Cardiology

The Food and Drug Administration has approved the Amplatzer Amulet left atrial appendage occluder (Abbott) to treat people with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

The Amulet and its competitor, Boston Scientific’s Watchman, are minimally invasive devices used to close off the left atrial appendage (LAA), an area where blood clots tend to form in people with atrial fibrillation.

Amulet uses dual-seal technology to completely and immediately seal the LAA, the company says, whereas the other minimally invasive solution uses a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring. The Amulet also has the widest range of occluder sizes on the market and is recapturable and repositionable to ensure optimal placement.

“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke. The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines,” Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health, Overland Park, Kan., and principal investigator for the study that led to FDA approval, said in a news release from Abbott.

The FDA approval is supported by findings from the global Amulet IDE trial, a head-to-head comparison of the Amulet and Watchman devices in 1,878 participants with nonvalvular atrial fibrillation. The results will be presented virtually on Aug. 30 at the 2021 annual congress of the European Society of Cardiology.

The Amplatzer Amulet received CE Mark designation in 2013 and is approved for use in more than 80 countries, including in Australia, Canada, and European countries.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the Amplatzer Amulet left atrial appendage occluder (Abbott) to treat people with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

The Amulet and its competitor, Boston Scientific’s Watchman, are minimally invasive devices used to close off the left atrial appendage (LAA), an area where blood clots tend to form in people with atrial fibrillation.

Amulet uses dual-seal technology to completely and immediately seal the LAA, the company says, whereas the other minimally invasive solution uses a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring. The Amulet also has the widest range of occluder sizes on the market and is recapturable and repositionable to ensure optimal placement.

“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke. The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines,” Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health, Overland Park, Kan., and principal investigator for the study that led to FDA approval, said in a news release from Abbott.

The FDA approval is supported by findings from the global Amulet IDE trial, a head-to-head comparison of the Amulet and Watchman devices in 1,878 participants with nonvalvular atrial fibrillation. The results will be presented virtually on Aug. 30 at the 2021 annual congress of the European Society of Cardiology.

The Amplatzer Amulet received CE Mark designation in 2013 and is approved for use in more than 80 countries, including in Australia, Canada, and European countries.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the Amplatzer Amulet left atrial appendage occluder (Abbott) to treat people with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

The Amulet and its competitor, Boston Scientific’s Watchman, are minimally invasive devices used to close off the left atrial appendage (LAA), an area where blood clots tend to form in people with atrial fibrillation.

Amulet uses dual-seal technology to completely and immediately seal the LAA, the company says, whereas the other minimally invasive solution uses a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring. The Amulet also has the widest range of occluder sizes on the market and is recapturable and repositionable to ensure optimal placement.

“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke. The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines,” Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health, Overland Park, Kan., and principal investigator for the study that led to FDA approval, said in a news release from Abbott.

The FDA approval is supported by findings from the global Amulet IDE trial, a head-to-head comparison of the Amulet and Watchman devices in 1,878 participants with nonvalvular atrial fibrillation. The results will be presented virtually on Aug. 30 at the 2021 annual congress of the European Society of Cardiology.

The Amplatzer Amulet received CE Mark designation in 2013 and is approved for use in more than 80 countries, including in Australia, Canada, and European countries.

A version of this article first appeared on Medscape.com.

REFERENCES

1. Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension global hypertension practice guidelines. Hypertension. 2020;75:1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026
2. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71:e127-e248.
3. US Preventive Services Task Force. Screening for hypertension in adults: US Preventive Services Task Force reaffirmation recommendation statement. JAMA. 2021;325:1650-1656. doi: 10.1001/jama.2021.4987

REFERENCES

1. Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension global hypertension practice guidelines. Hypertension. 2020;75:1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026
2. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71:e127-e248.
3. US Preventive Services Task Force. Screening for hypertension in adults: US Preventive Services Task Force reaffirmation recommendation statement. JAMA. 2021;325:1650-1656. doi: 10.1001/jama.2021.4987

REFERENCES

1. Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension global hypertension practice guidelines. Hypertension. 2020;75:1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026
2. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71:e127-e248.
3. US Preventive Services Task Force. Screening for hypertension in adults: US Preventive Services Task Force reaffirmation recommendation statement. JAMA. 2021;325:1650-1656. doi: 10.1001/jama.2021.4987

Case

A 65-year-old woman presents to the emergency department with a chief complaint of shortness of breath for 3 days. Medical history is notable for moderate chronic obstructive pulmonary disorder, systolic heart failure with last known ejection fraction (EF) of 35% and type 2 diabetes complicated by hyperglycemia when on steroids. You are talking the case over with colleagues and they suggest point-of-care ultrasound (POCUS) would be useful in her case.
 

Brief overview of the issue

Once mainly used by ED and critical care physicians, POCUS is now a tool that many hospitalists are using at the bedside. POCUS differs from traditional comprehensive ultrasounds in the following ways: POCUS is designed to answer a specific clinical question (as opposed to evaluating all organs in a specific region), POCUS exams are performed by the clinician who is formulating the clinical question (as opposed to by a consultative service such as cardiology and radiology), and POCUS can evaluate multiple organ systems (such as by evaluating a patient’s heart, lungs, and inferior vena cava to determine the etiology of hypoxia).

Hospitalist use of POCUS may include guiding procedures, aiding in diagnosis, and assessing effectiveness of treatment. Many high-quality studies have been published that support the use of POCUS and have proven that POCUS can decrease medical errors, help reach diagnoses in a more expedited fashion, and complement or replace more advanced imaging.

A challenge of POCUS is that it is user dependent and there are no established standards for hospitalists in POCUS training. As the Society of Hospital Medicine position statement on POCUS points out, there is a significant difference between skill levels required to obtain a certificate of completion for POCUS training and a certificate of competency in POCUS. Therefore, it is recommended hospitalists work with local credentialing committees to delineate the requirements for POCUS use.
 

Overview of the data

POCUS for initial assessment and diagnosis of heart failure (HF)

Use of POCUS in cases of suspected HF includes examination of the heart, lungs, and inferior vena cava (IVC). Cardiac ultrasound provides an estimated ejection fraction. Lung ultrasound (LUS) functions to examine for B lines and pleural effusions. The presence of more than three B lines per thoracic zone bilaterally suggests cardiogenic pulmonary edema. Scanning the IVC provides a noninvasive way to assess volume status and is especially helpful when body habitus prevents accurate assessment of jugular venous pressure.

Several studies have addressed the utility of bedside ultrasound in the initial assessment or diagnosis of acute decompensated heart failure (ADHF) in patients presenting with dyspnea in emergency or inpatient settings. Positive B lines are a useful finding, with high sensitivities, high specificities, and positive likelihood ratios. One large multicenter prospective study found LUS to have a sensitivity of 90.5%, specificity of 93.5%, and positive and negative LRs of 14.0 and 0.10, respectively.¹ Another large multicenter prospective cohort study showed that LUS was more sensitive and more specific than chest x-ray (CXR) and brain natriuretic peptide in detecting ADHF.² Additional POCUS findings that have shown relatively high sensitivities and specificities in the initial diagnosis of ADHF include pleural effusion, reduced left ventricular ejection fraction (LVEF), increased left ventricular end-diastolic dimension, and jugular venous distention.

Data also exists on assessments of ADHF using combinations of POCUS findings; for example, lung and cardiac ultrasound (LuCUS) protocols include an evaluation for B lines, assessment of IVC size and collapsibility, and determination of LVEF, although this has mainly been examined in ED patients. For patients who presented to the ED with undifferentiated dyspnea, one such study showed a specificity of 100% when a LuCUS protocol was used to diagnose ADHF while another study showed that the use of a LuCUS protocol changed management in 47% of patients.^3,4 Of note, although each LuCUS protocol integrated the use of lung findings, IVC collapsibility, and LVEF, the exact protocols varied by institution. Finally, it has been established in multiple studies that LUS used in addition to standard workup including history and physical, labs, and electrocardiogram has been shown to increase diagnostic accuracy.^2,5
 

Using POCUS to guide diuretic therapy in HF

To date, there have been multiple small studies published on the utility of daily POCUS in hospitalized patients with ADHF to help assess response to treatment and guide diuresis by looking for reduction in B lines on LUS or a change in IVC size or collapsibility. Volpicelli and colleagues showed that daily LUS was at least as good as daily CXR in monitoring response to therapy.⁶ Similarly, Mozzini and colleagues performed a randomized controlled trial of 120 patients admitted for ADHF who were randomized to a CXR group (who had a CXR performed on admission and discharge) and a LUS group (which was performed at admission, 24 hours, 48 hours, 72 hours, and discharge).⁷ This study found that the LUS group underwent a significantly higher number of diuretic dose adjustments as compared with the CXR group (P < .001) and had a modest improvement in LOS, compared with the CXR group. Specifically, median LOS was 8 days in CXR group (range, 4-17 days) and 7 days in the LUS group (range, 3-10 days; P < .001).

The impact of POCUS on length of stay (LOS) and readmissions

There is increasing data that POCUS can have meaningful impacts on patient-centered outcomes (morbidity, mortality, and readmission) while exposing patients to minimal discomfort, no venipuncture, and no radiation exposure. First, multiple studies looked at whether performing focused cardiac US of the IVC as a marker of volume status could predict readmission in patients hospitalized for ADHF.^8,9 Both of these trials showed that plethoric, noncollapsible IVC at discharge were statistically significant predictors of readmission. In fact, Goonewardena and colleagues demonstrated that patients who required readmission had an enlarged IVC at discharge nearly 3 times more frequently (21% vs. 61%, P < .001) and abnormal IVC collapsibility 1.5 times more frequently (41% vs. 71%, P = .01) as compared with patients who remained out of the hospital.⁹

Similarly, a subsequent trial looked at whether IVC size on admission was of prognostic importance in patients hospitalized for ADHF and showed that admission IVC diameter was an independent predictor of both 90-day mortality (hazard ratio, 5.88; 95% confidence interval, 1.21-28.10; P = .025) and 90-day readmission (HR, 3.20; 95% CI, 1.24-8.21; P = .016).¹⁰ Additionally, LUS heart failure assessment for pulmonary congestion by counting B lines also showed that having more than 15 B lines prior to discharge was an independent predictor of readmission for ADHF at 6 months (HR, 11.74; 95% CI, 1.30-106.16).¹¹

A challenge of POCUS: Obtaining competency

As previously noted, there are not yet any established standards for training and assessing hospitalists in POCUS. The SHM Position Statement on POCUS recommends the following criteria for training⁵: the training environment should be similar to the location in which the trainee will practice, training and feedback should occur in real time, the trainee should be taught specific applications of POCUS (such as cardiac US, LUS, and IVC US) as each application comes with unique skills and knowledge, clinical competence must be achieved and demonstrated, and continued education and feedback are necessary once competence is obtained.¹² SHM recommends residency-based training pathways, training through a local or national program such as the SHM POCUS certificate program, or training through other medical societies for hospitalists already in practice.

Application of the data to our original case

Targeted POCUS using the LuCUS protocol is performed and reveals three B lines in two lung zones bilaterally, moderate bilateral pleural effusions, EF 20%, and a noncollapsible IVC leading to a diagnosis of ADHF. Her ADHF is treated with intravenous diuresis. She is continued on her chronic maintenance chronic obstructive pulmonary disorder regimen but does not receive steroids, avoiding hyperglycemia that has complicated prior admissions. Over the next few days her respiratory and cardiac status is monitored using POCUS to assess her response to therapy and titrate her diuretics to her true dry weight, which was several pounds lower than her previously assumed dry weight. At discharge she is instructed to use the new dry weight which may avoid readmissions for HF.

Bottom line

POCUS improves diagnostic accuracy and facilitates volume assessment and management in acute decompensated heart failure.

Dr. Farber is a medical instructor at Duke University and hospitalist at Duke Regional Hospital, both in Durham, N.C. Dr. Marcantonio is a medical instructor in the department of internal medicine and department of pediatrics at Duke University and hospitalist at Duke University Hospital and Duke Regional Hospital. Dr. Stafford and Dr. Brooks are assistant professors of medicine and hospitalists at Duke Regional Hospital. Dr. Wachter is associate medical director at Duke Regional Hospital and assistant professor at Duke University. Dr. Menon is a hospitalist at Duke University. Dr. Sharma is associate medical director for clinical education at Duke Regional Hospital and associate professor of medicine at Duke University.

References

1. Pivetta E et al. Lung ultrasound integrated with clinical assessment for the diagnosis of acute decompensated heart failure in the emergency department: A randomized controlled trial. Eur J Heart Fail. 2019 Jun;21(6):754-66. doi: 10.1002/ejhf.1379.

2. Pivetta E et al. Lung ultrasound-implemented diagnosis of acute decompensated heart failure in the ED: A SIMEU multicenter study. Chest. 2015;148(1):202-10. doi: 10.1378/chest.14-2608.

3. Anderson KL et al. Diagnosing heart failure among acutely dyspneic patients with cardiac, inferior vena cava, and lung ultrasonography. Am J Emerg Med. 2013;31:1208-14. doi: 10.1016/j.ajem.2013.05.007.

4. Russell FM et al. Diagnosing acute heart failure in patients with undifferentiated dyspnea: A lung and cardiac ultrasound (LuCUS) protocol. Acad Emerg Med. 2015;22(2):182-91. doi:10.1111/acem.12570.

5. Maw AM et al. Diagnostic accuracy of point-of-care lung ultrasonography and chest radiography in adults with symptoms suggestive of acute decompensated heart failure: A systematic review and meta-analysis. JAMA Netw Open. 2019 Mar 1;2(3):e190703. doi:10.1001/jamanetworkopen.2019.0703.

6. Volpicelli G et al. Bedside ultrasound of the lung for the monitoring of acute decompensated heart failure. Am J Emerg Med. 2008 Jun;26(5):585-91. doi:10.1016/j.ajem.2007.09.014.

7. Mozzini C et al. Lung ultrasound in internal medicine efficiently drives the management of patients with heart failure and speeds up the discharge time. Intern Emerg Med. 2018 Jan;13(1):27-33. doi: 10.1007/s11739-017-1738-1.

8. Laffin LJ et al. Focused cardiac ultrasound as a predictor of readmission in acute decompensated heart failure. Int J Cardiovasc Imaging. 2018;34(7):1075-9. doi:10.1007/s10554-018-1317-1.

9. Goonewardena SN et al. Comparison of hand-carried ultrasound assessment of the inferior vena cava and N-terminal pro-brain natriuretic peptide for predicting readmission after hospitalization for acute decompensated heart failure. JACC Cardiovasc Imaging. 2008;1(5):595-601. doi:10.1016/j.jcmg.2008.06.005.

10. Cubo-Romano P et al. Admission inferior vena cava measurements are associated with mortality after hospitalization for acute decompensated heart failure. J Hosp Med. 2016 Nov;11(11):778-84. doi: 10.1002/jhm.2620.

11. Gargani L et al. Persistent pulmonary congestion before discharge predicts rehospitalization in heart failure: A lung ultrasound study. Cardiovasc Ultrasound. 2015 Sep 4;13:40. doi: 10.1186/s12947-015-0033-4.

12. Soni NJ et al. Point-of-care ultrasound for hospitalists: A Position Statement of the Society of Hospital Medicine. J Hosp Med. 2019 Jan 2;14:E1-6. doi: 10.12788/jhm.3079.

Key points

• Studies have found POCUS improves the diagnosis of acute decompensated heart failure in patients presenting with dyspnea.
• Daily evaluation with POCUS has decreased length of stay in acute decompensated heart failure.
• Credentialing requirements for hospitalists to use POCUS for clinical care vary by hospital.

Additional reading

Maw AM and Soni NJ. Annals for hospitalists inpatient notes – why should hospitalists use point-of-care ultrasound? Ann Intern Med. 2018 Apr 17;168(8):HO2-HO3. doi: 10.7326/M18-0367.

Lewiss RE. “The ultrasound looked fine”: Point of care ultrasound and patient safety. AHRQ’s Patient Safety Network. WebM&M: Case Studies. 2018 Jul 1. https://psnet.ahrq.gov/web-mm/ultrasound-looked-fine-point-care-ultrasound-and-patient-safety.

Quiz: Testing your POCUS knowledge

POCUS is increasingly prevalent in hospital medicine, but use varies among different disease processes. Which organ system ultrasound or lab test would be most helpful in the following scenario?

An acutely dyspneic patient with no past medical history presents to the ED. Chest x-ray is equivocal. Of the following, which study best confirms a diagnosis of acute decompensated heart failure?

A. Brain natriuretic peptide

B. Point-of-care cardiac ultrasound

C. Point-of-care lung ultrasound

D. Point-of-care inferior vena cava ultrasound

Answer

C. Point-of-care lung ultrasound

Multiple studies, including three systematic reviews, have shown that point-of-care lung ultrasound has high sensitivity and specificity to evaluate for B lines as a marker for cardiogenic pulmonary edema. Point-of-care ultrasound of ejection fraction and inferior vena cava have not been evaluated by systematic review although one randomized, controlled trial showed that an EF less than 45% had 74% specificity and 77% sensitivity and IVC collapsibility index less than 20% had an 86% specificity and 52% sensitivity for detection of acute decompensated heart failure. This same study showed that the combination of cardiac, lung, and IVC point-of-care ultrasound had 100% specificity for diagnosing acute decompensated heart failure. In the future, health care providers could rely on this multiorgan evaluation with point-of-care ultrasound to confirm a diagnosis of acute decompensated heart failure in a dyspneic patient.

Case

A 65-year-old woman presents to the emergency department with a chief complaint of shortness of breath for 3 days. Medical history is notable for moderate chronic obstructive pulmonary disorder, systolic heart failure with last known ejection fraction (EF) of 35% and type 2 diabetes complicated by hyperglycemia when on steroids. You are talking the case over with colleagues and they suggest point-of-care ultrasound (POCUS) would be useful in her case.
 

Brief overview of the issue

Once mainly used by ED and critical care physicians, POCUS is now a tool that many hospitalists are using at the bedside. POCUS differs from traditional comprehensive ultrasounds in the following ways: POCUS is designed to answer a specific clinical question (as opposed to evaluating all organs in a specific region), POCUS exams are performed by the clinician who is formulating the clinical question (as opposed to by a consultative service such as cardiology and radiology), and POCUS can evaluate multiple organ systems (such as by evaluating a patient’s heart, lungs, and inferior vena cava to determine the etiology of hypoxia).

Hospitalist use of POCUS may include guiding procedures, aiding in diagnosis, and assessing effectiveness of treatment. Many high-quality studies have been published that support the use of POCUS and have proven that POCUS can decrease medical errors, help reach diagnoses in a more expedited fashion, and complement or replace more advanced imaging.

A challenge of POCUS is that it is user dependent and there are no established standards for hospitalists in POCUS training. As the Society of Hospital Medicine position statement on POCUS points out, there is a significant difference between skill levels required to obtain a certificate of completion for POCUS training and a certificate of competency in POCUS. Therefore, it is recommended hospitalists work with local credentialing committees to delineate the requirements for POCUS use.
 

Overview of the data

POCUS for initial assessment and diagnosis of heart failure (HF)

Use of POCUS in cases of suspected HF includes examination of the heart, lungs, and inferior vena cava (IVC). Cardiac ultrasound provides an estimated ejection fraction. Lung ultrasound (LUS) functions to examine for B lines and pleural effusions. The presence of more than three B lines per thoracic zone bilaterally suggests cardiogenic pulmonary edema. Scanning the IVC provides a noninvasive way to assess volume status and is especially helpful when body habitus prevents accurate assessment of jugular venous pressure.

Several studies have addressed the utility of bedside ultrasound in the initial assessment or diagnosis of acute decompensated heart failure (ADHF) in patients presenting with dyspnea in emergency or inpatient settings. Positive B lines are a useful finding, with high sensitivities, high specificities, and positive likelihood ratios. One large multicenter prospective study found LUS to have a sensitivity of 90.5%, specificity of 93.5%, and positive and negative LRs of 14.0 and 0.10, respectively.¹ Another large multicenter prospective cohort study showed that LUS was more sensitive and more specific than chest x-ray (CXR) and brain natriuretic peptide in detecting ADHF.² Additional POCUS findings that have shown relatively high sensitivities and specificities in the initial diagnosis of ADHF include pleural effusion, reduced left ventricular ejection fraction (LVEF), increased left ventricular end-diastolic dimension, and jugular venous distention.

Data also exists on assessments of ADHF using combinations of POCUS findings; for example, lung and cardiac ultrasound (LuCUS) protocols include an evaluation for B lines, assessment of IVC size and collapsibility, and determination of LVEF, although this has mainly been examined in ED patients. For patients who presented to the ED with undifferentiated dyspnea, one such study showed a specificity of 100% when a LuCUS protocol was used to diagnose ADHF while another study showed that the use of a LuCUS protocol changed management in 47% of patients.^3,4 Of note, although each LuCUS protocol integrated the use of lung findings, IVC collapsibility, and LVEF, the exact protocols varied by institution. Finally, it has been established in multiple studies that LUS used in addition to standard workup including history and physical, labs, and electrocardiogram has been shown to increase diagnostic accuracy.^2,5
 

Using POCUS to guide diuretic therapy in HF

To date, there have been multiple small studies published on the utility of daily POCUS in hospitalized patients with ADHF to help assess response to treatment and guide diuresis by looking for reduction in B lines on LUS or a change in IVC size or collapsibility. Volpicelli and colleagues showed that daily LUS was at least as good as daily CXR in monitoring response to therapy.⁶ Similarly, Mozzini and colleagues performed a randomized controlled trial of 120 patients admitted for ADHF who were randomized to a CXR group (who had a CXR performed on admission and discharge) and a LUS group (which was performed at admission, 24 hours, 48 hours, 72 hours, and discharge).⁷ This study found that the LUS group underwent a significantly higher number of diuretic dose adjustments as compared with the CXR group (P < .001) and had a modest improvement in LOS, compared with the CXR group. Specifically, median LOS was 8 days in CXR group (range, 4-17 days) and 7 days in the LUS group (range, 3-10 days; P < .001).

The impact of POCUS on length of stay (LOS) and readmissions

There is increasing data that POCUS can have meaningful impacts on patient-centered outcomes (morbidity, mortality, and readmission) while exposing patients to minimal discomfort, no venipuncture, and no radiation exposure. First, multiple studies looked at whether performing focused cardiac US of the IVC as a marker of volume status could predict readmission in patients hospitalized for ADHF.^8,9 Both of these trials showed that plethoric, noncollapsible IVC at discharge were statistically significant predictors of readmission. In fact, Goonewardena and colleagues demonstrated that patients who required readmission had an enlarged IVC at discharge nearly 3 times more frequently (21% vs. 61%, P < .001) and abnormal IVC collapsibility 1.5 times more frequently (41% vs. 71%, P = .01) as compared with patients who remained out of the hospital.⁹

Similarly, a subsequent trial looked at whether IVC size on admission was of prognostic importance in patients hospitalized for ADHF and showed that admission IVC diameter was an independent predictor of both 90-day mortality (hazard ratio, 5.88; 95% confidence interval, 1.21-28.10; P = .025) and 90-day readmission (HR, 3.20; 95% CI, 1.24-8.21; P = .016).¹⁰ Additionally, LUS heart failure assessment for pulmonary congestion by counting B lines also showed that having more than 15 B lines prior to discharge was an independent predictor of readmission for ADHF at 6 months (HR, 11.74; 95% CI, 1.30-106.16).¹¹

A challenge of POCUS: Obtaining competency

As previously noted, there are not yet any established standards for training and assessing hospitalists in POCUS. The SHM Position Statement on POCUS recommends the following criteria for training⁵: the training environment should be similar to the location in which the trainee will practice, training and feedback should occur in real time, the trainee should be taught specific applications of POCUS (such as cardiac US, LUS, and IVC US) as each application comes with unique skills and knowledge, clinical competence must be achieved and demonstrated, and continued education and feedback are necessary once competence is obtained.¹² SHM recommends residency-based training pathways, training through a local or national program such as the SHM POCUS certificate program, or training through other medical societies for hospitalists already in practice.

Application of the data to our original case

Targeted POCUS using the LuCUS protocol is performed and reveals three B lines in two lung zones bilaterally, moderate bilateral pleural effusions, EF 20%, and a noncollapsible IVC leading to a diagnosis of ADHF. Her ADHF is treated with intravenous diuresis. She is continued on her chronic maintenance chronic obstructive pulmonary disorder regimen but does not receive steroids, avoiding hyperglycemia that has complicated prior admissions. Over the next few days her respiratory and cardiac status is monitored using POCUS to assess her response to therapy and titrate her diuretics to her true dry weight, which was several pounds lower than her previously assumed dry weight. At discharge she is instructed to use the new dry weight which may avoid readmissions for HF.

Bottom line

POCUS improves diagnostic accuracy and facilitates volume assessment and management in acute decompensated heart failure.

Dr. Farber is a medical instructor at Duke University and hospitalist at Duke Regional Hospital, both in Durham, N.C. Dr. Marcantonio is a medical instructor in the department of internal medicine and department of pediatrics at Duke University and hospitalist at Duke University Hospital and Duke Regional Hospital. Dr. Stafford and Dr. Brooks are assistant professors of medicine and hospitalists at Duke Regional Hospital. Dr. Wachter is associate medical director at Duke Regional Hospital and assistant professor at Duke University. Dr. Menon is a hospitalist at Duke University. Dr. Sharma is associate medical director for clinical education at Duke Regional Hospital and associate professor of medicine at Duke University.

References

1. Pivetta E et al. Lung ultrasound integrated with clinical assessment for the diagnosis of acute decompensated heart failure in the emergency department: A randomized controlled trial. Eur J Heart Fail. 2019 Jun;21(6):754-66. doi: 10.1002/ejhf.1379.

2. Pivetta E et al. Lung ultrasound-implemented diagnosis of acute decompensated heart failure in the ED: A SIMEU multicenter study. Chest. 2015;148(1):202-10. doi: 10.1378/chest.14-2608.

3. Anderson KL et al. Diagnosing heart failure among acutely dyspneic patients with cardiac, inferior vena cava, and lung ultrasonography. Am J Emerg Med. 2013;31:1208-14. doi: 10.1016/j.ajem.2013.05.007.

4. Russell FM et al. Diagnosing acute heart failure in patients with undifferentiated dyspnea: A lung and cardiac ultrasound (LuCUS) protocol. Acad Emerg Med. 2015;22(2):182-91. doi:10.1111/acem.12570.

5. Maw AM et al. Diagnostic accuracy of point-of-care lung ultrasonography and chest radiography in adults with symptoms suggestive of acute decompensated heart failure: A systematic review and meta-analysis. JAMA Netw Open. 2019 Mar 1;2(3):e190703. doi:10.1001/jamanetworkopen.2019.0703.

6. Volpicelli G et al. Bedside ultrasound of the lung for the monitoring of acute decompensated heart failure. Am J Emerg Med. 2008 Jun;26(5):585-91. doi:10.1016/j.ajem.2007.09.014.

7. Mozzini C et al. Lung ultrasound in internal medicine efficiently drives the management of patients with heart failure and speeds up the discharge time. Intern Emerg Med. 2018 Jan;13(1):27-33. doi: 10.1007/s11739-017-1738-1.

8. Laffin LJ et al. Focused cardiac ultrasound as a predictor of readmission in acute decompensated heart failure. Int J Cardiovasc Imaging. 2018;34(7):1075-9. doi:10.1007/s10554-018-1317-1.

9. Goonewardena SN et al. Comparison of hand-carried ultrasound assessment of the inferior vena cava and N-terminal pro-brain natriuretic peptide for predicting readmission after hospitalization for acute decompensated heart failure. JACC Cardiovasc Imaging. 2008;1(5):595-601. doi:10.1016/j.jcmg.2008.06.005.

10. Cubo-Romano P et al. Admission inferior vena cava measurements are associated with mortality after hospitalization for acute decompensated heart failure. J Hosp Med. 2016 Nov;11(11):778-84. doi: 10.1002/jhm.2620.

11. Gargani L et al. Persistent pulmonary congestion before discharge predicts rehospitalization in heart failure: A lung ultrasound study. Cardiovasc Ultrasound. 2015 Sep 4;13:40. doi: 10.1186/s12947-015-0033-4.

12. Soni NJ et al. Point-of-care ultrasound for hospitalists: A Position Statement of the Society of Hospital Medicine. J Hosp Med. 2019 Jan 2;14:E1-6. doi: 10.12788/jhm.3079.

Key points

• Studies have found POCUS improves the diagnosis of acute decompensated heart failure in patients presenting with dyspnea.
• Daily evaluation with POCUS has decreased length of stay in acute decompensated heart failure.
• Credentialing requirements for hospitalists to use POCUS for clinical care vary by hospital.

Additional reading

Maw AM and Soni NJ. Annals for hospitalists inpatient notes – why should hospitalists use point-of-care ultrasound? Ann Intern Med. 2018 Apr 17;168(8):HO2-HO3. doi: 10.7326/M18-0367.

Lewiss RE. “The ultrasound looked fine”: Point of care ultrasound and patient safety. AHRQ’s Patient Safety Network. WebM&M: Case Studies. 2018 Jul 1. https://psnet.ahrq.gov/web-mm/ultrasound-looked-fine-point-care-ultrasound-and-patient-safety.

Quiz: Testing your POCUS knowledge

POCUS is increasingly prevalent in hospital medicine, but use varies among different disease processes. Which organ system ultrasound or lab test would be most helpful in the following scenario?

An acutely dyspneic patient with no past medical history presents to the ED. Chest x-ray is equivocal. Of the following, which study best confirms a diagnosis of acute decompensated heart failure?

A. Brain natriuretic peptide

B. Point-of-care cardiac ultrasound

C. Point-of-care lung ultrasound

D. Point-of-care inferior vena cava ultrasound

Answer

C. Point-of-care lung ultrasound

Multiple studies, including three systematic reviews, have shown that point-of-care lung ultrasound has high sensitivity and specificity to evaluate for B lines as a marker for cardiogenic pulmonary edema. Point-of-care ultrasound of ejection fraction and inferior vena cava have not been evaluated by systematic review although one randomized, controlled trial showed that an EF less than 45% had 74% specificity and 77% sensitivity and IVC collapsibility index less than 20% had an 86% specificity and 52% sensitivity for detection of acute decompensated heart failure. This same study showed that the combination of cardiac, lung, and IVC point-of-care ultrasound had 100% specificity for diagnosing acute decompensated heart failure. In the future, health care providers could rely on this multiorgan evaluation with point-of-care ultrasound to confirm a diagnosis of acute decompensated heart failure in a dyspneic patient.

Case

A 65-year-old woman presents to the emergency department with a chief complaint of shortness of breath for 3 days. Medical history is notable for moderate chronic obstructive pulmonary disorder, systolic heart failure with last known ejection fraction (EF) of 35% and type 2 diabetes complicated by hyperglycemia when on steroids. You are talking the case over with colleagues and they suggest point-of-care ultrasound (POCUS) would be useful in her case.
 

Brief overview of the issue

Once mainly used by ED and critical care physicians, POCUS is now a tool that many hospitalists are using at the bedside. POCUS differs from traditional comprehensive ultrasounds in the following ways: POCUS is designed to answer a specific clinical question (as opposed to evaluating all organs in a specific region), POCUS exams are performed by the clinician who is formulating the clinical question (as opposed to by a consultative service such as cardiology and radiology), and POCUS can evaluate multiple organ systems (such as by evaluating a patient’s heart, lungs, and inferior vena cava to determine the etiology of hypoxia).

Hospitalist use of POCUS may include guiding procedures, aiding in diagnosis, and assessing effectiveness of treatment. Many high-quality studies have been published that support the use of POCUS and have proven that POCUS can decrease medical errors, help reach diagnoses in a more expedited fashion, and complement or replace more advanced imaging.

A challenge of POCUS is that it is user dependent and there are no established standards for hospitalists in POCUS training. As the Society of Hospital Medicine position statement on POCUS points out, there is a significant difference between skill levels required to obtain a certificate of completion for POCUS training and a certificate of competency in POCUS. Therefore, it is recommended hospitalists work with local credentialing committees to delineate the requirements for POCUS use.
 

Overview of the data

POCUS for initial assessment and diagnosis of heart failure (HF)

Use of POCUS in cases of suspected HF includes examination of the heart, lungs, and inferior vena cava (IVC). Cardiac ultrasound provides an estimated ejection fraction. Lung ultrasound (LUS) functions to examine for B lines and pleural effusions. The presence of more than three B lines per thoracic zone bilaterally suggests cardiogenic pulmonary edema. Scanning the IVC provides a noninvasive way to assess volume status and is especially helpful when body habitus prevents accurate assessment of jugular venous pressure.

Several studies have addressed the utility of bedside ultrasound in the initial assessment or diagnosis of acute decompensated heart failure (ADHF) in patients presenting with dyspnea in emergency or inpatient settings. Positive B lines are a useful finding, with high sensitivities, high specificities, and positive likelihood ratios. One large multicenter prospective study found LUS to have a sensitivity of 90.5%, specificity of 93.5%, and positive and negative LRs of 14.0 and 0.10, respectively.¹ Another large multicenter prospective cohort study showed that LUS was more sensitive and more specific than chest x-ray (CXR) and brain natriuretic peptide in detecting ADHF.² Additional POCUS findings that have shown relatively high sensitivities and specificities in the initial diagnosis of ADHF include pleural effusion, reduced left ventricular ejection fraction (LVEF), increased left ventricular end-diastolic dimension, and jugular venous distention.

Data also exists on assessments of ADHF using combinations of POCUS findings; for example, lung and cardiac ultrasound (LuCUS) protocols include an evaluation for B lines, assessment of IVC size and collapsibility, and determination of LVEF, although this has mainly been examined in ED patients. For patients who presented to the ED with undifferentiated dyspnea, one such study showed a specificity of 100% when a LuCUS protocol was used to diagnose ADHF while another study showed that the use of a LuCUS protocol changed management in 47% of patients.^3,4 Of note, although each LuCUS protocol integrated the use of lung findings, IVC collapsibility, and LVEF, the exact protocols varied by institution. Finally, it has been established in multiple studies that LUS used in addition to standard workup including history and physical, labs, and electrocardiogram has been shown to increase diagnostic accuracy.^2,5
 

Using POCUS to guide diuretic therapy in HF

To date, there have been multiple small studies published on the utility of daily POCUS in hospitalized patients with ADHF to help assess response to treatment and guide diuresis by looking for reduction in B lines on LUS or a change in IVC size or collapsibility. Volpicelli and colleagues showed that daily LUS was at least as good as daily CXR in monitoring response to therapy.⁶ Similarly, Mozzini and colleagues performed a randomized controlled trial of 120 patients admitted for ADHF who were randomized to a CXR group (who had a CXR performed on admission and discharge) and a LUS group (which was performed at admission, 24 hours, 48 hours, 72 hours, and discharge).⁷ This study found that the LUS group underwent a significantly higher number of diuretic dose adjustments as compared with the CXR group (P < .001) and had a modest improvement in LOS, compared with the CXR group. Specifically, median LOS was 8 days in CXR group (range, 4-17 days) and 7 days in the LUS group (range, 3-10 days; P < .001).

The impact of POCUS on length of stay (LOS) and readmissions

There is increasing data that POCUS can have meaningful impacts on patient-centered outcomes (morbidity, mortality, and readmission) while exposing patients to minimal discomfort, no venipuncture, and no radiation exposure. First, multiple studies looked at whether performing focused cardiac US of the IVC as a marker of volume status could predict readmission in patients hospitalized for ADHF.^8,9 Both of these trials showed that plethoric, noncollapsible IVC at discharge were statistically significant predictors of readmission. In fact, Goonewardena and colleagues demonstrated that patients who required readmission had an enlarged IVC at discharge nearly 3 times more frequently (21% vs. 61%, P < .001) and abnormal IVC collapsibility 1.5 times more frequently (41% vs. 71%, P = .01) as compared with patients who remained out of the hospital.⁹

Similarly, a subsequent trial looked at whether IVC size on admission was of prognostic importance in patients hospitalized for ADHF and showed that admission IVC diameter was an independent predictor of both 90-day mortality (hazard ratio, 5.88; 95% confidence interval, 1.21-28.10; P = .025) and 90-day readmission (HR, 3.20; 95% CI, 1.24-8.21; P = .016).¹⁰ Additionally, LUS heart failure assessment for pulmonary congestion by counting B lines also showed that having more than 15 B lines prior to discharge was an independent predictor of readmission for ADHF at 6 months (HR, 11.74; 95% CI, 1.30-106.16).¹¹

A challenge of POCUS: Obtaining competency

As previously noted, there are not yet any established standards for training and assessing hospitalists in POCUS. The SHM Position Statement on POCUS recommends the following criteria for training⁵: the training environment should be similar to the location in which the trainee will practice, training and feedback should occur in real time, the trainee should be taught specific applications of POCUS (such as cardiac US, LUS, and IVC US) as each application comes with unique skills and knowledge, clinical competence must be achieved and demonstrated, and continued education and feedback are necessary once competence is obtained.¹² SHM recommends residency-based training pathways, training through a local or national program such as the SHM POCUS certificate program, or training through other medical societies for hospitalists already in practice.

Application of the data to our original case

Targeted POCUS using the LuCUS protocol is performed and reveals three B lines in two lung zones bilaterally, moderate bilateral pleural effusions, EF 20%, and a noncollapsible IVC leading to a diagnosis of ADHF. Her ADHF is treated with intravenous diuresis. She is continued on her chronic maintenance chronic obstructive pulmonary disorder regimen but does not receive steroids, avoiding hyperglycemia that has complicated prior admissions. Over the next few days her respiratory and cardiac status is monitored using POCUS to assess her response to therapy and titrate her diuretics to her true dry weight, which was several pounds lower than her previously assumed dry weight. At discharge she is instructed to use the new dry weight which may avoid readmissions for HF.

Bottom line

POCUS improves diagnostic accuracy and facilitates volume assessment and management in acute decompensated heart failure.

Dr. Farber is a medical instructor at Duke University and hospitalist at Duke Regional Hospital, both in Durham, N.C. Dr. Marcantonio is a medical instructor in the department of internal medicine and department of pediatrics at Duke University and hospitalist at Duke University Hospital and Duke Regional Hospital. Dr. Stafford and Dr. Brooks are assistant professors of medicine and hospitalists at Duke Regional Hospital. Dr. Wachter is associate medical director at Duke Regional Hospital and assistant professor at Duke University. Dr. Menon is a hospitalist at Duke University. Dr. Sharma is associate medical director for clinical education at Duke Regional Hospital and associate professor of medicine at Duke University.

References

1. Pivetta E et al. Lung ultrasound integrated with clinical assessment for the diagnosis of acute decompensated heart failure in the emergency department: A randomized controlled trial. Eur J Heart Fail. 2019 Jun;21(6):754-66. doi: 10.1002/ejhf.1379.

2. Pivetta E et al. Lung ultrasound-implemented diagnosis of acute decompensated heart failure in the ED: A SIMEU multicenter study. Chest. 2015;148(1):202-10. doi: 10.1378/chest.14-2608.

3. Anderson KL et al. Diagnosing heart failure among acutely dyspneic patients with cardiac, inferior vena cava, and lung ultrasonography. Am J Emerg Med. 2013;31:1208-14. doi: 10.1016/j.ajem.2013.05.007.

4. Russell FM et al. Diagnosing acute heart failure in patients with undifferentiated dyspnea: A lung and cardiac ultrasound (LuCUS) protocol. Acad Emerg Med. 2015;22(2):182-91. doi:10.1111/acem.12570.

5. Maw AM et al. Diagnostic accuracy of point-of-care lung ultrasonography and chest radiography in adults with symptoms suggestive of acute decompensated heart failure: A systematic review and meta-analysis. JAMA Netw Open. 2019 Mar 1;2(3):e190703. doi:10.1001/jamanetworkopen.2019.0703.

6. Volpicelli G et al. Bedside ultrasound of the lung for the monitoring of acute decompensated heart failure. Am J Emerg Med. 2008 Jun;26(5):585-91. doi:10.1016/j.ajem.2007.09.014.

7. Mozzini C et al. Lung ultrasound in internal medicine efficiently drives the management of patients with heart failure and speeds up the discharge time. Intern Emerg Med. 2018 Jan;13(1):27-33. doi: 10.1007/s11739-017-1738-1.

8. Laffin LJ et al. Focused cardiac ultrasound as a predictor of readmission in acute decompensated heart failure. Int J Cardiovasc Imaging. 2018;34(7):1075-9. doi:10.1007/s10554-018-1317-1.

9. Goonewardena SN et al. Comparison of hand-carried ultrasound assessment of the inferior vena cava and N-terminal pro-brain natriuretic peptide for predicting readmission after hospitalization for acute decompensated heart failure. JACC Cardiovasc Imaging. 2008;1(5):595-601. doi:10.1016/j.jcmg.2008.06.005.

10. Cubo-Romano P et al. Admission inferior vena cava measurements are associated with mortality after hospitalization for acute decompensated heart failure. J Hosp Med. 2016 Nov;11(11):778-84. doi: 10.1002/jhm.2620.

11. Gargani L et al. Persistent pulmonary congestion before discharge predicts rehospitalization in heart failure: A lung ultrasound study. Cardiovasc Ultrasound. 2015 Sep 4;13:40. doi: 10.1186/s12947-015-0033-4.

12. Soni NJ et al. Point-of-care ultrasound for hospitalists: A Position Statement of the Society of Hospital Medicine. J Hosp Med. 2019 Jan 2;14:E1-6. doi: 10.12788/jhm.3079.

Key points

• Studies have found POCUS improves the diagnosis of acute decompensated heart failure in patients presenting with dyspnea.
• Daily evaluation with POCUS has decreased length of stay in acute decompensated heart failure.
• Credentialing requirements for hospitalists to use POCUS for clinical care vary by hospital.

Additional reading

Maw AM and Soni NJ. Annals for hospitalists inpatient notes – why should hospitalists use point-of-care ultrasound? Ann Intern Med. 2018 Apr 17;168(8):HO2-HO3. doi: 10.7326/M18-0367.

Lewiss RE. “The ultrasound looked fine”: Point of care ultrasound and patient safety. AHRQ’s Patient Safety Network. WebM&M: Case Studies. 2018 Jul 1. https://psnet.ahrq.gov/web-mm/ultrasound-looked-fine-point-care-ultrasound-and-patient-safety.

Quiz: Testing your POCUS knowledge

POCUS is increasingly prevalent in hospital medicine, but use varies among different disease processes. Which organ system ultrasound or lab test would be most helpful in the following scenario?

An acutely dyspneic patient with no past medical history presents to the ED. Chest x-ray is equivocal. Of the following, which study best confirms a diagnosis of acute decompensated heart failure?

A. Brain natriuretic peptide

B. Point-of-care cardiac ultrasound

C. Point-of-care lung ultrasound

D. Point-of-care inferior vena cava ultrasound

Answer

C. Point-of-care lung ultrasound

Multiple studies, including three systematic reviews, have shown that point-of-care lung ultrasound has high sensitivity and specificity to evaluate for B lines as a marker for cardiogenic pulmonary edema. Point-of-care ultrasound of ejection fraction and inferior vena cava have not been evaluated by systematic review although one randomized, controlled trial showed that an EF less than 45% had 74% specificity and 77% sensitivity and IVC collapsibility index less than 20% had an 86% specificity and 52% sensitivity for detection of acute decompensated heart failure. This same study showed that the combination of cardiac, lung, and IVC point-of-care ultrasound had 100% specificity for diagnosing acute decompensated heart failure. In the future, health care providers could rely on this multiorgan evaluation with point-of-care ultrasound to confirm a diagnosis of acute decompensated heart failure in a dyspneic patient.

Women have more in-hospital complications than men and double the risk for major adverse events after left atrial appendage occlusion (LAAO) with the Watchman device, according to new National Cardiovascular Data Registry (NCDR) LAAO Registry data.

In-hospital mortality was also twofold higher among women than men and hospital stay was longer. Even after adjustment for potential confounders, these relationships still exist, Douglas Darden, MD, University of California, San Diego, and colleagues reported online in JAMA Cardiology.

“I think this article certainly highlights – specific to a procedure that has gained more popularity and will become more commonplace in cardiovascular practice – that operators and patients need to pay more attention [to the fact] that women may be at more risk for adverse events and mortality,” senior author Jonathan Hsu, MD, also from UCSD, told this news organization.

Possible explanations for the disparities include anatomic differences between the sexes, such as smaller vessel diameter, thinner myocardial wall, and a more friable LLA in women; increased frailty; and clinician inexperience, the authors suggest.

“It could be something as simple or as specific as thinness of tissue or friability of tissue that may predispose women more than men to perforation or other risks that may put them at risk for adverse events specifically,” Dr. Hsu said.

Commenting further, he said, “I think we would be remiss not to mention the fact that part of this association may unfortunately be a disparity in care that women as a specific sex may receive,” he said.

Indeed, postimplantation women had higher adjusted odds of receiving a direct oral anticoagulant only (odds ratio, 1.07, P = .02) and warfarin only (OR, 1.12; P < .001), and lower odds of receiving clinical trial-recommended combined oral anticoagulants plus single antiplatelet therapy (OR, 0.91; P < .001).

“This article highlights the fact that in all aspects we need to pay attention that women receive as high-level, guideline-driven care as men,” Dr. Hsu said.

First author Dr. Darden pointed out in an email that women suffer disproportionately from atrial fibrillation (AFib), compared with men, with worse quality of life and higher risk for stroke. So “it’s only natural to seek further treatment in order to decrease that risk, specifically LAAO with Watchman.”

Despite the fact that women are known to be at greater risk for adverse events after invasive procedures, including AFib ablation and TAVR, little is known about sex differences with LAAO, as the LAAO clinical trials only included about 30% women, he said.

Two 2021 papers zeroing in on these sex differences produced mixed results. An American report in roughly 9,200 patients reported a higher risk for major in-hospital events in women after receipt of Watchman implants, whereas a German report found similar safety and efficacy among 387 consecutive patients, regardless of sex.

The present study involved 20,388 women and 28,969 men implanted with the Watchman device between January 2016 and June 2019 in the NCDR registry, the largest LAAO registry with adjudicated events with participation mandated for Medicare coverage.

The women were older (mean age, 76.5 vs. 75.8 years), had a higher mean CHA2DS2-VASc score (5.3 vs. 4.5), and were more likely to have a high fall risk as an indication for LAAO (39.8% vs. 33.5%).

Furthermore, women were more likely than men to have paroxysmal atrial fibrillation and uncontrolled hypertension, but less likely to have congestive heart failure, diabetes, and coronary artery disease.

After multivariable adjustment, all but one of the primary outcomes was significantly worse in women versus men:

• Aborted or canceled procedure: 3.0% vs. 2.9% (OR, 1.01; P = .87)
• Any adverse event: 6.3% vs. 3.9% (OR, 1.63; P < .001)
• Major adverse event: 4.1% vs. 2.0% (OR, 2.06; P < .001)
• Hospital stay more than 1 day: 16.0% vs. 11.6% (OR, 1.46; P < .001)
• Death: 58/0.3% vs. 37/0.1% (OR, 2.01; P = .001).

The authors point out that device-related adverse events are lower than in the PROTECT-AF and PREVAIL clinical trials of the Watchman, with 0.8% of patients developing a pericardial effusion requiring drainage and 1.2% having major bleeding, down from highs of 4.8% and 3.5%, respectively, in PROTECT-AF.

Although promising overall, adverse events among women were driven by higher rates of both pericardial effusion requiring draining (1.2% vs. 0.5%; P < .001) and major bleeding (1.7% vs. 0.8%; P < .001).

Commenting for this news organization John Mandrola, MD, Baptist Health, Louisville, Kentucky, expressed concern that despite its increasing popularity, the rate of serious complications appears to be increasing for the preventive procedure. “That’s peculiar because you’d expect increased experience and device iterations to decrease complications. And the NCDR data surely undercounts the real rate of adverse events because it only includes in-hospital complications.”

Based on the current data, he observed that there’s a 3% chance for a major complication overall, with the typical female Watchman patient facing a 6% chance of any adverse event and 4% risk for a major adverse event during her hospital stay alone.

“The striking difference in complications in women is a super important observation because higher upfront risk has an even more negative effect on the harm-benefit calculus of this procedure,” Dr. Mandrola said.

“Some of the increased harm in women may have been due to the slightly higher rate of comorbid conditions, but that is real-life,” he said. “Registry data like this is extremely valuable because, unlike the carefully selected randomized trial, registries reflect what is actually being done in practice.”

Dr. Hsu agreed that the absolute numbers are concerning. Nevertheless, “it doesn’t necessarily sound an alarm that our adverse events are worse in contemporary practice or that adverse events continue to increase. But, in general, it just points to the fact that there is this inherent larger risk in women, compared with men, and that we need to, first, figure out why, and second, we need to figure out how to improve.”

Strategies to mitigate procedural risk included ultrasound-guided venous access, preprocedural imaging, improved proficiency with LAAO devices, and continued development of safer devices, they note.

Despite the more generalizable nature of registry data, “the results of this study should not result in differing sex-based thresholds for LAAO implant,” the authors conclude.

The study was supported by the American College of Cardiology Foundation’s NCDR. Dr. Hsu reports financial relationships with Medtronic, Boston Scientific, Abbott, Biotronik, Janssen Pharmaceutical, Bristol Myers Squibb, Pfizer, Biosense Webster, Altathera Pharmaceuticals, and Zoll Medical and holding equity interest in Acutus Medical and Vektor Medical outside the submitted work. Dr. Darden reports no relevant financial relationships. Dr. Mandrola is a regular contributor to Medscape Cardiology.

A version of this article first appeared on Medscape.com.

Women have more in-hospital complications than men and double the risk for major adverse events after left atrial appendage occlusion (LAAO) with the Watchman device, according to new National Cardiovascular Data Registry (NCDR) LAAO Registry data.

In-hospital mortality was also twofold higher among women than men and hospital stay was longer. Even after adjustment for potential confounders, these relationships still exist, Douglas Darden, MD, University of California, San Diego, and colleagues reported online in JAMA Cardiology.

“I think this article certainly highlights – specific to a procedure that has gained more popularity and will become more commonplace in cardiovascular practice – that operators and patients need to pay more attention [to the fact] that women may be at more risk for adverse events and mortality,” senior author Jonathan Hsu, MD, also from UCSD, told this news organization.

Possible explanations for the disparities include anatomic differences between the sexes, such as smaller vessel diameter, thinner myocardial wall, and a more friable LLA in women; increased frailty; and clinician inexperience, the authors suggest.

“It could be something as simple or as specific as thinness of tissue or friability of tissue that may predispose women more than men to perforation or other risks that may put them at risk for adverse events specifically,” Dr. Hsu said.

Commenting further, he said, “I think we would be remiss not to mention the fact that part of this association may unfortunately be a disparity in care that women as a specific sex may receive,” he said.

Indeed, postimplantation women had higher adjusted odds of receiving a direct oral anticoagulant only (odds ratio, 1.07, P = .02) and warfarin only (OR, 1.12; P < .001), and lower odds of receiving clinical trial-recommended combined oral anticoagulants plus single antiplatelet therapy (OR, 0.91; P < .001).

“This article highlights the fact that in all aspects we need to pay attention that women receive as high-level, guideline-driven care as men,” Dr. Hsu said.

First author Dr. Darden pointed out in an email that women suffer disproportionately from atrial fibrillation (AFib), compared with men, with worse quality of life and higher risk for stroke. So “it’s only natural to seek further treatment in order to decrease that risk, specifically LAAO with Watchman.”

Despite the fact that women are known to be at greater risk for adverse events after invasive procedures, including AFib ablation and TAVR, little is known about sex differences with LAAO, as the LAAO clinical trials only included about 30% women, he said.

Two 2021 papers zeroing in on these sex differences produced mixed results. An American report in roughly 9,200 patients reported a higher risk for major in-hospital events in women after receipt of Watchman implants, whereas a German report found similar safety and efficacy among 387 consecutive patients, regardless of sex.

The present study involved 20,388 women and 28,969 men implanted with the Watchman device between January 2016 and June 2019 in the NCDR registry, the largest LAAO registry with adjudicated events with participation mandated for Medicare coverage.

The women were older (mean age, 76.5 vs. 75.8 years), had a higher mean CHA2DS2-VASc score (5.3 vs. 4.5), and were more likely to have a high fall risk as an indication for LAAO (39.8% vs. 33.5%).

Furthermore, women were more likely than men to have paroxysmal atrial fibrillation and uncontrolled hypertension, but less likely to have congestive heart failure, diabetes, and coronary artery disease.

After multivariable adjustment, all but one of the primary outcomes was significantly worse in women versus men:

• Aborted or canceled procedure: 3.0% vs. 2.9% (OR, 1.01; P = .87)
• Any adverse event: 6.3% vs. 3.9% (OR, 1.63; P < .001)
• Major adverse event: 4.1% vs. 2.0% (OR, 2.06; P < .001)
• Hospital stay more than 1 day: 16.0% vs. 11.6% (OR, 1.46; P < .001)
• Death: 58/0.3% vs. 37/0.1% (OR, 2.01; P = .001).

The authors point out that device-related adverse events are lower than in the PROTECT-AF and PREVAIL clinical trials of the Watchman, with 0.8% of patients developing a pericardial effusion requiring drainage and 1.2% having major bleeding, down from highs of 4.8% and 3.5%, respectively, in PROTECT-AF.

Although promising overall, adverse events among women were driven by higher rates of both pericardial effusion requiring draining (1.2% vs. 0.5%; P < .001) and major bleeding (1.7% vs. 0.8%; P < .001).

Commenting for this news organization John Mandrola, MD, Baptist Health, Louisville, Kentucky, expressed concern that despite its increasing popularity, the rate of serious complications appears to be increasing for the preventive procedure. “That’s peculiar because you’d expect increased experience and device iterations to decrease complications. And the NCDR data surely undercounts the real rate of adverse events because it only includes in-hospital complications.”

Based on the current data, he observed that there’s a 3% chance for a major complication overall, with the typical female Watchman patient facing a 6% chance of any adverse event and 4% risk for a major adverse event during her hospital stay alone.

“The striking difference in complications in women is a super important observation because higher upfront risk has an even more negative effect on the harm-benefit calculus of this procedure,” Dr. Mandrola said.

“Some of the increased harm in women may have been due to the slightly higher rate of comorbid conditions, but that is real-life,” he said. “Registry data like this is extremely valuable because, unlike the carefully selected randomized trial, registries reflect what is actually being done in practice.”

Dr. Hsu agreed that the absolute numbers are concerning. Nevertheless, “it doesn’t necessarily sound an alarm that our adverse events are worse in contemporary practice or that adverse events continue to increase. But, in general, it just points to the fact that there is this inherent larger risk in women, compared with men, and that we need to, first, figure out why, and second, we need to figure out how to improve.”

Strategies to mitigate procedural risk included ultrasound-guided venous access, preprocedural imaging, improved proficiency with LAAO devices, and continued development of safer devices, they note.

Despite the more generalizable nature of registry data, “the results of this study should not result in differing sex-based thresholds for LAAO implant,” the authors conclude.

The study was supported by the American College of Cardiology Foundation’s NCDR. Dr. Hsu reports financial relationships with Medtronic, Boston Scientific, Abbott, Biotronik, Janssen Pharmaceutical, Bristol Myers Squibb, Pfizer, Biosense Webster, Altathera Pharmaceuticals, and Zoll Medical and holding equity interest in Acutus Medical and Vektor Medical outside the submitted work. Dr. Darden reports no relevant financial relationships. Dr. Mandrola is a regular contributor to Medscape Cardiology.

A version of this article first appeared on Medscape.com.

Women have more in-hospital complications than men and double the risk for major adverse events after left atrial appendage occlusion (LAAO) with the Watchman device, according to new National Cardiovascular Data Registry (NCDR) LAAO Registry data.

In-hospital mortality was also twofold higher among women than men and hospital stay was longer. Even after adjustment for potential confounders, these relationships still exist, Douglas Darden, MD, University of California, San Diego, and colleagues reported online in JAMA Cardiology.

“I think this article certainly highlights – specific to a procedure that has gained more popularity and will become more commonplace in cardiovascular practice – that operators and patients need to pay more attention [to the fact] that women may be at more risk for adverse events and mortality,” senior author Jonathan Hsu, MD, also from UCSD, told this news organization.

Possible explanations for the disparities include anatomic differences between the sexes, such as smaller vessel diameter, thinner myocardial wall, and a more friable LLA in women; increased frailty; and clinician inexperience, the authors suggest.

“It could be something as simple or as specific as thinness of tissue or friability of tissue that may predispose women more than men to perforation or other risks that may put them at risk for adverse events specifically,” Dr. Hsu said.

Commenting further, he said, “I think we would be remiss not to mention the fact that part of this association may unfortunately be a disparity in care that women as a specific sex may receive,” he said.

Indeed, postimplantation women had higher adjusted odds of receiving a direct oral anticoagulant only (odds ratio, 1.07, P = .02) and warfarin only (OR, 1.12; P < .001), and lower odds of receiving clinical trial-recommended combined oral anticoagulants plus single antiplatelet therapy (OR, 0.91; P < .001).

“This article highlights the fact that in all aspects we need to pay attention that women receive as high-level, guideline-driven care as men,” Dr. Hsu said.

First author Dr. Darden pointed out in an email that women suffer disproportionately from atrial fibrillation (AFib), compared with men, with worse quality of life and higher risk for stroke. So “it’s only natural to seek further treatment in order to decrease that risk, specifically LAAO with Watchman.”

Despite the fact that women are known to be at greater risk for adverse events after invasive procedures, including AFib ablation and TAVR, little is known about sex differences with LAAO, as the LAAO clinical trials only included about 30% women, he said.

Two 2021 papers zeroing in on these sex differences produced mixed results. An American report in roughly 9,200 patients reported a higher risk for major in-hospital events in women after receipt of Watchman implants, whereas a German report found similar safety and efficacy among 387 consecutive patients, regardless of sex.

The present study involved 20,388 women and 28,969 men implanted with the Watchman device between January 2016 and June 2019 in the NCDR registry, the largest LAAO registry with adjudicated events with participation mandated for Medicare coverage.

The women were older (mean age, 76.5 vs. 75.8 years), had a higher mean CHA2DS2-VASc score (5.3 vs. 4.5), and were more likely to have a high fall risk as an indication for LAAO (39.8% vs. 33.5%).

Furthermore, women were more likely than men to have paroxysmal atrial fibrillation and uncontrolled hypertension, but less likely to have congestive heart failure, diabetes, and coronary artery disease.

After multivariable adjustment, all but one of the primary outcomes was significantly worse in women versus men:

• Aborted or canceled procedure: 3.0% vs. 2.9% (OR, 1.01; P = .87)
• Any adverse event: 6.3% vs. 3.9% (OR, 1.63; P < .001)
• Major adverse event: 4.1% vs. 2.0% (OR, 2.06; P < .001)
• Hospital stay more than 1 day: 16.0% vs. 11.6% (OR, 1.46; P < .001)
• Death: 58/0.3% vs. 37/0.1% (OR, 2.01; P = .001).

The authors point out that device-related adverse events are lower than in the PROTECT-AF and PREVAIL clinical trials of the Watchman, with 0.8% of patients developing a pericardial effusion requiring drainage and 1.2% having major bleeding, down from highs of 4.8% and 3.5%, respectively, in PROTECT-AF.

Although promising overall, adverse events among women were driven by higher rates of both pericardial effusion requiring draining (1.2% vs. 0.5%; P < .001) and major bleeding (1.7% vs. 0.8%; P < .001).

Commenting for this news organization John Mandrola, MD, Baptist Health, Louisville, Kentucky, expressed concern that despite its increasing popularity, the rate of serious complications appears to be increasing for the preventive procedure. “That’s peculiar because you’d expect increased experience and device iterations to decrease complications. And the NCDR data surely undercounts the real rate of adverse events because it only includes in-hospital complications.”

Based on the current data, he observed that there’s a 3% chance for a major complication overall, with the typical female Watchman patient facing a 6% chance of any adverse event and 4% risk for a major adverse event during her hospital stay alone.

“The striking difference in complications in women is a super important observation because higher upfront risk has an even more negative effect on the harm-benefit calculus of this procedure,” Dr. Mandrola said.

“Some of the increased harm in women may have been due to the slightly higher rate of comorbid conditions, but that is real-life,” he said. “Registry data like this is extremely valuable because, unlike the carefully selected randomized trial, registries reflect what is actually being done in practice.”

Dr. Hsu agreed that the absolute numbers are concerning. Nevertheless, “it doesn’t necessarily sound an alarm that our adverse events are worse in contemporary practice or that adverse events continue to increase. But, in general, it just points to the fact that there is this inherent larger risk in women, compared with men, and that we need to, first, figure out why, and second, we need to figure out how to improve.”

Strategies to mitigate procedural risk included ultrasound-guided venous access, preprocedural imaging, improved proficiency with LAAO devices, and continued development of safer devices, they note.

Despite the more generalizable nature of registry data, “the results of this study should not result in differing sex-based thresholds for LAAO implant,” the authors conclude.

The study was supported by the American College of Cardiology Foundation’s NCDR. Dr. Hsu reports financial relationships with Medtronic, Boston Scientific, Abbott, Biotronik, Janssen Pharmaceutical, Bristol Myers Squibb, Pfizer, Biosense Webster, Altathera Pharmaceuticals, and Zoll Medical and holding equity interest in Acutus Medical and Vektor Medical outside the submitted work. Dr. Darden reports no relevant financial relationships. Dr. Mandrola is a regular contributor to Medscape Cardiology.

A version of this article first appeared on Medscape.com.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

About one in six patients with heart failure in the United States are skipping doctors’ appointments, not taking their medications as directed, or forgoing some other type of care, and their recalcitrance actually ends up costing the health care system 20%-30% more per patient.

That’s according to a cross-sectional study using data from a large public database reported in JACC: Heart Failure on Aug. 11.

The investigators pooled data on 2,050 patients with HF enrolled in the Medical Expenditure Panel Survey, a public database sponsored by the Agency for Healthcare Research and Quality, from 2004 to 2015. Some 339 of those HF patients were classified in the forgone or delayed (F/D) care group. This is the first study to describe the cost impact of missed care in heart failure, lead author Alexander Thomas, MD, and colleagues wrote.

“I think we make a pretty strong case linking forgone care to higher cost,” Dr. Thomas said in an interview. “Obviously this is a prospective study, so causality is not made based on this study, but there’s a strong association, it appears.” He acknowledged that prospective studies would need to confirm these findings, but added, “I think even this is enough to give us cause to look at the somewhat granular reasons as to why patients are forgoing care.”

Average annual total costs for adults who skipped care were $8,027 higher than for those heart failure patients who kept up with their regimen (P = .02). However, for people 65 and older, the cost differential was even higher: $10,581 (P = .02), which translates into a 50% premium over average costs for compliant elderly patients, noted Dr. Thomas, a cardiovascular medicine fellow at Yale University, New Haven, Conn.

In the nonelderly F/D group, average per-patient costs were $27,000 annually; in the elderly, it was a little over $30,000.

However, nonelderly patients were more likely to forgo care. While 16% of all patients in the study were considered F/D, 27% of nonelderly patients were classified as such vs. 10% of the elderly.
 

Elderly forgoing care drives cost

But, Dr. Thomas said, elderly patients forgoing care drive higher costs because they’re more fragile, have more comorbidities and more advanced heart failure, and tend to decompensate more quickly. “For them, missing one appointment or missing some medications is not nearly as well tolerated as it is in the younger population,” he said. In these elderly patients, inpatient costs accounted for 75% of the increased expense, Dr. Thomas added.

Reasons for forgoing care range from the obvious, such as cost or insurance issues – 191 individuals cited the former, 69 the latter – to more granular reasons, such as transportation issues or lack of time.

The study also found a number of demographic features that were associated with forgone or delayed care: non-Hispanic Black race; lack of insurance; low-income; and worse cardiovascular risk factor profiles.

The study’s call to action is for further research and policy changes aimed at better understanding barriers to care and improving access. “It’s a really great driver for policy interventions to attack this problem and to have the financial backing also to put money and resources into fixing this problem – which is probably not only going to decrease costs and allow more cost-effective care, but lead to better outcomes in this population as well,” Dr. Thomas said.

The sentiment for policy changes was echoed in an accompanying editorial by Khadijah Breathett, MD, MS, a heart failure/transplant cardiologist at the Sarver Heart Center, University of Arizona, Tucson. But she also noted the study exposed insufficiencies with Medicare. In an interview, she expanded on that. 

“Our system is failing this population,” she said of the elderly with heart failure who have forgone care. “I think that’s because of the complexity of our system: One person’s Medicare is different from another’s. There are multiple parts to Medicare that provide different forms of care – hospital care, prescription care, and so forth – and everyone does not necessarily have the same parts.” Also, many Medicare beneficiaries are still working, and “they’re still trying to figure out how to make ends meet,” Dr. Breathett added.

The study also showed that the pre-Medicare population requires the attention of policymakers. “How do we help the younger population so that they don’t develop the comorbidities that worsen their quality of life and contribute to rising hospital costs?” Dr. Breathett said.

Dr. Thomas had no financial relationships to disclose. Dr. Breathett has received grants from the National Heart, Lung, and Blood Institute.

About one in six patients with heart failure in the United States are skipping doctors’ appointments, not taking their medications as directed, or forgoing some other type of care, and their recalcitrance actually ends up costing the health care system 20%-30% more per patient.

That’s according to a cross-sectional study using data from a large public database reported in JACC: Heart Failure on Aug. 11.

The investigators pooled data on 2,050 patients with HF enrolled in the Medical Expenditure Panel Survey, a public database sponsored by the Agency for Healthcare Research and Quality, from 2004 to 2015. Some 339 of those HF patients were classified in the forgone or delayed (F/D) care group. This is the first study to describe the cost impact of missed care in heart failure, lead author Alexander Thomas, MD, and colleagues wrote.

“I think we make a pretty strong case linking forgone care to higher cost,” Dr. Thomas said in an interview. “Obviously this is a prospective study, so causality is not made based on this study, but there’s a strong association, it appears.” He acknowledged that prospective studies would need to confirm these findings, but added, “I think even this is enough to give us cause to look at the somewhat granular reasons as to why patients are forgoing care.”

Average annual total costs for adults who skipped care were $8,027 higher than for those heart failure patients who kept up with their regimen (P = .02). However, for people 65 and older, the cost differential was even higher: $10,581 (P = .02), which translates into a 50% premium over average costs for compliant elderly patients, noted Dr. Thomas, a cardiovascular medicine fellow at Yale University, New Haven, Conn.

In the nonelderly F/D group, average per-patient costs were $27,000 annually; in the elderly, it was a little over $30,000.

However, nonelderly patients were more likely to forgo care. While 16% of all patients in the study were considered F/D, 27% of nonelderly patients were classified as such vs. 10% of the elderly.
 

Elderly forgoing care drives cost

But, Dr. Thomas said, elderly patients forgoing care drive higher costs because they’re more fragile, have more comorbidities and more advanced heart failure, and tend to decompensate more quickly. “For them, missing one appointment or missing some medications is not nearly as well tolerated as it is in the younger population,” he said. In these elderly patients, inpatient costs accounted for 75% of the increased expense, Dr. Thomas added.

Reasons for forgoing care range from the obvious, such as cost or insurance issues – 191 individuals cited the former, 69 the latter – to more granular reasons, such as transportation issues or lack of time.

The study also found a number of demographic features that were associated with forgone or delayed care: non-Hispanic Black race; lack of insurance; low-income; and worse cardiovascular risk factor profiles.

The study’s call to action is for further research and policy changes aimed at better understanding barriers to care and improving access. “It’s a really great driver for policy interventions to attack this problem and to have the financial backing also to put money and resources into fixing this problem – which is probably not only going to decrease costs and allow more cost-effective care, but lead to better outcomes in this population as well,” Dr. Thomas said.

The sentiment for policy changes was echoed in an accompanying editorial by Khadijah Breathett, MD, MS, a heart failure/transplant cardiologist at the Sarver Heart Center, University of Arizona, Tucson. But she also noted the study exposed insufficiencies with Medicare. In an interview, she expanded on that. 

“Our system is failing this population,” she said of the elderly with heart failure who have forgone care. “I think that’s because of the complexity of our system: One person’s Medicare is different from another’s. There are multiple parts to Medicare that provide different forms of care – hospital care, prescription care, and so forth – and everyone does not necessarily have the same parts.” Also, many Medicare beneficiaries are still working, and “they’re still trying to figure out how to make ends meet,” Dr. Breathett added.

The study also showed that the pre-Medicare population requires the attention of policymakers. “How do we help the younger population so that they don’t develop the comorbidities that worsen their quality of life and contribute to rising hospital costs?” Dr. Breathett said.

Dr. Thomas had no financial relationships to disclose. Dr. Breathett has received grants from the National Heart, Lung, and Blood Institute.

About one in six patients with heart failure in the United States are skipping doctors’ appointments, not taking their medications as directed, or forgoing some other type of care, and their recalcitrance actually ends up costing the health care system 20%-30% more per patient.

That’s according to a cross-sectional study using data from a large public database reported in JACC: Heart Failure on Aug. 11.

The investigators pooled data on 2,050 patients with HF enrolled in the Medical Expenditure Panel Survey, a public database sponsored by the Agency for Healthcare Research and Quality, from 2004 to 2015. Some 339 of those HF patients were classified in the forgone or delayed (F/D) care group. This is the first study to describe the cost impact of missed care in heart failure, lead author Alexander Thomas, MD, and colleagues wrote.

“I think we make a pretty strong case linking forgone care to higher cost,” Dr. Thomas said in an interview. “Obviously this is a prospective study, so causality is not made based on this study, but there’s a strong association, it appears.” He acknowledged that prospective studies would need to confirm these findings, but added, “I think even this is enough to give us cause to look at the somewhat granular reasons as to why patients are forgoing care.”

Average annual total costs for adults who skipped care were $8,027 higher than for those heart failure patients who kept up with their regimen (P = .02). However, for people 65 and older, the cost differential was even higher: $10,581 (P = .02), which translates into a 50% premium over average costs for compliant elderly patients, noted Dr. Thomas, a cardiovascular medicine fellow at Yale University, New Haven, Conn.

In the nonelderly F/D group, average per-patient costs were $27,000 annually; in the elderly, it was a little over $30,000.

However, nonelderly patients were more likely to forgo care. While 16% of all patients in the study were considered F/D, 27% of nonelderly patients were classified as such vs. 10% of the elderly.
 

Elderly forgoing care drives cost

But, Dr. Thomas said, elderly patients forgoing care drive higher costs because they’re more fragile, have more comorbidities and more advanced heart failure, and tend to decompensate more quickly. “For them, missing one appointment or missing some medications is not nearly as well tolerated as it is in the younger population,” he said. In these elderly patients, inpatient costs accounted for 75% of the increased expense, Dr. Thomas added.

Reasons for forgoing care range from the obvious, such as cost or insurance issues – 191 individuals cited the former, 69 the latter – to more granular reasons, such as transportation issues or lack of time.

The study also found a number of demographic features that were associated with forgone or delayed care: non-Hispanic Black race; lack of insurance; low-income; and worse cardiovascular risk factor profiles.

The study’s call to action is for further research and policy changes aimed at better understanding barriers to care and improving access. “It’s a really great driver for policy interventions to attack this problem and to have the financial backing also to put money and resources into fixing this problem – which is probably not only going to decrease costs and allow more cost-effective care, but lead to better outcomes in this population as well,” Dr. Thomas said.

The sentiment for policy changes was echoed in an accompanying editorial by Khadijah Breathett, MD, MS, a heart failure/transplant cardiologist at the Sarver Heart Center, University of Arizona, Tucson. But she also noted the study exposed insufficiencies with Medicare. In an interview, she expanded on that. 

“Our system is failing this population,” she said of the elderly with heart failure who have forgone care. “I think that’s because of the complexity of our system: One person’s Medicare is different from another’s. There are multiple parts to Medicare that provide different forms of care – hospital care, prescription care, and so forth – and everyone does not necessarily have the same parts.” Also, many Medicare beneficiaries are still working, and “they’re still trying to figure out how to make ends meet,” Dr. Breathett added.

The study also showed that the pre-Medicare population requires the attention of policymakers. “How do we help the younger population so that they don’t develop the comorbidities that worsen their quality of life and contribute to rising hospital costs?” Dr. Breathett said.

Dr. Thomas had no financial relationships to disclose. Dr. Breathett has received grants from the National Heart, Lung, and Blood Institute.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

A version of this article first appeared on Medscape.com.

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

A version of this article first appeared on Medscape.com.

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

A version of this article first appeared on Medscape.com.

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.