⁷⁵ This training should be followed by supervised ultrasound-guided CVC insertions until the learner has demonstrated minimal competence with a low rate of complications.³⁵ There is general consensus that arbitrary numbers should not be the sole determinant of competence, and that the most important determinant of competence should be an evaluation by an expert operator.¹⁷⁶

26. We recommend that didactic and hands-on training for trainees should coincide with anticipated times of increased performance of vascular access procedures. Refresher training sessions should be offered periodically.

Rationale: Simulation-based CVC training courses have shown a rapid improvement in skills, but lack of practice leads to deterioration of technical skills.^{161,162,177,178} Thus, a single immersive training session is insufficient to achieve and maintain mastery of skills, and an important factor to acquire technical expertise is sustained, deliberate practice with feedback.¹⁷⁹ Furthermore, an insidious decay in skills may go unrecognized as a learner’s comfort and self-confidence does not always correlate with actual performance, leading to increased risk of errors and potential for procedural complications.^{147,158,180-183} Given the decay in technical skills over time, simulation-based training sessions are most effective when they occur in close temporal proximity to times when those skills are most likely to be used; for example, a simulation-based training session for trainees may be most effective just before the start of a critical care rotation.¹⁵² Regularly scheduled training sessions with monitoring and feedback by expert operators can reinforce procedural skills and prevent decay. Some experts have recommended that a minimum of 10 ultrasound-guided CVC insertions should be performed annually to maintain proficiency.¹⁵³

27. We recommend that competency assessments should include formal evaluation of knowledge and technical skills using standardized assessment tools.

Rationale: Hospitalists and other healthcare providers that place vascular access catheters should undergo competency assessments proctored by an expert operator to verify that they have the required knowledge and skills.^184,185 Knowledge competence can be partially evaluated using a written assessment, such as a multiple-choice test, assessing the provider’s cognitive understanding of the procedure.¹⁷⁵ For ultrasound-guided CVC insertion, a written examination should be administered in conjunction with an ultrasound image assessment to test the learner’s recognition of normal vs abnormal vascular anatomy. Minimum passing standards should be established a priori according to local or institutional standards.

The final skills assessment should be objective, and the learner should be required to pass all critical steps of the procedure. Failure of the final skills assessment should lead to continued practice with supervision until the learner can consistently demonstrate correct performance of all critical steps. Checklists are commonly used to rate the technical performance of learners because they provide objective criteria for evaluation, can identify specific skill deficiencies, and can determine a learner’s readiness to perform procedures independently.^186,187 The administration of skills assessments and feedback methods should be standardized across faculty. Although passing scores on both knowledge and skills assessments do not guarantee safe performance of a procedure independently, they provide a metric to ensure that a minimum level of competence has been achieved before allowing learners to perform procedures on patients without supervision.¹⁸⁸

Competency assessments are a recommended component of intramural and extramural certification of skills in ultrasound-guided procedures. Intramural certification pathways differ by institution and often require additional resources including ultrasound machine(s), simulation equipment, and staff time, particularly when simulation-based assessments are incorporated into certification pathways. We recognize that some of these recommendations may not be feasible in resource-limited settings, such as rural hospitals. However, initial and ongoing competency assessments can be performed during routine performance of procedures on patients. For an in-depth review of credentialing pathways for ultrasound-guided bedside procedures, we recommend reviewing the SHM Position Statement on Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures.²⁴

28. We recommend that competency assessments should evaluate for proficiency in the following knowledge and skills of CVC insertion:
a. Knowledge of the target vein anatomy, proper vessel identification, and recognition of anatomical variants
b. Demonstration of CVC insertion with no technical errors based on a procedural checklist
c. Recognition and management of acute complications, including emergency management of life-threatening complications
d. Real-time needle tip tracking with ultrasound and cannulation on the first attempt in at least five consecutive simulations.

Rationale: Recommendations have been published with the minimal knowledge and skills learners must demonstrate to perform ultrasound-guided vascular access procedures. These include operation of an ultrasound machine to produce high-quality images of the target vessel, tracking of the needle tip with real-time ultrasound guidance, and recognition and understanding of the management of procedural complications.^154,175

First, learners must be able to perform a preprocedural assessment of the target vein, including size and patency of the vein; recognition of adjacent critical structures; and recognition of normal anatomical variants.^175,189 Second, learners must be able to demonstrate proficiency in tracking the needle tip penetrating the target vessel, inserting the catheter into the target vessel, and confirming catheter placement in the target vessel with ultrasound.^154,175 Third, learners must be able to demonstrate recognition of acute complications, including arterial puncture, hematoma formation, and development of pneumothorax.^154,175 Trainees should be familiar with recommended evaluation and management algorithms, including indications for emergent consultation.¹⁹⁰

29. We recommend a periodic proficiency assessments of all operators should be conducted to ensure maintenance of competency.

Rationale: Competency extends to periodic assessment and not merely an initial evaluation at the time of training.¹⁹¹ Periodic competency assessments should include assessment of proficiency of all providers that perform a procedure, including instructors and supervisors. Supervising providers should maintain their competency in CVC insertion through routine use of their skills in clinical practice.¹⁷⁵ An observational study of emergency medicine residents revealed that lack of faculty comfort with ultrasound hindered the residents’ use of ultrasound.¹⁹² Thus, there is a need to examine best practices for procedural supervision of trainees because providers are often supervising procedures that they are not comfortable performing on their own.¹⁹³

The process of producing this position statement revealed areas of uncertainty and important gaps in the literature regarding the use of ultrasound guidance for central and peripheral venous access and arterial access.

This position statement recommends a preprocedural ultrasound evaluation of blood vessels based on evidence that providers may detect anatomic anomalies, thrombosis, or vessel stenosis. Ultrasound can also reveal unsuspected high-risk structures in near proximity to the procedure site. Although previous studies have shown that providers can accurately assess vessels with ultrasound for these features, further study is needed to evaluate the effect of a standardized preprocedural ultrasound exam on clinical and procedural decision-making, as well as procedural outcomes.

Second, two ultrasound applications that are being increasingly used but have not been widely implemented are the use of ultrasound to evaluate lung sliding postprocedure to exclude pneumothorax and the verification of central line placement using a rapid infusion of agitated saline to visualize the RASS.^139-141 Both of these applications have the potential to expedite postprocedure clearance of central lines for usage and decrease patient radiation exposure by obviating the need for postprocedure CXRs. Despite the supporting evidence, both of these applications are not yet widely used, as few providers have been trained in these techniques which may be considered advanced skills.

Third, despite advances in our knowledge of effective training for vascular access procedures, there is limited agreement on how to define procedural competence. Notable advancements in training include improved understanding of systematic training programs, development of techniques for proctoring procedures, definition of elements for hands-on assessments, and definition of minimum experience needed to perform vascular access procedures independently. However, application of these concepts to move learners toward independent practice remains variably interpreted at different institutions, likely due to limited resources, engrained cultures about procedures, and a lack of national standards. The development of hospitalist-based procedure services at major academic medical centers with high training standards, close monitoring for quality assurance, and the use of databases to track clinical outcomes may advance our understanding and delivery of optimal procedural training.

Finally, ultrasound technology is rapidly evolving which will affect training, techniques, and clinical outcomes in coming years. Development of advanced imaging software with artificial intelligence can improve needle visualization and tracking. These technologies have the potential to facilitate provider training in real-time ultrasound-guided procedures and improve the overall safety of procedures. Emergence of affordable, handheld ultrasound devices is improving access to ultrasound technology, but their role in vascular access procedures is yet to be defined. Furthermore, availability of wireless handheld ultrasound technology and multifrequency transducers will create new possibilities for use of ultrasound in vascular access procedures.

We have presented several evidence-based recommendations on the use of ultrasound guidance for placement of central and peripheral vascular access catheters that are intended for hospitalists and other healthcare providers who routinely perform vascular access procedures. By allowing direct visualization of the needle tip and target vessel, the use of ultrasound guidance has been shown in randomized studies to reduce needle insertion attempts, reduce needle redirections, and increase overall procedure success rates. The accuracy of ultrasound to identify the target vessel, assess for thrombosis, and detect anatomical anomalies is superior to that of physical examination. Hospitalists can attain competence in performing ultrasound-guided vascular access procedures through systematic training programs that combine didactic and hands-on training, which optimally include patient-based competency assessments.

Acknowledgments

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

Collaborators of Society of Hospital Medicine Point-of-care Ultrasound Task Force: Robert Arntfield, Jeffrey Bates, Anjali Bhagra, Michael Blaivas, Daniel Brotman, Richard Hoppmann, Susan Hunt, Trevor P. Jensen, Venkat Kalidindi, Ketino Kobaidze, Joshua Lenchus, Paul Mayo, Satyen Nichani, Vicki Noble, Nitin Puri, Aliaksei Pustavoitau, Kreegan Reierson, Gerard Salame, Kirk Spencer, Vivek Tayal, David Tierney

SHM Point-of-care Ultrasound Task Force: CHAIRS: Nilam J. Soni, Ricardo Franco-Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Mathews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Mathews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen Lumbar Puncture Working Group: Nilam J. Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El-Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Daniel Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

Approximately five million central venous catheters (CVCs) are inserted in the United States annually, with over 15 million catheter days documented in intensive care units alone.¹ Traditional CVC insertion techniques using landmarks are associated with a high risk of mechanical complications, particularly pneumothorax and arterial puncture, which occur in 5%-19% patients.^2,3

Since the 1990s, several randomized controlled studies and meta-analyses have demonstrated that the use of real-time ultrasound guidance for CVC insertion increases procedure success rates and decreases mechanical complications.^4,5 Use of real-time ultrasound guidance was recommended by the Agency for Healthcare Research and Quality, the Institute of Medicine, the National Institute for Health and Care Excellence, the Centers for Disease Control and Prevention, and several medical specialty societies in the early 2000s.^6-14 Despite these recommendations, ultrasound guidance has not been universally adopted. Currently, an estimated 20%-55% of CVC insertions in the internal jugular vein are performed without ultrasound guidance.^15-17

Following the emergence of literature supporting the use of ultrasound guidance for CVC insertion, observational and randomized controlled studies demonstrated improved procedural success rates with the use of ultrasound guidance for the insertion of peripheral intravenous lines (PIVs), arterial catheters, and peripherally inserted central catheters (PICCs).^18-23

The purpose of this position statement is to present evidence-based recommendations on the use of ultrasound guidance for the insertion of central and peripheral vascular access catheters in adult patients. This document presents consensus-based recommendations with supporting evidence for clinical outcomes, techniques, and training for the use of ultrasound guidance for vascular access. We have subdivided the recommendations on techniques for central venous access, peripheral venous access, and arterial access individually, as some providers may not perform all types of vascular access procedures.

These recommendations are intended for hospitalists and other healthcare providers that routinely place central and peripheral vascular access catheters in acutely ill patients. However, this position statement does not mandate that all hospitalists should place central or peripheral vascular access catheters given the diverse array of hospitalist practice settings. For training and competency assessments, we recognize that some of these recommendations may not be feasible in resource-limited settings, such as rural hospitals, where equipment and staffing for assessments are not available. Recommendations and frameworks for initial and ongoing credentialing of hospitalists in ultrasound-guided bedside procedures have been previously published in an Society of Hospital Medicine (SHM) position statement titled, “Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures.”²⁴

Detailed methods are described in Appendix 1. The SHM Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced practice providers with expertise in POCUS. Expert panel members were divided into working group members, external peer reviewers, and a methodologist. All Task Force members were required to disclose any potential conflicts of interest (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the vascular access working group members themselves. Key clinical questions and draft recommendations were then prepared. A systematic literature search was conducted by a medical librarian based on the findings of the initial literature search and draft recommendations. The Medline, Embase, CINAHL, and Cochrane medical databases were searched from 1975 to December 2015 initially. Google Scholar was also searched without limiters. An updated search was conducted in November 2017. The literature search strings are included in Appendix 3. All article abstracts were initially screened for relevance by at least two members of the vascular access working group. Full-text versions of screened articles were reviewed, and articles on the use of ultrasound to guide vascular access were selected. The following article types were excluded: non-English language, nonhuman, age <18 years, meeting abstracts, meeting posters, narrative reviews, case reports, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled studies, and observational studies of ultrasound-guided vascular access were screened and selected (Appendix 3, Figure 1). All full-text articles were shared electronically among the working group members, and final article selection was based on working group consensus. Selected articles were incorporated into the draft recommendations.

These recommendations were developed using the Research and Development (RAND) Appropriateness Method that required panel judgment and consensus.¹⁴ The 28 voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering five transforming factors: (1) Problem priority and importance, (2) Level of quality of evidence, (3) Benefit/harm balance, (4) Benefit/burden balance, and (5) Certainty/concerns about PEAF (Preferences/Equity/Acceptability/Feasibility). Using an internet-based electronic data collection tool (REDCap™), panel members participated in two rounds of electronic voting, one in August 2018 and the other in October 2018 (Appendix 4). Voting on appropriateness was conducted using a nine-point Likert scale. The three zones of the nine-point Likert scale were inappropriate (1-3 points), uncertain (4-6 points), and appropriate (7-9 points). The degree of consensus was assessed using the RAND algorithm (Appendix 1, Figure 1 and Table 1). Establishing a recommendation required at least 70% agreement that a recommendation was “appropriate.” Disagreement was defined as >30% of panelists voting outside of the zone of the median. A strong recommendation required at least 80% of the votes within one integer of the median per the RAND rules.

Literature Search

A total of 5,563 references were pooled from an initial search performed by a certified medical librarian in December 2015 (4,668 citations) which was updated in November 2017 (791 citations), and from the personal bibliographies and searches (104 citations) performed by working group members. A total of 514 full-text articles were reviewed. The final selection included 192 articles that were abstracted into a data table and incorporated into the draft recommendations. See Appendix 3 for details of the literature search strategy.

Four domains (technique, clinical outcomes, training, and knowledge gaps) with 31 draft recommendations were generated based on a review of the literature. Selected references were abstracted and assigned to each draft recommendation. Rationales for each recommendation cite supporting evidence. After two rounds of panel voting, 31 recommendations achieved agreement based on the RAND rules. During the peer review process, two of the recommendations were merged with other recommendations. Thus, a total of 29 recommendations received final approval. The degree of consensus based on the median score and the dispersion of voting around the median are shown in Appendix 5. Twenty-seven statements were approved as strong recommendations, and two were approved as weak/conditional recommendations. The strength of each recommendation and degree of consensus are summarized in Table 3.

Terminology
Central Venous Catheterization

Central venous catheterization refers to insertion of tunneled or nontunneled large bore vascular catheters that are most commonly inserted into the internal jugular, subclavian, or femoral veins with the catheter tip located in a central vein. These vascular access catheters are synonymously referred to as central lines or central venous catheters (CVCs). Nontunneled catheters are designed for short-term use and should be removed promptly when no longer clinically indicated or after a maximum of 14 days.²⁵

Peripherally Inserted Central Catheter (PICC)

Peripherally inserted central catheters, or PICC lines, are inserted most commonly in the basilic or brachial veins in adult patients, and the catheter tip terminates in the distal superior vena cava or cavo-atrial junction. These catheters are designed to remain in place for a duration of several weeks, as long as it is clinically indicated.

Midline Catheterization

Midline catheters are a type of peripheral venous catheter that are an intermediary between a peripheral intravenous catheter and PICC line. Midline catheters are most commonly inserted in the brachial or basilic veins, but unlike PICC lines, the tips of these catheters terminate in the axillary or subclavian vein. Midline catheters are typically 8 cm to 20 cm in length and inserted for a duration <30 days.

Peripheral Intravenous Catheterization

Peripheral intravenous lines (PIV) refer to small bore venous catheters that are most commonly 14G to 24G and inserted into patients for short-term peripheral venous access. Common sites of ultrasound-guided PIV insertion include the superficial and deep veins of the hand, forearm, and arm.

Arterial Catheterization

Arterial catheters are commonly used for reliable blood pressure monitoring, frequent arterial blood sampling, and cardiac output monitoring. The most common arterial access sites are the femoral and radial arteries.

1. We recommend that providers should be familiar with the operation of their specific ultrasound machine prior to initiation of a vascular access procedure.

Rationale: There is strong consensus that providers must be familiar with the knobs and functions of the specific make and model of ultrasound machine that will be utilized for a vascular access procedure. Minimizing adjustments to the ultrasound machine during the procedure may reduce the risk of contaminating the sterile field.

2. We recommend that providers should use a high-frequency linear transducer with a sterile sheath and sterile gel to perform vascular access procedures.

Rationale: High-frequency linear-array transducers are recommended for the vast majority of vascular access procedures due to their superior resolution compared to other transducer types. Both central and peripheral vascular access procedures, including PIV, PICC, and arterial line placement, should be performed using sterile technique. A sterile transducer cover and sterile gel must be utilized, and providers must be trained in sterile preparation of the ultrasound transducer.^13,26,27

The depth of femoral vessels correlates with body mass index (BMI). When accessing these vessels in a morbidly obese patient with a thigh circumference >60 cm and vessel depth >8 cm, a curvilinear transducer may be preferred for its deeper penetration.²⁸ For patients who are poor candidates for bedside insertion of vascular access catheters, such as uncooperative patients, patients with atypical vascular anatomy or poorly visualized target vessels, we recommend consultation with a vascular access specialist prior to attempting the procedure.

3. We recommend that providers should use two-dimensional ultrasound to evaluate for anatomical variations and absence of vascular thrombosis during preprocedural site selection.

Rationale: A thorough ultrasound examination of the target vessel is warranted prior to catheter placement. Anatomical variations that may affect procedural decision-making are easily detected with ultrasound. A focused vascular ultrasound examination is particularly important in patients who have had temporary or tunneled venous catheters, which can cause stenosis or thrombosis of the target vein.

For internal jugular vein (IJV) CVCs, ultrasound is useful for visualizing the relationship between the IJV and common carotid artery (CCA), particularly in terms of vessel overlap. Furthermore, ultrasound allows for immediate revisualization upon changes in head position.^29-32 Troianos et al. found >75% overlap of the IJV and CCA in 54% of all patients and in 64% of older patients (age >60 years) whose heads were rotated to the contralateral side.³⁰ In one study of IJV CVC insertion, inadvertent carotid artery punctures were reduced (3% vs 10%) with the use of ultrasound guidance vs landmarks alone.³³ In a cohort of 64 high-risk neurosurgical patients, cannulation success was 100% with the use of ultrasound guidance, and there were no injuries to the carotid artery, even though the procedure was performed with a 30-degree head elevation and anomalous IJV anatomy in 39% of patients.³⁴ In a prospective, randomized controlled study of 1,332 patients, ultrasound-guided cannulation in a neutral position was demonstrated to be as safe as the 45-degree rotated position.³⁵

Ultrasound allows for the recognition of anatomical variations which may influence the selection of the vascular access site or technique. Benter et al. found that 36% of patients showed anatomical variations in the IJV and surrounding tissue.³⁶ Similarly Caridi showed the anatomy of the right IJV to be atypical in 29% of patients,³⁷ and Brusasco found that 37% of bariatric patients had anatomical variations of the IJV.³⁸ In a study of 58 patients, there was significant variability in the IJV position and IJV diameter, ranging from 0.5 cm to >2 cm.³⁹ In a study of hemodialysis patients, 75% of patients had sonographic venous abnormalities that led to a change in venous access approach.⁴⁰

To detect acute or chronic upper extremity deep venous thrombosis or stenosis, two-dimensional visualization with compression should be part of the ultrasound examination prior to central venous catheterization. In a study of patients that had undergone CVC insertion 9-19 weeks earlier, 50% of patients had an IJV thrombosis or stenosis leading to selection of an alternative site. In this study, use of ultrasound for a preprocedural site evaluation reduced unnecessary attempts at catheterizing an occluded vein.⁴¹ At least two other studies demonstrated an appreciable likelihood of thrombosis. In a study of bariatric patients, 8% of patients had asymptomatic thrombosis³⁸ and in another study, 9% of patients being evaluated for hemodialysis catheter placement had asymptomatic IJV thrombosis.³⁷

4. We recommend that providers should evaluate the target blood vessel size and depth during a preprocedural ultrasound evaluation.

Rationale: The size, depth, and anatomic location of central veins can vary considerably. These features are easily discernable using ultrasound. Contrary to traditional teaching, the IJV is located 1 cm anterolateral to the CCA in only about two-thirds of patients.^37,39,42,43 Furthermore, the diameter of the IJV can vary significantly, ranging from 0.5 cm to >2 cm.³⁹ The laterality of blood vessels may vary considerably as well. A preprocedural ultrasound evaluation of contralateral subclavian and axillary veins showed a significant absolute difference in cross-sectional area of 26.7 mm² (P < .001).⁴²

Blood vessels can also shift considerably when a patient is in the Trendelenburg position. In one study, the IJV diameter changed from 11.2 (± 1.5) mm to 15.4 (± 1.5) mm in the supine versus the Trendelenburg position at 15 degrees.³³ An observational study demonstrated a frog-legged position with reverse Trendelenburg increased the femoral vein size and reduced the common surface area with the common femoral artery compared to a neutral position. Thus, a frog-legged position with reverse Trendelenburg position may be preferred, since overall catheterization success rates are higher in this position.⁴⁴

General Techniques

5. We recommend that providers should avoid using static ultrasound alone to mark the needle insertion site for vascular access procedures.

Rationale: The use of static ultrasound guidance to mark a needle insertion site is not recommended because normal anatomical relationships of vessels vary, and site marking can be inaccurate with minimal changes in patient position, especially of the neck.^43,45,46 Benefits of using ultrasound guidance for vascular access are attained when ultrasound is used to track the needle tip in real-time as it is advanced toward the target vessel.

Although continuous-wave Doppler ultrasound without two-dimensional visualization was used in the past, it is no longer recommended for IJV CVC insertion.⁴⁷ In a study that randomized patients to IJV CVC insertion with continuous-wave Doppler alone vs two-dimensional ultrasound guidance, the use of two-dimensional ultrasound guidance showed significant improvement in first-pass success rates (97% vs 91%, P = .045), particularly in patients with BMI >30 (97% vs 77%, P = .011).⁴⁸

A randomized study comparing real-time ultrasound-guided, landmark-based, and ultrasound-marked techniques found higher success rates in the real-time ultrasound-guided group than the other two groups (100% vs 74% vs 73%, respectively; P = .01). The total number of mechanical complications was higher in the landmark-based and ultrasound-marked groups than in the real-time ultrasound-guided group (24% and 36% versus 0%, respectively; P = .01).⁴⁹ Another randomized controlled study found higher success rates with real-time ultrasound guidance (98%) versus an ultrasound-marked (82%) or landmark-based (64%) approach for central line placement.⁵⁰

6. We recommend that providers should use real-time (dynamic), two-dimensional ultrasound guidance with a high-frequency linear transducer for CVC insertion, regardless of the provider’s level of experience.

7. We suggest using either a transverse (short-axis) or longitudinal (long-axis) approach when performing real-time ultrasound-guided vascular access procedures.

Rationale: In clinical practice, the phrases transverse, short-axis, or out-of-plane approach are synonymous, as are longitudinal, long-axis, and in-plane approach. The short-axis approach involves tracking the needle tip as it approximates the target vessel with the ultrasound beam oriented in a transverse plane perpendicular to the target vessel. The target vessel is seen as a circular structure on the ultrasound screen as the needle tip approaches the target vessel from above. This approach is also called the out-of-plane technique since the needle passes through the ultrasound plane. The advantages of the short-axis approach include better visualization of adjacent vessels or nerves and the relative ease of skill acquisition for novice operators.⁹ When using the short-axis approach, extra care must be taken to track the needle tip from the point of insertion on the skin to the target vessel. A disadvantage of the short-axis approach is unintended posterior wall puncture of the target vessel.⁵⁵

In contrast to a short-axis approach, a long-axis approach is performed with the ultrasound beam aligned parallel to the vessel. The vessel appears as a long tubular structure and the entire needle is visualized as it traverses across the ultrasound screen to approach the target vessel. The long-axis approach is also called an in-plane technique because the needle is maintained within the plane of the ultrasound beam. The advantage of a long-axis approach is the ability to visualize the entire needle as it is inserted into the vessel.¹⁴ A randomized crossover study with simulation models compared a long-axis versus short-axis approach for both IJV and subclavian vein catheterization. This study showed decreased number of needle redirections (relative risk (RR) 0.5, 95% confidence interval (CI) 0.3 to 0.7), and posterior wall penetrations (OR 0.3, 95% CI 0.1 to 0.9) using a long-axis versus short-axis approach for subclavian vein catheterization.⁵⁶

A randomized controlled study comparing a long-axis or short-axis approach with ultrasound versus a landmark-based approach for IJV CVC insertion showed higher success rates (100% vs 90%; P < .001), lower insertion time (53 vs 116 seconds; P < .001), and fewer attempts to obtain access (2.5 vs 1.2 attempts, P < .001) with either the long- or short-axis ultrasound approach. The average time to obtain access and number of attempts were comparable between the short-axis and long-axis approaches with ultrasound. The incidence of carotid puncture and hematoma was significantly higher with the landmark-based approach versus either the long- or short-axis ultrasound approach (carotid puncture 17% vs 3%, P = .024; hematoma 23% vs 3%, P = .003).⁵⁷

High success rates have been reported using a short-axis approach for insertion of PIV lines.⁵⁸ A prospective, randomized trial compared the short-axis and long-axis approach in patients who had had ≥2 failed PIV insertion attempts. Success rate was 95% (95% CI, 0.85 to 1.00) in the short-axis group compared with 85% (95% CI, 0.69 to 1.00) in the long-axis group. All three subjects with failed PIV placement in the long-axis group had successful rescue placement using a short-axis approach. Furthermore, the short-axis approach was faster than the long-axis approach.⁵⁹

For radial artery cannulation, limited data exist comparing the short- and long-axis approaches. A randomized controlled study compared a long-axis vs short-axis ultrasound approach for radial artery cannulation. Although the overall procedure success rate was 100% in both groups, the long-axis approach had higher first-pass success rates (1.27 ± 0.4 vs 1.5 ± 0.5, P < .05), shorter cannulation times (24 ± 17 vs 47 ± 34 seconds, P < .05), fewer hematomas (4% vs 43%, P < .05) and fewer posterior wall penetrations (20% vs 56%, P < .05).⁶⁰

Another technique that has been described for IJV CVC insertion is an oblique-axis approach, a hybrid between the long- and short-axis approaches. In this approach, the transducer is aligned obliquely over the IJV and the needle is inserted using a long-axis or in-plane approach. A prospective randomized trial compared the short-axis, long-axis, and oblique-axis approaches during IJV cannulation. First-pass success rates were 70%, 52%, and 74% with the short-axis, long-axis, and oblique-axis approaches, respectively, and a statistically significant difference was found between the long- and oblique-axis approaches (P = .002). A higher rate of posterior wall puncture was observed with a short-axis approach (15%) compared with the oblique-axis (7%) and long-axis (4%) approaches (P = .047).⁶¹

8. We recommend that providers should visualize the needle tip and guidewire in the target vein prior to vessel dilatation.

Rationale: When real-time ultrasound guidance is used, visualization of the needle tip within the vein is the first step to confirm cannulation of the vein and not the artery. After the guidewire is advanced, the provider can use transverse and longitudinal views to reconfirm cannulation of the vein. In a longitudinal view, the guidewire is readily seen positioned within the vein, entering the anterior wall and lying along the posterior wall of the vein. Unintentional perforation of the posterior wall of the vein with entry into the underlying artery can be detected by ultrasound, allowing prompt removal of the needle and guidewire before proceeding with dilation of the vessel. In a prospective observational study that reviewed ultrasound-guided IJV CVC insertions, physicians were able to more readily visualize the guidewire than the needle in the vein.⁶² A prospective observational study determined that novice operators can visualize intravascular guidewires in simulation models with an overall accuracy of 97%.⁶³

In a retrospective review of CVC insertions where the guidewire position was routinely confirmed in the target vessel prior to dilation, there were no cases of arterial dilation, suggesting confirmation of guidewire position can potentially eliminate the morbidity and mortality associated with arterial dilation during CVC insertion.⁶⁴

9. To increase the success rate of ultrasound-guided vascular access procedures, we recommend that providers should utilize echogenic needles, plastic needle guides, and/or ultrasound beam steering when available.

Rationale: Echogenic needles have ridged tips that appear brighter on the screen, allowing for better visualization of the needle tip. Plastic needle guides help stabilize the needle alongside the transducer when using either a transverse or longitudinal approach. Although evidence is limited, some studies have reported higher procedural success rates when using echogenic needles, plastic needle guides, and ultrasound beam steering software. In a prospective observational study, Augustides et al. showed significantly higher IJV cannulation rates with versus without use of a needle guide after first (81% vs 69%, P = .0054) and second (93% vs 80%. P = .0001) needle passes.⁶⁵ A randomized study by Maecken et al. compared subclavian vein CVC insertion with or without use of a needle guide, and found higher procedure success rates within the first and second attempts, reduced time to obtain access (16 seconds vs 30 seconds; P = .0001) and increased needle visibility (86% vs 32%; P < .0001) with the use of a needle guide.⁶⁶ Another study comparing a short-axis versus long-axis approach with a needle guide showed improved needle visualization using a long-axis approach with a needle guide.⁶⁷ A randomized study comparing use of a novel, sled-mounted needle guide to a free-hand approach for venous cannulation in simulation models showed the novel, sled-mounted needle guide improved overall success rates and efficiency of cannulation.⁶⁸

10. We recommend that providers should use a standardized procedure checklist that includes use of real-time ultrasound guidance to reduce the risk of central line-associated bloodstream infection (CLABSI) from CVC insertion.

 

Rationale: A standardized checklist or protocol should be developed to ensure compliance with all recommendations for insertion of CVCs. Evidence-based protocols address periprocedural issues, such as indications for CVC, and procedural techniques, such as use of maximal sterile barrier precautions to reduce the risk of infection. Protocols and checklists that follow established guidelines for CVC insertion have been shown to decrease CLABSI rates.^69,70 Similarly, development of checklists and protocols for maintenance of central venous catheters have been effective in reducing CLABSIs.⁷¹ Although no externally-validated checklist has been universally accepted or endorsed by national safety organizations, a few internally-validated checklists are available through peer-reviewed publications.^72,73 An observational educational cohort of internal medicine residents who received training using simulation of the entire CVC insertion process was able to demonstrate fewer CLABSIs after the simulator-trained residents rotated in the intensive care unit (ICU) (0.50 vs 3.2 infections per 1,000 catheter days, P = .001).⁷⁴

11. We recommend that providers should use real-time ultrasound guidance, combined with aseptic technique and maximal sterile barrier precautions, to reduce the incidence of infectious complications from CVC insertion.

Rationale: The use of real-time ultrasound guidance for CVC placement has demonstrated a statistically significant reduction in CLABSIs compared to landmark-based techniques.⁷⁵ The Centers for Disease Control and Prevention (CDC) guidelines for the prevention of intravascular catheter-related infections recommend the use of ultrasound guidance to reduce the number of cannulation attempts and risk of mechanical complications.⁶⁹ A prospective, three-arm study comparing ultrasound-guided long-axis, short-axis, and landmark-based approaches showed a CLABSI rate of 20% in the landmark-based group versus 10% in each of the ultrasound groups.⁵⁷ Another randomized study comparing use of ultrasound guidance to a landmark-based technique for IJV CVC insertion demonstrated significantly lower CLABSI rates with the use of ultrasound (2% vs 10%; P < .05).⁷²

Studies have shown that a systems-based intervention featuring a standardized catheter kit or catheter bundle significantly reduced CLABSI rates.^76-78 A complete review of all preventive measures to reduce the risk of CLABSI is beyond the scope of this review, but a few key points will be mentioned. First, aseptic technique includes proper hand hygiene and skin sterilization, which are essential measures to reduce cutaneous colonization of the insertion site and reduce the risk of CLABSIs.⁷⁹ In a systematic review and meta-analysis of eight studies including over 4,000 catheter insertions, skin antisepsis with chlorhexidine was associated with a 50% reduction in CLABSIs compared with povidone iodine.¹¹ Therefore, a chlorhexidine-containing solution is recommended for skin preparation prior to CVC insertion per guidelines by Healthcare Infection Control Practices Advisory Committee/CDC, Society for Healthcare Epidemiology of America/Infectious Diseases Society of America, and American Society of Anesthesiologists.^11,69,80,81 Second, maximal sterile barrier precautions refer to the use of sterile gowns, sterile gloves, caps, masks covering both the mouth and nose, and sterile full-body patient drapes. Use of maximal sterile barrier precautions during CVC insertion has been shown to reduce the incidence of CLABSIs compared to standard precautions.^26,79,82-84 Third, catheters containing antimicrobial agents may be considered for hospital units with higher CLABSI rates than institutional goals, despite a comprehensive preventive strategy, and may be considered in specific patient populations at high risk of severe complications from a CLABSI.^11,69,80 Finally, providers should use a standardized procedure set-up when inserting CVCs to reduce the risk of CLABSIs. The operator should confirm availability and proper functioning of ultrasound equipment prior to commencing a vascular access procedure. Use of all-inclusive procedure carts or kits with sterile ultrasound probe covers, sterile gel, catheter kits, and other necessary supplies is recommended to minimize interruptions during the procedure, and can ultimately reduce the risk of CLABSIs by ensuring maintenance of a sterile field during the procedure.¹³

12. We recommend that providers should use real-time ultrasound guidance for internal jugular vein catheterization, which reduces the risk of mechanical and infectious complications, the number of needle passes, and time to cannulation and increases overall procedure success rates.

Rationale: The use of real-time ultrasound guidance for CVC insertion has repeatedly demonstrated better outcomes compared to a landmark-based approach in adults.¹³ Several randomized controlled studies have demonstrated that real-time ultrasound guidance for IJV cannulation reduces the risk of procedure-related mechanical and infectious complications, and improves first-pass and overall success rates in diverse care settings.^{27,29,45,50,53,65,75,85-90} Mechanical complications that are reduced with ultrasound guidance include pneumothorax and carotid artery puncture.^{4,5,45,46,53,62,75,86-93} Currently, several medical societies strongly recommend the use of ultrasound guidance during insertion of IJV CVCs.^{10-12,14,94-96}

A meta-analysis by Hind et al. that included 18 randomized controlled studies demonstrated use of real-time ultrasound guidance reduced failure rates (RR 0.14, 95% CI 0.06 to 0.33; P < .0001), increased first-attempt success rates (RR 0.59, 95% CI 0.39 to 0.88; P = .009), reduced complication rates (RR 0.43, 95% CI 0.22 to 0.87; P = .02) and reduced procedure time (P < .0001), compared to a traditional landmark-based approach when inserting IJV CVCs.⁵

A Cochrane systematic review compared ultrasound-guided versus landmark-based approaches for IJV CVC insertion and found use of real-time ultrasound guidance reduced total complication rates by 71% (RR 0.29, 95% CI 0.17 to 0.52; P < .0001), arterial puncture rates by 72% (RR 0.28, 95% CI 0.18 to 0.44; P < .00001), and rates of hematoma formation by 73% (RR 0.27, 95% CI 0.13 to 0.55; P = .0004). Furthermore, the number of attempts for successful cannulation was reduced (mean difference -1.19 attempts, 95% CI -1.45 to -0.92; P < .00001), the chance of successful insertion on the first attempt was increased by 57% (RR 1.57, 95% CI 1.36 to 1.82; P < .00001), and overall procedure success rates were modestly increased in all groups by 12% (RR 1.12, 95% CI 1.08 to 1.17; P < .00001).⁴⁶

An important consideration in performing ultrasound guidance is provider experience. A prospective observational study of patients undergoing elective CVC insertion demonstrated higher complication rates for operators that were inexperienced (25.2%) versus experienced (13.6%).⁵⁴ A randomized controlled study comparing experts and novices with or without the use of ultrasound guidance for IJV CVC insertion demonstrated higher success rates among expert operators and with the use of ultrasound guidance. Among novice operators, the complication rates were lower with the use of ultrasound guidance.⁹⁷ One study evaluated the procedural success and complication rates of a two-physician technique with one physician manipulating the transducer and another inserting the needle for IJV CVC insertion. This study concluded that procedural success rates and frequency of complications were directly affected by the experience of the physician manipulating the transducer and not by the experience of the physician inserting the needle.⁹⁸

The impact of ultrasound guidance on improving procedural success rates and reducing complication rates is greatest in patients that are obese, short necked, hypovolemic, or uncooperative.⁹³ Several studies have demonstrated fewer needle passes and decreased time to cannulation compared to the landmark technique in these populations.^{46,49,53,86-88,92,93}

Ultrasound-guided placement of IJV catheters can safely be performed in patients with disorders of hemostasis and those with multiple previous catheter insertions in the same vein.⁹ Ultrasound-guided placement of CVCs in patients with disorders of hemostasis is safe with high success and low complication rates. In a case series of liver patients with coagulopathy (mean INR 2.17 ± 1.16, median platelet count 150K), the use of ultrasound guidance for CVC insertion was highly successful with no major bleeding complications.⁹⁹

A study of renal failure patients found high success rates and low complication rates in the patients with a history of multiple previous catheterizations, poor compliance, skeletal deformities, previous failed cannulations, morbid obesity, and disorders of hemostasis.¹⁰⁰ A prospective observational study of 200 ultrasound-guided CVC insertions for apheresis showed a 100% success rate with a 92% first-pass success rate.¹⁰¹

The use of real-time ultrasound guidance for IJV CVC insertion has been shown to be cost effective by reducing procedure-related mechanical complications and improving procedural success rates. A companion cost-effectiveness analysis estimated that for every 1,000 patients, 90 complications would be avoided, with a net cost savings of approximately $3,200 using 2002 prices.¹⁰²

13. We recommend that providers who routinely insert subclavian vein CVCs should use real-time ultrasound guidance, which has been shown to reduce the risk of mechanical complications and number of needle passes and increase overall procedure success rates compared with landmark-based techniques.

Rationale: In clinical practice, the term ultrasound-guided subclavian vein CVC insertion is commonly used. However, the needle insertion site is often lateral to the first rib and providers are technically inserting the CVC in the axillary vein. The subclavian vein becomes the axillary vein at the lateral border of the first rib where the cephalic vein branches from the subclavian vein. To be consistent with common medical parlance, we use the phrase ultrasound-guided subclavian vein CVC insertion in this document.

Advantages of inserting CVCs in the subclavian vein include reliable surface anatomical landmarks for vein location, patient comfort, and lower risk of infection.¹⁰³ Several observational studies have demonstrated the technique for ultrasound-guided subclavian vein CVC insertion is feasible and safe.^104-107 In a large retrospective observational study of ultrasound-guided central venous access among a complex patient group, the majority of patients were cannulated successfully and safely. The subset of patients undergoing axillary vein CVC insertion (n = 1,923) demonstrated a low rate of complications (0.7%), proving it is a safe and effective alternative to the IJV CVC insertion.¹⁰⁷

A Cochrane review of ultrasound-guided subclavian vein cannulation (nine studies, 2,030 participants, 2,049 procedures), demonstrated that real-time two-dimensional ultrasound guidance reduced the risk of inadvertent arterial punctures (three studies, 498 participants, RR 0.21, 95% CI 0.06 to 0.82; P = .02) and hematoma formation (three studies, 498 participants, RR 0.26, 95% CI 0.09 to 0.76; P = .01).⁴⁶ A systematic review and meta-analysis of 10 randomized controlled studies comparing ultrasound-guided versus landmark-based subclavian vein CVC insertion demonstrated a reduction in the risk of arterial punctures, hematoma formation, pneumothorax, and failed catheterization with the use of ultrasound guidance.¹⁰⁵

A randomized controlled study comparing ultrasound-guided vs landmark-based approaches to subclavian vein cannulation found that use of ultrasound guidance had a higher success rate (92% vs 44%, P = .0003), fewer minor complications (1 vs 11, P = .002), fewer attempts (1.4 vs 2.5, P = .007) and fewer catheter kits used (1.0 vs 1.4, P = .0003) per cannulation.¹⁰⁸

Fragou et al. randomized patients undergoing subclavian vein CVC insertion to a long-axis approach versus a landmark-based approach and found a significantly higher success rate (100% vs 87.5%, P < .05) and lower rates of mechanical complications: artery puncture (0.5% vs 5.4%), hematoma (1.5% vs 5.4%), hemothorax (0% vs 4.4%), pneumothorax (0% vs 4.9%), brachial plexus injury (0% vs 2.9%), phrenic nerve injury (0% vs 1.5%), and cardiac tamponade (0% vs 0.5%).¹⁰⁹ The average time to obtain access and the average number of insertion attempts (1.1 ± 0.3 vs 1.9 ± 0.7, P < .05) were significantly reduced in the ultrasound group compared to the landmark-based group.⁹⁵

A retrospective review of subclavian vein CVC insertions using a supraclavicular approach found no reported complications with the use of ultrasound guidance vs 23 mechanical complications (8 pneumothorax, 15 arterial punctures) with a landmark-based approach.¹⁰⁶ However, it is important to note that a supraclavicular approach is not commonly used in clinical practice.

14. We recommend that providers should use real-time ultrasound guidance for femoral venous access, which has been shown to reduce the risk of arterial punctures and total procedure time and increase overall procedure success rates.

Rationale: Anatomy of the femoral region varies, and close proximity or overlap of the femoral vein and artery is common.⁵¹ Early studies showed that ultrasound guidance for femoral vein CVC insertion reduced arterial punctures compared with a landmark-based approach (7% vs 16%), reduced total procedure time (55 ± 19 vs 79 ± 62 seconds), and increased procedure success rates (100% vs 90%).⁵² A Cochrane review that pooled data from four randomized studies comparing ultrasound-guided vs landmark-based femoral vein CVC insertion found higher first-attempt success rates with the use of ultrasound guidance (RR 1.73, 95% CI 1.34 to 2.22; P < .0001) and a small increase in the overall procedure success rates (RR 1.11, 95% CI 1.00 to 1.23; P = .06). There was no difference in inadvertent arterial punctures or other complications.¹¹⁰

15. We recommend that providers should use real-time ultrasound guidance for the insertion of peripherally inserted central catheters (PICCs), which is associated with higher procedure success rates and may be more cost effective compared with landmark-based techniques.

Rationale: Several studies have demonstrated that providers who use ultrasound guidance vs landmarks for PICC insertion have higher procedural success rates, lower complication rates, and lower total placement costs. A prospective observational report of 350 PICC insertions using ultrasound guidance reported a 99% success rate with an average of 1.2 punctures per insertion and lower total costs.²⁰ A retrospective observational study of 500 PICC insertions by designated specialty nurses revealed an overall success rate of 95%, no evidence of phlebitis, and only one CLABSI among the catheters removed.²¹ A retrospective observational study comparing several PICC variables found higher success rates (99% vs 77%) and lower thrombosis rates (2% vs 9%) using ultrasound guidance vs landmarks alone.²² A study by Robinson et al. demonstrated that having a dedicated PICC team equipped with ultrasound increased their institutional insertion success rates from 73% to 94%.¹¹¹

A randomized controlled study comparing ultrasound-guided versus landmark-based PICC insertion found high success rates with both techniques (100% vs 96%). However, there was a reduction in the rate of unplanned catheter removals (4.0% vs 18.7%; P = .02), mechanical phlebitis (0% vs 22.9%; P < .001), and venous thrombosis (0% vs 8.3%; P = .037), but a higher rate of catheter migration (32% vs 2.1%; P < .001). Compared with the landmark-based group, the ultrasound-guided group had significantly lower incidence of severe contact dermatitis (P = .038), and improved comfort and costs up to 3 months after PICC placement (P < .05).¹¹²

Routine postprocedure chest x-ray (CXR) is generally considered unnecessary if the PICC is inserted with real-time ultrasound guidance along with use of a newer tracking devices, like the magnetic navigation system with intracardiac electrodes.⁹ Ultrasound can also be used to detect malpositioning of a PICC immediately after completing the procedure. A randomized controlled study comparing ultrasound versus postprocedure CXR detected one malpositioned PICC in the ultrasound group versus 11 in the control group. This study suggested that ultrasound can detect malpositioning immediately postprocedure and reduce the need for a CXR and the possibility of an additional procedure to reposition a catheter.¹¹³

16. We recommend that providers should use real-time ultrasound guidance for the placement of peripheral intravenous lines (PIV) in patients with difficult peripheral venous access to reduce the total procedure time, needle insertion attempts, and needle redirections. Ultrasound-guided PIV insertion is also an effective alternative to CVC insertion in patients with difficult venous access.

Rationale: Difficult venous access refers to patients that have had two unsuccessful attempts at PIV insertion using landmarks or a history of difficult access (i.e. edema, obesity, intravenous drug use, chemotherapy, diabetes, hypovolemia, chronic illness, vasculopathy, multiple prior hospitalizations). A meta-analysis of seven randomized controlled studies concluded that ultrasound guidance increases the likelihood of successful PIV insertion (pooled OR 2.42, 95% CI 1.26 to 4.68; P < .008).18 A second meta-analysis that pooled data from seven studies (six randomized controlled studies) confirmed that ultrasound guidance improves success rates of PIV insertion (OR 3.96, 95% CI 1.75 to 8.94).19 Approximately half of these studies had physician operators while the other half had nurse operators.

In one prospective observational study of emergency department patients with two failed attempts of landmark-based PIV insertion, ultrasound guidance with a modified-Seldinger technique showed a relatively high success rate (96%), fewer needle sticks (mean 1.32 sticks, 95% CI 1.12 to 1.52), and shorter time to obtain access (median time 68 seconds).¹¹⁴ Other prospective observational studies have demonstrated that ultrasound guidance for PIV insertion has a high success rate (87%),¹¹⁵ particularly with brachial or basilic veins PIV insertion, among patients with difficult PIV access, defined as having had ≥2 failed attempts.⁵⁸

Since insertion of PIVs with ultrasound guidance has a high success rate, there is potential to reduce the reliance on CVC insertion for venous access only. In a study of patients that had had two failed attempts at PIV insertion based on landmarks, a PIV was successfully inserted with ultrasound guidance in 84% of patients, obviating the need for CVC placement for venous access.¹¹⁶ A prospective observational study showed ultrasound-guided PIV insertion was an effective alternative to CVC placement in ED patients with difficult venous access with only 1% of patients requiring a CVC.¹¹⁷ Use of ultrasound by nurses for PIV placement has also been shown to reduce the time to obtain venous access, improve patient satisfaction, and reduce the need for physician intervention.¹¹⁸ In a prospective observational study of patients with difficult access, the majority of patients reported a better experience with ultrasound-guided PIV insertion compared to previous landmark-based attempts with an average satisfaction score of 9.2/10 with 76% of patients rating the experience a 10.¹¹⁹ A strong recommendation has been made for use of ultrasound guidance in patients with difficult PIV placement by la Société Française d’Anesthésie et de Réanimation (The French Society of Anesthesia and Resuscitation).⁹⁵

17. We suggest using real-time ultrasound guidance to reduce the risk of vascular, infectious, and neurological complications during PIV insertion, particularly in patients with difficult venous access.

Rationale: The incidence of complications from PIV insertion is often underestimated. Vascular complications include arterial puncture, hematoma formation, local infiltration or extravasation of fluid, and superficial or deep venous thrombosis. The most common infectious complications with PIV insertion are phlebitis and cellulitis.¹²⁰ One observational study reported PIV complications occurring in approximately half of all patients with the most common complications being phlebitis, hematoma formation, and fluid/blood leakage.¹²¹

A retrospective review of ICU patients who underwent ultrasound-guided PIV insertion by a single physician showed high success rates (99%) with low rates of phlebitis/cellulitis (0.7%).There was an assumed benefit of risk reduction due to the patients no longer requiring a CVC after successful PIV placement.¹²² Another study found very low rates of infection with both landmark-based and ultrasound-guided PIV placement performed by emergency department nurses, suggesting that there is no increased risk of infection with the use of ultrasound.¹²³ To reduce the risk of infection from PIV insertion, we recommend the use of sterile gel and sterile transducer cover (See Recommendation 2).

18. We recommend that providers should use real-time ultrasound guidance for arterial access, which has been shown to increase first-pass success rates, reduce the time to cannulation, and reduce the risk of hematoma development compared with landmark-based techniques.

Rationale: Several randomized controlled studies have assessed the value of ultrasound in arterial catheter insertion. Shiver et al. randomized 60 patients admitted to a tertiary center emergency department to either palpation or ultrasound-guided arterial cannulation. They demonstrated a first-pass success rate of 87% in the ultrasound group compared with 50% in the landmark technique group. In the same study, the use of ultrasound was also associated with reduced time needed to establish arterial access and a 43% reduction in the development of hematoma at the insertion site.¹²⁴ Levin et al. demonstrated a first-pass success rate of 62% using ultrasound versus 34% by palpation alone in 69 patients requiring intraoperative invasive hemodynamic monitoring.¹²⁵ Additional randomized controlled studies have demonstrated that ultrasound guidance increases first-attempt success rates compared to traditional palpation.^23,126,127

19. We recommend that providers should use real-time ultrasound guidance for femoral arterial access, which has been shown to increase first-pass success rates and reduce the risk of vascular complications.

Rationale: Although it is a less frequently used site, the femoral artery may be accessed for arterial blood sampling or invasive hemodynamic monitoring, and use of ultrasound guidance has been shown to improve the first-pass success rates of femoral artery cannulation. It is important to note that most of these studies comparing ultrasound-guided vs landmark-based femoral artery cannulation were performed in patients undergoing diagnostic or interventional vascular procedures.

A meta-analysis of randomized controlled studies comparing ultrasound-guided vs landmark-based femoral artery catheterization found use of ultrasound guidance was associated with a 49% reduction in overall complications (RR 0.51, 95% CI 0.28 to 0.91; P > .05) and 42% improvement in first-pass success rates.¹²⁸ In another study, precise site selection with ultrasound was associated with fewer pseudoaneurysms in patients undergoing femoral artery cannulation by ultrasound guidance vs palpation for cardiac catheterization (3% vs 5%, P < .05).¹²⁹

A multicenter randomized controlled study comparing ultrasound vs fluoroscopic guidance for femoral artery catheterization demonstrated ultrasound guidance improved rates of common femoral artery (CFA) cannulation in patients with high CFA bifurcations (83% vs 70%, P < .01).¹³⁰ Furthermore, ultrasound guidance improved first-pass success rates (83% vs 46%, P < .0001), reduced number of attempts (1.3 vs 3.0, P < .0001), reduced risk of venipuncture (2.4% vs 15.8%, P < .0001), and reduced median time to obtain access (136 seconds vs148 seconds, P = .003). Vascular complications occurred in fewer patients in the ultrasound vs fluoroscopy groups (1.4% vs 3.4% P = .04). Reduced risk of hematoma formation with routine use of ultrasound guidance was demonstrated in one retrospective observational study (RR 0.62, 95% CI 0.46 to 0.84; P < .01).¹³¹

20. We recommend that providers should use real-time ultrasound guidance for radial arterial access, which has been shown to increase first-pass success rates, reduce the time to successful cannulation, and reduce the risk of complications compared with landmark-based techniques.

Rationale: Ultrasound guidance is particularly useful for radial artery cannulation in patients with altered anatomy, obesity, nonpulsatile blood flow, low perfusion, and previously unsuccessful cannulation attempts using a landmark-guided approach.¹³² A meta-analysis of six randomized controlled studies in adults showed that use of ultrasound guidance significantly increased first-attempt success rate of radial artery catheterization by 14-37% (RR 1.4, 95% CI 1.28 to 1.64; P < .00001), reduced mean number of attempts (weighted mean difference (WMD) -1.17; 95% CI -2.21 to -0.13; P = .03), and mean time to successful cannulation (WMD -46 seconds; 95% CI -86.66 to -5.96, P = .02).¹³³ Other meta-analyses of randomized studies have demonstrated similar benefits of using ultrasound guidance for radial artery cannulation.^126,127,134

A multicenter randomized controlled study that was not included in the abovementioned meta-analyses showed similar benefits of using ultrasound guidance vs landmarks for radial artery catheterization: a reduction in the number of attempts with ultrasound guidance (1.65 ± 1.2 vs 3.05 ± 3.4, P < .0001) and time to obtain access (88 ± 78 vs 108 ± 112 seconds, P = .006), and increased first-pass success rates (65% vs 44%, P < .0001). The use of ultrasound guidance was found to be particularly useful in patients with difficult access by palpation alone.¹³⁵

Regarding the level of expertise required to use ultrasound guidance, a prospective observational study demonstrated that physicians with little previous ultrasound experience were able to improve their first-attempt success rates and procedure time for radial artery cannulation compared to historical data of landmark-based insertions.¹³⁶

21. We recommend that post-procedure pneumothorax should be ruled out by the detection of bilateral lung sliding using a high-frequency linear transducer before and after insertion of internal jugular and subclavian vein CVCs.

Rationale: Detection of lung sliding with two-dimensional ultrasound rules out pneumothorax, and disappearance of lung sliding in an area where it was previously seen is a strong predictor of postprocedure pneumothorax. In a study of critically ill patients, the disappearance of lung sliding was observed in 100% of patients with pneumothorax vs 8.8% of patients without pneumothorax. For detection of pneumothorax, lung sliding showed a sensitivity of 95%, specificity of 91%, and negative predictive value of 100% (P < .001).¹³⁷ Another study by the same author showed that the combination of horizontal artifacts (absence of comet-tail artifact) and absence of lung sliding had a sensitivity of 100%, specificity of 96.5%, and negative predictive value of 100% for the detection of pneumothorax.¹³⁸ A meta-analysis of 10 studies on the diagnostic accuracy of CVC confirmation with bedside ultrasound vs chest radiography reported detection of all 12 pneumothoraces with ultrasound, whereas chest radiography missed two pneumothoraces. The pooled sensitivity and specificity of ultrasound for the detection of pneumothorax was 100%, although an imperfect gold standard bias likely affected the results. An important advantage of bedside ultrasound is the ability to rule out pneumothorax immediately after the procedure while at the bedside. The mean time for confirmation of CVC placement with bedside ultrasound was 6 minutes versus 64 minutes and 143 minutes for completion and interpretation of a chest radiograph, respectively.¹³⁹

22. We recommend that providers should use ultrasound with rapid infusion of agitated saline to visualize a right atrial swirl sign (RASS) for detecting catheter tip misplacement during CVC insertion. The use of RASS to detect the catheter tip may be considered an advanced skill that requires specific training and expertise.

Rationale: Bedside echocardiography is a reliable tool to detect catheter tip misplacement during CVC insertion. In one study, catheter misplacement was detected by bedside echocardiography with a sensitivity of 96% and specificity of 83% (positive predictive value 98%, negative predictive value 55%) and prevented distal positioning of the catheter tip.¹⁴⁰ A prospective observational study assessed for RASS, which is turbulent flow in the right atrium after a rapid saline flush of the distal CVC port, to exclude catheter malposition. In this study with 135 CVC placements, visualization of RASS with ultrasound was able to identify all correct CVC placements and three of four catheter misplacements. Median times to complete the ultrasound exam vs CXR were 1 vs 20 minutes, respectively, with a median difference of 24 minutes (95% CI 19.6 to 29.3, P < .0001) between the two techniques.¹⁴¹

A prospective observational study assessed the ability of bedside transthoracic echocardiography to detect the guidewire, microbubbles, or both, in the right atrium compared to transesophageal echocardiography as the gold standard. Bedside transthoracic echocardiography allowed visualization of the right atrium in 94% of patients, and both microbubbles plus guidewire in 91% of patients.¹⁴² Hence, bedside transthoracic echocardiography allows adequate visualization of the right atrium. Another prospective observational study combining ultrasonography and contrast enhanced RASS resulted in 96% sensitivity and 93% specificity for the detection of a misplaced catheter, and the concordance with chest radiography was 96%.¹⁴³

23. To reduce the risk of mechanical and infectious complications, we recommend that novice providers should complete a systematic training program that includes a combination of simulation-based practice, supervised insertion on patients, and evaluation by an expert operator before attempting ultrasound-guided CVC insertion independently on patients.

Rationale: Cumulative experience has been recognized to not be a proxy for mastery of a clinical skill.¹⁴⁴ The National Institute for Clinical Excellence (NICE) has recommended that providers performing ultrasound-guided CVC insertion should receive appropriate training to achieve competence before performing the procedure independently.⁷ Surveys have demonstrated that lack of training is a commonly reported barrier for not using ultrasound.^145,146

Structured training programs on CVC insertion have been shown to reduce the occurrence of infectious and mechanical complications.^{74,143,147-149} The use of ultrasound and checklists, bundling of supplies, and practice with simulation models, as a part of a structured training program, can improve patient safety related to CVC insertion.^{9,140,150-154}

Simulation-based practice has been used in medical education to provide deliberate practice and foster skill development in a controlled learning environment.^155-158 Studies have shown transfer of skills demonstrated in a simulated environment to clinical practice, which can improve CVC insertion practices.^159,160 Simulation accelerates learning of all trainees, especially novice trainees, and mitigates risks to patients by allowing trainees to achieve a minimal level of competence before attempting the procedure on real patients.^152,161,162 Residents that have been trained using simulation preferentially select the IJV site,¹⁴⁷ and more reliably use ultrasound to guide their CVC insertions.^160,163

Additionally, simulation-based practice allows exposure to procedures and scenarios that may occur infrequently in clinical practice.

Although there is evidence on efficacy of simulation-based CVC training programs, there is no broadly accepted consensus on timing, duration, and content of CVC training programs for trainees or physicians in practice. The minimum recommended technical skills a trainee must master include the ability to (1) manipulate the ultrasound machine to produce a high-quality image to identify the target vessel, (2) advance the needle under direct visualization to the desired target site and depth, (3) deploy the catheter into the target vessel and confirm catheter placement in the target vessel using ultrasound, and (4) ensure the catheter has not been inadvertently placed in an unintended vessel or structure.¹⁵³

A variety of simulation models are currently used to practice CVC insertion at the most common sites: the internal jugular, subclavian, basilic, and brachial veins.^164,165 Effective simulation models should contain vessels that mimic normal anatomy with muscles, soft tissues, and bones. Animal tissue models, such as turkey or chicken breasts, may be effective for simulated practice of ultrasound-guided CVC insertion.^166,167 Ultrasound-guided CVC training using human cadavers has also been shown to be effective.¹⁶⁸

24. We recommend that cognitive training in ultrasound-guided CVC insertion should include basic anatomy, ultrasound physics, ultrasound machine knobology, fundamentals of image acquisition and interpretation, detection and management of procedural complications, infection prevention strategies, and pathways to attain competency.

Rationale: After receiving training in ultrasound-guided CVC insertion, physicians report significantly higher comfort with the use of ultrasound compared to those who have not received such training.¹⁴⁵ Learners find training sessions worthwhile to increase skill levels,¹⁶⁷ and skills learned from simulation-based mastery learning programs have been retained up to one year.¹⁵⁸

Several commonalities have been noted across training curricula. Anatomy and physiology didactics should include vessel anatomy (location, size, and course);⁹ vessel differentiation by ultrasound;^9,69 blood flow dynamics;⁶⁹ Virchow’s triad;⁶⁹ skin integrity and colonization;¹⁵⁰ peripheral nerve identification and distribution;⁹ respiratory anatomy;^9,69 upper and lower extremity, axillary, neck, and chest anatomy.^9,69 Vascular anatomy is an essential curricular component that may help avoid preventable CVC insertion complications, such as inadvertent nerve, artery, or lung puncture.^150,169 Training curricula should also include ultrasound physics (piezoelectric effect, frequency, resolution, attenuation, echogenicity, Doppler ultrasound, arterial and venous flow characteristics), image acquisition and optimization (imaging mode, focus, dynamic range, probe types), and artifacts (reverberation, mirror, shadowing, enhancement).

CVC-related infections are an important cause of morbidity and mortality in the acute and long-term care environment.⁶⁹ Infection and thrombosis can both be impacted by the insertion site selection, skin integrity, and catheter–vein ratio.^2,3,84 Inexperience generally leads to more insertion attempts that can increase trauma during CVC insertion and potentially increase the risk of infections.¹⁷⁰ To reduce the risk of infectious complications, training should include important factors to consider in site selection and maintenance of a sterile environment during CVC insertion, including use of maximal sterile barrier precautions, hand hygiene, and appropriate use of skin antiseptic solutions.

Professional society guidelines have been published with recommendations of appropriate techniques for ultrasound-guided vascular access that include training recommendations.^9,154 Training should deconstruct the insertion procedure into readily understood individual steps, and can be aided by demonstration of CVC insertion techniques using video clips. An alternative to face-to-face training is internet-based training that has been shown to be as effective as traditional teaching methods in some medical centers.¹⁷¹ Additional methods to deliver cognitive instruction include textbooks, continuing medical education courses, and digital videos.^164,172

25. We recommend that trainees should demonstrate minimal competence before placing ultrasound-guided CVCs independently. A minimum number of CVC insertions may inform this determination, but a proctored assessment of competence is most important.

Rationale: CVC catheter placement carries the risk of serious complications including arterial injury or dissection, pneumothorax, or damage to other local structures; arrhythmias; catheter malposition; infection; and thrombosis. Although there is a lack of consensus and high-quality evidence for the certification of skills to perform ultrasound-guided CVC insertion, recommendations have been published advocating for formal and comprehensive training programs in ultrasound-guided CVC insertion with an emphasis on expert supervision prior to independent practice.^9,153,154 Two groups of expert operators have recommended that training should include at least 8-10 supervised ultrasound-guided CVC insertions.^154,173,174 A consensus task force from the World Congress of Vascular Access has recommended a minimum of six to eight hours of didactic education, four hours of hands-on training on simulation models, and six hours of hands-on ultrasound training on human volunteers to assess normal anatomy.¹⁷⁵ This training should be followed by supervised ultrasound-guided CVC insertions until the learner has demonstrated minimal competence with a low rate of complications.³⁵ There is general consensus that arbitrary numbers should not be the sole determinant of competence, and that the most important determinant of competence should be an evaluation by an expert operator.¹⁷⁶

26. We recommend that didactic and hands-on training for trainees should coincide with anticipated times of increased performance of vascular access procedures. Refresher training sessions should be offered periodically.

Rationale: Simulation-based CVC training courses have shown a rapid improvement in skills, but lack of practice leads to deterioration of technical skills.^{161,162,177,178} Thus, a single immersive training session is insufficient to achieve and maintain mastery of skills, and an important factor to acquire technical expertise is sustained, deliberate practice with feedback.¹⁷⁹ Furthermore, an insidious decay in skills may go unrecognized as a learner’s comfort and self-confidence does not always correlate with actual performance, leading to increased risk of errors and potential for procedural complications.^{147,158,180-183} Given the decay in technical skills over time, simulation-based training sessions are most effective when they occur in close temporal proximity to times when those skills are most likely to be used; for example, a simulation-based training session for trainees may be most effective just before the start of a critical care rotation.¹⁵² Regularly scheduled training sessions with monitoring and feedback by expert operators can reinforce procedural skills and prevent decay. Some experts have recommended that a minimum of 10 ultrasound-guided CVC insertions should be performed annually to maintain proficiency.¹⁵³

27. We recommend that competency assessments should include formal evaluation of knowledge and technical skills using standardized assessment tools.

Rationale: Hospitalists and other healthcare providers that place vascular access catheters should undergo competency assessments proctored by an expert operator to verify that they have the required knowledge and skills.^184,185 Knowledge competence can be partially evaluated using a written assessment, such as a multiple-choice test, assessing the provider’s cognitive understanding of the procedure.¹⁷⁵ For ultrasound-guided CVC insertion, a written examination should be administered in conjunction with an ultrasound image assessment to test the learner’s recognition of normal vs abnormal vascular anatomy. Minimum passing standards should be established a priori according to local or institutional standards.

The final skills assessment should be objective, and the learner should be required to pass all critical steps of the procedure. Failure of the final skills assessment should lead to continued practice with supervision until the learner can consistently demonstrate correct performance of all critical steps. Checklists are commonly used to rate the technical performance of learners because they provide objective criteria for evaluation, can identify specific skill deficiencies, and can determine a learner’s readiness to perform procedures independently.^186,187 The administration of skills assessments and feedback methods should be standardized across faculty. Although passing scores on both knowledge and skills assessments do not guarantee safe performance of a procedure independently, they provide a metric to ensure that a minimum level of competence has been achieved before allowing learners to perform procedures on patients without supervision.¹⁸⁸

Competency assessments are a recommended component of intramural and extramural certification of skills in ultrasound-guided procedures. Intramural certification pathways differ by institution and often require additional resources including ultrasound machine(s), simulation equipment, and staff time, particularly when simulation-based assessments are incorporated into certification pathways. We recognize that some of these recommendations may not be feasible in resource-limited settings, such as rural hospitals. However, initial and ongoing competency assessments can be performed during routine performance of procedures on patients. For an in-depth review of credentialing pathways for ultrasound-guided bedside procedures, we recommend reviewing the SHM Position Statement on Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures.²⁴

28. We recommend that competency assessments should evaluate for proficiency in the following knowledge and skills of CVC insertion:
a. Knowledge of the target vein anatomy, proper vessel identification, and recognition of anatomical variants
b. Demonstration of CVC insertion with no technical errors based on a procedural checklist
c. Recognition and management of acute complications, including emergency management of life-threatening complications
d. Real-time needle tip tracking with ultrasound and cannulation on the first attempt in at least five consecutive simulations.

Rationale: Recommendations have been published with the minimal knowledge and skills learners must demonstrate to perform ultrasound-guided vascular access procedures. These include operation of an ultrasound machine to produce high-quality images of the target vessel, tracking of the needle tip with real-time ultrasound guidance, and recognition and understanding of the management of procedural complications.^154,175

First, learners must be able to perform a preprocedural assessment of the target vein, including size and patency of the vein; recognition of adjacent critical structures; and recognition of normal anatomical variants.^175,189 Second, learners must be able to demonstrate proficiency in tracking the needle tip penetrating the target vessel, inserting the catheter into the target vessel, and confirming catheter placement in the target vessel with ultrasound.^154,175 Third, learners must be able to demonstrate recognition of acute complications, including arterial puncture, hematoma formation, and development of pneumothorax.^154,175 Trainees should be familiar with recommended evaluation and management algorithms, including indications for emergent consultation.¹⁹⁰

29. We recommend a periodic proficiency assessments of all operators should be conducted to ensure maintenance of competency.

Rationale: Competency extends to periodic assessment and not merely an initial evaluation at the time of training.¹⁹¹ Periodic competency assessments should include assessment of proficiency of all providers that perform a procedure, including instructors and supervisors. Supervising providers should maintain their competency in CVC insertion through routine use of their skills in clinical practice.¹⁷⁵ An observational study of emergency medicine residents revealed that lack of faculty comfort with ultrasound hindered the residents’ use of ultrasound.¹⁹² Thus, there is a need to examine best practices for procedural supervision of trainees because providers are often supervising procedures that they are not comfortable performing on their own.¹⁹³

The process of producing this position statement revealed areas of uncertainty and important gaps in the literature regarding the use of ultrasound guidance for central and peripheral venous access and arterial access.

This position statement recommends a preprocedural ultrasound evaluation of blood vessels based on evidence that providers may detect anatomic anomalies, thrombosis, or vessel stenosis. Ultrasound can also reveal unsuspected high-risk structures in near proximity to the procedure site. Although previous studies have shown that providers can accurately assess vessels with ultrasound for these features, further study is needed to evaluate the effect of a standardized preprocedural ultrasound exam on clinical and procedural decision-making, as well as procedural outcomes.

Second, two ultrasound applications that are being increasingly used but have not been widely implemented are the use of ultrasound to evaluate lung sliding postprocedure to exclude pneumothorax and the verification of central line placement using a rapid infusion of agitated saline to visualize the RASS.^139-141 Both of these applications have the potential to expedite postprocedure clearance of central lines for usage and decrease patient radiation exposure by obviating the need for postprocedure CXRs. Despite the supporting evidence, both of these applications are not yet widely used, as few providers have been trained in these techniques which may be considered advanced skills.

Third, despite advances in our knowledge of effective training for vascular access procedures, there is limited agreement on how to define procedural competence. Notable advancements in training include improved understanding of systematic training programs, development of techniques for proctoring procedures, definition of elements for hands-on assessments, and definition of minimum experience needed to perform vascular access procedures independently. However, application of these concepts to move learners toward independent practice remains variably interpreted at different institutions, likely due to limited resources, engrained cultures about procedures, and a lack of national standards. The development of hospitalist-based procedure services at major academic medical centers with high training standards, close monitoring for quality assurance, and the use of databases to track clinical outcomes may advance our understanding and delivery of optimal procedural training.

Finally, ultrasound technology is rapidly evolving which will affect training, techniques, and clinical outcomes in coming years. Development of advanced imaging software with artificial intelligence can improve needle visualization and tracking. These technologies have the potential to facilitate provider training in real-time ultrasound-guided procedures and improve the overall safety of procedures. Emergence of affordable, handheld ultrasound devices is improving access to ultrasound technology, but their role in vascular access procedures is yet to be defined. Furthermore, availability of wireless handheld ultrasound technology and multifrequency transducers will create new possibilities for use of ultrasound in vascular access procedures.

We have presented several evidence-based recommendations on the use of ultrasound guidance for placement of central and peripheral vascular access catheters that are intended for hospitalists and other healthcare providers who routinely perform vascular access procedures. By allowing direct visualization of the needle tip and target vessel, the use of ultrasound guidance has been shown in randomized studies to reduce needle insertion attempts, reduce needle redirections, and increase overall procedure success rates. The accuracy of ultrasound to identify the target vessel, assess for thrombosis, and detect anatomical anomalies is superior to that of physical examination. Hospitalists can attain competence in performing ultrasound-guided vascular access procedures through systematic training programs that combine didactic and hands-on training, which optimally include patient-based competency assessments.

Acknowledgments

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

Collaborators of Society of Hospital Medicine Point-of-care Ultrasound Task Force: Robert Arntfield, Jeffrey Bates, Anjali Bhagra, Michael Blaivas, Daniel Brotman, Richard Hoppmann, Susan Hunt, Trevor P. Jensen, Venkat Kalidindi, Ketino Kobaidze, Joshua Lenchus, Paul Mayo, Satyen Nichani, Vicki Noble, Nitin Puri, Aliaksei Pustavoitau, Kreegan Reierson, Gerard Salame, Kirk Spencer, Vivek Tayal, David Tierney

SHM Point-of-care Ultrasound Task Force: CHAIRS: Nilam J. Soni, Ricardo Franco-Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Mathews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Mathews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen Lumbar Puncture Working Group: Nilam J. Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El-Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Daniel Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

Approximately five million central venous catheters (CVCs) are inserted in the United States annually, with over 15 million catheter days documented in intensive care units alone.¹ Traditional CVC insertion techniques using landmarks are associated with a high risk of mechanical complications, particularly pneumothorax and arterial puncture, which occur in 5%-19% patients.^2,3

Since the 1990s, several randomized controlled studies and meta-analyses have demonstrated that the use of real-time ultrasound guidance for CVC insertion increases procedure success rates and decreases mechanical complications.^4,5 Use of real-time ultrasound guidance was recommended by the Agency for Healthcare Research and Quality, the Institute of Medicine, the National Institute for Health and Care Excellence, the Centers for Disease Control and Prevention, and several medical specialty societies in the early 2000s.^6-14 Despite these recommendations, ultrasound guidance has not been universally adopted. Currently, an estimated 20%-55% of CVC insertions in the internal jugular vein are performed without ultrasound guidance.^15-17

Following the emergence of literature supporting the use of ultrasound guidance for CVC insertion, observational and randomized controlled studies demonstrated improved procedural success rates with the use of ultrasound guidance for the insertion of peripheral intravenous lines (PIVs), arterial catheters, and peripherally inserted central catheters (PICCs).^18-23

The purpose of this position statement is to present evidence-based recommendations on the use of ultrasound guidance for the insertion of central and peripheral vascular access catheters in adult patients. This document presents consensus-based recommendations with supporting evidence for clinical outcomes, techniques, and training for the use of ultrasound guidance for vascular access. We have subdivided the recommendations on techniques for central venous access, peripheral venous access, and arterial access individually, as some providers may not perform all types of vascular access procedures.

These recommendations are intended for hospitalists and other healthcare providers that routinely place central and peripheral vascular access catheters in acutely ill patients. However, this position statement does not mandate that all hospitalists should place central or peripheral vascular access catheters given the diverse array of hospitalist practice settings. For training and competency assessments, we recognize that some of these recommendations may not be feasible in resource-limited settings, such as rural hospitals, where equipment and staffing for assessments are not available. Recommendations and frameworks for initial and ongoing credentialing of hospitalists in ultrasound-guided bedside procedures have been previously published in an Society of Hospital Medicine (SHM) position statement titled, “Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures.”²⁴

Detailed methods are described in Appendix 1. The SHM Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced practice providers with expertise in POCUS. Expert panel members were divided into working group members, external peer reviewers, and a methodologist. All Task Force members were required to disclose any potential conflicts of interest (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the vascular access working group members themselves. Key clinical questions and draft recommendations were then prepared. A systematic literature search was conducted by a medical librarian based on the findings of the initial literature search and draft recommendations. The Medline, Embase, CINAHL, and Cochrane medical databases were searched from 1975 to December 2015 initially. Google Scholar was also searched without limiters. An updated search was conducted in November 2017. The literature search strings are included in Appendix 3. All article abstracts were initially screened for relevance by at least two members of the vascular access working group. Full-text versions of screened articles were reviewed, and articles on the use of ultrasound to guide vascular access were selected. The following article types were excluded: non-English language, nonhuman, age <18 years, meeting abstracts, meeting posters, narrative reviews, case reports, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled studies, and observational studies of ultrasound-guided vascular access were screened and selected (Appendix 3, Figure 1). All full-text articles were shared electronically among the working group members, and final article selection was based on working group consensus. Selected articles were incorporated into the draft recommendations.

These recommendations were developed using the Research and Development (RAND) Appropriateness Method that required panel judgment and consensus.¹⁴ The 28 voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering five transforming factors: (1) Problem priority and importance, (2) Level of quality of evidence, (3) Benefit/harm balance, (4) Benefit/burden balance, and (5) Certainty/concerns about PEAF (Preferences/Equity/Acceptability/Feasibility). Using an internet-based electronic data collection tool (REDCap™), panel members participated in two rounds of electronic voting, one in August 2018 and the other in October 2018 (Appendix 4). Voting on appropriateness was conducted using a nine-point Likert scale. The three zones of the nine-point Likert scale were inappropriate (1-3 points), uncertain (4-6 points), and appropriate (7-9 points). The degree of consensus was assessed using the RAND algorithm (Appendix 1, Figure 1 and Table 1). Establishing a recommendation required at least 70% agreement that a recommendation was “appropriate.” Disagreement was defined as >30% of panelists voting outside of the zone of the median. A strong recommendation required at least 80% of the votes within one integer of the median per the RAND rules.

Literature Search

A total of 5,563 references were pooled from an initial search performed by a certified medical librarian in December 2015 (4,668 citations) which was updated in November 2017 (791 citations), and from the personal bibliographies and searches (104 citations) performed by working group members. A total of 514 full-text articles were reviewed. The final selection included 192 articles that were abstracted into a data table and incorporated into the draft recommendations. See Appendix 3 for details of the literature search strategy.

Four domains (technique, clinical outcomes, training, and knowledge gaps) with 31 draft recommendations were generated based on a review of the literature. Selected references were abstracted and assigned to each draft recommendation. Rationales for each recommendation cite supporting evidence. After two rounds of panel voting, 31 recommendations achieved agreement based on the RAND rules. During the peer review process, two of the recommendations were merged with other recommendations. Thus, a total of 29 recommendations received final approval. The degree of consensus based on the median score and the dispersion of voting around the median are shown in Appendix 5. Twenty-seven statements were approved as strong recommendations, and two were approved as weak/conditional recommendations. The strength of each recommendation and degree of consensus are summarized in Table 3.

Terminology
Central Venous Catheterization

Central venous catheterization refers to insertion of tunneled or nontunneled large bore vascular catheters that are most commonly inserted into the internal jugular, subclavian, or femoral veins with the catheter tip located in a central vein. These vascular access catheters are synonymously referred to as central lines or central venous catheters (CVCs). Nontunneled catheters are designed for short-term use and should be removed promptly when no longer clinically indicated or after a maximum of 14 days.²⁵

Peripherally Inserted Central Catheter (PICC)

Peripherally inserted central catheters, or PICC lines, are inserted most commonly in the basilic or brachial veins in adult patients, and the catheter tip terminates in the distal superior vena cava or cavo-atrial junction. These catheters are designed to remain in place for a duration of several weeks, as long as it is clinically indicated.

Midline Catheterization

Midline catheters are a type of peripheral venous catheter that are an intermediary between a peripheral intravenous catheter and PICC line. Midline catheters are most commonly inserted in the brachial or basilic veins, but unlike PICC lines, the tips of these catheters terminate in the axillary or subclavian vein. Midline catheters are typically 8 cm to 20 cm in length and inserted for a duration <30 days.

Peripheral Intravenous Catheterization

Peripheral intravenous lines (PIV) refer to small bore venous catheters that are most commonly 14G to 24G and inserted into patients for short-term peripheral venous access. Common sites of ultrasound-guided PIV insertion include the superficial and deep veins of the hand, forearm, and arm.

Arterial Catheterization

Arterial catheters are commonly used for reliable blood pressure monitoring, frequent arterial blood sampling, and cardiac output monitoring. The most common arterial access sites are the femoral and radial arteries.

1. We recommend that providers should be familiar with the operation of their specific ultrasound machine prior to initiation of a vascular access procedure.

Rationale: There is strong consensus that providers must be familiar with the knobs and functions of the specific make and model of ultrasound machine that will be utilized for a vascular access procedure. Minimizing adjustments to the ultrasound machine during the procedure may reduce the risk of contaminating the sterile field.

2. We recommend that providers should use a high-frequency linear transducer with a sterile sheath and sterile gel to perform vascular access procedures.

Rationale: High-frequency linear-array transducers are recommended for the vast majority of vascular access procedures due to their superior resolution compared to other transducer types. Both central and peripheral vascular access procedures, including PIV, PICC, and arterial line placement, should be performed using sterile technique. A sterile transducer cover and sterile gel must be utilized, and providers must be trained in sterile preparation of the ultrasound transducer.^13,26,27

The depth of femoral vessels correlates with body mass index (BMI). When accessing these vessels in a morbidly obese patient with a thigh circumference >60 cm and vessel depth >8 cm, a curvilinear transducer may be preferred for its deeper penetration.²⁸ For patients who are poor candidates for bedside insertion of vascular access catheters, such as uncooperative patients, patients with atypical vascular anatomy or poorly visualized target vessels, we recommend consultation with a vascular access specialist prior to attempting the procedure.

3. We recommend that providers should use two-dimensional ultrasound to evaluate for anatomical variations and absence of vascular thrombosis during preprocedural site selection.

Rationale: A thorough ultrasound examination of the target vessel is warranted prior to catheter placement. Anatomical variations that may affect procedural decision-making are easily detected with ultrasound. A focused vascular ultrasound examination is particularly important in patients who have had temporary or tunneled venous catheters, which can cause stenosis or thrombosis of the target vein.

For internal jugular vein (IJV) CVCs, ultrasound is useful for visualizing the relationship between the IJV and common carotid artery (CCA), particularly in terms of vessel overlap. Furthermore, ultrasound allows for immediate revisualization upon changes in head position.^29-32 Troianos et al. found >75% overlap of the IJV and CCA in 54% of all patients and in 64% of older patients (age >60 years) whose heads were rotated to the contralateral side.³⁰ In one study of IJV CVC insertion, inadvertent carotid artery punctures were reduced (3% vs 10%) with the use of ultrasound guidance vs landmarks alone.³³ In a cohort of 64 high-risk neurosurgical patients, cannulation success was 100% with the use of ultrasound guidance, and there were no injuries to the carotid artery, even though the procedure was performed with a 30-degree head elevation and anomalous IJV anatomy in 39% of patients.³⁴ In a prospective, randomized controlled study of 1,332 patients, ultrasound-guided cannulation in a neutral position was demonstrated to be as safe as the 45-degree rotated position.³⁵

Ultrasound allows for the recognition of anatomical variations which may influence the selection of the vascular access site or technique. Benter et al. found that 36% of patients showed anatomical variations in the IJV and surrounding tissue.³⁶ Similarly Caridi showed the anatomy of the right IJV to be atypical in 29% of patients,³⁷ and Brusasco found that 37% of bariatric patients had anatomical variations of the IJV.³⁸ In a study of 58 patients, there was significant variability in the IJV position and IJV diameter, ranging from 0.5 cm to >2 cm.³⁹ In a study of hemodialysis patients, 75% of patients had sonographic venous abnormalities that led to a change in venous access approach.⁴⁰

To detect acute or chronic upper extremity deep venous thrombosis or stenosis, two-dimensional visualization with compression should be part of the ultrasound examination prior to central venous catheterization. In a study of patients that had undergone CVC insertion 9-19 weeks earlier, 50% of patients had an IJV thrombosis or stenosis leading to selection of an alternative site. In this study, use of ultrasound for a preprocedural site evaluation reduced unnecessary attempts at catheterizing an occluded vein.⁴¹ At least two other studies demonstrated an appreciable likelihood of thrombosis. In a study of bariatric patients, 8% of patients had asymptomatic thrombosis³⁸ and in another study, 9% of patients being evaluated for hemodialysis catheter placement had asymptomatic IJV thrombosis.³⁷

4. We recommend that providers should evaluate the target blood vessel size and depth during a preprocedural ultrasound evaluation.

Rationale: The size, depth, and anatomic location of central veins can vary considerably. These features are easily discernable using ultrasound. Contrary to traditional teaching, the IJV is located 1 cm anterolateral to the CCA in only about two-thirds of patients.^37,39,42,43 Furthermore, the diameter of the IJV can vary significantly, ranging from 0.5 cm to >2 cm.³⁹ The laterality of blood vessels may vary considerably as well. A preprocedural ultrasound evaluation of contralateral subclavian and axillary veins showed a significant absolute difference in cross-sectional area of 26.7 mm² (P < .001).⁴²

Blood vessels can also shift considerably when a patient is in the Trendelenburg position. In one study, the IJV diameter changed from 11.2 (± 1.5) mm to 15.4 (± 1.5) mm in the supine versus the Trendelenburg position at 15 degrees.³³ An observational study demonstrated a frog-legged position with reverse Trendelenburg increased the femoral vein size and reduced the common surface area with the common femoral artery compared to a neutral position. Thus, a frog-legged position with reverse Trendelenburg position may be preferred, since overall catheterization success rates are higher in this position.⁴⁴

General Techniques

5. We recommend that providers should avoid using static ultrasound alone to mark the needle insertion site for vascular access procedures.

Rationale: The use of static ultrasound guidance to mark a needle insertion site is not recommended because normal anatomical relationships of vessels vary, and site marking can be inaccurate with minimal changes in patient position, especially of the neck.^43,45,46 Benefits of using ultrasound guidance for vascular access are attained when ultrasound is used to track the needle tip in real-time as it is advanced toward the target vessel.

Although continuous-wave Doppler ultrasound without two-dimensional visualization was used in the past, it is no longer recommended for IJV CVC insertion.⁴⁷ In a study that randomized patients to IJV CVC insertion with continuous-wave Doppler alone vs two-dimensional ultrasound guidance, the use of two-dimensional ultrasound guidance showed significant improvement in first-pass success rates (97% vs 91%, P = .045), particularly in patients with BMI >30 (97% vs 77%, P = .011).⁴⁸

A randomized study comparing real-time ultrasound-guided, landmark-based, and ultrasound-marked techniques found higher success rates in the real-time ultrasound-guided group than the other two groups (100% vs 74% vs 73%, respectively; P = .01). The total number of mechanical complications was higher in the landmark-based and ultrasound-marked groups than in the real-time ultrasound-guided group (24% and 36% versus 0%, respectively; P = .01).⁴⁹ Another randomized controlled study found higher success rates with real-time ultrasound guidance (98%) versus an ultrasound-marked (82%) or landmark-based (64%) approach for central line placement.⁵⁰

6. We recommend that providers should use real-time (dynamic), two-dimensional ultrasound guidance with a high-frequency linear transducer for CVC insertion, regardless of the provider’s level of experience.

7. We suggest using either a transverse (short-axis) or longitudinal (long-axis) approach when performing real-time ultrasound-guided vascular access procedures.

Rationale: In clinical practice, the phrases transverse, short-axis, or out-of-plane approach are synonymous, as are longitudinal, long-axis, and in-plane approach. The short-axis approach involves tracking the needle tip as it approximates the target vessel with the ultrasound beam oriented in a transverse plane perpendicular to the target vessel. The target vessel is seen as a circular structure on the ultrasound screen as the needle tip approaches the target vessel from above. This approach is also called the out-of-plane technique since the needle passes through the ultrasound plane. The advantages of the short-axis approach include better visualization of adjacent vessels or nerves and the relative ease of skill acquisition for novice operators.⁹ When using the short-axis approach, extra care must be taken to track the needle tip from the point of insertion on the skin to the target vessel. A disadvantage of the short-axis approach is unintended posterior wall puncture of the target vessel.⁵⁵

In contrast to a short-axis approach, a long-axis approach is performed with the ultrasound beam aligned parallel to the vessel. The vessel appears as a long tubular structure and the entire needle is visualized as it traverses across the ultrasound screen to approach the target vessel. The long-axis approach is also called an in-plane technique because the needle is maintained within the plane of the ultrasound beam. The advantage of a long-axis approach is the ability to visualize the entire needle as it is inserted into the vessel.¹⁴ A randomized crossover study with simulation models compared a long-axis versus short-axis approach for both IJV and subclavian vein catheterization. This study showed decreased number of needle redirections (relative risk (RR) 0.5, 95% confidence interval (CI) 0.3 to 0.7), and posterior wall penetrations (OR 0.3, 95% CI 0.1 to 0.9) using a long-axis versus short-axis approach for subclavian vein catheterization.⁵⁶

A randomized controlled study comparing a long-axis or short-axis approach with ultrasound versus a landmark-based approach for IJV CVC insertion showed higher success rates (100% vs 90%; P < .001), lower insertion time (53 vs 116 seconds; P < .001), and fewer attempts to obtain access (2.5 vs 1.2 attempts, P < .001) with either the long- or short-axis ultrasound approach. The average time to obtain access and number of attempts were comparable between the short-axis and long-axis approaches with ultrasound. The incidence of carotid puncture and hematoma was significantly higher with the landmark-based approach versus either the long- or short-axis ultrasound approach (carotid puncture 17% vs 3%, P = .024; hematoma 23% vs 3%, P = .003).⁵⁷

High success rates have been reported using a short-axis approach for insertion of PIV lines.⁵⁸ A prospective, randomized trial compared the short-axis and long-axis approach in patients who had had ≥2 failed PIV insertion attempts. Success rate was 95% (95% CI, 0.85 to 1.00) in the short-axis group compared with 85% (95% CI, 0.69 to 1.00) in the long-axis group. All three subjects with failed PIV placement in the long-axis group had successful rescue placement using a short-axis approach. Furthermore, the short-axis approach was faster than the long-axis approach.⁵⁹

For radial artery cannulation, limited data exist comparing the short- and long-axis approaches. A randomized controlled study compared a long-axis vs short-axis ultrasound approach for radial artery cannulation. Although the overall procedure success rate was 100% in both groups, the long-axis approach had higher first-pass success rates (1.27 ± 0.4 vs 1.5 ± 0.5, P < .05), shorter cannulation times (24 ± 17 vs 47 ± 34 seconds, P < .05), fewer hematomas (4% vs 43%, P < .05) and fewer posterior wall penetrations (20% vs 56%, P < .05).⁶⁰

Another technique that has been described for IJV CVC insertion is an oblique-axis approach, a hybrid between the long- and short-axis approaches. In this approach, the transducer is aligned obliquely over the IJV and the needle is inserted using a long-axis or in-plane approach. A prospective randomized trial compared the short-axis, long-axis, and oblique-axis approaches during IJV cannulation. First-pass success rates were 70%, 52%, and 74% with the short-axis, long-axis, and oblique-axis approaches, respectively, and a statistically significant difference was found between the long- and oblique-axis approaches (P = .002). A higher rate of posterior wall puncture was observed with a short-axis approach (15%) compared with the oblique-axis (7%) and long-axis (4%) approaches (P = .047).⁶¹

8. We recommend that providers should visualize the needle tip and guidewire in the target vein prior to vessel dilatation.

Rationale: When real-time ultrasound guidance is used, visualization of the needle tip within the vein is the first step to confirm cannulation of the vein and not the artery. After the guidewire is advanced, the provider can use transverse and longitudinal views to reconfirm cannulation of the vein. In a longitudinal view, the guidewire is readily seen positioned within the vein, entering the anterior wall and lying along the posterior wall of the vein. Unintentional perforation of the posterior wall of the vein with entry into the underlying artery can be detected by ultrasound, allowing prompt removal of the needle and guidewire before proceeding with dilation of the vessel. In a prospective observational study that reviewed ultrasound-guided IJV CVC insertions, physicians were able to more readily visualize the guidewire than the needle in the vein.⁶² A prospective observational study determined that novice operators can visualize intravascular guidewires in simulation models with an overall accuracy of 97%.⁶³

In a retrospective review of CVC insertions where the guidewire position was routinely confirmed in the target vessel prior to dilation, there were no cases of arterial dilation, suggesting confirmation of guidewire position can potentially eliminate the morbidity and mortality associated with arterial dilation during CVC insertion.⁶⁴

9. To increase the success rate of ultrasound-guided vascular access procedures, we recommend that providers should utilize echogenic needles, plastic needle guides, and/or ultrasound beam steering when available.

Rationale: Echogenic needles have ridged tips that appear brighter on the screen, allowing for better visualization of the needle tip. Plastic needle guides help stabilize the needle alongside the transducer when using either a transverse or longitudinal approach. Although evidence is limited, some studies have reported higher procedural success rates when using echogenic needles, plastic needle guides, and ultrasound beam steering software. In a prospective observational study, Augustides et al. showed significantly higher IJV cannulation rates with versus without use of a needle guide after first (81% vs 69%, P = .0054) and second (93% vs 80%. P = .0001) needle passes.⁶⁵ A randomized study by Maecken et al. compared subclavian vein CVC insertion with or without use of a needle guide, and found higher procedure success rates within the first and second attempts, reduced time to obtain access (16 seconds vs 30 seconds; P = .0001) and increased needle visibility (86% vs 32%; P < .0001) with the use of a needle guide.⁶⁶ Another study comparing a short-axis versus long-axis approach with a needle guide showed improved needle visualization using a long-axis approach with a needle guide.⁶⁷ A randomized study comparing use of a novel, sled-mounted needle guide to a free-hand approach for venous cannulation in simulation models showed the novel, sled-mounted needle guide improved overall success rates and efficiency of cannulation.⁶⁸

10. We recommend that providers should use a standardized procedure checklist that includes use of real-time ultrasound guidance to reduce the risk of central line-associated bloodstream infection (CLABSI) from CVC insertion.

 

Rationale: A standardized checklist or protocol should be developed to ensure compliance with all recommendations for insertion of CVCs. Evidence-based protocols address periprocedural issues, such as indications for CVC, and procedural techniques, such as use of maximal sterile barrier precautions to reduce the risk of infection. Protocols and checklists that follow established guidelines for CVC insertion have been shown to decrease CLABSI rates.^69,70 Similarly, development of checklists and protocols for maintenance of central venous catheters have been effective in reducing CLABSIs.⁷¹ Although no externally-validated checklist has been universally accepted or endorsed by national safety organizations, a few internally-validated checklists are available through peer-reviewed publications.^72,73 An observational educational cohort of internal medicine residents who received training using simulation of the entire CVC insertion process was able to demonstrate fewer CLABSIs after the simulator-trained residents rotated in the intensive care unit (ICU) (0.50 vs 3.2 infections per 1,000 catheter days, P = .001).⁷⁴

11. We recommend that providers should use real-time ultrasound guidance, combined with aseptic technique and maximal sterile barrier precautions, to reduce the incidence of infectious complications from CVC insertion.

Rationale: The use of real-time ultrasound guidance for CVC placement has demonstrated a statistically significant reduction in CLABSIs compared to landmark-based techniques.⁷⁵ The Centers for Disease Control and Prevention (CDC) guidelines for the prevention of intravascular catheter-related infections recommend the use of ultrasound guidance to reduce the number of cannulation attempts and risk of mechanical complications.⁶⁹ A prospective, three-arm study comparing ultrasound-guided long-axis, short-axis, and landmark-based approaches showed a CLABSI rate of 20% in the landmark-based group versus 10% in each of the ultrasound groups.⁵⁷ Another randomized study comparing use of ultrasound guidance to a landmark-based technique for IJV CVC insertion demonstrated significantly lower CLABSI rates with the use of ultrasound (2% vs 10%; P < .05).⁷²

Studies have shown that a systems-based intervention featuring a standardized catheter kit or catheter bundle significantly reduced CLABSI rates.^76-78 A complete review of all preventive measures to reduce the risk of CLABSI is beyond the scope of this review, but a few key points will be mentioned. First, aseptic technique includes proper hand hygiene and skin sterilization, which are essential measures to reduce cutaneous colonization of the insertion site and reduce the risk of CLABSIs.⁷⁹ In a systematic review and meta-analysis of eight studies including over 4,000 catheter insertions, skin antisepsis with chlorhexidine was associated with a 50% reduction in CLABSIs compared with povidone iodine.¹¹ Therefore, a chlorhexidine-containing solution is recommended for skin preparation prior to CVC insertion per guidelines by Healthcare Infection Control Practices Advisory Committee/CDC, Society for Healthcare Epidemiology of America/Infectious Diseases Society of America, and American Society of Anesthesiologists.^11,69,80,81 Second, maximal sterile barrier precautions refer to the use of sterile gowns, sterile gloves, caps, masks covering both the mouth and nose, and sterile full-body patient drapes. Use of maximal sterile barrier precautions during CVC insertion has been shown to reduce the incidence of CLABSIs compared to standard precautions.^26,79,82-84 Third, catheters containing antimicrobial agents may be considered for hospital units with higher CLABSI rates than institutional goals, despite a comprehensive preventive strategy, and may be considered in specific patient populations at high risk of severe complications from a CLABSI.^11,69,80 Finally, providers should use a standardized procedure set-up when inserting CVCs to reduce the risk of CLABSIs. The operator should confirm availability and proper functioning of ultrasound equipment prior to commencing a vascular access procedure. Use of all-inclusive procedure carts or kits with sterile ultrasound probe covers, sterile gel, catheter kits, and other necessary supplies is recommended to minimize interruptions during the procedure, and can ultimately reduce the risk of CLABSIs by ensuring maintenance of a sterile field during the procedure.¹³

12. We recommend that providers should use real-time ultrasound guidance for internal jugular vein catheterization, which reduces the risk of mechanical and infectious complications, the number of needle passes, and time to cannulation and increases overall procedure success rates.

Rationale: The use of real-time ultrasound guidance for CVC insertion has repeatedly demonstrated better outcomes compared to a landmark-based approach in adults.¹³ Several randomized controlled studies have demonstrated that real-time ultrasound guidance for IJV cannulation reduces the risk of procedure-related mechanical and infectious complications, and improves first-pass and overall success rates in diverse care settings.^{27,29,45,50,53,65,75,85-90} Mechanical complications that are reduced with ultrasound guidance include pneumothorax and carotid artery puncture.^{4,5,45,46,53,62,75,86-93} Currently, several medical societies strongly recommend the use of ultrasound guidance during insertion of IJV CVCs.^{10-12,14,94-96}

A meta-analysis by Hind et al. that included 18 randomized controlled studies demonstrated use of real-time ultrasound guidance reduced failure rates (RR 0.14, 95% CI 0.06 to 0.33; P < .0001), increased first-attempt success rates (RR 0.59, 95% CI 0.39 to 0.88; P = .009), reduced complication rates (RR 0.43, 95% CI 0.22 to 0.87; P = .02) and reduced procedure time (P < .0001), compared to a traditional landmark-based approach when inserting IJV CVCs.⁵

A Cochrane systematic review compared ultrasound-guided versus landmark-based approaches for IJV CVC insertion and found use of real-time ultrasound guidance reduced total complication rates by 71% (RR 0.29, 95% CI 0.17 to 0.52; P < .0001), arterial puncture rates by 72% (RR 0.28, 95% CI 0.18 to 0.44; P < .00001), and rates of hematoma formation by 73% (RR 0.27, 95% CI 0.13 to 0.55; P = .0004). Furthermore, the number of attempts for successful cannulation was reduced (mean difference -1.19 attempts, 95% CI -1.45 to -0.92; P < .00001), the chance of successful insertion on the first attempt was increased by 57% (RR 1.57, 95% CI 1.36 to 1.82; P < .00001), and overall procedure success rates were modestly increased in all groups by 12% (RR 1.12, 95% CI 1.08 to 1.17; P < .00001).⁴⁶

An important consideration in performing ultrasound guidance is provider experience. A prospective observational study of patients undergoing elective CVC insertion demonstrated higher complication rates for operators that were inexperienced (25.2%) versus experienced (13.6%).⁵⁴ A randomized controlled study comparing experts and novices with or without the use of ultrasound guidance for IJV CVC insertion demonstrated higher success rates among expert operators and with the use of ultrasound guidance. Among novice operators, the complication rates were lower with the use of ultrasound guidance.⁹⁷ One study evaluated the procedural success and complication rates of a two-physician technique with one physician manipulating the transducer and another inserting the needle for IJV CVC insertion. This study concluded that procedural success rates and frequency of complications were directly affected by the experience of the physician manipulating the transducer and not by the experience of the physician inserting the needle.⁹⁸

The impact of ultrasound guidance on improving procedural success rates and reducing complication rates is greatest in patients that are obese, short necked, hypovolemic, or uncooperative.⁹³ Several studies have demonstrated fewer needle passes and decreased time to cannulation compared to the landmark technique in these populations.^{46,49,53,86-88,92,93}

Ultrasound-guided placement of IJV catheters can safely be performed in patients with disorders of hemostasis and those with multiple previous catheter insertions in the same vein.⁹ Ultrasound-guided placement of CVCs in patients with disorders of hemostasis is safe with high success and low complication rates. In a case series of liver patients with coagulopathy (mean INR 2.17 ± 1.16, median platelet count 150K), the use of ultrasound guidance for CVC insertion was highly successful with no major bleeding complications.⁹⁹

A study of renal failure patients found high success rates and low complication rates in the patients with a history of multiple previous catheterizations, poor compliance, skeletal deformities, previous failed cannulations, morbid obesity, and disorders of hemostasis.¹⁰⁰ A prospective observational study of 200 ultrasound-guided CVC insertions for apheresis showed a 100% success rate with a 92% first-pass success rate.¹⁰¹

The use of real-time ultrasound guidance for IJV CVC insertion has been shown to be cost effective by reducing procedure-related mechanical complications and improving procedural success rates. A companion cost-effectiveness analysis estimated that for every 1,000 patients, 90 complications would be avoided, with a net cost savings of approximately $3,200 using 2002 prices.¹⁰²

13. We recommend that providers who routinely insert subclavian vein CVCs should use real-time ultrasound guidance, which has been shown to reduce the risk of mechanical complications and number of needle passes and increase overall procedure success rates compared with landmark-based techniques.

Rationale: In clinical practice, the term ultrasound-guided subclavian vein CVC insertion is commonly used. However, the needle insertion site is often lateral to the first rib and providers are technically inserting the CVC in the axillary vein. The subclavian vein becomes the axillary vein at the lateral border of the first rib where the cephalic vein branches from the subclavian vein. To be consistent with common medical parlance, we use the phrase ultrasound-guided subclavian vein CVC insertion in this document.

Advantages of inserting CVCs in the subclavian vein include reliable surface anatomical landmarks for vein location, patient comfort, and lower risk of infection.¹⁰³ Several observational studies have demonstrated the technique for ultrasound-guided subclavian vein CVC insertion is feasible and safe.^104-107 In a large retrospective observational study of ultrasound-guided central venous access among a complex patient group, the majority of patients were cannulated successfully and safely. The subset of patients undergoing axillary vein CVC insertion (n = 1,923) demonstrated a low rate of complications (0.7%), proving it is a safe and effective alternative to the IJV CVC insertion.¹⁰⁷

A Cochrane review of ultrasound-guided subclavian vein cannulation (nine studies, 2,030 participants, 2,049 procedures), demonstrated that real-time two-dimensional ultrasound guidance reduced the risk of inadvertent arterial punctures (three studies, 498 participants, RR 0.21, 95% CI 0.06 to 0.82; P = .02) and hematoma formation (three studies, 498 participants, RR 0.26, 95% CI 0.09 to 0.76; P = .01).⁴⁶ A systematic review and meta-analysis of 10 randomized controlled studies comparing ultrasound-guided versus landmark-based subclavian vein CVC insertion demonstrated a reduction in the risk of arterial punctures, hematoma formation, pneumothorax, and failed catheterization with the use of ultrasound guidance.¹⁰⁵

A randomized controlled study comparing ultrasound-guided vs landmark-based approaches to subclavian vein cannulation found that use of ultrasound guidance had a higher success rate (92% vs 44%, P = .0003), fewer minor complications (1 vs 11, P = .002), fewer attempts (1.4 vs 2.5, P = .007) and fewer catheter kits used (1.0 vs 1.4, P = .0003) per cannulation.¹⁰⁸

Fragou et al. randomized patients undergoing subclavian vein CVC insertion to a long-axis approach versus a landmark-based approach and found a significantly higher success rate (100% vs 87.5%, P < .05) and lower rates of mechanical complications: artery puncture (0.5% vs 5.4%), hematoma (1.5% vs 5.4%), hemothorax (0% vs 4.4%), pneumothorax (0% vs 4.9%), brachial plexus injury (0% vs 2.9%), phrenic nerve injury (0% vs 1.5%), and cardiac tamponade (0% vs 0.5%).¹⁰⁹ The average time to obtain access and the average number of insertion attempts (1.1 ± 0.3 vs 1.9 ± 0.7, P < .05) were significantly reduced in the ultrasound group compared to the landmark-based group.⁹⁵

A retrospective review of subclavian vein CVC insertions using a supraclavicular approach found no reported complications with the use of ultrasound guidance vs 23 mechanical complications (8 pneumothorax, 15 arterial punctures) with a landmark-based approach.¹⁰⁶ However, it is important to note that a supraclavicular approach is not commonly used in clinical practice.

14. We recommend that providers should use real-time ultrasound guidance for femoral venous access, which has been shown to reduce the risk of arterial punctures and total procedure time and increase overall procedure success rates.

Rationale: Anatomy of the femoral region varies, and close proximity or overlap of the femoral vein and artery is common.⁵¹ Early studies showed that ultrasound guidance for femoral vein CVC insertion reduced arterial punctures compared with a landmark-based approach (7% vs 16%), reduced total procedure time (55 ± 19 vs 79 ± 62 seconds), and increased procedure success rates (100% vs 90%).⁵² A Cochrane review that pooled data from four randomized studies comparing ultrasound-guided vs landmark-based femoral vein CVC insertion found higher first-attempt success rates with the use of ultrasound guidance (RR 1.73, 95% CI 1.34 to 2.22; P < .0001) and a small increase in the overall procedure success rates (RR 1.11, 95% CI 1.00 to 1.23; P = .06). There was no difference in inadvertent arterial punctures or other complications.¹¹⁰

15. We recommend that providers should use real-time ultrasound guidance for the insertion of peripherally inserted central catheters (PICCs), which is associated with higher procedure success rates and may be more cost effective compared with landmark-based techniques.

Rationale: Several studies have demonstrated that providers who use ultrasound guidance vs landmarks for PICC insertion have higher procedural success rates, lower complication rates, and lower total placement costs. A prospective observational report of 350 PICC insertions using ultrasound guidance reported a 99% success rate with an average of 1.2 punctures per insertion and lower total costs.²⁰ A retrospective observational study of 500 PICC insertions by designated specialty nurses revealed an overall success rate of 95%, no evidence of phlebitis, and only one CLABSI among the catheters removed.²¹ A retrospective observational study comparing several PICC variables found higher success rates (99% vs 77%) and lower thrombosis rates (2% vs 9%) using ultrasound guidance vs landmarks alone.²² A study by Robinson et al. demonstrated that having a dedicated PICC team equipped with ultrasound increased their institutional insertion success rates from 73% to 94%.¹¹¹

A randomized controlled study comparing ultrasound-guided versus landmark-based PICC insertion found high success rates with both techniques (100% vs 96%). However, there was a reduction in the rate of unplanned catheter removals (4.0% vs 18.7%; P = .02), mechanical phlebitis (0% vs 22.9%; P < .001), and venous thrombosis (0% vs 8.3%; P = .037), but a higher rate of catheter migration (32% vs 2.1%; P < .001). Compared with the landmark-based group, the ultrasound-guided group had significantly lower incidence of severe contact dermatitis (P = .038), and improved comfort and costs up to 3 months after PICC placement (P < .05).¹¹²

Routine postprocedure chest x-ray (CXR) is generally considered unnecessary if the PICC is inserted with real-time ultrasound guidance along with use of a newer tracking devices, like the magnetic navigation system with intracardiac electrodes.⁹ Ultrasound can also be used to detect malpositioning of a PICC immediately after completing the procedure. A randomized controlled study comparing ultrasound versus postprocedure CXR detected one malpositioned PICC in the ultrasound group versus 11 in the control group. This study suggested that ultrasound can detect malpositioning immediately postprocedure and reduce the need for a CXR and the possibility of an additional procedure to reposition a catheter.¹¹³

16. We recommend that providers should use real-time ultrasound guidance for the placement of peripheral intravenous lines (PIV) in patients with difficult peripheral venous access to reduce the total procedure time, needle insertion attempts, and needle redirections. Ultrasound-guided PIV insertion is also an effective alternative to CVC insertion in patients with difficult venous access.

Rationale: Difficult venous access refers to patients that have had two unsuccessful attempts at PIV insertion using landmarks or a history of difficult access (i.e. edema, obesity, intravenous drug use, chemotherapy, diabetes, hypovolemia, chronic illness, vasculopathy, multiple prior hospitalizations). A meta-analysis of seven randomized controlled studies concluded that ultrasound guidance increases the likelihood of successful PIV insertion (pooled OR 2.42, 95% CI 1.26 to 4.68; P < .008).18 A second meta-analysis that pooled data from seven studies (six randomized controlled studies) confirmed that ultrasound guidance improves success rates of PIV insertion (OR 3.96, 95% CI 1.75 to 8.94).19 Approximately half of these studies had physician operators while the other half had nurse operators.

In one prospective observational study of emergency department patients with two failed attempts of landmark-based PIV insertion, ultrasound guidance with a modified-Seldinger technique showed a relatively high success rate (96%), fewer needle sticks (mean 1.32 sticks, 95% CI 1.12 to 1.52), and shorter time to obtain access (median time 68 seconds).¹¹⁴ Other prospective observational studies have demonstrated that ultrasound guidance for PIV insertion has a high success rate (87%),¹¹⁵ particularly with brachial or basilic veins PIV insertion, among patients with difficult PIV access, defined as having had ≥2 failed attempts.⁵⁸

Since insertion of PIVs with ultrasound guidance has a high success rate, there is potential to reduce the reliance on CVC insertion for venous access only. In a study of patients that had had two failed attempts at PIV insertion based on landmarks, a PIV was successfully inserted with ultrasound guidance in 84% of patients, obviating the need for CVC placement for venous access.¹¹⁶ A prospective observational study showed ultrasound-guided PIV insertion was an effective alternative to CVC placement in ED patients with difficult venous access with only 1% of patients requiring a CVC.¹¹⁷ Use of ultrasound by nurses for PIV placement has also been shown to reduce the time to obtain venous access, improve patient satisfaction, and reduce the need for physician intervention.¹¹⁸ In a prospective observational study of patients with difficult access, the majority of patients reported a better experience with ultrasound-guided PIV insertion compared to previous landmark-based attempts with an average satisfaction score of 9.2/10 with 76% of patients rating the experience a 10.¹¹⁹ A strong recommendation has been made for use of ultrasound guidance in patients with difficult PIV placement by la Société Française d’Anesthésie et de Réanimation (The French Society of Anesthesia and Resuscitation).⁹⁵

17. We suggest using real-time ultrasound guidance to reduce the risk of vascular, infectious, and neurological complications during PIV insertion, particularly in patients with difficult venous access.

Rationale: The incidence of complications from PIV insertion is often underestimated. Vascular complications include arterial puncture, hematoma formation, local infiltration or extravasation of fluid, and superficial or deep venous thrombosis. The most common infectious complications with PIV insertion are phlebitis and cellulitis.¹²⁰ One observational study reported PIV complications occurring in approximately half of all patients with the most common complications being phlebitis, hematoma formation, and fluid/blood leakage.¹²¹

A retrospective review of ICU patients who underwent ultrasound-guided PIV insertion by a single physician showed high success rates (99%) with low rates of phlebitis/cellulitis (0.7%).There was an assumed benefit of risk reduction due to the patients no longer requiring a CVC after successful PIV placement.¹²² Another study found very low rates of infection with both landmark-based and ultrasound-guided PIV placement performed by emergency department nurses, suggesting that there is no increased risk of infection with the use of ultrasound.¹²³ To reduce the risk of infection from PIV insertion, we recommend the use of sterile gel and sterile transducer cover (See Recommendation 2).

18. We recommend that providers should use real-time ultrasound guidance for arterial access, which has been shown to increase first-pass success rates, reduce the time to cannulation, and reduce the risk of hematoma development compared with landmark-based techniques.

Rationale: Several randomized controlled studies have assessed the value of ultrasound in arterial catheter insertion. Shiver et al. randomized 60 patients admitted to a tertiary center emergency department to either palpation or ultrasound-guided arterial cannulation. They demonstrated a first-pass success rate of 87% in the ultrasound group compared with 50% in the landmark technique group. In the same study, the use of ultrasound was also associated with reduced time needed to establish arterial access and a 43% reduction in the development of hematoma at the insertion site.¹²⁴ Levin et al. demonstrated a first-pass success rate of 62% using ultrasound versus 34% by palpation alone in 69 patients requiring intraoperative invasive hemodynamic monitoring.¹²⁵ Additional randomized controlled studies have demonstrated that ultrasound guidance increases first-attempt success rates compared to traditional palpation.^23,126,127

19. We recommend that providers should use real-time ultrasound guidance for femoral arterial access, which has been shown to increase first-pass success rates and reduce the risk of vascular complications.

Rationale: Although it is a less frequently used site, the femoral artery may be accessed for arterial blood sampling or invasive hemodynamic monitoring, and use of ultrasound guidance has been shown to improve the first-pass success rates of femoral artery cannulation. It is important to note that most of these studies comparing ultrasound-guided vs landmark-based femoral artery cannulation were performed in patients undergoing diagnostic or interventional vascular procedures.

A meta-analysis of randomized controlled studies comparing ultrasound-guided vs landmark-based femoral artery catheterization found use of ultrasound guidance was associated with a 49% reduction in overall complications (RR 0.51, 95% CI 0.28 to 0.91; P > .05) and 42% improvement in first-pass success rates.¹²⁸ In another study, precise site selection with ultrasound was associated with fewer pseudoaneurysms in patients undergoing femoral artery cannulation by ultrasound guidance vs palpation for cardiac catheterization (3% vs 5%, P < .05).¹²⁹

A multicenter randomized controlled study comparing ultrasound vs fluoroscopic guidance for femoral artery catheterization demonstrated ultrasound guidance improved rates of common femoral artery (CFA) cannulation in patients with high CFA bifurcations (83% vs 70%, P < .01).¹³⁰ Furthermore, ultrasound guidance improved first-pass success rates (83% vs 46%, P < .0001), reduced number of attempts (1.3 vs 3.0, P < .0001), reduced risk of venipuncture (2.4% vs 15.8%, P < .0001), and reduced median time to obtain access (136 seconds vs148 seconds, P = .003). Vascular complications occurred in fewer patients in the ultrasound vs fluoroscopy groups (1.4% vs 3.4% P = .04). Reduced risk of hematoma formation with routine use of ultrasound guidance was demonstrated in one retrospective observational study (RR 0.62, 95% CI 0.46 to 0.84; P < .01).¹³¹

20. We recommend that providers should use real-time ultrasound guidance for radial arterial access, which has been shown to increase first-pass success rates, reduce the time to successful cannulation, and reduce the risk of complications compared with landmark-based techniques.

Rationale: Ultrasound guidance is particularly useful for radial artery cannulation in patients with altered anatomy, obesity, nonpulsatile blood flow, low perfusion, and previously unsuccessful cannulation attempts using a landmark-guided approach.¹³² A meta-analysis of six randomized controlled studies in adults showed that use of ultrasound guidance significantly increased first-attempt success rate of radial artery catheterization by 14-37% (RR 1.4, 95% CI 1.28 to 1.64; P < .00001), reduced mean number of attempts (weighted mean difference (WMD) -1.17; 95% CI -2.21 to -0.13; P = .03), and mean time to successful cannulation (WMD -46 seconds; 95% CI -86.66 to -5.96, P = .02).¹³³ Other meta-analyses of randomized studies have demonstrated similar benefits of using ultrasound guidance for radial artery cannulation.^126,127,134

A multicenter randomized controlled study that was not included in the abovementioned meta-analyses showed similar benefits of using ultrasound guidance vs landmarks for radial artery catheterization: a reduction in the number of attempts with ultrasound guidance (1.65 ± 1.2 vs 3.05 ± 3.4, P < .0001) and time to obtain access (88 ± 78 vs 108 ± 112 seconds, P = .006), and increased first-pass success rates (65% vs 44%, P < .0001). The use of ultrasound guidance was found to be particularly useful in patients with difficult access by palpation alone.¹³⁵

Regarding the level of expertise required to use ultrasound guidance, a prospective observational study demonstrated that physicians with little previous ultrasound experience were able to improve their first-attempt success rates and procedure time for radial artery cannulation compared to historical data of landmark-based insertions.¹³⁶

21. We recommend that post-procedure pneumothorax should be ruled out by the detection of bilateral lung sliding using a high-frequency linear transducer before and after insertion of internal jugular and subclavian vein CVCs.

Rationale: Detection of lung sliding with two-dimensional ultrasound rules out pneumothorax, and disappearance of lung sliding in an area where it was previously seen is a strong predictor of postprocedure pneumothorax. In a study of critically ill patients, the disappearance of lung sliding was observed in 100% of patients with pneumothorax vs 8.8% of patients without pneumothorax. For detection of pneumothorax, lung sliding showed a sensitivity of 95%, specificity of 91%, and negative predictive value of 100% (P < .001).¹³⁷ Another study by the same author showed that the combination of horizontal artifacts (absence of comet-tail artifact) and absence of lung sliding had a sensitivity of 100%, specificity of 96.5%, and negative predictive value of 100% for the detection of pneumothorax.¹³⁸ A meta-analysis of 10 studies on the diagnostic accuracy of CVC confirmation with bedside ultrasound vs chest radiography reported detection of all 12 pneumothoraces with ultrasound, whereas chest radiography missed two pneumothoraces. The pooled sensitivity and specificity of ultrasound for the detection of pneumothorax was 100%, although an imperfect gold standard bias likely affected the results. An important advantage of bedside ultrasound is the ability to rule out pneumothorax immediately after the procedure while at the bedside. The mean time for confirmation of CVC placement with bedside ultrasound was 6 minutes versus 64 minutes and 143 minutes for completion and interpretation of a chest radiograph, respectively.¹³⁹

22. We recommend that providers should use ultrasound with rapid infusion of agitated saline to visualize a right atrial swirl sign (RASS) for detecting catheter tip misplacement during CVC insertion. The use of RASS to detect the catheter tip may be considered an advanced skill that requires specific training and expertise.

Rationale: Bedside echocardiography is a reliable tool to detect catheter tip misplacement during CVC insertion. In one study, catheter misplacement was detected by bedside echocardiography with a sensitivity of 96% and specificity of 83% (positive predictive value 98%, negative predictive value 55%) and prevented distal positioning of the catheter tip.¹⁴⁰ A prospective observational study assessed for RASS, which is turbulent flow in the right atrium after a rapid saline flush of the distal CVC port, to exclude catheter malposition. In this study with 135 CVC placements, visualization of RASS with ultrasound was able to identify all correct CVC placements and three of four catheter misplacements. Median times to complete the ultrasound exam vs CXR were 1 vs 20 minutes, respectively, with a median difference of 24 minutes (95% CI 19.6 to 29.3, P < .0001) between the two techniques.¹⁴¹

A prospective observational study assessed the ability of bedside transthoracic echocardiography to detect the guidewire, microbubbles, or both, in the right atrium compared to transesophageal echocardiography as the gold standard. Bedside transthoracic echocardiography allowed visualization of the right atrium in 94% of patients, and both microbubbles plus guidewire in 91% of patients.¹⁴² Hence, bedside transthoracic echocardiography allows adequate visualization of the right atrium. Another prospective observational study combining ultrasonography and contrast enhanced RASS resulted in 96% sensitivity and 93% specificity for the detection of a misplaced catheter, and the concordance with chest radiography was 96%.¹⁴³

23. To reduce the risk of mechanical and infectious complications, we recommend that novice providers should complete a systematic training program that includes a combination of simulation-based practice, supervised insertion on patients, and evaluation by an expert operator before attempting ultrasound-guided CVC insertion independently on patients.

Rationale: Cumulative experience has been recognized to not be a proxy for mastery of a clinical skill.¹⁴⁴ The National Institute for Clinical Excellence (NICE) has recommended that providers performing ultrasound-guided CVC insertion should receive appropriate training to achieve competence before performing the procedure independently.⁷ Surveys have demonstrated that lack of training is a commonly reported barrier for not using ultrasound.^145,146

Structured training programs on CVC insertion have been shown to reduce the occurrence of infectious and mechanical complications.^{74,143,147-149} The use of ultrasound and checklists, bundling of supplies, and practice with simulation models, as a part of a structured training program, can improve patient safety related to CVC insertion.^{9,140,150-154}

Simulation-based practice has been used in medical education to provide deliberate practice and foster skill development in a controlled learning environment.^155-158 Studies have shown transfer of skills demonstrated in a simulated environment to clinical practice, which can improve CVC insertion practices.^159,160 Simulation accelerates learning of all trainees, especially novice trainees, and mitigates risks to patients by allowing trainees to achieve a minimal level of competence before attempting the procedure on real patients.^152,161,162 Residents that have been trained using simulation preferentially select the IJV site,¹⁴⁷ and more reliably use ultrasound to guide their CVC insertions.^160,163

Additionally, simulation-based practice allows exposure to procedures and scenarios that may occur infrequently in clinical practice.

Although there is evidence on efficacy of simulation-based CVC training programs, there is no broadly accepted consensus on timing, duration, and content of CVC training programs for trainees or physicians in practice. The minimum recommended technical skills a trainee must master include the ability to (1) manipulate the ultrasound machine to produce a high-quality image to identify the target vessel, (2) advance the needle under direct visualization to the desired target site and depth, (3) deploy the catheter into the target vessel and confirm catheter placement in the target vessel using ultrasound, and (4) ensure the catheter has not been inadvertently placed in an unintended vessel or structure.¹⁵³

A variety of simulation models are currently used to practice CVC insertion at the most common sites: the internal jugular, subclavian, basilic, and brachial veins.^164,165 Effective simulation models should contain vessels that mimic normal anatomy with muscles, soft tissues, and bones. Animal tissue models, such as turkey or chicken breasts, may be effective for simulated practice of ultrasound-guided CVC insertion.^166,167 Ultrasound-guided CVC training using human cadavers has also been shown to be effective.¹⁶⁸

24. We recommend that cognitive training in ultrasound-guided CVC insertion should include basic anatomy, ultrasound physics, ultrasound machine knobology, fundamentals of image acquisition and interpretation, detection and management of procedural complications, infection prevention strategies, and pathways to attain competency.

Rationale: After receiving training in ultrasound-guided CVC insertion, physicians report significantly higher comfort with the use of ultrasound compared to those who have not received such training.¹⁴⁵ Learners find training sessions worthwhile to increase skill levels,¹⁶⁷ and skills learned from simulation-based mastery learning programs have been retained up to one year.¹⁵⁸

Several commonalities have been noted across training curricula. Anatomy and physiology didactics should include vessel anatomy (location, size, and course);⁹ vessel differentiation by ultrasound;^9,69 blood flow dynamics;⁶⁹ Virchow’s triad;⁶⁹ skin integrity and colonization;¹⁵⁰ peripheral nerve identification and distribution;⁹ respiratory anatomy;^9,69 upper and lower extremity, axillary, neck, and chest anatomy.^9,69 Vascular anatomy is an essential curricular component that may help avoid preventable CVC insertion complications, such as inadvertent nerve, artery, or lung puncture.^150,169 Training curricula should also include ultrasound physics (piezoelectric effect, frequency, resolution, attenuation, echogenicity, Doppler ultrasound, arterial and venous flow characteristics), image acquisition and optimization (imaging mode, focus, dynamic range, probe types), and artifacts (reverberation, mirror, shadowing, enhancement).

CVC-related infections are an important cause of morbidity and mortality in the acute and long-term care environment.⁶⁹ Infection and thrombosis can both be impacted by the insertion site selection, skin integrity, and catheter–vein ratio.^2,3,84 Inexperience generally leads to more insertion attempts that can increase trauma during CVC insertion and potentially increase the risk of infections.¹⁷⁰ To reduce the risk of infectious complications, training should include important factors to consider in site selection and maintenance of a sterile environment during CVC insertion, including use of maximal sterile barrier precautions, hand hygiene, and appropriate use of skin antiseptic solutions.

Professional society guidelines have been published with recommendations of appropriate techniques for ultrasound-guided vascular access that include training recommendations.^9,154 Training should deconstruct the insertion procedure into readily understood individual steps, and can be aided by demonstration of CVC insertion techniques using video clips. An alternative to face-to-face training is internet-based training that has been shown to be as effective as traditional teaching methods in some medical centers.¹⁷¹ Additional methods to deliver cognitive instruction include textbooks, continuing medical education courses, and digital videos.^164,172

25. We recommend that trainees should demonstrate minimal competence before placing ultrasound-guided CVCs independently. A minimum number of CVC insertions may inform this determination, but a proctored assessment of competence is most important.

Rationale: CVC catheter placement carries the risk of serious complications including arterial injury or dissection, pneumothorax, or damage to other local structures; arrhythmias; catheter malposition; infection; and thrombosis. Although there is a lack of consensus and high-quality evidence for the certification of skills to perform ultrasound-guided CVC insertion, recommendations have been published advocating for formal and comprehensive training programs in ultrasound-guided CVC insertion with an emphasis on expert supervision prior to independent practice.^9,153,154 Two groups of expert operators have recommended that training should include at least 8-10 supervised ultrasound-guided CVC insertions.^154,173,174 A consensus task force from the World Congress of Vascular Access has recommended a minimum of six to eight hours of didactic education, four hours of hands-on training on simulation models, and six hours of hands-on ultrasound training on human volunteers to assess normal anatomy.¹⁷⁵ This training should be followed by supervised ultrasound-guided CVC insertions until the learner has demonstrated minimal competence with a low rate of complications.³⁵ There is general consensus that arbitrary numbers should not be the sole determinant of competence, and that the most important determinant of competence should be an evaluation by an expert operator.¹⁷⁶

26. We recommend that didactic and hands-on training for trainees should coincide with anticipated times of increased performance of vascular access procedures. Refresher training sessions should be offered periodically.

Rationale: Simulation-based CVC training courses have shown a rapid improvement in skills, but lack of practice leads to deterioration of technical skills.^{161,162,177,178} Thus, a single immersive training session is insufficient to achieve and maintain mastery of skills, and an important factor to acquire technical expertise is sustained, deliberate practice with feedback.¹⁷⁹ Furthermore, an insidious decay in skills may go unrecognized as a learner’s comfort and self-confidence does not always correlate with actual performance, leading to increased risk of errors and potential for procedural complications.^{147,158,180-183} Given the decay in technical skills over time, simulation-based training sessions are most effective when they occur in close temporal proximity to times when those skills are most likely to be used; for example, a simulation-based training session for trainees may be most effective just before the start of a critical care rotation.¹⁵² Regularly scheduled training sessions with monitoring and feedback by expert operators can reinforce procedural skills and prevent decay. Some experts have recommended that a minimum of 10 ultrasound-guided CVC insertions should be performed annually to maintain proficiency.¹⁵³

27. We recommend that competency assessments should include formal evaluation of knowledge and technical skills using standardized assessment tools.

Rationale: Hospitalists and other healthcare providers that place vascular access catheters should undergo competency assessments proctored by an expert operator to verify that they have the required knowledge and skills.^184,185 Knowledge competence can be partially evaluated using a written assessment, such as a multiple-choice test, assessing the provider’s cognitive understanding of the procedure.¹⁷⁵ For ultrasound-guided CVC insertion, a written examination should be administered in conjunction with an ultrasound image assessment to test the learner’s recognition of normal vs abnormal vascular anatomy. Minimum passing standards should be established a priori according to local or institutional standards.

The final skills assessment should be objective, and the learner should be required to pass all critical steps of the procedure. Failure of the final skills assessment should lead to continued practice with supervision until the learner can consistently demonstrate correct performance of all critical steps. Checklists are commonly used to rate the technical performance of learners because they provide objective criteria for evaluation, can identify specific skill deficiencies, and can determine a learner’s readiness to perform procedures independently.^186,187 The administration of skills assessments and feedback methods should be standardized across faculty. Although passing scores on both knowledge and skills assessments do not guarantee safe performance of a procedure independently, they provide a metric to ensure that a minimum level of competence has been achieved before allowing learners to perform procedures on patients without supervision.¹⁸⁸

Competency assessments are a recommended component of intramural and extramural certification of skills in ultrasound-guided procedures. Intramural certification pathways differ by institution and often require additional resources including ultrasound machine(s), simulation equipment, and staff time, particularly when simulation-based assessments are incorporated into certification pathways. We recognize that some of these recommendations may not be feasible in resource-limited settings, such as rural hospitals. However, initial and ongoing competency assessments can be performed during routine performance of procedures on patients. For an in-depth review of credentialing pathways for ultrasound-guided bedside procedures, we recommend reviewing the SHM Position Statement on Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures.²⁴

28. We recommend that competency assessments should evaluate for proficiency in the following knowledge and skills of CVC insertion:
a. Knowledge of the target vein anatomy, proper vessel identification, and recognition of anatomical variants
b. Demonstration of CVC insertion with no technical errors based on a procedural checklist
c. Recognition and management of acute complications, including emergency management of life-threatening complications
d. Real-time needle tip tracking with ultrasound and cannulation on the first attempt in at least five consecutive simulations.

Rationale: Recommendations have been published with the minimal knowledge and skills learners must demonstrate to perform ultrasound-guided vascular access procedures. These include operation of an ultrasound machine to produce high-quality images of the target vessel, tracking of the needle tip with real-time ultrasound guidance, and recognition and understanding of the management of procedural complications.^154,175

First, learners must be able to perform a preprocedural assessment of the target vein, including size and patency of the vein; recognition of adjacent critical structures; and recognition of normal anatomical variants.^175,189 Second, learners must be able to demonstrate proficiency in tracking the needle tip penetrating the target vessel, inserting the catheter into the target vessel, and confirming catheter placement in the target vessel with ultrasound.^154,175 Third, learners must be able to demonstrate recognition of acute complications, including arterial puncture, hematoma formation, and development of pneumothorax.^154,175 Trainees should be familiar with recommended evaluation and management algorithms, including indications for emergent consultation.¹⁹⁰

29. We recommend a periodic proficiency assessments of all operators should be conducted to ensure maintenance of competency.

Rationale: Competency extends to periodic assessment and not merely an initial evaluation at the time of training.¹⁹¹ Periodic competency assessments should include assessment of proficiency of all providers that perform a procedure, including instructors and supervisors. Supervising providers should maintain their competency in CVC insertion through routine use of their skills in clinical practice.¹⁷⁵ An observational study of emergency medicine residents revealed that lack of faculty comfort with ultrasound hindered the residents’ use of ultrasound.¹⁹² Thus, there is a need to examine best practices for procedural supervision of trainees because providers are often supervising procedures that they are not comfortable performing on their own.¹⁹³

The process of producing this position statement revealed areas of uncertainty and important gaps in the literature regarding the use of ultrasound guidance for central and peripheral venous access and arterial access.

This position statement recommends a preprocedural ultrasound evaluation of blood vessels based on evidence that providers may detect anatomic anomalies, thrombosis, or vessel stenosis. Ultrasound can also reveal unsuspected high-risk structures in near proximity to the procedure site. Although previous studies have shown that providers can accurately assess vessels with ultrasound for these features, further study is needed to evaluate the effect of a standardized preprocedural ultrasound exam on clinical and procedural decision-making, as well as procedural outcomes.

Second, two ultrasound applications that are being increasingly used but have not been widely implemented are the use of ultrasound to evaluate lung sliding postprocedure to exclude pneumothorax and the verification of central line placement using a rapid infusion of agitated saline to visualize the RASS.^139-141 Both of these applications have the potential to expedite postprocedure clearance of central lines for usage and decrease patient radiation exposure by obviating the need for postprocedure CXRs. Despite the supporting evidence, both of these applications are not yet widely used, as few providers have been trained in these techniques which may be considered advanced skills.

Third, despite advances in our knowledge of effective training for vascular access procedures, there is limited agreement on how to define procedural competence. Notable advancements in training include improved understanding of systematic training programs, development of techniques for proctoring procedures, definition of elements for hands-on assessments, and definition of minimum experience needed to perform vascular access procedures independently. However, application of these concepts to move learners toward independent practice remains variably interpreted at different institutions, likely due to limited resources, engrained cultures about procedures, and a lack of national standards. The development of hospitalist-based procedure services at major academic medical centers with high training standards, close monitoring for quality assurance, and the use of databases to track clinical outcomes may advance our understanding and delivery of optimal procedural training.

Finally, ultrasound technology is rapidly evolving which will affect training, techniques, and clinical outcomes in coming years. Development of advanced imaging software with artificial intelligence can improve needle visualization and tracking. These technologies have the potential to facilitate provider training in real-time ultrasound-guided procedures and improve the overall safety of procedures. Emergence of affordable, handheld ultrasound devices is improving access to ultrasound technology, but their role in vascular access procedures is yet to be defined. Furthermore, availability of wireless handheld ultrasound technology and multifrequency transducers will create new possibilities for use of ultrasound in vascular access procedures.

We have presented several evidence-based recommendations on the use of ultrasound guidance for placement of central and peripheral vascular access catheters that are intended for hospitalists and other healthcare providers who routinely perform vascular access procedures. By allowing direct visualization of the needle tip and target vessel, the use of ultrasound guidance has been shown in randomized studies to reduce needle insertion attempts, reduce needle redirections, and increase overall procedure success rates. The accuracy of ultrasound to identify the target vessel, assess for thrombosis, and detect anatomical anomalies is superior to that of physical examination. Hospitalists can attain competence in performing ultrasound-guided vascular access procedures through systematic training programs that combine didactic and hands-on training, which optimally include patient-based competency assessments.

Acknowledgments

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

Collaborators of Society of Hospital Medicine Point-of-care Ultrasound Task Force: Robert Arntfield, Jeffrey Bates, Anjali Bhagra, Michael Blaivas, Daniel Brotman, Richard Hoppmann, Susan Hunt, Trevor P. Jensen, Venkat Kalidindi, Ketino Kobaidze, Joshua Lenchus, Paul Mayo, Satyen Nichani, Vicki Noble, Nitin Puri, Aliaksei Pustavoitau, Kreegan Reierson, Gerard Salame, Kirk Spencer, Vivek Tayal, David Tierney

SHM Point-of-care Ultrasound Task Force: CHAIRS: Nilam J. Soni, Ricardo Franco-Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Mathews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Mathews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen Lumbar Puncture Working Group: Nilam J. Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El-Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Daniel Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

In August of 2014, the Pediatric Hospital Medicine (PHM) community petitioned the American Board of Pediatrics (ABP) for a subspecialty certificate in PHM. A lengthy vetting process ensued during which the ABP consulted with a wide array of stakeholders. The ABP Board of Directors approved the request from the PHM community for a subspecialty certificate in December 2015 and published the results of the vetting process.¹

The ABP received a second petition posted on PHM listserv, which opened with the following statement:

“We submit this petition letter to register a formal complaint, demand immediate action, and request a formal response from the ABP regarding the practice pathway criteria and the application of these criteria for the Pediatric Hospital Medicine specialty exam. Recently there has been considerable discussion on the Pediatric Hospital Medicine ListServ suggesting that the ABP’s implementation of the career pathway criteria has failed to respect and fairly assess the diverse career paths of numerous experienced pediatric hospitalists, which may impede their opportunities for professional advancement. Anecdotal reports on the ListServ also suggest that the use of the current practice pathway criteria to evaluate exam applicants disadvantages women, though sufficient data is not available at this time to evaluate this assertion objectively.”

The ABP response to the PHM community’s concerns regarding the practice pathway for the first certifying exam in PHM is as follows.

ABP thanks the PHM community for the opportunity to respond to the attached petition. Our approach and response are grounded in our mission:

“Advancing child health by certifying pediatricians who meet standards of excellence and are committed to continuous learning and improvement.” 

Transparency is one of the ABP’s core values, which underpins this response. The ABP acknowledges that the petitioners did not find the guidance on the ABP website sufficiently transparent. We regret the distress this may have caused, will do our best to answer the questions forthrightly, and have revised the website language for greater clarity.

Some posts on the PHM listserv alleged gender (sex) bias against women in the ABP application process and outcomes. This allegation is not supported by the facts. A peer group of pediatric hospitalists constitutes the ABP PHM subboard which determined the eligibility criteria. The subboard thoughtfully developed these criteria and the American Board of Medical Specialties (ABMS) approved the broad eligibility criteria. The PHM subboard is composed of practicing pediatric hospitalists with a diversity of practice location, age, gender, and race. The majority of ABP PHM subboard members and medical editors are women.

Making unbiased decisions is also a core value of the ABP. Among the 1,627 applicants for the exam, the ABP has approved 1,515 (93%) as of August 15, 2019. Seventy percent of applications were from women, which mirrors the demographics of the pediatric workforce. There was no significant difference between the percentage of women (4.0%) and men (3.7%) who were denied admission to the exam (Table 1). As of August 15, 2019, the credentials committee of the PHM subboard is still reviewing 48 applications, including 35 appeals, of which 60% (N = 21) were from women and 40% (N = 14) were from men. Thirteen (N = 13) remaining applications are under review but not in the appeals process.

PHM is the 15^th pediatric subspecialty to begin the certification process with a practice pathway. In none of the prior cases was it possible to do a detailed implementation study to understand the myriad of ways in which individual pediatricians arrange their professional and personal time. This reality has led to the publication of only general, rather than specific practice pathway criteria at the start of the application process for PHM and every other pediatric subspecialty. Rather, in each case, a well-informed and diverse peer group of subspecialists (the subboard) has reviewed the applications to get a sense of the variations of practice and then decided on the criteria that a subspecialist must meet to be considered eligible to sit for the certifying exam. Clear-cut criteria were used consistently in adjudicating all applications. Although the ABP has not done this for other subspecialties, we agree that publishing the specific criteria once they had been decided upon would have improved the process. We commit to doing so in the future.

The eligibility criteria were designed to be true to the mission of the ABP and seek parity with the requirements used by other subspecialties and by the PHM training pathway. The assumption is that competent PHM practice of sufficient duration and breadth, attested to by a supervisor, would allow the ABP to represent to the public that the candidate is qualified to sit for the exam. The eligibility criteria focused on seven practice characteristics (Table 2):

The ABP recognizes that the use of %FTE, work hours, and leave exceptions led to unintended confusion among applicants. The intent had been to acknowledge the many valid reasons for interruption of practice, including parental leave. This response to the petition clarifies that the critical question from the public’s perspective is whether the candidate has accumulated enough hours of sustained practice to be considered competent in the field of PHM and specifically caring for hospitalized children (as defined above). Upon review, the ABP believes the workhours criteria (items 3 and 4) accomplish this critical goal and make the %FTE and practice interruption criteria largely redundant. Table 3 reflects the clarified and streamlined requirements. Re-examination of all the denied applications showed that using the criteria in Table 3 did not have a significant impact on the outcomes. One additional applicant’s appeal was granted, and this applicant has been so notified.

The right to appeal and the Appellate Review Procedure are included in a denial letter. The applicant is given a deadline of 14 days to notify the ABP of the intent to appeal. There is no appellate fee. Within one to three days, the ABP acknowledges receipt of the applicant’s intent to appeal and sends the applicant a date by which additional supporting information should be provided.

The appeal material is shared with the subboard credentials committee and each member individually reviews and votes on the appeal. The application is approved if a majority votes in favor of the applicant’s appeal. If there is no majority, the credentials committee discusses the case to reach a decision. The results of the appeal are final according to the ABP Appellate Review Procedure. We remain in the appeal process for several PHM applicants as of the date of this response.

Thank you for the opportunity to respond to the petition. The ABP is committed to dialogue, transparency, and continuously improving its processes.

Acknowledgment

The authors thank the ABP board of directors and the ABP PHM subboard for their review and thoughtful contributions.

Disclosures

Dr. Nichols reports other from The American Board of Pediatrics, during the conduct of the work. Dr. Woods has nothing to disclose.

In August of 2014, the Pediatric Hospital Medicine (PHM) community petitioned the American Board of Pediatrics (ABP) for a subspecialty certificate in PHM. A lengthy vetting process ensued during which the ABP consulted with a wide array of stakeholders. The ABP Board of Directors approved the request from the PHM community for a subspecialty certificate in December 2015 and published the results of the vetting process.¹

The ABP received a second petition posted on PHM listserv, which opened with the following statement:

“We submit this petition letter to register a formal complaint, demand immediate action, and request a formal response from the ABP regarding the practice pathway criteria and the application of these criteria for the Pediatric Hospital Medicine specialty exam. Recently there has been considerable discussion on the Pediatric Hospital Medicine ListServ suggesting that the ABP’s implementation of the career pathway criteria has failed to respect and fairly assess the diverse career paths of numerous experienced pediatric hospitalists, which may impede their opportunities for professional advancement. Anecdotal reports on the ListServ also suggest that the use of the current practice pathway criteria to evaluate exam applicants disadvantages women, though sufficient data is not available at this time to evaluate this assertion objectively.”

The ABP response to the PHM community’s concerns regarding the practice pathway for the first certifying exam in PHM is as follows.

ABP thanks the PHM community for the opportunity to respond to the attached petition. Our approach and response are grounded in our mission:

“Advancing child health by certifying pediatricians who meet standards of excellence and are committed to continuous learning and improvement.” 

Transparency is one of the ABP’s core values, which underpins this response. The ABP acknowledges that the petitioners did not find the guidance on the ABP website sufficiently transparent. We regret the distress this may have caused, will do our best to answer the questions forthrightly, and have revised the website language for greater clarity.

Some posts on the PHM listserv alleged gender (sex) bias against women in the ABP application process and outcomes. This allegation is not supported by the facts. A peer group of pediatric hospitalists constitutes the ABP PHM subboard which determined the eligibility criteria. The subboard thoughtfully developed these criteria and the American Board of Medical Specialties (ABMS) approved the broad eligibility criteria. The PHM subboard is composed of practicing pediatric hospitalists with a diversity of practice location, age, gender, and race. The majority of ABP PHM subboard members and medical editors are women.

Making unbiased decisions is also a core value of the ABP. Among the 1,627 applicants for the exam, the ABP has approved 1,515 (93%) as of August 15, 2019. Seventy percent of applications were from women, which mirrors the demographics of the pediatric workforce. There was no significant difference between the percentage of women (4.0%) and men (3.7%) who were denied admission to the exam (Table 1). As of August 15, 2019, the credentials committee of the PHM subboard is still reviewing 48 applications, including 35 appeals, of which 60% (N = 21) were from women and 40% (N = 14) were from men. Thirteen (N = 13) remaining applications are under review but not in the appeals process.

PHM is the 15^th pediatric subspecialty to begin the certification process with a practice pathway. In none of the prior cases was it possible to do a detailed implementation study to understand the myriad of ways in which individual pediatricians arrange their professional and personal time. This reality has led to the publication of only general, rather than specific practice pathway criteria at the start of the application process for PHM and every other pediatric subspecialty. Rather, in each case, a well-informed and diverse peer group of subspecialists (the subboard) has reviewed the applications to get a sense of the variations of practice and then decided on the criteria that a subspecialist must meet to be considered eligible to sit for the certifying exam. Clear-cut criteria were used consistently in adjudicating all applications. Although the ABP has not done this for other subspecialties, we agree that publishing the specific criteria once they had been decided upon would have improved the process. We commit to doing so in the future.

The eligibility criteria were designed to be true to the mission of the ABP and seek parity with the requirements used by other subspecialties and by the PHM training pathway. The assumption is that competent PHM practice of sufficient duration and breadth, attested to by a supervisor, would allow the ABP to represent to the public that the candidate is qualified to sit for the exam. The eligibility criteria focused on seven practice characteristics (Table 2):

The ABP recognizes that the use of %FTE, work hours, and leave exceptions led to unintended confusion among applicants. The intent had been to acknowledge the many valid reasons for interruption of practice, including parental leave. This response to the petition clarifies that the critical question from the public’s perspective is whether the candidate has accumulated enough hours of sustained practice to be considered competent in the field of PHM and specifically caring for hospitalized children (as defined above). Upon review, the ABP believes the workhours criteria (items 3 and 4) accomplish this critical goal and make the %FTE and practice interruption criteria largely redundant. Table 3 reflects the clarified and streamlined requirements. Re-examination of all the denied applications showed that using the criteria in Table 3 did not have a significant impact on the outcomes. One additional applicant’s appeal was granted, and this applicant has been so notified.

The right to appeal and the Appellate Review Procedure are included in a denial letter. The applicant is given a deadline of 14 days to notify the ABP of the intent to appeal. There is no appellate fee. Within one to three days, the ABP acknowledges receipt of the applicant’s intent to appeal and sends the applicant a date by which additional supporting information should be provided.

The appeal material is shared with the subboard credentials committee and each member individually reviews and votes on the appeal. The application is approved if a majority votes in favor of the applicant’s appeal. If there is no majority, the credentials committee discusses the case to reach a decision. The results of the appeal are final according to the ABP Appellate Review Procedure. We remain in the appeal process for several PHM applicants as of the date of this response.

Thank you for the opportunity to respond to the petition. The ABP is committed to dialogue, transparency, and continuously improving its processes.

Acknowledgment

The authors thank the ABP board of directors and the ABP PHM subboard for their review and thoughtful contributions.

Disclosures

Dr. Nichols reports other from The American Board of Pediatrics, during the conduct of the work. Dr. Woods has nothing to disclose.

In August of 2014, the Pediatric Hospital Medicine (PHM) community petitioned the American Board of Pediatrics (ABP) for a subspecialty certificate in PHM. A lengthy vetting process ensued during which the ABP consulted with a wide array of stakeholders. The ABP Board of Directors approved the request from the PHM community for a subspecialty certificate in December 2015 and published the results of the vetting process.¹

The ABP received a second petition posted on PHM listserv, which opened with the following statement:

“We submit this petition letter to register a formal complaint, demand immediate action, and request a formal response from the ABP regarding the practice pathway criteria and the application of these criteria for the Pediatric Hospital Medicine specialty exam. Recently there has been considerable discussion on the Pediatric Hospital Medicine ListServ suggesting that the ABP’s implementation of the career pathway criteria has failed to respect and fairly assess the diverse career paths of numerous experienced pediatric hospitalists, which may impede their opportunities for professional advancement. Anecdotal reports on the ListServ also suggest that the use of the current practice pathway criteria to evaluate exam applicants disadvantages women, though sufficient data is not available at this time to evaluate this assertion objectively.”

The ABP response to the PHM community’s concerns regarding the practice pathway for the first certifying exam in PHM is as follows.

ABP thanks the PHM community for the opportunity to respond to the attached petition. Our approach and response are grounded in our mission:

“Advancing child health by certifying pediatricians who meet standards of excellence and are committed to continuous learning and improvement.” 

Transparency is one of the ABP’s core values, which underpins this response. The ABP acknowledges that the petitioners did not find the guidance on the ABP website sufficiently transparent. We regret the distress this may have caused, will do our best to answer the questions forthrightly, and have revised the website language for greater clarity.

Some posts on the PHM listserv alleged gender (sex) bias against women in the ABP application process and outcomes. This allegation is not supported by the facts. A peer group of pediatric hospitalists constitutes the ABP PHM subboard which determined the eligibility criteria. The subboard thoughtfully developed these criteria and the American Board of Medical Specialties (ABMS) approved the broad eligibility criteria. The PHM subboard is composed of practicing pediatric hospitalists with a diversity of practice location, age, gender, and race. The majority of ABP PHM subboard members and medical editors are women.

Making unbiased decisions is also a core value of the ABP. Among the 1,627 applicants for the exam, the ABP has approved 1,515 (93%) as of August 15, 2019. Seventy percent of applications were from women, which mirrors the demographics of the pediatric workforce. There was no significant difference between the percentage of women (4.0%) and men (3.7%) who were denied admission to the exam (Table 1). As of August 15, 2019, the credentials committee of the PHM subboard is still reviewing 48 applications, including 35 appeals, of which 60% (N = 21) were from women and 40% (N = 14) were from men. Thirteen (N = 13) remaining applications are under review but not in the appeals process.

PHM is the 15^th pediatric subspecialty to begin the certification process with a practice pathway. In none of the prior cases was it possible to do a detailed implementation study to understand the myriad of ways in which individual pediatricians arrange their professional and personal time. This reality has led to the publication of only general, rather than specific practice pathway criteria at the start of the application process for PHM and every other pediatric subspecialty. Rather, in each case, a well-informed and diverse peer group of subspecialists (the subboard) has reviewed the applications to get a sense of the variations of practice and then decided on the criteria that a subspecialist must meet to be considered eligible to sit for the certifying exam. Clear-cut criteria were used consistently in adjudicating all applications. Although the ABP has not done this for other subspecialties, we agree that publishing the specific criteria once they had been decided upon would have improved the process. We commit to doing so in the future.

The eligibility criteria were designed to be true to the mission of the ABP and seek parity with the requirements used by other subspecialties and by the PHM training pathway. The assumption is that competent PHM practice of sufficient duration and breadth, attested to by a supervisor, would allow the ABP to represent to the public that the candidate is qualified to sit for the exam. The eligibility criteria focused on seven practice characteristics (Table 2):

The ABP recognizes that the use of %FTE, work hours, and leave exceptions led to unintended confusion among applicants. The intent had been to acknowledge the many valid reasons for interruption of practice, including parental leave. This response to the petition clarifies that the critical question from the public’s perspective is whether the candidate has accumulated enough hours of sustained practice to be considered competent in the field of PHM and specifically caring for hospitalized children (as defined above). Upon review, the ABP believes the workhours criteria (items 3 and 4) accomplish this critical goal and make the %FTE and practice interruption criteria largely redundant. Table 3 reflects the clarified and streamlined requirements. Re-examination of all the denied applications showed that using the criteria in Table 3 did not have a significant impact on the outcomes. One additional applicant’s appeal was granted, and this applicant has been so notified.

The right to appeal and the Appellate Review Procedure are included in a denial letter. The applicant is given a deadline of 14 days to notify the ABP of the intent to appeal. There is no appellate fee. Within one to three days, the ABP acknowledges receipt of the applicant’s intent to appeal and sends the applicant a date by which additional supporting information should be provided.

The appeal material is shared with the subboard credentials committee and each member individually reviews and votes on the appeal. The application is approved if a majority votes in favor of the applicant’s appeal. If there is no majority, the credentials committee discusses the case to reach a decision. The results of the appeal are final according to the ABP Appellate Review Procedure. We remain in the appeal process for several PHM applicants as of the date of this response.

Thank you for the opportunity to respond to the petition. The ABP is committed to dialogue, transparency, and continuously improving its processes.

Acknowledgment

The authors thank the ABP board of directors and the ABP PHM subboard for their review and thoughtful contributions.

Disclosures

Dr. Nichols reports other from The American Board of Pediatrics, during the conduct of the work. Dr. Woods has nothing to disclose.

Is there a single intervention more important to hospitalized patients than vascular access? Since their advent in the 1950s, small plastic tubes have revolutionized medication administration and become a mainstay of modern medicine. Yet, for much of the last 60 years, nurses and doctors have used the same landmark-guided approaches to acquire peripheral and, more specifically, central access.¹ Minor improvements to the Seldinger technique and sterile preparation have been reported.² However, for such a vital and common procedure, the complication rates of landmark-based approaches to central venous access remain unacceptably high.³

In the position statement released by the Society of Hospital Medicine (SHM), Franco–Sadud et al. outline the transformative effects ultrasound can have in obtaining adult vascular access.⁴ The authors cite comprehensive evidence, leaving little doubt of the technique’s benefits compared with landmark-based approaches. However, several questions remain: Is vascular access the domain of the hospitalist? If so, how can hospitalists pursue and afford ultrasound training? Finally, how will this shift toward ultrasound-guided vascular access affect patients in resource-limited settings?

Through an expert-driven literature review, the authors present 29 succinct recommendations for ultrasound use in vascular access. Supporting data consistently illustrate the association of ultrasound with increased successful vessel cannulation rates and decreased complication rates for all types of vascular access; including central venous access (internal jugular, subclavian, femoral), arterial line placement, peripherally inserted central catheters, and difficult peripheral venous access. Despite this compelling evidence, however, 20%-55% of all central venous catheters are still placed without ultrasound.⁵ How, then, can hospitalists expand ultrasound use for vascular access or perform these procedures in general?

Hospitalists likely fall into one of three categories in terms of vascular access: (1) they are proficient in ultrasound use for vascular access, (2) they still routinely use traditional landmark-based approaches, or (3) they have little to no involvement in vascular access and defer to intensivists, interventional radiologists, or nurse specialists. Franco-Sadud et al.’s position statement acknowledges the wide range of hospitalist practices and only asserts that, if providers perform vascular access, they should be trained and use ultrasound to do them. We would advocate further that, regardless of their practice, hospitalists have a role in expanding ultrasound use for vascular access given its direct impact on the patients they care for. Hospitalists who do not directly practice vascular access can still leverage the skills that have established hospital medicine’s reputation as leaders in patient safety and quality improvement. Hospitalists can partner with proceduralists in their institutions to ensure that they are supported and trained in the most evidence-based approaches to vascular access and that their patients have access to the highest quality of care.

For the individual hospitalist, the investment of time and resources to incorporate ultrasound into routine practice can seem daunting. In previous position statements, the SHM has advocated for the robust use of simulation and directly observed assessment in credentialing for all bedside procedures.⁶ However, the Society also acknowledges that this degree of training and monitoring can constitute significant barriers and has argued that the onus for change lies not only with providers but with healthcare institutions at large. How, then, can hospitalists approach their institutions to successfully solicit support? While the evidence is not yet conclusive, Cohen et al. have shown promising data for potential long-term cost savings through ultrasound-guided vascular access.⁷ Due to decreased complication rates, downstream benefits of lower resource use, higher patient satisfaction, and, theoretically, even lower clinician burnout rates have been attained. These effects, combined with hospitalists acquiring ultrasound skills translatable to other bedside procedures and fundamentals of diagnostic point of care ultrasound, form a compelling argument for institutional support. Many academic medical centers, typically with increased resources and training programs, have been early adopters; but, how will the shift from landmark-based to ultrasound-guided vascular access affect those in resource-limited settings?

While incredible strides have been made in care quality and patient safety over the last 15 years, improvements clearly do not always benefit patients, clinicians, or institutions equally.⁸ In fact, those in resource-limited settings often experience disproportionately reduced benefits. While focus on the “quality gap” has transformed the culture of the quality improvement and patient safety fields, an “equity gap” has long undermined and limited the impact of those very improvements. Unfortunately, changes in care driven by costly technological advances such as ultrasound are particularly likely to widen this “equity gap.” While ultrasound technology is rapidly becoming more affordable, a lack of access to machines and appropriate training remain significant barriers in the resource-limited settings that hospitalists are most likely to be performing these procedures. Without a focus on equity, the benefits offered by ultrasound will continue to be limited in their reach.

The SHM position statement by Franco-Sadud et al. is an important step in expanding evidence-based ultrasound use for vascular access and improving patient care. While the recommendations are, at times, aspirational and the barriers are real, hospitalists have shown time and again their ability to overcome these challenges and advance the standard of care for all.

Is there a single intervention more important to hospitalized patients than vascular access? Since their advent in the 1950s, small plastic tubes have revolutionized medication administration and become a mainstay of modern medicine. Yet, for much of the last 60 years, nurses and doctors have used the same landmark-guided approaches to acquire peripheral and, more specifically, central access.¹ Minor improvements to the Seldinger technique and sterile preparation have been reported.² However, for such a vital and common procedure, the complication rates of landmark-based approaches to central venous access remain unacceptably high.³

In the position statement released by the Society of Hospital Medicine (SHM), Franco–Sadud et al. outline the transformative effects ultrasound can have in obtaining adult vascular access.⁴ The authors cite comprehensive evidence, leaving little doubt of the technique’s benefits compared with landmark-based approaches. However, several questions remain: Is vascular access the domain of the hospitalist? If so, how can hospitalists pursue and afford ultrasound training? Finally, how will this shift toward ultrasound-guided vascular access affect patients in resource-limited settings?

Through an expert-driven literature review, the authors present 29 succinct recommendations for ultrasound use in vascular access. Supporting data consistently illustrate the association of ultrasound with increased successful vessel cannulation rates and decreased complication rates for all types of vascular access; including central venous access (internal jugular, subclavian, femoral), arterial line placement, peripherally inserted central catheters, and difficult peripheral venous access. Despite this compelling evidence, however, 20%-55% of all central venous catheters are still placed without ultrasound.⁵ How, then, can hospitalists expand ultrasound use for vascular access or perform these procedures in general?

Hospitalists likely fall into one of three categories in terms of vascular access: (1) they are proficient in ultrasound use for vascular access, (2) they still routinely use traditional landmark-based approaches, or (3) they have little to no involvement in vascular access and defer to intensivists, interventional radiologists, or nurse specialists. Franco-Sadud et al.’s position statement acknowledges the wide range of hospitalist practices and only asserts that, if providers perform vascular access, they should be trained and use ultrasound to do them. We would advocate further that, regardless of their practice, hospitalists have a role in expanding ultrasound use for vascular access given its direct impact on the patients they care for. Hospitalists who do not directly practice vascular access can still leverage the skills that have established hospital medicine’s reputation as leaders in patient safety and quality improvement. Hospitalists can partner with proceduralists in their institutions to ensure that they are supported and trained in the most evidence-based approaches to vascular access and that their patients have access to the highest quality of care.

For the individual hospitalist, the investment of time and resources to incorporate ultrasound into routine practice can seem daunting. In previous position statements, the SHM has advocated for the robust use of simulation and directly observed assessment in credentialing for all bedside procedures.⁶ However, the Society also acknowledges that this degree of training and monitoring can constitute significant barriers and has argued that the onus for change lies not only with providers but with healthcare institutions at large. How, then, can hospitalists approach their institutions to successfully solicit support? While the evidence is not yet conclusive, Cohen et al. have shown promising data for potential long-term cost savings through ultrasound-guided vascular access.⁷ Due to decreased complication rates, downstream benefits of lower resource use, higher patient satisfaction, and, theoretically, even lower clinician burnout rates have been attained. These effects, combined with hospitalists acquiring ultrasound skills translatable to other bedside procedures and fundamentals of diagnostic point of care ultrasound, form a compelling argument for institutional support. Many academic medical centers, typically with increased resources and training programs, have been early adopters; but, how will the shift from landmark-based to ultrasound-guided vascular access affect those in resource-limited settings?

While incredible strides have been made in care quality and patient safety over the last 15 years, improvements clearly do not always benefit patients, clinicians, or institutions equally.⁸ In fact, those in resource-limited settings often experience disproportionately reduced benefits. While focus on the “quality gap” has transformed the culture of the quality improvement and patient safety fields, an “equity gap” has long undermined and limited the impact of those very improvements. Unfortunately, changes in care driven by costly technological advances such as ultrasound are particularly likely to widen this “equity gap.” While ultrasound technology is rapidly becoming more affordable, a lack of access to machines and appropriate training remain significant barriers in the resource-limited settings that hospitalists are most likely to be performing these procedures. Without a focus on equity, the benefits offered by ultrasound will continue to be limited in their reach.

The SHM position statement by Franco-Sadud et al. is an important step in expanding evidence-based ultrasound use for vascular access and improving patient care. While the recommendations are, at times, aspirational and the barriers are real, hospitalists have shown time and again their ability to overcome these challenges and advance the standard of care for all.

Is there a single intervention more important to hospitalized patients than vascular access? Since their advent in the 1950s, small plastic tubes have revolutionized medication administration and become a mainstay of modern medicine. Yet, for much of the last 60 years, nurses and doctors have used the same landmark-guided approaches to acquire peripheral and, more specifically, central access.¹ Minor improvements to the Seldinger technique and sterile preparation have been reported.² However, for such a vital and common procedure, the complication rates of landmark-based approaches to central venous access remain unacceptably high.³

In the position statement released by the Society of Hospital Medicine (SHM), Franco–Sadud et al. outline the transformative effects ultrasound can have in obtaining adult vascular access.⁴ The authors cite comprehensive evidence, leaving little doubt of the technique’s benefits compared with landmark-based approaches. However, several questions remain: Is vascular access the domain of the hospitalist? If so, how can hospitalists pursue and afford ultrasound training? Finally, how will this shift toward ultrasound-guided vascular access affect patients in resource-limited settings?

Through an expert-driven literature review, the authors present 29 succinct recommendations for ultrasound use in vascular access. Supporting data consistently illustrate the association of ultrasound with increased successful vessel cannulation rates and decreased complication rates for all types of vascular access; including central venous access (internal jugular, subclavian, femoral), arterial line placement, peripherally inserted central catheters, and difficult peripheral venous access. Despite this compelling evidence, however, 20%-55% of all central venous catheters are still placed without ultrasound.⁵ How, then, can hospitalists expand ultrasound use for vascular access or perform these procedures in general?

Hospitalists likely fall into one of three categories in terms of vascular access: (1) they are proficient in ultrasound use for vascular access, (2) they still routinely use traditional landmark-based approaches, or (3) they have little to no involvement in vascular access and defer to intensivists, interventional radiologists, or nurse specialists. Franco-Sadud et al.’s position statement acknowledges the wide range of hospitalist practices and only asserts that, if providers perform vascular access, they should be trained and use ultrasound to do them. We would advocate further that, regardless of their practice, hospitalists have a role in expanding ultrasound use for vascular access given its direct impact on the patients they care for. Hospitalists who do not directly practice vascular access can still leverage the skills that have established hospital medicine’s reputation as leaders in patient safety and quality improvement. Hospitalists can partner with proceduralists in their institutions to ensure that they are supported and trained in the most evidence-based approaches to vascular access and that their patients have access to the highest quality of care.

For the individual hospitalist, the investment of time and resources to incorporate ultrasound into routine practice can seem daunting. In previous position statements, the SHM has advocated for the robust use of simulation and directly observed assessment in credentialing for all bedside procedures.⁶ However, the Society also acknowledges that this degree of training and monitoring can constitute significant barriers and has argued that the onus for change lies not only with providers but with healthcare institutions at large. How, then, can hospitalists approach their institutions to successfully solicit support? While the evidence is not yet conclusive, Cohen et al. have shown promising data for potential long-term cost savings through ultrasound-guided vascular access.⁷ Due to decreased complication rates, downstream benefits of lower resource use, higher patient satisfaction, and, theoretically, even lower clinician burnout rates have been attained. These effects, combined with hospitalists acquiring ultrasound skills translatable to other bedside procedures and fundamentals of diagnostic point of care ultrasound, form a compelling argument for institutional support. Many academic medical centers, typically with increased resources and training programs, have been early adopters; but, how will the shift from landmark-based to ultrasound-guided vascular access affect those in resource-limited settings?

While incredible strides have been made in care quality and patient safety over the last 15 years, improvements clearly do not always benefit patients, clinicians, or institutions equally.⁸ In fact, those in resource-limited settings often experience disproportionately reduced benefits. While focus on the “quality gap” has transformed the culture of the quality improvement and patient safety fields, an “equity gap” has long undermined and limited the impact of those very improvements. Unfortunately, changes in care driven by costly technological advances such as ultrasound are particularly likely to widen this “equity gap.” While ultrasound technology is rapidly becoming more affordable, a lack of access to machines and appropriate training remain significant barriers in the resource-limited settings that hospitalists are most likely to be performing these procedures. Without a focus on equity, the benefits offered by ultrasound will continue to be limited in their reach.

The SHM position statement by Franco-Sadud et al. is an important step in expanding evidence-based ultrasound use for vascular access and improving patient care. While the recommendations are, at times, aspirational and the barriers are real, hospitalists have shown time and again their ability to overcome these challenges and advance the standard of care for all.

Candida albicans (C albicans) is a normal commensal in the human gastrointestinal (GI) tract. In addition to localized infections in healthy human beings, dissemination with fatal outcome can occur in immunocompromised individuals.¹

Invasive candidiasis (IC) due to C albicans is the most common nosocomial mycosis in the world and has 2 forms, candidemia and deep-seated tissue candidiasis, which can lead to multisystem organ failure.² The deep-seated form may originate from nonhematogenous routes, such as introduction through a peritoneal catheter or ascending infection from cystitis.² In addition, about 50% of primary candidemia cases lead to secondary deep-seated candidiasis; however, only about 40% of these cases show positive blood cultures. Since the window of opportunity for a positive culture is narrow, active candidemia may be missed.^3,4

Once developed, the prognosis for IC is grim: Mortality is 40% regardless of therapy.² IC typically occurs in immunocompromised hosts; IC in immunocompetent persons has rarely been reported.^5,6 It is challenging to diagnose IC in the immunocompetent patients as 50% to 70% of the general population is naturally colonized by this organism, and when found, it is assumed to be mostly innocuous. Neutrophil-driven cell-mediated immunity associated with IL-1 and IL-17 response prevent fungal growth and dissemination, protecting the immunocompetent host.⁷

We report on a patient who showed no neutropenia or leukocytopenia but developed disseminated candidiasis. This report is one of the rare cases of full-blown disseminated candidiasis with lesions related to C albicans found in almost all of the important organs.

Case Presentation

A 67-year-old male patient with a history of hypertension, peripheral vascular disease, daily heavy alcohol consumption, and a 50-pack-year history of smoking developed gangrene of the left fifth toe. He underwent vascular surgery consultation with an aortogram/left lower extremity angiography that showed occlusion of the left external iliac artery as well as the left common femoral artery. It was decided to improve inflow in the common iliac artery by placing a bare metal stent and subsequent balloon dilatation before a right to left femoral to femoral artery bypass. The patient tolerated the procedure well and was discharged home.

Two days later, the patient was admitted to a US Department of Veterans Affairs (VA) complexity level 1a hospital with weakness and worsening pain in the left lower extremities. Examination revealed chronic ischemic changes in the feet bilaterally and evidence of dry gangrene in the left fifth toe requiring femoral bypass surgery. But poor nutritional status and cardiac status prevented pursuing a permanent solution.

Following completion of a stress echocardiogram, the patient developed shock with systolic blood pressure of 60 mm Hg, and atrial fibrillation (AF) with rapid ventricular rate (RVR). He was initially treated with IV fluid supplementation, vasopressor therapy, synchronized cardioversion, and IV amiodarone/anticoagulation therapy, due to his persistent AF with RVR. The patient was transferred to a tertiary care center for persistent hypothermia and received treatment with warm saline. After initial recovery with warm saline resuscitation, he had a prolonged, complicated hospital course in which he developed progressive respiratory failure requiring intubation and critical care support. He developed a right internal jugular deep venous thrombosis, heparin-induced thrombocytopenia, lower GI bleeding requiring emergent embolization by interventional radiology, inferior vena cava filter placement, renal failure requiring dialysis, small bowel obstruction secondary to right lower quadrant phlegmon and perforation requiring small bowel resection and end ileostomy. His antibiotic regimen included therapy with vancomycin and piperacillin-tazobactam.

He eventually recovered and was extubated and subsequently transferred back to the VA hospital where cefepime was initiated because of suspicion of a urinary tract infection and septicemia (urine cultures eventually grew C albicans). Over the subsequent 3 days, the patient’s renal output and hyperkalemia worsened, he also developed increased anion gap metabolic acidosis and was intubated again and placed on full mechanical ventilatory support. His blood cultures were negative, and sputum cultures revealed normal respiratory flora and 1+ C albicans. Infectious diseases consultation recommended an abdominal ultrasound, which revealed nonspecific findings. The antibiotic regimen was changed to daptomycin and piperacillin-tazobactam. A follow-up chest X-ray revealed a developing right lower lobe pneumonia and hilar prominence suggestive of lymphadenopathy. The patient’s clinical condition deteriorated, and he subsequently developed cardiac arrest; resuscitation was not successful and he expired.

Outcome and Follow-up

An autopsy disclosed the cause of death to be bilateral candida pneumonia, part of a disseminated (invasive) candidiasis, in a patient rendered vulnerable to such infection by peripheral vascular disease and renal insufficiency. Purulent inflammation was noted at the site of disarticulation of the left foot and confluent consolidation of the lower lobes of both lungs as well as focal consolidation of the middle lobe of the right lung. Examination of histologic sections, with staining both by routine method (hematoxylin and eosin) and the Grocott-Gömöri methenamine silver method for fungus, disclosed fungal forms (yeast and filamentous) in most tissues, including the lungs (Figure 1 A and B) and kidneys (Figure 1 C and D). The pulmonary sections in addition to massive inflammation showed macrophages with engulfed yeast (Figure 2 A) and a lymphatic channel, stuffed with yeast in an alveolar septum (Figure 2 B). These findings confirmed the antemortem presence of the fungus and the body’s response to it. Inflammation was noted around glomeruli overgrown by candida (Figure 1 C and D); fungi also were seen in capsular regions (not depicted). C albicans was present in the myocardium (Figure 1 E and F), brain, thyroid, and adrenal glands (Figure 3); the only organ without C albicans was the liver, either because invasion was truly absent here or because sampling had not managed to retrieve it.

Paraffin-embedded blocks of lung tissue, sent to the University of Washington Molecular Diagnosis Microbiology Laboratory for broad-range polymerase chain reaction (PCR) identification, were positive for C albicans after extraction of gDNA and conduction of PCR using internal transcribed spacer 1 and 2 specific primers.

Discussion

IC is rare among immunocompetent individuals, but C albicans can evolve into a fatal disseminated infection. We report an atypical case of IC, with profound pulmonary infection in a patient who died 1 month after hospitalization for lower extremity pain.

Cell-mediated immunity involving neutrophils and macrophages plays a major role in protection against candidiasis, while cytokines and chemokines involve regulating balanced immunity.^1,2 A series of recent studies show that alcohol impairs neutrophil-mediated killing and phagocytic-mediated uptake of a pathogen in this process.^8,9 As the patient chronically misused alcohol, his immune system may have experienced a subclinical immunosuppression, which would have become clinically relevant once C albicans was introduced systemically. Recent studies of bacterial pathogenesis and alcoholism strongly support this hypothesis.^10,11

Most patients with the unusual diagnosis of candida pneumonia have had a background of malignancy or immunosuppressive factors (eg, administration of corticosteroids).¹² In a series of 20 cases, 14 had sputum cultures positive for the organism, 6 had positive urine cultures, and 6 had positive blood cultures. Chest radiographs usually showed confluent bronchopneumonia. Five patients were diagnosed antemortem and treated with amphotericin B, but none survived.¹³ In the literature a positive blood culture or demonstration of yeast within pulmonary histiocytes has been considered proof of the pathogenicity of the fungus, as opposed to noninvasive colonization of the airways, a common occurrence in patients receiving mechanical ventilation.²

The C albicans in this case may have been introduced hematogenously from the amputation site or through an ascending cystitis, or possibly have been derived from commensal flora in the GI tract. The iron supplementation provided to the patient may have promoted the growth and virulence of the candida; studies have shown that the kidneys assimilate increased levels of iron during disseminated candidiasis thus providing a more favorable site for colonization.¹⁷The presence of C albicans in a single collection of sputum or urine does not ordinarily indicate infection in an immunocompetent individual. Estimation of serum procalcitonin, a biomarker for bacterial infection and sepsis, might be useful if negative, for turning attention to a nonbacterial (such as, candida) source as the causative agent.¹⁸

Conclusion

C albicans can rarely cause disseminated disease in nonimmunocompromised critically ill patients. Low serum procalcitonin levels in a septic patient might indicate nonbacterial cause such as candidiasis. Even with disseminated candidiasis, blood cultures may remain negative.

Candida albicans (C albicans) is a normal commensal in the human gastrointestinal (GI) tract. In addition to localized infections in healthy human beings, dissemination with fatal outcome can occur in immunocompromised individuals.¹

Invasive candidiasis (IC) due to C albicans is the most common nosocomial mycosis in the world and has 2 forms, candidemia and deep-seated tissue candidiasis, which can lead to multisystem organ failure.² The deep-seated form may originate from nonhematogenous routes, such as introduction through a peritoneal catheter or ascending infection from cystitis.² In addition, about 50% of primary candidemia cases lead to secondary deep-seated candidiasis; however, only about 40% of these cases show positive blood cultures. Since the window of opportunity for a positive culture is narrow, active candidemia may be missed.^3,4

Once developed, the prognosis for IC is grim: Mortality is 40% regardless of therapy.² IC typically occurs in immunocompromised hosts; IC in immunocompetent persons has rarely been reported.^5,6 It is challenging to diagnose IC in the immunocompetent patients as 50% to 70% of the general population is naturally colonized by this organism, and when found, it is assumed to be mostly innocuous. Neutrophil-driven cell-mediated immunity associated with IL-1 and IL-17 response prevent fungal growth and dissemination, protecting the immunocompetent host.⁷

We report on a patient who showed no neutropenia or leukocytopenia but developed disseminated candidiasis. This report is one of the rare cases of full-blown disseminated candidiasis with lesions related to C albicans found in almost all of the important organs.

Case Presentation

A 67-year-old male patient with a history of hypertension, peripheral vascular disease, daily heavy alcohol consumption, and a 50-pack-year history of smoking developed gangrene of the left fifth toe. He underwent vascular surgery consultation with an aortogram/left lower extremity angiography that showed occlusion of the left external iliac artery as well as the left common femoral artery. It was decided to improve inflow in the common iliac artery by placing a bare metal stent and subsequent balloon dilatation before a right to left femoral to femoral artery bypass. The patient tolerated the procedure well and was discharged home.

Two days later, the patient was admitted to a US Department of Veterans Affairs (VA) complexity level 1a hospital with weakness and worsening pain in the left lower extremities. Examination revealed chronic ischemic changes in the feet bilaterally and evidence of dry gangrene in the left fifth toe requiring femoral bypass surgery. But poor nutritional status and cardiac status prevented pursuing a permanent solution.

Following completion of a stress echocardiogram, the patient developed shock with systolic blood pressure of 60 mm Hg, and atrial fibrillation (AF) with rapid ventricular rate (RVR). He was initially treated with IV fluid supplementation, vasopressor therapy, synchronized cardioversion, and IV amiodarone/anticoagulation therapy, due to his persistent AF with RVR. The patient was transferred to a tertiary care center for persistent hypothermia and received treatment with warm saline. After initial recovery with warm saline resuscitation, he had a prolonged, complicated hospital course in which he developed progressive respiratory failure requiring intubation and critical care support. He developed a right internal jugular deep venous thrombosis, heparin-induced thrombocytopenia, lower GI bleeding requiring emergent embolization by interventional radiology, inferior vena cava filter placement, renal failure requiring dialysis, small bowel obstruction secondary to right lower quadrant phlegmon and perforation requiring small bowel resection and end ileostomy. His antibiotic regimen included therapy with vancomycin and piperacillin-tazobactam.

He eventually recovered and was extubated and subsequently transferred back to the VA hospital where cefepime was initiated because of suspicion of a urinary tract infection and septicemia (urine cultures eventually grew C albicans). Over the subsequent 3 days, the patient’s renal output and hyperkalemia worsened, he also developed increased anion gap metabolic acidosis and was intubated again and placed on full mechanical ventilatory support. His blood cultures were negative, and sputum cultures revealed normal respiratory flora and 1+ C albicans. Infectious diseases consultation recommended an abdominal ultrasound, which revealed nonspecific findings. The antibiotic regimen was changed to daptomycin and piperacillin-tazobactam. A follow-up chest X-ray revealed a developing right lower lobe pneumonia and hilar prominence suggestive of lymphadenopathy. The patient’s clinical condition deteriorated, and he subsequently developed cardiac arrest; resuscitation was not successful and he expired.

Outcome and Follow-up

An autopsy disclosed the cause of death to be bilateral candida pneumonia, part of a disseminated (invasive) candidiasis, in a patient rendered vulnerable to such infection by peripheral vascular disease and renal insufficiency. Purulent inflammation was noted at the site of disarticulation of the left foot and confluent consolidation of the lower lobes of both lungs as well as focal consolidation of the middle lobe of the right lung. Examination of histologic sections, with staining both by routine method (hematoxylin and eosin) and the Grocott-Gömöri methenamine silver method for fungus, disclosed fungal forms (yeast and filamentous) in most tissues, including the lungs (Figure 1 A and B) and kidneys (Figure 1 C and D). The pulmonary sections in addition to massive inflammation showed macrophages with engulfed yeast (Figure 2 A) and a lymphatic channel, stuffed with yeast in an alveolar septum (Figure 2 B). These findings confirmed the antemortem presence of the fungus and the body’s response to it. Inflammation was noted around glomeruli overgrown by candida (Figure 1 C and D); fungi also were seen in capsular regions (not depicted). C albicans was present in the myocardium (Figure 1 E and F), brain, thyroid, and adrenal glands (Figure 3); the only organ without C albicans was the liver, either because invasion was truly absent here or because sampling had not managed to retrieve it.

Paraffin-embedded blocks of lung tissue, sent to the University of Washington Molecular Diagnosis Microbiology Laboratory for broad-range polymerase chain reaction (PCR) identification, were positive for C albicans after extraction of gDNA and conduction of PCR using internal transcribed spacer 1 and 2 specific primers.

Discussion

IC is rare among immunocompetent individuals, but C albicans can evolve into a fatal disseminated infection. We report an atypical case of IC, with profound pulmonary infection in a patient who died 1 month after hospitalization for lower extremity pain.

Cell-mediated immunity involving neutrophils and macrophages plays a major role in protection against candidiasis, while cytokines and chemokines involve regulating balanced immunity.^1,2 A series of recent studies show that alcohol impairs neutrophil-mediated killing and phagocytic-mediated uptake of a pathogen in this process.^8,9 As the patient chronically misused alcohol, his immune system may have experienced a subclinical immunosuppression, which would have become clinically relevant once C albicans was introduced systemically. Recent studies of bacterial pathogenesis and alcoholism strongly support this hypothesis.^10,11

Most patients with the unusual diagnosis of candida pneumonia have had a background of malignancy or immunosuppressive factors (eg, administration of corticosteroids).¹² In a series of 20 cases, 14 had sputum cultures positive for the organism, 6 had positive urine cultures, and 6 had positive blood cultures. Chest radiographs usually showed confluent bronchopneumonia. Five patients were diagnosed antemortem and treated with amphotericin B, but none survived.¹³ In the literature a positive blood culture or demonstration of yeast within pulmonary histiocytes has been considered proof of the pathogenicity of the fungus, as opposed to noninvasive colonization of the airways, a common occurrence in patients receiving mechanical ventilation.²

The C albicans in this case may have been introduced hematogenously from the amputation site or through an ascending cystitis, or possibly have been derived from commensal flora in the GI tract. The iron supplementation provided to the patient may have promoted the growth and virulence of the candida; studies have shown that the kidneys assimilate increased levels of iron during disseminated candidiasis thus providing a more favorable site for colonization.¹⁷The presence of C albicans in a single collection of sputum or urine does not ordinarily indicate infection in an immunocompetent individual. Estimation of serum procalcitonin, a biomarker for bacterial infection and sepsis, might be useful if negative, for turning attention to a nonbacterial (such as, candida) source as the causative agent.¹⁸

Conclusion

C albicans can rarely cause disseminated disease in nonimmunocompromised critically ill patients. Low serum procalcitonin levels in a septic patient might indicate nonbacterial cause such as candidiasis. Even with disseminated candidiasis, blood cultures may remain negative.

Candida albicans (C albicans) is a normal commensal in the human gastrointestinal (GI) tract. In addition to localized infections in healthy human beings, dissemination with fatal outcome can occur in immunocompromised individuals.¹

Invasive candidiasis (IC) due to C albicans is the most common nosocomial mycosis in the world and has 2 forms, candidemia and deep-seated tissue candidiasis, which can lead to multisystem organ failure.² The deep-seated form may originate from nonhematogenous routes, such as introduction through a peritoneal catheter or ascending infection from cystitis.² In addition, about 50% of primary candidemia cases lead to secondary deep-seated candidiasis; however, only about 40% of these cases show positive blood cultures. Since the window of opportunity for a positive culture is narrow, active candidemia may be missed.^3,4

Once developed, the prognosis for IC is grim: Mortality is 40% regardless of therapy.² IC typically occurs in immunocompromised hosts; IC in immunocompetent persons has rarely been reported.^5,6 It is challenging to diagnose IC in the immunocompetent patients as 50% to 70% of the general population is naturally colonized by this organism, and when found, it is assumed to be mostly innocuous. Neutrophil-driven cell-mediated immunity associated with IL-1 and IL-17 response prevent fungal growth and dissemination, protecting the immunocompetent host.⁷

We report on a patient who showed no neutropenia or leukocytopenia but developed disseminated candidiasis. This report is one of the rare cases of full-blown disseminated candidiasis with lesions related to C albicans found in almost all of the important organs.

Case Presentation

A 67-year-old male patient with a history of hypertension, peripheral vascular disease, daily heavy alcohol consumption, and a 50-pack-year history of smoking developed gangrene of the left fifth toe. He underwent vascular surgery consultation with an aortogram/left lower extremity angiography that showed occlusion of the left external iliac artery as well as the left common femoral artery. It was decided to improve inflow in the common iliac artery by placing a bare metal stent and subsequent balloon dilatation before a right to left femoral to femoral artery bypass. The patient tolerated the procedure well and was discharged home.

Two days later, the patient was admitted to a US Department of Veterans Affairs (VA) complexity level 1a hospital with weakness and worsening pain in the left lower extremities. Examination revealed chronic ischemic changes in the feet bilaterally and evidence of dry gangrene in the left fifth toe requiring femoral bypass surgery. But poor nutritional status and cardiac status prevented pursuing a permanent solution.

Following completion of a stress echocardiogram, the patient developed shock with systolic blood pressure of 60 mm Hg, and atrial fibrillation (AF) with rapid ventricular rate (RVR). He was initially treated with IV fluid supplementation, vasopressor therapy, synchronized cardioversion, and IV amiodarone/anticoagulation therapy, due to his persistent AF with RVR. The patient was transferred to a tertiary care center for persistent hypothermia and received treatment with warm saline. After initial recovery with warm saline resuscitation, he had a prolonged, complicated hospital course in which he developed progressive respiratory failure requiring intubation and critical care support. He developed a right internal jugular deep venous thrombosis, heparin-induced thrombocytopenia, lower GI bleeding requiring emergent embolization by interventional radiology, inferior vena cava filter placement, renal failure requiring dialysis, small bowel obstruction secondary to right lower quadrant phlegmon and perforation requiring small bowel resection and end ileostomy. His antibiotic regimen included therapy with vancomycin and piperacillin-tazobactam.

He eventually recovered and was extubated and subsequently transferred back to the VA hospital where cefepime was initiated because of suspicion of a urinary tract infection and septicemia (urine cultures eventually grew C albicans). Over the subsequent 3 days, the patient’s renal output and hyperkalemia worsened, he also developed increased anion gap metabolic acidosis and was intubated again and placed on full mechanical ventilatory support. His blood cultures were negative, and sputum cultures revealed normal respiratory flora and 1+ C albicans. Infectious diseases consultation recommended an abdominal ultrasound, which revealed nonspecific findings. The antibiotic regimen was changed to daptomycin and piperacillin-tazobactam. A follow-up chest X-ray revealed a developing right lower lobe pneumonia and hilar prominence suggestive of lymphadenopathy. The patient’s clinical condition deteriorated, and he subsequently developed cardiac arrest; resuscitation was not successful and he expired.

Outcome and Follow-up

An autopsy disclosed the cause of death to be bilateral candida pneumonia, part of a disseminated (invasive) candidiasis, in a patient rendered vulnerable to such infection by peripheral vascular disease and renal insufficiency. Purulent inflammation was noted at the site of disarticulation of the left foot and confluent consolidation of the lower lobes of both lungs as well as focal consolidation of the middle lobe of the right lung. Examination of histologic sections, with staining both by routine method (hematoxylin and eosin) and the Grocott-Gömöri methenamine silver method for fungus, disclosed fungal forms (yeast and filamentous) in most tissues, including the lungs (Figure 1 A and B) and kidneys (Figure 1 C and D). The pulmonary sections in addition to massive inflammation showed macrophages with engulfed yeast (Figure 2 A) and a lymphatic channel, stuffed with yeast in an alveolar septum (Figure 2 B). These findings confirmed the antemortem presence of the fungus and the body’s response to it. Inflammation was noted around glomeruli overgrown by candida (Figure 1 C and D); fungi also were seen in capsular regions (not depicted). C albicans was present in the myocardium (Figure 1 E and F), brain, thyroid, and adrenal glands (Figure 3); the only organ without C albicans was the liver, either because invasion was truly absent here or because sampling had not managed to retrieve it.

Paraffin-embedded blocks of lung tissue, sent to the University of Washington Molecular Diagnosis Microbiology Laboratory for broad-range polymerase chain reaction (PCR) identification, were positive for C albicans after extraction of gDNA and conduction of PCR using internal transcribed spacer 1 and 2 specific primers.

Discussion

IC is rare among immunocompetent individuals, but C albicans can evolve into a fatal disseminated infection. We report an atypical case of IC, with profound pulmonary infection in a patient who died 1 month after hospitalization for lower extremity pain.

Cell-mediated immunity involving neutrophils and macrophages plays a major role in protection against candidiasis, while cytokines and chemokines involve regulating balanced immunity.^1,2 A series of recent studies show that alcohol impairs neutrophil-mediated killing and phagocytic-mediated uptake of a pathogen in this process.^8,9 As the patient chronically misused alcohol, his immune system may have experienced a subclinical immunosuppression, which would have become clinically relevant once C albicans was introduced systemically. Recent studies of bacterial pathogenesis and alcoholism strongly support this hypothesis.^10,11

Most patients with the unusual diagnosis of candida pneumonia have had a background of malignancy or immunosuppressive factors (eg, administration of corticosteroids).¹² In a series of 20 cases, 14 had sputum cultures positive for the organism, 6 had positive urine cultures, and 6 had positive blood cultures. Chest radiographs usually showed confluent bronchopneumonia. Five patients were diagnosed antemortem and treated with amphotericin B, but none survived.¹³ In the literature a positive blood culture or demonstration of yeast within pulmonary histiocytes has been considered proof of the pathogenicity of the fungus, as opposed to noninvasive colonization of the airways, a common occurrence in patients receiving mechanical ventilation.²

The C albicans in this case may have been introduced hematogenously from the amputation site or through an ascending cystitis, or possibly have been derived from commensal flora in the GI tract. The iron supplementation provided to the patient may have promoted the growth and virulence of the candida; studies have shown that the kidneys assimilate increased levels of iron during disseminated candidiasis thus providing a more favorable site for colonization.¹⁷The presence of C albicans in a single collection of sputum or urine does not ordinarily indicate infection in an immunocompetent individual. Estimation of serum procalcitonin, a biomarker for bacterial infection and sepsis, might be useful if negative, for turning attention to a nonbacterial (such as, candida) source as the causative agent.¹⁸

Conclusion

C albicans can rarely cause disseminated disease in nonimmunocompromised critically ill patients. Low serum procalcitonin levels in a septic patient might indicate nonbacterial cause such as candidiasis. Even with disseminated candidiasis, blood cultures may remain negative.

The Federal Bureau of Labor Statistics projects 37% job growth for physician assistants (PAs) from 2016 to 2026, much greater than the average for all other occupations as well as for other medical professions.¹ This growth has been accompanied by increased enrollment in medical (doctor of medicine [MD], doctor of osteopathic medicine) and nurse practitioner (NP) schools.² Clinical teaching sites serve a crucial function in the training of all clinical disciplines. These sites provide hands-on and experiential learning in medical settings, necessary components for learners practicing to become clinicians. Significant PA program expansion has led to increased demand for clinical training, creating competition for sites and a shortage of willing and well-trained preceptors.³

This challenge has been recognized by PA program directors. In the Joint Report of the 2013 Multi-Discipline Clerkship/Clinical Training Site Survey, PA program directors expressed concern about the adequacy of clinical opportunities for students, increased difficulty developing new core sites, and preserving existing core sites. In addition, they noted that a shortage of clinical sites was one of the greatest barriers to the PA programs’ sustained growth and success.⁴

Program directors also indicated difficulty securing clinical training sites in internal medicine (IM) and high rates of attrition of medicine clinical preceptors for their students.⁵ The reasons are multifold: increasing clinical demands, time, teaching competence, lack of experience, academic affiliation, lack of reimbursement, or compensation. Moreover, there is a declining number of PAs who work in primary care compared with specialty and subspecialty care, limiting the availability of clinical training preceptors in medicine and primary care.^6-8 According to the American Academy of PAs (AAPA) census and salary survey data, the percentage of PAs working in the primary care specialties (ie, family medicine, IM, and general pediatrics) has decreased from > 47% in 1995 to 24% in 2017.⁹ As such, there is a need to broaden the educational landscape to provide more high-quality training sites in IM.

The postacute health care setting may address this training need. It offers a unique clinical opportunity to expose learners to a broad range of disease complexity and clinical acuity, as the percentage of patients discharged from hospitals to postacute care (PAC) has increased and care shifts from the hospital to the PAC setting.^10,11 The longer PAC length of stay also enables learners to follow patients longitudinally over several weeks and experience interprofessional team-based care. In addition, the PAC setting offers learners the ability to acquire the necessary skills for smooth and effective transitions of care. This setting has been extensively used for trainees of nursing, pharmacy, physical therapy (PT) and occupational therapy (OT), speech-language pathology, psychology, and social work (SW), but few programs have used the PAC setting as clerkship sites for IM rotations for PA students. To address this need for IM sites, the VA Boston Healthcare System (VABHS), in conjunction with the Boston University School of Medicine Physician Assistant Program, developed a novel medicine clinical clerkship site for physician assistants in the PAC unit of the community living center (CLC) at VABHS. This report describes the program structure, curriculum, and participant evaluation results.

Clinical Clerkship Program

VABHS CLC is a 110-bed facility comprising 3 units: a 65-bed PAC unit, a 15-bed closed hospice/palliative care unit, and a 30-bed long-term care unit. The service is staffed continuously with physicians, PAs, and NPs. A majority of patients are admitted from the acute care hospital of VABHS (West Roxbury campus) and other regional VA facilities. The CLC offers dynamic services, including phlebotomy, general radiology, IV diuretics and antibiotics, wound care, and subacute PT, OT, and speech-language pathology rehabilitation. The CLC serves as a venue for transitioning patients from acute inpatient care to home. The patient population is often elderly, with multiple active comorbidities and variable medical literacy, adherence, and follow-up.

The CLC provides a diverse interprofessional learning environment, offering core IM rotations for first-year psychiatry residents, oral and maxillofacial surgery residents, and PA students. The CLC also has expanded as a clinical site both for transitions-in-care IM resident curricula and electives as well as a geriatrics fellowship. In addition, the site offers rotations for NPs, nursing, pharmacy, physical and occupational therapies, speech-language pathology, psychology, and SW.

The Boston University School of Medicine Physician Assistant Program was founded in 2015 as a master’s degree program completed over 28 months. The first 12 months are didactic, and the following 16 months are clinical training with 14 months of rotations (2 IM, family medicine, pediatrics, emergency medicine, general surgery, obstetrics and gynecology, psychiatry, neurology, and 5 elective rotations), and 2 months for a thesis. The program has about 30 students per year and 4 clerkship sites for IM.

Program Description

The VABHS medicine clerkship hosts 1 to 2 PA students for 4-week blocks in the PAC unit of the CLC. Each student rotates on both PA and MD teams. Students follow 3 to 4 patients and participate fully in their care from admission to discharge; they prepare daily presentations and participate in medical management, family meetings, chart documentation, and care coordination with the interprofessional team. Students are provided a physical examination checklist and feedback form, and they are expected to track findings and record feedback and goals with their supervising preceptor weekly. They also make formal case presentations and participate in monthly medicine didactic rounds available to all VABHS IM students and trainees via videoconference.

In addition, beginning in July 2017, all PA students in the CLC began to participate in a 4-week Interprofessional Curriculum in Transitional Care. The curriculum includes 14 didactic lectures taught by 16 interprofessional faculty, including medicine, geriatric, and palliative care physicians; PAs; social workers; physical and occupational therapists; pharmacists; and a geriatric psychologist. The didactics include topics on the interprofessional team, the care continuum, teams and teamwork, interdisciplinary coordination of care, components of effective transitions in care, medication reconciliation, approaching difficult conversations, advance care planning, and quality improvement. The goal of the curriculum is to provide learners the knowledge, skills, and dispositions necessary for high-quality transitional care and interprofessional practice as well as specific training for effective and safe transfers of care between clinical settings. Although PA students are the main participants in this curriculum, all other learners in the PAC unit are also invited to attend the lectures.

The unique attributes of this training site include direct interaction with supervising PAs and physicians, rather than experiencing the traditional teaching hierarchy (with interns, residents, fellows); observation of the natural progression of disease of both acute care and primary care issues due to the longer length of stay (2 to 6 weeks, where the typical student will see the same patient 7 to 10 times during their rotation); exposure to a host of medically complex patients offering a multitude of clinical scenarios and abnormal physical exam findings; exposure to a hospice/palliative care ward and end-of-life care; and interaction within an interprofessional training environment of nursing, pharmacy, PT, OT, speech-language pathology, psychology, and SW trainees.

Program Evaluation

At the end of rotations continuously through the year, PA students electronically complete a site evaluation from the Boston University School of Medicine Physician Assistant Program. The evaluation consists of 14 questions: 6 about site quality and 8 about instruction quality. The questions are answered on a 5-point Likert scale. Also included are 2 open-ended response questions that ask what they liked about the rotation and what they felt could be improved. Results are anonymous, de-identified and blinded both to the program as well as the clerkship site. Results are aggregated and provided to program sites annually. Responses are converted to a dichotomous variable, where any good or excellent response (4 or 5) is considered positive and any neutral or below (3, 2, 1) is considered a nonpositive response.

Results

The clerkship site has been operational since June 22, 2015. There have been 59 students who participated in the rotation. A different scale in these evaluations was used between June 22, 2015, and September 13, 2015. Therefore, 7 responses were excluded from the analysis, leaving 52 usable evaluations. The responses were analyzed both in total (for the CLC as well as other IM rotation sites) and by individual clerkship year to look for any trends over time: September 14, 2015, through April 24, 2016; April 25, 2016, through April 28, 2017; and May 1, 2017, through March 1, 2018 (Table).

Site evaluations showed high satisfaction regarding the quality of the physical environment as well as the learning environment. Students endorsed the PAC unit having resources and physical space for them, such as a desk and computer, opportunity for participation in patient care, and parking (100%; n = 52). Site evaluations revealed high satisfaction with the quality of teaching and faculty encouragement and support of their learning (100%; n = 52). The evaluations revealed that bedside teaching was strong (94%; n = 49). The students reported high satisfaction with the volume of patients provided (92%; n = 48) as well as the diversity of diagnoses (92%; n = 48).

There were fewer positive responses in the first 2 years of the rotation with regard to formal lectures (50% and 67%; 7/14 and 16/24, respectively). In the third year of the rotation, students had a much higher satisfaction rate (93%; 13/14). This increased satisfaction was associated with the development and incorporation of the Interprofessional Curriculum in Transitional Care in 2017.

Discussion

Access to high-quality PA student clerkship sites has become a pressing issue in recent years because of increased competition for sites and a shortage of willing and well-trained preceptors. There has been marked growth in schools and enrollment across all medical professions. The Accreditation Review Commission on Education for the PA (ARC-PA) reported that the total number of accredited entry-level PA programs in 2018 was 246, with 58 new accredited programs projected by 2022.¹² The Joint Report of the 2013 Multi-Discipline Clerkship/Clinical Training Site Survey reported a 66% increase in first-year enrollment in PA programs from 2002 to 2012.⁵ Programs must implement alternative strategies to attract clinical sites (eg, academic appointments, increased clinical resources to training sites) or face continued challenges with recruiting training sites for their students. Postacute care may be a natural extension to expand the footprint for clinical sites for these programs, augmenting acute inpatient and outpatient rotations. This implementation would increase the pool of clinical training sites and preceptors.

The experience with this novel training site, based on PA student feedback and evaluations, has been positive, and the postacute setting can provide students with high-quality IM clinical experiences. Students report adequate patient volume and diversity. In addition, evaluations are comparable with that of other IM site rotations the students experience. Qualitative feedback has emphasized the value of following patients over longer periods; eg, weeks vs days (as in acute care) enabling students to build relationships with patients as well as observe a richer clinical spectrum of disease over a less compressed period. “Patients have complex issues, so from a medical standpoint it challenges you to think of new ways to manage their care,” commented a representative student. “It is really beneficial that you can follow them over time.”

Furthermore, in response to student feedback on didactics, an interprofessional curriculum was developed to add formal structure as well as to create a curriculum in care transitions. This curriculum provided a unique opportunity for PA students to receive formal instruction on areas of particular relevance for transitional care (eg, care continuum, end of life issues, and care transitions). The curriculum also allows the interprofessional faculty a unique and enjoyable opportunity for interprofessional collaboration.

The 1 month PAC rotation is augmented with inpatient IM and outpatient family medicine rotations, consequently giving exposure to the full continuum of care. The PAC setting provides learners multifaceted benefits: the opportunity to strengthen and develop the knowledge, attitudes, and skills necessary for IM; increased understanding of other professions by observing and interacting as a team caring for a patient over a longer period as opposed to the acute care setting; the ability to perform effective, efficient, and safe transfer between clinical settings; and broad exposure to transitional care. As a result, the PAC rotation enhances but does not replace the necessary and essential rotations of inpatient and outpatient medicine.

Moreover, this rotation provides unique and core IM training for PA students. Our site focuses on interprofessional collaboration, emphasizing the importance of team-based care, an essential concept in modern day medicine. Formal exposure to other care specialties, such as PT and OT, SW, and mental health, is essential for students to appreciate clinical medicine and a patient’s physical and mental experience over the course of a disease and clinical state. In addition, the physical exam checklist ensures that students are exposed to the full spectrum of IM examination findings during their rotation. Finally, weekly feedback forms require students to ask and receive concrete feedback from their supervising providers.

Limitations

The generalizability of this model requires careful consideration. VABHS is a tertiary care integrated health care system, enabling students to learn from patients moving through multiple care transitions in a single health care system. In addition, other settings may not have the staffing or clinical volume to sustain such a model. All PAC clinical faculty teach voluntarily, and local leadership has set expectations for all clinicians to participate in teaching of trainees and PA students. Evaluations also note less diversity in the patient population, a challenge that some VA facilities face. This issue could be addressed by ensuring that students also have IM rotations at other inpatient medical facilities. A more balanced experience, where students reap the positive benefits of PAC but do not lose exposure to a diverse patient pool, could result. Furthermore, some of the perceived positive impacts also may be related to professional and personal attributes of the teaching clinicians rather than to the PAC setting.

Conclusion

PAC settings can be effective training sites for medicine clerkships for PA students and can provide high-quality training in IM as PA programs continue to expand. This setting offers students exposure to interprofessional, team-based care and the opportunity to care for patients with a broad range of disease complexity. Learning is further enhanced by the ability to follow patients longitudinally over their disease course as well as to work directly with teaching faculty and other interprofessional health care professionals. Evaluations of this novel clerkship experience have shown high levels of student satisfaction in knowledge growth, clinical skills, bedside teaching, and mentorship.

Acknowledgments
We thank Juman Hijab for her critical role in establishing and maintaining the clerkship. We thank Steven Simon, Matt Russell, and Thomas Parrino for their leadership and guidance in establishing and maintaining the clerkship. We thank the Boston University School of Medicine Physician Assistant Program Director Mary Warner for her support and guidance in creating and supporting the clerkship. In addition, we thank the interprofessional education faculty for their dedicated involvement in teaching, including Stephanie Saunders, Lindsay Lefers, Jessica Rawlins, Lindsay Brennan, Angela Viani, Eric Charette, Nicole O’Neil, Susan Nathan, Jordana Meyerson, Shivani Jindal, Wei Shen, Amy Hanson, Gilda Cain, and Kate Hinrichs.

The Federal Bureau of Labor Statistics projects 37% job growth for physician assistants (PAs) from 2016 to 2026, much greater than the average for all other occupations as well as for other medical professions.¹ This growth has been accompanied by increased enrollment in medical (doctor of medicine [MD], doctor of osteopathic medicine) and nurse practitioner (NP) schools.² Clinical teaching sites serve a crucial function in the training of all clinical disciplines. These sites provide hands-on and experiential learning in medical settings, necessary components for learners practicing to become clinicians. Significant PA program expansion has led to increased demand for clinical training, creating competition for sites and a shortage of willing and well-trained preceptors.³

This challenge has been recognized by PA program directors. In the Joint Report of the 2013 Multi-Discipline Clerkship/Clinical Training Site Survey, PA program directors expressed concern about the adequacy of clinical opportunities for students, increased difficulty developing new core sites, and preserving existing core sites. In addition, they noted that a shortage of clinical sites was one of the greatest barriers to the PA programs’ sustained growth and success.⁴

Program directors also indicated difficulty securing clinical training sites in internal medicine (IM) and high rates of attrition of medicine clinical preceptors for their students.⁵ The reasons are multifold: increasing clinical demands, time, teaching competence, lack of experience, academic affiliation, lack of reimbursement, or compensation. Moreover, there is a declining number of PAs who work in primary care compared with specialty and subspecialty care, limiting the availability of clinical training preceptors in medicine and primary care.^6-8 According to the American Academy of PAs (AAPA) census and salary survey data, the percentage of PAs working in the primary care specialties (ie, family medicine, IM, and general pediatrics) has decreased from > 47% in 1995 to 24% in 2017.⁹ As such, there is a need to broaden the educational landscape to provide more high-quality training sites in IM.

The postacute health care setting may address this training need. It offers a unique clinical opportunity to expose learners to a broad range of disease complexity and clinical acuity, as the percentage of patients discharged from hospitals to postacute care (PAC) has increased and care shifts from the hospital to the PAC setting.^10,11 The longer PAC length of stay also enables learners to follow patients longitudinally over several weeks and experience interprofessional team-based care. In addition, the PAC setting offers learners the ability to acquire the necessary skills for smooth and effective transitions of care. This setting has been extensively used for trainees of nursing, pharmacy, physical therapy (PT) and occupational therapy (OT), speech-language pathology, psychology, and social work (SW), but few programs have used the PAC setting as clerkship sites for IM rotations for PA students. To address this need for IM sites, the VA Boston Healthcare System (VABHS), in conjunction with the Boston University School of Medicine Physician Assistant Program, developed a novel medicine clinical clerkship site for physician assistants in the PAC unit of the community living center (CLC) at VABHS. This report describes the program structure, curriculum, and participant evaluation results.

Clinical Clerkship Program

VABHS CLC is a 110-bed facility comprising 3 units: a 65-bed PAC unit, a 15-bed closed hospice/palliative care unit, and a 30-bed long-term care unit. The service is staffed continuously with physicians, PAs, and NPs. A majority of patients are admitted from the acute care hospital of VABHS (West Roxbury campus) and other regional VA facilities. The CLC offers dynamic services, including phlebotomy, general radiology, IV diuretics and antibiotics, wound care, and subacute PT, OT, and speech-language pathology rehabilitation. The CLC serves as a venue for transitioning patients from acute inpatient care to home. The patient population is often elderly, with multiple active comorbidities and variable medical literacy, adherence, and follow-up.

The CLC provides a diverse interprofessional learning environment, offering core IM rotations for first-year psychiatry residents, oral and maxillofacial surgery residents, and PA students. The CLC also has expanded as a clinical site both for transitions-in-care IM resident curricula and electives as well as a geriatrics fellowship. In addition, the site offers rotations for NPs, nursing, pharmacy, physical and occupational therapies, speech-language pathology, psychology, and SW.

The Boston University School of Medicine Physician Assistant Program was founded in 2015 as a master’s degree program completed over 28 months. The first 12 months are didactic, and the following 16 months are clinical training with 14 months of rotations (2 IM, family medicine, pediatrics, emergency medicine, general surgery, obstetrics and gynecology, psychiatry, neurology, and 5 elective rotations), and 2 months for a thesis. The program has about 30 students per year and 4 clerkship sites for IM.

Program Description

The VABHS medicine clerkship hosts 1 to 2 PA students for 4-week blocks in the PAC unit of the CLC. Each student rotates on both PA and MD teams. Students follow 3 to 4 patients and participate fully in their care from admission to discharge; they prepare daily presentations and participate in medical management, family meetings, chart documentation, and care coordination with the interprofessional team. Students are provided a physical examination checklist and feedback form, and they are expected to track findings and record feedback and goals with their supervising preceptor weekly. They also make formal case presentations and participate in monthly medicine didactic rounds available to all VABHS IM students and trainees via videoconference.

In addition, beginning in July 2017, all PA students in the CLC began to participate in a 4-week Interprofessional Curriculum in Transitional Care. The curriculum includes 14 didactic lectures taught by 16 interprofessional faculty, including medicine, geriatric, and palliative care physicians; PAs; social workers; physical and occupational therapists; pharmacists; and a geriatric psychologist. The didactics include topics on the interprofessional team, the care continuum, teams and teamwork, interdisciplinary coordination of care, components of effective transitions in care, medication reconciliation, approaching difficult conversations, advance care planning, and quality improvement. The goal of the curriculum is to provide learners the knowledge, skills, and dispositions necessary for high-quality transitional care and interprofessional practice as well as specific training for effective and safe transfers of care between clinical settings. Although PA students are the main participants in this curriculum, all other learners in the PAC unit are also invited to attend the lectures.

The unique attributes of this training site include direct interaction with supervising PAs and physicians, rather than experiencing the traditional teaching hierarchy (with interns, residents, fellows); observation of the natural progression of disease of both acute care and primary care issues due to the longer length of stay (2 to 6 weeks, where the typical student will see the same patient 7 to 10 times during their rotation); exposure to a host of medically complex patients offering a multitude of clinical scenarios and abnormal physical exam findings; exposure to a hospice/palliative care ward and end-of-life care; and interaction within an interprofessional training environment of nursing, pharmacy, PT, OT, speech-language pathology, psychology, and SW trainees.

Program Evaluation

At the end of rotations continuously through the year, PA students electronically complete a site evaluation from the Boston University School of Medicine Physician Assistant Program. The evaluation consists of 14 questions: 6 about site quality and 8 about instruction quality. The questions are answered on a 5-point Likert scale. Also included are 2 open-ended response questions that ask what they liked about the rotation and what they felt could be improved. Results are anonymous, de-identified and blinded both to the program as well as the clerkship site. Results are aggregated and provided to program sites annually. Responses are converted to a dichotomous variable, where any good or excellent response (4 or 5) is considered positive and any neutral or below (3, 2, 1) is considered a nonpositive response.

Results

The clerkship site has been operational since June 22, 2015. There have been 59 students who participated in the rotation. A different scale in these evaluations was used between June 22, 2015, and September 13, 2015. Therefore, 7 responses were excluded from the analysis, leaving 52 usable evaluations. The responses were analyzed both in total (for the CLC as well as other IM rotation sites) and by individual clerkship year to look for any trends over time: September 14, 2015, through April 24, 2016; April 25, 2016, through April 28, 2017; and May 1, 2017, through March 1, 2018 (Table).

Site evaluations showed high satisfaction regarding the quality of the physical environment as well as the learning environment. Students endorsed the PAC unit having resources and physical space for them, such as a desk and computer, opportunity for participation in patient care, and parking (100%; n = 52). Site evaluations revealed high satisfaction with the quality of teaching and faculty encouragement and support of their learning (100%; n = 52). The evaluations revealed that bedside teaching was strong (94%; n = 49). The students reported high satisfaction with the volume of patients provided (92%; n = 48) as well as the diversity of diagnoses (92%; n = 48).

There were fewer positive responses in the first 2 years of the rotation with regard to formal lectures (50% and 67%; 7/14 and 16/24, respectively). In the third year of the rotation, students had a much higher satisfaction rate (93%; 13/14). This increased satisfaction was associated with the development and incorporation of the Interprofessional Curriculum in Transitional Care in 2017.

Discussion

Access to high-quality PA student clerkship sites has become a pressing issue in recent years because of increased competition for sites and a shortage of willing and well-trained preceptors. There has been marked growth in schools and enrollment across all medical professions. The Accreditation Review Commission on Education for the PA (ARC-PA) reported that the total number of accredited entry-level PA programs in 2018 was 246, with 58 new accredited programs projected by 2022.¹² The Joint Report of the 2013 Multi-Discipline Clerkship/Clinical Training Site Survey reported a 66% increase in first-year enrollment in PA programs from 2002 to 2012.⁵ Programs must implement alternative strategies to attract clinical sites (eg, academic appointments, increased clinical resources to training sites) or face continued challenges with recruiting training sites for their students. Postacute care may be a natural extension to expand the footprint for clinical sites for these programs, augmenting acute inpatient and outpatient rotations. This implementation would increase the pool of clinical training sites and preceptors.

The experience with this novel training site, based on PA student feedback and evaluations, has been positive, and the postacute setting can provide students with high-quality IM clinical experiences. Students report adequate patient volume and diversity. In addition, evaluations are comparable with that of other IM site rotations the students experience. Qualitative feedback has emphasized the value of following patients over longer periods; eg, weeks vs days (as in acute care) enabling students to build relationships with patients as well as observe a richer clinical spectrum of disease over a less compressed period. “Patients have complex issues, so from a medical standpoint it challenges you to think of new ways to manage their care,” commented a representative student. “It is really beneficial that you can follow them over time.”

Furthermore, in response to student feedback on didactics, an interprofessional curriculum was developed to add formal structure as well as to create a curriculum in care transitions. This curriculum provided a unique opportunity for PA students to receive formal instruction on areas of particular relevance for transitional care (eg, care continuum, end of life issues, and care transitions). The curriculum also allows the interprofessional faculty a unique and enjoyable opportunity for interprofessional collaboration.

The 1 month PAC rotation is augmented with inpatient IM and outpatient family medicine rotations, consequently giving exposure to the full continuum of care. The PAC setting provides learners multifaceted benefits: the opportunity to strengthen and develop the knowledge, attitudes, and skills necessary for IM; increased understanding of other professions by observing and interacting as a team caring for a patient over a longer period as opposed to the acute care setting; the ability to perform effective, efficient, and safe transfer between clinical settings; and broad exposure to transitional care. As a result, the PAC rotation enhances but does not replace the necessary and essential rotations of inpatient and outpatient medicine.

Moreover, this rotation provides unique and core IM training for PA students. Our site focuses on interprofessional collaboration, emphasizing the importance of team-based care, an essential concept in modern day medicine. Formal exposure to other care specialties, such as PT and OT, SW, and mental health, is essential for students to appreciate clinical medicine and a patient’s physical and mental experience over the course of a disease and clinical state. In addition, the physical exam checklist ensures that students are exposed to the full spectrum of IM examination findings during their rotation. Finally, weekly feedback forms require students to ask and receive concrete feedback from their supervising providers.

Limitations

The generalizability of this model requires careful consideration. VABHS is a tertiary care integrated health care system, enabling students to learn from patients moving through multiple care transitions in a single health care system. In addition, other settings may not have the staffing or clinical volume to sustain such a model. All PAC clinical faculty teach voluntarily, and local leadership has set expectations for all clinicians to participate in teaching of trainees and PA students. Evaluations also note less diversity in the patient population, a challenge that some VA facilities face. This issue could be addressed by ensuring that students also have IM rotations at other inpatient medical facilities. A more balanced experience, where students reap the positive benefits of PAC but do not lose exposure to a diverse patient pool, could result. Furthermore, some of the perceived positive impacts also may be related to professional and personal attributes of the teaching clinicians rather than to the PAC setting.

Conclusion

PAC settings can be effective training sites for medicine clerkships for PA students and can provide high-quality training in IM as PA programs continue to expand. This setting offers students exposure to interprofessional, team-based care and the opportunity to care for patients with a broad range of disease complexity. Learning is further enhanced by the ability to follow patients longitudinally over their disease course as well as to work directly with teaching faculty and other interprofessional health care professionals. Evaluations of this novel clerkship experience have shown high levels of student satisfaction in knowledge growth, clinical skills, bedside teaching, and mentorship.

Acknowledgments
We thank Juman Hijab for her critical role in establishing and maintaining the clerkship. We thank Steven Simon, Matt Russell, and Thomas Parrino for their leadership and guidance in establishing and maintaining the clerkship. We thank the Boston University School of Medicine Physician Assistant Program Director Mary Warner for her support and guidance in creating and supporting the clerkship. In addition, we thank the interprofessional education faculty for their dedicated involvement in teaching, including Stephanie Saunders, Lindsay Lefers, Jessica Rawlins, Lindsay Brennan, Angela Viani, Eric Charette, Nicole O’Neil, Susan Nathan, Jordana Meyerson, Shivani Jindal, Wei Shen, Amy Hanson, Gilda Cain, and Kate Hinrichs.

The Federal Bureau of Labor Statistics projects 37% job growth for physician assistants (PAs) from 2016 to 2026, much greater than the average for all other occupations as well as for other medical professions.¹ This growth has been accompanied by increased enrollment in medical (doctor of medicine [MD], doctor of osteopathic medicine) and nurse practitioner (NP) schools.² Clinical teaching sites serve a crucial function in the training of all clinical disciplines. These sites provide hands-on and experiential learning in medical settings, necessary components for learners practicing to become clinicians. Significant PA program expansion has led to increased demand for clinical training, creating competition for sites and a shortage of willing and well-trained preceptors.³

This challenge has been recognized by PA program directors. In the Joint Report of the 2013 Multi-Discipline Clerkship/Clinical Training Site Survey, PA program directors expressed concern about the adequacy of clinical opportunities for students, increased difficulty developing new core sites, and preserving existing core sites. In addition, they noted that a shortage of clinical sites was one of the greatest barriers to the PA programs’ sustained growth and success.⁴

Program directors also indicated difficulty securing clinical training sites in internal medicine (IM) and high rates of attrition of medicine clinical preceptors for their students.⁵ The reasons are multifold: increasing clinical demands, time, teaching competence, lack of experience, academic affiliation, lack of reimbursement, or compensation. Moreover, there is a declining number of PAs who work in primary care compared with specialty and subspecialty care, limiting the availability of clinical training preceptors in medicine and primary care.^6-8 According to the American Academy of PAs (AAPA) census and salary survey data, the percentage of PAs working in the primary care specialties (ie, family medicine, IM, and general pediatrics) has decreased from > 47% in 1995 to 24% in 2017.⁹ As such, there is a need to broaden the educational landscape to provide more high-quality training sites in IM.

The postacute health care setting may address this training need. It offers a unique clinical opportunity to expose learners to a broad range of disease complexity and clinical acuity, as the percentage of patients discharged from hospitals to postacute care (PAC) has increased and care shifts from the hospital to the PAC setting.^10,11 The longer PAC length of stay also enables learners to follow patients longitudinally over several weeks and experience interprofessional team-based care. In addition, the PAC setting offers learners the ability to acquire the necessary skills for smooth and effective transitions of care. This setting has been extensively used for trainees of nursing, pharmacy, physical therapy (PT) and occupational therapy (OT), speech-language pathology, psychology, and social work (SW), but few programs have used the PAC setting as clerkship sites for IM rotations for PA students. To address this need for IM sites, the VA Boston Healthcare System (VABHS), in conjunction with the Boston University School of Medicine Physician Assistant Program, developed a novel medicine clinical clerkship site for physician assistants in the PAC unit of the community living center (CLC) at VABHS. This report describes the program structure, curriculum, and participant evaluation results.

Clinical Clerkship Program

VABHS CLC is a 110-bed facility comprising 3 units: a 65-bed PAC unit, a 15-bed closed hospice/palliative care unit, and a 30-bed long-term care unit. The service is staffed continuously with physicians, PAs, and NPs. A majority of patients are admitted from the acute care hospital of VABHS (West Roxbury campus) and other regional VA facilities. The CLC offers dynamic services, including phlebotomy, general radiology, IV diuretics and antibiotics, wound care, and subacute PT, OT, and speech-language pathology rehabilitation. The CLC serves as a venue for transitioning patients from acute inpatient care to home. The patient population is often elderly, with multiple active comorbidities and variable medical literacy, adherence, and follow-up.

The CLC provides a diverse interprofessional learning environment, offering core IM rotations for first-year psychiatry residents, oral and maxillofacial surgery residents, and PA students. The CLC also has expanded as a clinical site both for transitions-in-care IM resident curricula and electives as well as a geriatrics fellowship. In addition, the site offers rotations for NPs, nursing, pharmacy, physical and occupational therapies, speech-language pathology, psychology, and SW.

The Boston University School of Medicine Physician Assistant Program was founded in 2015 as a master’s degree program completed over 28 months. The first 12 months are didactic, and the following 16 months are clinical training with 14 months of rotations (2 IM, family medicine, pediatrics, emergency medicine, general surgery, obstetrics and gynecology, psychiatry, neurology, and 5 elective rotations), and 2 months for a thesis. The program has about 30 students per year and 4 clerkship sites for IM.

Program Description

The VABHS medicine clerkship hosts 1 to 2 PA students for 4-week blocks in the PAC unit of the CLC. Each student rotates on both PA and MD teams. Students follow 3 to 4 patients and participate fully in their care from admission to discharge; they prepare daily presentations and participate in medical management, family meetings, chart documentation, and care coordination with the interprofessional team. Students are provided a physical examination checklist and feedback form, and they are expected to track findings and record feedback and goals with their supervising preceptor weekly. They also make formal case presentations and participate in monthly medicine didactic rounds available to all VABHS IM students and trainees via videoconference.

In addition, beginning in July 2017, all PA students in the CLC began to participate in a 4-week Interprofessional Curriculum in Transitional Care. The curriculum includes 14 didactic lectures taught by 16 interprofessional faculty, including medicine, geriatric, and palliative care physicians; PAs; social workers; physical and occupational therapists; pharmacists; and a geriatric psychologist. The didactics include topics on the interprofessional team, the care continuum, teams and teamwork, interdisciplinary coordination of care, components of effective transitions in care, medication reconciliation, approaching difficult conversations, advance care planning, and quality improvement. The goal of the curriculum is to provide learners the knowledge, skills, and dispositions necessary for high-quality transitional care and interprofessional practice as well as specific training for effective and safe transfers of care between clinical settings. Although PA students are the main participants in this curriculum, all other learners in the PAC unit are also invited to attend the lectures.

The unique attributes of this training site include direct interaction with supervising PAs and physicians, rather than experiencing the traditional teaching hierarchy (with interns, residents, fellows); observation of the natural progression of disease of both acute care and primary care issues due to the longer length of stay (2 to 6 weeks, where the typical student will see the same patient 7 to 10 times during their rotation); exposure to a host of medically complex patients offering a multitude of clinical scenarios and abnormal physical exam findings; exposure to a hospice/palliative care ward and end-of-life care; and interaction within an interprofessional training environment of nursing, pharmacy, PT, OT, speech-language pathology, psychology, and SW trainees.

Program Evaluation

At the end of rotations continuously through the year, PA students electronically complete a site evaluation from the Boston University School of Medicine Physician Assistant Program. The evaluation consists of 14 questions: 6 about site quality and 8 about instruction quality. The questions are answered on a 5-point Likert scale. Also included are 2 open-ended response questions that ask what they liked about the rotation and what they felt could be improved. Results are anonymous, de-identified and blinded both to the program as well as the clerkship site. Results are aggregated and provided to program sites annually. Responses are converted to a dichotomous variable, where any good or excellent response (4 or 5) is considered positive and any neutral or below (3, 2, 1) is considered a nonpositive response.

Results

The clerkship site has been operational since June 22, 2015. There have been 59 students who participated in the rotation. A different scale in these evaluations was used between June 22, 2015, and September 13, 2015. Therefore, 7 responses were excluded from the analysis, leaving 52 usable evaluations. The responses were analyzed both in total (for the CLC as well as other IM rotation sites) and by individual clerkship year to look for any trends over time: September 14, 2015, through April 24, 2016; April 25, 2016, through April 28, 2017; and May 1, 2017, through March 1, 2018 (Table).

Site evaluations showed high satisfaction regarding the quality of the physical environment as well as the learning environment. Students endorsed the PAC unit having resources and physical space for them, such as a desk and computer, opportunity for participation in patient care, and parking (100%; n = 52). Site evaluations revealed high satisfaction with the quality of teaching and faculty encouragement and support of their learning (100%; n = 52). The evaluations revealed that bedside teaching was strong (94%; n = 49). The students reported high satisfaction with the volume of patients provided (92%; n = 48) as well as the diversity of diagnoses (92%; n = 48).

There were fewer positive responses in the first 2 years of the rotation with regard to formal lectures (50% and 67%; 7/14 and 16/24, respectively). In the third year of the rotation, students had a much higher satisfaction rate (93%; 13/14). This increased satisfaction was associated with the development and incorporation of the Interprofessional Curriculum in Transitional Care in 2017.

Discussion

Access to high-quality PA student clerkship sites has become a pressing issue in recent years because of increased competition for sites and a shortage of willing and well-trained preceptors. There has been marked growth in schools and enrollment across all medical professions. The Accreditation Review Commission on Education for the PA (ARC-PA) reported that the total number of accredited entry-level PA programs in 2018 was 246, with 58 new accredited programs projected by 2022.¹² The Joint Report of the 2013 Multi-Discipline Clerkship/Clinical Training Site Survey reported a 66% increase in first-year enrollment in PA programs from 2002 to 2012.⁵ Programs must implement alternative strategies to attract clinical sites (eg, academic appointments, increased clinical resources to training sites) or face continued challenges with recruiting training sites for their students. Postacute care may be a natural extension to expand the footprint for clinical sites for these programs, augmenting acute inpatient and outpatient rotations. This implementation would increase the pool of clinical training sites and preceptors.

The experience with this novel training site, based on PA student feedback and evaluations, has been positive, and the postacute setting can provide students with high-quality IM clinical experiences. Students report adequate patient volume and diversity. In addition, evaluations are comparable with that of other IM site rotations the students experience. Qualitative feedback has emphasized the value of following patients over longer periods; eg, weeks vs days (as in acute care) enabling students to build relationships with patients as well as observe a richer clinical spectrum of disease over a less compressed period. “Patients have complex issues, so from a medical standpoint it challenges you to think of new ways to manage their care,” commented a representative student. “It is really beneficial that you can follow them over time.”

Furthermore, in response to student feedback on didactics, an interprofessional curriculum was developed to add formal structure as well as to create a curriculum in care transitions. This curriculum provided a unique opportunity for PA students to receive formal instruction on areas of particular relevance for transitional care (eg, care continuum, end of life issues, and care transitions). The curriculum also allows the interprofessional faculty a unique and enjoyable opportunity for interprofessional collaboration.

The 1 month PAC rotation is augmented with inpatient IM and outpatient family medicine rotations, consequently giving exposure to the full continuum of care. The PAC setting provides learners multifaceted benefits: the opportunity to strengthen and develop the knowledge, attitudes, and skills necessary for IM; increased understanding of other professions by observing and interacting as a team caring for a patient over a longer period as opposed to the acute care setting; the ability to perform effective, efficient, and safe transfer between clinical settings; and broad exposure to transitional care. As a result, the PAC rotation enhances but does not replace the necessary and essential rotations of inpatient and outpatient medicine.

Moreover, this rotation provides unique and core IM training for PA students. Our site focuses on interprofessional collaboration, emphasizing the importance of team-based care, an essential concept in modern day medicine. Formal exposure to other care specialties, such as PT and OT, SW, and mental health, is essential for students to appreciate clinical medicine and a patient’s physical and mental experience over the course of a disease and clinical state. In addition, the physical exam checklist ensures that students are exposed to the full spectrum of IM examination findings during their rotation. Finally, weekly feedback forms require students to ask and receive concrete feedback from their supervising providers.

Limitations

The generalizability of this model requires careful consideration. VABHS is a tertiary care integrated health care system, enabling students to learn from patients moving through multiple care transitions in a single health care system. In addition, other settings may not have the staffing or clinical volume to sustain such a model. All PAC clinical faculty teach voluntarily, and local leadership has set expectations for all clinicians to participate in teaching of trainees and PA students. Evaluations also note less diversity in the patient population, a challenge that some VA facilities face. This issue could be addressed by ensuring that students also have IM rotations at other inpatient medical facilities. A more balanced experience, where students reap the positive benefits of PAC but do not lose exposure to a diverse patient pool, could result. Furthermore, some of the perceived positive impacts also may be related to professional and personal attributes of the teaching clinicians rather than to the PAC setting.

Conclusion

PAC settings can be effective training sites for medicine clerkships for PA students and can provide high-quality training in IM as PA programs continue to expand. This setting offers students exposure to interprofessional, team-based care and the opportunity to care for patients with a broad range of disease complexity. Learning is further enhanced by the ability to follow patients longitudinally over their disease course as well as to work directly with teaching faculty and other interprofessional health care professionals. Evaluations of this novel clerkship experience have shown high levels of student satisfaction in knowledge growth, clinical skills, bedside teaching, and mentorship.

Acknowledgments
We thank Juman Hijab for her critical role in establishing and maintaining the clerkship. We thank Steven Simon, Matt Russell, and Thomas Parrino for their leadership and guidance in establishing and maintaining the clerkship. We thank the Boston University School of Medicine Physician Assistant Program Director Mary Warner for her support and guidance in creating and supporting the clerkship. In addition, we thank the interprofessional education faculty for their dedicated involvement in teaching, including Stephanie Saunders, Lindsay Lefers, Jessica Rawlins, Lindsay Brennan, Angela Viani, Eric Charette, Nicole O’Neil, Susan Nathan, Jordana Meyerson, Shivani Jindal, Wei Shen, Amy Hanson, Gilda Cain, and Kate Hinrichs.

An 83-year-old woman with hypertension, hypothyroidism, and a history of depression presented to the emergency department with acute shortness of breath and hypoxia. She was found to have submassive pulmonary embolism, and a heparin infusion was started immediately.

Urgent nasopharyngeal laryngoscopy revealed a hematoma at the base of her tongue that extended into the vallecula, piriform sinuses, and aryepiglottic fold, causing acute airway obstruction. These features combined with the supratherapeutic aPTT led to the diagnosis of pseudo-Ludwig angina.

DANGER OF RAPID AIRWAY COMPROMISE

Pseudo-Ludwig angina is a rare condition in which over-anticoagulation causes sublingual swelling leading to airway obstruction, whereas true Ludwig angina is an infectious regional suppuration of the neck.

Most reported cases of pseudo-Ludwig angina have resulted from overanticogulation with warfarin or warfarin-like substances (rodenticides), or from coagulopathy due to liver disease.^1–3 Early recognition is essential to avoid airway compromise.

In our patient, all anticoagulation was discontinued, and she was intubated until the hematoma began to resolve, the aPTT returned to normal, and respiratory compromise improved. At follow-up 2 months later, the sublingual hematoma had completely resolved (Figure 1). And at a 6-month follow-up visit, the pulmonary embolism had resolved, and pulmonary pressures by 2-dimensional echocardiography were normal.

An 83-year-old woman with hypertension, hypothyroidism, and a history of depression presented to the emergency department with acute shortness of breath and hypoxia. She was found to have submassive pulmonary embolism, and a heparin infusion was started immediately.

Urgent nasopharyngeal laryngoscopy revealed a hematoma at the base of her tongue that extended into the vallecula, piriform sinuses, and aryepiglottic fold, causing acute airway obstruction. These features combined with the supratherapeutic aPTT led to the diagnosis of pseudo-Ludwig angina.

DANGER OF RAPID AIRWAY COMPROMISE

Pseudo-Ludwig angina is a rare condition in which over-anticoagulation causes sublingual swelling leading to airway obstruction, whereas true Ludwig angina is an infectious regional suppuration of the neck.

Most reported cases of pseudo-Ludwig angina have resulted from overanticogulation with warfarin or warfarin-like substances (rodenticides), or from coagulopathy due to liver disease.^1–3 Early recognition is essential to avoid airway compromise.

In our patient, all anticoagulation was discontinued, and she was intubated until the hematoma began to resolve, the aPTT returned to normal, and respiratory compromise improved. At follow-up 2 months later, the sublingual hematoma had completely resolved (Figure 1). And at a 6-month follow-up visit, the pulmonary embolism had resolved, and pulmonary pressures by 2-dimensional echocardiography were normal.

An 83-year-old woman with hypertension, hypothyroidism, and a history of depression presented to the emergency department with acute shortness of breath and hypoxia. She was found to have submassive pulmonary embolism, and a heparin infusion was started immediately.

Urgent nasopharyngeal laryngoscopy revealed a hematoma at the base of her tongue that extended into the vallecula, piriform sinuses, and aryepiglottic fold, causing acute airway obstruction. These features combined with the supratherapeutic aPTT led to the diagnosis of pseudo-Ludwig angina.

DANGER OF RAPID AIRWAY COMPROMISE

Pseudo-Ludwig angina is a rare condition in which over-anticoagulation causes sublingual swelling leading to airway obstruction, whereas true Ludwig angina is an infectious regional suppuration of the neck.

Most reported cases of pseudo-Ludwig angina have resulted from overanticogulation with warfarin or warfarin-like substances (rodenticides), or from coagulopathy due to liver disease.^1–3 Early recognition is essential to avoid airway compromise.

In our patient, all anticoagulation was discontinued, and she was intubated until the hematoma began to resolve, the aPTT returned to normal, and respiratory compromise improved. At follow-up 2 months later, the sublingual hematoma had completely resolved (Figure 1). And at a 6-month follow-up visit, the pulmonary embolism had resolved, and pulmonary pressures by 2-dimensional echocardiography were normal.

No, they are not required or needed, but daily radiography and arterial blood gas testing are common practice: eg, 60% of intensive care unit (ICU) patients get daily radiographs,¹ even though results provide low diagnostic yield and are unlikely to alter patient management compared with testing only when indicated.

The Choosing Wisely campaign,² a collaborative effort of a number of professional societies, advises against ordering these diagnostic tests daily because routine testing increases risks to patients and burdens the healthcare system. Instead, testing is recommended only in response to a specific clinical question, or when the test results will affect the patient’s treatment.

CHEST RADIOGRAPHS: DAILY VS CLINICALLY INDICATED

Chest radiographs enable practitioners to monitor the position of endotracheal tubes and central venous catheters, evaluate fluid status, follow up on abnormal findings, detect complications of procedures (such as a pneumothorax), and identify otherwise undetected conditions.

And daily chest radiographs often detect abnormalities. A 1991 study by Hall et al³ of 538 chest radiographs in 74 patients on mechanical ventilation reported that 30% of daily routine chest radiographs disclosed a new but minor finding (eg, a small change in endotracheal tube position or a small infiltrate). The new findings were major in 13 (17.6%) of the 74 patients (95% confidence interval [CI] 9%–26%). These included findings that required an immediate diagnostic or therapeutic intervention (eg, endotracheal tube below the tracheal carina, malposition of a catheter, pneumothorax, large pleural effusion).

But most studies say daily radiographs are not needed. In a large prospective study published in 2006, Graat et al⁴ evaluated the clinical value of 2,457 routine chest radiographs in 754 patients in a combined surgical and medical ICU. Daily chest radiographs revealed new or unexpected findings in 5.8% of cases, but only 2.2% warranted a change in therapy. No differences were found between the medical and surgical patients. The authors concluded that daily routine radiographs in ICU patients seldom reveal unexpected, clinically relevant abnormalities, and those findings rarely require urgent intervention.

A 2010 meta-analysis of 8 studies (7,078 patients) by Oba and Zaza⁵ compared on-demand and daily routine strategies of performing chest radiographs. They estimated that eliminating daily routine chest radiographs would not affect death rates in the hospital (odds ratio [OR] 1.02, 95% CI 0.89–1.17, P = .78) or the ICU (OR 0.92, 95% CI 0.76–1.11, P = .4). They also found no significant differences in length of stay or duration of mechanical ventilation. This meta-analysis suggests that routine radiographs can be eliminated without adversely affecting outcomes in ICU patients.

A larger meta-analysis (9 trials, 39,358 radiographs, 9,611 patients) published in 2012 by Ganapathy et al⁶ also found no harm associated with restrictive radiography protocols. These investigators compared a daily chest radiography protocol against a protocol based on clinical indications. The primary outcome was the mortality rate in the ICU; secondary outcomes were the mortality rate in the hospital, the length of stay in the ICU, and duration of mechanical ventilation. They found no differences between routine and restrictive strategies in terms of ICU mortality (risk ratio [RR] 1.04, 95% CI 0.84–1.28, P = .72), hospital mortality (RR 0.98, 95% CI 0.68–1.41, P = .91), or other secondary outcomes.

Clinically indicated testing is better

The conclusion from these studies is that routine chest radiographs in patients undergoing mechanical ventilation does not improve patient outcomes, and thus, a clinically indicated protocol is preferred.

Furthermore, routine daily radiographs have adverse effects such as more cumulative radiation exposure to the patient⁷ and greater risk of accidental removal of devices (eg, catheters, tubes).⁸ Another concern is a higher risk of hospital-associated infections from bacterial spread from caregivers’ hands.⁹

Finally, daily radiographs increase the use of healthcare resources and expenditures. In a 2011 study, Gershengorn et al¹ estimated that adopting a clinically indicated radiography strategy could save more than $144 million annually in the United States.

The ACR agrees. Appropriateness criteria published by the American College of Radiology (ACR) in 2015¹⁰ recommend against routine daily chest radiographs in the ICU, in keeping with the findings of the critical care community. The ACR recommends an initial radiograph at admission to the ICU. However, follow-up radiographs should be obtained only for specific clinical indications, including a change in the patient’s clinical condition or to check for proper placement of endotracheal or nasogastric or orogastric tubes, pulmonary arterial catheters, central venous catheters, chest tubes, and other life-support devices.

Ultrasonography as an alternative

Ultrasonography is widely available and provides an alternative to chest radiography for detecting significant abnormalities in patients on mechanical ventilation without exposing them to radiation and using relatively fewer resources.

A 2012 meta-analysis (8 studies, 1,048 patients) found that bedside ultrasonography reliably detects pneumothorax.¹¹ It can also provide a rapid diagnosis of the cause of acute respiratory failure such as pneumonia or pulmonary edema.¹² Ultrasonography, with the appropriate expertise, can also confirm the position of an endotracheal tube¹³ or central venous catheter.¹⁴

Arterial blood gas testing has value for managing patients undergoing mechanical ventilation, and it is one of the most commonly performed diagnostic tests in the ICU. It provides reliable information about the patient’s oxygenation and acid-base status. It is commonly requested when changing ventilator settings.

Downsides. Arterial blood gas measurements account for 10% to 20% of the cost incurred during ICU stay.¹⁵ In addition, they require an arterial puncture—an invasive procedure associated with potentially serious complications such as occlusion of the artery, digital embolization leading to digital ischemia, local infection, pseudoaneurysm, hematoma, bleeding, and skin necrosis.

Is daily testing needed?

Guidelines say no. The 2013 American Association for Respiratory Care¹⁶ guidelines suggest that arterial blood gas testing should be based on the clinical assessment of the patient. They recommend blood gas analysis to evaluate the patient’s ventilatory status (reflected by the partial pressure of arterial carbon dioxide [PaCO₂], acid-base status (reflected by pH), arterial oxygenation (partial pressure of arterial oxygen [PaO₂] and oxyhemoglobin saturation), oxygen-carrying capacity, and whether the patient likely has an intrapulmonary shunt. They state that testing is useful to quantify the response to therapeutic or diagnostic interventions such as cardiopulmonary exercise testing, to monitor severity and progression of documented disease, and to assess the adequacy of circulatory response.

Studies agree

The ACR recommendation to test “as clinically indicated” is supported by studies showing that patient outcomes are not inferior for arterial blood gas testing when clinically indicated instead of daily, and that this practice is associated with fewer complications, less resource use, and reduced overall patient care costs.

A 2015 study compared the efficacy and safety of obtaining arterial blood gases based on clinical assessment vs daily in 300 critically ill patients.¹⁷ Overall, fewer samples were obtained per patient in the clinical assessment group than in the daily group (all patients 3.7 vs 5.5; ventilated patients 2.03 vs 6.12; P < .001 for both). In ventilated patients, there was a 60% decrease in arterial blood gas orders without affecting patient outcomes and safety, including a lower risk of complications and overall cost of care.

In another study, Martinez-Balzano et al¹⁸ evaluated the effect of guidelines they developed to optimize the use of arterial blood gas testing in their ICUs. These guidelines encouraged testing of arterial blood gases after an acute respiratory event or for a rational clinical concern, and discouraged testing for routine surveillance, after planned changes of positive end-expiratory pressure or inspired oxygen fraction on mechanical ventilation, for spontaneous breathing trials, or when a disorder was not suspected.

Compared with data collected before implementation, these guidelines reduced the number of arterial blood gas tests by 821.5 per month (41.5%), or approximately 1 test per patient per mechanical-ventilation day for each month (43.1%; P < .001). Appropriately indicated testing rose to 83.4% from a baseline of 67.5% (P = .002). Additionally, this approach was associated with saving 49 liters of blood, reducing ICU costs by $39,432, and freeing up 1,643 staff work hours for other tasks. There were no significant differences in days on mechanical ventilation, severity of illness, or mortality between the 2 periods.¹⁸

Extubation effects. Routine arterial blood gas testing has not been shown to affect extubation decisions in patients on mechanical ventilation. In a study of 83 patients who completed a spontaneous breathing trial (total of 100 trials), Salam et al¹⁹ found arterial blood gas values obtained during the trial did not change the extubation decision in 93% of the cases.

In a study of 54 extubations in 52 patients,²⁰ 65% of the extubations were performed without obtaining an arterial blood gas test after the patient completed a trial of spontaneous breathing. The extubation success rate was 94% for the entire group, and it was the same regardless of whether testing was done (94.7% vs 94.3%, respectively).

Alternatives to arterial blood gases

There are less-invasive means to obtain the information that comes from an arterial blood gas test.

Pulse oximetry is a rapid noninvasive tool that provides continuous assessment of peripheral arterial oxygen saturation as a surrogate marker for tissue arterial oxygenation. However, it cannot measure PaO₂ or PaCO₂.²¹

Transcutaneous carbon dioxide (PTCO₂) monitoring is another continuous noninvasive alternative. The newer PTCO₂ devices are useful in patients with acute respiratory failure and in critically ill patients on vasopressors or vasodilators. Studies have shown good correlation between PTCO₂ and PaCO₂.^22,23

End-tidal carbon dioxide (PetCO₂) is another alternative to estimate PaCO₂. It can also be used to confirm endotracheal tube placement, during transportation, during procedures in which the patient is under conscious sedation, and to monitor the effectiveness of cardiopulmonary resuscitation and return of circulation after cardiac arrest. PetCO₂ measurements are not as accurate as arterial blood gas testing owing to a difference of approximately 2 to 5 mm Hg between PaCO₂ and PetCO₂ in normal lungs due to alveolar dead space. This difference may be much higher depending on the clinical condition and the degree of alveolar dead space.^21,24,25

Venous blood gases, which can be obtained from a peripheral or central venous catheter, are adequate to assess pH and partial pressure of carbon dioxide (PCO₂) in hemodynamically stable patients. Walkey et al²⁶ found that the accuracy of venous blood gas measurement to predict arterial blood gases was 90%. They recommended adjusting the venous pH up by 0.05 and the PCO₂ down by 5 mm Hg to account for the positive bias of venous blood gases. A limitation of this method is that the values are not reliable in patients who are in shock.

These alternatives can be used as a substitute for daily arterial blood gases. However, in certain clinical scenarios, arterial blood gas measurement remains a necessary and useful clinical tool.

TAKE-HOME MESSAGE

Most scientific evidence suggests that chest radiographs and arterial blood gas measurement in patients undergoing mechanical ventilation—and critically ill, in general—are best done when clinically indicated rather than routinely on a daily basis. This will reduce cost and harm to patients that may result from these unnecessary tests and not adversely affect outcomes.

No, they are not required or needed, but daily radiography and arterial blood gas testing are common practice: eg, 60% of intensive care unit (ICU) patients get daily radiographs,¹ even though results provide low diagnostic yield and are unlikely to alter patient management compared with testing only when indicated.

The Choosing Wisely campaign,² a collaborative effort of a number of professional societies, advises against ordering these diagnostic tests daily because routine testing increases risks to patients and burdens the healthcare system. Instead, testing is recommended only in response to a specific clinical question, or when the test results will affect the patient’s treatment.

CHEST RADIOGRAPHS: DAILY VS CLINICALLY INDICATED

Chest radiographs enable practitioners to monitor the position of endotracheal tubes and central venous catheters, evaluate fluid status, follow up on abnormal findings, detect complications of procedures (such as a pneumothorax), and identify otherwise undetected conditions.

And daily chest radiographs often detect abnormalities. A 1991 study by Hall et al³ of 538 chest radiographs in 74 patients on mechanical ventilation reported that 30% of daily routine chest radiographs disclosed a new but minor finding (eg, a small change in endotracheal tube position or a small infiltrate). The new findings were major in 13 (17.6%) of the 74 patients (95% confidence interval [CI] 9%–26%). These included findings that required an immediate diagnostic or therapeutic intervention (eg, endotracheal tube below the tracheal carina, malposition of a catheter, pneumothorax, large pleural effusion).

But most studies say daily radiographs are not needed. In a large prospective study published in 2006, Graat et al⁴ evaluated the clinical value of 2,457 routine chest radiographs in 754 patients in a combined surgical and medical ICU. Daily chest radiographs revealed new or unexpected findings in 5.8% of cases, but only 2.2% warranted a change in therapy. No differences were found between the medical and surgical patients. The authors concluded that daily routine radiographs in ICU patients seldom reveal unexpected, clinically relevant abnormalities, and those findings rarely require urgent intervention.

A 2010 meta-analysis of 8 studies (7,078 patients) by Oba and Zaza⁵ compared on-demand and daily routine strategies of performing chest radiographs. They estimated that eliminating daily routine chest radiographs would not affect death rates in the hospital (odds ratio [OR] 1.02, 95% CI 0.89–1.17, P = .78) or the ICU (OR 0.92, 95% CI 0.76–1.11, P = .4). They also found no significant differences in length of stay or duration of mechanical ventilation. This meta-analysis suggests that routine radiographs can be eliminated without adversely affecting outcomes in ICU patients.

A larger meta-analysis (9 trials, 39,358 radiographs, 9,611 patients) published in 2012 by Ganapathy et al⁶ also found no harm associated with restrictive radiography protocols. These investigators compared a daily chest radiography protocol against a protocol based on clinical indications. The primary outcome was the mortality rate in the ICU; secondary outcomes were the mortality rate in the hospital, the length of stay in the ICU, and duration of mechanical ventilation. They found no differences between routine and restrictive strategies in terms of ICU mortality (risk ratio [RR] 1.04, 95% CI 0.84–1.28, P = .72), hospital mortality (RR 0.98, 95% CI 0.68–1.41, P = .91), or other secondary outcomes.

Clinically indicated testing is better

The conclusion from these studies is that routine chest radiographs in patients undergoing mechanical ventilation does not improve patient outcomes, and thus, a clinically indicated protocol is preferred.

Furthermore, routine daily radiographs have adverse effects such as more cumulative radiation exposure to the patient⁷ and greater risk of accidental removal of devices (eg, catheters, tubes).⁸ Another concern is a higher risk of hospital-associated infections from bacterial spread from caregivers’ hands.⁹

Finally, daily radiographs increase the use of healthcare resources and expenditures. In a 2011 study, Gershengorn et al¹ estimated that adopting a clinically indicated radiography strategy could save more than $144 million annually in the United States.

The ACR agrees. Appropriateness criteria published by the American College of Radiology (ACR) in 2015¹⁰ recommend against routine daily chest radiographs in the ICU, in keeping with the findings of the critical care community. The ACR recommends an initial radiograph at admission to the ICU. However, follow-up radiographs should be obtained only for specific clinical indications, including a change in the patient’s clinical condition or to check for proper placement of endotracheal or nasogastric or orogastric tubes, pulmonary arterial catheters, central venous catheters, chest tubes, and other life-support devices.

Ultrasonography as an alternative

Ultrasonography is widely available and provides an alternative to chest radiography for detecting significant abnormalities in patients on mechanical ventilation without exposing them to radiation and using relatively fewer resources.

A 2012 meta-analysis (8 studies, 1,048 patients) found that bedside ultrasonography reliably detects pneumothorax.¹¹ It can also provide a rapid diagnosis of the cause of acute respiratory failure such as pneumonia or pulmonary edema.¹² Ultrasonography, with the appropriate expertise, can also confirm the position of an endotracheal tube¹³ or central venous catheter.¹⁴

Arterial blood gas testing has value for managing patients undergoing mechanical ventilation, and it is one of the most commonly performed diagnostic tests in the ICU. It provides reliable information about the patient’s oxygenation and acid-base status. It is commonly requested when changing ventilator settings.

Downsides. Arterial blood gas measurements account for 10% to 20% of the cost incurred during ICU stay.¹⁵ In addition, they require an arterial puncture—an invasive procedure associated with potentially serious complications such as occlusion of the artery, digital embolization leading to digital ischemia, local infection, pseudoaneurysm, hematoma, bleeding, and skin necrosis.

Is daily testing needed?

Guidelines say no. The 2013 American Association for Respiratory Care¹⁶ guidelines suggest that arterial blood gas testing should be based on the clinical assessment of the patient. They recommend blood gas analysis to evaluate the patient’s ventilatory status (reflected by the partial pressure of arterial carbon dioxide [PaCO₂], acid-base status (reflected by pH), arterial oxygenation (partial pressure of arterial oxygen [PaO₂] and oxyhemoglobin saturation), oxygen-carrying capacity, and whether the patient likely has an intrapulmonary shunt. They state that testing is useful to quantify the response to therapeutic or diagnostic interventions such as cardiopulmonary exercise testing, to monitor severity and progression of documented disease, and to assess the adequacy of circulatory response.

Studies agree

The ACR recommendation to test “as clinically indicated” is supported by studies showing that patient outcomes are not inferior for arterial blood gas testing when clinically indicated instead of daily, and that this practice is associated with fewer complications, less resource use, and reduced overall patient care costs.

A 2015 study compared the efficacy and safety of obtaining arterial blood gases based on clinical assessment vs daily in 300 critically ill patients.¹⁷ Overall, fewer samples were obtained per patient in the clinical assessment group than in the daily group (all patients 3.7 vs 5.5; ventilated patients 2.03 vs 6.12; P < .001 for both). In ventilated patients, there was a 60% decrease in arterial blood gas orders without affecting patient outcomes and safety, including a lower risk of complications and overall cost of care.

In another study, Martinez-Balzano et al¹⁸ evaluated the effect of guidelines they developed to optimize the use of arterial blood gas testing in their ICUs. These guidelines encouraged testing of arterial blood gases after an acute respiratory event or for a rational clinical concern, and discouraged testing for routine surveillance, after planned changes of positive end-expiratory pressure or inspired oxygen fraction on mechanical ventilation, for spontaneous breathing trials, or when a disorder was not suspected.

Compared with data collected before implementation, these guidelines reduced the number of arterial blood gas tests by 821.5 per month (41.5%), or approximately 1 test per patient per mechanical-ventilation day for each month (43.1%; P < .001). Appropriately indicated testing rose to 83.4% from a baseline of 67.5% (P = .002). Additionally, this approach was associated with saving 49 liters of blood, reducing ICU costs by $39,432, and freeing up 1,643 staff work hours for other tasks. There were no significant differences in days on mechanical ventilation, severity of illness, or mortality between the 2 periods.¹⁸

Extubation effects. Routine arterial blood gas testing has not been shown to affect extubation decisions in patients on mechanical ventilation. In a study of 83 patients who completed a spontaneous breathing trial (total of 100 trials), Salam et al¹⁹ found arterial blood gas values obtained during the trial did not change the extubation decision in 93% of the cases.

In a study of 54 extubations in 52 patients,²⁰ 65% of the extubations were performed without obtaining an arterial blood gas test after the patient completed a trial of spontaneous breathing. The extubation success rate was 94% for the entire group, and it was the same regardless of whether testing was done (94.7% vs 94.3%, respectively).

Alternatives to arterial blood gases

There are less-invasive means to obtain the information that comes from an arterial blood gas test.

Pulse oximetry is a rapid noninvasive tool that provides continuous assessment of peripheral arterial oxygen saturation as a surrogate marker for tissue arterial oxygenation. However, it cannot measure PaO₂ or PaCO₂.²¹

Transcutaneous carbon dioxide (PTCO₂) monitoring is another continuous noninvasive alternative. The newer PTCO₂ devices are useful in patients with acute respiratory failure and in critically ill patients on vasopressors or vasodilators. Studies have shown good correlation between PTCO₂ and PaCO₂.^22,23

End-tidal carbon dioxide (PetCO₂) is another alternative to estimate PaCO₂. It can also be used to confirm endotracheal tube placement, during transportation, during procedures in which the patient is under conscious sedation, and to monitor the effectiveness of cardiopulmonary resuscitation and return of circulation after cardiac arrest. PetCO₂ measurements are not as accurate as arterial blood gas testing owing to a difference of approximately 2 to 5 mm Hg between PaCO₂ and PetCO₂ in normal lungs due to alveolar dead space. This difference may be much higher depending on the clinical condition and the degree of alveolar dead space.^21,24,25

Venous blood gases, which can be obtained from a peripheral or central venous catheter, are adequate to assess pH and partial pressure of carbon dioxide (PCO₂) in hemodynamically stable patients. Walkey et al²⁶ found that the accuracy of venous blood gas measurement to predict arterial blood gases was 90%. They recommended adjusting the venous pH up by 0.05 and the PCO₂ down by 5 mm Hg to account for the positive bias of venous blood gases. A limitation of this method is that the values are not reliable in patients who are in shock.

These alternatives can be used as a substitute for daily arterial blood gases. However, in certain clinical scenarios, arterial blood gas measurement remains a necessary and useful clinical tool.

TAKE-HOME MESSAGE

Most scientific evidence suggests that chest radiographs and arterial blood gas measurement in patients undergoing mechanical ventilation—and critically ill, in general—are best done when clinically indicated rather than routinely on a daily basis. This will reduce cost and harm to patients that may result from these unnecessary tests and not adversely affect outcomes.

No, they are not required or needed, but daily radiography and arterial blood gas testing are common practice: eg, 60% of intensive care unit (ICU) patients get daily radiographs,¹ even though results provide low diagnostic yield and are unlikely to alter patient management compared with testing only when indicated.

The Choosing Wisely campaign,² a collaborative effort of a number of professional societies, advises against ordering these diagnostic tests daily because routine testing increases risks to patients and burdens the healthcare system. Instead, testing is recommended only in response to a specific clinical question, or when the test results will affect the patient’s treatment.

CHEST RADIOGRAPHS: DAILY VS CLINICALLY INDICATED

Chest radiographs enable practitioners to monitor the position of endotracheal tubes and central venous catheters, evaluate fluid status, follow up on abnormal findings, detect complications of procedures (such as a pneumothorax), and identify otherwise undetected conditions.

And daily chest radiographs often detect abnormalities. A 1991 study by Hall et al³ of 538 chest radiographs in 74 patients on mechanical ventilation reported that 30% of daily routine chest radiographs disclosed a new but minor finding (eg, a small change in endotracheal tube position or a small infiltrate). The new findings were major in 13 (17.6%) of the 74 patients (95% confidence interval [CI] 9%–26%). These included findings that required an immediate diagnostic or therapeutic intervention (eg, endotracheal tube below the tracheal carina, malposition of a catheter, pneumothorax, large pleural effusion).

But most studies say daily radiographs are not needed. In a large prospective study published in 2006, Graat et al⁴ evaluated the clinical value of 2,457 routine chest radiographs in 754 patients in a combined surgical and medical ICU. Daily chest radiographs revealed new or unexpected findings in 5.8% of cases, but only 2.2% warranted a change in therapy. No differences were found between the medical and surgical patients. The authors concluded that daily routine radiographs in ICU patients seldom reveal unexpected, clinically relevant abnormalities, and those findings rarely require urgent intervention.

A 2010 meta-analysis of 8 studies (7,078 patients) by Oba and Zaza⁵ compared on-demand and daily routine strategies of performing chest radiographs. They estimated that eliminating daily routine chest radiographs would not affect death rates in the hospital (odds ratio [OR] 1.02, 95% CI 0.89–1.17, P = .78) or the ICU (OR 0.92, 95% CI 0.76–1.11, P = .4). They also found no significant differences in length of stay or duration of mechanical ventilation. This meta-analysis suggests that routine radiographs can be eliminated without adversely affecting outcomes in ICU patients.

A larger meta-analysis (9 trials, 39,358 radiographs, 9,611 patients) published in 2012 by Ganapathy et al⁶ also found no harm associated with restrictive radiography protocols. These investigators compared a daily chest radiography protocol against a protocol based on clinical indications. The primary outcome was the mortality rate in the ICU; secondary outcomes were the mortality rate in the hospital, the length of stay in the ICU, and duration of mechanical ventilation. They found no differences between routine and restrictive strategies in terms of ICU mortality (risk ratio [RR] 1.04, 95% CI 0.84–1.28, P = .72), hospital mortality (RR 0.98, 95% CI 0.68–1.41, P = .91), or other secondary outcomes.

Clinically indicated testing is better

The conclusion from these studies is that routine chest radiographs in patients undergoing mechanical ventilation does not improve patient outcomes, and thus, a clinically indicated protocol is preferred.

Furthermore, routine daily radiographs have adverse effects such as more cumulative radiation exposure to the patient⁷ and greater risk of accidental removal of devices (eg, catheters, tubes).⁸ Another concern is a higher risk of hospital-associated infections from bacterial spread from caregivers’ hands.⁹

Finally, daily radiographs increase the use of healthcare resources and expenditures. In a 2011 study, Gershengorn et al¹ estimated that adopting a clinically indicated radiography strategy could save more than $144 million annually in the United States.

The ACR agrees. Appropriateness criteria published by the American College of Radiology (ACR) in 2015¹⁰ recommend against routine daily chest radiographs in the ICU, in keeping with the findings of the critical care community. The ACR recommends an initial radiograph at admission to the ICU. However, follow-up radiographs should be obtained only for specific clinical indications, including a change in the patient’s clinical condition or to check for proper placement of endotracheal or nasogastric or orogastric tubes, pulmonary arterial catheters, central venous catheters, chest tubes, and other life-support devices.

Ultrasonography as an alternative

Ultrasonography is widely available and provides an alternative to chest radiography for detecting significant abnormalities in patients on mechanical ventilation without exposing them to radiation and using relatively fewer resources.

A 2012 meta-analysis (8 studies, 1,048 patients) found that bedside ultrasonography reliably detects pneumothorax.¹¹ It can also provide a rapid diagnosis of the cause of acute respiratory failure such as pneumonia or pulmonary edema.¹² Ultrasonography, with the appropriate expertise, can also confirm the position of an endotracheal tube¹³ or central venous catheter.¹⁴

Arterial blood gas testing has value for managing patients undergoing mechanical ventilation, and it is one of the most commonly performed diagnostic tests in the ICU. It provides reliable information about the patient’s oxygenation and acid-base status. It is commonly requested when changing ventilator settings.

Downsides. Arterial blood gas measurements account for 10% to 20% of the cost incurred during ICU stay.¹⁵ In addition, they require an arterial puncture—an invasive procedure associated with potentially serious complications such as occlusion of the artery, digital embolization leading to digital ischemia, local infection, pseudoaneurysm, hematoma, bleeding, and skin necrosis.

Is daily testing needed?

Guidelines say no. The 2013 American Association for Respiratory Care¹⁶ guidelines suggest that arterial blood gas testing should be based on the clinical assessment of the patient. They recommend blood gas analysis to evaluate the patient’s ventilatory status (reflected by the partial pressure of arterial carbon dioxide [PaCO₂], acid-base status (reflected by pH), arterial oxygenation (partial pressure of arterial oxygen [PaO₂] and oxyhemoglobin saturation), oxygen-carrying capacity, and whether the patient likely has an intrapulmonary shunt. They state that testing is useful to quantify the response to therapeutic or diagnostic interventions such as cardiopulmonary exercise testing, to monitor severity and progression of documented disease, and to assess the adequacy of circulatory response.

Studies agree

The ACR recommendation to test “as clinically indicated” is supported by studies showing that patient outcomes are not inferior for arterial blood gas testing when clinically indicated instead of daily, and that this practice is associated with fewer complications, less resource use, and reduced overall patient care costs.

A 2015 study compared the efficacy and safety of obtaining arterial blood gases based on clinical assessment vs daily in 300 critically ill patients.¹⁷ Overall, fewer samples were obtained per patient in the clinical assessment group than in the daily group (all patients 3.7 vs 5.5; ventilated patients 2.03 vs 6.12; P < .001 for both). In ventilated patients, there was a 60% decrease in arterial blood gas orders without affecting patient outcomes and safety, including a lower risk of complications and overall cost of care.

In another study, Martinez-Balzano et al¹⁸ evaluated the effect of guidelines they developed to optimize the use of arterial blood gas testing in their ICUs. These guidelines encouraged testing of arterial blood gases after an acute respiratory event or for a rational clinical concern, and discouraged testing for routine surveillance, after planned changes of positive end-expiratory pressure or inspired oxygen fraction on mechanical ventilation, for spontaneous breathing trials, or when a disorder was not suspected.

Compared with data collected before implementation, these guidelines reduced the number of arterial blood gas tests by 821.5 per month (41.5%), or approximately 1 test per patient per mechanical-ventilation day for each month (43.1%; P < .001). Appropriately indicated testing rose to 83.4% from a baseline of 67.5% (P = .002). Additionally, this approach was associated with saving 49 liters of blood, reducing ICU costs by $39,432, and freeing up 1,643 staff work hours for other tasks. There were no significant differences in days on mechanical ventilation, severity of illness, or mortality between the 2 periods.¹⁸

Extubation effects. Routine arterial blood gas testing has not been shown to affect extubation decisions in patients on mechanical ventilation. In a study of 83 patients who completed a spontaneous breathing trial (total of 100 trials), Salam et al¹⁹ found arterial blood gas values obtained during the trial did not change the extubation decision in 93% of the cases.

In a study of 54 extubations in 52 patients,²⁰ 65% of the extubations were performed without obtaining an arterial blood gas test after the patient completed a trial of spontaneous breathing. The extubation success rate was 94% for the entire group, and it was the same regardless of whether testing was done (94.7% vs 94.3%, respectively).

Alternatives to arterial blood gases

There are less-invasive means to obtain the information that comes from an arterial blood gas test.

Pulse oximetry is a rapid noninvasive tool that provides continuous assessment of peripheral arterial oxygen saturation as a surrogate marker for tissue arterial oxygenation. However, it cannot measure PaO₂ or PaCO₂.²¹

Transcutaneous carbon dioxide (PTCO₂) monitoring is another continuous noninvasive alternative. The newer PTCO₂ devices are useful in patients with acute respiratory failure and in critically ill patients on vasopressors or vasodilators. Studies have shown good correlation between PTCO₂ and PaCO₂.^22,23

End-tidal carbon dioxide (PetCO₂) is another alternative to estimate PaCO₂. It can also be used to confirm endotracheal tube placement, during transportation, during procedures in which the patient is under conscious sedation, and to monitor the effectiveness of cardiopulmonary resuscitation and return of circulation after cardiac arrest. PetCO₂ measurements are not as accurate as arterial blood gas testing owing to a difference of approximately 2 to 5 mm Hg between PaCO₂ and PetCO₂ in normal lungs due to alveolar dead space. This difference may be much higher depending on the clinical condition and the degree of alveolar dead space.^21,24,25

Venous blood gases, which can be obtained from a peripheral or central venous catheter, are adequate to assess pH and partial pressure of carbon dioxide (PCO₂) in hemodynamically stable patients. Walkey et al²⁶ found that the accuracy of venous blood gas measurement to predict arterial blood gases was 90%. They recommended adjusting the venous pH up by 0.05 and the PCO₂ down by 5 mm Hg to account for the positive bias of venous blood gases. A limitation of this method is that the values are not reliable in patients who are in shock.

These alternatives can be used as a substitute for daily arterial blood gases. However, in certain clinical scenarios, arterial blood gas measurement remains a necessary and useful clinical tool.

TAKE-HOME MESSAGE

Most scientific evidence suggests that chest radiographs and arterial blood gas measurement in patients undergoing mechanical ventilation—and critically ill, in general—are best done when clinically indicated rather than routinely on a daily basis. This will reduce cost and harm to patients that may result from these unnecessary tests and not adversely affect outcomes.

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).