User login
Extended Anticoagulation Therapy and Recurrent Rates of Venous Thromboembolism
Clinical question: Among patients with a first episode of unprovoked pulmonary embolism (PE), what are the benefits and harms of extending the duration of anticoagulation for secondary prophylaxis against recurrent VTE?
Background: Optimal duration of anticoagulation after initial unprovoked PE is not known. Prior studies demonstrated risk reduction of recurrent VTE while on therapy but have had inadequate long-term monitoring of patients or enrollment of patients with PE, who are known to have a higher case-fatality rate of recurrent VTE than patients with DVT.
Study design: Multicenter, randomized, double-blinded, parallel-grouped, placebo-controlled trial.
Setting: Fourteen French hospitals from 2007 to 2012.
Synopsis: Investigators randomized 371 patients with a first episode of symptomatic unprovoked PE who had completed six months of warfarin to 18 additional months of warfarin or placebo. Patients were followed for 24 months after discontinuation of therapy.
During the treatment period, the primary outcome (composite of recurrent VTE and major bleeding) occurred in 3.3% of the warfarin group vs. 13.5% of the placebo group (HR 0.22). This difference was primarily due to reduction in risk of recurrent VTE (1.7% vs. 13.5%, HR 0.15), with only minimal increased bleeding risk (2.2% vs. 0.5%, NS).
There was no significant difference in the composite outcome (20.8% in warfarin group vs. 24% in placebo) on analysis of the entire study period (treatment and follow-up), however, suggesting the benefit of extended warfarin therapy upon recurrent VTE risk diminished upon cessation.
Bottom line: Patients treated with extended-therapy warfarin after a first unprovoked PE have a decreased risk of recurrent VTE compared to standard therapy only while on treatment; the risk of recurrent VTE returns upon cessation of therapy.
Citation: Couturand F, Sanchez O, Pernod G, et al. Six months vs extended oral anticoagulation after a first episode of pulmonary embolism: The PADIS-PE randomized clinical trial. JAMA. 2015;314(1):31-40.
Clinical question: Among patients with a first episode of unprovoked pulmonary embolism (PE), what are the benefits and harms of extending the duration of anticoagulation for secondary prophylaxis against recurrent VTE?
Background: Optimal duration of anticoagulation after initial unprovoked PE is not known. Prior studies demonstrated risk reduction of recurrent VTE while on therapy but have had inadequate long-term monitoring of patients or enrollment of patients with PE, who are known to have a higher case-fatality rate of recurrent VTE than patients with DVT.
Study design: Multicenter, randomized, double-blinded, parallel-grouped, placebo-controlled trial.
Setting: Fourteen French hospitals from 2007 to 2012.
Synopsis: Investigators randomized 371 patients with a first episode of symptomatic unprovoked PE who had completed six months of warfarin to 18 additional months of warfarin or placebo. Patients were followed for 24 months after discontinuation of therapy.
During the treatment period, the primary outcome (composite of recurrent VTE and major bleeding) occurred in 3.3% of the warfarin group vs. 13.5% of the placebo group (HR 0.22). This difference was primarily due to reduction in risk of recurrent VTE (1.7% vs. 13.5%, HR 0.15), with only minimal increased bleeding risk (2.2% vs. 0.5%, NS).
There was no significant difference in the composite outcome (20.8% in warfarin group vs. 24% in placebo) on analysis of the entire study period (treatment and follow-up), however, suggesting the benefit of extended warfarin therapy upon recurrent VTE risk diminished upon cessation.
Bottom line: Patients treated with extended-therapy warfarin after a first unprovoked PE have a decreased risk of recurrent VTE compared to standard therapy only while on treatment; the risk of recurrent VTE returns upon cessation of therapy.
Citation: Couturand F, Sanchez O, Pernod G, et al. Six months vs extended oral anticoagulation after a first episode of pulmonary embolism: The PADIS-PE randomized clinical trial. JAMA. 2015;314(1):31-40.
Clinical question: Among patients with a first episode of unprovoked pulmonary embolism (PE), what are the benefits and harms of extending the duration of anticoagulation for secondary prophylaxis against recurrent VTE?
Background: Optimal duration of anticoagulation after initial unprovoked PE is not known. Prior studies demonstrated risk reduction of recurrent VTE while on therapy but have had inadequate long-term monitoring of patients or enrollment of patients with PE, who are known to have a higher case-fatality rate of recurrent VTE than patients with DVT.
Study design: Multicenter, randomized, double-blinded, parallel-grouped, placebo-controlled trial.
Setting: Fourteen French hospitals from 2007 to 2012.
Synopsis: Investigators randomized 371 patients with a first episode of symptomatic unprovoked PE who had completed six months of warfarin to 18 additional months of warfarin or placebo. Patients were followed for 24 months after discontinuation of therapy.
During the treatment period, the primary outcome (composite of recurrent VTE and major bleeding) occurred in 3.3% of the warfarin group vs. 13.5% of the placebo group (HR 0.22). This difference was primarily due to reduction in risk of recurrent VTE (1.7% vs. 13.5%, HR 0.15), with only minimal increased bleeding risk (2.2% vs. 0.5%, NS).
There was no significant difference in the composite outcome (20.8% in warfarin group vs. 24% in placebo) on analysis of the entire study period (treatment and follow-up), however, suggesting the benefit of extended warfarin therapy upon recurrent VTE risk diminished upon cessation.
Bottom line: Patients treated with extended-therapy warfarin after a first unprovoked PE have a decreased risk of recurrent VTE compared to standard therapy only while on treatment; the risk of recurrent VTE returns upon cessation of therapy.
Citation: Couturand F, Sanchez O, Pernod G, et al. Six months vs extended oral anticoagulation after a first episode of pulmonary embolism: The PADIS-PE randomized clinical trial. JAMA. 2015;314(1):31-40.
Wells Score Can't Rule Out Deep Vein Thrombosis in Inpatient Setting
Clinical question: Should the Wells score be used for DVT risk stratification in the hospital?
Background: The Wells score was derived to reduce lower extremity ultrasounds (LEUS) in the outpatient evaluation of DVTs. There has never been a large prospective trial to validate its use in hospitalized patients.
Study design: Single-center, prospective cohort study.
Setting: Quaternary care, academic hospital.
Synopsis: Between November 2012 and December 2013, all inpatients at a single medical center who underwent a LEUS for suspected DVT, including 1,135 inpatients 16 years or older, had Wells risk factors recorded. The incidence of proximal DVTs noted for low, moderate, and high pretest probability groups were 5.9%, 9.5%, and 16.4%, respectively. Compared to the outpatient incidence of 3.0%, 16.6%, and 74.6% reported by Wells and colleagues, there were nonsignificant differences among inpatient groups. The difference between low and moderate pretest probability groups was not significant.
Discrimination of risk for DVT in hospitalized patients performed only slightly better than chance (AUC, 0.60) and the failure rate was double that of the original outpatient study (5.9% vs. 3.0%).
A possible explanation for these findings is the increased prevalence of immobilization (6x), cancer (3x), and risk factors not included in the Wells score (COPD, heart failure, and infection) in hospitalized patients.
Bottom line: The Wells score may not be sufficient to rule out DVT or influence management in the inpatient setting.
Citation: Silveira PC, Ip IK, Goldhaber SZ, Piazza G, Benson CB, Khorasani R. Performance of Wells score for deep vein thrombosis in the inpatient setting. JAMA Intern Med. 2015;175(7):1112-1117.
Clinical question: Should the Wells score be used for DVT risk stratification in the hospital?
Background: The Wells score was derived to reduce lower extremity ultrasounds (LEUS) in the outpatient evaluation of DVTs. There has never been a large prospective trial to validate its use in hospitalized patients.
Study design: Single-center, prospective cohort study.
Setting: Quaternary care, academic hospital.
Synopsis: Between November 2012 and December 2013, all inpatients at a single medical center who underwent a LEUS for suspected DVT, including 1,135 inpatients 16 years or older, had Wells risk factors recorded. The incidence of proximal DVTs noted for low, moderate, and high pretest probability groups were 5.9%, 9.5%, and 16.4%, respectively. Compared to the outpatient incidence of 3.0%, 16.6%, and 74.6% reported by Wells and colleagues, there were nonsignificant differences among inpatient groups. The difference between low and moderate pretest probability groups was not significant.
Discrimination of risk for DVT in hospitalized patients performed only slightly better than chance (AUC, 0.60) and the failure rate was double that of the original outpatient study (5.9% vs. 3.0%).
A possible explanation for these findings is the increased prevalence of immobilization (6x), cancer (3x), and risk factors not included in the Wells score (COPD, heart failure, and infection) in hospitalized patients.
Bottom line: The Wells score may not be sufficient to rule out DVT or influence management in the inpatient setting.
Citation: Silveira PC, Ip IK, Goldhaber SZ, Piazza G, Benson CB, Khorasani R. Performance of Wells score for deep vein thrombosis in the inpatient setting. JAMA Intern Med. 2015;175(7):1112-1117.
Clinical question: Should the Wells score be used for DVT risk stratification in the hospital?
Background: The Wells score was derived to reduce lower extremity ultrasounds (LEUS) in the outpatient evaluation of DVTs. There has never been a large prospective trial to validate its use in hospitalized patients.
Study design: Single-center, prospective cohort study.
Setting: Quaternary care, academic hospital.
Synopsis: Between November 2012 and December 2013, all inpatients at a single medical center who underwent a LEUS for suspected DVT, including 1,135 inpatients 16 years or older, had Wells risk factors recorded. The incidence of proximal DVTs noted for low, moderate, and high pretest probability groups were 5.9%, 9.5%, and 16.4%, respectively. Compared to the outpatient incidence of 3.0%, 16.6%, and 74.6% reported by Wells and colleagues, there were nonsignificant differences among inpatient groups. The difference between low and moderate pretest probability groups was not significant.
Discrimination of risk for DVT in hospitalized patients performed only slightly better than chance (AUC, 0.60) and the failure rate was double that of the original outpatient study (5.9% vs. 3.0%).
A possible explanation for these findings is the increased prevalence of immobilization (6x), cancer (3x), and risk factors not included in the Wells score (COPD, heart failure, and infection) in hospitalized patients.
Bottom line: The Wells score may not be sufficient to rule out DVT or influence management in the inpatient setting.
Citation: Silveira PC, Ip IK, Goldhaber SZ, Piazza G, Benson CB, Khorasani R. Performance of Wells score for deep vein thrombosis in the inpatient setting. JAMA Intern Med. 2015;175(7):1112-1117.
Antibiotic Therapy, Appendectomy for Uncomplicated Acute Appendicitis
Clinical question: Is antibiotic therapy noninferior to appendectomy for treatment of uncomplicated acute appendicitis?
Background: Previous randomized clinical trials have compared antibiotic therapy versus appendectomy for the treatment of uncomplicated, acute appendicitis. Each of these studies had significant limitations, and appendectomy has remained the standard of care.
Study design: Noninferiority, randomized clinical trial.
Setting: Six hospitals in Finland.
Synopsis: Investigators randomized 530 patients with uncomplicated appendicitis confirmed on CT to appendectomy or antibiotic therapy, with a noninferiority margin of 24%. Of the 256 patients randomized to antibiotics who were available for follow-up, 70 received surgical intervention within one year. This resulted in a difference between treatment groups of -27%. Further analysis revealed that five of those patients had normal appendices and did not actually require appendectomy. Secondary outcome analysis demonstrated a significantly lower complication rate among patients in the antibiotic group (2.8%) compared with the surgical group (20.5%); however, the open operative approach used on most patients may have resulted in increased wound complications.
Although noninferiority of antibiotic treatment was not demonstrated, the majority of patients in the antibiotic group (73%) were found to have successful treatment with antibiotics alone. None of these patients, including those eventually undergoing appendectomy, suffered major complications. Although the overall approach to uncomplicated appendicitis may not change, physicians and patients should utilize this data to make an informed decision between antibiotic treatment and appendectomy.
Bottom line: In patients with CT-proven, uncomplicated acute appendicitis, antibiotic treatment did not meet the pre-specified threshold for noninferiority compared with appendectomy, yet a significant majority of patients in the antibiotic arm had successful recovery.
Citation: Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: The APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348
Clinical question: Is antibiotic therapy noninferior to appendectomy for treatment of uncomplicated acute appendicitis?
Background: Previous randomized clinical trials have compared antibiotic therapy versus appendectomy for the treatment of uncomplicated, acute appendicitis. Each of these studies had significant limitations, and appendectomy has remained the standard of care.
Study design: Noninferiority, randomized clinical trial.
Setting: Six hospitals in Finland.
Synopsis: Investigators randomized 530 patients with uncomplicated appendicitis confirmed on CT to appendectomy or antibiotic therapy, with a noninferiority margin of 24%. Of the 256 patients randomized to antibiotics who were available for follow-up, 70 received surgical intervention within one year. This resulted in a difference between treatment groups of -27%. Further analysis revealed that five of those patients had normal appendices and did not actually require appendectomy. Secondary outcome analysis demonstrated a significantly lower complication rate among patients in the antibiotic group (2.8%) compared with the surgical group (20.5%); however, the open operative approach used on most patients may have resulted in increased wound complications.
Although noninferiority of antibiotic treatment was not demonstrated, the majority of patients in the antibiotic group (73%) were found to have successful treatment with antibiotics alone. None of these patients, including those eventually undergoing appendectomy, suffered major complications. Although the overall approach to uncomplicated appendicitis may not change, physicians and patients should utilize this data to make an informed decision between antibiotic treatment and appendectomy.
Bottom line: In patients with CT-proven, uncomplicated acute appendicitis, antibiotic treatment did not meet the pre-specified threshold for noninferiority compared with appendectomy, yet a significant majority of patients in the antibiotic arm had successful recovery.
Citation: Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: The APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348
Clinical question: Is antibiotic therapy noninferior to appendectomy for treatment of uncomplicated acute appendicitis?
Background: Previous randomized clinical trials have compared antibiotic therapy versus appendectomy for the treatment of uncomplicated, acute appendicitis. Each of these studies had significant limitations, and appendectomy has remained the standard of care.
Study design: Noninferiority, randomized clinical trial.
Setting: Six hospitals in Finland.
Synopsis: Investigators randomized 530 patients with uncomplicated appendicitis confirmed on CT to appendectomy or antibiotic therapy, with a noninferiority margin of 24%. Of the 256 patients randomized to antibiotics who were available for follow-up, 70 received surgical intervention within one year. This resulted in a difference between treatment groups of -27%. Further analysis revealed that five of those patients had normal appendices and did not actually require appendectomy. Secondary outcome analysis demonstrated a significantly lower complication rate among patients in the antibiotic group (2.8%) compared with the surgical group (20.5%); however, the open operative approach used on most patients may have resulted in increased wound complications.
Although noninferiority of antibiotic treatment was not demonstrated, the majority of patients in the antibiotic group (73%) were found to have successful treatment with antibiotics alone. None of these patients, including those eventually undergoing appendectomy, suffered major complications. Although the overall approach to uncomplicated appendicitis may not change, physicians and patients should utilize this data to make an informed decision between antibiotic treatment and appendectomy.
Bottom line: In patients with CT-proven, uncomplicated acute appendicitis, antibiotic treatment did not meet the pre-specified threshold for noninferiority compared with appendectomy, yet a significant majority of patients in the antibiotic arm had successful recovery.
Citation: Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: The APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348
Social, System Factors Can Influence Decisions to Continue Patient Care
Clinical question: Why do healthcare providers work while sick?
Background: Healthcare providers generally are aware of the risks of infection to hospitalized patients; however, despite this knowledge, several studies have revealed providers continue to work while ill.
Study design: Mixed-method analysis of a cross-sectional survey.
Setting: Large academic children’s hospital.
Synopsis: Investigators completed 538 of 929 surveys of attending physicians and advanced practice clinicians (APCs), a response rate of 58%. Of the respondents, 95% agreed that sick providers continuing patient care increased their patients’ risk for infection; however, 83% admitted to caring for patients while sick, with physicians being more likely to do so.
Several factors contributed to this behavior, including fear of letting colleagues or patients down, fear of ostracism by colleagues, and concerns for understaffing or discontinuity of care. Qualitative analysis of free-text responses revealed additional factors, including the difficulty of finding sick coverage, the strong cultural norms to continue working unless severely ill, and the ambiguity of defining “too sick to work.”
Limitations of this study included possible response bias, lack of a validated survey, and inclusion of only a single center; however, results confirm prior studies and reveal additional systems factors that hospital leadership could address, supporting providers and improving patient care.
Bottom line: Sick healthcare providers face several challenges that drive them to put their patients at risk by continuing patient care, and these factors could be addressed by healthcare systems as a means of improving overall quality of care.
Citation: Szymczak JE, Smathers S, Hoegg C, Klieger S, Coffin SE, Sammons JS. Reasons why physicians and advanced practice clinicians work while sick: a mixed-methods analysis. JAMA Pediatr. 2015;169(9):815-821. doi:10.1001/jamapediatrics.2015.0684.
Clinical question: Why do healthcare providers work while sick?
Background: Healthcare providers generally are aware of the risks of infection to hospitalized patients; however, despite this knowledge, several studies have revealed providers continue to work while ill.
Study design: Mixed-method analysis of a cross-sectional survey.
Setting: Large academic children’s hospital.
Synopsis: Investigators completed 538 of 929 surveys of attending physicians and advanced practice clinicians (APCs), a response rate of 58%. Of the respondents, 95% agreed that sick providers continuing patient care increased their patients’ risk for infection; however, 83% admitted to caring for patients while sick, with physicians being more likely to do so.
Several factors contributed to this behavior, including fear of letting colleagues or patients down, fear of ostracism by colleagues, and concerns for understaffing or discontinuity of care. Qualitative analysis of free-text responses revealed additional factors, including the difficulty of finding sick coverage, the strong cultural norms to continue working unless severely ill, and the ambiguity of defining “too sick to work.”
Limitations of this study included possible response bias, lack of a validated survey, and inclusion of only a single center; however, results confirm prior studies and reveal additional systems factors that hospital leadership could address, supporting providers and improving patient care.
Bottom line: Sick healthcare providers face several challenges that drive them to put their patients at risk by continuing patient care, and these factors could be addressed by healthcare systems as a means of improving overall quality of care.
Citation: Szymczak JE, Smathers S, Hoegg C, Klieger S, Coffin SE, Sammons JS. Reasons why physicians and advanced practice clinicians work while sick: a mixed-methods analysis. JAMA Pediatr. 2015;169(9):815-821. doi:10.1001/jamapediatrics.2015.0684.
Clinical question: Why do healthcare providers work while sick?
Background: Healthcare providers generally are aware of the risks of infection to hospitalized patients; however, despite this knowledge, several studies have revealed providers continue to work while ill.
Study design: Mixed-method analysis of a cross-sectional survey.
Setting: Large academic children’s hospital.
Synopsis: Investigators completed 538 of 929 surveys of attending physicians and advanced practice clinicians (APCs), a response rate of 58%. Of the respondents, 95% agreed that sick providers continuing patient care increased their patients’ risk for infection; however, 83% admitted to caring for patients while sick, with physicians being more likely to do so.
Several factors contributed to this behavior, including fear of letting colleagues or patients down, fear of ostracism by colleagues, and concerns for understaffing or discontinuity of care. Qualitative analysis of free-text responses revealed additional factors, including the difficulty of finding sick coverage, the strong cultural norms to continue working unless severely ill, and the ambiguity of defining “too sick to work.”
Limitations of this study included possible response bias, lack of a validated survey, and inclusion of only a single center; however, results confirm prior studies and reveal additional systems factors that hospital leadership could address, supporting providers and improving patient care.
Bottom line: Sick healthcare providers face several challenges that drive them to put their patients at risk by continuing patient care, and these factors could be addressed by healthcare systems as a means of improving overall quality of care.
Citation: Szymczak JE, Smathers S, Hoegg C, Klieger S, Coffin SE, Sammons JS. Reasons why physicians and advanced practice clinicians work while sick: a mixed-methods analysis. JAMA Pediatr. 2015;169(9):815-821. doi:10.1001/jamapediatrics.2015.0684.
COPD Exacerbation Prevention: April 2015 CHEST Guidelines
Background
The CHEST guidelines for the prevention of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were developed through a collaboration between the American College of Chest Physicians (CHEST) and the Canadian Thoracic Society (CTS). They are the first evidence-based guidelines dedicated entirely to the prevention of AECOPD and largely exclude material related to the treatment of symptomatic disease.1
Patients with AECOPD are commonly cared for by hospitalists, so we fill an important role in the longitudinal treatment of this disease. Acute exacerbations and hospitalizations for COPD account for 50% of all COPD-related expenses.2,3 Further, the Agency for Healthcare Research and Quality showed a 20% readmission rate nationally for AECOPD, far higher than the rate for most other diagnoses.4 Consequently, COPD readmission has been added to Medicare’s Hospital Readmissions Reduction Program for fiscal year 2015.5
Hospitalization, when the patient is a captive audience and many of the necessary resources are available, may be a time to initiate preventative strategies.
Guideline Updates
The guidelines for non-pharmacologic interventions start with vaccination and continue with behavioral modification. They support the use of the 23-valent polysaccharide pneumococcal vaccine and annual influenza vaccination, noting that only influenza vaccination has been shown to decrease AECOPD.
Pulmonary rehabilitation is recommended for patients with a recent (fewer than four weeks) exacerbation. Several recommendations favor combining social work interventions with education, adding that face-to-face verbal education is superior to written educational materials. Interestingly, smoking cessation interventions received a weak recommendation, based upon lack of literature specifically focusing on the prevention of AECOPD. Despite this recommendation, smoking cessation intervention is strongly encouraged by the authors, given evidence of a marked reduction in morbidity, mortality, and healthcare utilization among smokers with COPD who quit.6 Finally, telemonitoring is not considered to be superior to usual care.
The guidelines concerning inhaled therapies fall into three major drug classes, including short- and long-acting inhaled muscarinic antagonists (anticholinergic agents), short- and long-acting inhaled beta-agonists, and inhaled corticosteroids.
Long-acting medications are generally considered more effective in preventing exacerbations than those that are short acting. Long-acting muscarinic antagonists (LAMAs) are highlighted for their efficacy, and combination inhaled long-acting beta-agonists (LABAs) and inhaled corticosteroids are preferred over monotherapy with either agent alone. LAMAs are preferred to inhaled corticosteroids or LABAs when given as monotherapy.
Short-acting agents are rated as inferior at preventing exacerbations compared to their long-acting analogs, but short-acting medications are better than placebo when combined with long-acting agents from other drug classes. Triple drug therapy (inhaled LAMAs, LABAs, and corticosteroids) can be considered based on current evidence.
The final recommendations address the use of oral medications. A potentially practice-changing guideline is the recommendation for long-term use of N-acetylcysteine tablets twice daily for patients who have experienced more than two exacerbations within two years. A more intuitive recommendation in this group is that treating an AECOPD with oral or IV steroids decreases the chance of recurrent exacerbations in the future.
The remaining recommendations include daily macrolide therapy, the phosphodiesterate-4 inhibitor roflumilast for those with chronic bronchitis and a recent exacerbation, and slow-release theophylline for stable disease. These guidelines also point out that statins do not have a role in AECOPD prevention. An expert consensus also recommends carbocysteine for patients who have failed “maximal” therapy.1
Established Guideline Analysis
Prior guidelines that address stable COPD do exist, most notably from Quaseem and colleagues in the 2011 Annals of Internal Medicine (AIM) and the 2015 GOLD guidelines.7,8 The prior guidelines published in AIM offered limited recommendations on the preventative interventions of bronchodilator use, pulmonary rehabilitation, and oxygen use.
The recommendations made in AIM are similar to those in the CHEST guidelines; the lack of breadth in the AIM report reflects new data generated over the last half decade. They include preventing causative exposures (e.g. tobacco, occupational), recommending bronchodilator use (with or without inhaled corticosteroids), possibly using phosphodiesterase-4 inhibitors (PD-4 inhibitors), administering appropriate vaccines, and providing education; however, GOLD does not actually present or rate the evidence associated with those recommendations. GOLD does specifically state that statins have no role in AECOPD prevention, a position that is updated from more recent literature.8,9
The National Guideline Clearinghouse (NGC) also includes some references to prevention of AECOPD but has no sections explicitly dedicated to prevention. Of note, the NGC still endorses statin use and does not appear to have incorporated data from newer studies.8,10
Hospitalist Takeaways
Given the high rate of COPD readmissions and its broad impact on morbidity and healthcare costs, measures to prevent COPD exacerbations cannot remain out of scope of care for inpatient physicians. It is important to initiate pulmonary rehab within four weeks of an exacerbation of COPD to prevent future exacerbations. Systems should be put in place to assure that all patients who qualify are vaccinated for influenza and patients who continue to smoke receive cessation counseling.
Today, hospitalists are comfortable with these non-pharmacologic interventions, as well as medications that include inhaled bronchodilators, nebulized medications, macrolide maintenance therapy, and oral steroids; however, other oral medications, such as phosphodiesterase inhibitors, theophylline, and N-acetylcysteine, may be appropriate for select patients, and hospitalists should become more familiar with their utility.11,12,13,14
Finally, it is important to note that both short- and long-acting inhaled muscarinic antagonists have come to the forefront of pharmacologic interventions for COPD exacerbation prevention.
Dr. Lampman, MD, is a hospitalist, consulting provider, and physician leader of the physician advisor program at Duke Regional Hospital in Durham, N.C. Dr. Lovins is a hospitalist, associate chief medical informatics officer, and assistant professor of medicine at Duke University and Duke Regional Hospital.
References
- Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acute exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest. 2015;147(4):894-942.
- Miravitlles M, Garcia-Polo C, Domenech A, Villegas G, Conget F, de la Roza C. Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease. Lung. 2013;191(5):523-530.
- Miravitlles M, Murio C, Guerrero T, Gisbert R; DAFNE Study Group. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest. 2002;121(5):1449-1455.
- Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: Statistical Brief #121.In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, Md.: Agency for Health Care Policy and Research: 2006.
- Readmissions Reduction Program. Centers for Medicare and Medicaid Services website. Accessed September 8, 2015.
- Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibáñez-Nolla J. The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice. Lung. 2014;192(4):505-518.
- Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-191.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Global Strategy for the Diagnosis, Management, and Prevention of COPD. Accessed September 8, 2015.
- Criner GJ, Connett JE, Aaron SK, et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014;370(23):2201-2210.
- Agency for Healthcare Research and Quality. National Guideline Clearinghouse. COPD – chronic obstructive pulmonary disease. In: Pulmonary (acute & chronic). Accessed September 8, 2015.
- Cazzola M, Matera MG. N-acetylcysteine in COPD may be beneficial, but for whom? Lancet Respir Med. 2014;2(3):166-167.
- Turner RD Bothamley. N-acetylcysteine for COPD: the evidence remains inconclusive. Lancet Respir Med. 2014;2(4):e3.
- Zheng JP, Wen FQ, Bai CX, et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2(3):187-194.
- Amazon.com. Amazon Search. 2015 06/1/2015].
Background
The CHEST guidelines for the prevention of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were developed through a collaboration between the American College of Chest Physicians (CHEST) and the Canadian Thoracic Society (CTS). They are the first evidence-based guidelines dedicated entirely to the prevention of AECOPD and largely exclude material related to the treatment of symptomatic disease.1
Patients with AECOPD are commonly cared for by hospitalists, so we fill an important role in the longitudinal treatment of this disease. Acute exacerbations and hospitalizations for COPD account for 50% of all COPD-related expenses.2,3 Further, the Agency for Healthcare Research and Quality showed a 20% readmission rate nationally for AECOPD, far higher than the rate for most other diagnoses.4 Consequently, COPD readmission has been added to Medicare’s Hospital Readmissions Reduction Program for fiscal year 2015.5
Hospitalization, when the patient is a captive audience and many of the necessary resources are available, may be a time to initiate preventative strategies.
Guideline Updates
The guidelines for non-pharmacologic interventions start with vaccination and continue with behavioral modification. They support the use of the 23-valent polysaccharide pneumococcal vaccine and annual influenza vaccination, noting that only influenza vaccination has been shown to decrease AECOPD.
Pulmonary rehabilitation is recommended for patients with a recent (fewer than four weeks) exacerbation. Several recommendations favor combining social work interventions with education, adding that face-to-face verbal education is superior to written educational materials. Interestingly, smoking cessation interventions received a weak recommendation, based upon lack of literature specifically focusing on the prevention of AECOPD. Despite this recommendation, smoking cessation intervention is strongly encouraged by the authors, given evidence of a marked reduction in morbidity, mortality, and healthcare utilization among smokers with COPD who quit.6 Finally, telemonitoring is not considered to be superior to usual care.
The guidelines concerning inhaled therapies fall into three major drug classes, including short- and long-acting inhaled muscarinic antagonists (anticholinergic agents), short- and long-acting inhaled beta-agonists, and inhaled corticosteroids.
Long-acting medications are generally considered more effective in preventing exacerbations than those that are short acting. Long-acting muscarinic antagonists (LAMAs) are highlighted for their efficacy, and combination inhaled long-acting beta-agonists (LABAs) and inhaled corticosteroids are preferred over monotherapy with either agent alone. LAMAs are preferred to inhaled corticosteroids or LABAs when given as monotherapy.
Short-acting agents are rated as inferior at preventing exacerbations compared to their long-acting analogs, but short-acting medications are better than placebo when combined with long-acting agents from other drug classes. Triple drug therapy (inhaled LAMAs, LABAs, and corticosteroids) can be considered based on current evidence.
The final recommendations address the use of oral medications. A potentially practice-changing guideline is the recommendation for long-term use of N-acetylcysteine tablets twice daily for patients who have experienced more than two exacerbations within two years. A more intuitive recommendation in this group is that treating an AECOPD with oral or IV steroids decreases the chance of recurrent exacerbations in the future.
The remaining recommendations include daily macrolide therapy, the phosphodiesterate-4 inhibitor roflumilast for those with chronic bronchitis and a recent exacerbation, and slow-release theophylline for stable disease. These guidelines also point out that statins do not have a role in AECOPD prevention. An expert consensus also recommends carbocysteine for patients who have failed “maximal” therapy.1
Established Guideline Analysis
Prior guidelines that address stable COPD do exist, most notably from Quaseem and colleagues in the 2011 Annals of Internal Medicine (AIM) and the 2015 GOLD guidelines.7,8 The prior guidelines published in AIM offered limited recommendations on the preventative interventions of bronchodilator use, pulmonary rehabilitation, and oxygen use.
The recommendations made in AIM are similar to those in the CHEST guidelines; the lack of breadth in the AIM report reflects new data generated over the last half decade. They include preventing causative exposures (e.g. tobacco, occupational), recommending bronchodilator use (with or without inhaled corticosteroids), possibly using phosphodiesterase-4 inhibitors (PD-4 inhibitors), administering appropriate vaccines, and providing education; however, GOLD does not actually present or rate the evidence associated with those recommendations. GOLD does specifically state that statins have no role in AECOPD prevention, a position that is updated from more recent literature.8,9
The National Guideline Clearinghouse (NGC) also includes some references to prevention of AECOPD but has no sections explicitly dedicated to prevention. Of note, the NGC still endorses statin use and does not appear to have incorporated data from newer studies.8,10
Hospitalist Takeaways
Given the high rate of COPD readmissions and its broad impact on morbidity and healthcare costs, measures to prevent COPD exacerbations cannot remain out of scope of care for inpatient physicians. It is important to initiate pulmonary rehab within four weeks of an exacerbation of COPD to prevent future exacerbations. Systems should be put in place to assure that all patients who qualify are vaccinated for influenza and patients who continue to smoke receive cessation counseling.
Today, hospitalists are comfortable with these non-pharmacologic interventions, as well as medications that include inhaled bronchodilators, nebulized medications, macrolide maintenance therapy, and oral steroids; however, other oral medications, such as phosphodiesterase inhibitors, theophylline, and N-acetylcysteine, may be appropriate for select patients, and hospitalists should become more familiar with their utility.11,12,13,14
Finally, it is important to note that both short- and long-acting inhaled muscarinic antagonists have come to the forefront of pharmacologic interventions for COPD exacerbation prevention.
Dr. Lampman, MD, is a hospitalist, consulting provider, and physician leader of the physician advisor program at Duke Regional Hospital in Durham, N.C. Dr. Lovins is a hospitalist, associate chief medical informatics officer, and assistant professor of medicine at Duke University and Duke Regional Hospital.
References
- Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acute exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest. 2015;147(4):894-942.
- Miravitlles M, Garcia-Polo C, Domenech A, Villegas G, Conget F, de la Roza C. Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease. Lung. 2013;191(5):523-530.
- Miravitlles M, Murio C, Guerrero T, Gisbert R; DAFNE Study Group. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest. 2002;121(5):1449-1455.
- Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: Statistical Brief #121.In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, Md.: Agency for Health Care Policy and Research: 2006.
- Readmissions Reduction Program. Centers for Medicare and Medicaid Services website. Accessed September 8, 2015.
- Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibáñez-Nolla J. The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice. Lung. 2014;192(4):505-518.
- Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-191.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Global Strategy for the Diagnosis, Management, and Prevention of COPD. Accessed September 8, 2015.
- Criner GJ, Connett JE, Aaron SK, et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014;370(23):2201-2210.
- Agency for Healthcare Research and Quality. National Guideline Clearinghouse. COPD – chronic obstructive pulmonary disease. In: Pulmonary (acute & chronic). Accessed September 8, 2015.
- Cazzola M, Matera MG. N-acetylcysteine in COPD may be beneficial, but for whom? Lancet Respir Med. 2014;2(3):166-167.
- Turner RD Bothamley. N-acetylcysteine for COPD: the evidence remains inconclusive. Lancet Respir Med. 2014;2(4):e3.
- Zheng JP, Wen FQ, Bai CX, et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2(3):187-194.
- Amazon.com. Amazon Search. 2015 06/1/2015].
Background
The CHEST guidelines for the prevention of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were developed through a collaboration between the American College of Chest Physicians (CHEST) and the Canadian Thoracic Society (CTS). They are the first evidence-based guidelines dedicated entirely to the prevention of AECOPD and largely exclude material related to the treatment of symptomatic disease.1
Patients with AECOPD are commonly cared for by hospitalists, so we fill an important role in the longitudinal treatment of this disease. Acute exacerbations and hospitalizations for COPD account for 50% of all COPD-related expenses.2,3 Further, the Agency for Healthcare Research and Quality showed a 20% readmission rate nationally for AECOPD, far higher than the rate for most other diagnoses.4 Consequently, COPD readmission has been added to Medicare’s Hospital Readmissions Reduction Program for fiscal year 2015.5
Hospitalization, when the patient is a captive audience and many of the necessary resources are available, may be a time to initiate preventative strategies.
Guideline Updates
The guidelines for non-pharmacologic interventions start with vaccination and continue with behavioral modification. They support the use of the 23-valent polysaccharide pneumococcal vaccine and annual influenza vaccination, noting that only influenza vaccination has been shown to decrease AECOPD.
Pulmonary rehabilitation is recommended for patients with a recent (fewer than four weeks) exacerbation. Several recommendations favor combining social work interventions with education, adding that face-to-face verbal education is superior to written educational materials. Interestingly, smoking cessation interventions received a weak recommendation, based upon lack of literature specifically focusing on the prevention of AECOPD. Despite this recommendation, smoking cessation intervention is strongly encouraged by the authors, given evidence of a marked reduction in morbidity, mortality, and healthcare utilization among smokers with COPD who quit.6 Finally, telemonitoring is not considered to be superior to usual care.
The guidelines concerning inhaled therapies fall into three major drug classes, including short- and long-acting inhaled muscarinic antagonists (anticholinergic agents), short- and long-acting inhaled beta-agonists, and inhaled corticosteroids.
Long-acting medications are generally considered more effective in preventing exacerbations than those that are short acting. Long-acting muscarinic antagonists (LAMAs) are highlighted for their efficacy, and combination inhaled long-acting beta-agonists (LABAs) and inhaled corticosteroids are preferred over monotherapy with either agent alone. LAMAs are preferred to inhaled corticosteroids or LABAs when given as monotherapy.
Short-acting agents are rated as inferior at preventing exacerbations compared to their long-acting analogs, but short-acting medications are better than placebo when combined with long-acting agents from other drug classes. Triple drug therapy (inhaled LAMAs, LABAs, and corticosteroids) can be considered based on current evidence.
The final recommendations address the use of oral medications. A potentially practice-changing guideline is the recommendation for long-term use of N-acetylcysteine tablets twice daily for patients who have experienced more than two exacerbations within two years. A more intuitive recommendation in this group is that treating an AECOPD with oral or IV steroids decreases the chance of recurrent exacerbations in the future.
The remaining recommendations include daily macrolide therapy, the phosphodiesterate-4 inhibitor roflumilast for those with chronic bronchitis and a recent exacerbation, and slow-release theophylline for stable disease. These guidelines also point out that statins do not have a role in AECOPD prevention. An expert consensus also recommends carbocysteine for patients who have failed “maximal” therapy.1
Established Guideline Analysis
Prior guidelines that address stable COPD do exist, most notably from Quaseem and colleagues in the 2011 Annals of Internal Medicine (AIM) and the 2015 GOLD guidelines.7,8 The prior guidelines published in AIM offered limited recommendations on the preventative interventions of bronchodilator use, pulmonary rehabilitation, and oxygen use.
The recommendations made in AIM are similar to those in the CHEST guidelines; the lack of breadth in the AIM report reflects new data generated over the last half decade. They include preventing causative exposures (e.g. tobacco, occupational), recommending bronchodilator use (with or without inhaled corticosteroids), possibly using phosphodiesterase-4 inhibitors (PD-4 inhibitors), administering appropriate vaccines, and providing education; however, GOLD does not actually present or rate the evidence associated with those recommendations. GOLD does specifically state that statins have no role in AECOPD prevention, a position that is updated from more recent literature.8,9
The National Guideline Clearinghouse (NGC) also includes some references to prevention of AECOPD but has no sections explicitly dedicated to prevention. Of note, the NGC still endorses statin use and does not appear to have incorporated data from newer studies.8,10
Hospitalist Takeaways
Given the high rate of COPD readmissions and its broad impact on morbidity and healthcare costs, measures to prevent COPD exacerbations cannot remain out of scope of care for inpatient physicians. It is important to initiate pulmonary rehab within four weeks of an exacerbation of COPD to prevent future exacerbations. Systems should be put in place to assure that all patients who qualify are vaccinated for influenza and patients who continue to smoke receive cessation counseling.
Today, hospitalists are comfortable with these non-pharmacologic interventions, as well as medications that include inhaled bronchodilators, nebulized medications, macrolide maintenance therapy, and oral steroids; however, other oral medications, such as phosphodiesterase inhibitors, theophylline, and N-acetylcysteine, may be appropriate for select patients, and hospitalists should become more familiar with their utility.11,12,13,14
Finally, it is important to note that both short- and long-acting inhaled muscarinic antagonists have come to the forefront of pharmacologic interventions for COPD exacerbation prevention.
Dr. Lampman, MD, is a hospitalist, consulting provider, and physician leader of the physician advisor program at Duke Regional Hospital in Durham, N.C. Dr. Lovins is a hospitalist, associate chief medical informatics officer, and assistant professor of medicine at Duke University and Duke Regional Hospital.
References
- Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acute exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest. 2015;147(4):894-942.
- Miravitlles M, Garcia-Polo C, Domenech A, Villegas G, Conget F, de la Roza C. Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease. Lung. 2013;191(5):523-530.
- Miravitlles M, Murio C, Guerrero T, Gisbert R; DAFNE Study Group. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest. 2002;121(5):1449-1455.
- Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: Statistical Brief #121.In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, Md.: Agency for Health Care Policy and Research: 2006.
- Readmissions Reduction Program. Centers for Medicare and Medicaid Services website. Accessed September 8, 2015.
- Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibáñez-Nolla J. The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice. Lung. 2014;192(4):505-518.
- Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-191.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Global Strategy for the Diagnosis, Management, and Prevention of COPD. Accessed September 8, 2015.
- Criner GJ, Connett JE, Aaron SK, et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014;370(23):2201-2210.
- Agency for Healthcare Research and Quality. National Guideline Clearinghouse. COPD – chronic obstructive pulmonary disease. In: Pulmonary (acute & chronic). Accessed September 8, 2015.
- Cazzola M, Matera MG. N-acetylcysteine in COPD may be beneficial, but for whom? Lancet Respir Med. 2014;2(3):166-167.
- Turner RD Bothamley. N-acetylcysteine for COPD: the evidence remains inconclusive. Lancet Respir Med. 2014;2(4):e3.
- Zheng JP, Wen FQ, Bai CX, et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2(3):187-194.
- Amazon.com. Amazon Search. 2015 06/1/2015].
Washington legislative conference: Driving home the unfairness of narrow networks
I just returned from the American Academy of Dermatology’s Washington “fly-in” and wanted to share some of my experiences. Every year, 180 or so dermatologists (all are invited!) and patient advocates spend 3 days in D.C., getting informed, trained, and organized to deliver our message to Congress. Each year, members and AAD staff winnow our many “wants” down to three reasonable “asks.” Background is given and our message rehearsed, for delivery in congressional and Senate offices. On the third day, appointments are kept with your representatives, and you get to try and convince them that your particular ask is beneficial to the country and, most importantly, patients.
This year, our “asks” were for better access to medications, specifically the ability to compound medications in the office (think diluting Kenalog for injection, come on!), which new Food and Drug Administration rules will interfere with; emphasizing the unfairness of narrow Medicare advantage networks; and our last, and usually annual, request for increased research funding for skin disease research.
The fly-in is a fascinating, and often fun, experience, which does affect how the U.S. government works. Truly, the squeaky (and most coherent and organized, thanks to AAD staff) wheel gets the grease.
This year, we had the additional weapon of a Government Accountability Office report released the day before our Hill visit, which independently confirmed our allegations regarding the unfairness of narrow networks to patients.
You may recall that last year, the Center for Medicare & Medicaid Services published detailed rules on increasing the accuracy of provider networks, which would have corrected many of the current problems we face. The only deficiency was that CMS has no procedures to review, audit, or enforce the rules they wrote. At the prodding of the AAD, the GAO took CMS to the mat and pummeled them, including such choice quotes as “99% of current provider networks have never been reviewed for accuracy” and “exemptions to insurers with inadequate provider access are approved routinely and never reviewed again.” The GAO made several sweeping recommendations for increased accountability, and the Department of Health & Human Services agreed with all of them.
Boring? Hardly. Think of this as taking the wooden stake created by your AAD, which was adopted by one government agency, and having it driven through the heart of insurance company deceit by another. It made for great emphasis on the Hill, and I expect big changes (and moaning and groaning from Medicare advantage plan insurance providers) in the coming months.
We also made great progress (you can tell by the interest by the staffers and members in our topics) on our other issues. I want to emphasize how effective our patient advocates were in explaining how expensive generics and cost of new drugs adversely affects them, how they have seen their doctors “delisted” from their insurance because their care is expensive, and why research into skin disease is so important to them. They “tie it all together” and bring it home.
I often talk about my “Washington Epiphany,” which can be summarized as, “politicians don’t worry about doctors, but they do about patients.” When you talk to politicians, bureaucrats, policy wonks, or the public about the woes of medical practice, always align it with the needs of patients, and you will be well received. In short, take care of your patients and they will take care of you.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Reach him at dermnews@frontlinemedcom.com.
I just returned from the American Academy of Dermatology’s Washington “fly-in” and wanted to share some of my experiences. Every year, 180 or so dermatologists (all are invited!) and patient advocates spend 3 days in D.C., getting informed, trained, and organized to deliver our message to Congress. Each year, members and AAD staff winnow our many “wants” down to three reasonable “asks.” Background is given and our message rehearsed, for delivery in congressional and Senate offices. On the third day, appointments are kept with your representatives, and you get to try and convince them that your particular ask is beneficial to the country and, most importantly, patients.
This year, our “asks” were for better access to medications, specifically the ability to compound medications in the office (think diluting Kenalog for injection, come on!), which new Food and Drug Administration rules will interfere with; emphasizing the unfairness of narrow Medicare advantage networks; and our last, and usually annual, request for increased research funding for skin disease research.
The fly-in is a fascinating, and often fun, experience, which does affect how the U.S. government works. Truly, the squeaky (and most coherent and organized, thanks to AAD staff) wheel gets the grease.
This year, we had the additional weapon of a Government Accountability Office report released the day before our Hill visit, which independently confirmed our allegations regarding the unfairness of narrow networks to patients.
You may recall that last year, the Center for Medicare & Medicaid Services published detailed rules on increasing the accuracy of provider networks, which would have corrected many of the current problems we face. The only deficiency was that CMS has no procedures to review, audit, or enforce the rules they wrote. At the prodding of the AAD, the GAO took CMS to the mat and pummeled them, including such choice quotes as “99% of current provider networks have never been reviewed for accuracy” and “exemptions to insurers with inadequate provider access are approved routinely and never reviewed again.” The GAO made several sweeping recommendations for increased accountability, and the Department of Health & Human Services agreed with all of them.
Boring? Hardly. Think of this as taking the wooden stake created by your AAD, which was adopted by one government agency, and having it driven through the heart of insurance company deceit by another. It made for great emphasis on the Hill, and I expect big changes (and moaning and groaning from Medicare advantage plan insurance providers) in the coming months.
We also made great progress (you can tell by the interest by the staffers and members in our topics) on our other issues. I want to emphasize how effective our patient advocates were in explaining how expensive generics and cost of new drugs adversely affects them, how they have seen their doctors “delisted” from their insurance because their care is expensive, and why research into skin disease is so important to them. They “tie it all together” and bring it home.
I often talk about my “Washington Epiphany,” which can be summarized as, “politicians don’t worry about doctors, but they do about patients.” When you talk to politicians, bureaucrats, policy wonks, or the public about the woes of medical practice, always align it with the needs of patients, and you will be well received. In short, take care of your patients and they will take care of you.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Reach him at dermnews@frontlinemedcom.com.
I just returned from the American Academy of Dermatology’s Washington “fly-in” and wanted to share some of my experiences. Every year, 180 or so dermatologists (all are invited!) and patient advocates spend 3 days in D.C., getting informed, trained, and organized to deliver our message to Congress. Each year, members and AAD staff winnow our many “wants” down to three reasonable “asks.” Background is given and our message rehearsed, for delivery in congressional and Senate offices. On the third day, appointments are kept with your representatives, and you get to try and convince them that your particular ask is beneficial to the country and, most importantly, patients.
This year, our “asks” were for better access to medications, specifically the ability to compound medications in the office (think diluting Kenalog for injection, come on!), which new Food and Drug Administration rules will interfere with; emphasizing the unfairness of narrow Medicare advantage networks; and our last, and usually annual, request for increased research funding for skin disease research.
The fly-in is a fascinating, and often fun, experience, which does affect how the U.S. government works. Truly, the squeaky (and most coherent and organized, thanks to AAD staff) wheel gets the grease.
This year, we had the additional weapon of a Government Accountability Office report released the day before our Hill visit, which independently confirmed our allegations regarding the unfairness of narrow networks to patients.
You may recall that last year, the Center for Medicare & Medicaid Services published detailed rules on increasing the accuracy of provider networks, which would have corrected many of the current problems we face. The only deficiency was that CMS has no procedures to review, audit, or enforce the rules they wrote. At the prodding of the AAD, the GAO took CMS to the mat and pummeled them, including such choice quotes as “99% of current provider networks have never been reviewed for accuracy” and “exemptions to insurers with inadequate provider access are approved routinely and never reviewed again.” The GAO made several sweeping recommendations for increased accountability, and the Department of Health & Human Services agreed with all of them.
Boring? Hardly. Think of this as taking the wooden stake created by your AAD, which was adopted by one government agency, and having it driven through the heart of insurance company deceit by another. It made for great emphasis on the Hill, and I expect big changes (and moaning and groaning from Medicare advantage plan insurance providers) in the coming months.
We also made great progress (you can tell by the interest by the staffers and members in our topics) on our other issues. I want to emphasize how effective our patient advocates were in explaining how expensive generics and cost of new drugs adversely affects them, how they have seen their doctors “delisted” from their insurance because their care is expensive, and why research into skin disease is so important to them. They “tie it all together” and bring it home.
I often talk about my “Washington Epiphany,” which can be summarized as, “politicians don’t worry about doctors, but they do about patients.” When you talk to politicians, bureaucrats, policy wonks, or the public about the woes of medical practice, always align it with the needs of patients, and you will be well received. In short, take care of your patients and they will take care of you.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Reach him at dermnews@frontlinemedcom.com.
Learned helplessness
Apparently, it is well known among canine behavior specialists that under similar situations dogs will look at human faces while wolves continue about their business – usually eating (“Why Is That Dog Looking at Me?” by James Gorman, New York Times, Sept. 15, 2015).
It also has been shown that when presented with the challenge of opening a food container that has been sealed shut, dogs will give up quickly and look to a nearby human, presumably for help. On the other hand, wolves raised by humans don’t look for help, suggesting that this looking to humans for help behavior may have a genetic component.
If the container of food has been altered so that it can be opened, but only with significant effort, the wolves will persist until they succeed. The adult dogs give up too quickly to succeed and instead look to humans. But, it is very interesting that in some preexperiment trials, at least one 8-month-old puppy kept at it until he was able to open the container, suggesting that in addition to some genetic influence, hanging around humans may foster what we might consider learned helplessness.
This observation wouldn’t surprise the product engineers tasked with developing child-resistant closures that can be easily opened by an adult. And I’m sure this evidence of learned helplessness in an animal wouldn’t surprise those who believe that welfare in any form is an abomination. As a card-carrying centrist, I will leave that argument to the polarizers on both ends of the political spectrum.
But I think this observation is most interesting because it raises the question of how often today’s parents are contributing to their children’s sense of helplessness. You only have to watch a child or grandchild tackle and construct a Lego project to realize that children are natural problem solvers. They get the trial-and-error thing. The problem is that too often we adults intervene at the first hint of failure, and in doing so, screw up the beautiful simplicity of the trial-and-error method of learning.
Watching someone struggle with a challenge for which you know the solution is difficult, particularly difficult if the struggler is your child or spouse. It is tempting to step forward and offer, “Here, let me show you how to do it.” Or, even worse, “Let me do it for you.”
To return to the canine world, consider the dog that brings a ball or stick to his/her master and then sits patiently waiting for the object to be tossed. If nothing is thrown, the dog will eventually give up and curl up for a nap. Puppies, on the other hand, don’t expect someone to initiate the game. They will paw at the ball until it moves or chase some unsuspecting insect playmate.
While offering children the chance to participate in organized sports is preferable to having them sit inside watching television or glued to a computer screen, the pendulum has swung a little too far toward the “organized” side of things. Too many parents seem unaware that if children are placed in an environment with room to run, a ball or two, and a few older children from whom they can model behavior, the children will organize themselves. They will figure out how to choose teams, make rules, and settle disputes.
The sad thing is that too many children have been offered so few opportunities to exercise their own powers of invention that they believe they are helpless to organize themselves. To them a sport is just a miniature version of what they see on television and comes complete with full uniforms, organized teams, sidelines lined with adoring fans ... and – of course – team pictures and trophies for everyone at the end of the season.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” Email him at pdnews@frontlinemedcom.com.
Apparently, it is well known among canine behavior specialists that under similar situations dogs will look at human faces while wolves continue about their business – usually eating (“Why Is That Dog Looking at Me?” by James Gorman, New York Times, Sept. 15, 2015).
It also has been shown that when presented with the challenge of opening a food container that has been sealed shut, dogs will give up quickly and look to a nearby human, presumably for help. On the other hand, wolves raised by humans don’t look for help, suggesting that this looking to humans for help behavior may have a genetic component.
If the container of food has been altered so that it can be opened, but only with significant effort, the wolves will persist until they succeed. The adult dogs give up too quickly to succeed and instead look to humans. But, it is very interesting that in some preexperiment trials, at least one 8-month-old puppy kept at it until he was able to open the container, suggesting that in addition to some genetic influence, hanging around humans may foster what we might consider learned helplessness.
This observation wouldn’t surprise the product engineers tasked with developing child-resistant closures that can be easily opened by an adult. And I’m sure this evidence of learned helplessness in an animal wouldn’t surprise those who believe that welfare in any form is an abomination. As a card-carrying centrist, I will leave that argument to the polarizers on both ends of the political spectrum.
But I think this observation is most interesting because it raises the question of how often today’s parents are contributing to their children’s sense of helplessness. You only have to watch a child or grandchild tackle and construct a Lego project to realize that children are natural problem solvers. They get the trial-and-error thing. The problem is that too often we adults intervene at the first hint of failure, and in doing so, screw up the beautiful simplicity of the trial-and-error method of learning.
Watching someone struggle with a challenge for which you know the solution is difficult, particularly difficult if the struggler is your child or spouse. It is tempting to step forward and offer, “Here, let me show you how to do it.” Or, even worse, “Let me do it for you.”
To return to the canine world, consider the dog that brings a ball or stick to his/her master and then sits patiently waiting for the object to be tossed. If nothing is thrown, the dog will eventually give up and curl up for a nap. Puppies, on the other hand, don’t expect someone to initiate the game. They will paw at the ball until it moves or chase some unsuspecting insect playmate.
While offering children the chance to participate in organized sports is preferable to having them sit inside watching television or glued to a computer screen, the pendulum has swung a little too far toward the “organized” side of things. Too many parents seem unaware that if children are placed in an environment with room to run, a ball or two, and a few older children from whom they can model behavior, the children will organize themselves. They will figure out how to choose teams, make rules, and settle disputes.
The sad thing is that too many children have been offered so few opportunities to exercise their own powers of invention that they believe they are helpless to organize themselves. To them a sport is just a miniature version of what they see on television and comes complete with full uniforms, organized teams, sidelines lined with adoring fans ... and – of course – team pictures and trophies for everyone at the end of the season.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” Email him at pdnews@frontlinemedcom.com.
Apparently, it is well known among canine behavior specialists that under similar situations dogs will look at human faces while wolves continue about their business – usually eating (“Why Is That Dog Looking at Me?” by James Gorman, New York Times, Sept. 15, 2015).
It also has been shown that when presented with the challenge of opening a food container that has been sealed shut, dogs will give up quickly and look to a nearby human, presumably for help. On the other hand, wolves raised by humans don’t look for help, suggesting that this looking to humans for help behavior may have a genetic component.
If the container of food has been altered so that it can be opened, but only with significant effort, the wolves will persist until they succeed. The adult dogs give up too quickly to succeed and instead look to humans. But, it is very interesting that in some preexperiment trials, at least one 8-month-old puppy kept at it until he was able to open the container, suggesting that in addition to some genetic influence, hanging around humans may foster what we might consider learned helplessness.
This observation wouldn’t surprise the product engineers tasked with developing child-resistant closures that can be easily opened by an adult. And I’m sure this evidence of learned helplessness in an animal wouldn’t surprise those who believe that welfare in any form is an abomination. As a card-carrying centrist, I will leave that argument to the polarizers on both ends of the political spectrum.
But I think this observation is most interesting because it raises the question of how often today’s parents are contributing to their children’s sense of helplessness. You only have to watch a child or grandchild tackle and construct a Lego project to realize that children are natural problem solvers. They get the trial-and-error thing. The problem is that too often we adults intervene at the first hint of failure, and in doing so, screw up the beautiful simplicity of the trial-and-error method of learning.
Watching someone struggle with a challenge for which you know the solution is difficult, particularly difficult if the struggler is your child or spouse. It is tempting to step forward and offer, “Here, let me show you how to do it.” Or, even worse, “Let me do it for you.”
To return to the canine world, consider the dog that brings a ball or stick to his/her master and then sits patiently waiting for the object to be tossed. If nothing is thrown, the dog will eventually give up and curl up for a nap. Puppies, on the other hand, don’t expect someone to initiate the game. They will paw at the ball until it moves or chase some unsuspecting insect playmate.
While offering children the chance to participate in organized sports is preferable to having them sit inside watching television or glued to a computer screen, the pendulum has swung a little too far toward the “organized” side of things. Too many parents seem unaware that if children are placed in an environment with room to run, a ball or two, and a few older children from whom they can model behavior, the children will organize themselves. They will figure out how to choose teams, make rules, and settle disputes.
The sad thing is that too many children have been offered so few opportunities to exercise their own powers of invention that they believe they are helpless to organize themselves. To them a sport is just a miniature version of what they see on television and comes complete with full uniforms, organized teams, sidelines lined with adoring fans ... and – of course – team pictures and trophies for everyone at the end of the season.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” Email him at pdnews@frontlinemedcom.com.
Peramivir effective against most flu viruses circulating globally
SAN DIEGO – The neuraminidase inhibitor peramivir inhibited about 99% of seasonal influenza A and B viruses circulating globally during the 2013-2014 and 2014-2015 influenza seasons, a large analysis demonstrated.
“The frequency of H1N1pdm09 viruses carrying neuraminidase (NA) H275Y remained low during both seasons; this mutation confers resistance to oseltamivir and peramivir,” said Margaret Okomo-Adhiambo, Ph.D., at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. In addition, “a small proportion of viruses contained other neuraminidase changes that affect binding of peramivir to viral enzymes and may decrease virus susceptibility. These changes need to be closely monitored.”
Approved by the FDA in December of 2014, peramivir (Rapivab) is the only antiviral agent for influenza treatment to come to market in nearly 20 years. Approved for intravenous administration as a single dose, it is indicated for adults with acute uncomplicated influenza who may have trouble taking orally administered or inhaled neuraminidase (NA) inhibitors. Other NA inhibitors approved by the FDA for influenza infection include oseltamivir, which is orally administered, and zanamivir, which is inhaled.
For the current analysis, Dr. Okomo-Adhiambo of the influenza division at the Centers for Disease Control and Prevention, Atlanta, and her associates tested influenza virus susceptibility to peramivir during the 2013-2014 and 2014-2015 influenza seasons as part of the World Health Organization Global Influenza Surveillance and Response System. A total of 8,426 viruses were tested, 75% of which were circulating in the United States.
Dr. Okomo-Adhiambo reported that during the 2013-2014 and 2014-2015 influenza seasons, about 99% of influenza type A and B viruses were inhibited by peramivir, except for a few viruses belonging to subtype A(H1N1)pdm09 (1.5%), subtype A(H3N2) (0.2%), and type B (0.4%). In addition, NA activity of type A viruses was five to six times more sensitive to inhibition by peramivir, compared with type B NA.
She concluded her presentation by noting that studies “are needed to establish molecular markers of clinically relevant resistance to peramivir.”
The researchers reported having no financial disclosures.
SAN DIEGO – The neuraminidase inhibitor peramivir inhibited about 99% of seasonal influenza A and B viruses circulating globally during the 2013-2014 and 2014-2015 influenza seasons, a large analysis demonstrated.
“The frequency of H1N1pdm09 viruses carrying neuraminidase (NA) H275Y remained low during both seasons; this mutation confers resistance to oseltamivir and peramivir,” said Margaret Okomo-Adhiambo, Ph.D., at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. In addition, “a small proportion of viruses contained other neuraminidase changes that affect binding of peramivir to viral enzymes and may decrease virus susceptibility. These changes need to be closely monitored.”
Approved by the FDA in December of 2014, peramivir (Rapivab) is the only antiviral agent for influenza treatment to come to market in nearly 20 years. Approved for intravenous administration as a single dose, it is indicated for adults with acute uncomplicated influenza who may have trouble taking orally administered or inhaled neuraminidase (NA) inhibitors. Other NA inhibitors approved by the FDA for influenza infection include oseltamivir, which is orally administered, and zanamivir, which is inhaled.
For the current analysis, Dr. Okomo-Adhiambo of the influenza division at the Centers for Disease Control and Prevention, Atlanta, and her associates tested influenza virus susceptibility to peramivir during the 2013-2014 and 2014-2015 influenza seasons as part of the World Health Organization Global Influenza Surveillance and Response System. A total of 8,426 viruses were tested, 75% of which were circulating in the United States.
Dr. Okomo-Adhiambo reported that during the 2013-2014 and 2014-2015 influenza seasons, about 99% of influenza type A and B viruses were inhibited by peramivir, except for a few viruses belonging to subtype A(H1N1)pdm09 (1.5%), subtype A(H3N2) (0.2%), and type B (0.4%). In addition, NA activity of type A viruses was five to six times more sensitive to inhibition by peramivir, compared with type B NA.
She concluded her presentation by noting that studies “are needed to establish molecular markers of clinically relevant resistance to peramivir.”
The researchers reported having no financial disclosures.
SAN DIEGO – The neuraminidase inhibitor peramivir inhibited about 99% of seasonal influenza A and B viruses circulating globally during the 2013-2014 and 2014-2015 influenza seasons, a large analysis demonstrated.
“The frequency of H1N1pdm09 viruses carrying neuraminidase (NA) H275Y remained low during both seasons; this mutation confers resistance to oseltamivir and peramivir,” said Margaret Okomo-Adhiambo, Ph.D., at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. In addition, “a small proportion of viruses contained other neuraminidase changes that affect binding of peramivir to viral enzymes and may decrease virus susceptibility. These changes need to be closely monitored.”
Approved by the FDA in December of 2014, peramivir (Rapivab) is the only antiviral agent for influenza treatment to come to market in nearly 20 years. Approved for intravenous administration as a single dose, it is indicated for adults with acute uncomplicated influenza who may have trouble taking orally administered or inhaled neuraminidase (NA) inhibitors. Other NA inhibitors approved by the FDA for influenza infection include oseltamivir, which is orally administered, and zanamivir, which is inhaled.
For the current analysis, Dr. Okomo-Adhiambo of the influenza division at the Centers for Disease Control and Prevention, Atlanta, and her associates tested influenza virus susceptibility to peramivir during the 2013-2014 and 2014-2015 influenza seasons as part of the World Health Organization Global Influenza Surveillance and Response System. A total of 8,426 viruses were tested, 75% of which were circulating in the United States.
Dr. Okomo-Adhiambo reported that during the 2013-2014 and 2014-2015 influenza seasons, about 99% of influenza type A and B viruses were inhibited by peramivir, except for a few viruses belonging to subtype A(H1N1)pdm09 (1.5%), subtype A(H3N2) (0.2%), and type B (0.4%). In addition, NA activity of type A viruses was five to six times more sensitive to inhibition by peramivir, compared with type B NA.
She concluded her presentation by noting that studies “are needed to establish molecular markers of clinically relevant resistance to peramivir.”
The researchers reported having no financial disclosures.
AT ICAAC 2015
Key clinical point: Peramivir is potently effective against seasonal influenza viruses circulating globally.
Major finding: During the 2013-2014 and 2014-2015 influenza seasons, about 99% of influenza type A and B viruses were inhibited by peramivir.
Data source: An analysis of 8,426 influenza viruses that were tested during the 2013-2014 and 2014-2015 influenza seasons as part of the World Health Organization Global Influenza Surveillance and Response System.
Disclosures: The researchers reporting having no financial disclosures.
Reattaching intercostals fails to squelch spinal cord ischemia in TAAA repairs
CHICAGO – Intercostal artery reimplantation fails to significantly reduce spinal cord injury following thoracoabdominal aortic aneurysm surgery, results of a large retrospective study show.
“Although there was a small decrease in spinal cord ischemia with ICAR, reattaching the intercostals did not produce a statistically significant reduction in spinal cord ischemia, even in the highest risk patients,” Dr. Charles W. Acher of the University of Wisconsin–Madison, said at the annual meeting of the Midwestern Vascular Surgical Society.
Intercostal artery reimplantation (ICAR) is one of several strategies that have been used to prevent spinal cord ischemia (SCI), paraplegia, and paraparesis that occurs from the interruption of the blood supply to intercostal arteries (ICAs) during thoracoabdominal aortic aneurysm (TAAA) repair.
Surgeons at UW–Madison adopted the ICAR strategy in 2005and now reimplant open ICAs located at T7-L2 in all Type I, II, and III TAAAs, using a previously published technique (J Surg Res. 2009;154:99-104).
Using a prospectively maintained database, the current analysis sought to compare outcomes between 540 patients who had TAAA surgery during 1989-2004 when open ICAs were ligated and 265 patients who had surgery during 2005-2013 with ICAR.The surgical technique for both groups was cross clamp without assisted circulation. The anesthetic technique was also uniform during the study period and included moderate systemic hypothermia (32° - 33° C); spinal fluid drainage (spinal fluid pressure less than 5 mm Hg); naloxone 1 mcg/kg per hour; use of mannitol, methylprednisolone, and barbiturate burst suppression; goal-directed therapy for a mean arterial pressure of 90-100 mm Hg and cardiac index of 2.5 L per minute/meter2; and proactive component blood therapy to avoid anemia, hypovolemia, and hypertension.
Aneurysm extent, acuity, mortality, renal failure, and pulmonary failure were the same in both groups.
The incidence of SCI was similar in all TAAAs at 5.25% without ICAR and 3.4% with ICAR (P = .23) and in the subset of patients with Type I, II, and III aneurysms (8.8% vs. 5.1%; P = .152), Dr. Acher reported on behalf of lead author and his colleague, Dr. Martha M. Wynn.
Interestingly, ICAR patients had more dissections than did the open ICA ligation patients (18% vs. 15%; P = .0016), more previous aortic surgery (47% vs. 31%; P = .0004), and longer renal ischemia time (61 minutes vs. 53 minutes; P = .0001), but had a shorter length of stay (14 days vs. 22 days; P = .0001) and were younger (mean age, 66 years vs. 70 years; P = .0001).
In a multivariate model of all TAAAs, significant predictors of spinal cord ischemia/injury were type II TAAA (odds ratio, 7.59; P = .0001), dissection (OR, 4.25; P = .0015), age as a continuous variable (P = .0085), and acute TAAA (OR, 2.1; P = .0525), Dr. Acher said. Time period of surgery, and therefore ICAR, was not significant (OR, 0.78; P = .55).
ICAR also failed to achieve significance as an SCI predictor in a subanalysis restricted to the highest-risk patients, defined as those having Type II TAAA, dissection, and acute surgery (OR, 0.67; P = .3387).
“Interrupting blood supply to the spinal cord causes spinal cord ischemia that can be mitigated almost entirely by physiologic interventions that increase spinal cord ischemic tolerance and collateral network perfusion during and after surgery,” Dr. Acher said. “Although the cause of SCI in TAAA surgery is anatomic, prevention of the injury is largely physiologic.”
During a discussion of the study, Dr. Acher surprised the audience by saying the findings have not changed current practice at the university. He cited several reasons, observing that there were more dissections in the ICAR group, and most of the ischemia in the ICAR group was delayed, suggesting that more patients could be rescued. In addition, there was a slight downward trend in spinal cord injury and immediate paraplegia with ICAR, however, these were not statistically significant.
“Because of those things, I still think it’s valuable, particularly in patients that are at highest risk, which are the dissections, with lots of open intercostals, but the emphasis should still be on physiologic parameters,” he said. “If you want to salvage patients, that’s the most important thing.
“Even if ICAR were ever shown to be statistically significant in a larger patient population, any role it has in reducing spinal cord injury would be extremely small,” he added in an interview.
The authors reported having no conflicts of interest.
Spinal cord ischemia is a rare but devastating complication of thoracoabdominal aneurysm repair. Crawford and his colleagues documented in 1993 an incidence of spinal cord ischemia (SCI) as high as 30% for extensive thoracoabdominal repairs. Efforts to diminish the risk of SCI were concentrated in identifying and preserving the direct arterial perfusion to the spinal cord from segmental arteries but continued experimental and clinical experience have suggested that multiple factors contribute to SCI.
![]() |
Dr. Luis A. Sanchez |
Some generally accepted principles for minimizing SCI include hypothermia, distal aortic perfusion with atriofemoral bypass or partial cardiopulmonary bypass, cerebrospinal fluid drainage, and avoidance of hemodynamic instability. Reimplantation of intercostal branches has been suggested as an adjunct to these techniques by some investigators with limited data to support its generalized application. More recently, a growing body of evidence supports the concept of a collateral network that can support the perfusion to the spinal cord after interruption of multiple intercostal arteries and the importance of the hypogastric and subclavian arteries as critical branches that perfuse the spinal collateral network.
The retrospective review of the extensive experience at the University of Wisconsin in Madison supports the concept that “physiologic interventions that increase spinal cord tolerance and collateral network perfusion during and after surgery” are more important than the reimplantation of intercostal vessels during this complex procedure, even in patients considered at the highest risk for SCI. Intercostal artery reimplantation failed to achieve significance as an SCI predictor when comparing two large cohorts of patients (540 vs. 265) treated with intercostal ligation vs. reimplantation. Increasingly, available data support the concept of a collateral network that maintains perfusion to the spinal cord after intercostal artery occlusion.
Additional new concepts and techniques including a two-stage approach for extensive thoracoabdominal repair, preliminary occlusion of some segmental arteries, and the use of hybrid and endovascular techniques may further decrease the incidence of SCI by taking advantage of the collateral network and allow some preconditioning of the spinal cord. Fortunately for these challenging patients, significant advances continue to be made to better understand and prevent spinal cord ischemia.
Dr. Luis A. Sanchez is Chief, Section of Vascular Surgery and the Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Department of Surgery, Washington University in St. Louis.
Spinal cord ischemia is a rare but devastating complication of thoracoabdominal aneurysm repair. Crawford and his colleagues documented in 1993 an incidence of spinal cord ischemia (SCI) as high as 30% for extensive thoracoabdominal repairs. Efforts to diminish the risk of SCI were concentrated in identifying and preserving the direct arterial perfusion to the spinal cord from segmental arteries but continued experimental and clinical experience have suggested that multiple factors contribute to SCI.
![]() |
Dr. Luis A. Sanchez |
Some generally accepted principles for minimizing SCI include hypothermia, distal aortic perfusion with atriofemoral bypass or partial cardiopulmonary bypass, cerebrospinal fluid drainage, and avoidance of hemodynamic instability. Reimplantation of intercostal branches has been suggested as an adjunct to these techniques by some investigators with limited data to support its generalized application. More recently, a growing body of evidence supports the concept of a collateral network that can support the perfusion to the spinal cord after interruption of multiple intercostal arteries and the importance of the hypogastric and subclavian arteries as critical branches that perfuse the spinal collateral network.
The retrospective review of the extensive experience at the University of Wisconsin in Madison supports the concept that “physiologic interventions that increase spinal cord tolerance and collateral network perfusion during and after surgery” are more important than the reimplantation of intercostal vessels during this complex procedure, even in patients considered at the highest risk for SCI. Intercostal artery reimplantation failed to achieve significance as an SCI predictor when comparing two large cohorts of patients (540 vs. 265) treated with intercostal ligation vs. reimplantation. Increasingly, available data support the concept of a collateral network that maintains perfusion to the spinal cord after intercostal artery occlusion.
Additional new concepts and techniques including a two-stage approach for extensive thoracoabdominal repair, preliminary occlusion of some segmental arteries, and the use of hybrid and endovascular techniques may further decrease the incidence of SCI by taking advantage of the collateral network and allow some preconditioning of the spinal cord. Fortunately for these challenging patients, significant advances continue to be made to better understand and prevent spinal cord ischemia.
Dr. Luis A. Sanchez is Chief, Section of Vascular Surgery and the Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Department of Surgery, Washington University in St. Louis.
Spinal cord ischemia is a rare but devastating complication of thoracoabdominal aneurysm repair. Crawford and his colleagues documented in 1993 an incidence of spinal cord ischemia (SCI) as high as 30% for extensive thoracoabdominal repairs. Efforts to diminish the risk of SCI were concentrated in identifying and preserving the direct arterial perfusion to the spinal cord from segmental arteries but continued experimental and clinical experience have suggested that multiple factors contribute to SCI.
![]() |
Dr. Luis A. Sanchez |
Some generally accepted principles for minimizing SCI include hypothermia, distal aortic perfusion with atriofemoral bypass or partial cardiopulmonary bypass, cerebrospinal fluid drainage, and avoidance of hemodynamic instability. Reimplantation of intercostal branches has been suggested as an adjunct to these techniques by some investigators with limited data to support its generalized application. More recently, a growing body of evidence supports the concept of a collateral network that can support the perfusion to the spinal cord after interruption of multiple intercostal arteries and the importance of the hypogastric and subclavian arteries as critical branches that perfuse the spinal collateral network.
The retrospective review of the extensive experience at the University of Wisconsin in Madison supports the concept that “physiologic interventions that increase spinal cord tolerance and collateral network perfusion during and after surgery” are more important than the reimplantation of intercostal vessels during this complex procedure, even in patients considered at the highest risk for SCI. Intercostal artery reimplantation failed to achieve significance as an SCI predictor when comparing two large cohorts of patients (540 vs. 265) treated with intercostal ligation vs. reimplantation. Increasingly, available data support the concept of a collateral network that maintains perfusion to the spinal cord after intercostal artery occlusion.
Additional new concepts and techniques including a two-stage approach for extensive thoracoabdominal repair, preliminary occlusion of some segmental arteries, and the use of hybrid and endovascular techniques may further decrease the incidence of SCI by taking advantage of the collateral network and allow some preconditioning of the spinal cord. Fortunately for these challenging patients, significant advances continue to be made to better understand and prevent spinal cord ischemia.
Dr. Luis A. Sanchez is Chief, Section of Vascular Surgery and the Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Department of Surgery, Washington University in St. Louis.
CHICAGO – Intercostal artery reimplantation fails to significantly reduce spinal cord injury following thoracoabdominal aortic aneurysm surgery, results of a large retrospective study show.
“Although there was a small decrease in spinal cord ischemia with ICAR, reattaching the intercostals did not produce a statistically significant reduction in spinal cord ischemia, even in the highest risk patients,” Dr. Charles W. Acher of the University of Wisconsin–Madison, said at the annual meeting of the Midwestern Vascular Surgical Society.
Intercostal artery reimplantation (ICAR) is one of several strategies that have been used to prevent spinal cord ischemia (SCI), paraplegia, and paraparesis that occurs from the interruption of the blood supply to intercostal arteries (ICAs) during thoracoabdominal aortic aneurysm (TAAA) repair.
Surgeons at UW–Madison adopted the ICAR strategy in 2005and now reimplant open ICAs located at T7-L2 in all Type I, II, and III TAAAs, using a previously published technique (J Surg Res. 2009;154:99-104).
Using a prospectively maintained database, the current analysis sought to compare outcomes between 540 patients who had TAAA surgery during 1989-2004 when open ICAs were ligated and 265 patients who had surgery during 2005-2013 with ICAR.The surgical technique for both groups was cross clamp without assisted circulation. The anesthetic technique was also uniform during the study period and included moderate systemic hypothermia (32° - 33° C); spinal fluid drainage (spinal fluid pressure less than 5 mm Hg); naloxone 1 mcg/kg per hour; use of mannitol, methylprednisolone, and barbiturate burst suppression; goal-directed therapy for a mean arterial pressure of 90-100 mm Hg and cardiac index of 2.5 L per minute/meter2; and proactive component blood therapy to avoid anemia, hypovolemia, and hypertension.
Aneurysm extent, acuity, mortality, renal failure, and pulmonary failure were the same in both groups.
The incidence of SCI was similar in all TAAAs at 5.25% without ICAR and 3.4% with ICAR (P = .23) and in the subset of patients with Type I, II, and III aneurysms (8.8% vs. 5.1%; P = .152), Dr. Acher reported on behalf of lead author and his colleague, Dr. Martha M. Wynn.
Interestingly, ICAR patients had more dissections than did the open ICA ligation patients (18% vs. 15%; P = .0016), more previous aortic surgery (47% vs. 31%; P = .0004), and longer renal ischemia time (61 minutes vs. 53 minutes; P = .0001), but had a shorter length of stay (14 days vs. 22 days; P = .0001) and were younger (mean age, 66 years vs. 70 years; P = .0001).
In a multivariate model of all TAAAs, significant predictors of spinal cord ischemia/injury were type II TAAA (odds ratio, 7.59; P = .0001), dissection (OR, 4.25; P = .0015), age as a continuous variable (P = .0085), and acute TAAA (OR, 2.1; P = .0525), Dr. Acher said. Time period of surgery, and therefore ICAR, was not significant (OR, 0.78; P = .55).
ICAR also failed to achieve significance as an SCI predictor in a subanalysis restricted to the highest-risk patients, defined as those having Type II TAAA, dissection, and acute surgery (OR, 0.67; P = .3387).
“Interrupting blood supply to the spinal cord causes spinal cord ischemia that can be mitigated almost entirely by physiologic interventions that increase spinal cord ischemic tolerance and collateral network perfusion during and after surgery,” Dr. Acher said. “Although the cause of SCI in TAAA surgery is anatomic, prevention of the injury is largely physiologic.”
During a discussion of the study, Dr. Acher surprised the audience by saying the findings have not changed current practice at the university. He cited several reasons, observing that there were more dissections in the ICAR group, and most of the ischemia in the ICAR group was delayed, suggesting that more patients could be rescued. In addition, there was a slight downward trend in spinal cord injury and immediate paraplegia with ICAR, however, these were not statistically significant.
“Because of those things, I still think it’s valuable, particularly in patients that are at highest risk, which are the dissections, with lots of open intercostals, but the emphasis should still be on physiologic parameters,” he said. “If you want to salvage patients, that’s the most important thing.
“Even if ICAR were ever shown to be statistically significant in a larger patient population, any role it has in reducing spinal cord injury would be extremely small,” he added in an interview.
The authors reported having no conflicts of interest.
CHICAGO – Intercostal artery reimplantation fails to significantly reduce spinal cord injury following thoracoabdominal aortic aneurysm surgery, results of a large retrospective study show.
“Although there was a small decrease in spinal cord ischemia with ICAR, reattaching the intercostals did not produce a statistically significant reduction in spinal cord ischemia, even in the highest risk patients,” Dr. Charles W. Acher of the University of Wisconsin–Madison, said at the annual meeting of the Midwestern Vascular Surgical Society.
Intercostal artery reimplantation (ICAR) is one of several strategies that have been used to prevent spinal cord ischemia (SCI), paraplegia, and paraparesis that occurs from the interruption of the blood supply to intercostal arteries (ICAs) during thoracoabdominal aortic aneurysm (TAAA) repair.
Surgeons at UW–Madison adopted the ICAR strategy in 2005and now reimplant open ICAs located at T7-L2 in all Type I, II, and III TAAAs, using a previously published technique (J Surg Res. 2009;154:99-104).
Using a prospectively maintained database, the current analysis sought to compare outcomes between 540 patients who had TAAA surgery during 1989-2004 when open ICAs were ligated and 265 patients who had surgery during 2005-2013 with ICAR.The surgical technique for both groups was cross clamp without assisted circulation. The anesthetic technique was also uniform during the study period and included moderate systemic hypothermia (32° - 33° C); spinal fluid drainage (spinal fluid pressure less than 5 mm Hg); naloxone 1 mcg/kg per hour; use of mannitol, methylprednisolone, and barbiturate burst suppression; goal-directed therapy for a mean arterial pressure of 90-100 mm Hg and cardiac index of 2.5 L per minute/meter2; and proactive component blood therapy to avoid anemia, hypovolemia, and hypertension.
Aneurysm extent, acuity, mortality, renal failure, and pulmonary failure were the same in both groups.
The incidence of SCI was similar in all TAAAs at 5.25% without ICAR and 3.4% with ICAR (P = .23) and in the subset of patients with Type I, II, and III aneurysms (8.8% vs. 5.1%; P = .152), Dr. Acher reported on behalf of lead author and his colleague, Dr. Martha M. Wynn.
Interestingly, ICAR patients had more dissections than did the open ICA ligation patients (18% vs. 15%; P = .0016), more previous aortic surgery (47% vs. 31%; P = .0004), and longer renal ischemia time (61 minutes vs. 53 minutes; P = .0001), but had a shorter length of stay (14 days vs. 22 days; P = .0001) and were younger (mean age, 66 years vs. 70 years; P = .0001).
In a multivariate model of all TAAAs, significant predictors of spinal cord ischemia/injury were type II TAAA (odds ratio, 7.59; P = .0001), dissection (OR, 4.25; P = .0015), age as a continuous variable (P = .0085), and acute TAAA (OR, 2.1; P = .0525), Dr. Acher said. Time period of surgery, and therefore ICAR, was not significant (OR, 0.78; P = .55).
ICAR also failed to achieve significance as an SCI predictor in a subanalysis restricted to the highest-risk patients, defined as those having Type II TAAA, dissection, and acute surgery (OR, 0.67; P = .3387).
“Interrupting blood supply to the spinal cord causes spinal cord ischemia that can be mitigated almost entirely by physiologic interventions that increase spinal cord ischemic tolerance and collateral network perfusion during and after surgery,” Dr. Acher said. “Although the cause of SCI in TAAA surgery is anatomic, prevention of the injury is largely physiologic.”
During a discussion of the study, Dr. Acher surprised the audience by saying the findings have not changed current practice at the university. He cited several reasons, observing that there were more dissections in the ICAR group, and most of the ischemia in the ICAR group was delayed, suggesting that more patients could be rescued. In addition, there was a slight downward trend in spinal cord injury and immediate paraplegia with ICAR, however, these were not statistically significant.
“Because of those things, I still think it’s valuable, particularly in patients that are at highest risk, which are the dissections, with lots of open intercostals, but the emphasis should still be on physiologic parameters,” he said. “If you want to salvage patients, that’s the most important thing.
“Even if ICAR were ever shown to be statistically significant in a larger patient population, any role it has in reducing spinal cord injury would be extremely small,” he added in an interview.
The authors reported having no conflicts of interest.
AT MIDWESTERN VASCULAR 2015
Key clinical point: Intercostal artery reimplantation (ICAR) did not produce a significant reduction in spinal cord ischemia following thoracoabdominal aortic aneurysm repair, even in the highest risk patients.
Major finding: ICAR was not a significant predictor of spinal cord ischemia (OR, 0.78; P = .55).
Data source: Retrospective analysis of 805 patients undergoing TAAA with or without ICAR.
Disclosures: The authors reported having no conflicts of interest.
Coronary Computed Tomography Angiography, Radionuclide Stress Testing Similar for Evaluation of Chest Pain
Clinical question: Is coronary computed tomography angiography better than stress testing for detecting coronary artery disease?
Bottom line: For the evaluation of chest pain in intermediate-risk patients, coronary computed tomography angiography (CCTA) is comparable with myocardial perfusion imaging (MPI) in its ability to select patients for invasive management. Both modalities are also similar when it comes to downstream resource use and adverse cardiovascular events. CCTA is associated with less radiation exposure (LOE = 1b).
Reference: Levsky JM, Spevack DM, Travin MI, et al. Coronary computed tomography angiography versus radionuclide myocardial perfusion imaging in patients with chest pain admitted to telemetry. Ann Intern Med 2015;163(3):174-183.
Study design: Randomized controlled trial (nonblinded)
Funding source: Foundation
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
The effectiveness of a noninvasive coronary imaging modality lies in its ability to identify patients who will need invasive management. In this study, intermediate-risk patients admitted to telemetry for the evaluation of chest pain who clinically required noninvasive imaging were randomized, using concealed allocation, to receive either CCTA or radionuclide stress MPI.
At baseline, the mean age in both groups was 57 years, two-thirds of the patients were female, and more than 90% were ethnic minorities. Analysis was by intention to treat. The primary outcome was the rate of cardiac catheterization that did not lead to revascularization within one year of the imaging test. There was no significant difference between the two groups for this outcome. However, in a subgroup analysis of patients with signficantly abnormal results on their imaging test, there was a nonsignificant trend toward fewer catheterizations without revascularization in the CCTA group (25% vs 52%; P=0.083).
For secondary outcomes, there were no differences detected between the two groups in length of stay, major adverse cardiovascular events, or downstream resource use, including rehospitalizations and further imaging. The CCTA group had less radiation exposure and reported a better patient experience.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Is coronary computed tomography angiography better than stress testing for detecting coronary artery disease?
Bottom line: For the evaluation of chest pain in intermediate-risk patients, coronary computed tomography angiography (CCTA) is comparable with myocardial perfusion imaging (MPI) in its ability to select patients for invasive management. Both modalities are also similar when it comes to downstream resource use and adverse cardiovascular events. CCTA is associated with less radiation exposure (LOE = 1b).
Reference: Levsky JM, Spevack DM, Travin MI, et al. Coronary computed tomography angiography versus radionuclide myocardial perfusion imaging in patients with chest pain admitted to telemetry. Ann Intern Med 2015;163(3):174-183.
Study design: Randomized controlled trial (nonblinded)
Funding source: Foundation
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
The effectiveness of a noninvasive coronary imaging modality lies in its ability to identify patients who will need invasive management. In this study, intermediate-risk patients admitted to telemetry for the evaluation of chest pain who clinically required noninvasive imaging were randomized, using concealed allocation, to receive either CCTA or radionuclide stress MPI.
At baseline, the mean age in both groups was 57 years, two-thirds of the patients were female, and more than 90% were ethnic minorities. Analysis was by intention to treat. The primary outcome was the rate of cardiac catheterization that did not lead to revascularization within one year of the imaging test. There was no significant difference between the two groups for this outcome. However, in a subgroup analysis of patients with signficantly abnormal results on their imaging test, there was a nonsignificant trend toward fewer catheterizations without revascularization in the CCTA group (25% vs 52%; P=0.083).
For secondary outcomes, there were no differences detected between the two groups in length of stay, major adverse cardiovascular events, or downstream resource use, including rehospitalizations and further imaging. The CCTA group had less radiation exposure and reported a better patient experience.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Is coronary computed tomography angiography better than stress testing for detecting coronary artery disease?
Bottom line: For the evaluation of chest pain in intermediate-risk patients, coronary computed tomography angiography (CCTA) is comparable with myocardial perfusion imaging (MPI) in its ability to select patients for invasive management. Both modalities are also similar when it comes to downstream resource use and adverse cardiovascular events. CCTA is associated with less radiation exposure (LOE = 1b).
Reference: Levsky JM, Spevack DM, Travin MI, et al. Coronary computed tomography angiography versus radionuclide myocardial perfusion imaging in patients with chest pain admitted to telemetry. Ann Intern Med 2015;163(3):174-183.
Study design: Randomized controlled trial (nonblinded)
Funding source: Foundation
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
The effectiveness of a noninvasive coronary imaging modality lies in its ability to identify patients who will need invasive management. In this study, intermediate-risk patients admitted to telemetry for the evaluation of chest pain who clinically required noninvasive imaging were randomized, using concealed allocation, to receive either CCTA or radionuclide stress MPI.
At baseline, the mean age in both groups was 57 years, two-thirds of the patients were female, and more than 90% were ethnic minorities. Analysis was by intention to treat. The primary outcome was the rate of cardiac catheterization that did not lead to revascularization within one year of the imaging test. There was no significant difference between the two groups for this outcome. However, in a subgroup analysis of patients with signficantly abnormal results on their imaging test, there was a nonsignificant trend toward fewer catheterizations without revascularization in the CCTA group (25% vs 52%; P=0.083).
For secondary outcomes, there were no differences detected between the two groups in length of stay, major adverse cardiovascular events, or downstream resource use, including rehospitalizations and further imaging. The CCTA group had less radiation exposure and reported a better patient experience.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.