Cardiology

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.

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

The results were published online in the Journal of the American College of Cardiology.

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

The results were published online in the Journal of the American College of Cardiology.

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

The results were published online in the Journal of the American College of Cardiology.

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

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

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

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

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

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