Cardiology News

Zilebesiran (Alnylam Pharmaceuticals), an investigational, subcutaneously administered small-interfering RNA (siRNA) therapeutic in development for the treatment of hypertension, met the primary and secondary endpoints, with an “encouraging” safety profile in the phase 2 KARDIA-1 study, the company announced.

KARDIA-1 is a phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of zilebesiran as monotherapy in 394 adults with mild to moderate untreated hypertension or on stable therapy with one or more antihypertensive drugs.

Patients were randomly assigned to one of five treatment arms during a 12-month double-blind period and double-blind extension period: 150 mg or 300 mg zilebesiran subcutaneously once every 6 months, 300 mg or 600 mg zilebesiran subcutaneously once every 3 months, or placebo. Patients taking placebo were randomly assigned to one of the four initial zilebesiran dose regimens beginning at month 6.

The primary endpoint was change from baseline in systolic blood pressure (SBP) at 3 months assessed by 24-hour ambulatory blood pressure monitoring.

Topline data show a dose-dependent, clinically significant reduction in 24-hour mean SBP, with a placebo-subtracted reduction greater than 15 mm Hg (P < .0001) with both the 300 mg and 600 mg doses.

The study also met key secondary endpoints, showing “consistent and sustained reductions” in SBP at 6 months, which supports quarterly or biannual dosing, the company said.

There was one death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the drug. Serious adverse events were reported in 3.6% of zilebesiran-treated patients and 6.7% of placebo-treated patients. None was considered related to the study drug.

Adverse events occurring in 5% or more of zilebesiran-treated patients in any dose arm included COVID-19, injection-site reaction, hyperkalemia, hypertension, upper respiratory tract infection, arthralgia, and headache.

“As a physician, I believe these KARDIA-1 results, which demonstrate clinically significant reductions in systolic blood pressure of greater than 15 mm Hg, along with the ability to achieve durable tonic blood pressure control, provide hope that we may one day have access to a novel therapy with the potential to address the significant unmet needs of patients with uncontrolled hypertension who are at high risk of future cardiovascular events,” study investigator George L. Bakris, MD, director, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, said in a statement.

The phase 2 results “further validate” the phase 1 results, published in the New England Journal of Medicine, Simon Fox, PhD, vice president, zilebesiran program lead at Alnylam, said in the statement.

The full KARDIA-1 results will be reported at an upcoming scientific conference, the statement notes. Topline results from the KARDIA-2 phase 2 study of zilebesiran in combination with one of three standard classes of antihypertensive medications in patients with mild to moderate hypertension are expected in early 2024.

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

Zilebesiran (Alnylam Pharmaceuticals), an investigational, subcutaneously administered small-interfering RNA (siRNA) therapeutic in development for the treatment of hypertension, met the primary and secondary endpoints, with an “encouraging” safety profile in the phase 2 KARDIA-1 study, the company announced.

KARDIA-1 is a phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of zilebesiran as monotherapy in 394 adults with mild to moderate untreated hypertension or on stable therapy with one or more antihypertensive drugs.

Patients were randomly assigned to one of five treatment arms during a 12-month double-blind period and double-blind extension period: 150 mg or 300 mg zilebesiran subcutaneously once every 6 months, 300 mg or 600 mg zilebesiran subcutaneously once every 3 months, or placebo. Patients taking placebo were randomly assigned to one of the four initial zilebesiran dose regimens beginning at month 6.

The primary endpoint was change from baseline in systolic blood pressure (SBP) at 3 months assessed by 24-hour ambulatory blood pressure monitoring.

Topline data show a dose-dependent, clinically significant reduction in 24-hour mean SBP, with a placebo-subtracted reduction greater than 15 mm Hg (P < .0001) with both the 300 mg and 600 mg doses.

The study also met key secondary endpoints, showing “consistent and sustained reductions” in SBP at 6 months, which supports quarterly or biannual dosing, the company said.

There was one death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the drug. Serious adverse events were reported in 3.6% of zilebesiran-treated patients and 6.7% of placebo-treated patients. None was considered related to the study drug.

Adverse events occurring in 5% or more of zilebesiran-treated patients in any dose arm included COVID-19, injection-site reaction, hyperkalemia, hypertension, upper respiratory tract infection, arthralgia, and headache.

“As a physician, I believe these KARDIA-1 results, which demonstrate clinically significant reductions in systolic blood pressure of greater than 15 mm Hg, along with the ability to achieve durable tonic blood pressure control, provide hope that we may one day have access to a novel therapy with the potential to address the significant unmet needs of patients with uncontrolled hypertension who are at high risk of future cardiovascular events,” study investigator George L. Bakris, MD, director, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, said in a statement.

The phase 2 results “further validate” the phase 1 results, published in the New England Journal of Medicine, Simon Fox, PhD, vice president, zilebesiran program lead at Alnylam, said in the statement.

The full KARDIA-1 results will be reported at an upcoming scientific conference, the statement notes. Topline results from the KARDIA-2 phase 2 study of zilebesiran in combination with one of three standard classes of antihypertensive medications in patients with mild to moderate hypertension are expected in early 2024.

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

Zilebesiran (Alnylam Pharmaceuticals), an investigational, subcutaneously administered small-interfering RNA (siRNA) therapeutic in development for the treatment of hypertension, met the primary and secondary endpoints, with an “encouraging” safety profile in the phase 2 KARDIA-1 study, the company announced.

KARDIA-1 is a phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of zilebesiran as monotherapy in 394 adults with mild to moderate untreated hypertension or on stable therapy with one or more antihypertensive drugs.

Patients were randomly assigned to one of five treatment arms during a 12-month double-blind period and double-blind extension period: 150 mg or 300 mg zilebesiran subcutaneously once every 6 months, 300 mg or 600 mg zilebesiran subcutaneously once every 3 months, or placebo. Patients taking placebo were randomly assigned to one of the four initial zilebesiran dose regimens beginning at month 6.

The primary endpoint was change from baseline in systolic blood pressure (SBP) at 3 months assessed by 24-hour ambulatory blood pressure monitoring.

Topline data show a dose-dependent, clinically significant reduction in 24-hour mean SBP, with a placebo-subtracted reduction greater than 15 mm Hg (P < .0001) with both the 300 mg and 600 mg doses.

The study also met key secondary endpoints, showing “consistent and sustained reductions” in SBP at 6 months, which supports quarterly or biannual dosing, the company said.

There was one death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the drug. Serious adverse events were reported in 3.6% of zilebesiran-treated patients and 6.7% of placebo-treated patients. None was considered related to the study drug.

Adverse events occurring in 5% or more of zilebesiran-treated patients in any dose arm included COVID-19, injection-site reaction, hyperkalemia, hypertension, upper respiratory tract infection, arthralgia, and headache.

“As a physician, I believe these KARDIA-1 results, which demonstrate clinically significant reductions in systolic blood pressure of greater than 15 mm Hg, along with the ability to achieve durable tonic blood pressure control, provide hope that we may one day have access to a novel therapy with the potential to address the significant unmet needs of patients with uncontrolled hypertension who are at high risk of future cardiovascular events,” study investigator George L. Bakris, MD, director, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, said in a statement.

The phase 2 results “further validate” the phase 1 results, published in the New England Journal of Medicine, Simon Fox, PhD, vice president, zilebesiran program lead at Alnylam, said in the statement.

The full KARDIA-1 results will be reported at an upcoming scientific conference, the statement notes. Topline results from the KARDIA-2 phase 2 study of zilebesiran in combination with one of three standard classes of antihypertensive medications in patients with mild to moderate hypertension are expected in early 2024.

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

AMSTERDAM – For patients hospitalized for acute heart failure, initiating treatment with the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) before hospital discharge was safe, it appeared to improve diuresis and natriuresis while reducing the administered diuretic dose, and it meant quicker initiation of guideline-directed therapy in a controlled study of 238 patients.

Treatment with dapagliflozin was begun for people with heart failure on their first day of hospitalization for an acute episode. Such treatment “can be safely started to optimize a key medication,” Zachary Cox, PharmD, said at the annual congress of the European Society of Cardiology. It improved fluid removal, as evidenced in the “totality of diuretic measures,” it resulted in reduced doses of IV diuretics, and it shortened length of stay in the hospital.

In current U.S. practice, about 80% of people hospitalized with heart failure do not initially receive treatment with a sodium-glucose cotransporter 2 (SGLT2) inhibitor during their hospital stay when they are not already taking an agent from the class, noted Dr. Cox, professor of pharmacy at Lipscomb University College of Pharmacy in Nashville, Tenn.

Physicians are often uncomfortable changing a patient’s medications on the first day of a hospitalization, he noted. “Our results should embolden physicians” to begin treatment with an SGLT2 inhibitor early during hospitalization and to then continue it chronically, Dr. Cox said in a press briefing.

“Despite the messaging [from guidelines], we still see hesitancy. We hope more evidence of safety will improve uptake.” The study’s “key message is to start guideline-directed medical therapy early,” prior to hospital discharge, Dr. Cox concluded.
 

“Some support” for SGLT2 inhibitors

The study results “provide some support for SGLT2 inhibitors facilitating decongestion and hospital discharge without observed safety issues,” said Stephen D. Wiviott, MD, designated discussant for the report and a cardiologist and professor at Harvard Medical School in Boston.

While initiation of an SGLT2 inhibitor during an acute heart failure hospitalization received endorsement as a top management priority in both the 2023 heart failure guidelines of the European Society of Cardiology and in 2022 U.S. guidelines, evidence of the safety and efficacy of this approach has been scanty, Dr. Wiviott noted.

Two prior studies addressed the issue. The SOLOIST-WHF trial tested the combined SGLT1 and SGLT2 inhibitor sotagliflozin (Inpefa, Lexicon) for patients recently hospitalized for heart failure, but only 142 of the 596 participants who were randomly assigned to receive sotagliflozin began receiving it at least a day before hospital discharge; for the remaining 454, treatment with sotagliflozin began on their discharge day, noted Dr. Wiviott.

In the EMPULSE trial, 530 people hospitalized for acute heart failure were randomly assigned to initially receive empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) or placebo during hospitalization. The primary endpoint was largely driven by an improvement in the patient-reported outcome, as assessed on the basis of the Kansas City Cardiomyopathy Questionnaire Total Symptom Score, Dr. Wiviott added.

The DICTATE-AHF study included 238 adults who were within 24 hours of first presenting to any of six participating U.S. hospitals with hypervolemic acute heart failure. All patients underwent a standard treatment protocol with IV loop diuretics, and half received additional, open-label treatment with a daily 10-mg dose of dapagliflozin.

The average age of the patients was 65 years, 71% had type 2 diabetes (the study excluded people with type 1 diabetes), and about half had a left ventricular ejection fraction of 40% or less.
 

Similar weight loss with lower diuretics dose

The study’s primary outcome was a measure of diuretic efficiency, calculated as a person’s cumulative weight change divided by the cumulative dose of loop diuretics.

Both treatment arms experienced nearly identical weight loss, but for the people who received dapagliflozin, this occurred with a lower cumulative dose of diuretics. The diuretic efficiency with dapagliflozin produced comparable weight loss with a 35% lower amount of loop diuretic dose, a difference that fell just short of significance (P = .06).

However, treatment with dapagliflozin also significantly boosted 24-hour natriuresis and 24-hour diuresis, and it significantly shortened the time to stopping treatment with IV diuretics and to hospital discharge, Dr. Cox reported. Dapagliflozin initiation and ongoing treatment was also safe and well tolerated compared with usual care.

The fact that the primary endpoint fell short of significance was “largely related” to the study’s relatively small size, Dr. Wiviott suggested. He noted that the DAPA ACT HF-TIMI 68 study, which is a much larger and potentially more definitive study of the safety and efficacy of dapagliflozin in comparison with usual care for patients with acute heart failure, is in progress. The study includes about 2,400 patients.

The primary outcome is the combined rate of cardiovascular death or worsening heart failure during the 2 months following randomization. Results are expected in 2024.

DICTATE-AHF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Cox has received research funding from AstraZeneca and has been a consultant to Roche and Translational Catalyst. Dr. Wiviott has received research funding from AstraZeneca and from Merck and has been a consultant to Icon Clinical and Novo Nordisk.
 

A version of this article appeared on Medscape.com.

AMSTERDAM – For patients hospitalized for acute heart failure, initiating treatment with the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) before hospital discharge was safe, it appeared to improve diuresis and natriuresis while reducing the administered diuretic dose, and it meant quicker initiation of guideline-directed therapy in a controlled study of 238 patients.

Treatment with dapagliflozin was begun for people with heart failure on their first day of hospitalization for an acute episode. Such treatment “can be safely started to optimize a key medication,” Zachary Cox, PharmD, said at the annual congress of the European Society of Cardiology. It improved fluid removal, as evidenced in the “totality of diuretic measures,” it resulted in reduced doses of IV diuretics, and it shortened length of stay in the hospital.

In current U.S. practice, about 80% of people hospitalized with heart failure do not initially receive treatment with a sodium-glucose cotransporter 2 (SGLT2) inhibitor during their hospital stay when they are not already taking an agent from the class, noted Dr. Cox, professor of pharmacy at Lipscomb University College of Pharmacy in Nashville, Tenn.

Physicians are often uncomfortable changing a patient’s medications on the first day of a hospitalization, he noted. “Our results should embolden physicians” to begin treatment with an SGLT2 inhibitor early during hospitalization and to then continue it chronically, Dr. Cox said in a press briefing.

“Despite the messaging [from guidelines], we still see hesitancy. We hope more evidence of safety will improve uptake.” The study’s “key message is to start guideline-directed medical therapy early,” prior to hospital discharge, Dr. Cox concluded.
 

“Some support” for SGLT2 inhibitors

The study results “provide some support for SGLT2 inhibitors facilitating decongestion and hospital discharge without observed safety issues,” said Stephen D. Wiviott, MD, designated discussant for the report and a cardiologist and professor at Harvard Medical School in Boston.

While initiation of an SGLT2 inhibitor during an acute heart failure hospitalization received endorsement as a top management priority in both the 2023 heart failure guidelines of the European Society of Cardiology and in 2022 U.S. guidelines, evidence of the safety and efficacy of this approach has been scanty, Dr. Wiviott noted.

Two prior studies addressed the issue. The SOLOIST-WHF trial tested the combined SGLT1 and SGLT2 inhibitor sotagliflozin (Inpefa, Lexicon) for patients recently hospitalized for heart failure, but only 142 of the 596 participants who were randomly assigned to receive sotagliflozin began receiving it at least a day before hospital discharge; for the remaining 454, treatment with sotagliflozin began on their discharge day, noted Dr. Wiviott.

In the EMPULSE trial, 530 people hospitalized for acute heart failure were randomly assigned to initially receive empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) or placebo during hospitalization. The primary endpoint was largely driven by an improvement in the patient-reported outcome, as assessed on the basis of the Kansas City Cardiomyopathy Questionnaire Total Symptom Score, Dr. Wiviott added.

The DICTATE-AHF study included 238 adults who were within 24 hours of first presenting to any of six participating U.S. hospitals with hypervolemic acute heart failure. All patients underwent a standard treatment protocol with IV loop diuretics, and half received additional, open-label treatment with a daily 10-mg dose of dapagliflozin.

The average age of the patients was 65 years, 71% had type 2 diabetes (the study excluded people with type 1 diabetes), and about half had a left ventricular ejection fraction of 40% or less.
 

Similar weight loss with lower diuretics dose

The study’s primary outcome was a measure of diuretic efficiency, calculated as a person’s cumulative weight change divided by the cumulative dose of loop diuretics.

Both treatment arms experienced nearly identical weight loss, but for the people who received dapagliflozin, this occurred with a lower cumulative dose of diuretics. The diuretic efficiency with dapagliflozin produced comparable weight loss with a 35% lower amount of loop diuretic dose, a difference that fell just short of significance (P = .06).

However, treatment with dapagliflozin also significantly boosted 24-hour natriuresis and 24-hour diuresis, and it significantly shortened the time to stopping treatment with IV diuretics and to hospital discharge, Dr. Cox reported. Dapagliflozin initiation and ongoing treatment was also safe and well tolerated compared with usual care.

The fact that the primary endpoint fell short of significance was “largely related” to the study’s relatively small size, Dr. Wiviott suggested. He noted that the DAPA ACT HF-TIMI 68 study, which is a much larger and potentially more definitive study of the safety and efficacy of dapagliflozin in comparison with usual care for patients with acute heart failure, is in progress. The study includes about 2,400 patients.

The primary outcome is the combined rate of cardiovascular death or worsening heart failure during the 2 months following randomization. Results are expected in 2024.

DICTATE-AHF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Cox has received research funding from AstraZeneca and has been a consultant to Roche and Translational Catalyst. Dr. Wiviott has received research funding from AstraZeneca and from Merck and has been a consultant to Icon Clinical and Novo Nordisk.
 

A version of this article appeared on Medscape.com.

AMSTERDAM – For patients hospitalized for acute heart failure, initiating treatment with the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) before hospital discharge was safe, it appeared to improve diuresis and natriuresis while reducing the administered diuretic dose, and it meant quicker initiation of guideline-directed therapy in a controlled study of 238 patients.

Treatment with dapagliflozin was begun for people with heart failure on their first day of hospitalization for an acute episode. Such treatment “can be safely started to optimize a key medication,” Zachary Cox, PharmD, said at the annual congress of the European Society of Cardiology. It improved fluid removal, as evidenced in the “totality of diuretic measures,” it resulted in reduced doses of IV diuretics, and it shortened length of stay in the hospital.

In current U.S. practice, about 80% of people hospitalized with heart failure do not initially receive treatment with a sodium-glucose cotransporter 2 (SGLT2) inhibitor during their hospital stay when they are not already taking an agent from the class, noted Dr. Cox, professor of pharmacy at Lipscomb University College of Pharmacy in Nashville, Tenn.

Physicians are often uncomfortable changing a patient’s medications on the first day of a hospitalization, he noted. “Our results should embolden physicians” to begin treatment with an SGLT2 inhibitor early during hospitalization and to then continue it chronically, Dr. Cox said in a press briefing.

“Despite the messaging [from guidelines], we still see hesitancy. We hope more evidence of safety will improve uptake.” The study’s “key message is to start guideline-directed medical therapy early,” prior to hospital discharge, Dr. Cox concluded.
 

“Some support” for SGLT2 inhibitors

The study results “provide some support for SGLT2 inhibitors facilitating decongestion and hospital discharge without observed safety issues,” said Stephen D. Wiviott, MD, designated discussant for the report and a cardiologist and professor at Harvard Medical School in Boston.

While initiation of an SGLT2 inhibitor during an acute heart failure hospitalization received endorsement as a top management priority in both the 2023 heart failure guidelines of the European Society of Cardiology and in 2022 U.S. guidelines, evidence of the safety and efficacy of this approach has been scanty, Dr. Wiviott noted.

Two prior studies addressed the issue. The SOLOIST-WHF trial tested the combined SGLT1 and SGLT2 inhibitor sotagliflozin (Inpefa, Lexicon) for patients recently hospitalized for heart failure, but only 142 of the 596 participants who were randomly assigned to receive sotagliflozin began receiving it at least a day before hospital discharge; for the remaining 454, treatment with sotagliflozin began on their discharge day, noted Dr. Wiviott.

In the EMPULSE trial, 530 people hospitalized for acute heart failure were randomly assigned to initially receive empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) or placebo during hospitalization. The primary endpoint was largely driven by an improvement in the patient-reported outcome, as assessed on the basis of the Kansas City Cardiomyopathy Questionnaire Total Symptom Score, Dr. Wiviott added.

The DICTATE-AHF study included 238 adults who were within 24 hours of first presenting to any of six participating U.S. hospitals with hypervolemic acute heart failure. All patients underwent a standard treatment protocol with IV loop diuretics, and half received additional, open-label treatment with a daily 10-mg dose of dapagliflozin.

The average age of the patients was 65 years, 71% had type 2 diabetes (the study excluded people with type 1 diabetes), and about half had a left ventricular ejection fraction of 40% or less.
 

Similar weight loss with lower diuretics dose

The study’s primary outcome was a measure of diuretic efficiency, calculated as a person’s cumulative weight change divided by the cumulative dose of loop diuretics.

Both treatment arms experienced nearly identical weight loss, but for the people who received dapagliflozin, this occurred with a lower cumulative dose of diuretics. The diuretic efficiency with dapagliflozin produced comparable weight loss with a 35% lower amount of loop diuretic dose, a difference that fell just short of significance (P = .06).

However, treatment with dapagliflozin also significantly boosted 24-hour natriuresis and 24-hour diuresis, and it significantly shortened the time to stopping treatment with IV diuretics and to hospital discharge, Dr. Cox reported. Dapagliflozin initiation and ongoing treatment was also safe and well tolerated compared with usual care.

The fact that the primary endpoint fell short of significance was “largely related” to the study’s relatively small size, Dr. Wiviott suggested. He noted that the DAPA ACT HF-TIMI 68 study, which is a much larger and potentially more definitive study of the safety and efficacy of dapagliflozin in comparison with usual care for patients with acute heart failure, is in progress. The study includes about 2,400 patients.

The primary outcome is the combined rate of cardiovascular death or worsening heart failure during the 2 months following randomization. Results are expected in 2024.

DICTATE-AHF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Cox has received research funding from AstraZeneca and has been a consultant to Roche and Translational Catalyst. Dr. Wiviott has received research funding from AstraZeneca and from Merck and has been a consultant to Icon Clinical and Novo Nordisk.
 

A version of this article appeared on Medscape.com.

Moderna says its upcoming COVID-19 vaccine should work against the BA.2.86 variant that has caused worry about a possible surge in cases.

“The company said its shot generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86, which is being tracked by the World Health Organization and the U.S. Centers for Disease Control and Prevention,” Reuters reported.

“We think this is news people will want to hear as they prepare to go out and get their fall boosters,” Jacqueline Miller, Moderna head of infectious diseases, told the news agency.

The CDC said that the BA.2.86 variant might be more likely to infect people who have already had COVID or previous vaccinations. BA.2.86 is an Omicron variant. It has undergone more mutations than XBB.1.5, which has dominated most of this year and was the intended target of the updated shots.

BA.2.86 does not have a strong presence in the United States yet. However, officials are concerned about its high number of mutations, NBC News reported.

The FDA is expected to approve the new Moderna shot by early October.

Pfizer told NBC that its updated booster also generated a strong antibody response against Omicron variants, including BA.2.86.

COVID-19 cases and hospitalizations have been increasing in the U.S. because of the rise of several variants. 

Experts told Reuters that BA.2.86 probably won’t cause a wave of severe disease and death because immunity has been built up around the world through previous infections and mass vaccinations.

A version of this article appeared on WebMD.com.

Moderna says its upcoming COVID-19 vaccine should work against the BA.2.86 variant that has caused worry about a possible surge in cases.

“The company said its shot generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86, which is being tracked by the World Health Organization and the U.S. Centers for Disease Control and Prevention,” Reuters reported.

“We think this is news people will want to hear as they prepare to go out and get their fall boosters,” Jacqueline Miller, Moderna head of infectious diseases, told the news agency.

The CDC said that the BA.2.86 variant might be more likely to infect people who have already had COVID or previous vaccinations. BA.2.86 is an Omicron variant. It has undergone more mutations than XBB.1.5, which has dominated most of this year and was the intended target of the updated shots.

BA.2.86 does not have a strong presence in the United States yet. However, officials are concerned about its high number of mutations, NBC News reported.

The FDA is expected to approve the new Moderna shot by early October.

Pfizer told NBC that its updated booster also generated a strong antibody response against Omicron variants, including BA.2.86.

COVID-19 cases and hospitalizations have been increasing in the U.S. because of the rise of several variants. 

Experts told Reuters that BA.2.86 probably won’t cause a wave of severe disease and death because immunity has been built up around the world through previous infections and mass vaccinations.

A version of this article appeared on WebMD.com.

Moderna says its upcoming COVID-19 vaccine should work against the BA.2.86 variant that has caused worry about a possible surge in cases.

“The company said its shot generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86, which is being tracked by the World Health Organization and the U.S. Centers for Disease Control and Prevention,” Reuters reported.

“We think this is news people will want to hear as they prepare to go out and get their fall boosters,” Jacqueline Miller, Moderna head of infectious diseases, told the news agency.

The CDC said that the BA.2.86 variant might be more likely to infect people who have already had COVID or previous vaccinations. BA.2.86 is an Omicron variant. It has undergone more mutations than XBB.1.5, which has dominated most of this year and was the intended target of the updated shots.

BA.2.86 does not have a strong presence in the United States yet. However, officials are concerned about its high number of mutations, NBC News reported.

The FDA is expected to approve the new Moderna shot by early October.

Pfizer told NBC that its updated booster also generated a strong antibody response against Omicron variants, including BA.2.86.

COVID-19 cases and hospitalizations have been increasing in the U.S. because of the rise of several variants. 

Experts told Reuters that BA.2.86 probably won’t cause a wave of severe disease and death because immunity has been built up around the world through previous infections and mass vaccinations.

A version of this article appeared on WebMD.com.

To avoid cardiovascular disease, the American Heart Association (AHA) recommends performing at least 150 minutes of moderate-intensity aerobic activity every week, 75 minutes of intense aerobic activity every week, or a combination of both, preferably spread out throughout the week. But how knowledgeable are physicians when it comes to prescribing exercise, and how should patients be assessed so that appropriate physical activity can be recommended?

In a presentation titled, “Patient Evaluation and Exercise Prescription in Primary Prevention,” Thelma Sánchez Grillo, MD, a cardiologist at the Clínica Bíblica Hospital in San José, Costa Rica, explained the benefits and risks of exercise and gave recommendations for proper patient assessment before prescribing physical activity.

“Exercise has cardioprotective, emotional, antiarrhythmic, and antithrombotic benefits, and it reduces stress,” she explained.

She also noted that the risk regarding cardiopulmonary and musculoskeletal components must be evaluated, because exercise can itself trigger coronary events, and the last thing intended when prescribing exercise is to cause complications. “We must recommend exercise progressively. We can’t suggest a high-intensity regimen to a patient if they haven’t had any preconditioning where collateral circulation could be developed and lung and cardiac capacity could be improved.”

Dr. Sánchez went on to say that, according to the AHA, patients should be classified as follows: those who exercise and those who don’t, those with a history of cardiovascular, metabolic, or renal disease, and those with symptomatic and asymptomatic diseases, in order to consider the parameters when recommending exercise.

“If the patient has symptoms and is doing light physical activity, like walking, they can keep doing this exercise and don’t need further assessments. But if they have a symptomatic disease and are not exercising, they need to be evaluated after exercise has been prescribed, and not just clinically, either. Some sort of diagnostic method should be considered. Also, for patients who are physically active and who desire to increase the intensity of their exercise, the recommendation is to perform a detailed clinical examination and, if necessary, perform additional imaging studies.”

Warning signs

• Dizziness.
• Orthopnea.
• Abnormal heart rate.
• Edema in the lower extremities.
• Chest pain, especially when occurring with exercise.
• Intermittent claudication.
• Heart murmurs.
• Dyspnea.
• Reduced output.
• Fatigue.

Calibrating exercise parameters

The parameters of frequency (number of sessions per week), intensity (perceived exertion measured by heart rate reached), time, and type (aerobic exercise vs. strength training) should be considered when forming an appropriate prescription for exercise, explained Dr. Sánchez.

“The big problem is that most physicians don’t know how to prescribe it properly. And beyond knowing how, the important thing is that, when we’re with the patient during the consultation, we ought to be doing more than just establishing a routine. We need to be motivators and we need to be identifying obstacles and the patient’s interest in exercise, because it’s clear that incorporating physical activity into our daily lives helps improve the quality and length of life,” the specialist added.

The recommendations are straightforward: for individuals aged 18-64 years, 150 minutes of moderate-intensity activity per week, whether aerobic, strength training, or mixed, should be prescribed. “We need to encourage moving more and sitting less, and recommend comprehensive programs that include coordination, balance, and muscle strengthening. If a sedentary lifestyle is a risk factor, we need to encourage patients to start performing physical activity for 1-2 minutes every hour, because any exercise must be gradual and progressive to avoid complications,” she noted.
 

Evaluate, then recommend

The specialist emphasized the importance of making personalized prescriptions, exercising caution, and performing adequate assessments to know which exercise routine to recommend. “The patient should also be involved in their self-care and must have an adequate diet and hydration, and we need to remind them that they shouldn’t be exercising if they have an infection, due to the risk of myocarditis and sudden death,” she added.

Rafaelina Concepción, MD, cardiologist from the Dominican Republic and vice president of the Inter-American Society of Cardiology for Central America and the Caribbean, agreed with the importance of assessing risk and risk factors for patients who request an exercise routine. “For example, in patients with prediabetes, it has been shown that exercising can slow the progression to diabetes. The essential thing is to use stratification and know what kind of exercise to recommend, whether aerobic, strength training, or a combination of the two, to improve functional capacity without reaching the threshold heart rate while reducing the risk of other comorbidities like hypertension, obesity, and high lipids, and achieving lifestyle changes.”

Carlos Franco, MD, a cardiologist in El Salvador, emphasized that there is no such thing as zero risk when evaluating a patient. “Of course, there’s a difference between an athlete and someone who isn’t physically active, but we need to profile all patients correctly, evaluate risk factors in detail, not overlook subclinical cardiovascular disease, and check whether they need stress testing or additional imaging to assess cardiac functional capacity. Also, exercise must be prescribed gradually, and the patient’s nutritional status must be assessed.”

Dr. Franco ended by explaining that physicians must understand how to prescribe the basics of exercise and make small interventions of reasonable intensity, provide practical advice, and, to the extent possible, rely on specialists such as physiatrists, sports specialists, and physical therapists.

This article was translated from the Medscape Spanish Edition. A version of this article appeared on Medscape.com.

To avoid cardiovascular disease, the American Heart Association (AHA) recommends performing at least 150 minutes of moderate-intensity aerobic activity every week, 75 minutes of intense aerobic activity every week, or a combination of both, preferably spread out throughout the week. But how knowledgeable are physicians when it comes to prescribing exercise, and how should patients be assessed so that appropriate physical activity can be recommended?

In a presentation titled, “Patient Evaluation and Exercise Prescription in Primary Prevention,” Thelma Sánchez Grillo, MD, a cardiologist at the Clínica Bíblica Hospital in San José, Costa Rica, explained the benefits and risks of exercise and gave recommendations for proper patient assessment before prescribing physical activity.

“Exercise has cardioprotective, emotional, antiarrhythmic, and antithrombotic benefits, and it reduces stress,” she explained.

She also noted that the risk regarding cardiopulmonary and musculoskeletal components must be evaluated, because exercise can itself trigger coronary events, and the last thing intended when prescribing exercise is to cause complications. “We must recommend exercise progressively. We can’t suggest a high-intensity regimen to a patient if they haven’t had any preconditioning where collateral circulation could be developed and lung and cardiac capacity could be improved.”

Dr. Sánchez went on to say that, according to the AHA, patients should be classified as follows: those who exercise and those who don’t, those with a history of cardiovascular, metabolic, or renal disease, and those with symptomatic and asymptomatic diseases, in order to consider the parameters when recommending exercise.

“If the patient has symptoms and is doing light physical activity, like walking, they can keep doing this exercise and don’t need further assessments. But if they have a symptomatic disease and are not exercising, they need to be evaluated after exercise has been prescribed, and not just clinically, either. Some sort of diagnostic method should be considered. Also, for patients who are physically active and who desire to increase the intensity of their exercise, the recommendation is to perform a detailed clinical examination and, if necessary, perform additional imaging studies.”

Warning signs

• Dizziness.
• Orthopnea.
• Abnormal heart rate.
• Edema in the lower extremities.
• Chest pain, especially when occurring with exercise.
• Intermittent claudication.
• Heart murmurs.
• Dyspnea.
• Reduced output.
• Fatigue.

Calibrating exercise parameters

The parameters of frequency (number of sessions per week), intensity (perceived exertion measured by heart rate reached), time, and type (aerobic exercise vs. strength training) should be considered when forming an appropriate prescription for exercise, explained Dr. Sánchez.

“The big problem is that most physicians don’t know how to prescribe it properly. And beyond knowing how, the important thing is that, when we’re with the patient during the consultation, we ought to be doing more than just establishing a routine. We need to be motivators and we need to be identifying obstacles and the patient’s interest in exercise, because it’s clear that incorporating physical activity into our daily lives helps improve the quality and length of life,” the specialist added.

The recommendations are straightforward: for individuals aged 18-64 years, 150 minutes of moderate-intensity activity per week, whether aerobic, strength training, or mixed, should be prescribed. “We need to encourage moving more and sitting less, and recommend comprehensive programs that include coordination, balance, and muscle strengthening. If a sedentary lifestyle is a risk factor, we need to encourage patients to start performing physical activity for 1-2 minutes every hour, because any exercise must be gradual and progressive to avoid complications,” she noted.
 

Evaluate, then recommend

The specialist emphasized the importance of making personalized prescriptions, exercising caution, and performing adequate assessments to know which exercise routine to recommend. “The patient should also be involved in their self-care and must have an adequate diet and hydration, and we need to remind them that they shouldn’t be exercising if they have an infection, due to the risk of myocarditis and sudden death,” she added.

Rafaelina Concepción, MD, cardiologist from the Dominican Republic and vice president of the Inter-American Society of Cardiology for Central America and the Caribbean, agreed with the importance of assessing risk and risk factors for patients who request an exercise routine. “For example, in patients with prediabetes, it has been shown that exercising can slow the progression to diabetes. The essential thing is to use stratification and know what kind of exercise to recommend, whether aerobic, strength training, or a combination of the two, to improve functional capacity without reaching the threshold heart rate while reducing the risk of other comorbidities like hypertension, obesity, and high lipids, and achieving lifestyle changes.”

Carlos Franco, MD, a cardiologist in El Salvador, emphasized that there is no such thing as zero risk when evaluating a patient. “Of course, there’s a difference between an athlete and someone who isn’t physically active, but we need to profile all patients correctly, evaluate risk factors in detail, not overlook subclinical cardiovascular disease, and check whether they need stress testing or additional imaging to assess cardiac functional capacity. Also, exercise must be prescribed gradually, and the patient’s nutritional status must be assessed.”

Dr. Franco ended by explaining that physicians must understand how to prescribe the basics of exercise and make small interventions of reasonable intensity, provide practical advice, and, to the extent possible, rely on specialists such as physiatrists, sports specialists, and physical therapists.

This article was translated from the Medscape Spanish Edition. A version of this article appeared on Medscape.com.

To avoid cardiovascular disease, the American Heart Association (AHA) recommends performing at least 150 minutes of moderate-intensity aerobic activity every week, 75 minutes of intense aerobic activity every week, or a combination of both, preferably spread out throughout the week. But how knowledgeable are physicians when it comes to prescribing exercise, and how should patients be assessed so that appropriate physical activity can be recommended?

In a presentation titled, “Patient Evaluation and Exercise Prescription in Primary Prevention,” Thelma Sánchez Grillo, MD, a cardiologist at the Clínica Bíblica Hospital in San José, Costa Rica, explained the benefits and risks of exercise and gave recommendations for proper patient assessment before prescribing physical activity.

“Exercise has cardioprotective, emotional, antiarrhythmic, and antithrombotic benefits, and it reduces stress,” she explained.

She also noted that the risk regarding cardiopulmonary and musculoskeletal components must be evaluated, because exercise can itself trigger coronary events, and the last thing intended when prescribing exercise is to cause complications. “We must recommend exercise progressively. We can’t suggest a high-intensity regimen to a patient if they haven’t had any preconditioning where collateral circulation could be developed and lung and cardiac capacity could be improved.”

Dr. Sánchez went on to say that, according to the AHA, patients should be classified as follows: those who exercise and those who don’t, those with a history of cardiovascular, metabolic, or renal disease, and those with symptomatic and asymptomatic diseases, in order to consider the parameters when recommending exercise.

“If the patient has symptoms and is doing light physical activity, like walking, they can keep doing this exercise and don’t need further assessments. But if they have a symptomatic disease and are not exercising, they need to be evaluated after exercise has been prescribed, and not just clinically, either. Some sort of diagnostic method should be considered. Also, for patients who are physically active and who desire to increase the intensity of their exercise, the recommendation is to perform a detailed clinical examination and, if necessary, perform additional imaging studies.”

Warning signs

• Dizziness.
• Orthopnea.
• Abnormal heart rate.
• Edema in the lower extremities.
• Chest pain, especially when occurring with exercise.
• Intermittent claudication.
• Heart murmurs.
• Dyspnea.
• Reduced output.
• Fatigue.

Calibrating exercise parameters

The parameters of frequency (number of sessions per week), intensity (perceived exertion measured by heart rate reached), time, and type (aerobic exercise vs. strength training) should be considered when forming an appropriate prescription for exercise, explained Dr. Sánchez.

“The big problem is that most physicians don’t know how to prescribe it properly. And beyond knowing how, the important thing is that, when we’re with the patient during the consultation, we ought to be doing more than just establishing a routine. We need to be motivators and we need to be identifying obstacles and the patient’s interest in exercise, because it’s clear that incorporating physical activity into our daily lives helps improve the quality and length of life,” the specialist added.

The recommendations are straightforward: for individuals aged 18-64 years, 150 minutes of moderate-intensity activity per week, whether aerobic, strength training, or mixed, should be prescribed. “We need to encourage moving more and sitting less, and recommend comprehensive programs that include coordination, balance, and muscle strengthening. If a sedentary lifestyle is a risk factor, we need to encourage patients to start performing physical activity for 1-2 minutes every hour, because any exercise must be gradual and progressive to avoid complications,” she noted.
 

Evaluate, then recommend

The specialist emphasized the importance of making personalized prescriptions, exercising caution, and performing adequate assessments to know which exercise routine to recommend. “The patient should also be involved in their self-care and must have an adequate diet and hydration, and we need to remind them that they shouldn’t be exercising if they have an infection, due to the risk of myocarditis and sudden death,” she added.

Rafaelina Concepción, MD, cardiologist from the Dominican Republic and vice president of the Inter-American Society of Cardiology for Central America and the Caribbean, agreed with the importance of assessing risk and risk factors for patients who request an exercise routine. “For example, in patients with prediabetes, it has been shown that exercising can slow the progression to diabetes. The essential thing is to use stratification and know what kind of exercise to recommend, whether aerobic, strength training, or a combination of the two, to improve functional capacity without reaching the threshold heart rate while reducing the risk of other comorbidities like hypertension, obesity, and high lipids, and achieving lifestyle changes.”

Carlos Franco, MD, a cardiologist in El Salvador, emphasized that there is no such thing as zero risk when evaluating a patient. “Of course, there’s a difference between an athlete and someone who isn’t physically active, but we need to profile all patients correctly, evaluate risk factors in detail, not overlook subclinical cardiovascular disease, and check whether they need stress testing or additional imaging to assess cardiac functional capacity. Also, exercise must be prescribed gradually, and the patient’s nutritional status must be assessed.”

Dr. Franco ended by explaining that physicians must understand how to prescribe the basics of exercise and make small interventions of reasonable intensity, provide practical advice, and, to the extent possible, rely on specialists such as physiatrists, sports specialists, and physical therapists.

This article was translated from the Medscape Spanish Edition. A version of this article appeared on Medscape.com.

AMSTERDAM – At the Radical Health Festival Helsinki this past June, Gerhard Hindricks, MD, PhD, was challenged by a young man when he dared to look into the crystal ball. “In the middle of my presentation, a maybe 25-year-old man stood up and said, ‘Dr. Hindricks, in 10 years, we will no longer need you!’ ” Dr. Hindricks noted at the great debate event “Will Artificial Intelligence Replace Cardiologists?” held at the annual congress of the European Society of Cardiology. He subsequently had an interesting discussion with the man. In his opinion, the future role of the physician is “an unavoidable discussion for cardiovascular medicine.”

Dr. Hindricks, from the University of Leipzig (Germany), considered artificial intelligence in cardiology to be “potentially the most important topic of the congress” and suggested that “we have to be more open to introducing new technologies into our practice. I sometimes have the impression that we are neither quick nor open enough to introducing new technologies, to leaving the old and to letting the new, better technology be effective in our patients.”
 

Asset or threat?

AI is dramatically changing the field and the role of the physician – but it is not making cardiologists superfluous. In this respect, Dr. Hindricks; Folkert Asselbergs, MD, PhD, professor of cardiology at the Amsterdam Heart Center; and Harriette Van Spall, MD, associate professor of medicine at McMaster University in Hamilton, Ont., were unanimous: They agreed, although they assess the opportunities and risks posed by AI differently.

Dr. Asselbergs saw AI as less of a threat and more of an asset. In his opinion, a cardiology-specific speech model could be used to the advantage of both patient and physician. A medical chatbot could offer patients information and suggested readings, and it could create the patient’s self-reported medical history and medical summaries for laypersons.

For physicians, a medical chatbot could be beneficial in the creation of patient reports, the selection of relevant literature, the creation of automated laboratory orders, the review of clinical discharge reports, for consultations, and for processing the consultations, as well as for complying with guidelines.

Dr. Asselbergs considered AI’s primary advantage to be the time that it saves, which can then be used “for complex interventions, palliative care, and acute treatment.”

The advantages of AI, he said, include the following:

• Efficiency and scale of AI in data analysis
• Automation
• AI does not get tired and is not biased
• Proactive health care provision and early intervention
• Reduction in health care costs
• Remains up to date with the latest knowledge.

He sees the following disadvantages:

• Lack of human contact, empathy, and the physician-patient relationship
• Ethical implications and challenges
• The potential for AI to make incorrect diagnoses or to be influenced by bias in the training data.

Medical supervision needed

For Dr. Van Spall, AI is primarily a tool. A generative AI could create useful materials such as images, videos, text, sound, 3D models, virtual environments, notes for clinical visits, medical summaries, and answers to clinical queries. But “the use of AI can lead to misinformation and expose the patient to risk, and there are no laws regulating liability.”

Dr. Van Spall stressed that AI could greatly increase efficiency. For example, in echocardiography, chamber volumes and function can be quantified automatically. ECGs can be interpreted automatically. “Even the workload associated with reading off of screens can be reduced, compared with unsupported reading.” However, she maintained that the use of AI requires medical supervision. “AI cannot function without cardiologists,” since it has “enormous limitations.” Dr. Van Spall does not see “any way to close the gaps that cardiologists may leave in terms of knowledge, service, and communication.”

According to the American College of Cardiology, 26% of the 32,000 cardiologists in the United States are older than 61 years. “That is a net loss of 546 cardiologists per year. We must use AI to support cardiologists, not to replace them,” said Dr. Van Spall.
 

Cardiologists becoming supervisors?

Dr. Asselbergs saw AI as a means of creating more equality. “Nearly everyone now has a smartphone. Let’s take ultrasound via AI as an example. There are rural areas that have no access to health care. If nurses or dietitians there create an ultrasound based on AI and send pictures for medical analysis, it will really help people.”

Dr. Hindricks hypothesized that machine learning and AI will make a huge difference in the field of rare diseases. Rare diseases are massively underdiagnosed simply because they are so rare and it requires a lot of experience to recognize them. “Digital elements can significantly support this,” said Dr. Hindricks.

For Dr. Van Spall, AI could make care and treatment safer. There will be more digital tools and virtual models available during training too. “I believe that the cardiologist will continue to occupy an important role, in terms of communication and processes. I do not see this role disappearing,” she said. Efficiency and precision are so important. “To make good decisions, we also want to get in touch with the person we trust.”

For Dr. Asselbergs, the role of cardiologists will change to one of a supervisor. “More joint decision-making, more discussion with our patients: I think this is the direction we’re heading in.”

This article was translated from the Medscape German Edition.

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

AMSTERDAM – At the Radical Health Festival Helsinki this past June, Gerhard Hindricks, MD, PhD, was challenged by a young man when he dared to look into the crystal ball. “In the middle of my presentation, a maybe 25-year-old man stood up and said, ‘Dr. Hindricks, in 10 years, we will no longer need you!’ ” Dr. Hindricks noted at the great debate event “Will Artificial Intelligence Replace Cardiologists?” held at the annual congress of the European Society of Cardiology. He subsequently had an interesting discussion with the man. In his opinion, the future role of the physician is “an unavoidable discussion for cardiovascular medicine.”

Dr. Hindricks, from the University of Leipzig (Germany), considered artificial intelligence in cardiology to be “potentially the most important topic of the congress” and suggested that “we have to be more open to introducing new technologies into our practice. I sometimes have the impression that we are neither quick nor open enough to introducing new technologies, to leaving the old and to letting the new, better technology be effective in our patients.”
 

Asset or threat?

AI is dramatically changing the field and the role of the physician – but it is not making cardiologists superfluous. In this respect, Dr. Hindricks; Folkert Asselbergs, MD, PhD, professor of cardiology at the Amsterdam Heart Center; and Harriette Van Spall, MD, associate professor of medicine at McMaster University in Hamilton, Ont., were unanimous: They agreed, although they assess the opportunities and risks posed by AI differently.

Dr. Asselbergs saw AI as less of a threat and more of an asset. In his opinion, a cardiology-specific speech model could be used to the advantage of both patient and physician. A medical chatbot could offer patients information and suggested readings, and it could create the patient’s self-reported medical history and medical summaries for laypersons.

For physicians, a medical chatbot could be beneficial in the creation of patient reports, the selection of relevant literature, the creation of automated laboratory orders, the review of clinical discharge reports, for consultations, and for processing the consultations, as well as for complying with guidelines.

Dr. Asselbergs considered AI’s primary advantage to be the time that it saves, which can then be used “for complex interventions, palliative care, and acute treatment.”

The advantages of AI, he said, include the following:

• Efficiency and scale of AI in data analysis
• Automation
• AI does not get tired and is not biased
• Proactive health care provision and early intervention
• Reduction in health care costs
• Remains up to date with the latest knowledge.

He sees the following disadvantages:

• Lack of human contact, empathy, and the physician-patient relationship
• Ethical implications and challenges
• The potential for AI to make incorrect diagnoses or to be influenced by bias in the training data.

Medical supervision needed

For Dr. Van Spall, AI is primarily a tool. A generative AI could create useful materials such as images, videos, text, sound, 3D models, virtual environments, notes for clinical visits, medical summaries, and answers to clinical queries. But “the use of AI can lead to misinformation and expose the patient to risk, and there are no laws regulating liability.”

Dr. Van Spall stressed that AI could greatly increase efficiency. For example, in echocardiography, chamber volumes and function can be quantified automatically. ECGs can be interpreted automatically. “Even the workload associated with reading off of screens can be reduced, compared with unsupported reading.” However, she maintained that the use of AI requires medical supervision. “AI cannot function without cardiologists,” since it has “enormous limitations.” Dr. Van Spall does not see “any way to close the gaps that cardiologists may leave in terms of knowledge, service, and communication.”

According to the American College of Cardiology, 26% of the 32,000 cardiologists in the United States are older than 61 years. “That is a net loss of 546 cardiologists per year. We must use AI to support cardiologists, not to replace them,” said Dr. Van Spall.
 

Cardiologists becoming supervisors?

Dr. Asselbergs saw AI as a means of creating more equality. “Nearly everyone now has a smartphone. Let’s take ultrasound via AI as an example. There are rural areas that have no access to health care. If nurses or dietitians there create an ultrasound based on AI and send pictures for medical analysis, it will really help people.”

Dr. Hindricks hypothesized that machine learning and AI will make a huge difference in the field of rare diseases. Rare diseases are massively underdiagnosed simply because they are so rare and it requires a lot of experience to recognize them. “Digital elements can significantly support this,” said Dr. Hindricks.

For Dr. Van Spall, AI could make care and treatment safer. There will be more digital tools and virtual models available during training too. “I believe that the cardiologist will continue to occupy an important role, in terms of communication and processes. I do not see this role disappearing,” she said. Efficiency and precision are so important. “To make good decisions, we also want to get in touch with the person we trust.”

For Dr. Asselbergs, the role of cardiologists will change to one of a supervisor. “More joint decision-making, more discussion with our patients: I think this is the direction we’re heading in.”

This article was translated from the Medscape German Edition.

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

AMSTERDAM – At the Radical Health Festival Helsinki this past June, Gerhard Hindricks, MD, PhD, was challenged by a young man when he dared to look into the crystal ball. “In the middle of my presentation, a maybe 25-year-old man stood up and said, ‘Dr. Hindricks, in 10 years, we will no longer need you!’ ” Dr. Hindricks noted at the great debate event “Will Artificial Intelligence Replace Cardiologists?” held at the annual congress of the European Society of Cardiology. He subsequently had an interesting discussion with the man. In his opinion, the future role of the physician is “an unavoidable discussion for cardiovascular medicine.”

Dr. Hindricks, from the University of Leipzig (Germany), considered artificial intelligence in cardiology to be “potentially the most important topic of the congress” and suggested that “we have to be more open to introducing new technologies into our practice. I sometimes have the impression that we are neither quick nor open enough to introducing new technologies, to leaving the old and to letting the new, better technology be effective in our patients.”
 

Asset or threat?

AI is dramatically changing the field and the role of the physician – but it is not making cardiologists superfluous. In this respect, Dr. Hindricks; Folkert Asselbergs, MD, PhD, professor of cardiology at the Amsterdam Heart Center; and Harriette Van Spall, MD, associate professor of medicine at McMaster University in Hamilton, Ont., were unanimous: They agreed, although they assess the opportunities and risks posed by AI differently.

Dr. Asselbergs saw AI as less of a threat and more of an asset. In his opinion, a cardiology-specific speech model could be used to the advantage of both patient and physician. A medical chatbot could offer patients information and suggested readings, and it could create the patient’s self-reported medical history and medical summaries for laypersons.

For physicians, a medical chatbot could be beneficial in the creation of patient reports, the selection of relevant literature, the creation of automated laboratory orders, the review of clinical discharge reports, for consultations, and for processing the consultations, as well as for complying with guidelines.

Dr. Asselbergs considered AI’s primary advantage to be the time that it saves, which can then be used “for complex interventions, palliative care, and acute treatment.”

The advantages of AI, he said, include the following:

• Efficiency and scale of AI in data analysis
• Automation
• AI does not get tired and is not biased
• Proactive health care provision and early intervention
• Reduction in health care costs
• Remains up to date with the latest knowledge.

He sees the following disadvantages:

• Lack of human contact, empathy, and the physician-patient relationship
• Ethical implications and challenges
• The potential for AI to make incorrect diagnoses or to be influenced by bias in the training data.

Medical supervision needed

For Dr. Van Spall, AI is primarily a tool. A generative AI could create useful materials such as images, videos, text, sound, 3D models, virtual environments, notes for clinical visits, medical summaries, and answers to clinical queries. But “the use of AI can lead to misinformation and expose the patient to risk, and there are no laws regulating liability.”

Dr. Van Spall stressed that AI could greatly increase efficiency. For example, in echocardiography, chamber volumes and function can be quantified automatically. ECGs can be interpreted automatically. “Even the workload associated with reading off of screens can be reduced, compared with unsupported reading.” However, she maintained that the use of AI requires medical supervision. “AI cannot function without cardiologists,” since it has “enormous limitations.” Dr. Van Spall does not see “any way to close the gaps that cardiologists may leave in terms of knowledge, service, and communication.”

According to the American College of Cardiology, 26% of the 32,000 cardiologists in the United States are older than 61 years. “That is a net loss of 546 cardiologists per year. We must use AI to support cardiologists, not to replace them,” said Dr. Van Spall.
 

Cardiologists becoming supervisors?

Dr. Asselbergs saw AI as a means of creating more equality. “Nearly everyone now has a smartphone. Let’s take ultrasound via AI as an example. There are rural areas that have no access to health care. If nurses or dietitians there create an ultrasound based on AI and send pictures for medical analysis, it will really help people.”

Dr. Hindricks hypothesized that machine learning and AI will make a huge difference in the field of rare diseases. Rare diseases are massively underdiagnosed simply because they are so rare and it requires a lot of experience to recognize them. “Digital elements can significantly support this,” said Dr. Hindricks.

For Dr. Van Spall, AI could make care and treatment safer. There will be more digital tools and virtual models available during training too. “I believe that the cardiologist will continue to occupy an important role, in terms of communication and processes. I do not see this role disappearing,” she said. Efficiency and precision are so important. “To make good decisions, we also want to get in touch with the person we trust.”

For Dr. Asselbergs, the role of cardiologists will change to one of a supervisor. “More joint decision-making, more discussion with our patients: I think this is the direction we’re heading in.”

This article was translated from the Medscape German Edition.

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

AMSTERDAM – A short course of the interleukin-1 receptor antagonist, anakinra, appeared safe but did not reduce complications of acute myocarditis in the ARAMIS trial.

The trial was presented at the annual congress of the European Society of Cardiology.

Lead investigator, Mathieu Kerneis, MD, Pitie Salpetriere APHP University Hospital, Paris, said this was the largest randomized controlled trial of patients with acute myocarditis and probably the first ever study in the acute setting of myocarditis patients diagnosed with cardiac magnetic resonance (CMR) imaging, not on biopsy, who are mostly at low risk for events.

He suggested that one of the reasons for the neutral result could have been the low-risk population involved and the low complication rate. “We enrolled an all-comer acute myocarditis population diagnosed with CMR, who were mostly at a low risk of complications,” he noted.

“I don’t think the story of anti-inflammatory drugs in acute myocarditis is over. This is just the beginning. This was the first trial, and it was just a phase 2 trial. We need further randomized trials to explore the potential benefit of an anti-inflammatory strategy in acute myocarditis patients at higher risk of complications. In addition, larger studies are needed to evaluate prolonged anti-inflammatory strategies in acute myocarditis patients at low-to-moderate risk of complications,” Dr. Kerneis concluded.

“It is very challenging to do a trial in high-risk patients with myocarditis as these patients are quite rare,” he added.
 

Inflammation of the myocardium

Dr. Kerneis explained that acute myocarditis is an inflammation of the myocardium that can cause permanent damage to the heart muscle and lead to myocardial infarction, stroke, heart failure, arrhythmias, and death. The condition can occur in individuals of all ages but is most frequent in young people. There is no specific treatment, but patients are generally treated with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and sometimes steroids.

Anakinra is an interleukin-1 receptor antagonist that works by targeting the interleukin-1β innate immune pathway. Anakinra is used for the treatment of rheumatoid arthritis and has shown efficacy in pericarditis. Dr. Kerneis noted that there have been several case reports of successful treatment with anakinra in acute myocarditis.

The ARAMIS trial – conducted at six academic centers in France – was the first randomized study to evaluate inhibition of the interleukin-1β innate immune pathway in myocarditis patients. The trial enrolled 120 hospitalized, symptomatic patients with chest pain, increased cardiac troponin, and acute myocarditis diagnosed using CMR. More than half had had a recent bacterial or viral infection.

Patients were randomized within 72 hours of hospital admission to a daily subcutaneous dose of anakinra 100 mg or placebo until hospital discharge. Patients in both groups received standard-of-care treatments, including an ACE inhibitor, for at least 1 month. Consistent with prior data, the median age of participants was 28 years and 90% were men.

The primary endpoint was the number of days free of myocarditis complications (heart failure requiring hospitalization, chest pain requiring medication, left ventricular ejection fraction less than 50%, and ventricular arrhythmias) within 28 days postdischarge.

There was no significant difference in this endpoint between the two arms, with a median of 30 days for anakinra versus 31 days for placebo.

Overall, the rate of the composite endpoint of myocarditis complications occurred in 13.7% of patients, and there was a numerical reduction in the number of patients with these myocarditis complications with anakinra – 6 patients (10.5%) in the anakinra group versus 10 patients (16.5%) in the placebo group (odds ratio, 0.59; 95% confidence interval, 0.19-1.78). This was driven by fewer patients with chest pain requiring new medication (two patients versus six patients).

The safety endpoint was the number of serious adverse events within 28 days postdischarge. This endpoint occurred in seven patients (12.1%) in the anakinra arm and six patients (10.2%) in the placebo arm, with no significant difference between groups. Cases of severe infection within 28 days postdischarge were reported in both arms.
 

Low-risk population

Designated discussant of the study at the ESC Hotline session, Enrico Ammirati, MD, PhD, University of Milano-Bicocca, Monza, Italy, said that patients involved in ARAMIS fit the profile of acute myocarditis and that the CMR diagnosis was positive in all the patients enrolled.

Dr. Ammirati agreed with Dr. Kerneis that the neutral results of the study were probably caused by the low-risk population. “If we look at retrospective registries, at 30 days there are zero cardiac deaths or heart transplants at 30 days in patients with a low-risk presentation.

“The ARAMIS trial has shown the feasibility of conducting studies in the setting of acute myocarditis, and even if the primary endpoint was neutral, some important data are still missing, such as change in ejection fraction and troponin levels,” he noted.

“In terms of future perspective, we are moving to assessing efficacy of anakinra or other immunosuppressive drugs from acute low risk patients to higher risk patients with heart failure and severe dysfunction,” he said.  

Dr. Ammirati is the lead investigator of another ongoing study in such a higher-risk population; the MYTHS trial is investigating the use of intravenous steroids in patients with suspected acute myocarditis complicated by acute heart failure or cardiogenic shock, and an ejection fraction below 41%.

“So, we will have more results on the best treatment in this higher risk group of patients,” he concluded.

The ARAMIS trial was an academic study funded by the French Health Ministry and coordinated by the ACTION Group. Dr. Kerneis reports having received consulting fees from Kiniksa, Sanofi, and Bayer, and holds a patent for use of abatacept in immune checkpoint inhibitor (ICI)–induced myocarditis.

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

AMSTERDAM – A short course of the interleukin-1 receptor antagonist, anakinra, appeared safe but did not reduce complications of acute myocarditis in the ARAMIS trial.

The trial was presented at the annual congress of the European Society of Cardiology.

Lead investigator, Mathieu Kerneis, MD, Pitie Salpetriere APHP University Hospital, Paris, said this was the largest randomized controlled trial of patients with acute myocarditis and probably the first ever study in the acute setting of myocarditis patients diagnosed with cardiac magnetic resonance (CMR) imaging, not on biopsy, who are mostly at low risk for events.

He suggested that one of the reasons for the neutral result could have been the low-risk population involved and the low complication rate. “We enrolled an all-comer acute myocarditis population diagnosed with CMR, who were mostly at a low risk of complications,” he noted.

“I don’t think the story of anti-inflammatory drugs in acute myocarditis is over. This is just the beginning. This was the first trial, and it was just a phase 2 trial. We need further randomized trials to explore the potential benefit of an anti-inflammatory strategy in acute myocarditis patients at higher risk of complications. In addition, larger studies are needed to evaluate prolonged anti-inflammatory strategies in acute myocarditis patients at low-to-moderate risk of complications,” Dr. Kerneis concluded.

“It is very challenging to do a trial in high-risk patients with myocarditis as these patients are quite rare,” he added.
 

Inflammation of the myocardium

Dr. Kerneis explained that acute myocarditis is an inflammation of the myocardium that can cause permanent damage to the heart muscle and lead to myocardial infarction, stroke, heart failure, arrhythmias, and death. The condition can occur in individuals of all ages but is most frequent in young people. There is no specific treatment, but patients are generally treated with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and sometimes steroids.

Anakinra is an interleukin-1 receptor antagonist that works by targeting the interleukin-1β innate immune pathway. Anakinra is used for the treatment of rheumatoid arthritis and has shown efficacy in pericarditis. Dr. Kerneis noted that there have been several case reports of successful treatment with anakinra in acute myocarditis.

The ARAMIS trial – conducted at six academic centers in France – was the first randomized study to evaluate inhibition of the interleukin-1β innate immune pathway in myocarditis patients. The trial enrolled 120 hospitalized, symptomatic patients with chest pain, increased cardiac troponin, and acute myocarditis diagnosed using CMR. More than half had had a recent bacterial or viral infection.

Patients were randomized within 72 hours of hospital admission to a daily subcutaneous dose of anakinra 100 mg or placebo until hospital discharge. Patients in both groups received standard-of-care treatments, including an ACE inhibitor, for at least 1 month. Consistent with prior data, the median age of participants was 28 years and 90% were men.

The primary endpoint was the number of days free of myocarditis complications (heart failure requiring hospitalization, chest pain requiring medication, left ventricular ejection fraction less than 50%, and ventricular arrhythmias) within 28 days postdischarge.

There was no significant difference in this endpoint between the two arms, with a median of 30 days for anakinra versus 31 days for placebo.

Overall, the rate of the composite endpoint of myocarditis complications occurred in 13.7% of patients, and there was a numerical reduction in the number of patients with these myocarditis complications with anakinra – 6 patients (10.5%) in the anakinra group versus 10 patients (16.5%) in the placebo group (odds ratio, 0.59; 95% confidence interval, 0.19-1.78). This was driven by fewer patients with chest pain requiring new medication (two patients versus six patients).

The safety endpoint was the number of serious adverse events within 28 days postdischarge. This endpoint occurred in seven patients (12.1%) in the anakinra arm and six patients (10.2%) in the placebo arm, with no significant difference between groups. Cases of severe infection within 28 days postdischarge were reported in both arms.
 

Low-risk population

Designated discussant of the study at the ESC Hotline session, Enrico Ammirati, MD, PhD, University of Milano-Bicocca, Monza, Italy, said that patients involved in ARAMIS fit the profile of acute myocarditis and that the CMR diagnosis was positive in all the patients enrolled.

Dr. Ammirati agreed with Dr. Kerneis that the neutral results of the study were probably caused by the low-risk population. “If we look at retrospective registries, at 30 days there are zero cardiac deaths or heart transplants at 30 days in patients with a low-risk presentation.

“The ARAMIS trial has shown the feasibility of conducting studies in the setting of acute myocarditis, and even if the primary endpoint was neutral, some important data are still missing, such as change in ejection fraction and troponin levels,” he noted.

“In terms of future perspective, we are moving to assessing efficacy of anakinra or other immunosuppressive drugs from acute low risk patients to higher risk patients with heart failure and severe dysfunction,” he said.  

Dr. Ammirati is the lead investigator of another ongoing study in such a higher-risk population; the MYTHS trial is investigating the use of intravenous steroids in patients with suspected acute myocarditis complicated by acute heart failure or cardiogenic shock, and an ejection fraction below 41%.

“So, we will have more results on the best treatment in this higher risk group of patients,” he concluded.

The ARAMIS trial was an academic study funded by the French Health Ministry and coordinated by the ACTION Group. Dr. Kerneis reports having received consulting fees from Kiniksa, Sanofi, and Bayer, and holds a patent for use of abatacept in immune checkpoint inhibitor (ICI)–induced myocarditis.

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

AMSTERDAM – A short course of the interleukin-1 receptor antagonist, anakinra, appeared safe but did not reduce complications of acute myocarditis in the ARAMIS trial.

The trial was presented at the annual congress of the European Society of Cardiology.

Lead investigator, Mathieu Kerneis, MD, Pitie Salpetriere APHP University Hospital, Paris, said this was the largest randomized controlled trial of patients with acute myocarditis and probably the first ever study in the acute setting of myocarditis patients diagnosed with cardiac magnetic resonance (CMR) imaging, not on biopsy, who are mostly at low risk for events.

He suggested that one of the reasons for the neutral result could have been the low-risk population involved and the low complication rate. “We enrolled an all-comer acute myocarditis population diagnosed with CMR, who were mostly at a low risk of complications,” he noted.

“I don’t think the story of anti-inflammatory drugs in acute myocarditis is over. This is just the beginning. This was the first trial, and it was just a phase 2 trial. We need further randomized trials to explore the potential benefit of an anti-inflammatory strategy in acute myocarditis patients at higher risk of complications. In addition, larger studies are needed to evaluate prolonged anti-inflammatory strategies in acute myocarditis patients at low-to-moderate risk of complications,” Dr. Kerneis concluded.

“It is very challenging to do a trial in high-risk patients with myocarditis as these patients are quite rare,” he added.
 

Inflammation of the myocardium

Dr. Kerneis explained that acute myocarditis is an inflammation of the myocardium that can cause permanent damage to the heart muscle and lead to myocardial infarction, stroke, heart failure, arrhythmias, and death. The condition can occur in individuals of all ages but is most frequent in young people. There is no specific treatment, but patients are generally treated with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and sometimes steroids.

Anakinra is an interleukin-1 receptor antagonist that works by targeting the interleukin-1β innate immune pathway. Anakinra is used for the treatment of rheumatoid arthritis and has shown efficacy in pericarditis. Dr. Kerneis noted that there have been several case reports of successful treatment with anakinra in acute myocarditis.

The ARAMIS trial – conducted at six academic centers in France – was the first randomized study to evaluate inhibition of the interleukin-1β innate immune pathway in myocarditis patients. The trial enrolled 120 hospitalized, symptomatic patients with chest pain, increased cardiac troponin, and acute myocarditis diagnosed using CMR. More than half had had a recent bacterial or viral infection.

Patients were randomized within 72 hours of hospital admission to a daily subcutaneous dose of anakinra 100 mg or placebo until hospital discharge. Patients in both groups received standard-of-care treatments, including an ACE inhibitor, for at least 1 month. Consistent with prior data, the median age of participants was 28 years and 90% were men.

The primary endpoint was the number of days free of myocarditis complications (heart failure requiring hospitalization, chest pain requiring medication, left ventricular ejection fraction less than 50%, and ventricular arrhythmias) within 28 days postdischarge.

There was no significant difference in this endpoint between the two arms, with a median of 30 days for anakinra versus 31 days for placebo.

Overall, the rate of the composite endpoint of myocarditis complications occurred in 13.7% of patients, and there was a numerical reduction in the number of patients with these myocarditis complications with anakinra – 6 patients (10.5%) in the anakinra group versus 10 patients (16.5%) in the placebo group (odds ratio, 0.59; 95% confidence interval, 0.19-1.78). This was driven by fewer patients with chest pain requiring new medication (two patients versus six patients).

The safety endpoint was the number of serious adverse events within 28 days postdischarge. This endpoint occurred in seven patients (12.1%) in the anakinra arm and six patients (10.2%) in the placebo arm, with no significant difference between groups. Cases of severe infection within 28 days postdischarge were reported in both arms.
 

Low-risk population

Designated discussant of the study at the ESC Hotline session, Enrico Ammirati, MD, PhD, University of Milano-Bicocca, Monza, Italy, said that patients involved in ARAMIS fit the profile of acute myocarditis and that the CMR diagnosis was positive in all the patients enrolled.

Dr. Ammirati agreed with Dr. Kerneis that the neutral results of the study were probably caused by the low-risk population. “If we look at retrospective registries, at 30 days there are zero cardiac deaths or heart transplants at 30 days in patients with a low-risk presentation.

“The ARAMIS trial has shown the feasibility of conducting studies in the setting of acute myocarditis, and even if the primary endpoint was neutral, some important data are still missing, such as change in ejection fraction and troponin levels,” he noted.

“In terms of future perspective, we are moving to assessing efficacy of anakinra or other immunosuppressive drugs from acute low risk patients to higher risk patients with heart failure and severe dysfunction,” he said.  

Dr. Ammirati is the lead investigator of another ongoing study in such a higher-risk population; the MYTHS trial is investigating the use of intravenous steroids in patients with suspected acute myocarditis complicated by acute heart failure or cardiogenic shock, and an ejection fraction below 41%.

“So, we will have more results on the best treatment in this higher risk group of patients,” he concluded.

The ARAMIS trial was an academic study funded by the French Health Ministry and coordinated by the ACTION Group. Dr. Kerneis reports having received consulting fees from Kiniksa, Sanofi, and Bayer, and holds a patent for use of abatacept in immune checkpoint inhibitor (ICI)–induced myocarditis.

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

TOPLINE:

In contrast to an overall decline in cardiovascular mortality, obesity-related cardiovascular deaths have risen substantially in the past 2 decades, most prominently among Black women. “We observed a threefold increase in obesity-related cardiovascular age-adjusted mortality rates between 1999 and 2020,” wrote the authors.

METHODOLOGY:

Data from the U.S. population-level Multiple Cause of Death database were analyzed, including 281,135 deaths in 1999-2020 for which obesity was listed as a contributing factor.

TAKEAWAY:

• Overall, the crude rate of all cardiovascular deaths dropped by 17.6% across all races.
• However, age-adjusted obesity-related cardiovascular mortality tripled from 2.2/100,000 to 6.6/100,000 from 1999 to 2020, consistent across all racial groups.
• Blacks had the highest age-adjusted obesity-related cardiovascular mortality (rising from 4.2/100,000 in 1999 to 11.6/100,000 in 2000).
• Ischemic heart disease was the most common cardiovascular cause of death across all races, and hypertensive disease was second.
• Age-adjusted obesity-related cardiovascular mortality was higher among Blacks (6.7/100,000) than any other racial group, followed by American Indians or Alaskan Natives (3.8/100,000), and lowest among Asian or Pacific Islanders (0.9/100,000).
• The risk of obesity-related cardiovascular disease death rose most rapidly among American Indians and Alaskan Natives.
• Among Blacks, age-adjusted mortality was slightly higher among women than men (6.7/100,000 vs. 6.6/100,000), whereas the reverse was true for all other races (0.6-3.0/100,000 vs. 1.2-6.0/100,000).
• Blacks living in urban settings experienced higher rates of age-adjusted cardiovascular mortality than those living in rural areas (6.8/100,000 vs. 5.9/100,000), whereas the opposite was true for all other racial groups (0.9-3.5/100,000 vs. 2.2-5.4/100,000).

IN PRACTICE:

“There is need for dedicated health strategies aimed at individual communities to better understand and tackle the social determinants of obesity and to design interventions that may alleviate the population burden of both obesity and cardiovascular disease,” the authors wrote.

SOURCE:

The study, by Zahra Raisi-Estabragh, MD, PhD, Queen Mary University, London, and colleagues, was published online Sept. 6 in the Journal of the American Heart Association.

LIMITATIONS:

• Database limited to U.S. residents.
• Possible miscoding or diagnostic errors.
• Potential for residual confounding.
• No data on underlying drivers of observed trends.

DISCLOSURES:

Dr. Raisi-Estabragh has reported receiving funding from the Integrated Academic Training program of the National Institute for Health Research and a Clinical Research Training Fellowship from the British Heart Foundation. Another author has reported receiving research support from the National Heart, Lung, and Blood Institute.

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

TOPLINE:

In contrast to an overall decline in cardiovascular mortality, obesity-related cardiovascular deaths have risen substantially in the past 2 decades, most prominently among Black women. “We observed a threefold increase in obesity-related cardiovascular age-adjusted mortality rates between 1999 and 2020,” wrote the authors.

METHODOLOGY:

Data from the U.S. population-level Multiple Cause of Death database were analyzed, including 281,135 deaths in 1999-2020 for which obesity was listed as a contributing factor.

TAKEAWAY:

• Overall, the crude rate of all cardiovascular deaths dropped by 17.6% across all races.
• However, age-adjusted obesity-related cardiovascular mortality tripled from 2.2/100,000 to 6.6/100,000 from 1999 to 2020, consistent across all racial groups.
• Blacks had the highest age-adjusted obesity-related cardiovascular mortality (rising from 4.2/100,000 in 1999 to 11.6/100,000 in 2000).
• Ischemic heart disease was the most common cardiovascular cause of death across all races, and hypertensive disease was second.
• Age-adjusted obesity-related cardiovascular mortality was higher among Blacks (6.7/100,000) than any other racial group, followed by American Indians or Alaskan Natives (3.8/100,000), and lowest among Asian or Pacific Islanders (0.9/100,000).
• The risk of obesity-related cardiovascular disease death rose most rapidly among American Indians and Alaskan Natives.
• Among Blacks, age-adjusted mortality was slightly higher among women than men (6.7/100,000 vs. 6.6/100,000), whereas the reverse was true for all other races (0.6-3.0/100,000 vs. 1.2-6.0/100,000).
• Blacks living in urban settings experienced higher rates of age-adjusted cardiovascular mortality than those living in rural areas (6.8/100,000 vs. 5.9/100,000), whereas the opposite was true for all other racial groups (0.9-3.5/100,000 vs. 2.2-5.4/100,000).

IN PRACTICE:

“There is need for dedicated health strategies aimed at individual communities to better understand and tackle the social determinants of obesity and to design interventions that may alleviate the population burden of both obesity and cardiovascular disease,” the authors wrote.

SOURCE:

The study, by Zahra Raisi-Estabragh, MD, PhD, Queen Mary University, London, and colleagues, was published online Sept. 6 in the Journal of the American Heart Association.

LIMITATIONS:

• Database limited to U.S. residents.
• Possible miscoding or diagnostic errors.
• Potential for residual confounding.
• No data on underlying drivers of observed trends.

DISCLOSURES:

Dr. Raisi-Estabragh has reported receiving funding from the Integrated Academic Training program of the National Institute for Health Research and a Clinical Research Training Fellowship from the British Heart Foundation. Another author has reported receiving research support from the National Heart, Lung, and Blood Institute.

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

TOPLINE:

In contrast to an overall decline in cardiovascular mortality, obesity-related cardiovascular deaths have risen substantially in the past 2 decades, most prominently among Black women. “We observed a threefold increase in obesity-related cardiovascular age-adjusted mortality rates between 1999 and 2020,” wrote the authors.

METHODOLOGY:

Data from the U.S. population-level Multiple Cause of Death database were analyzed, including 281,135 deaths in 1999-2020 for which obesity was listed as a contributing factor.

TAKEAWAY:

• Overall, the crude rate of all cardiovascular deaths dropped by 17.6% across all races.
• However, age-adjusted obesity-related cardiovascular mortality tripled from 2.2/100,000 to 6.6/100,000 from 1999 to 2020, consistent across all racial groups.
• Blacks had the highest age-adjusted obesity-related cardiovascular mortality (rising from 4.2/100,000 in 1999 to 11.6/100,000 in 2000).
• Ischemic heart disease was the most common cardiovascular cause of death across all races, and hypertensive disease was second.
• Age-adjusted obesity-related cardiovascular mortality was higher among Blacks (6.7/100,000) than any other racial group, followed by American Indians or Alaskan Natives (3.8/100,000), and lowest among Asian or Pacific Islanders (0.9/100,000).
• The risk of obesity-related cardiovascular disease death rose most rapidly among American Indians and Alaskan Natives.
• Among Blacks, age-adjusted mortality was slightly higher among women than men (6.7/100,000 vs. 6.6/100,000), whereas the reverse was true for all other races (0.6-3.0/100,000 vs. 1.2-6.0/100,000).
• Blacks living in urban settings experienced higher rates of age-adjusted cardiovascular mortality than those living in rural areas (6.8/100,000 vs. 5.9/100,000), whereas the opposite was true for all other racial groups (0.9-3.5/100,000 vs. 2.2-5.4/100,000).

IN PRACTICE:

“There is need for dedicated health strategies aimed at individual communities to better understand and tackle the social determinants of obesity and to design interventions that may alleviate the population burden of both obesity and cardiovascular disease,” the authors wrote.

SOURCE:

The study, by Zahra Raisi-Estabragh, MD, PhD, Queen Mary University, London, and colleagues, was published online Sept. 6 in the Journal of the American Heart Association.

LIMITATIONS:

• Database limited to U.S. residents.
• Possible miscoding or diagnostic errors.
• Potential for residual confounding.
• No data on underlying drivers of observed trends.

DISCLOSURES:

Dr. Raisi-Estabragh has reported receiving funding from the Integrated Academic Training program of the National Institute for Health Research and a Clinical Research Training Fellowship from the British Heart Foundation. Another author has reported receiving research support from the National Heart, Lung, and Blood Institute.

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

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

AMSTERDAM – Dropping aspirin and using low-dose prasugrel (Effient) alone in the initial month of treatment after percutaneous coronary intervention (PCI) failed to lower bleeding risk, compared with dual antiplatelet therapy (DAPT), and there was a signal of possible harm in terms of increased subacute stent thrombosis, in the STOPDAPT-3 trial.

“Therefore, dual antiplatelet therapy with aspirin and a P2Y12 inhibitor should still remain the standard strategy at least for 1 month after PCI,” said the trial’s lead investigator Masahiro Natsuaki, MD, Saga (Japan) University.

The STOPDAPT-3 trial was presented at the recent annual congress of the European Society of Cardiology.

Designated discussant Marco Valgimigli, MD, Cardiocentro Ticino Foundation, Lugano, Switzerland, explained that the current wisdom before this study was that aspirin withdrawal in the postacute phase after PCI (after 1 month of DAPT onwards) is associated with lower bleeding risk without affecting ischemic risk, but this STOPDAPT-3 trial is the first to look at the idea of not giving aspirin at all.

“This study is a well-designed, well-conducted trial, and the results are very clear: there is no benefit of dropping aspirin in this early period with respect to major bleeding, and at the same time there was some signal for possible harm,” Dr. Valgimigli said.

He pointed out that the possible harm was not related to the coprimary cardiovascular composite endpoint, which did fulfill noninferiority, although he acknowledged the “generous” noninferiority margin.

Rather, the possible harm was related to an increase in subacute stent thrombosis, which was three times higher in the nonaspirin group (0.58% vs. 0.17%). 

“While these absolute event rates are extremely low, they are unquestionably higher in the nonaspirin group,” he added.

In his presentation, Dr. Natsuaki explained that very short durations (1-3 months) of DAPT followed by P2Y12 inhibitor monotherapy has been shown to reduce bleeding events without increasing cardiovascular events, compared with longer durations of DAPT after PCI using drug-eluting stents.

However, the incidence of major bleeding events within the 1-month mandatory DAPT period after PCI remains high in clinical practice, particularly in patients with ACS or high bleeding risk.

In single-arm studies, use of prasugrel or ticagrelor (Brilinta) alone following new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with or without ACS, and it is thought that removing aspirin from the DAPT regimen might reduce bleeding events early after PCI without compromising the risk of cardiovascular events. However, the efficacy and safety of this strategy has not been proven in randomized trials.
 

STOPDAPT-3 trial

STOPDAPT-3 investigated the efficacy and safety of prasugrel monotherapy compared with 1-month DAPT with aspirin and prasugrel in Japanese patients with ACS or high bleeding risk undergoing PCI with cobalt-chromium everolimus-eluting stents.

The study enrolled 6,002 patients with ACS or high bleeding risk who were randomly assigned to prasugrel monotherapy (3.75 mg/day; the licensed dose in Japan) or to DAPT with aspirin (81-100 mg/day) and prasugrel after a loading dose of prasugrel 20 mg in both groups.

There were two primary endpoints: major bleeding events (defined as BARC type 3 or 5) at 1 month for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month for noninferiority.

The major secondary endpoint was a composite of the coprimary bleeding and cardiovascular endpoints (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding) at 1 month representing net clinical benefit.

Results showed that, at 1 month, the no-aspirin strategy was not superior to DAPT for the coprimary bleeding endpoint, with major bleeding events occurring in 4.47% of the prasugrel monotherapy group versus 4.71% of those on DAPT (hazard ratio, 0.95; 95% confidence interval, 0.75-1.20).

The prasugrel monotherapy strategy was noninferior to DAPT, although there was a relative 50% margin for the coprimary cardiovascular endpoint. Cardiovascular endpoints occurred in 4.12% of prasugrel monotherapy group versus 3.69% of the DAPT patients (HR, 1.12; 95% CI, 0.87-1.45; P for noninferiority = .01).

The major secondary net clinical benefit endpoint occurred in 7.14% patients in the prasugrel monotherapy group and 7.38% patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit for both groups.

However, there was an excess of any coronary revascularization (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44%) in the prasugrel monotherapy group compared with the DAPT group, while definite stent thrombosis was not different between the two groups (0.47% vs. 0.37%).

In a subgroup analysis stratified by ACS and non-ACS, the excess risk for cardiovascular events in the no-aspirin group, compared with the DAPT group, was seen in patients with ACS, but not in those without ACS.
 

Future: Focus on dose and timing

In his discussion, Dr. Valgimigli said the implications of this trial for clinical practice were very clear: “Aspirin remains a cornerstone treatment in the periprocedural and acute phase of PCI in patients without indications for oral anticoagulation.” 

However, he added that the study opens several important points for subsequent discussion.

These include the role of type and dose of P2Y12 inhibitor therapy used; specifically, he questioned whether the 3.75-mg dose of prasugrel was enough.

Dr. Valgimigli also pointed out that this study did not include a purely high bleeding risk population, and he said there was still potential to investigate periprocedure versus postprocedure aspirin administration.

The STOPDAPT-3 trial was funded by Abbott Medical Japan. Dr. Natsuaki reported receiving honoraria from Abbott Medical Japan, Daiichi Sankyo, and Bayer.

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

AMSTERDAM – Dropping aspirin and using low-dose prasugrel (Effient) alone in the initial month of treatment after percutaneous coronary intervention (PCI) failed to lower bleeding risk, compared with dual antiplatelet therapy (DAPT), and there was a signal of possible harm in terms of increased subacute stent thrombosis, in the STOPDAPT-3 trial.

“Therefore, dual antiplatelet therapy with aspirin and a P2Y12 inhibitor should still remain the standard strategy at least for 1 month after PCI,” said the trial’s lead investigator Masahiro Natsuaki, MD, Saga (Japan) University.

The STOPDAPT-3 trial was presented at the recent annual congress of the European Society of Cardiology.

Designated discussant Marco Valgimigli, MD, Cardiocentro Ticino Foundation, Lugano, Switzerland, explained that the current wisdom before this study was that aspirin withdrawal in the postacute phase after PCI (after 1 month of DAPT onwards) is associated with lower bleeding risk without affecting ischemic risk, but this STOPDAPT-3 trial is the first to look at the idea of not giving aspirin at all.

“This study is a well-designed, well-conducted trial, and the results are very clear: there is no benefit of dropping aspirin in this early period with respect to major bleeding, and at the same time there was some signal for possible harm,” Dr. Valgimigli said.

He pointed out that the possible harm was not related to the coprimary cardiovascular composite endpoint, which did fulfill noninferiority, although he acknowledged the “generous” noninferiority margin.

Rather, the possible harm was related to an increase in subacute stent thrombosis, which was three times higher in the nonaspirin group (0.58% vs. 0.17%). 

“While these absolute event rates are extremely low, they are unquestionably higher in the nonaspirin group,” he added.

In his presentation, Dr. Natsuaki explained that very short durations (1-3 months) of DAPT followed by P2Y12 inhibitor monotherapy has been shown to reduce bleeding events without increasing cardiovascular events, compared with longer durations of DAPT after PCI using drug-eluting stents.

However, the incidence of major bleeding events within the 1-month mandatory DAPT period after PCI remains high in clinical practice, particularly in patients with ACS or high bleeding risk.

In single-arm studies, use of prasugrel or ticagrelor (Brilinta) alone following new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with or without ACS, and it is thought that removing aspirin from the DAPT regimen might reduce bleeding events early after PCI without compromising the risk of cardiovascular events. However, the efficacy and safety of this strategy has not been proven in randomized trials.
 

STOPDAPT-3 trial

STOPDAPT-3 investigated the efficacy and safety of prasugrel monotherapy compared with 1-month DAPT with aspirin and prasugrel in Japanese patients with ACS or high bleeding risk undergoing PCI with cobalt-chromium everolimus-eluting stents.

The study enrolled 6,002 patients with ACS or high bleeding risk who were randomly assigned to prasugrel monotherapy (3.75 mg/day; the licensed dose in Japan) or to DAPT with aspirin (81-100 mg/day) and prasugrel after a loading dose of prasugrel 20 mg in both groups.

There were two primary endpoints: major bleeding events (defined as BARC type 3 or 5) at 1 month for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month for noninferiority.

The major secondary endpoint was a composite of the coprimary bleeding and cardiovascular endpoints (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding) at 1 month representing net clinical benefit.

Results showed that, at 1 month, the no-aspirin strategy was not superior to DAPT for the coprimary bleeding endpoint, with major bleeding events occurring in 4.47% of the prasugrel monotherapy group versus 4.71% of those on DAPT (hazard ratio, 0.95; 95% confidence interval, 0.75-1.20).

The prasugrel monotherapy strategy was noninferior to DAPT, although there was a relative 50% margin for the coprimary cardiovascular endpoint. Cardiovascular endpoints occurred in 4.12% of prasugrel monotherapy group versus 3.69% of the DAPT patients (HR, 1.12; 95% CI, 0.87-1.45; P for noninferiority = .01).

The major secondary net clinical benefit endpoint occurred in 7.14% patients in the prasugrel monotherapy group and 7.38% patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit for both groups.

However, there was an excess of any coronary revascularization (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44%) in the prasugrel monotherapy group compared with the DAPT group, while definite stent thrombosis was not different between the two groups (0.47% vs. 0.37%).

In a subgroup analysis stratified by ACS and non-ACS, the excess risk for cardiovascular events in the no-aspirin group, compared with the DAPT group, was seen in patients with ACS, but not in those without ACS.
 

Future: Focus on dose and timing

In his discussion, Dr. Valgimigli said the implications of this trial for clinical practice were very clear: “Aspirin remains a cornerstone treatment in the periprocedural and acute phase of PCI in patients without indications for oral anticoagulation.” 

However, he added that the study opens several important points for subsequent discussion.

These include the role of type and dose of P2Y12 inhibitor therapy used; specifically, he questioned whether the 3.75-mg dose of prasugrel was enough.

Dr. Valgimigli also pointed out that this study did not include a purely high bleeding risk population, and he said there was still potential to investigate periprocedure versus postprocedure aspirin administration.

The STOPDAPT-3 trial was funded by Abbott Medical Japan. Dr. Natsuaki reported receiving honoraria from Abbott Medical Japan, Daiichi Sankyo, and Bayer.

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

AMSTERDAM – Dropping aspirin and using low-dose prasugrel (Effient) alone in the initial month of treatment after percutaneous coronary intervention (PCI) failed to lower bleeding risk, compared with dual antiplatelet therapy (DAPT), and there was a signal of possible harm in terms of increased subacute stent thrombosis, in the STOPDAPT-3 trial.

“Therefore, dual antiplatelet therapy with aspirin and a P2Y12 inhibitor should still remain the standard strategy at least for 1 month after PCI,” said the trial’s lead investigator Masahiro Natsuaki, MD, Saga (Japan) University.

The STOPDAPT-3 trial was presented at the recent annual congress of the European Society of Cardiology.

Designated discussant Marco Valgimigli, MD, Cardiocentro Ticino Foundation, Lugano, Switzerland, explained that the current wisdom before this study was that aspirin withdrawal in the postacute phase after PCI (after 1 month of DAPT onwards) is associated with lower bleeding risk without affecting ischemic risk, but this STOPDAPT-3 trial is the first to look at the idea of not giving aspirin at all.

“This study is a well-designed, well-conducted trial, and the results are very clear: there is no benefit of dropping aspirin in this early period with respect to major bleeding, and at the same time there was some signal for possible harm,” Dr. Valgimigli said.

He pointed out that the possible harm was not related to the coprimary cardiovascular composite endpoint, which did fulfill noninferiority, although he acknowledged the “generous” noninferiority margin.

Rather, the possible harm was related to an increase in subacute stent thrombosis, which was three times higher in the nonaspirin group (0.58% vs. 0.17%). 

“While these absolute event rates are extremely low, they are unquestionably higher in the nonaspirin group,” he added.

In his presentation, Dr. Natsuaki explained that very short durations (1-3 months) of DAPT followed by P2Y12 inhibitor monotherapy has been shown to reduce bleeding events without increasing cardiovascular events, compared with longer durations of DAPT after PCI using drug-eluting stents.

However, the incidence of major bleeding events within the 1-month mandatory DAPT period after PCI remains high in clinical practice, particularly in patients with ACS or high bleeding risk.

In single-arm studies, use of prasugrel or ticagrelor (Brilinta) alone following new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with or without ACS, and it is thought that removing aspirin from the DAPT regimen might reduce bleeding events early after PCI without compromising the risk of cardiovascular events. However, the efficacy and safety of this strategy has not been proven in randomized trials.
 

STOPDAPT-3 trial

STOPDAPT-3 investigated the efficacy and safety of prasugrel monotherapy compared with 1-month DAPT with aspirin and prasugrel in Japanese patients with ACS or high bleeding risk undergoing PCI with cobalt-chromium everolimus-eluting stents.

The study enrolled 6,002 patients with ACS or high bleeding risk who were randomly assigned to prasugrel monotherapy (3.75 mg/day; the licensed dose in Japan) or to DAPT with aspirin (81-100 mg/day) and prasugrel after a loading dose of prasugrel 20 mg in both groups.

There were two primary endpoints: major bleeding events (defined as BARC type 3 or 5) at 1 month for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month for noninferiority.

The major secondary endpoint was a composite of the coprimary bleeding and cardiovascular endpoints (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding) at 1 month representing net clinical benefit.

Results showed that, at 1 month, the no-aspirin strategy was not superior to DAPT for the coprimary bleeding endpoint, with major bleeding events occurring in 4.47% of the prasugrel monotherapy group versus 4.71% of those on DAPT (hazard ratio, 0.95; 95% confidence interval, 0.75-1.20).

The prasugrel monotherapy strategy was noninferior to DAPT, although there was a relative 50% margin for the coprimary cardiovascular endpoint. Cardiovascular endpoints occurred in 4.12% of prasugrel monotherapy group versus 3.69% of the DAPT patients (HR, 1.12; 95% CI, 0.87-1.45; P for noninferiority = .01).

The major secondary net clinical benefit endpoint occurred in 7.14% patients in the prasugrel monotherapy group and 7.38% patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit for both groups.

However, there was an excess of any coronary revascularization (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44%) in the prasugrel monotherapy group compared with the DAPT group, while definite stent thrombosis was not different between the two groups (0.47% vs. 0.37%).

In a subgroup analysis stratified by ACS and non-ACS, the excess risk for cardiovascular events in the no-aspirin group, compared with the DAPT group, was seen in patients with ACS, but not in those without ACS.
 

Future: Focus on dose and timing

In his discussion, Dr. Valgimigli said the implications of this trial for clinical practice were very clear: “Aspirin remains a cornerstone treatment in the periprocedural and acute phase of PCI in patients without indications for oral anticoagulation.” 

However, he added that the study opens several important points for subsequent discussion.

These include the role of type and dose of P2Y12 inhibitor therapy used; specifically, he questioned whether the 3.75-mg dose of prasugrel was enough.

Dr. Valgimigli also pointed out that this study did not include a purely high bleeding risk population, and he said there was still potential to investigate periprocedure versus postprocedure aspirin administration.

The STOPDAPT-3 trial was funded by Abbott Medical Japan. Dr. Natsuaki reported receiving honoraria from Abbott Medical Japan, Daiichi Sankyo, and Bayer.

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

The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.

The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.

“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.

Not an update, the ESC guidelines are the first to “include all cardiomyopathy subtypes, and the first time that specific recommendations are made for cardiomyopathies other than hypertrophic cardiomyopathy” (HCM), Dr. Arbelo said.
 

Guidelines organize cardiomyopathy phenotypes

Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.

“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.

As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.

“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
 

Genetic testing in children described

The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.

“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”

Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.

Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
 

Many symptoms are cardiomyopathy related

Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.

In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.

The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
 

32 key messages derived from guidelines

The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.

The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.

“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.

Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.

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

The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.

The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.

“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.

Not an update, the ESC guidelines are the first to “include all cardiomyopathy subtypes, and the first time that specific recommendations are made for cardiomyopathies other than hypertrophic cardiomyopathy” (HCM), Dr. Arbelo said.
 

Guidelines organize cardiomyopathy phenotypes

Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.

“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.

As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.

“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
 

Genetic testing in children described

The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.

“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”

Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.

Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
 

Many symptoms are cardiomyopathy related

Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.

In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.

The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
 

32 key messages derived from guidelines

The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.

The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.

“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.

Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.

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

The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.

The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.

“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.

Not an update, the ESC guidelines are the first to “include all cardiomyopathy subtypes, and the first time that specific recommendations are made for cardiomyopathies other than hypertrophic cardiomyopathy” (HCM), Dr. Arbelo said.
 

Guidelines organize cardiomyopathy phenotypes

Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.

“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.

As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.

“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
 

Genetic testing in children described

The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.

“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”

Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.

Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
 

Many symptoms are cardiomyopathy related

Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.

In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.

The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
 

32 key messages derived from guidelines

The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.

The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.

“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.

Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.

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