CAD & Atherosclerosis

For patients with coronary heart disease (CHD), following a Mediterranean diet is more effective in reducing progression of atherosclerosis than following a low-fat diet, according to new data from the CORDIOPREV randomized, controlled trial.

OksanaKiian/Getty Images

“The current study is, to our knowledge, the first to establish an effective dietary strategy for secondary cardiovascular prevention, reinforcing the fact that the Mediterranean diet rich in extra virgin olive oil (EVOO) could prevent the progression of atherosclerosis,” the study team said.

The data also show that patients with a higher atherosclerotic burden might benefit the most from the Mediterranean diet.

The study was published online Aug. 10, 2021, in Stroke.
 

Mediterranean or low fat?

“It is well established that lifestyle and dietary habits powerfully affect cardiovascular risk,” study investigator Elena M. Yubero-Serrano, PhD, with Reina Sofia University Hospital/University of Cordoba (Spain), told this news organization.

“The effectiveness of the Mediterranean diet in reducing cardiovascular risk has been seen in primary prevention. However, currently there is no consensus about a recommended dietary model for the secondary prevention of cardiovascular disease,” she said.

The Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention (CORDIOPREV) study is an ongoing prospective study comparing the effects of two healthy diets for secondary prevention of cardiovascular disease (CVD) in 1002 patients.

The comparative effect of the diets in reducing CVD risk, assessed by quantification of intima-media thickness of the common carotid arteries (IMT-CC), is a key secondary endpoint of the study.

During the study, half of the patients follow a Mediterranean diet rich in EVOO, fruit and vegetables, whole grains, fish, and nuts. The other half follow a diet low in fat and rich in complex carbohydrates.

A total of 939 participants (459 in the low-fat diet group and 480 in the Mediterranean diet group) completed IMT-CC evaluation at baseline, and 809 (377 and 432, respectively) completed the IMT-CC evaluation at 5 years; 731 (335 and 396, respectively) did so at 7 years.

The Mediterranean diet significantly decreased IMT-CC both after 5 years (–0.027; P < .001) and after 7 years (–0.031 mm; P < .001), relative to baseline. In contrast, the low-fat diet did not exert any change on IMT-CC after 5 or 7 years, the researchers report.

The higher the IMT-CC at baseline, the greater the reduction in this parameter.

The Mediterranean diet also produced a greater decrease in IMT-CC and carotid plaque maximum height, compared with the low-fat diet throughout follow-up.

There were no between-group differences in carotid plaque numbers during follow-up.

“Our findings, in addition to reinforcing the clinical benefits of the Mediterranean diet, provide a beneficial dietary strategy as a clinical and therapeutic tool that could reduce the high cardiovascular recurrence in the context of secondary prevention,” Dr. Yubero-Serrano said in an interview.

Earlier data from CORDIOPREV showed that, after 1 year of eating a Mediterranean diet, compared with the low-fat diet, endothelial function was improved among patients with CHD, even those with type 2 diabetes, which was associated with a better balance of vascular homeostasis.

The Mediterranean diet may also modulate the lipid profile, particularly by increasing HDL cholesterol levels. The anti-inflammatory capacity of the Mediterranean diet could be another factor that contributes to reducing the progression of atherosclerosis, the researchers say.
 

Important study

Reached for comment, Alan Rozanski, MD, professor of medicine, Icahn School of Medicine at Mount Sinai and cardiologist at Mount Sinai Morningside, New York, said: “We know very well that lifestyle factors, diet, and exercise in particular are extremely important in promoting health, vitality, and decreasing risk for chronic diseases, including heart attack and stroke.

“But a lot of the studies depend on epidemiological work. Until now, we haven’t had important prospective studies evaluating different kinds of dietary approaches and how they affect carotid intimal thickening assessments that we can do by ultrasound. So having this kind of imaging study which shows that diet can halt progression of atherosclerosis is important,” said Dr. Rozanski.

“Changing one’s diet is extremely important and potentially beneficial in many ways, and being able to say to a patient with atherosclerosis that we have data that shows you can halt the progression of the disease can be extraordinarily encouraging to many patients,” he noted.

“When people have disease, they very often gravitate toward drugs, but continuing to emphasize lifestyle changes in these people is extremely important,” he added.

The CORDIOPREV study was supported by the Fundación Patrimonio Comunal Olivarero. Dr. Yubero-Serrano and Dr. Rozanski disclosed no relevant financial relationships.

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

For patients with coronary heart disease (CHD), following a Mediterranean diet is more effective in reducing progression of atherosclerosis than following a low-fat diet, according to new data from the CORDIOPREV randomized, controlled trial.

OksanaKiian/Getty Images

“The current study is, to our knowledge, the first to establish an effective dietary strategy for secondary cardiovascular prevention, reinforcing the fact that the Mediterranean diet rich in extra virgin olive oil (EVOO) could prevent the progression of atherosclerosis,” the study team said.

The data also show that patients with a higher atherosclerotic burden might benefit the most from the Mediterranean diet.

The study was published online Aug. 10, 2021, in Stroke.
 

Mediterranean or low fat?

“It is well established that lifestyle and dietary habits powerfully affect cardiovascular risk,” study investigator Elena M. Yubero-Serrano, PhD, with Reina Sofia University Hospital/University of Cordoba (Spain), told this news organization.

“The effectiveness of the Mediterranean diet in reducing cardiovascular risk has been seen in primary prevention. However, currently there is no consensus about a recommended dietary model for the secondary prevention of cardiovascular disease,” she said.

The Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention (CORDIOPREV) study is an ongoing prospective study comparing the effects of two healthy diets for secondary prevention of cardiovascular disease (CVD) in 1002 patients.

The comparative effect of the diets in reducing CVD risk, assessed by quantification of intima-media thickness of the common carotid arteries (IMT-CC), is a key secondary endpoint of the study.

During the study, half of the patients follow a Mediterranean diet rich in EVOO, fruit and vegetables, whole grains, fish, and nuts. The other half follow a diet low in fat and rich in complex carbohydrates.

A total of 939 participants (459 in the low-fat diet group and 480 in the Mediterranean diet group) completed IMT-CC evaluation at baseline, and 809 (377 and 432, respectively) completed the IMT-CC evaluation at 5 years; 731 (335 and 396, respectively) did so at 7 years.

The Mediterranean diet significantly decreased IMT-CC both after 5 years (–0.027; P < .001) and after 7 years (–0.031 mm; P < .001), relative to baseline. In contrast, the low-fat diet did not exert any change on IMT-CC after 5 or 7 years, the researchers report.

The higher the IMT-CC at baseline, the greater the reduction in this parameter.

The Mediterranean diet also produced a greater decrease in IMT-CC and carotid plaque maximum height, compared with the low-fat diet throughout follow-up.

There were no between-group differences in carotid plaque numbers during follow-up.

“Our findings, in addition to reinforcing the clinical benefits of the Mediterranean diet, provide a beneficial dietary strategy as a clinical and therapeutic tool that could reduce the high cardiovascular recurrence in the context of secondary prevention,” Dr. Yubero-Serrano said in an interview.

Earlier data from CORDIOPREV showed that, after 1 year of eating a Mediterranean diet, compared with the low-fat diet, endothelial function was improved among patients with CHD, even those with type 2 diabetes, which was associated with a better balance of vascular homeostasis.

The Mediterranean diet may also modulate the lipid profile, particularly by increasing HDL cholesterol levels. The anti-inflammatory capacity of the Mediterranean diet could be another factor that contributes to reducing the progression of atherosclerosis, the researchers say.
 

Important study

Reached for comment, Alan Rozanski, MD, professor of medicine, Icahn School of Medicine at Mount Sinai and cardiologist at Mount Sinai Morningside, New York, said: “We know very well that lifestyle factors, diet, and exercise in particular are extremely important in promoting health, vitality, and decreasing risk for chronic diseases, including heart attack and stroke.

“But a lot of the studies depend on epidemiological work. Until now, we haven’t had important prospective studies evaluating different kinds of dietary approaches and how they affect carotid intimal thickening assessments that we can do by ultrasound. So having this kind of imaging study which shows that diet can halt progression of atherosclerosis is important,” said Dr. Rozanski.

“Changing one’s diet is extremely important and potentially beneficial in many ways, and being able to say to a patient with atherosclerosis that we have data that shows you can halt the progression of the disease can be extraordinarily encouraging to many patients,” he noted.

“When people have disease, they very often gravitate toward drugs, but continuing to emphasize lifestyle changes in these people is extremely important,” he added.

The CORDIOPREV study was supported by the Fundación Patrimonio Comunal Olivarero. Dr. Yubero-Serrano and Dr. Rozanski disclosed no relevant financial relationships.

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

For patients with coronary heart disease (CHD), following a Mediterranean diet is more effective in reducing progression of atherosclerosis than following a low-fat diet, according to new data from the CORDIOPREV randomized, controlled trial.

OksanaKiian/Getty Images

“The current study is, to our knowledge, the first to establish an effective dietary strategy for secondary cardiovascular prevention, reinforcing the fact that the Mediterranean diet rich in extra virgin olive oil (EVOO) could prevent the progression of atherosclerosis,” the study team said.

The data also show that patients with a higher atherosclerotic burden might benefit the most from the Mediterranean diet.

The study was published online Aug. 10, 2021, in Stroke.
 

Mediterranean or low fat?

“It is well established that lifestyle and dietary habits powerfully affect cardiovascular risk,” study investigator Elena M. Yubero-Serrano, PhD, with Reina Sofia University Hospital/University of Cordoba (Spain), told this news organization.

“The effectiveness of the Mediterranean diet in reducing cardiovascular risk has been seen in primary prevention. However, currently there is no consensus about a recommended dietary model for the secondary prevention of cardiovascular disease,” she said.

The Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention (CORDIOPREV) study is an ongoing prospective study comparing the effects of two healthy diets for secondary prevention of cardiovascular disease (CVD) in 1002 patients.

The comparative effect of the diets in reducing CVD risk, assessed by quantification of intima-media thickness of the common carotid arteries (IMT-CC), is a key secondary endpoint of the study.

During the study, half of the patients follow a Mediterranean diet rich in EVOO, fruit and vegetables, whole grains, fish, and nuts. The other half follow a diet low in fat and rich in complex carbohydrates.

A total of 939 participants (459 in the low-fat diet group and 480 in the Mediterranean diet group) completed IMT-CC evaluation at baseline, and 809 (377 and 432, respectively) completed the IMT-CC evaluation at 5 years; 731 (335 and 396, respectively) did so at 7 years.

The Mediterranean diet significantly decreased IMT-CC both after 5 years (–0.027; P < .001) and after 7 years (–0.031 mm; P < .001), relative to baseline. In contrast, the low-fat diet did not exert any change on IMT-CC after 5 or 7 years, the researchers report.

The higher the IMT-CC at baseline, the greater the reduction in this parameter.

The Mediterranean diet also produced a greater decrease in IMT-CC and carotid plaque maximum height, compared with the low-fat diet throughout follow-up.

There were no between-group differences in carotid plaque numbers during follow-up.

“Our findings, in addition to reinforcing the clinical benefits of the Mediterranean diet, provide a beneficial dietary strategy as a clinical and therapeutic tool that could reduce the high cardiovascular recurrence in the context of secondary prevention,” Dr. Yubero-Serrano said in an interview.

Earlier data from CORDIOPREV showed that, after 1 year of eating a Mediterranean diet, compared with the low-fat diet, endothelial function was improved among patients with CHD, even those with type 2 diabetes, which was associated with a better balance of vascular homeostasis.

The Mediterranean diet may also modulate the lipid profile, particularly by increasing HDL cholesterol levels. The anti-inflammatory capacity of the Mediterranean diet could be another factor that contributes to reducing the progression of atherosclerosis, the researchers say.
 

Important study

Reached for comment, Alan Rozanski, MD, professor of medicine, Icahn School of Medicine at Mount Sinai and cardiologist at Mount Sinai Morningside, New York, said: “We know very well that lifestyle factors, diet, and exercise in particular are extremely important in promoting health, vitality, and decreasing risk for chronic diseases, including heart attack and stroke.

“But a lot of the studies depend on epidemiological work. Until now, we haven’t had important prospective studies evaluating different kinds of dietary approaches and how they affect carotid intimal thickening assessments that we can do by ultrasound. So having this kind of imaging study which shows that diet can halt progression of atherosclerosis is important,” said Dr. Rozanski.

“Changing one’s diet is extremely important and potentially beneficial in many ways, and being able to say to a patient with atherosclerosis that we have data that shows you can halt the progression of the disease can be extraordinarily encouraging to many patients,” he noted.

“When people have disease, they very often gravitate toward drugs, but continuing to emphasize lifestyle changes in these people is extremely important,” he added.

The CORDIOPREV study was supported by the Fundación Patrimonio Comunal Olivarero. Dr. Yubero-Serrano and Dr. Rozanski disclosed no relevant financial relationships.

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

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

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

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

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

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

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

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

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

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

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

Can hospitals make exclusive deals?

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

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

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

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

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

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

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

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

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

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

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

Can excluded physicians get peer review?

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

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

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

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

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

Excluded physicians sometimes prevail

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

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

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

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

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

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

Many physicians don’t challenge the exclusion

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

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

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

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

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

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

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

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

Diverging expectations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Can hospitals make exclusive deals?

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

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

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

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

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

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

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

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

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

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

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

Can excluded physicians get peer review?

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

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

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

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

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

Excluded physicians sometimes prevail

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

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

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

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

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

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

Many physicians don’t challenge the exclusion

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

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

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

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

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

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

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

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

Diverging expectations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Can hospitals make exclusive deals?

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

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

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

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

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

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

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

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

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

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

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

Can excluded physicians get peer review?

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

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

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

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

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

Excluded physicians sometimes prevail

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

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

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

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

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

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

Many physicians don’t challenge the exclusion

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

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

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

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

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

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

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

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

Diverging expectations

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

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

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

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

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

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

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

Instants/Getty Images

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

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

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

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

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

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

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

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

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

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

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

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

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

Instants/Getty Images

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

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

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

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

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

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

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

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

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

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

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

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

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

Instants/Getty Images

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

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

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

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

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

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

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

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

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

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

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

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

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

Creatas Images/ThinkStockPhotos

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

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

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

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

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

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

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

Cardiovascular rehabilitation should include weight loss intervention

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

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

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

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

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

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

Medical therapy or bariatric surgery as other options?

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

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

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

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

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

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

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

Obesity is a disease; clinicians need to be respectful

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

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

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

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

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

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

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

Study findings

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

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

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

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

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

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

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

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

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

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

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

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

Creatas Images/ThinkStockPhotos

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

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

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

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

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

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

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

Cardiovascular rehabilitation should include weight loss intervention

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

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

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

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

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

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

Medical therapy or bariatric surgery as other options?

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

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

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

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

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

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

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

Obesity is a disease; clinicians need to be respectful

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

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

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

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

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

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

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

Study findings

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

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

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

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

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

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

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

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

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

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

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

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

Creatas Images/ThinkStockPhotos

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

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

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

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

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

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

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

Cardiovascular rehabilitation should include weight loss intervention

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

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

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

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

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

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

Medical therapy or bariatric surgery as other options?

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

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

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

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

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

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

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

Obesity is a disease; clinicians need to be respectful

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

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

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

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

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

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

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

Study findings

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

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

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

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

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

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

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

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

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

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

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

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

Kirby Hamilton/iStockphoto

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

An important study

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

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

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

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

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

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

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

Aversion of this article first appeared on Medscape.com.

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

Kirby Hamilton/iStockphoto

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

An important study

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

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

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

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

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

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

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

Aversion of this article first appeared on Medscape.com.

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

Kirby Hamilton/iStockphoto

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

An important study

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

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

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

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

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

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

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

Aversion of this article first appeared on Medscape.com.

Low dose acetylsalicylic acid (LDASA) may have some protective benefit against cognitive decline, but only if started well before symptoms begin, according to a retrospective analysis of two large cohorts. The association with all-cause dementia was weak, but much more pronounced in subjects with coronary heart disease.

The results underscore that individuals with cardiovascular disease risk factors should be prescribed LDASA, and they should be encouraged to be compliant. The study differed from previous observational and randomized, controlled trials, which yielded mixed results. Many looked at individuals older than age 65. The pathological changes associated with dementia may occur up to 2 decades before symptom onset, and it appears that LDASA cannot counter cognitive decline after a diagnosis is made. “The use of LDASA at this age may be already too late,” said Thi Ngoc Mai Nguyen, a PhD student at Network Aging Research, Heidelberg University, Germany. She presented the results at the 2021 Alzheimer’s Association International Conference.

Previous studies also included individuals using LDASA to prevent cardiovascular disease, and they didn’t always adjust for these risk factors. The current work used two large databases, UK Biobank and ESTHER, with a follow-up time of over 10 years for both. “We were able to balance out the distribution of measured baseline covariates (to be) similar between LDASA users and nonusers, and thus, we were able to adjust for confounders more comprehensively,” said Ms. Nguyen.
 

Not yet a definitive answer

Although the findings are promising, Ms. Nguyen noted that the study is not the final word. “Residual confounding is possible, and causation cannot be tested. The only way to answer this is to have clinical trials with at least 10 years of follow-up,” said Ms. Nguyen. She plans to conduct similar studies in non-White populations, and also to examine whether LDASA can help preserve cognitive function in middle-age adults.

The study is interesting, said Claire Sexton, DPhil, who was asked to comment, but she suggested that it is not practice changing. “There is not evidence from the dementia science perspective that should go against whatever the recommendations are for cardiovascular risk,” said Dr. Sexton, director of scientific programs and outreach at the Alzheimer’s Association. “I don’t think this study alone can provide a definitive answer on low-dose aspirin and its association with dementia and Alzheimer’s disease, but it’s an important addition to the literature,” she added.
 

Meta-analysis data

The researchers examined two prospective cohort studies, and combined them into a meta-analysis. It included the ESTHER cohort from Saarland, Germany, with 5,258 individuals and 14.3 years of follow-up, and the UK Biobank cohort, with 305,394 individuals and 11.6 years of follow-up. Subjects selected for analysis were 55 years old or older.

The meta-analysis showed no significant association between LDASA use and reduced risk of Alzheimer’s disease, but there was an association between LDASA use and all-cause dementia (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.93-0.99).

There were no sex differences with respect to Alzheimer’s dementia, but in males, LDASA was associated with lower risk of vascular dementia (HR, 0.85; 95% CI, 0.79-0.93) and all-cause dementia (HR, 0.87; 95% CI, 0.83-0.92). However, in females, LDASA was tied to greater risk of both vascular dementia (HR, 1.13; 95% CI, 1.02-1.24) and all-cause dementia (HR, 1.07; 95% CI, 1.02-1.13).

The strongest association between LDASA and reduced dementia risk was found in subjects with coronary heart disease (HR, 0.69; 95% CI, 0.59-0.80).

The researchers also used UK Biobank primary care data to analyze associations between longer use of LDASA and reduced dementia risk. Those who used LDASA for 0-5 years were at a higher than average risk of all-cause dementia (HR, 2.80; 95% CI, 2.48-3.16), Alzheimer’s disease (HR, 2.26; 95% CI, 1.84-2.77), and vascular dementia (HR, 3.79; 95% CI, 3.17-4.53). Long-term LDASA users, defined as 10 years or longer, had a lower risk of all-cause dementia (HR, 0.51; 95% CI, 0.47-0.56), Alzheimer’s disease (HR, 0.58; 95% CI, 0.51-0.68), and vascular dementia (HR, 0.48; 95% CI, 0.42-0.56).

Dr. Nguyen and Dr. Sexton have no relevant financial disclosures.

Low dose acetylsalicylic acid (LDASA) may have some protective benefit against cognitive decline, but only if started well before symptoms begin, according to a retrospective analysis of two large cohorts. The association with all-cause dementia was weak, but much more pronounced in subjects with coronary heart disease.

The results underscore that individuals with cardiovascular disease risk factors should be prescribed LDASA, and they should be encouraged to be compliant. The study differed from previous observational and randomized, controlled trials, which yielded mixed results. Many looked at individuals older than age 65. The pathological changes associated with dementia may occur up to 2 decades before symptom onset, and it appears that LDASA cannot counter cognitive decline after a diagnosis is made. “The use of LDASA at this age may be already too late,” said Thi Ngoc Mai Nguyen, a PhD student at Network Aging Research, Heidelberg University, Germany. She presented the results at the 2021 Alzheimer’s Association International Conference.

Previous studies also included individuals using LDASA to prevent cardiovascular disease, and they didn’t always adjust for these risk factors. The current work used two large databases, UK Biobank and ESTHER, with a follow-up time of over 10 years for both. “We were able to balance out the distribution of measured baseline covariates (to be) similar between LDASA users and nonusers, and thus, we were able to adjust for confounders more comprehensively,” said Ms. Nguyen.
 

Not yet a definitive answer

Although the findings are promising, Ms. Nguyen noted that the study is not the final word. “Residual confounding is possible, and causation cannot be tested. The only way to answer this is to have clinical trials with at least 10 years of follow-up,” said Ms. Nguyen. She plans to conduct similar studies in non-White populations, and also to examine whether LDASA can help preserve cognitive function in middle-age adults.

The study is interesting, said Claire Sexton, DPhil, who was asked to comment, but she suggested that it is not practice changing. “There is not evidence from the dementia science perspective that should go against whatever the recommendations are for cardiovascular risk,” said Dr. Sexton, director of scientific programs and outreach at the Alzheimer’s Association. “I don’t think this study alone can provide a definitive answer on low-dose aspirin and its association with dementia and Alzheimer’s disease, but it’s an important addition to the literature,” she added.
 

Meta-analysis data

The researchers examined two prospective cohort studies, and combined them into a meta-analysis. It included the ESTHER cohort from Saarland, Germany, with 5,258 individuals and 14.3 years of follow-up, and the UK Biobank cohort, with 305,394 individuals and 11.6 years of follow-up. Subjects selected for analysis were 55 years old or older.

The meta-analysis showed no significant association between LDASA use and reduced risk of Alzheimer’s disease, but there was an association between LDASA use and all-cause dementia (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.93-0.99).

There were no sex differences with respect to Alzheimer’s dementia, but in males, LDASA was associated with lower risk of vascular dementia (HR, 0.85; 95% CI, 0.79-0.93) and all-cause dementia (HR, 0.87; 95% CI, 0.83-0.92). However, in females, LDASA was tied to greater risk of both vascular dementia (HR, 1.13; 95% CI, 1.02-1.24) and all-cause dementia (HR, 1.07; 95% CI, 1.02-1.13).

The strongest association between LDASA and reduced dementia risk was found in subjects with coronary heart disease (HR, 0.69; 95% CI, 0.59-0.80).

The researchers also used UK Biobank primary care data to analyze associations between longer use of LDASA and reduced dementia risk. Those who used LDASA for 0-5 years were at a higher than average risk of all-cause dementia (HR, 2.80; 95% CI, 2.48-3.16), Alzheimer’s disease (HR, 2.26; 95% CI, 1.84-2.77), and vascular dementia (HR, 3.79; 95% CI, 3.17-4.53). Long-term LDASA users, defined as 10 years or longer, had a lower risk of all-cause dementia (HR, 0.51; 95% CI, 0.47-0.56), Alzheimer’s disease (HR, 0.58; 95% CI, 0.51-0.68), and vascular dementia (HR, 0.48; 95% CI, 0.42-0.56).

Dr. Nguyen and Dr. Sexton have no relevant financial disclosures.

Low dose acetylsalicylic acid (LDASA) may have some protective benefit against cognitive decline, but only if started well before symptoms begin, according to a retrospective analysis of two large cohorts. The association with all-cause dementia was weak, but much more pronounced in subjects with coronary heart disease.

The results underscore that individuals with cardiovascular disease risk factors should be prescribed LDASA, and they should be encouraged to be compliant. The study differed from previous observational and randomized, controlled trials, which yielded mixed results. Many looked at individuals older than age 65. The pathological changes associated with dementia may occur up to 2 decades before symptom onset, and it appears that LDASA cannot counter cognitive decline after a diagnosis is made. “The use of LDASA at this age may be already too late,” said Thi Ngoc Mai Nguyen, a PhD student at Network Aging Research, Heidelberg University, Germany. She presented the results at the 2021 Alzheimer’s Association International Conference.

Previous studies also included individuals using LDASA to prevent cardiovascular disease, and they didn’t always adjust for these risk factors. The current work used two large databases, UK Biobank and ESTHER, with a follow-up time of over 10 years for both. “We were able to balance out the distribution of measured baseline covariates (to be) similar between LDASA users and nonusers, and thus, we were able to adjust for confounders more comprehensively,” said Ms. Nguyen.
 

Not yet a definitive answer

Although the findings are promising, Ms. Nguyen noted that the study is not the final word. “Residual confounding is possible, and causation cannot be tested. The only way to answer this is to have clinical trials with at least 10 years of follow-up,” said Ms. Nguyen. She plans to conduct similar studies in non-White populations, and also to examine whether LDASA can help preserve cognitive function in middle-age adults.

The study is interesting, said Claire Sexton, DPhil, who was asked to comment, but she suggested that it is not practice changing. “There is not evidence from the dementia science perspective that should go against whatever the recommendations are for cardiovascular risk,” said Dr. Sexton, director of scientific programs and outreach at the Alzheimer’s Association. “I don’t think this study alone can provide a definitive answer on low-dose aspirin and its association with dementia and Alzheimer’s disease, but it’s an important addition to the literature,” she added.
 

Meta-analysis data

The researchers examined two prospective cohort studies, and combined them into a meta-analysis. It included the ESTHER cohort from Saarland, Germany, with 5,258 individuals and 14.3 years of follow-up, and the UK Biobank cohort, with 305,394 individuals and 11.6 years of follow-up. Subjects selected for analysis were 55 years old or older.

The meta-analysis showed no significant association between LDASA use and reduced risk of Alzheimer’s disease, but there was an association between LDASA use and all-cause dementia (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.93-0.99).

There were no sex differences with respect to Alzheimer’s dementia, but in males, LDASA was associated with lower risk of vascular dementia (HR, 0.85; 95% CI, 0.79-0.93) and all-cause dementia (HR, 0.87; 95% CI, 0.83-0.92). However, in females, LDASA was tied to greater risk of both vascular dementia (HR, 1.13; 95% CI, 1.02-1.24) and all-cause dementia (HR, 1.07; 95% CI, 1.02-1.13).

The strongest association between LDASA and reduced dementia risk was found in subjects with coronary heart disease (HR, 0.69; 95% CI, 0.59-0.80).

The researchers also used UK Biobank primary care data to analyze associations between longer use of LDASA and reduced dementia risk. Those who used LDASA for 0-5 years were at a higher than average risk of all-cause dementia (HR, 2.80; 95% CI, 2.48-3.16), Alzheimer’s disease (HR, 2.26; 95% CI, 1.84-2.77), and vascular dementia (HR, 3.79; 95% CI, 3.17-4.53). Long-term LDASA users, defined as 10 years or longer, had a lower risk of all-cause dementia (HR, 0.51; 95% CI, 0.47-0.56), Alzheimer’s disease (HR, 0.58; 95% CI, 0.51-0.68), and vascular dementia (HR, 0.48; 95% CI, 0.42-0.56).

Dr. Nguyen and Dr. Sexton have no relevant financial disclosures.

Based on a large registry, there appears to be no adverse consequences for same-day discharge following an elective percutaneous cardiovascular intervention (PCI), according to an analysis of a nationwide registry.

“Our data suggest there has been no negative impact on patient outcomes as a result of increasing use of same-day discharge,” lead investigator Steven M. Bradley, MD, said in an interview.

The analysis was based on data on 819,091 patients who underwent an elective PCI procedure during July 2009–December 2017 in the National CathPCI Registry. During this period, the proportion of elective PCIs performed with same-day discharge rose from 4.5% to 28.6%, a fivefold gain, according to Dr. Bradley, an associate cardiologist at the Minneapolis Heart Institute, and colleagues.

Within this study, outcomes in 212,369 patients were analyzed through a link to Centers for Medicare & Medicaid Services data. Despite the growth in same-day discharge PCIs over the study period, there was no change in 30-day mortality rates while the rate of 30-day rehospitalization fell after risk adjustment.

These data are considered to have a message for routine practice, particularly for those hospitals that have been slow to move to same-day discharge for elective PCI when lack of complications makes this appropriate.

However, “this does not mean same-day discharge is safe for all patients,” Dr. Bradley cautioned, but these data suggest “there is a clear opportunity at sites with low rates” to look for strategies that allow patients to recover at home, which is preferred by many patients and lowers costs.

In 2009, the first year in which the data were analyzed, there was relatively little variation in the rate of same day discharge for elective PCI among the 1,716 hospitals that contributed patients to the registry. At that point, almost all hospitals had rates below 10%, according to the report published in JACC: Cardiovascular Interventions on Aug 2, 2021 .

From 2011 onward, there were progressive gains at most hospitals, with an even steeper rise beginning in 2014. By 2017, even though some hospitals were still performing almost no same-day discharge PCIs, many were discharging up to 40%, and the outliers were discharging nearly all.

Expressed in interquartiles at the hospital level, the range climbed from 0.0% to 4.7% in 2009 and reached 4.5% to 41.0% by 2017. For 2017, relative to 2009, this produced an odds ratio for same-day discharge that was more than fourfold greater, after adjustment for year and access site.

Access site was an important variable. For those undergoing PCI with radial access, the median same-day discharge rates climbed from 21.8% in 2009 to 58.3% in 2017. Same-day discharge rates for elective PCI performed by femoral access, already lower in 2009, have consistently lagged. By 2017, the median rate of same-day discharge for those undergoing PCI by the femoral route was less than half of that associated with radial access.

Despite the faster rise in same-day discharge and radial access over the course of the study, these were not directly correlated. In 2017, 25% of sites performing PCI by radial access were still discharging fewer than 10% of patients on the same day as their elective PCI.

Several previous studies have also found that same-day discharge can be offered selectively after elective PCI without adversely affecting outcomes, according to multiple citations provided by the authors. The advantage of early discharge includes both convenience for the patient and lower costs, with some of the studies attempting to quantify savings. In one, it was estimated that per-case savings from performing radial-access elective PCI with same-day discharge was nearly $3,700 when compared with transfemoral access and an overnight stay.

Radial access key to same-day success

An accompanying editorial by Deepak Bhatt, MD, and Jonathan G. Sung, MBChB, who are both interventional cardiologists at Brigham and Women’s Hospital, Boston, generally agreed with the premise that these data support judicious use of same-day discharge for elective PCI.

They pointed out limitations in the study, including its retrospective design and the inability to look at important outcomes other than mortality and 30-day rehospitalization, such as bleeding, that are relevant to the safety of early discharge, but concluded that same-day discharge, as well as radial access procedures, are underused.

“For uncomplicated elective PCI, we should aim for same-day discharge,” Dr. Bhatt said in an interview. He linked this to radial access.

“Radial access certainly facilitates same-day discharge, though even beyond that aspect, it should be the default route of vascular access whenever possible,” Dr. Bhatt said. Yet he was careful to say that neither same-day discharge nor radial access can be recommended in all patients. While the operator needs “to be comfortable” with a radial access approach, there are multiple factors that might preclude early discharge.

“Of course, if a long procedure, high contrast use, bleeding, a long travel distance to get home, etc. [are considered], then an overnight stay may be warranted,” he said.

Dr. Bradley advised centers planning to increase their same-day discharge rates for elective PCI to use a systematic approach.

“Sites should identify areas for opportunity in the use of same-day discharge and then track the implications on patient outcomes to ensure that the approach being used maintains high-quality care,” he said.

Dr. Bradley reported no potential conflicts of interest. Dr. Bhatt has received research funding from a large number of pharmaceutical and device manufacturers, including those that make products relevant to PCI.

Based on a large registry, there appears to be no adverse consequences for same-day discharge following an elective percutaneous cardiovascular intervention (PCI), according to an analysis of a nationwide registry.

“Our data suggest there has been no negative impact on patient outcomes as a result of increasing use of same-day discharge,” lead investigator Steven M. Bradley, MD, said in an interview.

The analysis was based on data on 819,091 patients who underwent an elective PCI procedure during July 2009–December 2017 in the National CathPCI Registry. During this period, the proportion of elective PCIs performed with same-day discharge rose from 4.5% to 28.6%, a fivefold gain, according to Dr. Bradley, an associate cardiologist at the Minneapolis Heart Institute, and colleagues.

Within this study, outcomes in 212,369 patients were analyzed through a link to Centers for Medicare & Medicaid Services data. Despite the growth in same-day discharge PCIs over the study period, there was no change in 30-day mortality rates while the rate of 30-day rehospitalization fell after risk adjustment.

These data are considered to have a message for routine practice, particularly for those hospitals that have been slow to move to same-day discharge for elective PCI when lack of complications makes this appropriate.

However, “this does not mean same-day discharge is safe for all patients,” Dr. Bradley cautioned, but these data suggest “there is a clear opportunity at sites with low rates” to look for strategies that allow patients to recover at home, which is preferred by many patients and lowers costs.

In 2009, the first year in which the data were analyzed, there was relatively little variation in the rate of same day discharge for elective PCI among the 1,716 hospitals that contributed patients to the registry. At that point, almost all hospitals had rates below 10%, according to the report published in JACC: Cardiovascular Interventions on Aug 2, 2021 .

From 2011 onward, there were progressive gains at most hospitals, with an even steeper rise beginning in 2014. By 2017, even though some hospitals were still performing almost no same-day discharge PCIs, many were discharging up to 40%, and the outliers were discharging nearly all.

Expressed in interquartiles at the hospital level, the range climbed from 0.0% to 4.7% in 2009 and reached 4.5% to 41.0% by 2017. For 2017, relative to 2009, this produced an odds ratio for same-day discharge that was more than fourfold greater, after adjustment for year and access site.

Access site was an important variable. For those undergoing PCI with radial access, the median same-day discharge rates climbed from 21.8% in 2009 to 58.3% in 2017. Same-day discharge rates for elective PCI performed by femoral access, already lower in 2009, have consistently lagged. By 2017, the median rate of same-day discharge for those undergoing PCI by the femoral route was less than half of that associated with radial access.

Despite the faster rise in same-day discharge and radial access over the course of the study, these were not directly correlated. In 2017, 25% of sites performing PCI by radial access were still discharging fewer than 10% of patients on the same day as their elective PCI.

Several previous studies have also found that same-day discharge can be offered selectively after elective PCI without adversely affecting outcomes, according to multiple citations provided by the authors. The advantage of early discharge includes both convenience for the patient and lower costs, with some of the studies attempting to quantify savings. In one, it was estimated that per-case savings from performing radial-access elective PCI with same-day discharge was nearly $3,700 when compared with transfemoral access and an overnight stay.

Radial access key to same-day success

An accompanying editorial by Deepak Bhatt, MD, and Jonathan G. Sung, MBChB, who are both interventional cardiologists at Brigham and Women’s Hospital, Boston, generally agreed with the premise that these data support judicious use of same-day discharge for elective PCI.

They pointed out limitations in the study, including its retrospective design and the inability to look at important outcomes other than mortality and 30-day rehospitalization, such as bleeding, that are relevant to the safety of early discharge, but concluded that same-day discharge, as well as radial access procedures, are underused.

“For uncomplicated elective PCI, we should aim for same-day discharge,” Dr. Bhatt said in an interview. He linked this to radial access.

“Radial access certainly facilitates same-day discharge, though even beyond that aspect, it should be the default route of vascular access whenever possible,” Dr. Bhatt said. Yet he was careful to say that neither same-day discharge nor radial access can be recommended in all patients. While the operator needs “to be comfortable” with a radial access approach, there are multiple factors that might preclude early discharge.

“Of course, if a long procedure, high contrast use, bleeding, a long travel distance to get home, etc. [are considered], then an overnight stay may be warranted,” he said.

Dr. Bradley advised centers planning to increase their same-day discharge rates for elective PCI to use a systematic approach.

“Sites should identify areas for opportunity in the use of same-day discharge and then track the implications on patient outcomes to ensure that the approach being used maintains high-quality care,” he said.

Dr. Bradley reported no potential conflicts of interest. Dr. Bhatt has received research funding from a large number of pharmaceutical and device manufacturers, including those that make products relevant to PCI.

Based on a large registry, there appears to be no adverse consequences for same-day discharge following an elective percutaneous cardiovascular intervention (PCI), according to an analysis of a nationwide registry.

“Our data suggest there has been no negative impact on patient outcomes as a result of increasing use of same-day discharge,” lead investigator Steven M. Bradley, MD, said in an interview.

The analysis was based on data on 819,091 patients who underwent an elective PCI procedure during July 2009–December 2017 in the National CathPCI Registry. During this period, the proportion of elective PCIs performed with same-day discharge rose from 4.5% to 28.6%, a fivefold gain, according to Dr. Bradley, an associate cardiologist at the Minneapolis Heart Institute, and colleagues.

Within this study, outcomes in 212,369 patients were analyzed through a link to Centers for Medicare & Medicaid Services data. Despite the growth in same-day discharge PCIs over the study period, there was no change in 30-day mortality rates while the rate of 30-day rehospitalization fell after risk adjustment.

These data are considered to have a message for routine practice, particularly for those hospitals that have been slow to move to same-day discharge for elective PCI when lack of complications makes this appropriate.

However, “this does not mean same-day discharge is safe for all patients,” Dr. Bradley cautioned, but these data suggest “there is a clear opportunity at sites with low rates” to look for strategies that allow patients to recover at home, which is preferred by many patients and lowers costs.

In 2009, the first year in which the data were analyzed, there was relatively little variation in the rate of same day discharge for elective PCI among the 1,716 hospitals that contributed patients to the registry. At that point, almost all hospitals had rates below 10%, according to the report published in JACC: Cardiovascular Interventions on Aug 2, 2021 .

From 2011 onward, there were progressive gains at most hospitals, with an even steeper rise beginning in 2014. By 2017, even though some hospitals were still performing almost no same-day discharge PCIs, many were discharging up to 40%, and the outliers were discharging nearly all.

Expressed in interquartiles at the hospital level, the range climbed from 0.0% to 4.7% in 2009 and reached 4.5% to 41.0% by 2017. For 2017, relative to 2009, this produced an odds ratio for same-day discharge that was more than fourfold greater, after adjustment for year and access site.

Access site was an important variable. For those undergoing PCI with radial access, the median same-day discharge rates climbed from 21.8% in 2009 to 58.3% in 2017. Same-day discharge rates for elective PCI performed by femoral access, already lower in 2009, have consistently lagged. By 2017, the median rate of same-day discharge for those undergoing PCI by the femoral route was less than half of that associated with radial access.

Despite the faster rise in same-day discharge and radial access over the course of the study, these were not directly correlated. In 2017, 25% of sites performing PCI by radial access were still discharging fewer than 10% of patients on the same day as their elective PCI.

Several previous studies have also found that same-day discharge can be offered selectively after elective PCI without adversely affecting outcomes, according to multiple citations provided by the authors. The advantage of early discharge includes both convenience for the patient and lower costs, with some of the studies attempting to quantify savings. In one, it was estimated that per-case savings from performing radial-access elective PCI with same-day discharge was nearly $3,700 when compared with transfemoral access and an overnight stay.

Radial access key to same-day success

An accompanying editorial by Deepak Bhatt, MD, and Jonathan G. Sung, MBChB, who are both interventional cardiologists at Brigham and Women’s Hospital, Boston, generally agreed with the premise that these data support judicious use of same-day discharge for elective PCI.

They pointed out limitations in the study, including its retrospective design and the inability to look at important outcomes other than mortality and 30-day rehospitalization, such as bleeding, that are relevant to the safety of early discharge, but concluded that same-day discharge, as well as radial access procedures, are underused.

“For uncomplicated elective PCI, we should aim for same-day discharge,” Dr. Bhatt said in an interview. He linked this to radial access.

“Radial access certainly facilitates same-day discharge, though even beyond that aspect, it should be the default route of vascular access whenever possible,” Dr. Bhatt said. Yet he was careful to say that neither same-day discharge nor radial access can be recommended in all patients. While the operator needs “to be comfortable” with a radial access approach, there are multiple factors that might preclude early discharge.

“Of course, if a long procedure, high contrast use, bleeding, a long travel distance to get home, etc. [are considered], then an overnight stay may be warranted,” he said.

Dr. Bradley advised centers planning to increase their same-day discharge rates for elective PCI to use a systematic approach.

“Sites should identify areas for opportunity in the use of same-day discharge and then track the implications on patient outcomes to ensure that the approach being used maintains high-quality care,” he said.

Dr. Bradley reported no potential conflicts of interest. Dr. Bhatt has received research funding from a large number of pharmaceutical and device manufacturers, including those that make products relevant to PCI.

The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.

One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.

Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.

One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.

Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.

One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.

Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

An incidental diagnosis of intracranial atherosclerotic stenosis in stroke-free individuals should trigger a thorough assessment of vascular health, according to the authors of a study identifying risk factors and vascular event risk in asymptomatic ICAS.

mr.suphachai praserdumrongchai/iStock/Getty Images Plus

That conclusion emerged from data collected on more than 1,000 stroke-free participants in NOMAS (Northern Manhattan Study), a trial that prospectively followed participants who underwent a brain magnetic resonance angiogram (MRA) during 2003-2008.

In ICAS patients with stenosis of at least 70%, even with aggressive medical therapy, the annual stroke recurrence rate is 10%-20% in those with occlusions and at least three or more vascular risk factors. This high rate of recurrent vascular events in patients with stroke caused by ICAS warrants greater focus on primary prevention and targeted interventions for stroke-free individuals at highest risk for ICAS-related events, the investigators concluded.
 

Identify high-risk ICAS

Using NOMAS data, the investigators, led by Jose Gutierrez, MD, MPH, tested the hypothesis that stroke-free subjects at high risk of stroke and vascular events could be identified through the presence of asymptomatic ICAS. NOMAS is an ongoing, population-based epidemiologic study among randomly selected people with home telephones living in northern Manhattan.

During 2003-2008, investigators invited participants who were at least 50 years old, stroke free, and without contraindications to undergo brain MRA. The 1,211 study members were followed annually via telephone and in-person adjudication of events. A control group of 79 patients with no MRA was also identified with similar rates of hypertension, diabetes, hypercholesterolemia and current smoking.

Mean age was about 71 years (59% female, 65% Hispanic, 45% any stenosis). At the time of MRA, 78% had hypertension, 25% had diabetes, 81% had hypercholesterolemia, and 11% were current smokers.

Researchers rated stenoses in 11 brain arteries as 0, with no stenosis; 1, with less than 50% stenosis or luminal irregularities; 2, 50%-69% stenosis; and 3, at least 70% stenosis or flow gap. Outcomes included vascular death, myocardial infarction, ischemic stroke, cardioembolic stroke, intracranial artery disease stroke (which combined intracranial small and large artery disease strokes), and any vascular events (defined as a composite of vascular death, any stroke, or MI).
 

Greater stenosis denotes higher risk

Analysis found ICAS to be associated with older age (odds ratio, 1.02 per year; 95% confidence interval, 1.01-1.04), hypertension duration (OR, 1.01 per year; 95% CI, 1.00-1.02), higher number of glucose-lowering drugs (OR, 1.64 per each medication; 95% CI, 1.24-2.15), and HDL cholesterol(OR, 0.96 per mg/dL; 95% CI, 0.92-0.99). Event risk was greater among participants with ICAS of at least 70% (5.5% annual risk of vascular events; HR, 2.1; 95% CI, 1.4-3.2; compared with those with no ICAS), the investigators reported in the Journal of the American College of Cardiology.

Furthermore, 80% of incident strokes initially classified as small artery disease occurred among individuals with evidence of any degree of ICAS at their baseline MRI, the investigators noted. They found also that individuals with ICAS who had a primary care physician at the time of their initial MRI had a lower risk of events. Frequent primary care visits, they observed, might imply greater control of risk factors and other unmeasured confounders, such as health literacy, health care trust, access, and availability.
 

Incidental ICAS should trigger vascular assessment

An incidental diagnosis of ICAS in stroke-free subjects should trigger a thorough assessment of vascular health, the investigators concluded. They commented also that prophylaxis of first-ever stroke at this asymptomatic stage “may magnify the societal benefits of vascular prevention and decrease stroke-related disability and vascular death in our communities.”

“The big gap in our knowledge,” Tanya N. Turan, MD, professor of neurology at Medical University of South Carolina, Charleston, wrote in an accompanying editorial “is understanding the pathophysiological triggers for an asymptomatic stenosis to become a high-risk symptomatic stenosis. Until that question is answered, screening for asymptomatic ICAS is unlikely to change management among patients with known vascular risk factors.” In an interview, she observed further that “MRI plaque imaging could be a useful research tool to see if certain plaque features in an asymptomatic lesion are high risk for causing stroke. If that were proven, then it would make more sense to screen for ICAS and develop specific therapeutic strategies targeting high-risk asymptomatic plaque.”
 

Focus on recurrent stroke misplaced

Dr. Gutierrez said in an interview: “In the stroke world, most of what we do focuses on preventing recurrent stroke. Nonetheless, three-fourths of strokes in this country are new strokes, so to me it doesn’t make much sense to spend most of our efforts and attention to prevent the smallest fractions of strokes that occur in our society.”

He stressed that “the first immediate application of our results is that if people having a brain MRA for other reasons are found to have incidental, and therefore asymptomatic, ICAS, then they should be aggressively treated for vascular risk factors.” Secondly, “we hope to identify the patients at the highest risk of prevalent ICAS before they have a stroke. Among them, a brain MRI/MRA evaluating the phenotype would determine how aggressively to treat LDL.”

Dr. Gutierrez, professor of neurology at Columbia University Irving Medical Center, New York, noted that educating patients of their underlying high risk of events may have the effect of engaging them more in their own care. “There is evidence that actually showing people scans increases compliance and health literacy. It’s not yet standard of care, but we hope our future projects will help advance the field in the primary prevention direction,” he said.

This work was supported by the National Institutes of Health. The authors reported that they had no relevant financial disclosures.

An incidental diagnosis of intracranial atherosclerotic stenosis in stroke-free individuals should trigger a thorough assessment of vascular health, according to the authors of a study identifying risk factors and vascular event risk in asymptomatic ICAS.

mr.suphachai praserdumrongchai/iStock/Getty Images Plus

That conclusion emerged from data collected on more than 1,000 stroke-free participants in NOMAS (Northern Manhattan Study), a trial that prospectively followed participants who underwent a brain magnetic resonance angiogram (MRA) during 2003-2008.

In ICAS patients with stenosis of at least 70%, even with aggressive medical therapy, the annual stroke recurrence rate is 10%-20% in those with occlusions and at least three or more vascular risk factors. This high rate of recurrent vascular events in patients with stroke caused by ICAS warrants greater focus on primary prevention and targeted interventions for stroke-free individuals at highest risk for ICAS-related events, the investigators concluded.
 

Identify high-risk ICAS

Using NOMAS data, the investigators, led by Jose Gutierrez, MD, MPH, tested the hypothesis that stroke-free subjects at high risk of stroke and vascular events could be identified through the presence of asymptomatic ICAS. NOMAS is an ongoing, population-based epidemiologic study among randomly selected people with home telephones living in northern Manhattan.

During 2003-2008, investigators invited participants who were at least 50 years old, stroke free, and without contraindications to undergo brain MRA. The 1,211 study members were followed annually via telephone and in-person adjudication of events. A control group of 79 patients with no MRA was also identified with similar rates of hypertension, diabetes, hypercholesterolemia and current smoking.

Mean age was about 71 years (59% female, 65% Hispanic, 45% any stenosis). At the time of MRA, 78% had hypertension, 25% had diabetes, 81% had hypercholesterolemia, and 11% were current smokers.

Researchers rated stenoses in 11 brain arteries as 0, with no stenosis; 1, with less than 50% stenosis or luminal irregularities; 2, 50%-69% stenosis; and 3, at least 70% stenosis or flow gap. Outcomes included vascular death, myocardial infarction, ischemic stroke, cardioembolic stroke, intracranial artery disease stroke (which combined intracranial small and large artery disease strokes), and any vascular events (defined as a composite of vascular death, any stroke, or MI).
 

Greater stenosis denotes higher risk

Analysis found ICAS to be associated with older age (odds ratio, 1.02 per year; 95% confidence interval, 1.01-1.04), hypertension duration (OR, 1.01 per year; 95% CI, 1.00-1.02), higher number of glucose-lowering drugs (OR, 1.64 per each medication; 95% CI, 1.24-2.15), and HDL cholesterol(OR, 0.96 per mg/dL; 95% CI, 0.92-0.99). Event risk was greater among participants with ICAS of at least 70% (5.5% annual risk of vascular events; HR, 2.1; 95% CI, 1.4-3.2; compared with those with no ICAS), the investigators reported in the Journal of the American College of Cardiology.

Furthermore, 80% of incident strokes initially classified as small artery disease occurred among individuals with evidence of any degree of ICAS at their baseline MRI, the investigators noted. They found also that individuals with ICAS who had a primary care physician at the time of their initial MRI had a lower risk of events. Frequent primary care visits, they observed, might imply greater control of risk factors and other unmeasured confounders, such as health literacy, health care trust, access, and availability.
 

Incidental ICAS should trigger vascular assessment

An incidental diagnosis of ICAS in stroke-free subjects should trigger a thorough assessment of vascular health, the investigators concluded. They commented also that prophylaxis of first-ever stroke at this asymptomatic stage “may magnify the societal benefits of vascular prevention and decrease stroke-related disability and vascular death in our communities.”

“The big gap in our knowledge,” Tanya N. Turan, MD, professor of neurology at Medical University of South Carolina, Charleston, wrote in an accompanying editorial “is understanding the pathophysiological triggers for an asymptomatic stenosis to become a high-risk symptomatic stenosis. Until that question is answered, screening for asymptomatic ICAS is unlikely to change management among patients with known vascular risk factors.” In an interview, she observed further that “MRI plaque imaging could be a useful research tool to see if certain plaque features in an asymptomatic lesion are high risk for causing stroke. If that were proven, then it would make more sense to screen for ICAS and develop specific therapeutic strategies targeting high-risk asymptomatic plaque.”
 

Focus on recurrent stroke misplaced

Dr. Gutierrez said in an interview: “In the stroke world, most of what we do focuses on preventing recurrent stroke. Nonetheless, three-fourths of strokes in this country are new strokes, so to me it doesn’t make much sense to spend most of our efforts and attention to prevent the smallest fractions of strokes that occur in our society.”

He stressed that “the first immediate application of our results is that if people having a brain MRA for other reasons are found to have incidental, and therefore asymptomatic, ICAS, then they should be aggressively treated for vascular risk factors.” Secondly, “we hope to identify the patients at the highest risk of prevalent ICAS before they have a stroke. Among them, a brain MRI/MRA evaluating the phenotype would determine how aggressively to treat LDL.”

Dr. Gutierrez, professor of neurology at Columbia University Irving Medical Center, New York, noted that educating patients of their underlying high risk of events may have the effect of engaging them more in their own care. “There is evidence that actually showing people scans increases compliance and health literacy. It’s not yet standard of care, but we hope our future projects will help advance the field in the primary prevention direction,” he said.

This work was supported by the National Institutes of Health. The authors reported that they had no relevant financial disclosures.

An incidental diagnosis of intracranial atherosclerotic stenosis in stroke-free individuals should trigger a thorough assessment of vascular health, according to the authors of a study identifying risk factors and vascular event risk in asymptomatic ICAS.

mr.suphachai praserdumrongchai/iStock/Getty Images Plus

That conclusion emerged from data collected on more than 1,000 stroke-free participants in NOMAS (Northern Manhattan Study), a trial that prospectively followed participants who underwent a brain magnetic resonance angiogram (MRA) during 2003-2008.

In ICAS patients with stenosis of at least 70%, even with aggressive medical therapy, the annual stroke recurrence rate is 10%-20% in those with occlusions and at least three or more vascular risk factors. This high rate of recurrent vascular events in patients with stroke caused by ICAS warrants greater focus on primary prevention and targeted interventions for stroke-free individuals at highest risk for ICAS-related events, the investigators concluded.
 

Identify high-risk ICAS

Using NOMAS data, the investigators, led by Jose Gutierrez, MD, MPH, tested the hypothesis that stroke-free subjects at high risk of stroke and vascular events could be identified through the presence of asymptomatic ICAS. NOMAS is an ongoing, population-based epidemiologic study among randomly selected people with home telephones living in northern Manhattan.

During 2003-2008, investigators invited participants who were at least 50 years old, stroke free, and without contraindications to undergo brain MRA. The 1,211 study members were followed annually via telephone and in-person adjudication of events. A control group of 79 patients with no MRA was also identified with similar rates of hypertension, diabetes, hypercholesterolemia and current smoking.

Mean age was about 71 years (59% female, 65% Hispanic, 45% any stenosis). At the time of MRA, 78% had hypertension, 25% had diabetes, 81% had hypercholesterolemia, and 11% were current smokers.

Researchers rated stenoses in 11 brain arteries as 0, with no stenosis; 1, with less than 50% stenosis or luminal irregularities; 2, 50%-69% stenosis; and 3, at least 70% stenosis or flow gap. Outcomes included vascular death, myocardial infarction, ischemic stroke, cardioembolic stroke, intracranial artery disease stroke (which combined intracranial small and large artery disease strokes), and any vascular events (defined as a composite of vascular death, any stroke, or MI).
 

Greater stenosis denotes higher risk

Analysis found ICAS to be associated with older age (odds ratio, 1.02 per year; 95% confidence interval, 1.01-1.04), hypertension duration (OR, 1.01 per year; 95% CI, 1.00-1.02), higher number of glucose-lowering drugs (OR, 1.64 per each medication; 95% CI, 1.24-2.15), and HDL cholesterol(OR, 0.96 per mg/dL; 95% CI, 0.92-0.99). Event risk was greater among participants with ICAS of at least 70% (5.5% annual risk of vascular events; HR, 2.1; 95% CI, 1.4-3.2; compared with those with no ICAS), the investigators reported in the Journal of the American College of Cardiology.

Furthermore, 80% of incident strokes initially classified as small artery disease occurred among individuals with evidence of any degree of ICAS at their baseline MRI, the investigators noted. They found also that individuals with ICAS who had a primary care physician at the time of their initial MRI had a lower risk of events. Frequent primary care visits, they observed, might imply greater control of risk factors and other unmeasured confounders, such as health literacy, health care trust, access, and availability.
 

Incidental ICAS should trigger vascular assessment

An incidental diagnosis of ICAS in stroke-free subjects should trigger a thorough assessment of vascular health, the investigators concluded. They commented also that prophylaxis of first-ever stroke at this asymptomatic stage “may magnify the societal benefits of vascular prevention and decrease stroke-related disability and vascular death in our communities.”

“The big gap in our knowledge,” Tanya N. Turan, MD, professor of neurology at Medical University of South Carolina, Charleston, wrote in an accompanying editorial “is understanding the pathophysiological triggers for an asymptomatic stenosis to become a high-risk symptomatic stenosis. Until that question is answered, screening for asymptomatic ICAS is unlikely to change management among patients with known vascular risk factors.” In an interview, she observed further that “MRI plaque imaging could be a useful research tool to see if certain plaque features in an asymptomatic lesion are high risk for causing stroke. If that were proven, then it would make more sense to screen for ICAS and develop specific therapeutic strategies targeting high-risk asymptomatic plaque.”
 

Focus on recurrent stroke misplaced

Dr. Gutierrez said in an interview: “In the stroke world, most of what we do focuses on preventing recurrent stroke. Nonetheless, three-fourths of strokes in this country are new strokes, so to me it doesn’t make much sense to spend most of our efforts and attention to prevent the smallest fractions of strokes that occur in our society.”

He stressed that “the first immediate application of our results is that if people having a brain MRA for other reasons are found to have incidental, and therefore asymptomatic, ICAS, then they should be aggressively treated for vascular risk factors.” Secondly, “we hope to identify the patients at the highest risk of prevalent ICAS before they have a stroke. Among them, a brain MRI/MRA evaluating the phenotype would determine how aggressively to treat LDL.”

Dr. Gutierrez, professor of neurology at Columbia University Irving Medical Center, New York, noted that educating patients of their underlying high risk of events may have the effect of engaging them more in their own care. “There is evidence that actually showing people scans increases compliance and health literacy. It’s not yet standard of care, but we hope our future projects will help advance the field in the primary prevention direction,” he said.

This work was supported by the National Institutes of Health. The authors reported that they had no relevant financial disclosures.

Today there are so many evidence-based drug therapies for heart failure with reduced ejection fraction (HFrEF) that physicians treating HF patients almost don’t know what to do them.

It’s an exciting new age that way, but to many vexingly unclear how best to merge the shiny new options with mainstay regimens based on time-honored renin-angiotensin system (RAS) inhibitors and beta-blockers.

To impart some clarity, the authors of a new HF guideline document recently took center stage at the Heart Failure Association of the European Society of Cardiology (ESC-HFA) annual meeting to preview their updated recommendations, with novel twists based on recent major trials, for the new age of HF pharmacotherapeutics.

The guideline committee considered the evidence base that existed “up until the end of March of this year,” Theresa A. McDonagh, MD, King’s College London, said during the presentation. The document “is now finalized, it’s with the publishers, and it will be presented in full with simultaneous publication at the ESC meeting” that starts August 27.

It describes a game plan, already followed by some clinicians in practice without official guidance, for initiating drugs from each of four classes in virtually all patients with HFrEF.
 

New indicated drugs, new perspective for HFrEF

Three of the drug categories are old acquaintances. Among them are the RAS inhibitors, which include angiotensin-receptor/neprilysin inhibitors, beta-blockers, and the mineralocorticoid receptor antagonists. The latter drugs are gaining new respect after having been underplayed in HF prescribing despite longstanding evidence of efficacy.

Completing the quartet of first-line HFrEF drug classes is a recent arrival to the HF arena, the sodium-glucose cotransporter 2 inhibitors.

“We now have new data and a simplified treatment algorithm for heart failure with reduced ejection fraction based on the early administration of the four major classes of drugs,” said Marco Metra, MD, University of Brescia (Italy), previewing the medical-therapy portions of the new guideline at the ESC-HFA sessions, which launched virtually and live in Florence, Italy, on July 29.

The new game plan offers a simple answer to a once-common but complex question: How and in what order are the different drug classes initiated in patients with HFrEF? In the new document, the stated goal is to get them all on board expeditiously and safely, by any means possible.

The guideline writers did not specify a sequence, preferring to leave that decision to physicians, said Dr. Metra, who stated only two guiding principles. The first is to consider the patient’s unique circumstances. The order in which the drugs are introduced might vary, depending on, for example, whether the patient has low or high blood pressure or renal dysfunction.

Second, “it is very important that we try to give all four classes of drugs to the patient in the shortest time possible, because this saves lives,” he said.

That there is no recommendation on sequencing the drugs has led some to the wrong interpretation that all should be started at once, observed coauthor Javed Butler, MD, MPH, University of Mississippi, Jackson, as a panelist during the presentation. Far from it, he said. “The doctor with the patient in front of you can make the best decision. The idea here is to get all the therapies on as soon as possible, as safely as possible.”

“The order in which they are introduced is not really important,” agreed Vijay Chopra, MD, Max Super Specialty Hospital Saket, New Delhi, another coauthor on the panel. “The important thing is that at least some dose of all the four drugs needs to be introduced in the first 4-6 weeks, and then up-titrated.”

Other medical therapy can be more tailored, Dr. Metra noted, such as loop diuretics for patients with congestion, iron for those with iron deficiency, and other drugs depending on whether there is, for example, atrial fibrillation or coronary disease.
 

Adoption of emerging definitions

The document adopts the emerging characterization of HFrEF by a left ventricular ejection fraction (LVEF) up to 40%.

And it will leverage an expanding evidence base for medication in a segment of patients once said to have HF with preserved ejection fraction (HFpEF), who had therefore lacked specific, guideline-directed medical therapies. Now, patients with an LVEF of 41%-49% will be said to have HF with mildly reduced ejection fraction (HFmrEF), a tweak to the recently introduced HF with “mid-range” LVEF that is designed to assert its nature as something to treat. The new document’s HFmrEF recommendations come with various class and level-of-evidence ratings.

That leaves HFpEF to be characterized by an LVEF of 50% in combination with structural or functional abnormalities associated with LV diastolic dysfunction or raised LV filling pressures, including raised natriuretic peptide levels.

The definitions are consistent with those proposed internationally by the ESC-HFA, the Heart Failure Society of America, and other groups in a statement published in March.
 

Expanded HFrEF med landscape

Since the 2016 ESC guideline on HF therapy, Dr. McDonagh said, “there’s been no substantial change in the evidence for many of the classical drugs that we use in heart failure. However, we had a lot of new and exciting evidence to consider,” especially in support of the SGLT2 inhibitors as one of the core medications in HFrEF.

The new data came from two controlled trials in particular. In DAPA-HF, patients with HFrEF who were initially without diabetes and who went on dapagliflozin (Farxiga, AstraZeneca) showed a 27% drop in cardiovascular (CV) death or worsening-HF events over a median of 18 months.

“That was followed up with very concordant results with empagliflozin [Jardiance, Boehringer Ingelheim/Eli Lilly] in HFrEF in the EMPEROR-Reduced trial,” Dr. McDonagh said. In that trial, comparable patients who took empagliflozin showed a 25% drop in a primary endpoint similar to that in DAPA-HF over the median 16-month follow-up.

Other HFrEF recommendations are for selected patients. They include ivabradine, already in the guidelines, for patients in sinus rhythm with an elevated resting heart rate who can’t take beta-blockers for whatever reason. But, Dr. McDonagh noted, “we had some new classes of drugs to consider as well.”

In particular, the oral soluble guanylate-cyclase receptor stimulator vericiguat (Verquvo) emerged about a year ago from the VICTORIA trial as a modest success for patients with HFrEF and a previous HF hospitalization. In the trial with more than 5,000 patients, treatment with vericiguat atop standard drug and device therapy was followed by a significant 10% drop in risk for CV death or HF hospitalization.

Available now or likely to be available in the United States, the European Union, Japan, and other countries, vericiguat is recommended in the new guideline for VICTORIA-like patients who don’t adequately respond to other indicated medications.
 

Little for HFpEF as newly defined

“Almost nothing is new” in the guidelines for HFpEF, Dr. Metra said. The document recommends screening for and treatment of any underlying disorder and comorbidities, plus diuretics for any congestion. “That’s what we have to date.”

But that evidence base might soon change. The new HFpEF recommendations could possibly be up-staged at the ESC sessions by the August 27 scheduled presentation of EMPEROR-Preserved, a randomized test of empagliflozin in HFpEF and – it could be said – HFmrEF. The trial entered patients with chronic HF and an LVEF greater than 40%.

Eli Lilly and Boehringer Ingelheim offered the world a peek at the results, which suggest the SGLT2 inhibitor had a positive impact on the primary endpoint of CV death or HF hospitalization. They announced the cursory top-line outcomes in early July as part of its regulatory obligations, noting that the trial had “met” its primary endpoint.

But many unknowns remain, including the degree of benefit and whether it varied among subgroups, and especially whether outcomes were different for HFmrEF than for HFpEF.
 

Upgrades for familiar agents

Still, HFmrEF gets noteworthy attention in the document. “For the first time, we have recommendations for these patients,” Dr. Metra said. “We already knew that diuretics are indicated for the treatment of congestion. But now, ACE inhibitors, ARBs, beta-blockers, mineralocorticoid antagonists, as well as sacubitril/valsartan, may be considered to improve outcomes in these patients.” Their upgrades in the new guidelines were based on review of trials in the CHARM program and of TOPCAT and PARAGON-HF, among others, he said.

The new document also includes “treatment algorithms based on phenotypes”; that is, comorbidities and less common HF precipitants. For example, “assessment of iron status is now mandated in all patients with heart failure,” Dr. Metra said.

AFFIRM-HF is the key trial in this arena, with its more than 1,100 iron-deficient patients with LVEF less than 50% who had been recently hospitalized for HF. A year of treatment with ferric carboxymaltose (Ferinject/Injectafer, Vifor) led to a 26% drop in risk for HF hospitalization, but without affecting mortality.

For those who are iron deficient, Dr. Metra said, “ferric carboxymaltose intravenously should be considered not only in patients with low ejection fraction and outpatients, but also in patients recently hospitalized for acute heart failure.”

The SGLT2 inhibitors are recommended in HFrEF patients with type 2 diabetes. And treatment with tafamidis (Vyndaqel, Pfizer) in patients with genetic or wild-type transthyretin cardiac amyloidosis gets a class I recommendation based on survival gains seen in the ATTR-ACT trial.

Also recommended is a full CV assessment for patients with cancer who are on cardiotoxic agents or otherwise might be at risk for chemotherapy cardiotoxicity. “Beta-blockers and ACE inhibitors should be considered in those who develop left ventricular systolic dysfunction after anticancer therapy,” Dr. Metra said.

The ongoing pandemic made its mark on the document’s genesis, as it has with most everything else. “For better or worse, we were a ‘COVID guideline,’ ” Dr. McDonagh said. The writing committee consisted of “a large task force of 31 individuals, including two patients,” and there were “only two face-to-face meetings prior to the first wave of COVID hitting Europe.”

The committee voted on each of the recommendations, “and we had to have agreement of more than 75% of the task force to assign a class of recommendation or level of evidence,” she said. “I think we did the best we could in the circumstances. We had the benefit of many discussions over Zoom, and I think at the end of the day we have achieved a consensus.”

With such a large body of participants and the 75% threshold for agreement, “you end up with perhaps a conservative guideline. But that’s not a bad thing for clinical practice, for guidelines to be conservative,” Dr. McDonagh said. “They’re mainly concerned with looking at evidence and safety.”

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

Today there are so many evidence-based drug therapies for heart failure with reduced ejection fraction (HFrEF) that physicians treating HF patients almost don’t know what to do them.

It’s an exciting new age that way, but to many vexingly unclear how best to merge the shiny new options with mainstay regimens based on time-honored renin-angiotensin system (RAS) inhibitors and beta-blockers.

To impart some clarity, the authors of a new HF guideline document recently took center stage at the Heart Failure Association of the European Society of Cardiology (ESC-HFA) annual meeting to preview their updated recommendations, with novel twists based on recent major trials, for the new age of HF pharmacotherapeutics.

The guideline committee considered the evidence base that existed “up until the end of March of this year,” Theresa A. McDonagh, MD, King’s College London, said during the presentation. The document “is now finalized, it’s with the publishers, and it will be presented in full with simultaneous publication at the ESC meeting” that starts August 27.

It describes a game plan, already followed by some clinicians in practice without official guidance, for initiating drugs from each of four classes in virtually all patients with HFrEF.
 

New indicated drugs, new perspective for HFrEF

Three of the drug categories are old acquaintances. Among them are the RAS inhibitors, which include angiotensin-receptor/neprilysin inhibitors, beta-blockers, and the mineralocorticoid receptor antagonists. The latter drugs are gaining new respect after having been underplayed in HF prescribing despite longstanding evidence of efficacy.

Completing the quartet of first-line HFrEF drug classes is a recent arrival to the HF arena, the sodium-glucose cotransporter 2 inhibitors.

“We now have new data and a simplified treatment algorithm for heart failure with reduced ejection fraction based on the early administration of the four major classes of drugs,” said Marco Metra, MD, University of Brescia (Italy), previewing the medical-therapy portions of the new guideline at the ESC-HFA sessions, which launched virtually and live in Florence, Italy, on July 29.

The new game plan offers a simple answer to a once-common but complex question: How and in what order are the different drug classes initiated in patients with HFrEF? In the new document, the stated goal is to get them all on board expeditiously and safely, by any means possible.

The guideline writers did not specify a sequence, preferring to leave that decision to physicians, said Dr. Metra, who stated only two guiding principles. The first is to consider the patient’s unique circumstances. The order in which the drugs are introduced might vary, depending on, for example, whether the patient has low or high blood pressure or renal dysfunction.

Second, “it is very important that we try to give all four classes of drugs to the patient in the shortest time possible, because this saves lives,” he said.

That there is no recommendation on sequencing the drugs has led some to the wrong interpretation that all should be started at once, observed coauthor Javed Butler, MD, MPH, University of Mississippi, Jackson, as a panelist during the presentation. Far from it, he said. “The doctor with the patient in front of you can make the best decision. The idea here is to get all the therapies on as soon as possible, as safely as possible.”

“The order in which they are introduced is not really important,” agreed Vijay Chopra, MD, Max Super Specialty Hospital Saket, New Delhi, another coauthor on the panel. “The important thing is that at least some dose of all the four drugs needs to be introduced in the first 4-6 weeks, and then up-titrated.”

Other medical therapy can be more tailored, Dr. Metra noted, such as loop diuretics for patients with congestion, iron for those with iron deficiency, and other drugs depending on whether there is, for example, atrial fibrillation or coronary disease.
 

Adoption of emerging definitions

The document adopts the emerging characterization of HFrEF by a left ventricular ejection fraction (LVEF) up to 40%.

And it will leverage an expanding evidence base for medication in a segment of patients once said to have HF with preserved ejection fraction (HFpEF), who had therefore lacked specific, guideline-directed medical therapies. Now, patients with an LVEF of 41%-49% will be said to have HF with mildly reduced ejection fraction (HFmrEF), a tweak to the recently introduced HF with “mid-range” LVEF that is designed to assert its nature as something to treat. The new document’s HFmrEF recommendations come with various class and level-of-evidence ratings.

That leaves HFpEF to be characterized by an LVEF of 50% in combination with structural or functional abnormalities associated with LV diastolic dysfunction or raised LV filling pressures, including raised natriuretic peptide levels.

The definitions are consistent with those proposed internationally by the ESC-HFA, the Heart Failure Society of America, and other groups in a statement published in March.
 

Expanded HFrEF med landscape

Since the 2016 ESC guideline on HF therapy, Dr. McDonagh said, “there’s been no substantial change in the evidence for many of the classical drugs that we use in heart failure. However, we had a lot of new and exciting evidence to consider,” especially in support of the SGLT2 inhibitors as one of the core medications in HFrEF.

The new data came from two controlled trials in particular. In DAPA-HF, patients with HFrEF who were initially without diabetes and who went on dapagliflozin (Farxiga, AstraZeneca) showed a 27% drop in cardiovascular (CV) death or worsening-HF events over a median of 18 months.

“That was followed up with very concordant results with empagliflozin [Jardiance, Boehringer Ingelheim/Eli Lilly] in HFrEF in the EMPEROR-Reduced trial,” Dr. McDonagh said. In that trial, comparable patients who took empagliflozin showed a 25% drop in a primary endpoint similar to that in DAPA-HF over the median 16-month follow-up.

Other HFrEF recommendations are for selected patients. They include ivabradine, already in the guidelines, for patients in sinus rhythm with an elevated resting heart rate who can’t take beta-blockers for whatever reason. But, Dr. McDonagh noted, “we had some new classes of drugs to consider as well.”

In particular, the oral soluble guanylate-cyclase receptor stimulator vericiguat (Verquvo) emerged about a year ago from the VICTORIA trial as a modest success for patients with HFrEF and a previous HF hospitalization. In the trial with more than 5,000 patients, treatment with vericiguat atop standard drug and device therapy was followed by a significant 10% drop in risk for CV death or HF hospitalization.

Available now or likely to be available in the United States, the European Union, Japan, and other countries, vericiguat is recommended in the new guideline for VICTORIA-like patients who don’t adequately respond to other indicated medications.
 

Little for HFpEF as newly defined

“Almost nothing is new” in the guidelines for HFpEF, Dr. Metra said. The document recommends screening for and treatment of any underlying disorder and comorbidities, plus diuretics for any congestion. “That’s what we have to date.”

But that evidence base might soon change. The new HFpEF recommendations could possibly be up-staged at the ESC sessions by the August 27 scheduled presentation of EMPEROR-Preserved, a randomized test of empagliflozin in HFpEF and – it could be said – HFmrEF. The trial entered patients with chronic HF and an LVEF greater than 40%.

Eli Lilly and Boehringer Ingelheim offered the world a peek at the results, which suggest the SGLT2 inhibitor had a positive impact on the primary endpoint of CV death or HF hospitalization. They announced the cursory top-line outcomes in early July as part of its regulatory obligations, noting that the trial had “met” its primary endpoint.

But many unknowns remain, including the degree of benefit and whether it varied among subgroups, and especially whether outcomes were different for HFmrEF than for HFpEF.
 

Upgrades for familiar agents

Still, HFmrEF gets noteworthy attention in the document. “For the first time, we have recommendations for these patients,” Dr. Metra said. “We already knew that diuretics are indicated for the treatment of congestion. But now, ACE inhibitors, ARBs, beta-blockers, mineralocorticoid antagonists, as well as sacubitril/valsartan, may be considered to improve outcomes in these patients.” Their upgrades in the new guidelines were based on review of trials in the CHARM program and of TOPCAT and PARAGON-HF, among others, he said.

The new document also includes “treatment algorithms based on phenotypes”; that is, comorbidities and less common HF precipitants. For example, “assessment of iron status is now mandated in all patients with heart failure,” Dr. Metra said.

AFFIRM-HF is the key trial in this arena, with its more than 1,100 iron-deficient patients with LVEF less than 50% who had been recently hospitalized for HF. A year of treatment with ferric carboxymaltose (Ferinject/Injectafer, Vifor) led to a 26% drop in risk for HF hospitalization, but without affecting mortality.

For those who are iron deficient, Dr. Metra said, “ferric carboxymaltose intravenously should be considered not only in patients with low ejection fraction and outpatients, but also in patients recently hospitalized for acute heart failure.”

The SGLT2 inhibitors are recommended in HFrEF patients with type 2 diabetes. And treatment with tafamidis (Vyndaqel, Pfizer) in patients with genetic or wild-type transthyretin cardiac amyloidosis gets a class I recommendation based on survival gains seen in the ATTR-ACT trial.

Also recommended is a full CV assessment for patients with cancer who are on cardiotoxic agents or otherwise might be at risk for chemotherapy cardiotoxicity. “Beta-blockers and ACE inhibitors should be considered in those who develop left ventricular systolic dysfunction after anticancer therapy,” Dr. Metra said.

The ongoing pandemic made its mark on the document’s genesis, as it has with most everything else. “For better or worse, we were a ‘COVID guideline,’ ” Dr. McDonagh said. The writing committee consisted of “a large task force of 31 individuals, including two patients,” and there were “only two face-to-face meetings prior to the first wave of COVID hitting Europe.”

The committee voted on each of the recommendations, “and we had to have agreement of more than 75% of the task force to assign a class of recommendation or level of evidence,” she said. “I think we did the best we could in the circumstances. We had the benefit of many discussions over Zoom, and I think at the end of the day we have achieved a consensus.”

With such a large body of participants and the 75% threshold for agreement, “you end up with perhaps a conservative guideline. But that’s not a bad thing for clinical practice, for guidelines to be conservative,” Dr. McDonagh said. “They’re mainly concerned with looking at evidence and safety.”

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

Today there are so many evidence-based drug therapies for heart failure with reduced ejection fraction (HFrEF) that physicians treating HF patients almost don’t know what to do them.

It’s an exciting new age that way, but to many vexingly unclear how best to merge the shiny new options with mainstay regimens based on time-honored renin-angiotensin system (RAS) inhibitors and beta-blockers.

To impart some clarity, the authors of a new HF guideline document recently took center stage at the Heart Failure Association of the European Society of Cardiology (ESC-HFA) annual meeting to preview their updated recommendations, with novel twists based on recent major trials, for the new age of HF pharmacotherapeutics.

The guideline committee considered the evidence base that existed “up until the end of March of this year,” Theresa A. McDonagh, MD, King’s College London, said during the presentation. The document “is now finalized, it’s with the publishers, and it will be presented in full with simultaneous publication at the ESC meeting” that starts August 27.

It describes a game plan, already followed by some clinicians in practice without official guidance, for initiating drugs from each of four classes in virtually all patients with HFrEF.
 

New indicated drugs, new perspective for HFrEF

Three of the drug categories are old acquaintances. Among them are the RAS inhibitors, which include angiotensin-receptor/neprilysin inhibitors, beta-blockers, and the mineralocorticoid receptor antagonists. The latter drugs are gaining new respect after having been underplayed in HF prescribing despite longstanding evidence of efficacy.

Completing the quartet of first-line HFrEF drug classes is a recent arrival to the HF arena, the sodium-glucose cotransporter 2 inhibitors.

“We now have new data and a simplified treatment algorithm for heart failure with reduced ejection fraction based on the early administration of the four major classes of drugs,” said Marco Metra, MD, University of Brescia (Italy), previewing the medical-therapy portions of the new guideline at the ESC-HFA sessions, which launched virtually and live in Florence, Italy, on July 29.

The new game plan offers a simple answer to a once-common but complex question: How and in what order are the different drug classes initiated in patients with HFrEF? In the new document, the stated goal is to get them all on board expeditiously and safely, by any means possible.

The guideline writers did not specify a sequence, preferring to leave that decision to physicians, said Dr. Metra, who stated only two guiding principles. The first is to consider the patient’s unique circumstances. The order in which the drugs are introduced might vary, depending on, for example, whether the patient has low or high blood pressure or renal dysfunction.

Second, “it is very important that we try to give all four classes of drugs to the patient in the shortest time possible, because this saves lives,” he said.

That there is no recommendation on sequencing the drugs has led some to the wrong interpretation that all should be started at once, observed coauthor Javed Butler, MD, MPH, University of Mississippi, Jackson, as a panelist during the presentation. Far from it, he said. “The doctor with the patient in front of you can make the best decision. The idea here is to get all the therapies on as soon as possible, as safely as possible.”

“The order in which they are introduced is not really important,” agreed Vijay Chopra, MD, Max Super Specialty Hospital Saket, New Delhi, another coauthor on the panel. “The important thing is that at least some dose of all the four drugs needs to be introduced in the first 4-6 weeks, and then up-titrated.”

Other medical therapy can be more tailored, Dr. Metra noted, such as loop diuretics for patients with congestion, iron for those with iron deficiency, and other drugs depending on whether there is, for example, atrial fibrillation or coronary disease.
 

Adoption of emerging definitions

The document adopts the emerging characterization of HFrEF by a left ventricular ejection fraction (LVEF) up to 40%.

And it will leverage an expanding evidence base for medication in a segment of patients once said to have HF with preserved ejection fraction (HFpEF), who had therefore lacked specific, guideline-directed medical therapies. Now, patients with an LVEF of 41%-49% will be said to have HF with mildly reduced ejection fraction (HFmrEF), a tweak to the recently introduced HF with “mid-range” LVEF that is designed to assert its nature as something to treat. The new document’s HFmrEF recommendations come with various class and level-of-evidence ratings.

That leaves HFpEF to be characterized by an LVEF of 50% in combination with structural or functional abnormalities associated with LV diastolic dysfunction or raised LV filling pressures, including raised natriuretic peptide levels.

The definitions are consistent with those proposed internationally by the ESC-HFA, the Heart Failure Society of America, and other groups in a statement published in March.
 

Expanded HFrEF med landscape

Since the 2016 ESC guideline on HF therapy, Dr. McDonagh said, “there’s been no substantial change in the evidence for many of the classical drugs that we use in heart failure. However, we had a lot of new and exciting evidence to consider,” especially in support of the SGLT2 inhibitors as one of the core medications in HFrEF.

The new data came from two controlled trials in particular. In DAPA-HF, patients with HFrEF who were initially without diabetes and who went on dapagliflozin (Farxiga, AstraZeneca) showed a 27% drop in cardiovascular (CV) death or worsening-HF events over a median of 18 months.

“That was followed up with very concordant results with empagliflozin [Jardiance, Boehringer Ingelheim/Eli Lilly] in HFrEF in the EMPEROR-Reduced trial,” Dr. McDonagh said. In that trial, comparable patients who took empagliflozin showed a 25% drop in a primary endpoint similar to that in DAPA-HF over the median 16-month follow-up.

Other HFrEF recommendations are for selected patients. They include ivabradine, already in the guidelines, for patients in sinus rhythm with an elevated resting heart rate who can’t take beta-blockers for whatever reason. But, Dr. McDonagh noted, “we had some new classes of drugs to consider as well.”

In particular, the oral soluble guanylate-cyclase receptor stimulator vericiguat (Verquvo) emerged about a year ago from the VICTORIA trial as a modest success for patients with HFrEF and a previous HF hospitalization. In the trial with more than 5,000 patients, treatment with vericiguat atop standard drug and device therapy was followed by a significant 10% drop in risk for CV death or HF hospitalization.

Available now or likely to be available in the United States, the European Union, Japan, and other countries, vericiguat is recommended in the new guideline for VICTORIA-like patients who don’t adequately respond to other indicated medications.
 

Little for HFpEF as newly defined

“Almost nothing is new” in the guidelines for HFpEF, Dr. Metra said. The document recommends screening for and treatment of any underlying disorder and comorbidities, plus diuretics for any congestion. “That’s what we have to date.”

But that evidence base might soon change. The new HFpEF recommendations could possibly be up-staged at the ESC sessions by the August 27 scheduled presentation of EMPEROR-Preserved, a randomized test of empagliflozin in HFpEF and – it could be said – HFmrEF. The trial entered patients with chronic HF and an LVEF greater than 40%.

Eli Lilly and Boehringer Ingelheim offered the world a peek at the results, which suggest the SGLT2 inhibitor had a positive impact on the primary endpoint of CV death or HF hospitalization. They announced the cursory top-line outcomes in early July as part of its regulatory obligations, noting that the trial had “met” its primary endpoint.

But many unknowns remain, including the degree of benefit and whether it varied among subgroups, and especially whether outcomes were different for HFmrEF than for HFpEF.
 

Upgrades for familiar agents

Still, HFmrEF gets noteworthy attention in the document. “For the first time, we have recommendations for these patients,” Dr. Metra said. “We already knew that diuretics are indicated for the treatment of congestion. But now, ACE inhibitors, ARBs, beta-blockers, mineralocorticoid antagonists, as well as sacubitril/valsartan, may be considered to improve outcomes in these patients.” Their upgrades in the new guidelines were based on review of trials in the CHARM program and of TOPCAT and PARAGON-HF, among others, he said.

The new document also includes “treatment algorithms based on phenotypes”; that is, comorbidities and less common HF precipitants. For example, “assessment of iron status is now mandated in all patients with heart failure,” Dr. Metra said.

AFFIRM-HF is the key trial in this arena, with its more than 1,100 iron-deficient patients with LVEF less than 50% who had been recently hospitalized for HF. A year of treatment with ferric carboxymaltose (Ferinject/Injectafer, Vifor) led to a 26% drop in risk for HF hospitalization, but without affecting mortality.

For those who are iron deficient, Dr. Metra said, “ferric carboxymaltose intravenously should be considered not only in patients with low ejection fraction and outpatients, but also in patients recently hospitalized for acute heart failure.”

The SGLT2 inhibitors are recommended in HFrEF patients with type 2 diabetes. And treatment with tafamidis (Vyndaqel, Pfizer) in patients with genetic or wild-type transthyretin cardiac amyloidosis gets a class I recommendation based on survival gains seen in the ATTR-ACT trial.

Also recommended is a full CV assessment for patients with cancer who are on cardiotoxic agents or otherwise might be at risk for chemotherapy cardiotoxicity. “Beta-blockers and ACE inhibitors should be considered in those who develop left ventricular systolic dysfunction after anticancer therapy,” Dr. Metra said.

The ongoing pandemic made its mark on the document’s genesis, as it has with most everything else. “For better or worse, we were a ‘COVID guideline,’ ” Dr. McDonagh said. The writing committee consisted of “a large task force of 31 individuals, including two patients,” and there were “only two face-to-face meetings prior to the first wave of COVID hitting Europe.”

The committee voted on each of the recommendations, “and we had to have agreement of more than 75% of the task force to assign a class of recommendation or level of evidence,” she said. “I think we did the best we could in the circumstances. We had the benefit of many discussions over Zoom, and I think at the end of the day we have achieved a consensus.”

With such a large body of participants and the 75% threshold for agreement, “you end up with perhaps a conservative guideline. But that’s not a bad thing for clinical practice, for guidelines to be conservative,” Dr. McDonagh said. “They’re mainly concerned with looking at evidence and safety.”

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