Interventional Cardiology & Surgery

WIESBADEN, GERMANY — Crowded waiting rooms, long wait times, irritable patients, and aggression toward nursing staff and doctors are increasingly the reality in German emergency rooms. Clearly, emergencies belong in the emergency room. However, “In about half of all patients in the emergency room, there is no urgent medical emergency,” Norbert Schütz, MD, director of geriatrics and rheumatology at Helios Dr. Horst Schmidt Hospital in Wiesbaden, Germany, said at a press conference for the 130th Annual Meeting of the German Society of Internal Medicine (DGIM).

“In our daily medical practice, we repeatedly experience people either accessing our emergency departments and ambulances too quickly or lingering at home for too long when they have severe symptoms,” said Dr. Schütz, who organized the Patient Day during the Internist Congress.
 

DGIM Educates Patients

What is an emergency? “I think the public is quite well informed about conditions associated with loss of consciousness, severe pain, chest pain, or paralysis: Think stroke or heart attack. This is undoubtedly a success of recent years. The difficulty arises with everything in between. For instance, should I go to the hospital with severe headaches?” asked Dr. Schütz.

When is a patient a case for the emergency room, the physician on-call service, or the general practitioner? At the Patient Day in Wiesbaden, DGIM aims to educate and train interested parties with a dedicated lecture. The focus is on recognizing an emergency, specifically emergencies in children and mental illnesses.

“Our Patient Day aims to contribute to making the right decisions. We want to inform, answer questions, and alleviate fears,” said Dr. Schütz. Interested parties can refresh their emergency knowledge, tour ambulances, and have the equipment explained. The public also has the opportunity to learn about resuscitation techniques theoretically and practically.

“In general, the general practitioner should always be the first point of contact. They know their patients best and have the most background information,” explained Dr. Schütz. A trusting relationship is crucial for correctly assessing an unclear medical situation. “Should, for whatever reason, the general practitioner not be reachable, the physician on-call service can be reached,” said Dr. Schütz. It may happen, however, that neither the general practitioner nor the on-call physician is immediately available.
 

What Are Emergencies?

In cases of severe health impairment, urgency is required, and a severe emergency should be assumed in the following cases:

• Chest pain
• Circulatory disorder
• Disorders of consciousness
• Breathing difficulties
• Sudden weakness or numbness/paralysis
• Severe bleeding
• Allergic shock

“In such cases, the emergency departments of the hospitals are available around the clock, and if necessary, an emergency doctor should be present during transportation to the hospital,” said Dr. Schütz.

Classifying emergencies is challenging, especially with children. “Children often find it difficult to clearly categorize or describe symptoms,” said Dr. Schütz. A situation is critical if, for example, the child’s breathing or consciousness is impaired.

Mental emergencies pose a particular challenge for patients and relatives because the patient and relatives are often overwhelmed by the situation. If there are suicidal thoughts, the patient should present him- or herself immediately to an emergency room.

“Patients who come to the emergency room because they cannot get appointments with their general practitioner or specialist, for whatever reason, are no emergency. We also see this in the emergency room from time to time,” said Dr. Schütz. Emergency rooms are not intended for this purpose. “And generally, these are not emergencies.”
 

Four of 10 Cases

The number of patients in emergency rooms has steadily increased in recent years. Statistically, only 4 out of 10 cases are genuine emergencies, as detailed surveys of patients in the emergency rooms of northern German hospitals have shown.

In the PiNo Nord cross-sectional study, Martin Scherer, MD, of University Hospital Hamburg-Eppendorf in Hamburg, Germany, and his team examined the reasons why patients visit the emergency room. They interviewed 1175 patients in five hospitals and documented the medical diagnoses. Patients classified as “immediately” or “very urgently” in need of treatment were excluded.

The surveyed patients were on average 41.8 years old, 52.9% were men, and 54.7% of the patients indicated a low urgency of treatment. About 41% of the patients visited the emergency room on their own initiative, 17% stated they were referred or entrusted by their general practitioner, and 8% were referred by a specialist in the emergency room.

The strongest predictors for low subjective treatment urgency were musculoskeletal trauma (odds ratio [OR], 2.18), skin afflictions (OR, 2.15), and the unavailability of an open general practitioner’s office (OR, 1.70).

According to Dr. Scherer and his colleagues, the reasons for visiting an emergency room are diverse and can be based on the perceived structural conditions and individual patient preferences in addition to the urgency of the health problem.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

WIESBADEN, GERMANY — Crowded waiting rooms, long wait times, irritable patients, and aggression toward nursing staff and doctors are increasingly the reality in German emergency rooms. Clearly, emergencies belong in the emergency room. However, “In about half of all patients in the emergency room, there is no urgent medical emergency,” Norbert Schütz, MD, director of geriatrics and rheumatology at Helios Dr. Horst Schmidt Hospital in Wiesbaden, Germany, said at a press conference for the 130th Annual Meeting of the German Society of Internal Medicine (DGIM).

“In our daily medical practice, we repeatedly experience people either accessing our emergency departments and ambulances too quickly or lingering at home for too long when they have severe symptoms,” said Dr. Schütz, who organized the Patient Day during the Internist Congress.
 

DGIM Educates Patients

What is an emergency? “I think the public is quite well informed about conditions associated with loss of consciousness, severe pain, chest pain, or paralysis: Think stroke or heart attack. This is undoubtedly a success of recent years. The difficulty arises with everything in between. For instance, should I go to the hospital with severe headaches?” asked Dr. Schütz.

When is a patient a case for the emergency room, the physician on-call service, or the general practitioner? At the Patient Day in Wiesbaden, DGIM aims to educate and train interested parties with a dedicated lecture. The focus is on recognizing an emergency, specifically emergencies in children and mental illnesses.

“Our Patient Day aims to contribute to making the right decisions. We want to inform, answer questions, and alleviate fears,” said Dr. Schütz. Interested parties can refresh their emergency knowledge, tour ambulances, and have the equipment explained. The public also has the opportunity to learn about resuscitation techniques theoretically and practically.

“In general, the general practitioner should always be the first point of contact. They know their patients best and have the most background information,” explained Dr. Schütz. A trusting relationship is crucial for correctly assessing an unclear medical situation. “Should, for whatever reason, the general practitioner not be reachable, the physician on-call service can be reached,” said Dr. Schütz. It may happen, however, that neither the general practitioner nor the on-call physician is immediately available.
 

What Are Emergencies?

In cases of severe health impairment, urgency is required, and a severe emergency should be assumed in the following cases:

• Chest pain
• Circulatory disorder
• Disorders of consciousness
• Breathing difficulties
• Sudden weakness or numbness/paralysis
• Severe bleeding
• Allergic shock

“In such cases, the emergency departments of the hospitals are available around the clock, and if necessary, an emergency doctor should be present during transportation to the hospital,” said Dr. Schütz.

Classifying emergencies is challenging, especially with children. “Children often find it difficult to clearly categorize or describe symptoms,” said Dr. Schütz. A situation is critical if, for example, the child’s breathing or consciousness is impaired.

Mental emergencies pose a particular challenge for patients and relatives because the patient and relatives are often overwhelmed by the situation. If there are suicidal thoughts, the patient should present him- or herself immediately to an emergency room.

“Patients who come to the emergency room because they cannot get appointments with their general practitioner or specialist, for whatever reason, are no emergency. We also see this in the emergency room from time to time,” said Dr. Schütz. Emergency rooms are not intended for this purpose. “And generally, these are not emergencies.”
 

Four of 10 Cases

The number of patients in emergency rooms has steadily increased in recent years. Statistically, only 4 out of 10 cases are genuine emergencies, as detailed surveys of patients in the emergency rooms of northern German hospitals have shown.

In the PiNo Nord cross-sectional study, Martin Scherer, MD, of University Hospital Hamburg-Eppendorf in Hamburg, Germany, and his team examined the reasons why patients visit the emergency room. They interviewed 1175 patients in five hospitals and documented the medical diagnoses. Patients classified as “immediately” or “very urgently” in need of treatment were excluded.

The surveyed patients were on average 41.8 years old, 52.9% were men, and 54.7% of the patients indicated a low urgency of treatment. About 41% of the patients visited the emergency room on their own initiative, 17% stated they were referred or entrusted by their general practitioner, and 8% were referred by a specialist in the emergency room.

The strongest predictors for low subjective treatment urgency were musculoskeletal trauma (odds ratio [OR], 2.18), skin afflictions (OR, 2.15), and the unavailability of an open general practitioner’s office (OR, 1.70).

According to Dr. Scherer and his colleagues, the reasons for visiting an emergency room are diverse and can be based on the perceived structural conditions and individual patient preferences in addition to the urgency of the health problem.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

WIESBADEN, GERMANY — Crowded waiting rooms, long wait times, irritable patients, and aggression toward nursing staff and doctors are increasingly the reality in German emergency rooms. Clearly, emergencies belong in the emergency room. However, “In about half of all patients in the emergency room, there is no urgent medical emergency,” Norbert Schütz, MD, director of geriatrics and rheumatology at Helios Dr. Horst Schmidt Hospital in Wiesbaden, Germany, said at a press conference for the 130th Annual Meeting of the German Society of Internal Medicine (DGIM).

“In our daily medical practice, we repeatedly experience people either accessing our emergency departments and ambulances too quickly or lingering at home for too long when they have severe symptoms,” said Dr. Schütz, who organized the Patient Day during the Internist Congress.
 

DGIM Educates Patients

What is an emergency? “I think the public is quite well informed about conditions associated with loss of consciousness, severe pain, chest pain, or paralysis: Think stroke or heart attack. This is undoubtedly a success of recent years. The difficulty arises with everything in between. For instance, should I go to the hospital with severe headaches?” asked Dr. Schütz.

When is a patient a case for the emergency room, the physician on-call service, or the general practitioner? At the Patient Day in Wiesbaden, DGIM aims to educate and train interested parties with a dedicated lecture. The focus is on recognizing an emergency, specifically emergencies in children and mental illnesses.

“Our Patient Day aims to contribute to making the right decisions. We want to inform, answer questions, and alleviate fears,” said Dr. Schütz. Interested parties can refresh their emergency knowledge, tour ambulances, and have the equipment explained. The public also has the opportunity to learn about resuscitation techniques theoretically and practically.

“In general, the general practitioner should always be the first point of contact. They know their patients best and have the most background information,” explained Dr. Schütz. A trusting relationship is crucial for correctly assessing an unclear medical situation. “Should, for whatever reason, the general practitioner not be reachable, the physician on-call service can be reached,” said Dr. Schütz. It may happen, however, that neither the general practitioner nor the on-call physician is immediately available.
 

What Are Emergencies?

In cases of severe health impairment, urgency is required, and a severe emergency should be assumed in the following cases:

• Chest pain
• Circulatory disorder
• Disorders of consciousness
• Breathing difficulties
• Sudden weakness or numbness/paralysis
• Severe bleeding
• Allergic shock

“In such cases, the emergency departments of the hospitals are available around the clock, and if necessary, an emergency doctor should be present during transportation to the hospital,” said Dr. Schütz.

Classifying emergencies is challenging, especially with children. “Children often find it difficult to clearly categorize or describe symptoms,” said Dr. Schütz. A situation is critical if, for example, the child’s breathing or consciousness is impaired.

Mental emergencies pose a particular challenge for patients and relatives because the patient and relatives are often overwhelmed by the situation. If there are suicidal thoughts, the patient should present him- or herself immediately to an emergency room.

“Patients who come to the emergency room because they cannot get appointments with their general practitioner or specialist, for whatever reason, are no emergency. We also see this in the emergency room from time to time,” said Dr. Schütz. Emergency rooms are not intended for this purpose. “And generally, these are not emergencies.”
 

Four of 10 Cases

The number of patients in emergency rooms has steadily increased in recent years. Statistically, only 4 out of 10 cases are genuine emergencies, as detailed surveys of patients in the emergency rooms of northern German hospitals have shown.

In the PiNo Nord cross-sectional study, Martin Scherer, MD, of University Hospital Hamburg-Eppendorf in Hamburg, Germany, and his team examined the reasons why patients visit the emergency room. They interviewed 1175 patients in five hospitals and documented the medical diagnoses. Patients classified as “immediately” or “very urgently” in need of treatment were excluded.

The surveyed patients were on average 41.8 years old, 52.9% were men, and 54.7% of the patients indicated a low urgency of treatment. About 41% of the patients visited the emergency room on their own initiative, 17% stated they were referred or entrusted by their general practitioner, and 8% were referred by a specialist in the emergency room.

The strongest predictors for low subjective treatment urgency were musculoskeletal trauma (odds ratio [OR], 2.18), skin afflictions (OR, 2.15), and the unavailability of an open general practitioner’s office (OR, 1.70).

According to Dr. Scherer and his colleagues, the reasons for visiting an emergency room are diverse and can be based on the perceived structural conditions and individual patient preferences in addition to the urgency of the health problem.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

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

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

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

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

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

People who mainly sit while on the job increase their risk of dying of cardiovascular disease (CVD) by more than one third compared with peers who largely don’t sit at work, new research shows. 

However, daily breaks from sitting and leisure-time activity can help mitigate the “serious” risks associated with prolonged occupational sitting, the researchers say. 

“As part of modern lifestyles, prolonged occupational sitting is considered normal and has not received due attention, even though its deleterious effect on health outcomes has been demonstrated,” wrote the authors, led by Wayne Gao, PhD, with Taipei Medical University College of Public Health, Taipei City, Taiwan. 

“The importance of physical activity and moving around can never be overstated,” Michelle Bloom, MD, director of the cardio-oncology program at NYU Langone Health in New York, who wasn’t involved in the study, told this news organization. 

“As a cardiologist, I bring this up at almost every visit with every patient regardless of why they’re seeing me, because I think that patients respond better when their doctor says it than when they just kind of know it in the back of their mind,” said Dr. Bloom, who is also a professor in the Division of Cardiology, NYU Grossman Long Island School of Medicine, New York. 

The study was published online in JAMA Network Open.

Prolonged Sitting Hard on the Heart 

2020 marked the first time that guidelines on physical activity from the World Health Organization recommended reducing sedentary behaviors owing to their health consequences. Less is known on the specific association of prolonged occupational sitting with health outcomes, especially in the context of low physical activity. 

For their study, Dr. Gao and colleagues quantified health risks associated with prolonged sitting on the job and determined whether a certain threshold of physical activity may attenuate this risk. 

Participants included 481,688 adults (mean age, 39 years; 53% women) in a health surveillance program in Taiwan. Data on occupational sitting, leisure-time physical activity, lifestyle, and metabolic parameters were collected. 

During an average follow up of nearly 13 years, 26,257 participants died; more than half (57%) of the deaths occurred in individuals who mostly sat at work. There were 5371 CVD-related deaths, with 60% occurring in the mostly sitting group. 

In multivariate analysis that adjusted for sex, age, education, smoking, drinking, and body mass index, adults who mostly sat at work had a 16% higher risk of dying of any cause (hazard ratio [HR], 1.16; 95% CI, 1.11-1.20) and a 34% increased risk of dying of CVD (HR, 1.34; 95% CI, 1.22-1.46) compared with those who mostly did not sit at work. 

Adults who mostly alternated between sitting and not sitting at work were not at increased risk of all-cause mortality compared with individuals who mostly did not at work (HR, 1.01; 95% CI, 0.97-1.05). 

Among adults who mostly sat at work and engaged in low (15-29 minutes) or no (< 15 minutes) daily leisure-time activity, increasing activity by 15 and 30 minutes per day, respectively, lowered the risk for mortality to a level similar to that of inactive individuals who mostly do not sit at work. 

“Overall, our findings from a large prospective cohort help to strengthen the increasingly accumulating evidence linking a sedentary lifestyle and health risks,” the authors wrote. 

“Systemic changes, such as more frequent breaks, standing desks, designated workplace areas for physical activity, and gym membership benefits, can help reduce risk,” they added. 

Simple Yet Profound Message 

Reached for comment, Anu Lala, MD, with Icahn School of Medicine at Mount Sinai and Mount Sinai Fuster Heart Hospital in New York, said this study provides a “simple yet profound message” about the dangers of prolonged sitting. 

The finding of a 16% higher all-cause mortality in those who mostly sat at work after adjustment for major risk factors is “pretty remarkable. And for CVD mortality, it’s double that,” Dr. Lala told this news organization.

“I think we undervalue the importance of movement, however simple it is. Even simple actions, like squatting and standing up have benefits for the heart,” Dr. Lala added. 

Dr. Bloom said she tells her patients, “You don’t have to go out tomorrow and run a marathon. Just get up a few times a day, walk a few laps in your office, walk back and forth from the mailbox, walk up and down your steps a couple of times — just do something more than you’re doing already.”

The study had no commercial funding. Dr. Gao and Dr. Bloom have no relevant disclosures. Dr. Lala has serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Novartis, AstraZeneca, Merck, Bayer, Novo Nordisk, Cordio, Zoll, and Sequana Medical.

A version of this article appeared on Medscape.com.

People who mainly sit while on the job increase their risk of dying of cardiovascular disease (CVD) by more than one third compared with peers who largely don’t sit at work, new research shows. 

However, daily breaks from sitting and leisure-time activity can help mitigate the “serious” risks associated with prolonged occupational sitting, the researchers say. 

“As part of modern lifestyles, prolonged occupational sitting is considered normal and has not received due attention, even though its deleterious effect on health outcomes has been demonstrated,” wrote the authors, led by Wayne Gao, PhD, with Taipei Medical University College of Public Health, Taipei City, Taiwan. 

“The importance of physical activity and moving around can never be overstated,” Michelle Bloom, MD, director of the cardio-oncology program at NYU Langone Health in New York, who wasn’t involved in the study, told this news organization. 

“As a cardiologist, I bring this up at almost every visit with every patient regardless of why they’re seeing me, because I think that patients respond better when their doctor says it than when they just kind of know it in the back of their mind,” said Dr. Bloom, who is also a professor in the Division of Cardiology, NYU Grossman Long Island School of Medicine, New York. 

The study was published online in JAMA Network Open.

Prolonged Sitting Hard on the Heart 

2020 marked the first time that guidelines on physical activity from the World Health Organization recommended reducing sedentary behaviors owing to their health consequences. Less is known on the specific association of prolonged occupational sitting with health outcomes, especially in the context of low physical activity. 

For their study, Dr. Gao and colleagues quantified health risks associated with prolonged sitting on the job and determined whether a certain threshold of physical activity may attenuate this risk. 

Participants included 481,688 adults (mean age, 39 years; 53% women) in a health surveillance program in Taiwan. Data on occupational sitting, leisure-time physical activity, lifestyle, and metabolic parameters were collected. 

During an average follow up of nearly 13 years, 26,257 participants died; more than half (57%) of the deaths occurred in individuals who mostly sat at work. There were 5371 CVD-related deaths, with 60% occurring in the mostly sitting group. 

In multivariate analysis that adjusted for sex, age, education, smoking, drinking, and body mass index, adults who mostly sat at work had a 16% higher risk of dying of any cause (hazard ratio [HR], 1.16; 95% CI, 1.11-1.20) and a 34% increased risk of dying of CVD (HR, 1.34; 95% CI, 1.22-1.46) compared with those who mostly did not sit at work. 

Adults who mostly alternated between sitting and not sitting at work were not at increased risk of all-cause mortality compared with individuals who mostly did not at work (HR, 1.01; 95% CI, 0.97-1.05). 

Among adults who mostly sat at work and engaged in low (15-29 minutes) or no (< 15 minutes) daily leisure-time activity, increasing activity by 15 and 30 minutes per day, respectively, lowered the risk for mortality to a level similar to that of inactive individuals who mostly do not sit at work. 

“Overall, our findings from a large prospective cohort help to strengthen the increasingly accumulating evidence linking a sedentary lifestyle and health risks,” the authors wrote. 

“Systemic changes, such as more frequent breaks, standing desks, designated workplace areas for physical activity, and gym membership benefits, can help reduce risk,” they added. 

Simple Yet Profound Message 

Reached for comment, Anu Lala, MD, with Icahn School of Medicine at Mount Sinai and Mount Sinai Fuster Heart Hospital in New York, said this study provides a “simple yet profound message” about the dangers of prolonged sitting. 

The finding of a 16% higher all-cause mortality in those who mostly sat at work after adjustment for major risk factors is “pretty remarkable. And for CVD mortality, it’s double that,” Dr. Lala told this news organization.

“I think we undervalue the importance of movement, however simple it is. Even simple actions, like squatting and standing up have benefits for the heart,” Dr. Lala added. 

Dr. Bloom said she tells her patients, “You don’t have to go out tomorrow and run a marathon. Just get up a few times a day, walk a few laps in your office, walk back and forth from the mailbox, walk up and down your steps a couple of times — just do something more than you’re doing already.”

The study had no commercial funding. Dr. Gao and Dr. Bloom have no relevant disclosures. Dr. Lala has serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Novartis, AstraZeneca, Merck, Bayer, Novo Nordisk, Cordio, Zoll, and Sequana Medical.

A version of this article appeared on Medscape.com.

People who mainly sit while on the job increase their risk of dying of cardiovascular disease (CVD) by more than one third compared with peers who largely don’t sit at work, new research shows. 

However, daily breaks from sitting and leisure-time activity can help mitigate the “serious” risks associated with prolonged occupational sitting, the researchers say. 

“As part of modern lifestyles, prolonged occupational sitting is considered normal and has not received due attention, even though its deleterious effect on health outcomes has been demonstrated,” wrote the authors, led by Wayne Gao, PhD, with Taipei Medical University College of Public Health, Taipei City, Taiwan. 

“The importance of physical activity and moving around can never be overstated,” Michelle Bloom, MD, director of the cardio-oncology program at NYU Langone Health in New York, who wasn’t involved in the study, told this news organization. 

“As a cardiologist, I bring this up at almost every visit with every patient regardless of why they’re seeing me, because I think that patients respond better when their doctor says it than when they just kind of know it in the back of their mind,” said Dr. Bloom, who is also a professor in the Division of Cardiology, NYU Grossman Long Island School of Medicine, New York. 

The study was published online in JAMA Network Open.

Prolonged Sitting Hard on the Heart 

2020 marked the first time that guidelines on physical activity from the World Health Organization recommended reducing sedentary behaviors owing to their health consequences. Less is known on the specific association of prolonged occupational sitting with health outcomes, especially in the context of low physical activity. 

For their study, Dr. Gao and colleagues quantified health risks associated with prolonged sitting on the job and determined whether a certain threshold of physical activity may attenuate this risk. 

Participants included 481,688 adults (mean age, 39 years; 53% women) in a health surveillance program in Taiwan. Data on occupational sitting, leisure-time physical activity, lifestyle, and metabolic parameters were collected. 

During an average follow up of nearly 13 years, 26,257 participants died; more than half (57%) of the deaths occurred in individuals who mostly sat at work. There were 5371 CVD-related deaths, with 60% occurring in the mostly sitting group. 

In multivariate analysis that adjusted for sex, age, education, smoking, drinking, and body mass index, adults who mostly sat at work had a 16% higher risk of dying of any cause (hazard ratio [HR], 1.16; 95% CI, 1.11-1.20) and a 34% increased risk of dying of CVD (HR, 1.34; 95% CI, 1.22-1.46) compared with those who mostly did not sit at work. 

Adults who mostly alternated between sitting and not sitting at work were not at increased risk of all-cause mortality compared with individuals who mostly did not at work (HR, 1.01; 95% CI, 0.97-1.05). 

Among adults who mostly sat at work and engaged in low (15-29 minutes) or no (< 15 minutes) daily leisure-time activity, increasing activity by 15 and 30 minutes per day, respectively, lowered the risk for mortality to a level similar to that of inactive individuals who mostly do not sit at work. 

“Overall, our findings from a large prospective cohort help to strengthen the increasingly accumulating evidence linking a sedentary lifestyle and health risks,” the authors wrote. 

“Systemic changes, such as more frequent breaks, standing desks, designated workplace areas for physical activity, and gym membership benefits, can help reduce risk,” they added. 

Simple Yet Profound Message 

Reached for comment, Anu Lala, MD, with Icahn School of Medicine at Mount Sinai and Mount Sinai Fuster Heart Hospital in New York, said this study provides a “simple yet profound message” about the dangers of prolonged sitting. 

The finding of a 16% higher all-cause mortality in those who mostly sat at work after adjustment for major risk factors is “pretty remarkable. And for CVD mortality, it’s double that,” Dr. Lala told this news organization.

“I think we undervalue the importance of movement, however simple it is. Even simple actions, like squatting and standing up have benefits for the heart,” Dr. Lala added. 

Dr. Bloom said she tells her patients, “You don’t have to go out tomorrow and run a marathon. Just get up a few times a day, walk a few laps in your office, walk back and forth from the mailbox, walk up and down your steps a couple of times — just do something more than you’re doing already.”

The study had no commercial funding. Dr. Gao and Dr. Bloom have no relevant disclosures. Dr. Lala has serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Novartis, AstraZeneca, Merck, Bayer, Novo Nordisk, Cordio, Zoll, and Sequana Medical.

A version of this article appeared on Medscape.com.

The long-term impact of traumatic brain injury (TBI) on neurologic and psychiatric function is well-established, but a growing body of research is pointing to unexpected medical sequalae, including cardiovascular disease (CVD).

A recent review looked at the investigation to date into this surprising connection, not only summarizing study findings but also suggesting potential mechanisms that might account for the association.

“This work offers further evidence that individuals with TBI are at an elevated risk of unfavorable cardiovascular outcomes for an extended period following the initial incident; consequently, they should undergo regular monitoring,” senior author Ross Zafonte, DO, president of Spaulding Rehabilitation Network, Boston, and lead author Saef Izzy, MD, MBChB, a neurologist at the Stroke and Cerebrovascular Center of Brigham and Women’s Hospital, Boston, Massachusetts, told this news organization.

“This holds significant importance for healthcare practitioners, as there exist several strategies to mitigate cardiovascular disease risk — including weight management, adopting a healthy diet, engaging in regular physical activity, and quitting smoking,” they stated.

Leslie Croll, MD, American Heart Association volunteer and assistant professor of clinical neurology at the Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania, told this news organization that it’s “extremely important to learn more about the interplay between TBI, neurologic disease, psychiatric complications, and the cardiovascular system.”

Hopefully, she added, “future research will help us understand what kind of cardiovascular disease monitoring and prevention measures stand to give TBI patients the most benefit.”
 

Chronic Condition

TBI is “a major cause of long-term disability and premature death,” and is “highly prevalent among contact sports players, military personnel (eg, due to injuries sustained during conflict), and the general population (eg, due to falls and road traffic incidents),” the authors wrote.

Most studies pertaining to TBI have “primarily focused on establishing connections between single TBI, repetitive TBI, and their acute and chronic neurological and psychiatric consequences, such as Parkinson’s disease, Alzheimer’s disease, and chronic traumatic encephalopathy (CTE),” Drs. Zafonte and Izzy noted. By contrast, there has been a “notable lack of research attention given to non-neurological conditions associated with TBI.”

They pointed out that recent insights into TBI — particularly the acknowledgment of TBI as an “emerging chronic condition rather than merely an acute aftermath of brain injury” — have come to light through epidemiologic and pathologic investigations involving military veterans, professional American-style football players, and the civilian population. “This recognition opens up an opportunity to broaden our perspective and delve into the medical aspects of health that may be influenced by TBI.”

To broaden the investigation, the researchers reviewed literature published between January 1, 2001, and June 18, 2023. Of 26,335 articles, they narrowed their review down to 15 studies that investigated CVD, CVD risk factors, and cerebrovascular disease in the chronic phase of TBI, including community, military, or sport-related brain trauma, regardless of the timing of disease occurrence with respect to brain injury via TBI or repetitive head impact.
 

New Cardiovascular Risk

Studies that used national or local registries tended to be retrospective and predominantly conducted in people with preexisting cardiovascular conditions. In these studies, TBI was found to be an independent risk factor for myocardial dysfunction. However, although these studies do provide evidence of elevated cardiovascular risk subsequent to a single TBI, including individuals with preexisting medical comorbidities “makes it difficult to determine the timing of incident cardiovascular disease and cardiovascular risk factors subsequent to brain injury,” they wrote.

However, some studies showed that even individuals with TBI but without preexisting myocardial dysfunction at baseline had a significantly higher risk for CVD than those without a history of TBI.

In fact, several studies included populations without preexisting medical and cardiovascular comorbidities to “better refine the order and timing of CVD and other risk factors in individuals with TBI.”

For example, one study of concussion survivors without preexisting diagnoses showed that cardiovascular, endocrinological, and neuropsychiatric comorbidities occurred at a “significantly higher incidence within 5 years after concussive TBI compared with healthy individuals who were matched in terms of age, race, and sex and didn’t have a TBI exposure.” Other studies yielded similar findings.

Because cardiovascular risk factors and events become more common with age, it’s important to account for age in evaluating the effects of TBI. Although many studies of TBI and subsequent CVD didn’t stratify individuals by age, one 10-year study of people without any known cardiovascular or neuropsychiatric conditions who sustained TBI found that people as young as 18-40 years were more likely to develop hypertension, hyperlipidemia, obesity, and diabetes within 3-5 years following brain injury than matched individuals in the control group.

“Individuals who have encountered TBI, surprisingly even those who are young and in good health with no prior comorbid conditions, face an increased risk of adverse cardiovascular outcomes for an extended duration after the initial event,” Drs. Zafonte and Izzy summarized. “Therefore, it’s imperative that they receive regular and long-term screenings for CVD and associated risk factors.”
 

Bidirectional Relationship

Brain injury has been associated with acute cardiovascular dysfunction, including autonomic heart-brain axis dysregulation, imbalances between the sympathetic and parasympathetic nervous systems, and excessive catecholamine release, the authors noted.

Drs. Zafonte and Izzy suggested several plausible links between TBI and cardiovascular dysfunction, noting that they are “likely multifaceted, potentially encompassing risk factors that span the pre-injury, injury, and post-injury phases of the condition.”

TBI may induce alterations in neurobiological processes, which have been reported to be associated with an increased risk for CVD (eg, chronic dysfunction of the autonomic system, systemic inflammation, and modifications in the brain-gut connection).

Patients with TBI might develop additional risk factors following the injury, including conditions like posttraumatic stress disorder, depression, and other psychiatric illnesses, which are “known to augment the risk of CVD.”

TBI can lead to subsequent behavioral and lifestyle changes that place patients at an elevated risk for both cardiovascular and cognitive dysfunction when compared to the general population of TBI survivors.

There may be additional as yet undefined risks.

They believe there’s a bidirectional relationship between TBI and CVD. “On one hand, TBI has been associated with an elevated risk of CVD,” they said. “Conversely, cardiovascular risk factors such as diabetes, hypertension, hyperlipidemia, and sleep disturbances that have been demonstrated to negatively influence cognitive function and heighten the risk of dementia. Consequently, this interplay can further compound the long-term consequences of the injury.”

Their work aims to try and disentangle this “complex series of relationships.”

They recommend screening to identify diseases in their earliest and “most manageable phases” because TBI has been “unveiled as an underappreciated risk factor for CVD within contact sports, military, and community setting.”

An effective screening program “should rely on quantifiable and dependable biomarkers such as blood pressure, BMI, waist circumference, blood lipid levels, and glucose. Additionally, it should take into account other factors like smoking habits, physical activity, and dietary choices,” they recommended.
 

Heart-Brain Connection

Dr. Croll noted that TBI is “associated with many poorly understood physiologic changes and complications, so it’s exciting to see research aimed at clarifying this chronic disease process.”

In recent years, “we have seen a greater appreciation and understanding of the heart-brain connection,” she said. “Moving forward, more research, including TBI research, will target that connection.”

She added that there are probably “multiple mechanisms” at play underlying the connection between TBI and CVD.

Most importantly, “we are increasingly learning that TBI is not only a discrete event that requires immediate treatment but also a chronic disease process,” and when we “think about the substantial long-term morbidity associated with TBI, we should keep increased risk for CVD on top of mind,” said Dr. Croll.

The review received no funding. Izzy reported receiving grants from the US National Institutes of Health (NIH) and 2023 Stepping Strong Innovator Award. Dr. Zafonte reported receiving grants from the NIH and royalties from Springer and Demos publishing for serving as a coeditor of Brain Injury Medicine. Dr. Zafonte has also served as an adviser to Myomo, Oncare.ai, Nanodiagnostics, and Kisbee. He reported evaluating patients in the Massachusetts General Hospital Brain and Body–TRUST Program, which is funded by the NFL Players Association. The other authors’ disclosures are listed on the original paper. Dr. Croll declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

The long-term impact of traumatic brain injury (TBI) on neurologic and psychiatric function is well-established, but a growing body of research is pointing to unexpected medical sequalae, including cardiovascular disease (CVD).

A recent review looked at the investigation to date into this surprising connection, not only summarizing study findings but also suggesting potential mechanisms that might account for the association.

“This work offers further evidence that individuals with TBI are at an elevated risk of unfavorable cardiovascular outcomes for an extended period following the initial incident; consequently, they should undergo regular monitoring,” senior author Ross Zafonte, DO, president of Spaulding Rehabilitation Network, Boston, and lead author Saef Izzy, MD, MBChB, a neurologist at the Stroke and Cerebrovascular Center of Brigham and Women’s Hospital, Boston, Massachusetts, told this news organization.

“This holds significant importance for healthcare practitioners, as there exist several strategies to mitigate cardiovascular disease risk — including weight management, adopting a healthy diet, engaging in regular physical activity, and quitting smoking,” they stated.

Leslie Croll, MD, American Heart Association volunteer and assistant professor of clinical neurology at the Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania, told this news organization that it’s “extremely important to learn more about the interplay between TBI, neurologic disease, psychiatric complications, and the cardiovascular system.”

Hopefully, she added, “future research will help us understand what kind of cardiovascular disease monitoring and prevention measures stand to give TBI patients the most benefit.”
 

Chronic Condition

TBI is “a major cause of long-term disability and premature death,” and is “highly prevalent among contact sports players, military personnel (eg, due to injuries sustained during conflict), and the general population (eg, due to falls and road traffic incidents),” the authors wrote.

Most studies pertaining to TBI have “primarily focused on establishing connections between single TBI, repetitive TBI, and their acute and chronic neurological and psychiatric consequences, such as Parkinson’s disease, Alzheimer’s disease, and chronic traumatic encephalopathy (CTE),” Drs. Zafonte and Izzy noted. By contrast, there has been a “notable lack of research attention given to non-neurological conditions associated with TBI.”

They pointed out that recent insights into TBI — particularly the acknowledgment of TBI as an “emerging chronic condition rather than merely an acute aftermath of brain injury” — have come to light through epidemiologic and pathologic investigations involving military veterans, professional American-style football players, and the civilian population. “This recognition opens up an opportunity to broaden our perspective and delve into the medical aspects of health that may be influenced by TBI.”

To broaden the investigation, the researchers reviewed literature published between January 1, 2001, and June 18, 2023. Of 26,335 articles, they narrowed their review down to 15 studies that investigated CVD, CVD risk factors, and cerebrovascular disease in the chronic phase of TBI, including community, military, or sport-related brain trauma, regardless of the timing of disease occurrence with respect to brain injury via TBI or repetitive head impact.
 

New Cardiovascular Risk

Studies that used national or local registries tended to be retrospective and predominantly conducted in people with preexisting cardiovascular conditions. In these studies, TBI was found to be an independent risk factor for myocardial dysfunction. However, although these studies do provide evidence of elevated cardiovascular risk subsequent to a single TBI, including individuals with preexisting medical comorbidities “makes it difficult to determine the timing of incident cardiovascular disease and cardiovascular risk factors subsequent to brain injury,” they wrote.

However, some studies showed that even individuals with TBI but without preexisting myocardial dysfunction at baseline had a significantly higher risk for CVD than those without a history of TBI.

In fact, several studies included populations without preexisting medical and cardiovascular comorbidities to “better refine the order and timing of CVD and other risk factors in individuals with TBI.”

For example, one study of concussion survivors without preexisting diagnoses showed that cardiovascular, endocrinological, and neuropsychiatric comorbidities occurred at a “significantly higher incidence within 5 years after concussive TBI compared with healthy individuals who were matched in terms of age, race, and sex and didn’t have a TBI exposure.” Other studies yielded similar findings.

Because cardiovascular risk factors and events become more common with age, it’s important to account for age in evaluating the effects of TBI. Although many studies of TBI and subsequent CVD didn’t stratify individuals by age, one 10-year study of people without any known cardiovascular or neuropsychiatric conditions who sustained TBI found that people as young as 18-40 years were more likely to develop hypertension, hyperlipidemia, obesity, and diabetes within 3-5 years following brain injury than matched individuals in the control group.

“Individuals who have encountered TBI, surprisingly even those who are young and in good health with no prior comorbid conditions, face an increased risk of adverse cardiovascular outcomes for an extended duration after the initial event,” Drs. Zafonte and Izzy summarized. “Therefore, it’s imperative that they receive regular and long-term screenings for CVD and associated risk factors.”
 

Bidirectional Relationship

Brain injury has been associated with acute cardiovascular dysfunction, including autonomic heart-brain axis dysregulation, imbalances between the sympathetic and parasympathetic nervous systems, and excessive catecholamine release, the authors noted.

Drs. Zafonte and Izzy suggested several plausible links between TBI and cardiovascular dysfunction, noting that they are “likely multifaceted, potentially encompassing risk factors that span the pre-injury, injury, and post-injury phases of the condition.”

TBI may induce alterations in neurobiological processes, which have been reported to be associated with an increased risk for CVD (eg, chronic dysfunction of the autonomic system, systemic inflammation, and modifications in the brain-gut connection).

Patients with TBI might develop additional risk factors following the injury, including conditions like posttraumatic stress disorder, depression, and other psychiatric illnesses, which are “known to augment the risk of CVD.”

TBI can lead to subsequent behavioral and lifestyle changes that place patients at an elevated risk for both cardiovascular and cognitive dysfunction when compared to the general population of TBI survivors.

There may be additional as yet undefined risks.

They believe there’s a bidirectional relationship between TBI and CVD. “On one hand, TBI has been associated with an elevated risk of CVD,” they said. “Conversely, cardiovascular risk factors such as diabetes, hypertension, hyperlipidemia, and sleep disturbances that have been demonstrated to negatively influence cognitive function and heighten the risk of dementia. Consequently, this interplay can further compound the long-term consequences of the injury.”

Their work aims to try and disentangle this “complex series of relationships.”

They recommend screening to identify diseases in their earliest and “most manageable phases” because TBI has been “unveiled as an underappreciated risk factor for CVD within contact sports, military, and community setting.”

An effective screening program “should rely on quantifiable and dependable biomarkers such as blood pressure, BMI, waist circumference, blood lipid levels, and glucose. Additionally, it should take into account other factors like smoking habits, physical activity, and dietary choices,” they recommended.
 

Heart-Brain Connection

Dr. Croll noted that TBI is “associated with many poorly understood physiologic changes and complications, so it’s exciting to see research aimed at clarifying this chronic disease process.”

In recent years, “we have seen a greater appreciation and understanding of the heart-brain connection,” she said. “Moving forward, more research, including TBI research, will target that connection.”

She added that there are probably “multiple mechanisms” at play underlying the connection between TBI and CVD.

Most importantly, “we are increasingly learning that TBI is not only a discrete event that requires immediate treatment but also a chronic disease process,” and when we “think about the substantial long-term morbidity associated with TBI, we should keep increased risk for CVD on top of mind,” said Dr. Croll.

The review received no funding. Izzy reported receiving grants from the US National Institutes of Health (NIH) and 2023 Stepping Strong Innovator Award. Dr. Zafonte reported receiving grants from the NIH and royalties from Springer and Demos publishing for serving as a coeditor of Brain Injury Medicine. Dr. Zafonte has also served as an adviser to Myomo, Oncare.ai, Nanodiagnostics, and Kisbee. He reported evaluating patients in the Massachusetts General Hospital Brain and Body–TRUST Program, which is funded by the NFL Players Association. The other authors’ disclosures are listed on the original paper. Dr. Croll declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

The long-term impact of traumatic brain injury (TBI) on neurologic and psychiatric function is well-established, but a growing body of research is pointing to unexpected medical sequalae, including cardiovascular disease (CVD).

A recent review looked at the investigation to date into this surprising connection, not only summarizing study findings but also suggesting potential mechanisms that might account for the association.

“This work offers further evidence that individuals with TBI are at an elevated risk of unfavorable cardiovascular outcomes for an extended period following the initial incident; consequently, they should undergo regular monitoring,” senior author Ross Zafonte, DO, president of Spaulding Rehabilitation Network, Boston, and lead author Saef Izzy, MD, MBChB, a neurologist at the Stroke and Cerebrovascular Center of Brigham and Women’s Hospital, Boston, Massachusetts, told this news organization.

“This holds significant importance for healthcare practitioners, as there exist several strategies to mitigate cardiovascular disease risk — including weight management, adopting a healthy diet, engaging in regular physical activity, and quitting smoking,” they stated.

Leslie Croll, MD, American Heart Association volunteer and assistant professor of clinical neurology at the Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania, told this news organization that it’s “extremely important to learn more about the interplay between TBI, neurologic disease, psychiatric complications, and the cardiovascular system.”

Hopefully, she added, “future research will help us understand what kind of cardiovascular disease monitoring and prevention measures stand to give TBI patients the most benefit.”
 

Chronic Condition

TBI is “a major cause of long-term disability and premature death,” and is “highly prevalent among contact sports players, military personnel (eg, due to injuries sustained during conflict), and the general population (eg, due to falls and road traffic incidents),” the authors wrote.

Most studies pertaining to TBI have “primarily focused on establishing connections between single TBI, repetitive TBI, and their acute and chronic neurological and psychiatric consequences, such as Parkinson’s disease, Alzheimer’s disease, and chronic traumatic encephalopathy (CTE),” Drs. Zafonte and Izzy noted. By contrast, there has been a “notable lack of research attention given to non-neurological conditions associated with TBI.”

They pointed out that recent insights into TBI — particularly the acknowledgment of TBI as an “emerging chronic condition rather than merely an acute aftermath of brain injury” — have come to light through epidemiologic and pathologic investigations involving military veterans, professional American-style football players, and the civilian population. “This recognition opens up an opportunity to broaden our perspective and delve into the medical aspects of health that may be influenced by TBI.”

To broaden the investigation, the researchers reviewed literature published between January 1, 2001, and June 18, 2023. Of 26,335 articles, they narrowed their review down to 15 studies that investigated CVD, CVD risk factors, and cerebrovascular disease in the chronic phase of TBI, including community, military, or sport-related brain trauma, regardless of the timing of disease occurrence with respect to brain injury via TBI or repetitive head impact.
 

New Cardiovascular Risk

Studies that used national or local registries tended to be retrospective and predominantly conducted in people with preexisting cardiovascular conditions. In these studies, TBI was found to be an independent risk factor for myocardial dysfunction. However, although these studies do provide evidence of elevated cardiovascular risk subsequent to a single TBI, including individuals with preexisting medical comorbidities “makes it difficult to determine the timing of incident cardiovascular disease and cardiovascular risk factors subsequent to brain injury,” they wrote.

However, some studies showed that even individuals with TBI but without preexisting myocardial dysfunction at baseline had a significantly higher risk for CVD than those without a history of TBI.

In fact, several studies included populations without preexisting medical and cardiovascular comorbidities to “better refine the order and timing of CVD and other risk factors in individuals with TBI.”

For example, one study of concussion survivors without preexisting diagnoses showed that cardiovascular, endocrinological, and neuropsychiatric comorbidities occurred at a “significantly higher incidence within 5 years after concussive TBI compared with healthy individuals who were matched in terms of age, race, and sex and didn’t have a TBI exposure.” Other studies yielded similar findings.

Because cardiovascular risk factors and events become more common with age, it’s important to account for age in evaluating the effects of TBI. Although many studies of TBI and subsequent CVD didn’t stratify individuals by age, one 10-year study of people without any known cardiovascular or neuropsychiatric conditions who sustained TBI found that people as young as 18-40 years were more likely to develop hypertension, hyperlipidemia, obesity, and diabetes within 3-5 years following brain injury than matched individuals in the control group.

“Individuals who have encountered TBI, surprisingly even those who are young and in good health with no prior comorbid conditions, face an increased risk of adverse cardiovascular outcomes for an extended duration after the initial event,” Drs. Zafonte and Izzy summarized. “Therefore, it’s imperative that they receive regular and long-term screenings for CVD and associated risk factors.”
 

Bidirectional Relationship

Brain injury has been associated with acute cardiovascular dysfunction, including autonomic heart-brain axis dysregulation, imbalances between the sympathetic and parasympathetic nervous systems, and excessive catecholamine release, the authors noted.

Drs. Zafonte and Izzy suggested several plausible links between TBI and cardiovascular dysfunction, noting that they are “likely multifaceted, potentially encompassing risk factors that span the pre-injury, injury, and post-injury phases of the condition.”

TBI may induce alterations in neurobiological processes, which have been reported to be associated with an increased risk for CVD (eg, chronic dysfunction of the autonomic system, systemic inflammation, and modifications in the brain-gut connection).

Patients with TBI might develop additional risk factors following the injury, including conditions like posttraumatic stress disorder, depression, and other psychiatric illnesses, which are “known to augment the risk of CVD.”

TBI can lead to subsequent behavioral and lifestyle changes that place patients at an elevated risk for both cardiovascular and cognitive dysfunction when compared to the general population of TBI survivors.

There may be additional as yet undefined risks.

They believe there’s a bidirectional relationship between TBI and CVD. “On one hand, TBI has been associated with an elevated risk of CVD,” they said. “Conversely, cardiovascular risk factors such as diabetes, hypertension, hyperlipidemia, and sleep disturbances that have been demonstrated to negatively influence cognitive function and heighten the risk of dementia. Consequently, this interplay can further compound the long-term consequences of the injury.”

Their work aims to try and disentangle this “complex series of relationships.”

They recommend screening to identify diseases in their earliest and “most manageable phases” because TBI has been “unveiled as an underappreciated risk factor for CVD within contact sports, military, and community setting.”

An effective screening program “should rely on quantifiable and dependable biomarkers such as blood pressure, BMI, waist circumference, blood lipid levels, and glucose. Additionally, it should take into account other factors like smoking habits, physical activity, and dietary choices,” they recommended.
 

Heart-Brain Connection

Dr. Croll noted that TBI is “associated with many poorly understood physiologic changes and complications, so it’s exciting to see research aimed at clarifying this chronic disease process.”

In recent years, “we have seen a greater appreciation and understanding of the heart-brain connection,” she said. “Moving forward, more research, including TBI research, will target that connection.”

She added that there are probably “multiple mechanisms” at play underlying the connection between TBI and CVD.

Most importantly, “we are increasingly learning that TBI is not only a discrete event that requires immediate treatment but also a chronic disease process,” and when we “think about the substantial long-term morbidity associated with TBI, we should keep increased risk for CVD on top of mind,” said Dr. Croll.

The review received no funding. Izzy reported receiving grants from the US National Institutes of Health (NIH) and 2023 Stepping Strong Innovator Award. Dr. Zafonte reported receiving grants from the NIH and royalties from Springer and Demos publishing for serving as a coeditor of Brain Injury Medicine. Dr. Zafonte has also served as an adviser to Myomo, Oncare.ai, Nanodiagnostics, and Kisbee. He reported evaluating patients in the Massachusetts General Hospital Brain and Body–TRUST Program, which is funded by the NFL Players Association. The other authors’ disclosures are listed on the original paper. Dr. Croll declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients undergoing transcatheter aortic valve replacement (TAVR) have a higher risk for stroke for up to 2 years compared with an age- and sex-matched population, after which their risks are comparable, results of a large Swiss registry study suggest.

METHODOLOGY:

• The study included 11,957 patients from the prospective SwissTAVI Registry, an ongoing mandatory cohort study enrolling consecutive patients undergoing TAVR in Switzerland.
• The study population, which had a mean age of 81.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) of 4.62, with 11.8% having a history of cerebrovascular accident (CVA) and 32.3% a history of atrial fibrillation, underwent TAVR at 15 centers between February 2011 and June 2021.
• The primary outcome was the incidence of stroke, with secondary outcomes including the incidence of CVA, a composite of stroke and transient ischemic attack (TIA).
• Researchers calculated standardized stroke ratios (SSRs) and compared stroke trends in patients undergoing TAVR with those of an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease (GBD) study.

TAKEAWAY:

• The 30-day incidence rates of CVA and stroke were 3.3% and 3.0%, respectively, with the highest risk within the first 48 hours post TAVR, accounting for 69% of these events.
• After excluding 30-day events, the 1-year incidence rates of CVA and stroke were 1.7% and 1.4%, respectively, followed by an annual stroke incidence of 1.2%, 0.8%, 0.9%, and 0.7% in the second, third, fourth, and fifth years post TAVR, respectively.
• Only increased age and moderate/severe paravalvular leakage (PVL) at discharge were associated with an increased risk for early stroke (up to 30 days post TAVR), whereas dyslipidemia and history of atrial fibrillation and of CVA were associated with an increased risk for late stroke (30 days to 5 years after TAVR).
• SSR in the study population returned to a level comparable to that expected in the general Swiss population after 2 years and through to 5 years post-TAVR.

IN PRACTICE:

Although the study results “are reassuring” with respect to stroke risk beyond 2 years post TAVR, “our findings underscore the continued efforts of stroke-prevention measures” early and longer term, wrote the authors.

In an accompanying editorial, Lauge Østergaard, MD, PhD, Department of Cardiology, University of Copenhagen, Denmark, noted the study suggests reduced PVL could lower the risk for early stroke following TAVR and “highlights how assessment of usual risk factors (dyslipidemia and atrial fibrillation) could help reduce the burden of stroke in the long term.”

SOURCE:

The study was carried out by Taishi Okuno, MD, Department of Cardiology, Bern University Hospital, University of Bern, Switzerland, and colleagues. It was published online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

LIMITATIONS:

The study couldn’t investigate the association between antithrombotic regimens and the risk for CVA. Definitions of CVA in the SwissTAVI Registry might differ from those used in the GBD study from which the matched population data were derived. The general population wasn’t matched on comorbidities usually associated with elevated stroke risk, which may have led to underestimation of stroke. As the mean age in the study was 82 years, results may not be extrapolated to a younger population.

DISCLOSURES:

The SwissTAVI registry is supported by the Swiss Heart Foundation, Swiss Working Group of Interventional Cardiology and Acute Coronary Syndromes, Medtronic, Edwards Lifesciences, Boston Scientific/Symetis, JenaValve, and St. Jude Medical. Dr. Okuno has no relevant conflicts of interest; see paper for disclosures of other study authors. Dr. Østergaard has received an independent research grant from the Novo Nordisk Foundation.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients undergoing transcatheter aortic valve replacement (TAVR) have a higher risk for stroke for up to 2 years compared with an age- and sex-matched population, after which their risks are comparable, results of a large Swiss registry study suggest.

METHODOLOGY:

• The study included 11,957 patients from the prospective SwissTAVI Registry, an ongoing mandatory cohort study enrolling consecutive patients undergoing TAVR in Switzerland.
• The study population, which had a mean age of 81.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) of 4.62, with 11.8% having a history of cerebrovascular accident (CVA) and 32.3% a history of atrial fibrillation, underwent TAVR at 15 centers between February 2011 and June 2021.
• The primary outcome was the incidence of stroke, with secondary outcomes including the incidence of CVA, a composite of stroke and transient ischemic attack (TIA).
• Researchers calculated standardized stroke ratios (SSRs) and compared stroke trends in patients undergoing TAVR with those of an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease (GBD) study.

TAKEAWAY:

• The 30-day incidence rates of CVA and stroke were 3.3% and 3.0%, respectively, with the highest risk within the first 48 hours post TAVR, accounting for 69% of these events.
• After excluding 30-day events, the 1-year incidence rates of CVA and stroke were 1.7% and 1.4%, respectively, followed by an annual stroke incidence of 1.2%, 0.8%, 0.9%, and 0.7% in the second, third, fourth, and fifth years post TAVR, respectively.
• Only increased age and moderate/severe paravalvular leakage (PVL) at discharge were associated with an increased risk for early stroke (up to 30 days post TAVR), whereas dyslipidemia and history of atrial fibrillation and of CVA were associated with an increased risk for late stroke (30 days to 5 years after TAVR).
• SSR in the study population returned to a level comparable to that expected in the general Swiss population after 2 years and through to 5 years post-TAVR.

IN PRACTICE:

Although the study results “are reassuring” with respect to stroke risk beyond 2 years post TAVR, “our findings underscore the continued efforts of stroke-prevention measures” early and longer term, wrote the authors.

In an accompanying editorial, Lauge Østergaard, MD, PhD, Department of Cardiology, University of Copenhagen, Denmark, noted the study suggests reduced PVL could lower the risk for early stroke following TAVR and “highlights how assessment of usual risk factors (dyslipidemia and atrial fibrillation) could help reduce the burden of stroke in the long term.”

SOURCE:

The study was carried out by Taishi Okuno, MD, Department of Cardiology, Bern University Hospital, University of Bern, Switzerland, and colleagues. It was published online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

LIMITATIONS:

The study couldn’t investigate the association between antithrombotic regimens and the risk for CVA. Definitions of CVA in the SwissTAVI Registry might differ from those used in the GBD study from which the matched population data were derived. The general population wasn’t matched on comorbidities usually associated with elevated stroke risk, which may have led to underestimation of stroke. As the mean age in the study was 82 years, results may not be extrapolated to a younger population.

DISCLOSURES:

The SwissTAVI registry is supported by the Swiss Heart Foundation, Swiss Working Group of Interventional Cardiology and Acute Coronary Syndromes, Medtronic, Edwards Lifesciences, Boston Scientific/Symetis, JenaValve, and St. Jude Medical. Dr. Okuno has no relevant conflicts of interest; see paper for disclosures of other study authors. Dr. Østergaard has received an independent research grant from the Novo Nordisk Foundation.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients undergoing transcatheter aortic valve replacement (TAVR) have a higher risk for stroke for up to 2 years compared with an age- and sex-matched population, after which their risks are comparable, results of a large Swiss registry study suggest.

METHODOLOGY:

• The study included 11,957 patients from the prospective SwissTAVI Registry, an ongoing mandatory cohort study enrolling consecutive patients undergoing TAVR in Switzerland.
• The study population, which had a mean age of 81.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) of 4.62, with 11.8% having a history of cerebrovascular accident (CVA) and 32.3% a history of atrial fibrillation, underwent TAVR at 15 centers between February 2011 and June 2021.
• The primary outcome was the incidence of stroke, with secondary outcomes including the incidence of CVA, a composite of stroke and transient ischemic attack (TIA).
• Researchers calculated standardized stroke ratios (SSRs) and compared stroke trends in patients undergoing TAVR with those of an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease (GBD) study.

TAKEAWAY:

• The 30-day incidence rates of CVA and stroke were 3.3% and 3.0%, respectively, with the highest risk within the first 48 hours post TAVR, accounting for 69% of these events.
• After excluding 30-day events, the 1-year incidence rates of CVA and stroke were 1.7% and 1.4%, respectively, followed by an annual stroke incidence of 1.2%, 0.8%, 0.9%, and 0.7% in the second, third, fourth, and fifth years post TAVR, respectively.
• Only increased age and moderate/severe paravalvular leakage (PVL) at discharge were associated with an increased risk for early stroke (up to 30 days post TAVR), whereas dyslipidemia and history of atrial fibrillation and of CVA were associated with an increased risk for late stroke (30 days to 5 years after TAVR).
• SSR in the study population returned to a level comparable to that expected in the general Swiss population after 2 years and through to 5 years post-TAVR.

IN PRACTICE:

Although the study results “are reassuring” with respect to stroke risk beyond 2 years post TAVR, “our findings underscore the continued efforts of stroke-prevention measures” early and longer term, wrote the authors.

In an accompanying editorial, Lauge Østergaard, MD, PhD, Department of Cardiology, University of Copenhagen, Denmark, noted the study suggests reduced PVL could lower the risk for early stroke following TAVR and “highlights how assessment of usual risk factors (dyslipidemia and atrial fibrillation) could help reduce the burden of stroke in the long term.”

SOURCE:

The study was carried out by Taishi Okuno, MD, Department of Cardiology, Bern University Hospital, University of Bern, Switzerland, and colleagues. It was published online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

LIMITATIONS:

The study couldn’t investigate the association between antithrombotic regimens and the risk for CVA. Definitions of CVA in the SwissTAVI Registry might differ from those used in the GBD study from which the matched population data were derived. The general population wasn’t matched on comorbidities usually associated with elevated stroke risk, which may have led to underestimation of stroke. As the mean age in the study was 82 years, results may not be extrapolated to a younger population.

DISCLOSURES:

The SwissTAVI registry is supported by the Swiss Heart Foundation, Swiss Working Group of Interventional Cardiology and Acute Coronary Syndromes, Medtronic, Edwards Lifesciences, Boston Scientific/Symetis, JenaValve, and St. Jude Medical. Dr. Okuno has no relevant conflicts of interest; see paper for disclosures of other study authors. Dr. Østergaard has received an independent research grant from the Novo Nordisk Foundation.

A version of this article appeared on Medscape.com.

Often known as a “silent killer,” ascending thoracic aortic aneurysms (ATAAs) may grow asymptomatically until they rupture, at which point, mortality is over 90%.

But ATAAs may also carry a potential flip side: Apparent protection against the development of atherosclerotic plaque and by extension, for those who have one, a significantly reduced risk for coronary artery disease and myocardial infarction (MI).

“We noticed in the operating room that many patients we worked on who had an ATAA had pristine arteries, like a teenager’s,” said John Elefteriades, MD, William W.L. Glenn Professor of Cardiothoracic Surgery and former chief of cardiothoracic surgery at Yale University and Yale New Haven Hospital, New Haven, Connecticut. “The same was true of the femoral artery, which we use to hook up to the heart-lung machine.”

Elefteriades and colleagues have been investigating the implications of this association for more than two decades. Many of their studies are highlighted in a recent review of the evidence supporting the protective relationship between ATAAs and the development of atherosclerosis and the possible mechanisms driving the relationship.

“We see four different layers of protection,” said Sandip Mukherjee, MD, medical director of the Aortic Institute at Yale New Haven Hospital and a senior editor of the journal AORTA. Mukherjee collaborated with Elefteriades on many of the studies.

The first layer of protection is lower intima-media thickness, specifically, 0.131 mm lower than in individuals without an ATAA. “It may not seem like very much, but one point can actually translate into a 13%-15% decline in the rate of myocardial infarction or stroke,” Dr. Mukherjee said.

The second layer is lower levels of low-density lipoprotein (LDL) cholesterol. Lower LDL cholesterol levels (75 mg/dL) were associated with increased odds of ATAAs (odds ratio [OR], 1.21), whereas elevated levels (150 mg/dL and 200 mg/dL) were associated with decreased odds of ATAAs (OR, 0.62 and 0.29, respectively).

Lower calcification scores for the coronary arteries are the third layer of protection (6.73 vs 9.36 in one study).

The fourth protective layer is a significantly reduced prevalence of coronary artery disease. A study of individuals with ATAA compared to controls found 61 of those with ATAA had coronary artery disease vs 140 of controls, and 11 vs 83 had experienced an MI. Of note, patients with ATAAs were protected despite having higher body mass indices than controls.

Other MI risk factors such as age increased the risk even among those with an ATAA but, again, much less so than among controls; a multivariable binary logistic regression of data in the team’s review showed that patients with ATAAs were 298, 250, and 232 times less likely to have an MI than if they had a family history of MI, dyslipidemia, or hypertension, respectively.

Why the Protection?

The ligamentum arteriosum separates the ascending from the descending (thoracoabdominal) aorta. ATAAs, located above the ligamentum, tend to be pro-aneurysmal but anti-atherosclerotic. In the descending aorta, below the ligamentum, atherosclerotic aneurysms develop.

The differences between the two sections of the aorta originate in the germ layer in the embryo, Dr. Elefteriades said. “The fundamental difference in tissue of origin translates into marked differences in the character of aneurysms in the different aortic segments.”

What specifically underlies the reduced cardiovascular risk? “We don’t really know, but we think that there may be two possible etiologies,” Dr. Mukherjee said. One hypothesis involves transforming growth factor–beta (TGF-beta), which is overexpressed in patients with ATAA and seems to increase their vulnerability to aneurysms while also conferring protection from coronary disease risk.

Some studies have shown differences in cellular responses to TGF-beta between the thoracic and abdominal aorta, including collagen production and contractility. Others have shown that some patients who have had an MI have polymorphisms that decrease their levels of TGF-beta.

Furthermore, TGF-beta plays a key role in the development of the intimal layer, which could underpin the lack of intimal thickening in patients with ATAA.

But overall, studies have been mixed and challenging to interpret, Dr. Elefteriades and Dr. Mukherjee agreed. TGF-beta has multiple remodeling roles in the body, and it is difficult at this point to isolate its exact role in aortic disease.

Another hypothesis involves matrix metalloproteinases (MMPs), which are dysregulated in patients with ATAA and may confer some protection, Mukherjee said. Several studies have shown higher plasma levels of certain MMPs in patients with ATAAs. MMPs also were found to be elevated in the thoracic aortic walls of patients with ATAA who had an aortic dissection, as well as in the aortic smooth muscle cells in the intima and media.

In addition, some studies have shown increased levels of MMP-2 in the aortas of patients with ATAAs compared with patients with coronary artery disease.

Adding to the mix of possibilities, “We recently found a gene that’s dysregulated in our aneurysm patients that is very intimately related to atherosclerosis,” Dr. Elefteriades said. “But the work is too preliminary to say anything more at this point.”

“It would be fabulous to prove what it is causing this protection,” Dr. Mukherjee added. “But the truth is we don’t know. These are hypotheses.”

“The most important message from our work is that most clinicians need to dissociate an ATAA from the concept of atherosclerosis,” Dr. Elefteriades said. “The ascending aorta is not an atherosclerotic phenomenon.”

How to Manage Patients With ATAA

What does the distinct character of ATAAs mean for patient management? “Finding a drug to treat ATAAs — to prevent growth, rupture, or dissection — has been like a search for the Holy Grail,” Dr. Elefteriades said. “Statins are not necessary, as this is a non-atherosclerotic process. Although sporadic studies have reported beneficial effects from beta-blockers or angiotensin II receptor blockers (ARBs), this has often been based on ‘soft’ evidence, requiring a combination of outcome measures to achieve significance.”

That said, he noted, “The mainstay, common sense treatment is to keep blood pressure controlled. This is usually achieved by a beta-blocker and an ARB, even if the benefit is not via a direct biologic effect on the aneurysmal degenerative process, but via simple hemodynamics — discouraging rupture by keeping pressure in the aorta low.”

Dr. Mukherjee suggested that these patients should be referred to a specialty aneurysm center where their genes will be evaluated, and then the aneurysm will be followed very closely.

“If the aneurysm is larger than 4.5 cm, we screen the patient every single year, and if they have chest pain, we treat them the same way as we treat other aneurysms,” he said. “As a rule of thumb, if the aneurysm reaches 5 cm, it should come out, although the size at which this should happen may differ between 4.5 cm and 5.5 cm, depending on the patient’s body size.”

As for lifestyle management, Dr. Elefteriades said, “Protection from atherosclerosis and MI won’t go away after the aneurysm is removed. We think it’s in the body’s chemistry. But even though it’s very hard for those patients to have a heart attack, we don’t recommend they eat roast beef every night — although I do think they’d be protected from such lifestyle aberrations.”

For now, he added, “Our team is on a hunt to find a drug to treat ascending disease directly and effectively. We have ongoing laboratory experiments with two drugs undergoing investigation at some level. We hope to embark soon on clinical trials.”

‘A Milestone’

James Hamilton Black III, MD, vice chair of the writing committee for the 2022 American College of Cardiology/American Heart Association Aortic Disease Guideline and chief of Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins Medicine, Baltimore, commented on the review and the concept of ATAA’s atherosclerotic protection.

“The association of ascending aortic aneurysms with a lower risk for MI is an interesting one, but it’s probably influenced, at least in part, by the patient population.” That population is at least partially curated since people are coming to an academic center. In addition, Dr. Black noted, “the patients with ATAAs are younger, and so age may be a confounding factor in the analyses. We wouldn’t expect them to have the same burden of atherosclerosis” as older patients.

Nevertheless, he said, “the findings speak to an emerging body of literature suggesting that although the aorta is a single organ, there are certainly different areas, and these would respond quite differently to environmental or genetic or heritable stressors. This isn’t surprising, and there probably are a lot of factors involved.”

Overall, he said, the findings underscore “the precision medicine approaches we need to take with patients with aortic diseases.”

In a commentary on the team’s review article, published in 2022, John G.T. Augoustides, MD, professor of anesthesiology and critical care at the Perelman School of Medicine in Philadelphia, Pennsylvania, suggested that ATAA’s “silver lining” could advance the understanding of thoracic aortic aneurysm (TAA) management, be integrated with the expanding horizons in hereditary thoracic aortic disease, and might be explored in the context of bicuspid aortic valve disease.

Highlighting the “relative absence” of atherosclerosis in ascending aortic aneurysms and its importance is a “milestone in our understanding,” he concluded. “It is likely that future advances in TAAs will be significantly influenced by this observation.”

Dr. Elefteriades, Dr. Mukherjee, and Dr. Black have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Often known as a “silent killer,” ascending thoracic aortic aneurysms (ATAAs) may grow asymptomatically until they rupture, at which point, mortality is over 90%.

But ATAAs may also carry a potential flip side: Apparent protection against the development of atherosclerotic plaque and by extension, for those who have one, a significantly reduced risk for coronary artery disease and myocardial infarction (MI).

“We noticed in the operating room that many patients we worked on who had an ATAA had pristine arteries, like a teenager’s,” said John Elefteriades, MD, William W.L. Glenn Professor of Cardiothoracic Surgery and former chief of cardiothoracic surgery at Yale University and Yale New Haven Hospital, New Haven, Connecticut. “The same was true of the femoral artery, which we use to hook up to the heart-lung machine.”

Elefteriades and colleagues have been investigating the implications of this association for more than two decades. Many of their studies are highlighted in a recent review of the evidence supporting the protective relationship between ATAAs and the development of atherosclerosis and the possible mechanisms driving the relationship.

“We see four different layers of protection,” said Sandip Mukherjee, MD, medical director of the Aortic Institute at Yale New Haven Hospital and a senior editor of the journal AORTA. Mukherjee collaborated with Elefteriades on many of the studies.

The first layer of protection is lower intima-media thickness, specifically, 0.131 mm lower than in individuals without an ATAA. “It may not seem like very much, but one point can actually translate into a 13%-15% decline in the rate of myocardial infarction or stroke,” Dr. Mukherjee said.

The second layer is lower levels of low-density lipoprotein (LDL) cholesterol. Lower LDL cholesterol levels (75 mg/dL) were associated with increased odds of ATAAs (odds ratio [OR], 1.21), whereas elevated levels (150 mg/dL and 200 mg/dL) were associated with decreased odds of ATAAs (OR, 0.62 and 0.29, respectively).

Lower calcification scores for the coronary arteries are the third layer of protection (6.73 vs 9.36 in one study).

The fourth protective layer is a significantly reduced prevalence of coronary artery disease. A study of individuals with ATAA compared to controls found 61 of those with ATAA had coronary artery disease vs 140 of controls, and 11 vs 83 had experienced an MI. Of note, patients with ATAAs were protected despite having higher body mass indices than controls.

Other MI risk factors such as age increased the risk even among those with an ATAA but, again, much less so than among controls; a multivariable binary logistic regression of data in the team’s review showed that patients with ATAAs were 298, 250, and 232 times less likely to have an MI than if they had a family history of MI, dyslipidemia, or hypertension, respectively.

Why the Protection?

The ligamentum arteriosum separates the ascending from the descending (thoracoabdominal) aorta. ATAAs, located above the ligamentum, tend to be pro-aneurysmal but anti-atherosclerotic. In the descending aorta, below the ligamentum, atherosclerotic aneurysms develop.

The differences between the two sections of the aorta originate in the germ layer in the embryo, Dr. Elefteriades said. “The fundamental difference in tissue of origin translates into marked differences in the character of aneurysms in the different aortic segments.”

What specifically underlies the reduced cardiovascular risk? “We don’t really know, but we think that there may be two possible etiologies,” Dr. Mukherjee said. One hypothesis involves transforming growth factor–beta (TGF-beta), which is overexpressed in patients with ATAA and seems to increase their vulnerability to aneurysms while also conferring protection from coronary disease risk.

Some studies have shown differences in cellular responses to TGF-beta between the thoracic and abdominal aorta, including collagen production and contractility. Others have shown that some patients who have had an MI have polymorphisms that decrease their levels of TGF-beta.

Furthermore, TGF-beta plays a key role in the development of the intimal layer, which could underpin the lack of intimal thickening in patients with ATAA.

But overall, studies have been mixed and challenging to interpret, Dr. Elefteriades and Dr. Mukherjee agreed. TGF-beta has multiple remodeling roles in the body, and it is difficult at this point to isolate its exact role in aortic disease.

Another hypothesis involves matrix metalloproteinases (MMPs), which are dysregulated in patients with ATAA and may confer some protection, Mukherjee said. Several studies have shown higher plasma levels of certain MMPs in patients with ATAAs. MMPs also were found to be elevated in the thoracic aortic walls of patients with ATAA who had an aortic dissection, as well as in the aortic smooth muscle cells in the intima and media.

In addition, some studies have shown increased levels of MMP-2 in the aortas of patients with ATAAs compared with patients with coronary artery disease.

Adding to the mix of possibilities, “We recently found a gene that’s dysregulated in our aneurysm patients that is very intimately related to atherosclerosis,” Dr. Elefteriades said. “But the work is too preliminary to say anything more at this point.”

“It would be fabulous to prove what it is causing this protection,” Dr. Mukherjee added. “But the truth is we don’t know. These are hypotheses.”

“The most important message from our work is that most clinicians need to dissociate an ATAA from the concept of atherosclerosis,” Dr. Elefteriades said. “The ascending aorta is not an atherosclerotic phenomenon.”

How to Manage Patients With ATAA

What does the distinct character of ATAAs mean for patient management? “Finding a drug to treat ATAAs — to prevent growth, rupture, or dissection — has been like a search for the Holy Grail,” Dr. Elefteriades said. “Statins are not necessary, as this is a non-atherosclerotic process. Although sporadic studies have reported beneficial effects from beta-blockers or angiotensin II receptor blockers (ARBs), this has often been based on ‘soft’ evidence, requiring a combination of outcome measures to achieve significance.”

That said, he noted, “The mainstay, common sense treatment is to keep blood pressure controlled. This is usually achieved by a beta-blocker and an ARB, even if the benefit is not via a direct biologic effect on the aneurysmal degenerative process, but via simple hemodynamics — discouraging rupture by keeping pressure in the aorta low.”

Dr. Mukherjee suggested that these patients should be referred to a specialty aneurysm center where their genes will be evaluated, and then the aneurysm will be followed very closely.

“If the aneurysm is larger than 4.5 cm, we screen the patient every single year, and if they have chest pain, we treat them the same way as we treat other aneurysms,” he said. “As a rule of thumb, if the aneurysm reaches 5 cm, it should come out, although the size at which this should happen may differ between 4.5 cm and 5.5 cm, depending on the patient’s body size.”

As for lifestyle management, Dr. Elefteriades said, “Protection from atherosclerosis and MI won’t go away after the aneurysm is removed. We think it’s in the body’s chemistry. But even though it’s very hard for those patients to have a heart attack, we don’t recommend they eat roast beef every night — although I do think they’d be protected from such lifestyle aberrations.”

For now, he added, “Our team is on a hunt to find a drug to treat ascending disease directly and effectively. We have ongoing laboratory experiments with two drugs undergoing investigation at some level. We hope to embark soon on clinical trials.”

‘A Milestone’

James Hamilton Black III, MD, vice chair of the writing committee for the 2022 American College of Cardiology/American Heart Association Aortic Disease Guideline and chief of Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins Medicine, Baltimore, commented on the review and the concept of ATAA’s atherosclerotic protection.

“The association of ascending aortic aneurysms with a lower risk for MI is an interesting one, but it’s probably influenced, at least in part, by the patient population.” That population is at least partially curated since people are coming to an academic center. In addition, Dr. Black noted, “the patients with ATAAs are younger, and so age may be a confounding factor in the analyses. We wouldn’t expect them to have the same burden of atherosclerosis” as older patients.

Nevertheless, he said, “the findings speak to an emerging body of literature suggesting that although the aorta is a single organ, there are certainly different areas, and these would respond quite differently to environmental or genetic or heritable stressors. This isn’t surprising, and there probably are a lot of factors involved.”

Overall, he said, the findings underscore “the precision medicine approaches we need to take with patients with aortic diseases.”

In a commentary on the team’s review article, published in 2022, John G.T. Augoustides, MD, professor of anesthesiology and critical care at the Perelman School of Medicine in Philadelphia, Pennsylvania, suggested that ATAA’s “silver lining” could advance the understanding of thoracic aortic aneurysm (TAA) management, be integrated with the expanding horizons in hereditary thoracic aortic disease, and might be explored in the context of bicuspid aortic valve disease.

Highlighting the “relative absence” of atherosclerosis in ascending aortic aneurysms and its importance is a “milestone in our understanding,” he concluded. “It is likely that future advances in TAAs will be significantly influenced by this observation.”

Dr. Elefteriades, Dr. Mukherjee, and Dr. Black have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Often known as a “silent killer,” ascending thoracic aortic aneurysms (ATAAs) may grow asymptomatically until they rupture, at which point, mortality is over 90%.

But ATAAs may also carry a potential flip side: Apparent protection against the development of atherosclerotic plaque and by extension, for those who have one, a significantly reduced risk for coronary artery disease and myocardial infarction (MI).

“We noticed in the operating room that many patients we worked on who had an ATAA had pristine arteries, like a teenager’s,” said John Elefteriades, MD, William W.L. Glenn Professor of Cardiothoracic Surgery and former chief of cardiothoracic surgery at Yale University and Yale New Haven Hospital, New Haven, Connecticut. “The same was true of the femoral artery, which we use to hook up to the heart-lung machine.”

Elefteriades and colleagues have been investigating the implications of this association for more than two decades. Many of their studies are highlighted in a recent review of the evidence supporting the protective relationship between ATAAs and the development of atherosclerosis and the possible mechanisms driving the relationship.

“We see four different layers of protection,” said Sandip Mukherjee, MD, medical director of the Aortic Institute at Yale New Haven Hospital and a senior editor of the journal AORTA. Mukherjee collaborated with Elefteriades on many of the studies.

The first layer of protection is lower intima-media thickness, specifically, 0.131 mm lower than in individuals without an ATAA. “It may not seem like very much, but one point can actually translate into a 13%-15% decline in the rate of myocardial infarction or stroke,” Dr. Mukherjee said.

The second layer is lower levels of low-density lipoprotein (LDL) cholesterol. Lower LDL cholesterol levels (75 mg/dL) were associated with increased odds of ATAAs (odds ratio [OR], 1.21), whereas elevated levels (150 mg/dL and 200 mg/dL) were associated with decreased odds of ATAAs (OR, 0.62 and 0.29, respectively).

Lower calcification scores for the coronary arteries are the third layer of protection (6.73 vs 9.36 in one study).

The fourth protective layer is a significantly reduced prevalence of coronary artery disease. A study of individuals with ATAA compared to controls found 61 of those with ATAA had coronary artery disease vs 140 of controls, and 11 vs 83 had experienced an MI. Of note, patients with ATAAs were protected despite having higher body mass indices than controls.

Other MI risk factors such as age increased the risk even among those with an ATAA but, again, much less so than among controls; a multivariable binary logistic regression of data in the team’s review showed that patients with ATAAs were 298, 250, and 232 times less likely to have an MI than if they had a family history of MI, dyslipidemia, or hypertension, respectively.

Why the Protection?

The ligamentum arteriosum separates the ascending from the descending (thoracoabdominal) aorta. ATAAs, located above the ligamentum, tend to be pro-aneurysmal but anti-atherosclerotic. In the descending aorta, below the ligamentum, atherosclerotic aneurysms develop.

The differences between the two sections of the aorta originate in the germ layer in the embryo, Dr. Elefteriades said. “The fundamental difference in tissue of origin translates into marked differences in the character of aneurysms in the different aortic segments.”

What specifically underlies the reduced cardiovascular risk? “We don’t really know, but we think that there may be two possible etiologies,” Dr. Mukherjee said. One hypothesis involves transforming growth factor–beta (TGF-beta), which is overexpressed in patients with ATAA and seems to increase their vulnerability to aneurysms while also conferring protection from coronary disease risk.

Some studies have shown differences in cellular responses to TGF-beta between the thoracic and abdominal aorta, including collagen production and contractility. Others have shown that some patients who have had an MI have polymorphisms that decrease their levels of TGF-beta.

Furthermore, TGF-beta plays a key role in the development of the intimal layer, which could underpin the lack of intimal thickening in patients with ATAA.

But overall, studies have been mixed and challenging to interpret, Dr. Elefteriades and Dr. Mukherjee agreed. TGF-beta has multiple remodeling roles in the body, and it is difficult at this point to isolate its exact role in aortic disease.

Another hypothesis involves matrix metalloproteinases (MMPs), which are dysregulated in patients with ATAA and may confer some protection, Mukherjee said. Several studies have shown higher plasma levels of certain MMPs in patients with ATAAs. MMPs also were found to be elevated in the thoracic aortic walls of patients with ATAA who had an aortic dissection, as well as in the aortic smooth muscle cells in the intima and media.

In addition, some studies have shown increased levels of MMP-2 in the aortas of patients with ATAAs compared with patients with coronary artery disease.

Adding to the mix of possibilities, “We recently found a gene that’s dysregulated in our aneurysm patients that is very intimately related to atherosclerosis,” Dr. Elefteriades said. “But the work is too preliminary to say anything more at this point.”

“It would be fabulous to prove what it is causing this protection,” Dr. Mukherjee added. “But the truth is we don’t know. These are hypotheses.”

“The most important message from our work is that most clinicians need to dissociate an ATAA from the concept of atherosclerosis,” Dr. Elefteriades said. “The ascending aorta is not an atherosclerotic phenomenon.”

How to Manage Patients With ATAA

What does the distinct character of ATAAs mean for patient management? “Finding a drug to treat ATAAs — to prevent growth, rupture, or dissection — has been like a search for the Holy Grail,” Dr. Elefteriades said. “Statins are not necessary, as this is a non-atherosclerotic process. Although sporadic studies have reported beneficial effects from beta-blockers or angiotensin II receptor blockers (ARBs), this has often been based on ‘soft’ evidence, requiring a combination of outcome measures to achieve significance.”

That said, he noted, “The mainstay, common sense treatment is to keep blood pressure controlled. This is usually achieved by a beta-blocker and an ARB, even if the benefit is not via a direct biologic effect on the aneurysmal degenerative process, but via simple hemodynamics — discouraging rupture by keeping pressure in the aorta low.”

Dr. Mukherjee suggested that these patients should be referred to a specialty aneurysm center where their genes will be evaluated, and then the aneurysm will be followed very closely.

“If the aneurysm is larger than 4.5 cm, we screen the patient every single year, and if they have chest pain, we treat them the same way as we treat other aneurysms,” he said. “As a rule of thumb, if the aneurysm reaches 5 cm, it should come out, although the size at which this should happen may differ between 4.5 cm and 5.5 cm, depending on the patient’s body size.”

As for lifestyle management, Dr. Elefteriades said, “Protection from atherosclerosis and MI won’t go away after the aneurysm is removed. We think it’s in the body’s chemistry. But even though it’s very hard for those patients to have a heart attack, we don’t recommend they eat roast beef every night — although I do think they’d be protected from such lifestyle aberrations.”

For now, he added, “Our team is on a hunt to find a drug to treat ascending disease directly and effectively. We have ongoing laboratory experiments with two drugs undergoing investigation at some level. We hope to embark soon on clinical trials.”

‘A Milestone’

James Hamilton Black III, MD, vice chair of the writing committee for the 2022 American College of Cardiology/American Heart Association Aortic Disease Guideline and chief of Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins Medicine, Baltimore, commented on the review and the concept of ATAA’s atherosclerotic protection.

“The association of ascending aortic aneurysms with a lower risk for MI is an interesting one, but it’s probably influenced, at least in part, by the patient population.” That population is at least partially curated since people are coming to an academic center. In addition, Dr. Black noted, “the patients with ATAAs are younger, and so age may be a confounding factor in the analyses. We wouldn’t expect them to have the same burden of atherosclerosis” as older patients.

Nevertheless, he said, “the findings speak to an emerging body of literature suggesting that although the aorta is a single organ, there are certainly different areas, and these would respond quite differently to environmental or genetic or heritable stressors. This isn’t surprising, and there probably are a lot of factors involved.”

Overall, he said, the findings underscore “the precision medicine approaches we need to take with patients with aortic diseases.”

In a commentary on the team’s review article, published in 2022, John G.T. Augoustides, MD, professor of anesthesiology and critical care at the Perelman School of Medicine in Philadelphia, Pennsylvania, suggested that ATAA’s “silver lining” could advance the understanding of thoracic aortic aneurysm (TAA) management, be integrated with the expanding horizons in hereditary thoracic aortic disease, and might be explored in the context of bicuspid aortic valve disease.

Highlighting the “relative absence” of atherosclerosis in ascending aortic aneurysms and its importance is a “milestone in our understanding,” he concluded. “It is likely that future advances in TAAs will be significantly influenced by this observation.”

Dr. Elefteriades, Dr. Mukherjee, and Dr. Black have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Can the US healthcare system learn something about how to operate from car dealerships? Lawrence Kosinski, MD, MBA, a governing board member of American Gastroenterological Association (AGA), believes so.

There’s growing concern in the United States about the lack of clarity surrounding facility fees, which are intended to cover costs of maintaining medical facilities. Dr. Kosinski thinks that Congress should look into the transparency mandate it created for car prices as a model for how to address this.

A 1958 federal law set the stage for the consumer-friendly breakdown of costs and relevant performance data that anyone who has bought a new vehicle in the United States would recognize.

“You look at that and you know exactly what you are paying for,” Dr. Kosinski told this news organization. “In healthcare, we need something like that.”

Novel solutions like Dr. Kosinski’s will be increasingly necessary, as lawmakers on the state and federal level have begun to set their sights on tackling this issue.

The Biden administration in July expressed concern about an increased use of facility fees for healthcare provided at doctors’ offices, saying these additional costs often surprise consumers. House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) also raised this issue several times this year, including at a May meeting about pending legislation on price transparency for health services, where she mentioned the case of a man who underwent eye surgery in Maine.

“His bill included three separate facility fees totaling $7800 and professional fees totaling $6200,” Ms. Rodgers said. “Why are three facility fees necessary for 1 hour of surgery in one O.R.?”

AGA’s Dr. Kosinski said facility fees cover the additional costs hospitals and clinics face in providing even routine treatments for some patients. For example, colonoscopy for a patient with a body mass index of 50 would pose special challenges for the anesthesiologist.

These factors need to be considered in setting policies on facility fees, he said. But there is no reason hospitals and other sites of medical care can’t make the information about facility fees easy for patients to find and understand, Dr. Kosinski said.

“I’m struggling to see a reason why we can’t be more transparent,” he said.

Big Battles Ahead

There are two connected battles ahead regarding facility fees: Efforts to restrict these additional charges for many medical services and fights over the need for greater transparency in general about health costs.

Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) is seeking to broadly restrict facility fees through his pending Primary Care and Health Workforce Act (S. 2840). The measure would block hospitals from charging health plans facility fees for many evaluation, management, and telehealth services.

The American Hospital Association (AHA) opposes it. They argue that the current payment approach rightly accounts for the added costs incurred when hospitals treat patients who are more likely to be ill or have chronic conditions than those seen in independent practices.

AHA said hospitals also need to maintain standby capacity for natural and man-made disasters, public health emergencies, and unexpected traumatic events. In September, AHA launched a television ad campaign to oppose any drive toward site-neutral policies. AHA says reducing the extra payments could cause more hospitals to shut their doors.

But there’s persistent interest in site-neutral payment, the term describing when the same reimbursement is given for care regardless of setting. This would lower pay for hospitals.

Among those pressing for change is an umbrella group of medical organizations known as the Alliance for Site Neutral Payment Reform. Its members include the American Academy of Family Physicians, American Academy of Orthopaedic Surgeons, American College of Physicians, Community Oncology Alliance, and Digestive Health Physicians Association.

And on November 9, Sen. Maggie Hassan (D-NH) argued for eventually including a site-neutral Medicare provision to a major healthcare package that the Senate Finance Committee is putting together.

Sen. Hassan is seeking to end what she called the “the practice of charging patients unfair hospital facility fees for care provided in the off-campus outpatient setting, like at a regular doctor’s office.”

Senate Finance Chairman Ron Wyden (D-OR) and the ranking Republican on the committee, Sen. Mike Crapo (R-ID), told Sen. Hassan they intended to work with her to see if this issue could be addressed in the pending legislative package.

A 2015 budget deal marked the last time Congress took a major step to address the higher cost of services provided in hospital-owned facilities.

Lawmakers then were scrambling to find cuts to offset spending in what became the 2015 Bipartisan Budget Act. This law established site-neutral payments under Medicare for services received at off-campus outpatient departments but exempted hospitals that already ran these kinds of operations or had advanced plans to create them.

Lawmakers are well aware of the potential savings from site-neutral policies and could look in time again to use them as part of a future budget deal.

In fact, in June, Sen. Hassan and Sens. Mike Braun (R-IN) and John Kennedy (R-LA) introduced a bill meant to basically end the exemption given in the 2015 deal to existing hospital outpatient departments, which has allowed higher Medicare payments. In a press release, Braun estimated that their proposed site-neutral change could save taxpayers $40 billion over a decade.

As Debate Continues, States Are Moving Ahead With Changes

Consumer activists have won a few battles this year at the state level about facility fees.

In July, Maine Gov. Janet Mills, a Democrat, signed a law that requires medical organizations to report facility fees to the state, which will share them publicly. Facility fees can pop up after a patient has received an insurance company estimate of the out-of-pocket costs for care.

“Patients receive bills bloated by healthcare providers that overcharge for services and insurance companies that deny claims without explanation,” the Portland Press Herald reported in a 2022 story. “And with little clout to fight back or even negotiate, feeling helpless, they often give up and pay, worn down by a system that is as time-consuming as it is obtuse.”

In May, Colorado enacted a law that will require patient notification about facility fees at many hospitals in the state.

In June, Connecticut expanded its law regarding facility fees and prohibited them for certain routine outpatient healthcare services. A statement from Gov. Ned Lamont’s office said the original intent of these facility fees was to ensure hospitals could maintain the around-the-clock care needed for inpatient and emergency care.

“However, these fees have been increasingly applied to services such as diagnostic testing and other routine services,” the statement said.

But there have been setbacks as well for those seeking to curb facilities.

The Texas Hospital Association (THA) in May said its advocacy defeated a pair of state bills, House bill 1692 and Senate bill 1275, that sought to limit facility fees for outpatient services.

In rallying opposition to these bills, THA said the loss of facility fees would threaten care for patients. Facility fees help cover costs “beyond the doctor’s bill,” such as “lab technicians, interpreters, medical records, security personnel, janitorial staff, and others,” THA said.

More Patients Shopping?

It’s unclear when — or if — Congress and other states will take major steps to reduce additional payments to hospitals for outpatient care.

But the increased use of high deductibles in health plans is driving more consumers to try to understand all of the costs of medical procedures ahead of time and, thus, drawing attention to facility fees, said Charlie Byrge, the chief operating officer of MDsave.

The average annual deductible levels for an individual increased by 3.0% to $2004 from 2020 to 2021 and for a family plan by 3.9% to $3868, according to a federal report. Some people have higher deductibles, exceeding $5000, Mr. Byrge said.

“That’s creating an opportunity for firms that can connect physicians directly with patients who will pay part or all of the costs of a treatment out of pocket,” he told this news organization.

Doctors and hospitals work with MDsave to charge preset prices for certain services, such as colonoscopies and mammograms. Consumers then can shop online to see if they can save. For example, in Nashville, Tennessee, where MDsave is based, the cost of a colonoscopy through MDsave is $2334, about half of the $4714 national average, according to the firm’s website.

This model for pricing routine medical care is akin to those used for other products and services, where companies decide ahead of time what to charge, he said.

“You don’t buy an airline ticket from Southwest or United or Delta and then there’s a bill after the fact because the price of gas went up a little bit on your flight,” Mr. Byrge said.

This will drive more competition among hospitals and clinics, in places where there are several sites of care in a region, Mr. Byrge said. But there are advantages for physicians and hospitals from the MDsave approach, he said.

“They know they’re getting paid upfront. They’re not going through the delays and headaches of the insurance reimbursement process. There are no denials. It’s just an upfront payment, and I think that’s what we’re starting to see the market really moving toward,” he said.
 

A version of this article appeared on Medscape.com.

Can the US healthcare system learn something about how to operate from car dealerships? Lawrence Kosinski, MD, MBA, a governing board member of American Gastroenterological Association (AGA), believes so.

There’s growing concern in the United States about the lack of clarity surrounding facility fees, which are intended to cover costs of maintaining medical facilities. Dr. Kosinski thinks that Congress should look into the transparency mandate it created for car prices as a model for how to address this.

A 1958 federal law set the stage for the consumer-friendly breakdown of costs and relevant performance data that anyone who has bought a new vehicle in the United States would recognize.

“You look at that and you know exactly what you are paying for,” Dr. Kosinski told this news organization. “In healthcare, we need something like that.”

Novel solutions like Dr. Kosinski’s will be increasingly necessary, as lawmakers on the state and federal level have begun to set their sights on tackling this issue.

The Biden administration in July expressed concern about an increased use of facility fees for healthcare provided at doctors’ offices, saying these additional costs often surprise consumers. House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) also raised this issue several times this year, including at a May meeting about pending legislation on price transparency for health services, where she mentioned the case of a man who underwent eye surgery in Maine.

“His bill included three separate facility fees totaling $7800 and professional fees totaling $6200,” Ms. Rodgers said. “Why are three facility fees necessary for 1 hour of surgery in one O.R.?”

AGA’s Dr. Kosinski said facility fees cover the additional costs hospitals and clinics face in providing even routine treatments for some patients. For example, colonoscopy for a patient with a body mass index of 50 would pose special challenges for the anesthesiologist.

These factors need to be considered in setting policies on facility fees, he said. But there is no reason hospitals and other sites of medical care can’t make the information about facility fees easy for patients to find and understand, Dr. Kosinski said.

“I’m struggling to see a reason why we can’t be more transparent,” he said.

Big Battles Ahead

There are two connected battles ahead regarding facility fees: Efforts to restrict these additional charges for many medical services and fights over the need for greater transparency in general about health costs.

Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) is seeking to broadly restrict facility fees through his pending Primary Care and Health Workforce Act (S. 2840). The measure would block hospitals from charging health plans facility fees for many evaluation, management, and telehealth services.

The American Hospital Association (AHA) opposes it. They argue that the current payment approach rightly accounts for the added costs incurred when hospitals treat patients who are more likely to be ill or have chronic conditions than those seen in independent practices.

AHA said hospitals also need to maintain standby capacity for natural and man-made disasters, public health emergencies, and unexpected traumatic events. In September, AHA launched a television ad campaign to oppose any drive toward site-neutral policies. AHA says reducing the extra payments could cause more hospitals to shut their doors.

But there’s persistent interest in site-neutral payment, the term describing when the same reimbursement is given for care regardless of setting. This would lower pay for hospitals.

Among those pressing for change is an umbrella group of medical organizations known as the Alliance for Site Neutral Payment Reform. Its members include the American Academy of Family Physicians, American Academy of Orthopaedic Surgeons, American College of Physicians, Community Oncology Alliance, and Digestive Health Physicians Association.

And on November 9, Sen. Maggie Hassan (D-NH) argued for eventually including a site-neutral Medicare provision to a major healthcare package that the Senate Finance Committee is putting together.

Sen. Hassan is seeking to end what she called the “the practice of charging patients unfair hospital facility fees for care provided in the off-campus outpatient setting, like at a regular doctor’s office.”

Senate Finance Chairman Ron Wyden (D-OR) and the ranking Republican on the committee, Sen. Mike Crapo (R-ID), told Sen. Hassan they intended to work with her to see if this issue could be addressed in the pending legislative package.

A 2015 budget deal marked the last time Congress took a major step to address the higher cost of services provided in hospital-owned facilities.

Lawmakers then were scrambling to find cuts to offset spending in what became the 2015 Bipartisan Budget Act. This law established site-neutral payments under Medicare for services received at off-campus outpatient departments but exempted hospitals that already ran these kinds of operations or had advanced plans to create them.

Lawmakers are well aware of the potential savings from site-neutral policies and could look in time again to use them as part of a future budget deal.

In fact, in June, Sen. Hassan and Sens. Mike Braun (R-IN) and John Kennedy (R-LA) introduced a bill meant to basically end the exemption given in the 2015 deal to existing hospital outpatient departments, which has allowed higher Medicare payments. In a press release, Braun estimated that their proposed site-neutral change could save taxpayers $40 billion over a decade.

As Debate Continues, States Are Moving Ahead With Changes

Consumer activists have won a few battles this year at the state level about facility fees.

In July, Maine Gov. Janet Mills, a Democrat, signed a law that requires medical organizations to report facility fees to the state, which will share them publicly. Facility fees can pop up after a patient has received an insurance company estimate of the out-of-pocket costs for care.

“Patients receive bills bloated by healthcare providers that overcharge for services and insurance companies that deny claims without explanation,” the Portland Press Herald reported in a 2022 story. “And with little clout to fight back or even negotiate, feeling helpless, they often give up and pay, worn down by a system that is as time-consuming as it is obtuse.”

In May, Colorado enacted a law that will require patient notification about facility fees at many hospitals in the state.

In June, Connecticut expanded its law regarding facility fees and prohibited them for certain routine outpatient healthcare services. A statement from Gov. Ned Lamont’s office said the original intent of these facility fees was to ensure hospitals could maintain the around-the-clock care needed for inpatient and emergency care.

“However, these fees have been increasingly applied to services such as diagnostic testing and other routine services,” the statement said.

But there have been setbacks as well for those seeking to curb facilities.

The Texas Hospital Association (THA) in May said its advocacy defeated a pair of state bills, House bill 1692 and Senate bill 1275, that sought to limit facility fees for outpatient services.

In rallying opposition to these bills, THA said the loss of facility fees would threaten care for patients. Facility fees help cover costs “beyond the doctor’s bill,” such as “lab technicians, interpreters, medical records, security personnel, janitorial staff, and others,” THA said.

More Patients Shopping?

It’s unclear when — or if — Congress and other states will take major steps to reduce additional payments to hospitals for outpatient care.

But the increased use of high deductibles in health plans is driving more consumers to try to understand all of the costs of medical procedures ahead of time and, thus, drawing attention to facility fees, said Charlie Byrge, the chief operating officer of MDsave.

The average annual deductible levels for an individual increased by 3.0% to $2004 from 2020 to 2021 and for a family plan by 3.9% to $3868, according to a federal report. Some people have higher deductibles, exceeding $5000, Mr. Byrge said.

“That’s creating an opportunity for firms that can connect physicians directly with patients who will pay part or all of the costs of a treatment out of pocket,” he told this news organization.

Doctors and hospitals work with MDsave to charge preset prices for certain services, such as colonoscopies and mammograms. Consumers then can shop online to see if they can save. For example, in Nashville, Tennessee, where MDsave is based, the cost of a colonoscopy through MDsave is $2334, about half of the $4714 national average, according to the firm’s website.

This model for pricing routine medical care is akin to those used for other products and services, where companies decide ahead of time what to charge, he said.

“You don’t buy an airline ticket from Southwest or United or Delta and then there’s a bill after the fact because the price of gas went up a little bit on your flight,” Mr. Byrge said.

This will drive more competition among hospitals and clinics, in places where there are several sites of care in a region, Mr. Byrge said. But there are advantages for physicians and hospitals from the MDsave approach, he said.

“They know they’re getting paid upfront. They’re not going through the delays and headaches of the insurance reimbursement process. There are no denials. It’s just an upfront payment, and I think that’s what we’re starting to see the market really moving toward,” he said.
 

A version of this article appeared on Medscape.com.

Can the US healthcare system learn something about how to operate from car dealerships? Lawrence Kosinski, MD, MBA, a governing board member of American Gastroenterological Association (AGA), believes so.

There’s growing concern in the United States about the lack of clarity surrounding facility fees, which are intended to cover costs of maintaining medical facilities. Dr. Kosinski thinks that Congress should look into the transparency mandate it created for car prices as a model for how to address this.

A 1958 federal law set the stage for the consumer-friendly breakdown of costs and relevant performance data that anyone who has bought a new vehicle in the United States would recognize.

“You look at that and you know exactly what you are paying for,” Dr. Kosinski told this news organization. “In healthcare, we need something like that.”

Novel solutions like Dr. Kosinski’s will be increasingly necessary, as lawmakers on the state and federal level have begun to set their sights on tackling this issue.

The Biden administration in July expressed concern about an increased use of facility fees for healthcare provided at doctors’ offices, saying these additional costs often surprise consumers. House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) also raised this issue several times this year, including at a May meeting about pending legislation on price transparency for health services, where she mentioned the case of a man who underwent eye surgery in Maine.

“His bill included three separate facility fees totaling $7800 and professional fees totaling $6200,” Ms. Rodgers said. “Why are three facility fees necessary for 1 hour of surgery in one O.R.?”

AGA’s Dr. Kosinski said facility fees cover the additional costs hospitals and clinics face in providing even routine treatments for some patients. For example, colonoscopy for a patient with a body mass index of 50 would pose special challenges for the anesthesiologist.

These factors need to be considered in setting policies on facility fees, he said. But there is no reason hospitals and other sites of medical care can’t make the information about facility fees easy for patients to find and understand, Dr. Kosinski said.

“I’m struggling to see a reason why we can’t be more transparent,” he said.

Big Battles Ahead

There are two connected battles ahead regarding facility fees: Efforts to restrict these additional charges for many medical services and fights over the need for greater transparency in general about health costs.

Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) is seeking to broadly restrict facility fees through his pending Primary Care and Health Workforce Act (S. 2840). The measure would block hospitals from charging health plans facility fees for many evaluation, management, and telehealth services.

The American Hospital Association (AHA) opposes it. They argue that the current payment approach rightly accounts for the added costs incurred when hospitals treat patients who are more likely to be ill or have chronic conditions than those seen in independent practices.

AHA said hospitals also need to maintain standby capacity for natural and man-made disasters, public health emergencies, and unexpected traumatic events. In September, AHA launched a television ad campaign to oppose any drive toward site-neutral policies. AHA says reducing the extra payments could cause more hospitals to shut their doors.

But there’s persistent interest in site-neutral payment, the term describing when the same reimbursement is given for care regardless of setting. This would lower pay for hospitals.

Among those pressing for change is an umbrella group of medical organizations known as the Alliance for Site Neutral Payment Reform. Its members include the American Academy of Family Physicians, American Academy of Orthopaedic Surgeons, American College of Physicians, Community Oncology Alliance, and Digestive Health Physicians Association.

And on November 9, Sen. Maggie Hassan (D-NH) argued for eventually including a site-neutral Medicare provision to a major healthcare package that the Senate Finance Committee is putting together.

Sen. Hassan is seeking to end what she called the “the practice of charging patients unfair hospital facility fees for care provided in the off-campus outpatient setting, like at a regular doctor’s office.”

Senate Finance Chairman Ron Wyden (D-OR) and the ranking Republican on the committee, Sen. Mike Crapo (R-ID), told Sen. Hassan they intended to work with her to see if this issue could be addressed in the pending legislative package.

A 2015 budget deal marked the last time Congress took a major step to address the higher cost of services provided in hospital-owned facilities.

Lawmakers then were scrambling to find cuts to offset spending in what became the 2015 Bipartisan Budget Act. This law established site-neutral payments under Medicare for services received at off-campus outpatient departments but exempted hospitals that already ran these kinds of operations or had advanced plans to create them.

Lawmakers are well aware of the potential savings from site-neutral policies and could look in time again to use them as part of a future budget deal.

In fact, in June, Sen. Hassan and Sens. Mike Braun (R-IN) and John Kennedy (R-LA) introduced a bill meant to basically end the exemption given in the 2015 deal to existing hospital outpatient departments, which has allowed higher Medicare payments. In a press release, Braun estimated that their proposed site-neutral change could save taxpayers $40 billion over a decade.

As Debate Continues, States Are Moving Ahead With Changes

Consumer activists have won a few battles this year at the state level about facility fees.

In July, Maine Gov. Janet Mills, a Democrat, signed a law that requires medical organizations to report facility fees to the state, which will share them publicly. Facility fees can pop up after a patient has received an insurance company estimate of the out-of-pocket costs for care.

“Patients receive bills bloated by healthcare providers that overcharge for services and insurance companies that deny claims without explanation,” the Portland Press Herald reported in a 2022 story. “And with little clout to fight back or even negotiate, feeling helpless, they often give up and pay, worn down by a system that is as time-consuming as it is obtuse.”

In May, Colorado enacted a law that will require patient notification about facility fees at many hospitals in the state.

In June, Connecticut expanded its law regarding facility fees and prohibited them for certain routine outpatient healthcare services. A statement from Gov. Ned Lamont’s office said the original intent of these facility fees was to ensure hospitals could maintain the around-the-clock care needed for inpatient and emergency care.

“However, these fees have been increasingly applied to services such as diagnostic testing and other routine services,” the statement said.

But there have been setbacks as well for those seeking to curb facilities.

The Texas Hospital Association (THA) in May said its advocacy defeated a pair of state bills, House bill 1692 and Senate bill 1275, that sought to limit facility fees for outpatient services.

In rallying opposition to these bills, THA said the loss of facility fees would threaten care for patients. Facility fees help cover costs “beyond the doctor’s bill,” such as “lab technicians, interpreters, medical records, security personnel, janitorial staff, and others,” THA said.

More Patients Shopping?

It’s unclear when — or if — Congress and other states will take major steps to reduce additional payments to hospitals for outpatient care.

But the increased use of high deductibles in health plans is driving more consumers to try to understand all of the costs of medical procedures ahead of time and, thus, drawing attention to facility fees, said Charlie Byrge, the chief operating officer of MDsave.

The average annual deductible levels for an individual increased by 3.0% to $2004 from 2020 to 2021 and for a family plan by 3.9% to $3868, according to a federal report. Some people have higher deductibles, exceeding $5000, Mr. Byrge said.

“That’s creating an opportunity for firms that can connect physicians directly with patients who will pay part or all of the costs of a treatment out of pocket,” he told this news organization.

Doctors and hospitals work with MDsave to charge preset prices for certain services, such as colonoscopies and mammograms. Consumers then can shop online to see if they can save. For example, in Nashville, Tennessee, where MDsave is based, the cost of a colonoscopy through MDsave is $2334, about half of the $4714 national average, according to the firm’s website.

This model for pricing routine medical care is akin to those used for other products and services, where companies decide ahead of time what to charge, he said.

“You don’t buy an airline ticket from Southwest or United or Delta and then there’s a bill after the fact because the price of gas went up a little bit on your flight,” Mr. Byrge said.

This will drive more competition among hospitals and clinics, in places where there are several sites of care in a region, Mr. Byrge said. But there are advantages for physicians and hospitals from the MDsave approach, he said.

“They know they’re getting paid upfront. They’re not going through the delays and headaches of the insurance reimbursement process. There are no denials. It’s just an upfront payment, and I think that’s what we’re starting to see the market really moving toward,” he said.
 

A version of this article appeared on Medscape.com.

Use of pharmacomechanical catheter-directory thrombolysis significantly reduced the number of pulmonary artery branches with total or subtotal occlusions in patients with acute pulmonary embolism, based on data from more than 100 individuals.

Reduced distal vascular volume is a significant predictor of 30-day and 90-day mortality in acute pulmonary embolism (PE) patients, and pulmonary obstruction is often the cause, wrote Riyaz Bashir, MD, of Temple University, Philadelphia, Pennsylvania, and colleagues.

Some studies of catheter-based treatments have shown a reduction in pulmonary artery (PA) obstruction in PE patients, but the impact has been modest, the researchers said.

“The recently published RESCUE (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden) trial showed a 35.9% reduction in PA obstruction using the Refined Modified Miller Index (RMMI), the largest reduction of all published catheter studies with core lab measurement, with similar doses of tissue plasminogen activator (tPA),” the researchers wrote.

The Bashir endovascular catheter was designed to maximize thrombus reduction via a pharmacomechanical infusion. The catheter features an expandable basket of 6 nitinol-reinforced infusion limbs.

“There are three crucial goals that we want to accomplish in patients who have a severe pulmonary embolism,” Dr. Bashir said in an interview. “Those include, in the order of importance, survival, recovery of right ventricular function, and resolution of blocked pulmonary arteries; both segmental and proximal pulmonary arteries,” he said.

Most previous studies have focused on the first two goals, but they still need to evaluate the resolution of PA blockages carefully, said Dr. Bashir. “In our clinical practice, we have seen a large number of patients who develop debilitating shortness of breath from these blockages. We decided to carefully evaluate these blockages before and after pharmacomechanical catheter-directed thrombolysis with the Bashir endovascular catheter using the core lab data from the RESCUE study,” he said.

In the current study published in JACC: Advances), the researchers used baseline and 48-hour posttreatment contrast-enhanced chest computed tomography angiography of adult PE patients with right ventricular dilatation.

The study population included 107 adults with acute intermediate-risk PE who were treated with pharmacomechanical catheter-directory thrombolysis (PM-CDT) at 18 sites in the United States. Of these, 98 had intermediate high-risk PE with elevated troponin and/or brain-type natriuretic peptide (BNP) levels and 102 had bilateral PE.

The primary endpoint was the change in the number of segmental and proximal PA branches with total or subtotal occlusions (defined as > 65%) after 48 hours compared to baseline. Occlusions were assessed using McNemar’s test.

Patients with bilateral PE received two Bashir catheters; those with unilateral PE received one catheter each.

Each patient received a pulse spray of 2 mg of recombinant tPA (r-tPA) into each lung, followed by 5 mg of r-tPA over 5 hours; the total dose was 7 mg of r-tPA for patients with unilateral PEs and 14 mg for those with bilateral PEs, the researchers said. The median times for catheter placement and total procedure were 15 minutes and 54 minutes, respectively.

The number of segmental PA branches with total or subtotal occlusions decreased significantly, from 40.5% at baseline to 11.7% at 48 hours, and proximal PA branch total or subtotal occlusions decreased significantly, from 28.7% at baseline to 11.0% at 48 hours (P < 0.0001 for both).

The magnitude of the reductions in both total and subtotal occlusions of segmental arteries was significantly correlated with the extent of right ventricle recovery (measured by the reduction in right ventricular/left ventricular ratio) with a correlation coefficient of 0.287 (P = .0026); however, this correlation was not observed in the proximal PA arteries (correlation coefficient 0.132, P = .173).

One major bleeding event occurred within 72 hours in a patient who also experienced a device-related left common iliac vein thrombosis while not taking anticoagulation medication, and one death unrelated to PE occurred within 30 days.

“The two findings that surprised me include, first, a more than 70% reduction in total and subtotal occlusions in the segmental arteries with such a low dose of r-tPA and, second, the resolution of the blockages was seen not only in the arteries where the device was placed but also at remote sites away from the location of the catheter,” Dr. Bashir told this news organization.

The findings were limited by several factors including the lack of long-term clinical follow-up outcomes data and lack of comparison groups who underwent other treatments.

However, “This study implies that we now have a safe therapy for these patients that improves survival and right ventricular recovery in addition to dramatically improving blocked pulmonary arteries,” Dr. Bashir said.

As for additional research, “we need all the current and future prospective pulmonary embolism studies to include an assessment of pulmonary artery blockage resolution as an essential endpoint,” he said.
 

Catheter Expands Treatment Options

The current study, a subgroup analysis of the RESCUE trial, was one of the first to examine the impact of catheter-directed lysis on distal occlusions, study coauthor Parth M. Rali, MD, said in an interview.

To this point, literature has been limited to evaluation for proximal disease, said Dr. Rali, director of thoracic surgery and medicine and part of the Pulmonary Embolism Response Team at Temple University Hospital, Philadelphia.

Dr. Rali said he was encouraged to see confirmation that the BEC catheter, because of its design, works in patients with proximal or distal occlusive disease.

In clinical practice, “the catheter provides an additional option for care in patients with multiple distal occlusive disease when a systemic tissue plasminogen activator (tPA), may put patient at high bleeding risk,” Dr. Rali said.

Looking ahead, a prospective, observational multicenter study would be useful to validate the findings from the post hoc analysis of the current study, he noted.

The study was sponsored by the National Heart, Lung, and Blood Institute, Commonwealth of Pennsylvania, and Thrombolex Inc., a medical device company developing interventional catheter-based therapies for the rapid and effective treatment of acute venous thromboembolic disorders. Dr. Bashir is a cofounder and has an equity interest in Thrombolex Inc. Dr. Rali disclosed serving as a consultant for Thrombolex, Inari Medical, Viz AI, and ThinkSono.

Use of pharmacomechanical catheter-directory thrombolysis significantly reduced the number of pulmonary artery branches with total or subtotal occlusions in patients with acute pulmonary embolism, based on data from more than 100 individuals.

Reduced distal vascular volume is a significant predictor of 30-day and 90-day mortality in acute pulmonary embolism (PE) patients, and pulmonary obstruction is often the cause, wrote Riyaz Bashir, MD, of Temple University, Philadelphia, Pennsylvania, and colleagues.

Some studies of catheter-based treatments have shown a reduction in pulmonary artery (PA) obstruction in PE patients, but the impact has been modest, the researchers said.

“The recently published RESCUE (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden) trial showed a 35.9% reduction in PA obstruction using the Refined Modified Miller Index (RMMI), the largest reduction of all published catheter studies with core lab measurement, with similar doses of tissue plasminogen activator (tPA),” the researchers wrote.

The Bashir endovascular catheter was designed to maximize thrombus reduction via a pharmacomechanical infusion. The catheter features an expandable basket of 6 nitinol-reinforced infusion limbs.

“There are three crucial goals that we want to accomplish in patients who have a severe pulmonary embolism,” Dr. Bashir said in an interview. “Those include, in the order of importance, survival, recovery of right ventricular function, and resolution of blocked pulmonary arteries; both segmental and proximal pulmonary arteries,” he said.

Most previous studies have focused on the first two goals, but they still need to evaluate the resolution of PA blockages carefully, said Dr. Bashir. “In our clinical practice, we have seen a large number of patients who develop debilitating shortness of breath from these blockages. We decided to carefully evaluate these blockages before and after pharmacomechanical catheter-directed thrombolysis with the Bashir endovascular catheter using the core lab data from the RESCUE study,” he said.

In the current study published in JACC: Advances), the researchers used baseline and 48-hour posttreatment contrast-enhanced chest computed tomography angiography of adult PE patients with right ventricular dilatation.

The study population included 107 adults with acute intermediate-risk PE who were treated with pharmacomechanical catheter-directory thrombolysis (PM-CDT) at 18 sites in the United States. Of these, 98 had intermediate high-risk PE with elevated troponin and/or brain-type natriuretic peptide (BNP) levels and 102 had bilateral PE.

The primary endpoint was the change in the number of segmental and proximal PA branches with total or subtotal occlusions (defined as > 65%) after 48 hours compared to baseline. Occlusions were assessed using McNemar’s test.

Patients with bilateral PE received two Bashir catheters; those with unilateral PE received one catheter each.

Each patient received a pulse spray of 2 mg of recombinant tPA (r-tPA) into each lung, followed by 5 mg of r-tPA over 5 hours; the total dose was 7 mg of r-tPA for patients with unilateral PEs and 14 mg for those with bilateral PEs, the researchers said. The median times for catheter placement and total procedure were 15 minutes and 54 minutes, respectively.

The number of segmental PA branches with total or subtotal occlusions decreased significantly, from 40.5% at baseline to 11.7% at 48 hours, and proximal PA branch total or subtotal occlusions decreased significantly, from 28.7% at baseline to 11.0% at 48 hours (P < 0.0001 for both).

The magnitude of the reductions in both total and subtotal occlusions of segmental arteries was significantly correlated with the extent of right ventricle recovery (measured by the reduction in right ventricular/left ventricular ratio) with a correlation coefficient of 0.287 (P = .0026); however, this correlation was not observed in the proximal PA arteries (correlation coefficient 0.132, P = .173).

One major bleeding event occurred within 72 hours in a patient who also experienced a device-related left common iliac vein thrombosis while not taking anticoagulation medication, and one death unrelated to PE occurred within 30 days.

“The two findings that surprised me include, first, a more than 70% reduction in total and subtotal occlusions in the segmental arteries with such a low dose of r-tPA and, second, the resolution of the blockages was seen not only in the arteries where the device was placed but also at remote sites away from the location of the catheter,” Dr. Bashir told this news organization.

The findings were limited by several factors including the lack of long-term clinical follow-up outcomes data and lack of comparison groups who underwent other treatments.

However, “This study implies that we now have a safe therapy for these patients that improves survival and right ventricular recovery in addition to dramatically improving blocked pulmonary arteries,” Dr. Bashir said.

As for additional research, “we need all the current and future prospective pulmonary embolism studies to include an assessment of pulmonary artery blockage resolution as an essential endpoint,” he said.
 

Catheter Expands Treatment Options

The current study, a subgroup analysis of the RESCUE trial, was one of the first to examine the impact of catheter-directed lysis on distal occlusions, study coauthor Parth M. Rali, MD, said in an interview.

To this point, literature has been limited to evaluation for proximal disease, said Dr. Rali, director of thoracic surgery and medicine and part of the Pulmonary Embolism Response Team at Temple University Hospital, Philadelphia.

Dr. Rali said he was encouraged to see confirmation that the BEC catheter, because of its design, works in patients with proximal or distal occlusive disease.

In clinical practice, “the catheter provides an additional option for care in patients with multiple distal occlusive disease when a systemic tissue plasminogen activator (tPA), may put patient at high bleeding risk,” Dr. Rali said.

Looking ahead, a prospective, observational multicenter study would be useful to validate the findings from the post hoc analysis of the current study, he noted.

The study was sponsored by the National Heart, Lung, and Blood Institute, Commonwealth of Pennsylvania, and Thrombolex Inc., a medical device company developing interventional catheter-based therapies for the rapid and effective treatment of acute venous thromboembolic disorders. Dr. Bashir is a cofounder and has an equity interest in Thrombolex Inc. Dr. Rali disclosed serving as a consultant for Thrombolex, Inari Medical, Viz AI, and ThinkSono.

Use of pharmacomechanical catheter-directory thrombolysis significantly reduced the number of pulmonary artery branches with total or subtotal occlusions in patients with acute pulmonary embolism, based on data from more than 100 individuals.

Reduced distal vascular volume is a significant predictor of 30-day and 90-day mortality in acute pulmonary embolism (PE) patients, and pulmonary obstruction is often the cause, wrote Riyaz Bashir, MD, of Temple University, Philadelphia, Pennsylvania, and colleagues.

Some studies of catheter-based treatments have shown a reduction in pulmonary artery (PA) obstruction in PE patients, but the impact has been modest, the researchers said.

“The recently published RESCUE (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden) trial showed a 35.9% reduction in PA obstruction using the Refined Modified Miller Index (RMMI), the largest reduction of all published catheter studies with core lab measurement, with similar doses of tissue plasminogen activator (tPA),” the researchers wrote.

The Bashir endovascular catheter was designed to maximize thrombus reduction via a pharmacomechanical infusion. The catheter features an expandable basket of 6 nitinol-reinforced infusion limbs.

“There are three crucial goals that we want to accomplish in patients who have a severe pulmonary embolism,” Dr. Bashir said in an interview. “Those include, in the order of importance, survival, recovery of right ventricular function, and resolution of blocked pulmonary arteries; both segmental and proximal pulmonary arteries,” he said.

Most previous studies have focused on the first two goals, but they still need to evaluate the resolution of PA blockages carefully, said Dr. Bashir. “In our clinical practice, we have seen a large number of patients who develop debilitating shortness of breath from these blockages. We decided to carefully evaluate these blockages before and after pharmacomechanical catheter-directed thrombolysis with the Bashir endovascular catheter using the core lab data from the RESCUE study,” he said.

In the current study published in JACC: Advances), the researchers used baseline and 48-hour posttreatment contrast-enhanced chest computed tomography angiography of adult PE patients with right ventricular dilatation.

The study population included 107 adults with acute intermediate-risk PE who were treated with pharmacomechanical catheter-directory thrombolysis (PM-CDT) at 18 sites in the United States. Of these, 98 had intermediate high-risk PE with elevated troponin and/or brain-type natriuretic peptide (BNP) levels and 102 had bilateral PE.

The primary endpoint was the change in the number of segmental and proximal PA branches with total or subtotal occlusions (defined as > 65%) after 48 hours compared to baseline. Occlusions were assessed using McNemar’s test.

Patients with bilateral PE received two Bashir catheters; those with unilateral PE received one catheter each.

Each patient received a pulse spray of 2 mg of recombinant tPA (r-tPA) into each lung, followed by 5 mg of r-tPA over 5 hours; the total dose was 7 mg of r-tPA for patients with unilateral PEs and 14 mg for those with bilateral PEs, the researchers said. The median times for catheter placement and total procedure were 15 minutes and 54 minutes, respectively.

The number of segmental PA branches with total or subtotal occlusions decreased significantly, from 40.5% at baseline to 11.7% at 48 hours, and proximal PA branch total or subtotal occlusions decreased significantly, from 28.7% at baseline to 11.0% at 48 hours (P < 0.0001 for both).

The magnitude of the reductions in both total and subtotal occlusions of segmental arteries was significantly correlated with the extent of right ventricle recovery (measured by the reduction in right ventricular/left ventricular ratio) with a correlation coefficient of 0.287 (P = .0026); however, this correlation was not observed in the proximal PA arteries (correlation coefficient 0.132, P = .173).

One major bleeding event occurred within 72 hours in a patient who also experienced a device-related left common iliac vein thrombosis while not taking anticoagulation medication, and one death unrelated to PE occurred within 30 days.

“The two findings that surprised me include, first, a more than 70% reduction in total and subtotal occlusions in the segmental arteries with such a low dose of r-tPA and, second, the resolution of the blockages was seen not only in the arteries where the device was placed but also at remote sites away from the location of the catheter,” Dr. Bashir told this news organization.

The findings were limited by several factors including the lack of long-term clinical follow-up outcomes data and lack of comparison groups who underwent other treatments.

However, “This study implies that we now have a safe therapy for these patients that improves survival and right ventricular recovery in addition to dramatically improving blocked pulmonary arteries,” Dr. Bashir said.

As for additional research, “we need all the current and future prospective pulmonary embolism studies to include an assessment of pulmonary artery blockage resolution as an essential endpoint,” he said.
 

Catheter Expands Treatment Options

The current study, a subgroup analysis of the RESCUE trial, was one of the first to examine the impact of catheter-directed lysis on distal occlusions, study coauthor Parth M. Rali, MD, said in an interview.

To this point, literature has been limited to evaluation for proximal disease, said Dr. Rali, director of thoracic surgery and medicine and part of the Pulmonary Embolism Response Team at Temple University Hospital, Philadelphia.

Dr. Rali said he was encouraged to see confirmation that the BEC catheter, because of its design, works in patients with proximal or distal occlusive disease.

In clinical practice, “the catheter provides an additional option for care in patients with multiple distal occlusive disease when a systemic tissue plasminogen activator (tPA), may put patient at high bleeding risk,” Dr. Rali said.

Looking ahead, a prospective, observational multicenter study would be useful to validate the findings from the post hoc analysis of the current study, he noted.

The study was sponsored by the National Heart, Lung, and Blood Institute, Commonwealth of Pennsylvania, and Thrombolex Inc., a medical device company developing interventional catheter-based therapies for the rapid and effective treatment of acute venous thromboembolic disorders. Dr. Bashir is a cofounder and has an equity interest in Thrombolex Inc. Dr. Rali disclosed serving as a consultant for Thrombolex, Inari Medical, Viz AI, and ThinkSono.

The proposal by the major cardiovascular societies in the US to form a new board of cardiovascular medicine to manage initial and ongoing certification of cardiologists represents something of a revolution in the field of continuing medical education and assessment of competency. 

Five US cardiovascular societies — the American College of Cardiology (ACC), the American Heart Association (AHA), the Heart Failure Society of America (HFSA), the Heart Rhythm Society (HRS), and the Society for Cardiovascular Angiography & Interventions (SCAI) — have now joined forces to propose a new professional certification board for cardiovascular medicine, to be known as the American Board of Cardiovascular Medicine (ABCVM). 

The ABCVM would be independent of the American Board of Internal Medicine (ABIM), the current organization providing maintenance of certification for cardiologists as well as many other internal medicine subspecialties. The ABIM’s maintenance of certification process has been widely criticized for many years and has been described as “needlessly burdensome and expensive.” 

The ABCVM is hoping to offer a more appropriate and supportive approach, according to Jeffrey Kuvin, MD, a trustee of the ACC, who has been heading up the working group to develop this plan. 

Dr. Kuvin, who is chair of the cardiology at Northwell Health, Manhasset, New York, a large academic healthcare system, explained that maintenance of certification has been a topic of discussion across the cardiovascular community for many years, and the ACC has a working group focused on the next steps for evaluation of competency, which he chairs.

“The topic of evaluation of competence has been on the mind of the ACC for many years and hence a work group was developed to focus on this,” Dr. Kuvin noted. “A lot of evolution of the concepts and next steps have been drawn out of this working group. And now other cardiovascular societies have joined to show unification across the house of cardiology and that this is indeed the way that the cardiovascular profession should move.” 
 

“Time to Separate from Internal Medicine”

The general concept behind the new cardiology board is to separate cardiology from the ABIM. 

“This is rooted from the concept that cardiology has evolved so much over the last few decades into such a large multidimensional specialty that it really does demarcate itself from internal medicine, and as such, it deserves a separate board governed by cardiologists with collaboration across the entirely of cardiology,” Dr. Kuvin said. 

Cardiology has had significant growth and expansion of technology, tools, medications, and the approach to patients in many specialities and subspecialties, he added. “We have defined training programs in many different areas within cardiology; we have our own guidelines, our own competency statements, and in many cases, cardiology exists as its own department outside of medicine in many institutions. It’s just time to separate cardiology from the umbrella of internal medicine.” 

The new cardiology board would be separate from, and not report to, the ABIM; rather, it would report directly to the American Board of Medical Specialties (ABMS), the only recognized medical certification body in the US. 
 

What Are the Proposed Changes

Under the present system, managed by the ABIM, clinicians must undergo two stages of certification to be a cardiologist. First, they have to pass the initial certification exam in general cardiology, and then exams in one of four subspecialties if they plan to enter one of these, including interventional cardiology, electrophysiology, advanced heart failure or adult congenital heart disease. 

Next, clinicians enter the maintenance of certification phase, which can take three different forms: 1) taking another recertification exam every 10 years; 2) the collaborative maintenance pathway — a collaboration between ACC and ABIM, which includes evaluation, learning and a certified exam each year; or 3) longitudinal knowledge and assessment — in which the program interacts with the clinician on an ongoing basis, sending secured questions regularly. 

All three of these pathways for maintenance of certification involve high stakes questions and a set bar for passing or failing. 

Under the proposed new cardiology board, an initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured, with the new approach taking the form of continuous learning and assessment of competency. 

“This is an iterative process, but we envision with a new American Board of Cardiovascular Medicine, we will pick up where the ABIM left off,” Dr. Kuvin notes. “That includes an initial certifying examination for the five areas that already exist under the ABIM system but with the opportunities to expand that to further specialties as well.”

He points out that there are several areas in cardiology that are currently not represented by these five areas that warrant some discussion, including multimodality imaging, vascular heart disease, and cardio-oncology. 

“At present, everybody has to pass the general cardiology exam and then some may wish to further train and get certified in one of the other four other specific areas. But one topic that has been discussed over many years is how do we maintain competency in the areas in which clinicians practice over their lifetime as a cardiologist,” Dr. Kuvin commented. 

He said the proposed cardiology board would like to adhere to some basic principles that are fundamental to the practice of medicine. 

“We want to make sure that we are practicing medicine so that our patients derive the most benefit from seeing a cardiologist,” he said. “We also want to make sure, however, that this is a supportive process, supporting cardiologists to learn what they know and more importantly what they don’t know; to identify knowledge gaps in specific area; to help the cardiologist fill those knowledge gaps; to acknowledge those gaps have been filled; and then move on to another area of interest. This will be the focus of this new and improved model of continuous competency.”

The proposed new board also says it wants to make sure this is appropriate to the area in which the clinician is practicing.

“To take a closed book certified exam every 10 years on the world of cardiology as happens at the current time – or the assessments conducted in the other two pathways – is often meaningless to the cardiologist,” Dr. Kuvin says. “All three current pathways involve high stakes questions that are often irrelevant to one’s clinical practice.” 
 

Lifelong Learning

“The crux of the changes we are proposing will be away from the focus of passing a test towards a model of helping the individual with their competency, with continuous learning and evaluation of competency to help the clinician fill in their knowledge gaps,” he explains.

He described the new approach as “lifelong learning,” adding that, instead of it being “a punitive pass/fail environment with no feedback, which causes a lot of discontent among clinicians,” it will be a supportive process, where a clinician will be helped in filling their knowledge gaps. 

“I think this would be a welcome change not just for cardiology but across medical specialties,” Dr. Kuvin said. 

He also pointed out the ABMS itself is considering a continuous competency approach, and the proposed new cardiology board aims to work with the ABMS to make sure that their goals of continuous competency assessment are matched. 

“The world has changed. The ability to access information has changed. It is no longer imperative for a clinician to have every piece of knowledge in their brain, but rather to know how to get knowledge and to incorporate that knowledge into clinical practice,” Dr. Kuvin noted. “Competency should not involve knowledge alone as in a closed book exam. It is more about understanding the world that we live in, how to synthesize information, where we need to improve knowledge and how to do that.” 

Dr. Kuvin acknowledged that asking clinicians questions is a very helpful tool to identify their knowledge base and their knowledge gaps. “But we believe the clinician needs to be given resources — that could be a conference, an article, a simulation — to fill that knowledge gap. Then we could ask clinicians some different questions and if they get those right then we have provided a service.” 

Tactile skills for cardiologists needing to perform procedures – such as interventionalists or electrophysiologists may be incorporated by simulation in a technology-based scenario.

On how often these assessments would take place, Dr. Kuvin said that hadn’t been decided for sure. 

“We certainly do not think an assessment every 10 years is appropriate. We envision, instead of an episodic model, it will be rather a lifelong journey of education and competency. This will involve frequent contact and making sure knowledge gaps are being filled. There are criteria being set out by the ABMS that there should be a certain number of touch points with individuals on an annual as well as a 5-year basis to make sure cardiologists are staying within specific guardrails. The exact nature of these is yet to be determined,” he said. 

Dr. Kuvin added that it was not known yet what sort of hours would be required but added that “this will not be a significant time burden.”
 

What is the Timeframe?

The application to the ABMS for a separate cardiology board is still ongoing and has not yet received formal acceptance. Representatives from the five US cardiovascular societies are in the initial stages of formulating a transition board. 

“The submission to the ABMS will take time for them to review. This could take up to a year or so,” Dr. Kuvin estimates. 

This is the first time the ABMS has entertained the concept of a new board in many years, he noted. “It will be a paradigm shift for the whole country. I think that cardiology is really at the forefront and in a position where we can actually do this. If cardiovascular medicine is granted a new board, I think this will help change the approach of how physicians are assessed in terms of continuous competency not just in cardiology but across all specialties of medicine.”

He added: “We are confident that we can work within the construct of the ABMS guidelines that have been revised to be much more holistic in the approach of continuous competence across the board. This includes thinking beyond rote medical knowledge and thinking about the clinician as a whole and their abilities to communicate, act professionally, work within a complex medical system, utilize medical resources effectively. These all have to be part of continuous competence.”
 

How Much Will This Cost?

Noting that the ABIM has received criticism over the costs of the certification process, Dr. Kuvin said they intend to make this “as lean a machine as possible with the focus on reducing the financial [burden] as well as the time burden for cardiologists. It is very important that this is not cumbersome, that it is woven into clinical practice, and that it is not costly.” 

But he pointed out that building a new board will have significant costs. 

“We have to think about developing initial board certification examinations as well as changing the paradigm on continuous certification,” he said. “This will take some up-front costs, and our society partners have decided that they are willing to provide some start-up funds for this. We anticipate the initial certification will remain somewhat similar in price, but the cost of ongoing continuous competency assessment will be significantly reduced compared to today’s models.”

Dr. Kuvin said the collaboration of the five participating US cardiovascular societies was unprecedented. But he noted that while the transition board is beginning with representatives of these individual societies, it will ultimately be independent from these societies and have its own board of directors. 

He suggested that other societies representing other parts of cardiology are also interested. “Cardiology has recognized how important this is,” he said. “Everybody is excited about this.”

A version of this article appeared on Medscape.com.

The proposal by the major cardiovascular societies in the US to form a new board of cardiovascular medicine to manage initial and ongoing certification of cardiologists represents something of a revolution in the field of continuing medical education and assessment of competency. 

Five US cardiovascular societies — the American College of Cardiology (ACC), the American Heart Association (AHA), the Heart Failure Society of America (HFSA), the Heart Rhythm Society (HRS), and the Society for Cardiovascular Angiography & Interventions (SCAI) — have now joined forces to propose a new professional certification board for cardiovascular medicine, to be known as the American Board of Cardiovascular Medicine (ABCVM). 

The ABCVM would be independent of the American Board of Internal Medicine (ABIM), the current organization providing maintenance of certification for cardiologists as well as many other internal medicine subspecialties. The ABIM’s maintenance of certification process has been widely criticized for many years and has been described as “needlessly burdensome and expensive.” 

The ABCVM is hoping to offer a more appropriate and supportive approach, according to Jeffrey Kuvin, MD, a trustee of the ACC, who has been heading up the working group to develop this plan. 

Dr. Kuvin, who is chair of the cardiology at Northwell Health, Manhasset, New York, a large academic healthcare system, explained that maintenance of certification has been a topic of discussion across the cardiovascular community for many years, and the ACC has a working group focused on the next steps for evaluation of competency, which he chairs.

“The topic of evaluation of competence has been on the mind of the ACC for many years and hence a work group was developed to focus on this,” Dr. Kuvin noted. “A lot of evolution of the concepts and next steps have been drawn out of this working group. And now other cardiovascular societies have joined to show unification across the house of cardiology and that this is indeed the way that the cardiovascular profession should move.” 
 

“Time to Separate from Internal Medicine”

The general concept behind the new cardiology board is to separate cardiology from the ABIM. 

“This is rooted from the concept that cardiology has evolved so much over the last few decades into such a large multidimensional specialty that it really does demarcate itself from internal medicine, and as such, it deserves a separate board governed by cardiologists with collaboration across the entirely of cardiology,” Dr. Kuvin said. 

Cardiology has had significant growth and expansion of technology, tools, medications, and the approach to patients in many specialities and subspecialties, he added. “We have defined training programs in many different areas within cardiology; we have our own guidelines, our own competency statements, and in many cases, cardiology exists as its own department outside of medicine in many institutions. It’s just time to separate cardiology from the umbrella of internal medicine.” 

The new cardiology board would be separate from, and not report to, the ABIM; rather, it would report directly to the American Board of Medical Specialties (ABMS), the only recognized medical certification body in the US. 
 

What Are the Proposed Changes

Under the present system, managed by the ABIM, clinicians must undergo two stages of certification to be a cardiologist. First, they have to pass the initial certification exam in general cardiology, and then exams in one of four subspecialties if they plan to enter one of these, including interventional cardiology, electrophysiology, advanced heart failure or adult congenital heart disease. 

Next, clinicians enter the maintenance of certification phase, which can take three different forms: 1) taking another recertification exam every 10 years; 2) the collaborative maintenance pathway — a collaboration between ACC and ABIM, which includes evaluation, learning and a certified exam each year; or 3) longitudinal knowledge and assessment — in which the program interacts with the clinician on an ongoing basis, sending secured questions regularly. 

All three of these pathways for maintenance of certification involve high stakes questions and a set bar for passing or failing. 

Under the proposed new cardiology board, an initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured, with the new approach taking the form of continuous learning and assessment of competency. 

“This is an iterative process, but we envision with a new American Board of Cardiovascular Medicine, we will pick up where the ABIM left off,” Dr. Kuvin notes. “That includes an initial certifying examination for the five areas that already exist under the ABIM system but with the opportunities to expand that to further specialties as well.”

He points out that there are several areas in cardiology that are currently not represented by these five areas that warrant some discussion, including multimodality imaging, vascular heart disease, and cardio-oncology. 

“At present, everybody has to pass the general cardiology exam and then some may wish to further train and get certified in one of the other four other specific areas. But one topic that has been discussed over many years is how do we maintain competency in the areas in which clinicians practice over their lifetime as a cardiologist,” Dr. Kuvin commented. 

He said the proposed cardiology board would like to adhere to some basic principles that are fundamental to the practice of medicine. 

“We want to make sure that we are practicing medicine so that our patients derive the most benefit from seeing a cardiologist,” he said. “We also want to make sure, however, that this is a supportive process, supporting cardiologists to learn what they know and more importantly what they don’t know; to identify knowledge gaps in specific area; to help the cardiologist fill those knowledge gaps; to acknowledge those gaps have been filled; and then move on to another area of interest. This will be the focus of this new and improved model of continuous competency.”

The proposed new board also says it wants to make sure this is appropriate to the area in which the clinician is practicing.

“To take a closed book certified exam every 10 years on the world of cardiology as happens at the current time – or the assessments conducted in the other two pathways – is often meaningless to the cardiologist,” Dr. Kuvin says. “All three current pathways involve high stakes questions that are often irrelevant to one’s clinical practice.” 
 

Lifelong Learning

“The crux of the changes we are proposing will be away from the focus of passing a test towards a model of helping the individual with their competency, with continuous learning and evaluation of competency to help the clinician fill in their knowledge gaps,” he explains.

He described the new approach as “lifelong learning,” adding that, instead of it being “a punitive pass/fail environment with no feedback, which causes a lot of discontent among clinicians,” it will be a supportive process, where a clinician will be helped in filling their knowledge gaps. 

“I think this would be a welcome change not just for cardiology but across medical specialties,” Dr. Kuvin said. 

He also pointed out the ABMS itself is considering a continuous competency approach, and the proposed new cardiology board aims to work with the ABMS to make sure that their goals of continuous competency assessment are matched. 

“The world has changed. The ability to access information has changed. It is no longer imperative for a clinician to have every piece of knowledge in their brain, but rather to know how to get knowledge and to incorporate that knowledge into clinical practice,” Dr. Kuvin noted. “Competency should not involve knowledge alone as in a closed book exam. It is more about understanding the world that we live in, how to synthesize information, where we need to improve knowledge and how to do that.” 

Dr. Kuvin acknowledged that asking clinicians questions is a very helpful tool to identify their knowledge base and their knowledge gaps. “But we believe the clinician needs to be given resources — that could be a conference, an article, a simulation — to fill that knowledge gap. Then we could ask clinicians some different questions and if they get those right then we have provided a service.” 

Tactile skills for cardiologists needing to perform procedures – such as interventionalists or electrophysiologists may be incorporated by simulation in a technology-based scenario.

On how often these assessments would take place, Dr. Kuvin said that hadn’t been decided for sure. 

“We certainly do not think an assessment every 10 years is appropriate. We envision, instead of an episodic model, it will be rather a lifelong journey of education and competency. This will involve frequent contact and making sure knowledge gaps are being filled. There are criteria being set out by the ABMS that there should be a certain number of touch points with individuals on an annual as well as a 5-year basis to make sure cardiologists are staying within specific guardrails. The exact nature of these is yet to be determined,” he said. 

Dr. Kuvin added that it was not known yet what sort of hours would be required but added that “this will not be a significant time burden.”
 

What is the Timeframe?

The application to the ABMS for a separate cardiology board is still ongoing and has not yet received formal acceptance. Representatives from the five US cardiovascular societies are in the initial stages of formulating a transition board. 

“The submission to the ABMS will take time for them to review. This could take up to a year or so,” Dr. Kuvin estimates. 

This is the first time the ABMS has entertained the concept of a new board in many years, he noted. “It will be a paradigm shift for the whole country. I think that cardiology is really at the forefront and in a position where we can actually do this. If cardiovascular medicine is granted a new board, I think this will help change the approach of how physicians are assessed in terms of continuous competency not just in cardiology but across all specialties of medicine.”

He added: “We are confident that we can work within the construct of the ABMS guidelines that have been revised to be much more holistic in the approach of continuous competence across the board. This includes thinking beyond rote medical knowledge and thinking about the clinician as a whole and their abilities to communicate, act professionally, work within a complex medical system, utilize medical resources effectively. These all have to be part of continuous competence.”
 

How Much Will This Cost?

Noting that the ABIM has received criticism over the costs of the certification process, Dr. Kuvin said they intend to make this “as lean a machine as possible with the focus on reducing the financial [burden] as well as the time burden for cardiologists. It is very important that this is not cumbersome, that it is woven into clinical practice, and that it is not costly.” 

But he pointed out that building a new board will have significant costs. 

“We have to think about developing initial board certification examinations as well as changing the paradigm on continuous certification,” he said. “This will take some up-front costs, and our society partners have decided that they are willing to provide some start-up funds for this. We anticipate the initial certification will remain somewhat similar in price, but the cost of ongoing continuous competency assessment will be significantly reduced compared to today’s models.”

Dr. Kuvin said the collaboration of the five participating US cardiovascular societies was unprecedented. But he noted that while the transition board is beginning with representatives of these individual societies, it will ultimately be independent from these societies and have its own board of directors. 

He suggested that other societies representing other parts of cardiology are also interested. “Cardiology has recognized how important this is,” he said. “Everybody is excited about this.”

A version of this article appeared on Medscape.com.

The proposal by the major cardiovascular societies in the US to form a new board of cardiovascular medicine to manage initial and ongoing certification of cardiologists represents something of a revolution in the field of continuing medical education and assessment of competency. 

Five US cardiovascular societies — the American College of Cardiology (ACC), the American Heart Association (AHA), the Heart Failure Society of America (HFSA), the Heart Rhythm Society (HRS), and the Society for Cardiovascular Angiography & Interventions (SCAI) — have now joined forces to propose a new professional certification board for cardiovascular medicine, to be known as the American Board of Cardiovascular Medicine (ABCVM). 

The ABCVM would be independent of the American Board of Internal Medicine (ABIM), the current organization providing maintenance of certification for cardiologists as well as many other internal medicine subspecialties. The ABIM’s maintenance of certification process has been widely criticized for many years and has been described as “needlessly burdensome and expensive.” 

The ABCVM is hoping to offer a more appropriate and supportive approach, according to Jeffrey Kuvin, MD, a trustee of the ACC, who has been heading up the working group to develop this plan. 

Dr. Kuvin, who is chair of the cardiology at Northwell Health, Manhasset, New York, a large academic healthcare system, explained that maintenance of certification has been a topic of discussion across the cardiovascular community for many years, and the ACC has a working group focused on the next steps for evaluation of competency, which he chairs.

“The topic of evaluation of competence has been on the mind of the ACC for many years and hence a work group was developed to focus on this,” Dr. Kuvin noted. “A lot of evolution of the concepts and next steps have been drawn out of this working group. And now other cardiovascular societies have joined to show unification across the house of cardiology and that this is indeed the way that the cardiovascular profession should move.” 
 

“Time to Separate from Internal Medicine”

The general concept behind the new cardiology board is to separate cardiology from the ABIM. 

“This is rooted from the concept that cardiology has evolved so much over the last few decades into such a large multidimensional specialty that it really does demarcate itself from internal medicine, and as such, it deserves a separate board governed by cardiologists with collaboration across the entirely of cardiology,” Dr. Kuvin said. 

Cardiology has had significant growth and expansion of technology, tools, medications, and the approach to patients in many specialities and subspecialties, he added. “We have defined training programs in many different areas within cardiology; we have our own guidelines, our own competency statements, and in many cases, cardiology exists as its own department outside of medicine in many institutions. It’s just time to separate cardiology from the umbrella of internal medicine.” 

The new cardiology board would be separate from, and not report to, the ABIM; rather, it would report directly to the American Board of Medical Specialties (ABMS), the only recognized medical certification body in the US. 
 

What Are the Proposed Changes

Under the present system, managed by the ABIM, clinicians must undergo two stages of certification to be a cardiologist. First, they have to pass the initial certification exam in general cardiology, and then exams in one of four subspecialties if they plan to enter one of these, including interventional cardiology, electrophysiology, advanced heart failure or adult congenital heart disease. 

Next, clinicians enter the maintenance of certification phase, which can take three different forms: 1) taking another recertification exam every 10 years; 2) the collaborative maintenance pathway — a collaboration between ACC and ABIM, which includes evaluation, learning and a certified exam each year; or 3) longitudinal knowledge and assessment — in which the program interacts with the clinician on an ongoing basis, sending secured questions regularly. 

All three of these pathways for maintenance of certification involve high stakes questions and a set bar for passing or failing. 

Under the proposed new cardiology board, an initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured, with the new approach taking the form of continuous learning and assessment of competency. 

“This is an iterative process, but we envision with a new American Board of Cardiovascular Medicine, we will pick up where the ABIM left off,” Dr. Kuvin notes. “That includes an initial certifying examination for the five areas that already exist under the ABIM system but with the opportunities to expand that to further specialties as well.”

He points out that there are several areas in cardiology that are currently not represented by these five areas that warrant some discussion, including multimodality imaging, vascular heart disease, and cardio-oncology. 

“At present, everybody has to pass the general cardiology exam and then some may wish to further train and get certified in one of the other four other specific areas. But one topic that has been discussed over many years is how do we maintain competency in the areas in which clinicians practice over their lifetime as a cardiologist,” Dr. Kuvin commented. 

He said the proposed cardiology board would like to adhere to some basic principles that are fundamental to the practice of medicine. 

“We want to make sure that we are practicing medicine so that our patients derive the most benefit from seeing a cardiologist,” he said. “We also want to make sure, however, that this is a supportive process, supporting cardiologists to learn what they know and more importantly what they don’t know; to identify knowledge gaps in specific area; to help the cardiologist fill those knowledge gaps; to acknowledge those gaps have been filled; and then move on to another area of interest. This will be the focus of this new and improved model of continuous competency.”

The proposed new board also says it wants to make sure this is appropriate to the area in which the clinician is practicing.

“To take a closed book certified exam every 10 years on the world of cardiology as happens at the current time – or the assessments conducted in the other two pathways – is often meaningless to the cardiologist,” Dr. Kuvin says. “All three current pathways involve high stakes questions that are often irrelevant to one’s clinical practice.” 
 

Lifelong Learning

“The crux of the changes we are proposing will be away from the focus of passing a test towards a model of helping the individual with their competency, with continuous learning and evaluation of competency to help the clinician fill in their knowledge gaps,” he explains.

He described the new approach as “lifelong learning,” adding that, instead of it being “a punitive pass/fail environment with no feedback, which causes a lot of discontent among clinicians,” it will be a supportive process, where a clinician will be helped in filling their knowledge gaps. 

“I think this would be a welcome change not just for cardiology but across medical specialties,” Dr. Kuvin said. 

He also pointed out the ABMS itself is considering a continuous competency approach, and the proposed new cardiology board aims to work with the ABMS to make sure that their goals of continuous competency assessment are matched. 

“The world has changed. The ability to access information has changed. It is no longer imperative for a clinician to have every piece of knowledge in their brain, but rather to know how to get knowledge and to incorporate that knowledge into clinical practice,” Dr. Kuvin noted. “Competency should not involve knowledge alone as in a closed book exam. It is more about understanding the world that we live in, how to synthesize information, where we need to improve knowledge and how to do that.” 

Dr. Kuvin acknowledged that asking clinicians questions is a very helpful tool to identify their knowledge base and their knowledge gaps. “But we believe the clinician needs to be given resources — that could be a conference, an article, a simulation — to fill that knowledge gap. Then we could ask clinicians some different questions and if they get those right then we have provided a service.” 

Tactile skills for cardiologists needing to perform procedures – such as interventionalists or electrophysiologists may be incorporated by simulation in a technology-based scenario.

On how often these assessments would take place, Dr. Kuvin said that hadn’t been decided for sure. 

“We certainly do not think an assessment every 10 years is appropriate. We envision, instead of an episodic model, it will be rather a lifelong journey of education and competency. This will involve frequent contact and making sure knowledge gaps are being filled. There are criteria being set out by the ABMS that there should be a certain number of touch points with individuals on an annual as well as a 5-year basis to make sure cardiologists are staying within specific guardrails. The exact nature of these is yet to be determined,” he said. 

Dr. Kuvin added that it was not known yet what sort of hours would be required but added that “this will not be a significant time burden.”
 

What is the Timeframe?

The application to the ABMS for a separate cardiology board is still ongoing and has not yet received formal acceptance. Representatives from the five US cardiovascular societies are in the initial stages of formulating a transition board. 

“The submission to the ABMS will take time for them to review. This could take up to a year or so,” Dr. Kuvin estimates. 

This is the first time the ABMS has entertained the concept of a new board in many years, he noted. “It will be a paradigm shift for the whole country. I think that cardiology is really at the forefront and in a position where we can actually do this. If cardiovascular medicine is granted a new board, I think this will help change the approach of how physicians are assessed in terms of continuous competency not just in cardiology but across all specialties of medicine.”

He added: “We are confident that we can work within the construct of the ABMS guidelines that have been revised to be much more holistic in the approach of continuous competence across the board. This includes thinking beyond rote medical knowledge and thinking about the clinician as a whole and their abilities to communicate, act professionally, work within a complex medical system, utilize medical resources effectively. These all have to be part of continuous competence.”
 

How Much Will This Cost?

Noting that the ABIM has received criticism over the costs of the certification process, Dr. Kuvin said they intend to make this “as lean a machine as possible with the focus on reducing the financial [burden] as well as the time burden for cardiologists. It is very important that this is not cumbersome, that it is woven into clinical practice, and that it is not costly.” 

But he pointed out that building a new board will have significant costs. 

“We have to think about developing initial board certification examinations as well as changing the paradigm on continuous certification,” he said. “This will take some up-front costs, and our society partners have decided that they are willing to provide some start-up funds for this. We anticipate the initial certification will remain somewhat similar in price, but the cost of ongoing continuous competency assessment will be significantly reduced compared to today’s models.”

Dr. Kuvin said the collaboration of the five participating US cardiovascular societies was unprecedented. But he noted that while the transition board is beginning with representatives of these individual societies, it will ultimately be independent from these societies and have its own board of directors. 

He suggested that other societies representing other parts of cardiology are also interested. “Cardiology has recognized how important this is,” he said. “Everybody is excited about this.”

A version of this article appeared on Medscape.com.

Repairing patent foramen ovale (PFO) and other right-to-left shunt disorders for the prevention of migraine has generated mixed results, but the potential for these repairs also includes reducing the risk of stroke, according to a discussion at the 2023 Scottsdale Headache Symposium.

In two clinical trials evaluating whether PFO closure reduces migraine risk, the primary endpoints were not met, but a signal of benefit on secondary endpoints and the association between PFO, migraine, and stroke are among the reasons that PFO closure should be reevaluated, according to Andrew Charles MD, Director of the Goldberg Migraine Program, University of California, Los Angeles.

Charles_Andrew_LA_web.jpg

One Intervention, Two Potential Benefits

Fixing these defects is therefore at least theoretically attractive for preventing both migraine and stroke, but Dr. Charles said the opportunity for preventing both migraine and stroke is most attractive in migraine patients who have additional stroke risk factors.

Use of oral contraceptives, which produce a hypercoagulable state, is an example.

“Are these the people we should really be thinking about if they have PFO and migraine, particularly migraine with aura?” Dr. Charles asked.

The association between right-to-left shunts and migraine is strong. Although PFO is common, presenting in 20%-25% of the adult population, it has been found in up to 50% of individuals who have migraine with aura. In patients with migraine but no aura, the prevalence of PFO has been estimated to be approximately 35% or still somewhat elevated relative to the general population.
 

Primary Endpoint Missed in Clinical Trials

The question of whether risk of migraine can be reduced with repair of PFO or other right-to-left shunts remains unresolved. In two high-quality randomized trials undertaken in PFO repair, neither met its primary endpoint. In one of these, called PRIMA, which was terminated early for slow enrollment, the reduction in mean headache attacks was not significant relative to medical therapy.

In the second, called PREMIUM, device closure of PFO also failed to significantly reduce migraine attacks over sham procedure although it was associated with complete migraine remission (10% vs 1%).

A pooled analysis of these two studies that was conducted subsequently concluded that PFO closure reduces mean monthly migraine days (-3.1 vs. -1.9 days; P = -.02) and increases the likelihood of complete migraine cessation (9% vs. 0.7%; P < .001), but Dr. Charles pointed out the primary endpoint was migraine attacks not migraine days, so other analyses can only be considered hypothesis-generating.

There are several reasons to relook at the relationship between migraine and PFO but the potential to prevent both migraine and stroke with PFO closure could be one of the most important.

Several years ago, Dr. Charles and his coinvestigators from UCLA evaluated more than 700 ischemic strokes. Of these, 127 strokes were characterized as cryptogenic because of lack of another identifiable etiology. While 59% of these patients had PFO, which is several times higher than the general population, the prevalence of PFO in patients with a cryptogenic stroke and a history of migraine was 79% in this published study.

“So, in this group of patients who did not have any other clear cause for a stroke, a diagnosis of PFO was very much overrepresented,” Dr. Charles said.
 

Migraine Days Might Be a Better Endpoint

For patients with migraine who have risk factors for stroke, this makes PFO closure an attractive intervention, but a positive randomized trial is needed. Several are underway. Importantly, the trials now enrolling are using migraine days, which was significantly reduced in both PREMIUM and PRIMA, rather than migraine attacks as the primary endpoint.

“Migraine days is now accepted by the Food and Drug Administration as a criterion of benefit,” reported Jonathan Tobis, MD, Research Director, Interventional Cardiology, UCLA David Geffen School of Medicine, Los Angeles.

He explained that the FDA insisted on migraine attacks as the endpoint for the PREMIUM trial, but this was a far more challenging endpoint on which to show a statistical benefit. He emphasized that a new set of trials will now test efficacy on the basis of migraine days.

One of these trials, called RELIEF, which is randomizing patients to device closure of PFO or a sham procedure. Both groups are receiving clopidogrel or prasugrel based on a previous observation that patients who respond to these drugs are also more likely to respond to PFO closure.

Another trial, called COMPETE-2, is comparing PFO closure with a device to aspirin plus a sham closure. This trial is ongoing in China.

Stroke is not being evaluated as an endpoint in either trial, but Dr. Charles suggested that this does warrant attention.

“I would also just put it out there that, apart from simply migraine, this is a therapeutic approach that we might actually think about in terms of helping to prevent stroke in our migraine patients,” he said.

Senior author of a recent meta-analysis of trials evaluating PFO closure and control of migraine, Ling Liu, MD, Department of Neurology, University of Sichuan, Chengdu, China, agreed that PFO closure for the treatment of migraine deserves “a reevaluation.”

In his meta-analysis of three randomized trials, one pooled study, and eight retrospective case series with 1,165 patients, PFO closure was associated with a nearly 75% reduction (odds ratio [OR], 0.259; P = .0048) reduction in migraine days and 50% increase in resolution of migraine in patients with a history of migraine with aura (OR, 1.586; P = .227).

The incidence of stroke was not evaluated in this meta-analysis, but Dr. Liu believes that the evidence of reducing the burden of migraine with PFO closure is compelling. Given the evidence from this meta-analysis that PFO closure is safe, Dr. Liu maintained that a definitive trial is needed “especially for migraine with frequent aura.”

As an interventional cardiologist, Dr. Tobis said that when PFO closures is performed for prevention of stroke in patients with migraine, it often leads to reduced migraine activity and, in some cases, elimination of migraine. Like others, he believes new analyses should be conducted.

“Everyone involved in this field believes there is something there,” Dr. Tobis said. The missing link is a clinical trial to confirm it.

Dr. Charles and Dr. Liu report no potential conflicts of interest. Dr. Tobis reports a financial relationship with Holistick Medical.

Repairing patent foramen ovale (PFO) and other right-to-left shunt disorders for the prevention of migraine has generated mixed results, but the potential for these repairs also includes reducing the risk of stroke, according to a discussion at the 2023 Scottsdale Headache Symposium.

In two clinical trials evaluating whether PFO closure reduces migraine risk, the primary endpoints were not met, but a signal of benefit on secondary endpoints and the association between PFO, migraine, and stroke are among the reasons that PFO closure should be reevaluated, according to Andrew Charles MD, Director of the Goldberg Migraine Program, University of California, Los Angeles.

Charles_Andrew_LA_web.jpg

One Intervention, Two Potential Benefits

Fixing these defects is therefore at least theoretically attractive for preventing both migraine and stroke, but Dr. Charles said the opportunity for preventing both migraine and stroke is most attractive in migraine patients who have additional stroke risk factors.

Use of oral contraceptives, which produce a hypercoagulable state, is an example.

“Are these the people we should really be thinking about if they have PFO and migraine, particularly migraine with aura?” Dr. Charles asked.

The association between right-to-left shunts and migraine is strong. Although PFO is common, presenting in 20%-25% of the adult population, it has been found in up to 50% of individuals who have migraine with aura. In patients with migraine but no aura, the prevalence of PFO has been estimated to be approximately 35% or still somewhat elevated relative to the general population.
 

Primary Endpoint Missed in Clinical Trials

The question of whether risk of migraine can be reduced with repair of PFO or other right-to-left shunts remains unresolved. In two high-quality randomized trials undertaken in PFO repair, neither met its primary endpoint. In one of these, called PRIMA, which was terminated early for slow enrollment, the reduction in mean headache attacks was not significant relative to medical therapy.

In the second, called PREMIUM, device closure of PFO also failed to significantly reduce migraine attacks over sham procedure although it was associated with complete migraine remission (10% vs 1%).

A pooled analysis of these two studies that was conducted subsequently concluded that PFO closure reduces mean monthly migraine days (-3.1 vs. -1.9 days; P = -.02) and increases the likelihood of complete migraine cessation (9% vs. 0.7%; P < .001), but Dr. Charles pointed out the primary endpoint was migraine attacks not migraine days, so other analyses can only be considered hypothesis-generating.

There are several reasons to relook at the relationship between migraine and PFO but the potential to prevent both migraine and stroke with PFO closure could be one of the most important.

Several years ago, Dr. Charles and his coinvestigators from UCLA evaluated more than 700 ischemic strokes. Of these, 127 strokes were characterized as cryptogenic because of lack of another identifiable etiology. While 59% of these patients had PFO, which is several times higher than the general population, the prevalence of PFO in patients with a cryptogenic stroke and a history of migraine was 79% in this published study.

“So, in this group of patients who did not have any other clear cause for a stroke, a diagnosis of PFO was very much overrepresented,” Dr. Charles said.
 

Migraine Days Might Be a Better Endpoint

For patients with migraine who have risk factors for stroke, this makes PFO closure an attractive intervention, but a positive randomized trial is needed. Several are underway. Importantly, the trials now enrolling are using migraine days, which was significantly reduced in both PREMIUM and PRIMA, rather than migraine attacks as the primary endpoint.

“Migraine days is now accepted by the Food and Drug Administration as a criterion of benefit,” reported Jonathan Tobis, MD, Research Director, Interventional Cardiology, UCLA David Geffen School of Medicine, Los Angeles.

He explained that the FDA insisted on migraine attacks as the endpoint for the PREMIUM trial, but this was a far more challenging endpoint on which to show a statistical benefit. He emphasized that a new set of trials will now test efficacy on the basis of migraine days.

One of these trials, called RELIEF, which is randomizing patients to device closure of PFO or a sham procedure. Both groups are receiving clopidogrel or prasugrel based on a previous observation that patients who respond to these drugs are also more likely to respond to PFO closure.

Another trial, called COMPETE-2, is comparing PFO closure with a device to aspirin plus a sham closure. This trial is ongoing in China.

Stroke is not being evaluated as an endpoint in either trial, but Dr. Charles suggested that this does warrant attention.

“I would also just put it out there that, apart from simply migraine, this is a therapeutic approach that we might actually think about in terms of helping to prevent stroke in our migraine patients,” he said.

Senior author of a recent meta-analysis of trials evaluating PFO closure and control of migraine, Ling Liu, MD, Department of Neurology, University of Sichuan, Chengdu, China, agreed that PFO closure for the treatment of migraine deserves “a reevaluation.”

In his meta-analysis of three randomized trials, one pooled study, and eight retrospective case series with 1,165 patients, PFO closure was associated with a nearly 75% reduction (odds ratio [OR], 0.259; P = .0048) reduction in migraine days and 50% increase in resolution of migraine in patients with a history of migraine with aura (OR, 1.586; P = .227).

The incidence of stroke was not evaluated in this meta-analysis, but Dr. Liu believes that the evidence of reducing the burden of migraine with PFO closure is compelling. Given the evidence from this meta-analysis that PFO closure is safe, Dr. Liu maintained that a definitive trial is needed “especially for migraine with frequent aura.”

As an interventional cardiologist, Dr. Tobis said that when PFO closures is performed for prevention of stroke in patients with migraine, it often leads to reduced migraine activity and, in some cases, elimination of migraine. Like others, he believes new analyses should be conducted.

“Everyone involved in this field believes there is something there,” Dr. Tobis said. The missing link is a clinical trial to confirm it.

Dr. Charles and Dr. Liu report no potential conflicts of interest. Dr. Tobis reports a financial relationship with Holistick Medical.

Repairing patent foramen ovale (PFO) and other right-to-left shunt disorders for the prevention of migraine has generated mixed results, but the potential for these repairs also includes reducing the risk of stroke, according to a discussion at the 2023 Scottsdale Headache Symposium.

In two clinical trials evaluating whether PFO closure reduces migraine risk, the primary endpoints were not met, but a signal of benefit on secondary endpoints and the association between PFO, migraine, and stroke are among the reasons that PFO closure should be reevaluated, according to Andrew Charles MD, Director of the Goldberg Migraine Program, University of California, Los Angeles.

Charles_Andrew_LA_web.jpg

One Intervention, Two Potential Benefits

Fixing these defects is therefore at least theoretically attractive for preventing both migraine and stroke, but Dr. Charles said the opportunity for preventing both migraine and stroke is most attractive in migraine patients who have additional stroke risk factors.

Use of oral contraceptives, which produce a hypercoagulable state, is an example.

“Are these the people we should really be thinking about if they have PFO and migraine, particularly migraine with aura?” Dr. Charles asked.

The association between right-to-left shunts and migraine is strong. Although PFO is common, presenting in 20%-25% of the adult population, it has been found in up to 50% of individuals who have migraine with aura. In patients with migraine but no aura, the prevalence of PFO has been estimated to be approximately 35% or still somewhat elevated relative to the general population.
 

Primary Endpoint Missed in Clinical Trials

The question of whether risk of migraine can be reduced with repair of PFO or other right-to-left shunts remains unresolved. In two high-quality randomized trials undertaken in PFO repair, neither met its primary endpoint. In one of these, called PRIMA, which was terminated early for slow enrollment, the reduction in mean headache attacks was not significant relative to medical therapy.

In the second, called PREMIUM, device closure of PFO also failed to significantly reduce migraine attacks over sham procedure although it was associated with complete migraine remission (10% vs 1%).

A pooled analysis of these two studies that was conducted subsequently concluded that PFO closure reduces mean monthly migraine days (-3.1 vs. -1.9 days; P = -.02) and increases the likelihood of complete migraine cessation (9% vs. 0.7%; P < .001), but Dr. Charles pointed out the primary endpoint was migraine attacks not migraine days, so other analyses can only be considered hypothesis-generating.

There are several reasons to relook at the relationship between migraine and PFO but the potential to prevent both migraine and stroke with PFO closure could be one of the most important.

Several years ago, Dr. Charles and his coinvestigators from UCLA evaluated more than 700 ischemic strokes. Of these, 127 strokes were characterized as cryptogenic because of lack of another identifiable etiology. While 59% of these patients had PFO, which is several times higher than the general population, the prevalence of PFO in patients with a cryptogenic stroke and a history of migraine was 79% in this published study.

“So, in this group of patients who did not have any other clear cause for a stroke, a diagnosis of PFO was very much overrepresented,” Dr. Charles said.
 

Migraine Days Might Be a Better Endpoint

For patients with migraine who have risk factors for stroke, this makes PFO closure an attractive intervention, but a positive randomized trial is needed. Several are underway. Importantly, the trials now enrolling are using migraine days, which was significantly reduced in both PREMIUM and PRIMA, rather than migraine attacks as the primary endpoint.

“Migraine days is now accepted by the Food and Drug Administration as a criterion of benefit,” reported Jonathan Tobis, MD, Research Director, Interventional Cardiology, UCLA David Geffen School of Medicine, Los Angeles.

He explained that the FDA insisted on migraine attacks as the endpoint for the PREMIUM trial, but this was a far more challenging endpoint on which to show a statistical benefit. He emphasized that a new set of trials will now test efficacy on the basis of migraine days.

One of these trials, called RELIEF, which is randomizing patients to device closure of PFO or a sham procedure. Both groups are receiving clopidogrel or prasugrel based on a previous observation that patients who respond to these drugs are also more likely to respond to PFO closure.

Another trial, called COMPETE-2, is comparing PFO closure with a device to aspirin plus a sham closure. This trial is ongoing in China.

Stroke is not being evaluated as an endpoint in either trial, but Dr. Charles suggested that this does warrant attention.

“I would also just put it out there that, apart from simply migraine, this is a therapeutic approach that we might actually think about in terms of helping to prevent stroke in our migraine patients,” he said.

Senior author of a recent meta-analysis of trials evaluating PFO closure and control of migraine, Ling Liu, MD, Department of Neurology, University of Sichuan, Chengdu, China, agreed that PFO closure for the treatment of migraine deserves “a reevaluation.”

In his meta-analysis of three randomized trials, one pooled study, and eight retrospective case series with 1,165 patients, PFO closure was associated with a nearly 75% reduction (odds ratio [OR], 0.259; P = .0048) reduction in migraine days and 50% increase in resolution of migraine in patients with a history of migraine with aura (OR, 1.586; P = .227).

The incidence of stroke was not evaluated in this meta-analysis, but Dr. Liu believes that the evidence of reducing the burden of migraine with PFO closure is compelling. Given the evidence from this meta-analysis that PFO closure is safe, Dr. Liu maintained that a definitive trial is needed “especially for migraine with frequent aura.”

As an interventional cardiologist, Dr. Tobis said that when PFO closures is performed for prevention of stroke in patients with migraine, it often leads to reduced migraine activity and, in some cases, elimination of migraine. Like others, he believes new analyses should be conducted.

“Everyone involved in this field believes there is something there,” Dr. Tobis said. The missing link is a clinical trial to confirm it.

Dr. Charles and Dr. Liu report no potential conflicts of interest. Dr. Tobis reports a financial relationship with Holistick Medical.