Heart Failure

There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the U.S. Food and Drug Administration says in a letter to health care professionals posted on its website.  

Evidence in the literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.

The Trifecta and Trifecta GT valves are heart valve replacement devices intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves, the letter notes. The first-generation Trifecta valve was approved in 2011 but is no longer marketed in the United States. The Trifecta GT valve was approved in 2016.

Medical device reports (MDRs) received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant. “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death,” the FDA notes.

In a letter to customers, Abbott says a “complaint analysis has shown that most cases of early SVD which occur within 5 years post-implant are characterized as a non-calcific leaflet tear, while most cases of late SVD which occur beyond 5 years post-implant are characterized as a fibrous-calcific SVD.” 

The FDA recommends that health care providers take the following actions:

• Be aware of the potential risk of early SVD with Trifecta valves, and current patient management considerations, as communicated by Abbott.
• Discuss the risks and benefits of all available aortic valve treatment options with patients and caregivers as part of shared clinical decision-making prior to surgery.
• Read and carefully follow the Instructions for Use when implanting a Trifecta GT valve.
• Monitor patients who have undergone implantation with Trifecta valves for signs and symptoms of potential SVD.
• Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
• Ensure lifelong follow-up visits, conducted at least yearly, including transthoracic echocardiogram assessment of the valve beginning 1-year post-implant.

The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.

Clinicians are encouraged to report any adverse events or quality problems with the Trifecta valves to their local Abbott representative or the customer service department at 1-800-544-1664.

Health care professionals can also report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the U.S. Food and Drug Administration says in a letter to health care professionals posted on its website.  

Evidence in the literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.

The Trifecta and Trifecta GT valves are heart valve replacement devices intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves, the letter notes. The first-generation Trifecta valve was approved in 2011 but is no longer marketed in the United States. The Trifecta GT valve was approved in 2016.

Medical device reports (MDRs) received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant. “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death,” the FDA notes.

In a letter to customers, Abbott says a “complaint analysis has shown that most cases of early SVD which occur within 5 years post-implant are characterized as a non-calcific leaflet tear, while most cases of late SVD which occur beyond 5 years post-implant are characterized as a fibrous-calcific SVD.” 

The FDA recommends that health care providers take the following actions:

• Be aware of the potential risk of early SVD with Trifecta valves, and current patient management considerations, as communicated by Abbott.
• Discuss the risks and benefits of all available aortic valve treatment options with patients and caregivers as part of shared clinical decision-making prior to surgery.
• Read and carefully follow the Instructions for Use when implanting a Trifecta GT valve.
• Monitor patients who have undergone implantation with Trifecta valves for signs and symptoms of potential SVD.
• Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
• Ensure lifelong follow-up visits, conducted at least yearly, including transthoracic echocardiogram assessment of the valve beginning 1-year post-implant.

The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.

Clinicians are encouraged to report any adverse events or quality problems with the Trifecta valves to their local Abbott representative or the customer service department at 1-800-544-1664.

Health care professionals can also report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the U.S. Food and Drug Administration says in a letter to health care professionals posted on its website.  

Evidence in the literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.

The Trifecta and Trifecta GT valves are heart valve replacement devices intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves, the letter notes. The first-generation Trifecta valve was approved in 2011 but is no longer marketed in the United States. The Trifecta GT valve was approved in 2016.

Medical device reports (MDRs) received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant. “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death,” the FDA notes.

In a letter to customers, Abbott says a “complaint analysis has shown that most cases of early SVD which occur within 5 years post-implant are characterized as a non-calcific leaflet tear, while most cases of late SVD which occur beyond 5 years post-implant are characterized as a fibrous-calcific SVD.” 

The FDA recommends that health care providers take the following actions:

• Be aware of the potential risk of early SVD with Trifecta valves, and current patient management considerations, as communicated by Abbott.
• Discuss the risks and benefits of all available aortic valve treatment options with patients and caregivers as part of shared clinical decision-making prior to surgery.
• Read and carefully follow the Instructions for Use when implanting a Trifecta GT valve.
• Monitor patients who have undergone implantation with Trifecta valves for signs and symptoms of potential SVD.
• Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
• Ensure lifelong follow-up visits, conducted at least yearly, including transthoracic echocardiogram assessment of the valve beginning 1-year post-implant.

The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.

Clinicians are encouraged to report any adverse events or quality problems with the Trifecta valves to their local Abbott representative or the customer service department at 1-800-544-1664.

Health care professionals can also report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

Fewer than 10% of American adults with type 2 diabetes who qualified for treatment with newer agents – such as an SGLT2 inhibitor or GLP-1 agonist – actually received treatment with at least one drug from drug class in 2017-2020, based on a new analysis of just over a thousand adults who participated in a representative, biannual survey and self-reported a diabetes diagnosis.

The cost of these agents, and their uncertain cost-effectiveness at current prices, is likely a key driver of the low usage rate, say the authors of a brief report published in Annals of Internal Medicine.

“Clinical studies have shown that both GLP-1 [glucagonlike peptide–1] receptor agonists and SGLT2 [sodium-glucose cotransporter 2] inhibitors yield additional clinical benefits, compared with older treatments in reducing body weight and progression of cardiovascular disease and chronic kidney disease,” write Shichao Tang, PhD, from the U.S. Centers for Disease Control and Prevention, Atlanta, and colleagues.

“However, these medications come at a substantially higher cost,” they stress.

Dr. Tang explained in an interview that the new study “points to prior studies about the high cost of these medications as a potential barrier to use, but more research is needed to understand cost-effectiveness and any potential barriers to use, including cost.”

The work “did not include research into cost-effectiveness or why the percentage of people already using these medications was low,” he emphasized.

Dr. Tang and colleagues used data collected by the U.S. National Health and Nutrition Examination Survey during two 2-year cycles between 2017 and 2020 that included 1,417 people who self-identified a diagnosis of diabetes.

Excluding those who likely had type 1 diabetes and those with incomplete data left 1,330 survey participants, including 1,133 (85%) who fit criteria for the treatment of type 2 diabetes with an agent from one of the two studied classes, as recommended in 2022 by a panel representing the American Diabetes Association and the European Association for the Study of Diabetes.

Among these 1,133 people – who represent more than 22 million American adults with type 2 diabetes who fit the 2022 criteria – a scant 3.7% were actually taking a GLP-1 agonist and 5.3% were taking an SGLT2 inhibitor.

“While it’s important to note that our data predate the 2022 recommendations, these drugs were offered as second-line therapy for patients with certain diabetes-related complications in 2017-2020” and hence provide potentially useful insights, noted Dr. Tang, a health economist with the CDC National Center for Chronic Disease Prevention and Health Promotion.

Based on retail prices listed on a United States–based website, a 30-day supply of an oral SGLT2 inhibitor can cost about $550-$600 per month, while common subcutaneously injected GLP-1 receptor agonists can run from a few hundred dollars for a daily injection or close to $1,000 for a formulation administered weekly.

“Cost-effectiveness was not formally considered in the current guideline, but an assessment of cost-effectiveness may assist better targeting of interventions to achieve the greatest effect at a sustainable cost,” the researchers conclude.

The study received no commercial funding. None of the authors had relevant financial relationships.

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

Fewer than 10% of American adults with type 2 diabetes who qualified for treatment with newer agents – such as an SGLT2 inhibitor or GLP-1 agonist – actually received treatment with at least one drug from drug class in 2017-2020, based on a new analysis of just over a thousand adults who participated in a representative, biannual survey and self-reported a diabetes diagnosis.

The cost of these agents, and their uncertain cost-effectiveness at current prices, is likely a key driver of the low usage rate, say the authors of a brief report published in Annals of Internal Medicine.

“Clinical studies have shown that both GLP-1 [glucagonlike peptide–1] receptor agonists and SGLT2 [sodium-glucose cotransporter 2] inhibitors yield additional clinical benefits, compared with older treatments in reducing body weight and progression of cardiovascular disease and chronic kidney disease,” write Shichao Tang, PhD, from the U.S. Centers for Disease Control and Prevention, Atlanta, and colleagues.

“However, these medications come at a substantially higher cost,” they stress.

Dr. Tang explained in an interview that the new study “points to prior studies about the high cost of these medications as a potential barrier to use, but more research is needed to understand cost-effectiveness and any potential barriers to use, including cost.”

The work “did not include research into cost-effectiveness or why the percentage of people already using these medications was low,” he emphasized.

Dr. Tang and colleagues used data collected by the U.S. National Health and Nutrition Examination Survey during two 2-year cycles between 2017 and 2020 that included 1,417 people who self-identified a diagnosis of diabetes.

Excluding those who likely had type 1 diabetes and those with incomplete data left 1,330 survey participants, including 1,133 (85%) who fit criteria for the treatment of type 2 diabetes with an agent from one of the two studied classes, as recommended in 2022 by a panel representing the American Diabetes Association and the European Association for the Study of Diabetes.

Among these 1,133 people – who represent more than 22 million American adults with type 2 diabetes who fit the 2022 criteria – a scant 3.7% were actually taking a GLP-1 agonist and 5.3% were taking an SGLT2 inhibitor.

“While it’s important to note that our data predate the 2022 recommendations, these drugs were offered as second-line therapy for patients with certain diabetes-related complications in 2017-2020” and hence provide potentially useful insights, noted Dr. Tang, a health economist with the CDC National Center for Chronic Disease Prevention and Health Promotion.

Based on retail prices listed on a United States–based website, a 30-day supply of an oral SGLT2 inhibitor can cost about $550-$600 per month, while common subcutaneously injected GLP-1 receptor agonists can run from a few hundred dollars for a daily injection or close to $1,000 for a formulation administered weekly.

“Cost-effectiveness was not formally considered in the current guideline, but an assessment of cost-effectiveness may assist better targeting of interventions to achieve the greatest effect at a sustainable cost,” the researchers conclude.

The study received no commercial funding. None of the authors had relevant financial relationships.

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

Fewer than 10% of American adults with type 2 diabetes who qualified for treatment with newer agents – such as an SGLT2 inhibitor or GLP-1 agonist – actually received treatment with at least one drug from drug class in 2017-2020, based on a new analysis of just over a thousand adults who participated in a representative, biannual survey and self-reported a diabetes diagnosis.

The cost of these agents, and their uncertain cost-effectiveness at current prices, is likely a key driver of the low usage rate, say the authors of a brief report published in Annals of Internal Medicine.

“Clinical studies have shown that both GLP-1 [glucagonlike peptide–1] receptor agonists and SGLT2 [sodium-glucose cotransporter 2] inhibitors yield additional clinical benefits, compared with older treatments in reducing body weight and progression of cardiovascular disease and chronic kidney disease,” write Shichao Tang, PhD, from the U.S. Centers for Disease Control and Prevention, Atlanta, and colleagues.

“However, these medications come at a substantially higher cost,” they stress.

Dr. Tang explained in an interview that the new study “points to prior studies about the high cost of these medications as a potential barrier to use, but more research is needed to understand cost-effectiveness and any potential barriers to use, including cost.”

The work “did not include research into cost-effectiveness or why the percentage of people already using these medications was low,” he emphasized.

Dr. Tang and colleagues used data collected by the U.S. National Health and Nutrition Examination Survey during two 2-year cycles between 2017 and 2020 that included 1,417 people who self-identified a diagnosis of diabetes.

Excluding those who likely had type 1 diabetes and those with incomplete data left 1,330 survey participants, including 1,133 (85%) who fit criteria for the treatment of type 2 diabetes with an agent from one of the two studied classes, as recommended in 2022 by a panel representing the American Diabetes Association and the European Association for the Study of Diabetes.

Among these 1,133 people – who represent more than 22 million American adults with type 2 diabetes who fit the 2022 criteria – a scant 3.7% were actually taking a GLP-1 agonist and 5.3% were taking an SGLT2 inhibitor.

“While it’s important to note that our data predate the 2022 recommendations, these drugs were offered as second-line therapy for patients with certain diabetes-related complications in 2017-2020” and hence provide potentially useful insights, noted Dr. Tang, a health economist with the CDC National Center for Chronic Disease Prevention and Health Promotion.

Based on retail prices listed on a United States–based website, a 30-day supply of an oral SGLT2 inhibitor can cost about $550-$600 per month, while common subcutaneously injected GLP-1 receptor agonists can run from a few hundred dollars for a daily injection or close to $1,000 for a formulation administered weekly.

“Cost-effectiveness was not formally considered in the current guideline, but an assessment of cost-effectiveness may assist better targeting of interventions to achieve the greatest effect at a sustainable cost,” the researchers conclude.

The study received no commercial funding. None of the authors had relevant financial relationships.

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

Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?

In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.

For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.

This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.

“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.

When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”

Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
 

Okay to breach patient confidentiality?

More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.

“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.

In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.

Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.

Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
 

Support for physician-assisted dying?

Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.

Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”

However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.

As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.

Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.

More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.

Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”

The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.

Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.

This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
 

Romancing a patient?

More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.

Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.

“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.

Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.

In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.

“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.

Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”

But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.

Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”

When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.

“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.

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

Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?

In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.

For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.

This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.

“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.

When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”

Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
 

Okay to breach patient confidentiality?

More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.

“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.

In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.

Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.

Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
 

Support for physician-assisted dying?

Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.

Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”

However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.

As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.

Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.

More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.

Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”

The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.

Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.

This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
 

Romancing a patient?

More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.

Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.

“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.

Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.

In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.

“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.

Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”

But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.

Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”

When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.

“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.

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

Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?

In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.

For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.

This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.

“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.

When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”

Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
 

Okay to breach patient confidentiality?

More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.

“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.

In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.

Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.

Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
 

Support for physician-assisted dying?

Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.

Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”

However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.

As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.

Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.

More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.

Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”

The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.

Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.

This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
 

Romancing a patient?

More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.

Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.

“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.

Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.

In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.

“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.

Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”

But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.

Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”

When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.

“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.

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

A jump in natriuretic peptide levels over several years in middle-aged adults points to worsened long-term risks for incident heart failure (HF) and death. But their predicted long-term survival improves if serial testing shows a drop in those levels, suggests a new analysis based on a well-known longitudinal study cohort.

The findings support the risk-stratification potential of serial natriuretic peptide testing, which may improve on individual assays for predicting future HF. Such serial assays might also be useful for guiding therapy aimed at preventing, for example, progression to clinical HF, researchers speculate on the basis of the current study,

The analysis of almost 1,000 members of the ARIC (Atherosclerosis Risk in Community) cohort had been free of clinical HF at the first of two NT-proBNP assays, which were performed 6 years apart. Their 20-year clinical risk was linked to the trajectory of NT-proBNP levels across the two earlier assays.

For example, adjusted risk of incident HF more than doubled for participants with NT-proBNP levels exceeding 125 pg/mL on both assays, compared with levels that stayed under the cut point at both assays. Their mortality risk climbed by about two-thirds.

Risk for incident HF and of death climbed 86% and 32%, respectively, if NT-proBNP levels rose over the 6 years from less than to greater than 125 pg/mL. But long-term survival improved if serial assays showed a drop from the higher to the lower level.

Rising NT-proBNP levels over several years probably reflect ongoing exposure to risk factors such as hypertension or diabetes. Conversely, decreasing NT-proBNP levels likely reflect some success at keeping such risk factors under control, propose the authors of the analysis published in JAMA Cardiology. The study was led by Xiaoming Jia, MD, Baylor College of Medicine, Houston.

The findings raise the possibility that reducing NT-proBNP levels through risk-factor modification, tracked by serial assays, may potentially improve long-term risk for death or incident HF.

Such therapy, guided by natriuretic peptides, might prove especially useful in asymptomatic adults with modifiable HF risk factors but without known NT-proBNP elevation or cardiac structural changes, so-called stage A HF, senior author Vijay Nambi, MD, PhD, also of Baylor, observed for this news organization.

The best populations for serial NT-proBNP assays to guide therapy, Dr. Nambi said, should become clear “as more data emerges.” But the threshold for ordering such tests would probably be lower for people in stage A whose rising NT-proBNP levels later reclassify them as stage B, also called pre-HF.

In such cases, he speculated, intensified therapy of HF risk factors such as uncontrolled hypertension or diabetes – prompted by greater NT-proBNP levels at serial testing – might possibly avert progression to clinical HF.

Mitchel L. Zoler/MDedge News

“These investigators have nicely demonstrated that one measurement of the biomarker may not be sufficient, that maybe it undercaptures the true burden of people who eventually will develop heart failure,” Muthiah Vaduganathan, MD, MPH, told this news organization.

The study raises the possibility “that the serial natriuretic peptide strategy may be more efficient and more comprehensive in identifying those who will eventually progress,” said Dr. Vaduganathan, of Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not associated with the ARIC analysis.

An open question, he added, is whether the predicted risk is modifiable. “If you are able to provide the biomarker information to treating clinicians, can they do something to attenuate the risk?”

The outlook is hopeful, given contemporary therapies “that can slow and even prevent heart failure in at-risk populations,” Dr. Vaduganathan said. For example, “The selective allocation of SGLT2 inhibitors to those with elevated natriuretic peptide levels, perhaps as captured in serial measurements, would be of great interest.”

The analysis included 9,776 adults (56.5% women, 21.3% Black) without HF who underwent NT-proBNP testing at the second and – about 6 years later – the fourth scheduled clinical visits in the ARIC study, which had enrolled persons aged 45-64 from four diverse communities from across the United States.

Adjusted hazard ratios for incident HF according to NT-proBNP changes from the first to second assays relative to 125 pg/mL were as follows:

• 1.86 (95% confidence interval, 1.60-2.16) when levels rose to higher than the cut point.
• 2.40 (95% CI, 2.00-2.88) when both levels exceeded the cut point.

The corresponding adjusted HRs for death from any cause were as follows:

• 1.32 (95%CI, 1.19-1.47) when levels rose to higher than 125 mg/mL.
• 1.68 (95% CI, 1.47-1.91) when both levels were above the cut point.

The risks for incident HF and for death rose significantly by 6% and 5%, respectively, per standard deviation NT-proBNP increase from the first to second assay.

Risks for HF and mortality for participants whose NT-proBNP levels declined from greater than to less than 125 pg/mL were similar to those whose levels remained low at both assays.

Cost-effectiveness would be another issue when implementing a strategy that calls for multiple biomarker assays, Dr. Vaduganathan observed.

“Surely, we would want to demonstrate that the laboratory measurement costs are offset by downstream prevention of heart failure events that could be averted by use of effective medical therapy, such SGLT2 inhibitors.”

ARIC has been funded by the National Institutes of Health and Department of Health and Human Services. Dr. Nambi discloses receiving grants from the National Institutes of Health during the conduct of the study; support from Amgen; and stocks from Abbott Laboratories. Disclosures for the other authors are in the report. Dr. Vaduganathan has disclosed receiving grants or serving on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaking for AstraZeneca, Novartis, and Roche Diagnostics; and serving on trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics.

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

A jump in natriuretic peptide levels over several years in middle-aged adults points to worsened long-term risks for incident heart failure (HF) and death. But their predicted long-term survival improves if serial testing shows a drop in those levels, suggests a new analysis based on a well-known longitudinal study cohort.

The findings support the risk-stratification potential of serial natriuretic peptide testing, which may improve on individual assays for predicting future HF. Such serial assays might also be useful for guiding therapy aimed at preventing, for example, progression to clinical HF, researchers speculate on the basis of the current study,

The analysis of almost 1,000 members of the ARIC (Atherosclerosis Risk in Community) cohort had been free of clinical HF at the first of two NT-proBNP assays, which were performed 6 years apart. Their 20-year clinical risk was linked to the trajectory of NT-proBNP levels across the two earlier assays.

For example, adjusted risk of incident HF more than doubled for participants with NT-proBNP levels exceeding 125 pg/mL on both assays, compared with levels that stayed under the cut point at both assays. Their mortality risk climbed by about two-thirds.

Risk for incident HF and of death climbed 86% and 32%, respectively, if NT-proBNP levels rose over the 6 years from less than to greater than 125 pg/mL. But long-term survival improved if serial assays showed a drop from the higher to the lower level.

Rising NT-proBNP levels over several years probably reflect ongoing exposure to risk factors such as hypertension or diabetes. Conversely, decreasing NT-proBNP levels likely reflect some success at keeping such risk factors under control, propose the authors of the analysis published in JAMA Cardiology. The study was led by Xiaoming Jia, MD, Baylor College of Medicine, Houston.

The findings raise the possibility that reducing NT-proBNP levels through risk-factor modification, tracked by serial assays, may potentially improve long-term risk for death or incident HF.

Such therapy, guided by natriuretic peptides, might prove especially useful in asymptomatic adults with modifiable HF risk factors but without known NT-proBNP elevation or cardiac structural changes, so-called stage A HF, senior author Vijay Nambi, MD, PhD, also of Baylor, observed for this news organization.

The best populations for serial NT-proBNP assays to guide therapy, Dr. Nambi said, should become clear “as more data emerges.” But the threshold for ordering such tests would probably be lower for people in stage A whose rising NT-proBNP levels later reclassify them as stage B, also called pre-HF.

In such cases, he speculated, intensified therapy of HF risk factors such as uncontrolled hypertension or diabetes – prompted by greater NT-proBNP levels at serial testing – might possibly avert progression to clinical HF.

Mitchel L. Zoler/MDedge News

“These investigators have nicely demonstrated that one measurement of the biomarker may not be sufficient, that maybe it undercaptures the true burden of people who eventually will develop heart failure,” Muthiah Vaduganathan, MD, MPH, told this news organization.

The study raises the possibility “that the serial natriuretic peptide strategy may be more efficient and more comprehensive in identifying those who will eventually progress,” said Dr. Vaduganathan, of Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not associated with the ARIC analysis.

An open question, he added, is whether the predicted risk is modifiable. “If you are able to provide the biomarker information to treating clinicians, can they do something to attenuate the risk?”

The outlook is hopeful, given contemporary therapies “that can slow and even prevent heart failure in at-risk populations,” Dr. Vaduganathan said. For example, “The selective allocation of SGLT2 inhibitors to those with elevated natriuretic peptide levels, perhaps as captured in serial measurements, would be of great interest.”

The analysis included 9,776 adults (56.5% women, 21.3% Black) without HF who underwent NT-proBNP testing at the second and – about 6 years later – the fourth scheduled clinical visits in the ARIC study, which had enrolled persons aged 45-64 from four diverse communities from across the United States.

Adjusted hazard ratios for incident HF according to NT-proBNP changes from the first to second assays relative to 125 pg/mL were as follows:

• 1.86 (95% confidence interval, 1.60-2.16) when levels rose to higher than the cut point.
• 2.40 (95% CI, 2.00-2.88) when both levels exceeded the cut point.

The corresponding adjusted HRs for death from any cause were as follows:

• 1.32 (95%CI, 1.19-1.47) when levels rose to higher than 125 mg/mL.
• 1.68 (95% CI, 1.47-1.91) when both levels were above the cut point.

The risks for incident HF and for death rose significantly by 6% and 5%, respectively, per standard deviation NT-proBNP increase from the first to second assay.

Risks for HF and mortality for participants whose NT-proBNP levels declined from greater than to less than 125 pg/mL were similar to those whose levels remained low at both assays.

Cost-effectiveness would be another issue when implementing a strategy that calls for multiple biomarker assays, Dr. Vaduganathan observed.

“Surely, we would want to demonstrate that the laboratory measurement costs are offset by downstream prevention of heart failure events that could be averted by use of effective medical therapy, such SGLT2 inhibitors.”

ARIC has been funded by the National Institutes of Health and Department of Health and Human Services. Dr. Nambi discloses receiving grants from the National Institutes of Health during the conduct of the study; support from Amgen; and stocks from Abbott Laboratories. Disclosures for the other authors are in the report. Dr. Vaduganathan has disclosed receiving grants or serving on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaking for AstraZeneca, Novartis, and Roche Diagnostics; and serving on trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics.

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

A jump in natriuretic peptide levels over several years in middle-aged adults points to worsened long-term risks for incident heart failure (HF) and death. But their predicted long-term survival improves if serial testing shows a drop in those levels, suggests a new analysis based on a well-known longitudinal study cohort.

The findings support the risk-stratification potential of serial natriuretic peptide testing, which may improve on individual assays for predicting future HF. Such serial assays might also be useful for guiding therapy aimed at preventing, for example, progression to clinical HF, researchers speculate on the basis of the current study,

The analysis of almost 1,000 members of the ARIC (Atherosclerosis Risk in Community) cohort had been free of clinical HF at the first of two NT-proBNP assays, which were performed 6 years apart. Their 20-year clinical risk was linked to the trajectory of NT-proBNP levels across the two earlier assays.

For example, adjusted risk of incident HF more than doubled for participants with NT-proBNP levels exceeding 125 pg/mL on both assays, compared with levels that stayed under the cut point at both assays. Their mortality risk climbed by about two-thirds.

Risk for incident HF and of death climbed 86% and 32%, respectively, if NT-proBNP levels rose over the 6 years from less than to greater than 125 pg/mL. But long-term survival improved if serial assays showed a drop from the higher to the lower level.

Rising NT-proBNP levels over several years probably reflect ongoing exposure to risk factors such as hypertension or diabetes. Conversely, decreasing NT-proBNP levels likely reflect some success at keeping such risk factors under control, propose the authors of the analysis published in JAMA Cardiology. The study was led by Xiaoming Jia, MD, Baylor College of Medicine, Houston.

The findings raise the possibility that reducing NT-proBNP levels through risk-factor modification, tracked by serial assays, may potentially improve long-term risk for death or incident HF.

Such therapy, guided by natriuretic peptides, might prove especially useful in asymptomatic adults with modifiable HF risk factors but without known NT-proBNP elevation or cardiac structural changes, so-called stage A HF, senior author Vijay Nambi, MD, PhD, also of Baylor, observed for this news organization.

The best populations for serial NT-proBNP assays to guide therapy, Dr. Nambi said, should become clear “as more data emerges.” But the threshold for ordering such tests would probably be lower for people in stage A whose rising NT-proBNP levels later reclassify them as stage B, also called pre-HF.

In such cases, he speculated, intensified therapy of HF risk factors such as uncontrolled hypertension or diabetes – prompted by greater NT-proBNP levels at serial testing – might possibly avert progression to clinical HF.

Mitchel L. Zoler/MDedge News

“These investigators have nicely demonstrated that one measurement of the biomarker may not be sufficient, that maybe it undercaptures the true burden of people who eventually will develop heart failure,” Muthiah Vaduganathan, MD, MPH, told this news organization.

The study raises the possibility “that the serial natriuretic peptide strategy may be more efficient and more comprehensive in identifying those who will eventually progress,” said Dr. Vaduganathan, of Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not associated with the ARIC analysis.

An open question, he added, is whether the predicted risk is modifiable. “If you are able to provide the biomarker information to treating clinicians, can they do something to attenuate the risk?”

The outlook is hopeful, given contemporary therapies “that can slow and even prevent heart failure in at-risk populations,” Dr. Vaduganathan said. For example, “The selective allocation of SGLT2 inhibitors to those with elevated natriuretic peptide levels, perhaps as captured in serial measurements, would be of great interest.”

The analysis included 9,776 adults (56.5% women, 21.3% Black) without HF who underwent NT-proBNP testing at the second and – about 6 years later – the fourth scheduled clinical visits in the ARIC study, which had enrolled persons aged 45-64 from four diverse communities from across the United States.

Adjusted hazard ratios for incident HF according to NT-proBNP changes from the first to second assays relative to 125 pg/mL were as follows:

• 1.86 (95% confidence interval, 1.60-2.16) when levels rose to higher than the cut point.
• 2.40 (95% CI, 2.00-2.88) when both levels exceeded the cut point.

The corresponding adjusted HRs for death from any cause were as follows:

• 1.32 (95%CI, 1.19-1.47) when levels rose to higher than 125 mg/mL.
• 1.68 (95% CI, 1.47-1.91) when both levels were above the cut point.

The risks for incident HF and for death rose significantly by 6% and 5%, respectively, per standard deviation NT-proBNP increase from the first to second assay.

Risks for HF and mortality for participants whose NT-proBNP levels declined from greater than to less than 125 pg/mL were similar to those whose levels remained low at both assays.

Cost-effectiveness would be another issue when implementing a strategy that calls for multiple biomarker assays, Dr. Vaduganathan observed.

“Surely, we would want to demonstrate that the laboratory measurement costs are offset by downstream prevention of heart failure events that could be averted by use of effective medical therapy, such SGLT2 inhibitors.”

ARIC has been funded by the National Institutes of Health and Department of Health and Human Services. Dr. Nambi discloses receiving grants from the National Institutes of Health during the conduct of the study; support from Amgen; and stocks from Abbott Laboratories. Disclosures for the other authors are in the report. Dr. Vaduganathan has disclosed receiving grants or serving on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaking for AstraZeneca, Novartis, and Roche Diagnostics; and serving on trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics.

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

Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.

The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.

“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”

“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”

The study, published online  in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
 

Injury patterns different

Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.

Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.

Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).

Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).

The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).

Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).

The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).

However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).

The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.

During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).

Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).

“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.

Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
 

‘Tour de force’

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”

Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”

Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.

“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.

No commercial funding or relevant financial relationships were reported.

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

Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.

The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.

“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”

“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”

The study, published online  in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
 

Injury patterns different

Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.

Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.

Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).

Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).

The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).

Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).

The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).

However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).

The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.

During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).

Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).

“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.

Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
 

‘Tour de force’

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”

Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”

Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.

“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.

No commercial funding or relevant financial relationships were reported.

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

Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.

The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.

“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”

“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”

The study, published online  in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
 

Injury patterns different

Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.

Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.

Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).

Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).

The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).

Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).

The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).

However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).

The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.

During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).

Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).

“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.

Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
 

‘Tour de force’

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”

Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”

Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.

“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.

No commercial funding or relevant financial relationships were reported.

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

The European Commission has expanded the indication for dapagliflozin (Forxiga) to include heart failure across the full spectrum of left ventricular ejection fraction – including HF with mildly reduced and preserved ejection fraction, AstraZeneca has announced.

The EC nod for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (known as Farxiga in the United States) follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022.

The committee’s decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.

The study was published in the New England Journal of Medicine and presented at the European Society of Cardiology’s annual congress.

The data support the use of SGLT2 inhibitors as “foundational agents for virtually all patients with heart failure” regardless of their ejection fraction or whether or not they have type 2 diabetes, said study presenter Scott D. Solomon, MD, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston.

The Food and Drug Administration is currently reviewing AstraZeneca’s application to expand the HF indication for dapagliflozin in the United States.

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

The European Commission has expanded the indication for dapagliflozin (Forxiga) to include heart failure across the full spectrum of left ventricular ejection fraction – including HF with mildly reduced and preserved ejection fraction, AstraZeneca has announced.

The EC nod for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (known as Farxiga in the United States) follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022.

The committee’s decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.

The study was published in the New England Journal of Medicine and presented at the European Society of Cardiology’s annual congress.

The data support the use of SGLT2 inhibitors as “foundational agents for virtually all patients with heart failure” regardless of their ejection fraction or whether or not they have type 2 diabetes, said study presenter Scott D. Solomon, MD, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston.

The Food and Drug Administration is currently reviewing AstraZeneca’s application to expand the HF indication for dapagliflozin in the United States.

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

The European Commission has expanded the indication for dapagliflozin (Forxiga) to include heart failure across the full spectrum of left ventricular ejection fraction – including HF with mildly reduced and preserved ejection fraction, AstraZeneca has announced.

The EC nod for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (known as Farxiga in the United States) follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022.

The committee’s decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.

The study was published in the New England Journal of Medicine and presented at the European Society of Cardiology’s annual congress.

The data support the use of SGLT2 inhibitors as “foundational agents for virtually all patients with heart failure” regardless of their ejection fraction or whether or not they have type 2 diabetes, said study presenter Scott D. Solomon, MD, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston.

The Food and Drug Administration is currently reviewing AstraZeneca’s application to expand the HF indication for dapagliflozin in the United States.

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

Beyond Reps (dba IronRod Health and Cardiac Monitoring Services) has agreed to pay $673,200 to resolve allegations that it submitted false claims to federal health care programs relating to remote cardiac monitoring services.

The U.S. Department of Justice alleges that between Jan. 1, 2018, and April 30, 2021, IronRod, with headquarters in Phoenix, used technicians who lacked required credentials to conduct remote cardiac monitoring readings.

The government further alleges that between June 1, 2018, and Aug. 20, 2018, the company misrepresented that it performed services in New York state in order to get higher reimbursements from Medicare for remote cardiac monitoring services.

“Providers that seek payment from federal health programs are required to follow laws meant to protect beneficiaries, as well as to protect the integrity of those programs,” U.S. Attorney Trini E. Ross said in a statement.

“Our office is committed to pursuing cases against any provider that cuts corners or seeks to obtain payments for which they are not entitled,” Ms. Ross said.

A request to Beyond Reps for comment was not returned.

The civil settlement resolves claims brought under the qui tam (whistleblower) provisions of the False Claims Act by Coleen DeGroat.

Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Ms. DeGroat will receive a share of the settlement.

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

Beyond Reps (dba IronRod Health and Cardiac Monitoring Services) has agreed to pay $673,200 to resolve allegations that it submitted false claims to federal health care programs relating to remote cardiac monitoring services.

The U.S. Department of Justice alleges that between Jan. 1, 2018, and April 30, 2021, IronRod, with headquarters in Phoenix, used technicians who lacked required credentials to conduct remote cardiac monitoring readings.

The government further alleges that between June 1, 2018, and Aug. 20, 2018, the company misrepresented that it performed services in New York state in order to get higher reimbursements from Medicare for remote cardiac monitoring services.

“Providers that seek payment from federal health programs are required to follow laws meant to protect beneficiaries, as well as to protect the integrity of those programs,” U.S. Attorney Trini E. Ross said in a statement.

“Our office is committed to pursuing cases against any provider that cuts corners or seeks to obtain payments for which they are not entitled,” Ms. Ross said.

A request to Beyond Reps for comment was not returned.

The civil settlement resolves claims brought under the qui tam (whistleblower) provisions of the False Claims Act by Coleen DeGroat.

Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Ms. DeGroat will receive a share of the settlement.

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

Beyond Reps (dba IronRod Health and Cardiac Monitoring Services) has agreed to pay $673,200 to resolve allegations that it submitted false claims to federal health care programs relating to remote cardiac monitoring services.

The U.S. Department of Justice alleges that between Jan. 1, 2018, and April 30, 2021, IronRod, with headquarters in Phoenix, used technicians who lacked required credentials to conduct remote cardiac monitoring readings.

The government further alleges that between June 1, 2018, and Aug. 20, 2018, the company misrepresented that it performed services in New York state in order to get higher reimbursements from Medicare for remote cardiac monitoring services.

“Providers that seek payment from federal health programs are required to follow laws meant to protect beneficiaries, as well as to protect the integrity of those programs,” U.S. Attorney Trini E. Ross said in a statement.

“Our office is committed to pursuing cases against any provider that cuts corners or seeks to obtain payments for which they are not entitled,” Ms. Ross said.

A request to Beyond Reps for comment was not returned.

The civil settlement resolves claims brought under the qui tam (whistleblower) provisions of the False Claims Act by Coleen DeGroat.

Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Ms. DeGroat will receive a share of the settlement.

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

The overall case volume for surgical mitral valve (MV) repair of degenerative mitral regurgitation (DMR) hasn’t changed much nearly a decade into the age of transcatheter edge-to-edge repair (TEER). But, over the same period, there’s been a shift in the surgical–MV repair case mix at centers that have offered both the surgical option and TEER, a new study suggests.

Once TEER was introduced, those centers over time used the operative approach less in higher– and intermediate–surgical risk patients and more often in those deemed low risk for surgery. And that trend – at centers offering both approaches – paralleled improved risk-adjusted surgical repair short-term complications and 30-day and 5-year mortality.

The findings come from an analysis based on Society of Thoracic Surgeons and Medicare claims data collected from 2011 through 2018 at surgical–MV repair centers that also offered TEER for DMR after its 2013 approval. The transcatheter procedure, until only recently the exclusive domain of Abbott’s MitraClip in various incarnations, is officially indicated for patients judged too high risk for surgical MV repair.

A shift in surgical MV repair to predominantly lower-risk patients would be expected to improve outcomes. But the improvements seen in the current study seem to have a more complex explanation, Sreekanth Vemulapalli, MD, told this news organization.

The data seem to show TEER indication creep from higher-risk cases, for which there is clinical trial support, to intermediate-risk patients, that lack such evidence in favor of TEER. That seemed to push surgical repair toward even lower-risk cases. “I think that’s exactly right,” said Dr. Vemulapalli, Duke Clinical Research Institute, Durham, N.C.

Still, he observed, the analysis was adjusted for surgical risk, and “Even after that adjustment, it looked like surgical outcomes were getting better after the availability of transcatheter mitral repair techniques.”

That observation may be explained by an increasingly sharp, “more careful” process for selecting patients for surgical repair vs. TEER, said Dr. Vemulapalli, who is senior author of the study published in the Journal of the American College of Cardiology. Angela M. Lowenstern, MD, Vanderbilt University, Nashville, and Andrew M. Vekstein, MD, Duke Clinical Research Institute, were the lead authors.

Indeed, the report states, the analysis supports the view that “a systematic evaluation by a heart team able to direct patients towards either surgical or transcatheter approaches enhances both short-term and long-term surgical outcomes.”

“In a world where both surgical and transcatheter techniques are going to be available,” Dr. Vemulapalli said, “patient selection becomes very, very important.”

An accompanying editorial acknowledges the heart-team approach’s potential for improving the selection of patients for surgery and perhaps therefore outcomes. But it also cites issues with that interpretation of the data.

For example, the heart-team approach is not used in consistent ways across the United States. And “although the heart team is recommended in multiple guidelines for valvular heart therapies, there is little evidence for its efficacy, specifically regarding improving clinical outcomes,” write Matthew W. Sherwood, MD, MHS, and Wayne B. Batchelor, MD, MHS, Inova Heart and Vascular Institute, Falls Church, Va.

The editorialists highlight the study’s “significant downtrend in both high-risk and intermediate-risk surgical cases, with a concomitant increase in low-risk cases,” after introduction of TEER. That shift in case mix, they write, “would seem to be a more likely explanation for the modest improvement in outcomes for surgical MV repair.”

Also, importantly, the analysis didn’t include data on TEER procedures, only indirect evidence for TEER’s effect on surgical MV repair, the editorialists observe, and study authors acknowledge.

Still, the analysis looked at nearly 14,000 patients at 278 U.S. sites with surgical MV repair that launched TEER programs during the study period. They accounted for 6,806 surgical cases before and 7,153 surgical cases after the advent of TEER.

Their median annualized institutional surgical MV repair volume was 32 before and 29 after TEER availability (P = .06).

The risk-adjusted odds ratio for 30-day mortality after vs. before TEER became an option was 0.73 (95% confidence interval, 0.54-0.99). The corresponding hazard ratio for mortality at 5 years was 0.75 (95% CI, 0.66-0.86).

Other risk-adjusted surgical outcomes improved once TEER became available, including MV adverse outcomes (OR, 0.71; 95% CI, 0.58-0.86; P < .001), operative mortality (OR, 0.73; 95% CI, 0.54-0.99; P = .041), and major morbidity (OR, 0.85; 95% CI, 0.73-0.98; P = .026)

Despite the data’s suggestion of TEER indication creep from solely high–surgical risk patients to those at intermediate risk, Dr. Vemulapalli said, “I don’t think that people should be doing transcatheter mitral repair in intermediate- or low-risk patients as a general rule.” Although, he added, “there will always be certain exceptions, depending on the patient’s specific situation.”

Dr. Vemulapalli pointed to several ongoing trials comparing TEER vs. surgical MR repair in patients with DMR at intermediate surgical risk, including REPAIR MR and PRIMARY.

The study was supported by the National Institutes of Health and Abbott. Dr. Vemulapalli discloses receiving grants or contracts from the American College of Cardiology, the Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, the National Institutes of Health, and Boston Scientific; and consulting or serving on an advisory board for Janssen, the American College of Physicians, HeartFlow, and Edwards LifeSciences. Dr. Sherwood discloses receiving honoraria or consulting fees from Medtronic and Boston Scientific. Dr. Batchelor discloses receiving consulting fees from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott.

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

The overall case volume for surgical mitral valve (MV) repair of degenerative mitral regurgitation (DMR) hasn’t changed much nearly a decade into the age of transcatheter edge-to-edge repair (TEER). But, over the same period, there’s been a shift in the surgical–MV repair case mix at centers that have offered both the surgical option and TEER, a new study suggests.

Once TEER was introduced, those centers over time used the operative approach less in higher– and intermediate–surgical risk patients and more often in those deemed low risk for surgery. And that trend – at centers offering both approaches – paralleled improved risk-adjusted surgical repair short-term complications and 30-day and 5-year mortality.

The findings come from an analysis based on Society of Thoracic Surgeons and Medicare claims data collected from 2011 through 2018 at surgical–MV repair centers that also offered TEER for DMR after its 2013 approval. The transcatheter procedure, until only recently the exclusive domain of Abbott’s MitraClip in various incarnations, is officially indicated for patients judged too high risk for surgical MV repair.

A shift in surgical MV repair to predominantly lower-risk patients would be expected to improve outcomes. But the improvements seen in the current study seem to have a more complex explanation, Sreekanth Vemulapalli, MD, told this news organization.

The data seem to show TEER indication creep from higher-risk cases, for which there is clinical trial support, to intermediate-risk patients, that lack such evidence in favor of TEER. That seemed to push surgical repair toward even lower-risk cases. “I think that’s exactly right,” said Dr. Vemulapalli, Duke Clinical Research Institute, Durham, N.C.

Still, he observed, the analysis was adjusted for surgical risk, and “Even after that adjustment, it looked like surgical outcomes were getting better after the availability of transcatheter mitral repair techniques.”

That observation may be explained by an increasingly sharp, “more careful” process for selecting patients for surgical repair vs. TEER, said Dr. Vemulapalli, who is senior author of the study published in the Journal of the American College of Cardiology. Angela M. Lowenstern, MD, Vanderbilt University, Nashville, and Andrew M. Vekstein, MD, Duke Clinical Research Institute, were the lead authors.

Indeed, the report states, the analysis supports the view that “a systematic evaluation by a heart team able to direct patients towards either surgical or transcatheter approaches enhances both short-term and long-term surgical outcomes.”

“In a world where both surgical and transcatheter techniques are going to be available,” Dr. Vemulapalli said, “patient selection becomes very, very important.”

An accompanying editorial acknowledges the heart-team approach’s potential for improving the selection of patients for surgery and perhaps therefore outcomes. But it also cites issues with that interpretation of the data.

For example, the heart-team approach is not used in consistent ways across the United States. And “although the heart team is recommended in multiple guidelines for valvular heart therapies, there is little evidence for its efficacy, specifically regarding improving clinical outcomes,” write Matthew W. Sherwood, MD, MHS, and Wayne B. Batchelor, MD, MHS, Inova Heart and Vascular Institute, Falls Church, Va.

The editorialists highlight the study’s “significant downtrend in both high-risk and intermediate-risk surgical cases, with a concomitant increase in low-risk cases,” after introduction of TEER. That shift in case mix, they write, “would seem to be a more likely explanation for the modest improvement in outcomes for surgical MV repair.”

Also, importantly, the analysis didn’t include data on TEER procedures, only indirect evidence for TEER’s effect on surgical MV repair, the editorialists observe, and study authors acknowledge.

Still, the analysis looked at nearly 14,000 patients at 278 U.S. sites with surgical MV repair that launched TEER programs during the study period. They accounted for 6,806 surgical cases before and 7,153 surgical cases after the advent of TEER.

Their median annualized institutional surgical MV repair volume was 32 before and 29 after TEER availability (P = .06).

The risk-adjusted odds ratio for 30-day mortality after vs. before TEER became an option was 0.73 (95% confidence interval, 0.54-0.99). The corresponding hazard ratio for mortality at 5 years was 0.75 (95% CI, 0.66-0.86).

Other risk-adjusted surgical outcomes improved once TEER became available, including MV adverse outcomes (OR, 0.71; 95% CI, 0.58-0.86; P < .001), operative mortality (OR, 0.73; 95% CI, 0.54-0.99; P = .041), and major morbidity (OR, 0.85; 95% CI, 0.73-0.98; P = .026)

Despite the data’s suggestion of TEER indication creep from solely high–surgical risk patients to those at intermediate risk, Dr. Vemulapalli said, “I don’t think that people should be doing transcatheter mitral repair in intermediate- or low-risk patients as a general rule.” Although, he added, “there will always be certain exceptions, depending on the patient’s specific situation.”

Dr. Vemulapalli pointed to several ongoing trials comparing TEER vs. surgical MR repair in patients with DMR at intermediate surgical risk, including REPAIR MR and PRIMARY.

The study was supported by the National Institutes of Health and Abbott. Dr. Vemulapalli discloses receiving grants or contracts from the American College of Cardiology, the Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, the National Institutes of Health, and Boston Scientific; and consulting or serving on an advisory board for Janssen, the American College of Physicians, HeartFlow, and Edwards LifeSciences. Dr. Sherwood discloses receiving honoraria or consulting fees from Medtronic and Boston Scientific. Dr. Batchelor discloses receiving consulting fees from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott.

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

The overall case volume for surgical mitral valve (MV) repair of degenerative mitral regurgitation (DMR) hasn’t changed much nearly a decade into the age of transcatheter edge-to-edge repair (TEER). But, over the same period, there’s been a shift in the surgical–MV repair case mix at centers that have offered both the surgical option and TEER, a new study suggests.

Once TEER was introduced, those centers over time used the operative approach less in higher– and intermediate–surgical risk patients and more often in those deemed low risk for surgery. And that trend – at centers offering both approaches – paralleled improved risk-adjusted surgical repair short-term complications and 30-day and 5-year mortality.

The findings come from an analysis based on Society of Thoracic Surgeons and Medicare claims data collected from 2011 through 2018 at surgical–MV repair centers that also offered TEER for DMR after its 2013 approval. The transcatheter procedure, until only recently the exclusive domain of Abbott’s MitraClip in various incarnations, is officially indicated for patients judged too high risk for surgical MV repair.

A shift in surgical MV repair to predominantly lower-risk patients would be expected to improve outcomes. But the improvements seen in the current study seem to have a more complex explanation, Sreekanth Vemulapalli, MD, told this news organization.

The data seem to show TEER indication creep from higher-risk cases, for which there is clinical trial support, to intermediate-risk patients, that lack such evidence in favor of TEER. That seemed to push surgical repair toward even lower-risk cases. “I think that’s exactly right,” said Dr. Vemulapalli, Duke Clinical Research Institute, Durham, N.C.

Still, he observed, the analysis was adjusted for surgical risk, and “Even after that adjustment, it looked like surgical outcomes were getting better after the availability of transcatheter mitral repair techniques.”

That observation may be explained by an increasingly sharp, “more careful” process for selecting patients for surgical repair vs. TEER, said Dr. Vemulapalli, who is senior author of the study published in the Journal of the American College of Cardiology. Angela M. Lowenstern, MD, Vanderbilt University, Nashville, and Andrew M. Vekstein, MD, Duke Clinical Research Institute, were the lead authors.

Indeed, the report states, the analysis supports the view that “a systematic evaluation by a heart team able to direct patients towards either surgical or transcatheter approaches enhances both short-term and long-term surgical outcomes.”

“In a world where both surgical and transcatheter techniques are going to be available,” Dr. Vemulapalli said, “patient selection becomes very, very important.”

An accompanying editorial acknowledges the heart-team approach’s potential for improving the selection of patients for surgery and perhaps therefore outcomes. But it also cites issues with that interpretation of the data.

For example, the heart-team approach is not used in consistent ways across the United States. And “although the heart team is recommended in multiple guidelines for valvular heart therapies, there is little evidence for its efficacy, specifically regarding improving clinical outcomes,” write Matthew W. Sherwood, MD, MHS, and Wayne B. Batchelor, MD, MHS, Inova Heart and Vascular Institute, Falls Church, Va.

The editorialists highlight the study’s “significant downtrend in both high-risk and intermediate-risk surgical cases, with a concomitant increase in low-risk cases,” after introduction of TEER. That shift in case mix, they write, “would seem to be a more likely explanation for the modest improvement in outcomes for surgical MV repair.”

Also, importantly, the analysis didn’t include data on TEER procedures, only indirect evidence for TEER’s effect on surgical MV repair, the editorialists observe, and study authors acknowledge.

Still, the analysis looked at nearly 14,000 patients at 278 U.S. sites with surgical MV repair that launched TEER programs during the study period. They accounted for 6,806 surgical cases before and 7,153 surgical cases after the advent of TEER.

Their median annualized institutional surgical MV repair volume was 32 before and 29 after TEER availability (P = .06).

The risk-adjusted odds ratio for 30-day mortality after vs. before TEER became an option was 0.73 (95% confidence interval, 0.54-0.99). The corresponding hazard ratio for mortality at 5 years was 0.75 (95% CI, 0.66-0.86).

Other risk-adjusted surgical outcomes improved once TEER became available, including MV adverse outcomes (OR, 0.71; 95% CI, 0.58-0.86; P < .001), operative mortality (OR, 0.73; 95% CI, 0.54-0.99; P = .041), and major morbidity (OR, 0.85; 95% CI, 0.73-0.98; P = .026)

Despite the data’s suggestion of TEER indication creep from solely high–surgical risk patients to those at intermediate risk, Dr. Vemulapalli said, “I don’t think that people should be doing transcatheter mitral repair in intermediate- or low-risk patients as a general rule.” Although, he added, “there will always be certain exceptions, depending on the patient’s specific situation.”

Dr. Vemulapalli pointed to several ongoing trials comparing TEER vs. surgical MR repair in patients with DMR at intermediate surgical risk, including REPAIR MR and PRIMARY.

The study was supported by the National Institutes of Health and Abbott. Dr. Vemulapalli discloses receiving grants or contracts from the American College of Cardiology, the Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, the National Institutes of Health, and Boston Scientific; and consulting or serving on an advisory board for Janssen, the American College of Physicians, HeartFlow, and Edwards LifeSciences. Dr. Sherwood discloses receiving honoraria or consulting fees from Medtronic and Boston Scientific. Dr. Batchelor discloses receiving consulting fees from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott.

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

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

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

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

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

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

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

One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. While they were all waiting for the ambulance, Mr. Snitcofsky went over, tilted the man’s head back, and confirmed that he wasn’t breathing, that he wasn’t choking. And then he started chest compressions, just like he’d learned in a CPR class he’d taken 2 decades earlier. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.

Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.

“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”

We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.

In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.

“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
 

Doing one’s duty

There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.

“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”

Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”

Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.

Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.

In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:

• The lay rescuers possessed helping traits and high motivation.  
• The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
• The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event.
“Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.

Potential trauma

In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”

Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.

Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.

“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.

“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.

“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.

For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.

In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.

But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
 

Other obstacles

Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.

Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”

Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.

“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.

“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”

Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.

“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.

It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”

Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.

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

One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. While they were all waiting for the ambulance, Mr. Snitcofsky went over, tilted the man’s head back, and confirmed that he wasn’t breathing, that he wasn’t choking. And then he started chest compressions, just like he’d learned in a CPR class he’d taken 2 decades earlier. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.

Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.

“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”

We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.

In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.

“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
 

Doing one’s duty

There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.

“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”

Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”

Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.

Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.

In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:

• The lay rescuers possessed helping traits and high motivation.  
• The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
• The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event.
“Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.

Potential trauma

In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”

Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.

Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.

“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.

“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.

“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.

For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.

In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.

But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
 

Other obstacles

Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.

Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”

Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.

“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.

“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”

Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.

“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.

It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”

Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.

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

One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. While they were all waiting for the ambulance, Mr. Snitcofsky went over, tilted the man’s head back, and confirmed that he wasn’t breathing, that he wasn’t choking. And then he started chest compressions, just like he’d learned in a CPR class he’d taken 2 decades earlier. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.

Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.

“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”

We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.

In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.

“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
 

Doing one’s duty

There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.

“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”

Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”

Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.

Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.

In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:

• The lay rescuers possessed helping traits and high motivation.  
• The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
• The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event.
“Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.

Potential trauma

In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”

Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.

Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.

“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.

“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.

“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.

For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.

In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.

But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
 

Other obstacles

Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.

Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”

Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.

“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.

“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”

Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.

“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.

It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”

Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.

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