MDedge Emergency Medicine

Cancer loses … by a nose

Since the human nose is unpredictable at best, we’ve learned to rely on animals for our detailed nozzle needs. But researchers have found the next best thing to man’s best friend to accurately identify cancers.

A team at the University of Pennsylvania has developed an electronic olfaction, or “e-nose,” that has a 95% accuracy rate in distinguishing benign and malignant pancreatic and ovarian cancer cells from a single blood sample. How?

The e-nose system is equipped with nanosensors that are able to detect the volatile organic compounds (VOCs) emitted by cells in a blood sample. Not only does this create an opportunity for an easier, noninvasive screening practice, but it’s fast. The e-nose can distinguish VOCs from healthy to cancerous blood cells in 20 minutes or less and is just as effective in picking up on early- and late-stage cancers. 

Lonely/Thinkstock

Do you think this is a (food) game?

Dieting and eating healthy is tough, even during the best of times, and it has not been the best of times. With all respect to Charles Dickens, it’s been the worst of times, full stop. Millions of people have spent the past year sitting around their homes doing nothing, and it’s only natural that many would let their discipline slide.

Naturally, the solution to unhealthy eating habits is to sit down and play with your phone. No, that’s not the joke, the Food Trainer app, available on all cellular devices near you, is designed to encourage healthy eating by turning it into a game of sorts. When users open the app, they’re presented with images of food, and they’re trained to tap on images of healthy food and pass on images of unhealthy ones. The process takes less than 5 minutes.

It sounds really simple, but in a study of more than 1,000 people, consumption of junk food fell by 1 point on an 8-point scale (ranging from four times per day to zero to one time per month), participants lost about half a kilogram (a little over one pound), and more healthy food was eaten. Those who used the app more regularly, along the lines of 10 times per month or more, saw greater benefits.

PxHere

It’s time for a little mass kickin’

The universe, scientists tell us, is a big place. Really big. Chromosomes, scientists tell us, are small. Really small. But despite this very fundamental difference, the universe and chromosomes share a deep, dark secret: unexplained mass.

This being a medical publication, we’ll start with chromosomes. A group of researchers measured their mass with x-rays for the first time and found that “the 46 chromosomes in each of our cells weigh 242 picograms (trillionths of a gram). This is heavier than we would expect, and, if replicated, points to unexplained excess mass in chromosomes,” Ian K. Robinson, PhD, said in a written statement.

Archana Bhatiya et al.

A photo finish for the Smart Toilet

We know that poop can tell us a lot about our health, but new research by scientists at Duke University is really on a roll. Their Smart Toilet has been created to help people keep an eye on their bowel health. The device takes pictures of poop after it is flushed and can tell whether the consistency is loose, bloody, or normal.

The Smart Toilet can really help people with issues such as irritable bowel syndrome and inflammatory bowel disease by helping them, and their doctors, keep tabs on their poop. “Typically, gastroenterologists have to rely on patient self-reported information about their stool to help determine the cause of their gastrointestinal health issues, which can be very unreliable,” study lead author Deborah Fisher said.

SutidaS/iStock/Getty Images Plus

Cancer loses … by a nose

Since the human nose is unpredictable at best, we’ve learned to rely on animals for our detailed nozzle needs. But researchers have found the next best thing to man’s best friend to accurately identify cancers.

A team at the University of Pennsylvania has developed an electronic olfaction, or “e-nose,” that has a 95% accuracy rate in distinguishing benign and malignant pancreatic and ovarian cancer cells from a single blood sample. How?

The e-nose system is equipped with nanosensors that are able to detect the volatile organic compounds (VOCs) emitted by cells in a blood sample. Not only does this create an opportunity for an easier, noninvasive screening practice, but it’s fast. The e-nose can distinguish VOCs from healthy to cancerous blood cells in 20 minutes or less and is just as effective in picking up on early- and late-stage cancers. 

Lonely/Thinkstock

Do you think this is a (food) game?

Dieting and eating healthy is tough, even during the best of times, and it has not been the best of times. With all respect to Charles Dickens, it’s been the worst of times, full stop. Millions of people have spent the past year sitting around their homes doing nothing, and it’s only natural that many would let their discipline slide.

Naturally, the solution to unhealthy eating habits is to sit down and play with your phone. No, that’s not the joke, the Food Trainer app, available on all cellular devices near you, is designed to encourage healthy eating by turning it into a game of sorts. When users open the app, they’re presented with images of food, and they’re trained to tap on images of healthy food and pass on images of unhealthy ones. The process takes less than 5 minutes.

It sounds really simple, but in a study of more than 1,000 people, consumption of junk food fell by 1 point on an 8-point scale (ranging from four times per day to zero to one time per month), participants lost about half a kilogram (a little over one pound), and more healthy food was eaten. Those who used the app more regularly, along the lines of 10 times per month or more, saw greater benefits.

PxHere

It’s time for a little mass kickin’

The universe, scientists tell us, is a big place. Really big. Chromosomes, scientists tell us, are small. Really small. But despite this very fundamental difference, the universe and chromosomes share a deep, dark secret: unexplained mass.

This being a medical publication, we’ll start with chromosomes. A group of researchers measured their mass with x-rays for the first time and found that “the 46 chromosomes in each of our cells weigh 242 picograms (trillionths of a gram). This is heavier than we would expect, and, if replicated, points to unexplained excess mass in chromosomes,” Ian K. Robinson, PhD, said in a written statement.

Archana Bhatiya et al.

A photo finish for the Smart Toilet

We know that poop can tell us a lot about our health, but new research by scientists at Duke University is really on a roll. Their Smart Toilet has been created to help people keep an eye on their bowel health. The device takes pictures of poop after it is flushed and can tell whether the consistency is loose, bloody, or normal.

The Smart Toilet can really help people with issues such as irritable bowel syndrome and inflammatory bowel disease by helping them, and their doctors, keep tabs on their poop. “Typically, gastroenterologists have to rely on patient self-reported information about their stool to help determine the cause of their gastrointestinal health issues, which can be very unreliable,” study lead author Deborah Fisher said.

SutidaS/iStock/Getty Images Plus

Cancer loses … by a nose

Since the human nose is unpredictable at best, we’ve learned to rely on animals for our detailed nozzle needs. But researchers have found the next best thing to man’s best friend to accurately identify cancers.

A team at the University of Pennsylvania has developed an electronic olfaction, or “e-nose,” that has a 95% accuracy rate in distinguishing benign and malignant pancreatic and ovarian cancer cells from a single blood sample. How?

The e-nose system is equipped with nanosensors that are able to detect the volatile organic compounds (VOCs) emitted by cells in a blood sample. Not only does this create an opportunity for an easier, noninvasive screening practice, but it’s fast. The e-nose can distinguish VOCs from healthy to cancerous blood cells in 20 minutes or less and is just as effective in picking up on early- and late-stage cancers. 

Lonely/Thinkstock

Do you think this is a (food) game?

Dieting and eating healthy is tough, even during the best of times, and it has not been the best of times. With all respect to Charles Dickens, it’s been the worst of times, full stop. Millions of people have spent the past year sitting around their homes doing nothing, and it’s only natural that many would let their discipline slide.

Naturally, the solution to unhealthy eating habits is to sit down and play with your phone. No, that’s not the joke, the Food Trainer app, available on all cellular devices near you, is designed to encourage healthy eating by turning it into a game of sorts. When users open the app, they’re presented with images of food, and they’re trained to tap on images of healthy food and pass on images of unhealthy ones. The process takes less than 5 minutes.

It sounds really simple, but in a study of more than 1,000 people, consumption of junk food fell by 1 point on an 8-point scale (ranging from four times per day to zero to one time per month), participants lost about half a kilogram (a little over one pound), and more healthy food was eaten. Those who used the app more regularly, along the lines of 10 times per month or more, saw greater benefits.

PxHere

It’s time for a little mass kickin’

The universe, scientists tell us, is a big place. Really big. Chromosomes, scientists tell us, are small. Really small. But despite this very fundamental difference, the universe and chromosomes share a deep, dark secret: unexplained mass.

This being a medical publication, we’ll start with chromosomes. A group of researchers measured their mass with x-rays for the first time and found that “the 46 chromosomes in each of our cells weigh 242 picograms (trillionths of a gram). This is heavier than we would expect, and, if replicated, points to unexplained excess mass in chromosomes,” Ian K. Robinson, PhD, said in a written statement.

Archana Bhatiya et al.

A photo finish for the Smart Toilet

We know that poop can tell us a lot about our health, but new research by scientists at Duke University is really on a roll. Their Smart Toilet has been created to help people keep an eye on their bowel health. The device takes pictures of poop after it is flushed and can tell whether the consistency is loose, bloody, or normal.

The Smart Toilet can really help people with issues such as irritable bowel syndrome and inflammatory bowel disease by helping them, and their doctors, keep tabs on their poop. “Typically, gastroenterologists have to rely on patient self-reported information about their stool to help determine the cause of their gastrointestinal health issues, which can be very unreliable,” study lead author Deborah Fisher said.

SutidaS/iStock/Getty Images Plus

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

Pericardial fat is associated with a heightened risk for heart failure, particularly in women, new research suggests.

In a prospective cohort study of nearly 7,000 individuals, excess pericardial fat was linked to a higher risk for heart failure, even after adjustment for established risk factors for heart failure.

Women with high pericardial fat volume (PFV), defined as more than 70 cm³ or 2.4 fluid ounces, had double the risk of developing heart failure. For men, high PFV, defined as more than 120 cm³ or 4.0 fluid ounces, was associated with a 50% increase in the risk for heart failure.

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

“People will ask why should they measure fat around the heart. Why can’t they just take the waist circumference or body mass index as a measure for increased risk?” lead author Satish Kenchaiah, MD, MPH, Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Yet, when we adjusted for waist circumference, hip circumference, waist to hip ratio, and other known variables, pericardial fat was still associated with an increased risk of heart failure. This tells me that it is not just overall fat in the body but something about its location around the heart that is playing a role,” Dr. Kenchaiah said.

“Now that we have found an association between any amount of fat around the pericardium and heart failure, it gives us an impetus to build future research on identifying how exactly these fat deposits influence the development of cardiomyopathy,” he said.

Dr. Kenchaiah and colleagues investigated the association of pericardial fat with incident heart failure by examining chest CT scans from 6,785 participants (3,584 women and 3,201 men aged 45-84 years) in the Multi-Ethnic Study of Atherosclerosis.

The participants were from four different ethnic groups: 38% were White; 28% were Black, 22% were Hispanic, and 12% were Chinese American. They were recruited between July 17, 2000, and Aug. 31, 2002, from six communities in the United States: Baltimore and Baltimore County; Chicago; Forsyth County, N.C.; Los Angeles County northern Manhattan and the Bronx, New York; and St. Paul, Minn.

All participants were free of cardiovascular disease at baseline.

The researchers followed participants for more than 17 years. During this time, 385 (5.7%; 164 women and 221 men) developed newly diagnosed heart failure.

In women, the hazard ratio for every 42 cm³ increase in PFV was 1.44 (95% confidence interval, 1.21-1.71; P < .001). In men, the HR was 1.13 (95% CI, 1.01-1.27; P = .03).

High PVF conferred a twofold greater risk for heart failure in women (HR, 2.06; 95% CI, 1.48-2.87; P < .001) and a 53% higher risk in men (HR, 1.53; 95% CI, 1.13-2.07; P = .006).

These associations remained significant after further adjustment for circulating markers of systemic inflammation (that is, C-reactive protein and interleukin-6), and abdominal subcutaneous or visceral fat.

They also found that the heightened risk persisted, even after adjustment for established risk factors for heart failure, such as age, cigarette smoking, alcohol consumption, sedentary lifestyle, high blood pressure, high blood sugar, high cholesterol, and myocardial infarction.

Results were similar among all of the ethnic groups studied.
 

A surprise finding

“The most surprising part of this study was that the risk for heart failure with increased pericardial fat does not seem to be explained by obesity and systemic inflammation alone,” Andreas P. Kalogeropoulos, MD, MPH, PhD, Stony Brook (N.Y.) University, said in an interview.

“If pericardial fat was merely a proxy for increased visceral fat, one would expect the association of pericardial fat with heart failure risk to go away after factoring in abdominal CT findings, which was not the case here. Also, accounting for inflammatory markers did not change things dramatically. However, we need to be careful here, as abdominal CT scans have not been done simultaneously with the pericardial fat scans in the study,” said Dr. Kalogeropoulos, who coauthored an accompanying editorial with Michael E. Hall, MD, University of Mississippi Medical Center, Jackson.

The other striking finding, although not entirely surprising, was the stronger association of pericardial fat with heart failure risk in women, he noted.

“Although several clues have been reported pointing to women being more sensitive to the adverse cardiac effects of pericardial fat, this is the first large prospective study to connect the dots and show much higher risk in women in a convincing way. For the record, this is the first prospective study to show the connection between pericardial fat and heart failure risk altogether,” Dr. Kalogeropoulos said.

“Obviously, we need to do more work to see how we can use the important findings of Kenchaiah and colleagues to reduce risk for heart failure among patients with increased pericardial fat, especially women. For starters, we would need a way to identify these patients,” he said. “In this aspect, it is encouraging that pericardial fat can be measured in low-radiation CT scans, similar to those used for coronary calcium, and that automation technology to speed up pericardial fat measurements is already in the pipeline.

“The next step would be to see what kind of interventions would reduce risk for heart failure in these patients,” he added. “Weight loss would be an obvious thing, but novel agents with favorable cardiometabolic effects, like newer antidiabetic medications, are intriguing options, too.”

The study was supported by the National Heart, Lung, and Blood Institute and the National Institutes of Health. Dr. Kenchaiah and Dr. Kalogeropoulos reported no relevant financial relationships.

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

Pericardial fat is associated with a heightened risk for heart failure, particularly in women, new research suggests.

In a prospective cohort study of nearly 7,000 individuals, excess pericardial fat was linked to a higher risk for heart failure, even after adjustment for established risk factors for heart failure.

Women with high pericardial fat volume (PFV), defined as more than 70 cm³ or 2.4 fluid ounces, had double the risk of developing heart failure. For men, high PFV, defined as more than 120 cm³ or 4.0 fluid ounces, was associated with a 50% increase in the risk for heart failure.

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

“People will ask why should they measure fat around the heart. Why can’t they just take the waist circumference or body mass index as a measure for increased risk?” lead author Satish Kenchaiah, MD, MPH, Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Yet, when we adjusted for waist circumference, hip circumference, waist to hip ratio, and other known variables, pericardial fat was still associated with an increased risk of heart failure. This tells me that it is not just overall fat in the body but something about its location around the heart that is playing a role,” Dr. Kenchaiah said.

“Now that we have found an association between any amount of fat around the pericardium and heart failure, it gives us an impetus to build future research on identifying how exactly these fat deposits influence the development of cardiomyopathy,” he said.

Dr. Kenchaiah and colleagues investigated the association of pericardial fat with incident heart failure by examining chest CT scans from 6,785 participants (3,584 women and 3,201 men aged 45-84 years) in the Multi-Ethnic Study of Atherosclerosis.

The participants were from four different ethnic groups: 38% were White; 28% were Black, 22% were Hispanic, and 12% were Chinese American. They were recruited between July 17, 2000, and Aug. 31, 2002, from six communities in the United States: Baltimore and Baltimore County; Chicago; Forsyth County, N.C.; Los Angeles County northern Manhattan and the Bronx, New York; and St. Paul, Minn.

All participants were free of cardiovascular disease at baseline.

The researchers followed participants for more than 17 years. During this time, 385 (5.7%; 164 women and 221 men) developed newly diagnosed heart failure.

In women, the hazard ratio for every 42 cm³ increase in PFV was 1.44 (95% confidence interval, 1.21-1.71; P < .001). In men, the HR was 1.13 (95% CI, 1.01-1.27; P = .03).

High PVF conferred a twofold greater risk for heart failure in women (HR, 2.06; 95% CI, 1.48-2.87; P < .001) and a 53% higher risk in men (HR, 1.53; 95% CI, 1.13-2.07; P = .006).

These associations remained significant after further adjustment for circulating markers of systemic inflammation (that is, C-reactive protein and interleukin-6), and abdominal subcutaneous or visceral fat.

They also found that the heightened risk persisted, even after adjustment for established risk factors for heart failure, such as age, cigarette smoking, alcohol consumption, sedentary lifestyle, high blood pressure, high blood sugar, high cholesterol, and myocardial infarction.

Results were similar among all of the ethnic groups studied.
 

A surprise finding

“The most surprising part of this study was that the risk for heart failure with increased pericardial fat does not seem to be explained by obesity and systemic inflammation alone,” Andreas P. Kalogeropoulos, MD, MPH, PhD, Stony Brook (N.Y.) University, said in an interview.

“If pericardial fat was merely a proxy for increased visceral fat, one would expect the association of pericardial fat with heart failure risk to go away after factoring in abdominal CT findings, which was not the case here. Also, accounting for inflammatory markers did not change things dramatically. However, we need to be careful here, as abdominal CT scans have not been done simultaneously with the pericardial fat scans in the study,” said Dr. Kalogeropoulos, who coauthored an accompanying editorial with Michael E. Hall, MD, University of Mississippi Medical Center, Jackson.

The other striking finding, although not entirely surprising, was the stronger association of pericardial fat with heart failure risk in women, he noted.

“Although several clues have been reported pointing to women being more sensitive to the adverse cardiac effects of pericardial fat, this is the first large prospective study to connect the dots and show much higher risk in women in a convincing way. For the record, this is the first prospective study to show the connection between pericardial fat and heart failure risk altogether,” Dr. Kalogeropoulos said.

“Obviously, we need to do more work to see how we can use the important findings of Kenchaiah and colleagues to reduce risk for heart failure among patients with increased pericardial fat, especially women. For starters, we would need a way to identify these patients,” he said. “In this aspect, it is encouraging that pericardial fat can be measured in low-radiation CT scans, similar to those used for coronary calcium, and that automation technology to speed up pericardial fat measurements is already in the pipeline.

“The next step would be to see what kind of interventions would reduce risk for heart failure in these patients,” he added. “Weight loss would be an obvious thing, but novel agents with favorable cardiometabolic effects, like newer antidiabetic medications, are intriguing options, too.”

The study was supported by the National Heart, Lung, and Blood Institute and the National Institutes of Health. Dr. Kenchaiah and Dr. Kalogeropoulos reported no relevant financial relationships.

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

Pericardial fat is associated with a heightened risk for heart failure, particularly in women, new research suggests.

In a prospective cohort study of nearly 7,000 individuals, excess pericardial fat was linked to a higher risk for heart failure, even after adjustment for established risk factors for heart failure.

Women with high pericardial fat volume (PFV), defined as more than 70 cm³ or 2.4 fluid ounces, had double the risk of developing heart failure. For men, high PFV, defined as more than 120 cm³ or 4.0 fluid ounces, was associated with a 50% increase in the risk for heart failure.

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

“People will ask why should they measure fat around the heart. Why can’t they just take the waist circumference or body mass index as a measure for increased risk?” lead author Satish Kenchaiah, MD, MPH, Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Yet, when we adjusted for waist circumference, hip circumference, waist to hip ratio, and other known variables, pericardial fat was still associated with an increased risk of heart failure. This tells me that it is not just overall fat in the body but something about its location around the heart that is playing a role,” Dr. Kenchaiah said.

“Now that we have found an association between any amount of fat around the pericardium and heart failure, it gives us an impetus to build future research on identifying how exactly these fat deposits influence the development of cardiomyopathy,” he said.

Dr. Kenchaiah and colleagues investigated the association of pericardial fat with incident heart failure by examining chest CT scans from 6,785 participants (3,584 women and 3,201 men aged 45-84 years) in the Multi-Ethnic Study of Atherosclerosis.

The participants were from four different ethnic groups: 38% were White; 28% were Black, 22% were Hispanic, and 12% were Chinese American. They were recruited between July 17, 2000, and Aug. 31, 2002, from six communities in the United States: Baltimore and Baltimore County; Chicago; Forsyth County, N.C.; Los Angeles County northern Manhattan and the Bronx, New York; and St. Paul, Minn.

All participants were free of cardiovascular disease at baseline.

The researchers followed participants for more than 17 years. During this time, 385 (5.7%; 164 women and 221 men) developed newly diagnosed heart failure.

In women, the hazard ratio for every 42 cm³ increase in PFV was 1.44 (95% confidence interval, 1.21-1.71; P < .001). In men, the HR was 1.13 (95% CI, 1.01-1.27; P = .03).

High PVF conferred a twofold greater risk for heart failure in women (HR, 2.06; 95% CI, 1.48-2.87; P < .001) and a 53% higher risk in men (HR, 1.53; 95% CI, 1.13-2.07; P = .006).

These associations remained significant after further adjustment for circulating markers of systemic inflammation (that is, C-reactive protein and interleukin-6), and abdominal subcutaneous or visceral fat.

They also found that the heightened risk persisted, even after adjustment for established risk factors for heart failure, such as age, cigarette smoking, alcohol consumption, sedentary lifestyle, high blood pressure, high blood sugar, high cholesterol, and myocardial infarction.

Results were similar among all of the ethnic groups studied.
 

A surprise finding

“The most surprising part of this study was that the risk for heart failure with increased pericardial fat does not seem to be explained by obesity and systemic inflammation alone,” Andreas P. Kalogeropoulos, MD, MPH, PhD, Stony Brook (N.Y.) University, said in an interview.

“If pericardial fat was merely a proxy for increased visceral fat, one would expect the association of pericardial fat with heart failure risk to go away after factoring in abdominal CT findings, which was not the case here. Also, accounting for inflammatory markers did not change things dramatically. However, we need to be careful here, as abdominal CT scans have not been done simultaneously with the pericardial fat scans in the study,” said Dr. Kalogeropoulos, who coauthored an accompanying editorial with Michael E. Hall, MD, University of Mississippi Medical Center, Jackson.

The other striking finding, although not entirely surprising, was the stronger association of pericardial fat with heart failure risk in women, he noted.

“Although several clues have been reported pointing to women being more sensitive to the adverse cardiac effects of pericardial fat, this is the first large prospective study to connect the dots and show much higher risk in women in a convincing way. For the record, this is the first prospective study to show the connection between pericardial fat and heart failure risk altogether,” Dr. Kalogeropoulos said.

“Obviously, we need to do more work to see how we can use the important findings of Kenchaiah and colleagues to reduce risk for heart failure among patients with increased pericardial fat, especially women. For starters, we would need a way to identify these patients,” he said. “In this aspect, it is encouraging that pericardial fat can be measured in low-radiation CT scans, similar to those used for coronary calcium, and that automation technology to speed up pericardial fat measurements is already in the pipeline.

“The next step would be to see what kind of interventions would reduce risk for heart failure in these patients,” he added. “Weight loss would be an obvious thing, but novel agents with favorable cardiometabolic effects, like newer antidiabetic medications, are intriguing options, too.”

The study was supported by the National Heart, Lung, and Blood Institute and the National Institutes of Health. Dr. Kenchaiah and Dr. Kalogeropoulos reported no relevant financial relationships.

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

The American Association of Clinical Endocrinology (AACE) has issued its first-ever official guidelines addressing the use of advanced technologies in the management of people with diabetes.

They were presented on May 28 at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists and simultaneously published in Endocrine Practice.

Previous AACE guidance on the clinical use of insulin pumps and CGM over the past decade has been published in the form of consensus or position statements rather than official evidence-based guidelines, task force cochair George Grunberger, MD, of the Grunberger Diabetes Institute, Bloomfield Hills, Mich., explained.

“There’s never really been, until now, hardcore evidence, [with] peer-reviewed, quality trials published in the literature to go after the evidence that is required for guidelines. ... This is not an opinion piece or position statement.”

The problem with that strict approach to “guidelines” is how quickly the diabetes technology field is evolving, he acknowledged. “It’s frustrating because we know what’s [coming up], but we can’t put it in a guideline because it hasn’t been published yet.”

In an AACE podcast, Dr. Grunberger said the guidelines will likely become a “living” document, along the lines of the American Diabetes Association’s annual Standards of Care, as “any cutoff date is arbitrary. More and more papers will be published on these technologies. ... This is certainly not a static field.”

In the meantime, task force cochair and author Jennifer Sherr, MD, PhD, a pediatric endocrinologist, said she hopes the guidelines will help to reduce insurance company barriers to use of the currently available technologies.

“I am very hopeful that these guidelines will also encourage payers to change their stance. And I think that we as a community can continue to advocate and inform them of these guidelines so they can appropriately change their coverage practices,” added Dr. Sherr, of Yale University, New Haven, Conn.
 

Recommendations address CGM, pumps, and connected systems

In the guidelines, CGM is “strongly recommended for all persons with diabetes treated with intensive insulin therapy, defined as three or more injections of insulin per day or the use of an insulin pump.” For those with diabetes who use CGM, “priority metrics” include a “time in range” of greater than 70% from 14 days of active use. Targets for mean glucose should be individualized, with glycemic variability 36% or lower.

Further specific CGM target metrics are given for people with type 1 diabetes, older/high risk individuals, and for pregnant women. The recommendations align with those issued in a 2019 joint consensus statement on CGM time-in-range endorsed by several organizations, including AACE.    

In response to an audience question about whether AACE is advising that time-in-range replace A1c for glycemia assessment, Dr. Sherr responded: “I think currently we’re not in a position where we can completely replace A1c with time in range. However, I’m hopeful that in future years we’ll see further data gathered ... to allow for that recommendation to occur.”

For now, she said, “What we really want to hone in on in the guidelines is that time-in-range and use of CGM truly allow clinicians to better understand how to optimize care for their persons with diabetes. It gives us a better picture. It’s not just a number of whether we’re hitting target. It tells us whether we need to attack time above range or time below range. So we really think it’s critical for clinical care.”

The document also provides specifics about real-time versus intermittently scanned CGM and use of diagnostic/professional CGM.

The “insulin delivery technologies” section covers use of connected pens, insulin pumps without CGM, insulin pumps with separate CGM, and the more advanced combined insulin pump-CGM systems including those with low-glucose suspend, predictive low-glucose suspend, and hybrid closed-loops (sometimes called the artificial pancreas).

In general, these automated insulin delivery systems (artificial pancreas), “are strongly recommended for all persons with [type 1 diabetes], since their use has been shown to increase time in range, especially in the overnight period, without causing an increased risk of hypoglycemia,” Dr. Sherr observed.
 

Other tech topics: Apps, telemedicine, and safety

The new guidelines say that “clinically validated” smartphone apps should be recommended to help teach or reinforce diabetes self-management skills and provide support and encouragement for healthy behaviors around food and exercise.

Dr. Grunberger pointed out: “As we know, there are tons of apps out there, and patients are using them. The problem is that very few of them have actually been validated in clinical trials in published peer-reviewed [journals].”

He recommended a joint statement on diabetes apps from the American Diabetes Association and the European Association for the Study of Diabetes that was initially discussed at the 2019 EASD meeting, as reported by this news organization, and subsequently published in January 2020 in Diabetes Care and Diabetologia.

“Telemedicine, including periodic phone calls, smartphone-web interactions ... by health care professionals ... is strongly recommended to treat persons with diabetes, provide diabetes education, remotely monitor glucose and/or insulin data to indicate the need for therapy adjustments, and improve diabetes-related outcomes/control with better engagement,” the document says.

Safety concerns addressed include the issue of certain medications interfering with CGM [readings] ... including acetaminophen, high-dose vitamin C, and hydroxyurea, as well as cautions about what to do in the event of device malfunction and assessing that the patient is sufficiently trained in proper device use. Criteria for insulin pump discontinuation are also given.
 

Implementation: Who will be prescribing? ‘This is not for amateurs’

A final section on implementation recommends that “initiation and use of diabetes technology should be implemented by health care professionals who are trained, committed, and experienced to prescribe and direct the use of these tools. Clinicians should have the infrastructure to support the needs of persons with diabetes using the technology.”

Dr. Grunberger commented: “I think the key is going to be who should be doing this? What is the role of a clinical endocrinologist in the future? What is our responsibility, [since] we don’t have the manpower and womanpower to take care of all these people as these technologies advance? It’s our responsibility to provide these hopefully valued recommendations as a resource for those who want to know more about it.”

However, he noted, “This is not for amateurs. If you want to actually use this in your practice, you need the infrastructure, the expertise, the training, the dedication, and the energy to be there for the patients all the time ... This clinical practice guideline is a foundation.”

Dr. Sherr added: “To me, it’s really thinking about ... changing our mindset from who is an appropriate candidate to who can benefit and how vast a group that entails ... I’m hopeful that we will see more technology use through continued conversations with our patients with diabetes, and hopefully through more clinicians being excited to be part of this revolution.”

Dr. Grunberger has reported being on speakers bureaus for Eli Lilly, Novo Nordisk, and Abbott. Dr. Sherr has reported being a consultant and speaker for Lilly and Medtronic Diabetes, a consultant for Insulet and Sanofi, and on advisory boards for Bigfoot Biomedical, Cecelia Health, Insulet, JDRF T1D fund, and Medtronic.

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

The American Association of Clinical Endocrinology (AACE) has issued its first-ever official guidelines addressing the use of advanced technologies in the management of people with diabetes.

They were presented on May 28 at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists and simultaneously published in Endocrine Practice.

Previous AACE guidance on the clinical use of insulin pumps and CGM over the past decade has been published in the form of consensus or position statements rather than official evidence-based guidelines, task force cochair George Grunberger, MD, of the Grunberger Diabetes Institute, Bloomfield Hills, Mich., explained.

“There’s never really been, until now, hardcore evidence, [with] peer-reviewed, quality trials published in the literature to go after the evidence that is required for guidelines. ... This is not an opinion piece or position statement.”

The problem with that strict approach to “guidelines” is how quickly the diabetes technology field is evolving, he acknowledged. “It’s frustrating because we know what’s [coming up], but we can’t put it in a guideline because it hasn’t been published yet.”

In an AACE podcast, Dr. Grunberger said the guidelines will likely become a “living” document, along the lines of the American Diabetes Association’s annual Standards of Care, as “any cutoff date is arbitrary. More and more papers will be published on these technologies. ... This is certainly not a static field.”

In the meantime, task force cochair and author Jennifer Sherr, MD, PhD, a pediatric endocrinologist, said she hopes the guidelines will help to reduce insurance company barriers to use of the currently available technologies.

“I am very hopeful that these guidelines will also encourage payers to change their stance. And I think that we as a community can continue to advocate and inform them of these guidelines so they can appropriately change their coverage practices,” added Dr. Sherr, of Yale University, New Haven, Conn.
 

Recommendations address CGM, pumps, and connected systems

In the guidelines, CGM is “strongly recommended for all persons with diabetes treated with intensive insulin therapy, defined as three or more injections of insulin per day or the use of an insulin pump.” For those with diabetes who use CGM, “priority metrics” include a “time in range” of greater than 70% from 14 days of active use. Targets for mean glucose should be individualized, with glycemic variability 36% or lower.

Further specific CGM target metrics are given for people with type 1 diabetes, older/high risk individuals, and for pregnant women. The recommendations align with those issued in a 2019 joint consensus statement on CGM time-in-range endorsed by several organizations, including AACE.    

In response to an audience question about whether AACE is advising that time-in-range replace A1c for glycemia assessment, Dr. Sherr responded: “I think currently we’re not in a position where we can completely replace A1c with time in range. However, I’m hopeful that in future years we’ll see further data gathered ... to allow for that recommendation to occur.”

For now, she said, “What we really want to hone in on in the guidelines is that time-in-range and use of CGM truly allow clinicians to better understand how to optimize care for their persons with diabetes. It gives us a better picture. It’s not just a number of whether we’re hitting target. It tells us whether we need to attack time above range or time below range. So we really think it’s critical for clinical care.”

The document also provides specifics about real-time versus intermittently scanned CGM and use of diagnostic/professional CGM.

The “insulin delivery technologies” section covers use of connected pens, insulin pumps without CGM, insulin pumps with separate CGM, and the more advanced combined insulin pump-CGM systems including those with low-glucose suspend, predictive low-glucose suspend, and hybrid closed-loops (sometimes called the artificial pancreas).

In general, these automated insulin delivery systems (artificial pancreas), “are strongly recommended for all persons with [type 1 diabetes], since their use has been shown to increase time in range, especially in the overnight period, without causing an increased risk of hypoglycemia,” Dr. Sherr observed.
 

Other tech topics: Apps, telemedicine, and safety

The new guidelines say that “clinically validated” smartphone apps should be recommended to help teach or reinforce diabetes self-management skills and provide support and encouragement for healthy behaviors around food and exercise.

Dr. Grunberger pointed out: “As we know, there are tons of apps out there, and patients are using them. The problem is that very few of them have actually been validated in clinical trials in published peer-reviewed [journals].”

He recommended a joint statement on diabetes apps from the American Diabetes Association and the European Association for the Study of Diabetes that was initially discussed at the 2019 EASD meeting, as reported by this news organization, and subsequently published in January 2020 in Diabetes Care and Diabetologia.

“Telemedicine, including periodic phone calls, smartphone-web interactions ... by health care professionals ... is strongly recommended to treat persons with diabetes, provide diabetes education, remotely monitor glucose and/or insulin data to indicate the need for therapy adjustments, and improve diabetes-related outcomes/control with better engagement,” the document says.

Safety concerns addressed include the issue of certain medications interfering with CGM [readings] ... including acetaminophen, high-dose vitamin C, and hydroxyurea, as well as cautions about what to do in the event of device malfunction and assessing that the patient is sufficiently trained in proper device use. Criteria for insulin pump discontinuation are also given.
 

Implementation: Who will be prescribing? ‘This is not for amateurs’

A final section on implementation recommends that “initiation and use of diabetes technology should be implemented by health care professionals who are trained, committed, and experienced to prescribe and direct the use of these tools. Clinicians should have the infrastructure to support the needs of persons with diabetes using the technology.”

Dr. Grunberger commented: “I think the key is going to be who should be doing this? What is the role of a clinical endocrinologist in the future? What is our responsibility, [since] we don’t have the manpower and womanpower to take care of all these people as these technologies advance? It’s our responsibility to provide these hopefully valued recommendations as a resource for those who want to know more about it.”

However, he noted, “This is not for amateurs. If you want to actually use this in your practice, you need the infrastructure, the expertise, the training, the dedication, and the energy to be there for the patients all the time ... This clinical practice guideline is a foundation.”

Dr. Sherr added: “To me, it’s really thinking about ... changing our mindset from who is an appropriate candidate to who can benefit and how vast a group that entails ... I’m hopeful that we will see more technology use through continued conversations with our patients with diabetes, and hopefully through more clinicians being excited to be part of this revolution.”

Dr. Grunberger has reported being on speakers bureaus for Eli Lilly, Novo Nordisk, and Abbott. Dr. Sherr has reported being a consultant and speaker for Lilly and Medtronic Diabetes, a consultant for Insulet and Sanofi, and on advisory boards for Bigfoot Biomedical, Cecelia Health, Insulet, JDRF T1D fund, and Medtronic.

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

The American Association of Clinical Endocrinology (AACE) has issued its first-ever official guidelines addressing the use of advanced technologies in the management of people with diabetes.

They were presented on May 28 at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists and simultaneously published in Endocrine Practice.

Previous AACE guidance on the clinical use of insulin pumps and CGM over the past decade has been published in the form of consensus or position statements rather than official evidence-based guidelines, task force cochair George Grunberger, MD, of the Grunberger Diabetes Institute, Bloomfield Hills, Mich., explained.

“There’s never really been, until now, hardcore evidence, [with] peer-reviewed, quality trials published in the literature to go after the evidence that is required for guidelines. ... This is not an opinion piece or position statement.”

The problem with that strict approach to “guidelines” is how quickly the diabetes technology field is evolving, he acknowledged. “It’s frustrating because we know what’s [coming up], but we can’t put it in a guideline because it hasn’t been published yet.”

In an AACE podcast, Dr. Grunberger said the guidelines will likely become a “living” document, along the lines of the American Diabetes Association’s annual Standards of Care, as “any cutoff date is arbitrary. More and more papers will be published on these technologies. ... This is certainly not a static field.”

In the meantime, task force cochair and author Jennifer Sherr, MD, PhD, a pediatric endocrinologist, said she hopes the guidelines will help to reduce insurance company barriers to use of the currently available technologies.

“I am very hopeful that these guidelines will also encourage payers to change their stance. And I think that we as a community can continue to advocate and inform them of these guidelines so they can appropriately change their coverage practices,” added Dr. Sherr, of Yale University, New Haven, Conn.
 

Recommendations address CGM, pumps, and connected systems

In the guidelines, CGM is “strongly recommended for all persons with diabetes treated with intensive insulin therapy, defined as three or more injections of insulin per day or the use of an insulin pump.” For those with diabetes who use CGM, “priority metrics” include a “time in range” of greater than 70% from 14 days of active use. Targets for mean glucose should be individualized, with glycemic variability 36% or lower.

Further specific CGM target metrics are given for people with type 1 diabetes, older/high risk individuals, and for pregnant women. The recommendations align with those issued in a 2019 joint consensus statement on CGM time-in-range endorsed by several organizations, including AACE.    

In response to an audience question about whether AACE is advising that time-in-range replace A1c for glycemia assessment, Dr. Sherr responded: “I think currently we’re not in a position where we can completely replace A1c with time in range. However, I’m hopeful that in future years we’ll see further data gathered ... to allow for that recommendation to occur.”

For now, she said, “What we really want to hone in on in the guidelines is that time-in-range and use of CGM truly allow clinicians to better understand how to optimize care for their persons with diabetes. It gives us a better picture. It’s not just a number of whether we’re hitting target. It tells us whether we need to attack time above range or time below range. So we really think it’s critical for clinical care.”

The document also provides specifics about real-time versus intermittently scanned CGM and use of diagnostic/professional CGM.

The “insulin delivery technologies” section covers use of connected pens, insulin pumps without CGM, insulin pumps with separate CGM, and the more advanced combined insulin pump-CGM systems including those with low-glucose suspend, predictive low-glucose suspend, and hybrid closed-loops (sometimes called the artificial pancreas).

In general, these automated insulin delivery systems (artificial pancreas), “are strongly recommended for all persons with [type 1 diabetes], since their use has been shown to increase time in range, especially in the overnight period, without causing an increased risk of hypoglycemia,” Dr. Sherr observed.
 

Other tech topics: Apps, telemedicine, and safety

The new guidelines say that “clinically validated” smartphone apps should be recommended to help teach or reinforce diabetes self-management skills and provide support and encouragement for healthy behaviors around food and exercise.

Dr. Grunberger pointed out: “As we know, there are tons of apps out there, and patients are using them. The problem is that very few of them have actually been validated in clinical trials in published peer-reviewed [journals].”

He recommended a joint statement on diabetes apps from the American Diabetes Association and the European Association for the Study of Diabetes that was initially discussed at the 2019 EASD meeting, as reported by this news organization, and subsequently published in January 2020 in Diabetes Care and Diabetologia.

“Telemedicine, including periodic phone calls, smartphone-web interactions ... by health care professionals ... is strongly recommended to treat persons with diabetes, provide diabetes education, remotely monitor glucose and/or insulin data to indicate the need for therapy adjustments, and improve diabetes-related outcomes/control with better engagement,” the document says.

Safety concerns addressed include the issue of certain medications interfering with CGM [readings] ... including acetaminophen, high-dose vitamin C, and hydroxyurea, as well as cautions about what to do in the event of device malfunction and assessing that the patient is sufficiently trained in proper device use. Criteria for insulin pump discontinuation are also given.
 

Implementation: Who will be prescribing? ‘This is not for amateurs’

A final section on implementation recommends that “initiation and use of diabetes technology should be implemented by health care professionals who are trained, committed, and experienced to prescribe and direct the use of these tools. Clinicians should have the infrastructure to support the needs of persons with diabetes using the technology.”

Dr. Grunberger commented: “I think the key is going to be who should be doing this? What is the role of a clinical endocrinologist in the future? What is our responsibility, [since] we don’t have the manpower and womanpower to take care of all these people as these technologies advance? It’s our responsibility to provide these hopefully valued recommendations as a resource for those who want to know more about it.”

However, he noted, “This is not for amateurs. If you want to actually use this in your practice, you need the infrastructure, the expertise, the training, the dedication, and the energy to be there for the patients all the time ... This clinical practice guideline is a foundation.”

Dr. Sherr added: “To me, it’s really thinking about ... changing our mindset from who is an appropriate candidate to who can benefit and how vast a group that entails ... I’m hopeful that we will see more technology use through continued conversations with our patients with diabetes, and hopefully through more clinicians being excited to be part of this revolution.”

Dr. Grunberger has reported being on speakers bureaus for Eli Lilly, Novo Nordisk, and Abbott. Dr. Sherr has reported being a consultant and speaker for Lilly and Medtronic Diabetes, a consultant for Insulet and Sanofi, and on advisory boards for Bigfoot Biomedical, Cecelia Health, Insulet, JDRF T1D fund, and Medtronic.

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

A subcutaneous dose of the second-generation glycoprotein IIb/IIIa inhibitor RUC-4 achieved rapid dose-dependent platelet inhibition in patients with ST-segment elevation MI (STEMI) undergoing stenting in the CEL-02 study.

Platelet inhibition occurred within 15 minutes among the 27 patients, and wore off rapidly, with almost 50% of platelet function recovered within 122 minutes.

The drug was well tolerated, with no thrombocytopenia in the first 72 hours after administration, one injection-site reaction, and two major bleeds likely caused by catheter-based trauma to the proximal radial artery, reported Jurrien ten Berg, MD, PhD, St. Antonius Hospital, Nieuwegein, the Netherlands.

The results were reported during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) and published simultaneously in EuroIntervention.

Dr. ten Berg noted that there is a need for drugs like RUC-4 in the early treatment of STEMI because oral P2Y12 inhibitors have a “seriously delayed” onset by about 2-4 hours. Prehospital use of the glycoprotein inhibitor (GPI) tirofiban was shown to improve reperfusion and late outcomes in the ON-TIME 2 trial, but GPIs require continuous intravenous administration and are associated with thrombocytopenia.

“Since RUC-4 is unique among small-molecule GPI in not inducing the receptor to undergo a major conformational change that has been implicated in the development of thrombocytopenia, it is possible that RUC-4 may be associated with fewer episodes of thrombocytopenia than current GPI,” the authors wrote.

RUC-4, also called zalunfiban, can be delivered with a single subcutaneous dose and, in a phase 1 study, demonstrated platelet inhibition within 15 minutes and was well tolerated up to a dose of 0.075 mg/kg among healthy volunteers and patients with stable coronary artery disease on aspirin.

In the CEL-02 study, 27 STEMI patients received a weight-adjusted subcutaneous injection of RUC-4 before primary percutaneous coronary intervention (PCI) in escalating doses of 0.075 mg/kg, 0.090 mg/kg, and 0.110 mg/kg. Patients were given standard treatment in the ambulance, which included aspirin (93%), ticagrelor (93%), and unfractionated heparin (96%). The activated clotting time was less than 200 seconds in 92% of patients who received additional heparin during cardiac catheterization.

The patients’ mean age was 62 years, 26% were women, and 96% were White. Pharmacodynamic data were available for 24 patients.

The average platelet inhibition 15 minutes after the injection was 77.5%, 87.5%, and 91.7%, respectively, for the three escalating doses (P = .002 for trend).

The primary endpoint of at least 77% inhibition of the iso-TRAP channel – which corresponds to 80% inhibition of light transmission aggregometry stimulated by 20 mcM adenosine diphosphate within 15 minutes – was achieved in three of eight patients at the lowest dose and in seven of eight patients at the middle and highest doses.

“Single-dose subcutaneous RUC-4 induces a fast, potent dose-dependent response of platelet inhibition in patients with STEMI presenting for primary PCI,” Dr. ten Berg concluded. “It is therefore promising for prehospital platelet inhibition in STEMI patients, and the results support further research on clinical benefit.”

The double-blind, randomized phase 2b CELEBRATE trial is underway, evaluating 1,668 STEMI patients treated with a 0.110 mg/kg or 0.130 mg/kg dose of RUC-4 or placebo in the ambulance. The coprimary outcomes are restoration of coronary artery blood flow and resolution of ST-segment deviation post-PCI/angiography. Primary completion is set for March 2023.

MDedge News

Marco Valgimigli, MD, who was not involved in the study, said in an interview that RUC-4 has “some theoretical advantages, compared with conventional IIb/IIIa inhibitors, namely the absence of thrombocytopenia which is, however, relatively rare, especially with tirofiban or eptifibatide.”

The subcutaneous approach may also offer an advantage. Yet, if the administration of RUC-4 is “to happen in the ambulance – a setting where an IV line is usually established – whether the subcutaneous versus IV administration of the treatment proves to be advantageous remains to be seen,” said Dr. Valgimigli, from Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.

“We would need to see the results of large randomized trials embracing this treatment option before a clinical decision can be made, especially considering that IIb/IIa inhibitors in the ambulance have been tested in the past but ultimately abandoned,” he said.

Limitations of the study are its open-label design, the fact that iso-TRAP channel assay data were not reported by the VeryifyNow instrument and had to be calculated from the raw data, and the fact that the timing of the RUC-4 injection immediately before PCI does not fully resemble the expected use of RUC-4 in clinical practice, where RUC-4 would be administered at the same time as the aspirin, ticagrelor, and heparin, and about an hour before PCI, ten Berg and colleagues wrote.

CeleCor Therapeutics sponsored the study and provided study materials. Dr. ten Berg reported receiving lecture or consultancy fees from AstraZeneca, Eli Lilly, Daiichi Sankyo, The Medicines Company, AccuMetrics, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Bayer, Ferrer, and Idorsia, and institutional research grants from ZonMw and AstraZeneca. Coauthor Barry S. Coller is an inventor of RUC-4 and a founder, equity holder, and consultant to CeleCor. He also receives royalties from Centocor/Janssen and the VerifyNow assays. Dr. Valgimigli has received grants from Abbott, Terumo, Medicure, and AstraZeneca, and personal fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, Alvimedica, AstraZeneca, Biosensors, and Idorsia.

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

A subcutaneous dose of the second-generation glycoprotein IIb/IIIa inhibitor RUC-4 achieved rapid dose-dependent platelet inhibition in patients with ST-segment elevation MI (STEMI) undergoing stenting in the CEL-02 study.

Platelet inhibition occurred within 15 minutes among the 27 patients, and wore off rapidly, with almost 50% of platelet function recovered within 122 minutes.

The drug was well tolerated, with no thrombocytopenia in the first 72 hours after administration, one injection-site reaction, and two major bleeds likely caused by catheter-based trauma to the proximal radial artery, reported Jurrien ten Berg, MD, PhD, St. Antonius Hospital, Nieuwegein, the Netherlands.

The results were reported during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) and published simultaneously in EuroIntervention.

Dr. ten Berg noted that there is a need for drugs like RUC-4 in the early treatment of STEMI because oral P2Y12 inhibitors have a “seriously delayed” onset by about 2-4 hours. Prehospital use of the glycoprotein inhibitor (GPI) tirofiban was shown to improve reperfusion and late outcomes in the ON-TIME 2 trial, but GPIs require continuous intravenous administration and are associated with thrombocytopenia.

“Since RUC-4 is unique among small-molecule GPI in not inducing the receptor to undergo a major conformational change that has been implicated in the development of thrombocytopenia, it is possible that RUC-4 may be associated with fewer episodes of thrombocytopenia than current GPI,” the authors wrote.

RUC-4, also called zalunfiban, can be delivered with a single subcutaneous dose and, in a phase 1 study, demonstrated platelet inhibition within 15 minutes and was well tolerated up to a dose of 0.075 mg/kg among healthy volunteers and patients with stable coronary artery disease on aspirin.

In the CEL-02 study, 27 STEMI patients received a weight-adjusted subcutaneous injection of RUC-4 before primary percutaneous coronary intervention (PCI) in escalating doses of 0.075 mg/kg, 0.090 mg/kg, and 0.110 mg/kg. Patients were given standard treatment in the ambulance, which included aspirin (93%), ticagrelor (93%), and unfractionated heparin (96%). The activated clotting time was less than 200 seconds in 92% of patients who received additional heparin during cardiac catheterization.

The patients’ mean age was 62 years, 26% were women, and 96% were White. Pharmacodynamic data were available for 24 patients.

The average platelet inhibition 15 minutes after the injection was 77.5%, 87.5%, and 91.7%, respectively, for the three escalating doses (P = .002 for trend).

The primary endpoint of at least 77% inhibition of the iso-TRAP channel – which corresponds to 80% inhibition of light transmission aggregometry stimulated by 20 mcM adenosine diphosphate within 15 minutes – was achieved in three of eight patients at the lowest dose and in seven of eight patients at the middle and highest doses.

“Single-dose subcutaneous RUC-4 induces a fast, potent dose-dependent response of platelet inhibition in patients with STEMI presenting for primary PCI,” Dr. ten Berg concluded. “It is therefore promising for prehospital platelet inhibition in STEMI patients, and the results support further research on clinical benefit.”

The double-blind, randomized phase 2b CELEBRATE trial is underway, evaluating 1,668 STEMI patients treated with a 0.110 mg/kg or 0.130 mg/kg dose of RUC-4 or placebo in the ambulance. The coprimary outcomes are restoration of coronary artery blood flow and resolution of ST-segment deviation post-PCI/angiography. Primary completion is set for March 2023.

MDedge News

Marco Valgimigli, MD, who was not involved in the study, said in an interview that RUC-4 has “some theoretical advantages, compared with conventional IIb/IIIa inhibitors, namely the absence of thrombocytopenia which is, however, relatively rare, especially with tirofiban or eptifibatide.”

The subcutaneous approach may also offer an advantage. Yet, if the administration of RUC-4 is “to happen in the ambulance – a setting where an IV line is usually established – whether the subcutaneous versus IV administration of the treatment proves to be advantageous remains to be seen,” said Dr. Valgimigli, from Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.

“We would need to see the results of large randomized trials embracing this treatment option before a clinical decision can be made, especially considering that IIb/IIa inhibitors in the ambulance have been tested in the past but ultimately abandoned,” he said.

Limitations of the study are its open-label design, the fact that iso-TRAP channel assay data were not reported by the VeryifyNow instrument and had to be calculated from the raw data, and the fact that the timing of the RUC-4 injection immediately before PCI does not fully resemble the expected use of RUC-4 in clinical practice, where RUC-4 would be administered at the same time as the aspirin, ticagrelor, and heparin, and about an hour before PCI, ten Berg and colleagues wrote.

CeleCor Therapeutics sponsored the study and provided study materials. Dr. ten Berg reported receiving lecture or consultancy fees from AstraZeneca, Eli Lilly, Daiichi Sankyo, The Medicines Company, AccuMetrics, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Bayer, Ferrer, and Idorsia, and institutional research grants from ZonMw and AstraZeneca. Coauthor Barry S. Coller is an inventor of RUC-4 and a founder, equity holder, and consultant to CeleCor. He also receives royalties from Centocor/Janssen and the VerifyNow assays. Dr. Valgimigli has received grants from Abbott, Terumo, Medicure, and AstraZeneca, and personal fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, Alvimedica, AstraZeneca, Biosensors, and Idorsia.

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

A subcutaneous dose of the second-generation glycoprotein IIb/IIIa inhibitor RUC-4 achieved rapid dose-dependent platelet inhibition in patients with ST-segment elevation MI (STEMI) undergoing stenting in the CEL-02 study.

Platelet inhibition occurred within 15 minutes among the 27 patients, and wore off rapidly, with almost 50% of platelet function recovered within 122 minutes.

The drug was well tolerated, with no thrombocytopenia in the first 72 hours after administration, one injection-site reaction, and two major bleeds likely caused by catheter-based trauma to the proximal radial artery, reported Jurrien ten Berg, MD, PhD, St. Antonius Hospital, Nieuwegein, the Netherlands.

The results were reported during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) and published simultaneously in EuroIntervention.

Dr. ten Berg noted that there is a need for drugs like RUC-4 in the early treatment of STEMI because oral P2Y12 inhibitors have a “seriously delayed” onset by about 2-4 hours. Prehospital use of the glycoprotein inhibitor (GPI) tirofiban was shown to improve reperfusion and late outcomes in the ON-TIME 2 trial, but GPIs require continuous intravenous administration and are associated with thrombocytopenia.

“Since RUC-4 is unique among small-molecule GPI in not inducing the receptor to undergo a major conformational change that has been implicated in the development of thrombocytopenia, it is possible that RUC-4 may be associated with fewer episodes of thrombocytopenia than current GPI,” the authors wrote.

RUC-4, also called zalunfiban, can be delivered with a single subcutaneous dose and, in a phase 1 study, demonstrated platelet inhibition within 15 minutes and was well tolerated up to a dose of 0.075 mg/kg among healthy volunteers and patients with stable coronary artery disease on aspirin.

In the CEL-02 study, 27 STEMI patients received a weight-adjusted subcutaneous injection of RUC-4 before primary percutaneous coronary intervention (PCI) in escalating doses of 0.075 mg/kg, 0.090 mg/kg, and 0.110 mg/kg. Patients were given standard treatment in the ambulance, which included aspirin (93%), ticagrelor (93%), and unfractionated heparin (96%). The activated clotting time was less than 200 seconds in 92% of patients who received additional heparin during cardiac catheterization.

The patients’ mean age was 62 years, 26% were women, and 96% were White. Pharmacodynamic data were available for 24 patients.

The average platelet inhibition 15 minutes after the injection was 77.5%, 87.5%, and 91.7%, respectively, for the three escalating doses (P = .002 for trend).

The primary endpoint of at least 77% inhibition of the iso-TRAP channel – which corresponds to 80% inhibition of light transmission aggregometry stimulated by 20 mcM adenosine diphosphate within 15 minutes – was achieved in three of eight patients at the lowest dose and in seven of eight patients at the middle and highest doses.

“Single-dose subcutaneous RUC-4 induces a fast, potent dose-dependent response of platelet inhibition in patients with STEMI presenting for primary PCI,” Dr. ten Berg concluded. “It is therefore promising for prehospital platelet inhibition in STEMI patients, and the results support further research on clinical benefit.”

The double-blind, randomized phase 2b CELEBRATE trial is underway, evaluating 1,668 STEMI patients treated with a 0.110 mg/kg or 0.130 mg/kg dose of RUC-4 or placebo in the ambulance. The coprimary outcomes are restoration of coronary artery blood flow and resolution of ST-segment deviation post-PCI/angiography. Primary completion is set for March 2023.

MDedge News

Marco Valgimigli, MD, who was not involved in the study, said in an interview that RUC-4 has “some theoretical advantages, compared with conventional IIb/IIIa inhibitors, namely the absence of thrombocytopenia which is, however, relatively rare, especially with tirofiban or eptifibatide.”

The subcutaneous approach may also offer an advantage. Yet, if the administration of RUC-4 is “to happen in the ambulance – a setting where an IV line is usually established – whether the subcutaneous versus IV administration of the treatment proves to be advantageous remains to be seen,” said Dr. Valgimigli, from Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.

“We would need to see the results of large randomized trials embracing this treatment option before a clinical decision can be made, especially considering that IIb/IIa inhibitors in the ambulance have been tested in the past but ultimately abandoned,” he said.

Limitations of the study are its open-label design, the fact that iso-TRAP channel assay data were not reported by the VeryifyNow instrument and had to be calculated from the raw data, and the fact that the timing of the RUC-4 injection immediately before PCI does not fully resemble the expected use of RUC-4 in clinical practice, where RUC-4 would be administered at the same time as the aspirin, ticagrelor, and heparin, and about an hour before PCI, ten Berg and colleagues wrote.

CeleCor Therapeutics sponsored the study and provided study materials. Dr. ten Berg reported receiving lecture or consultancy fees from AstraZeneca, Eli Lilly, Daiichi Sankyo, The Medicines Company, AccuMetrics, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Bayer, Ferrer, and Idorsia, and institutional research grants from ZonMw and AstraZeneca. Coauthor Barry S. Coller is an inventor of RUC-4 and a founder, equity holder, and consultant to CeleCor. He also receives royalties from Centocor/Janssen and the VerifyNow assays. Dr. Valgimigli has received grants from Abbott, Terumo, Medicure, and AstraZeneca, and personal fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, Alvimedica, AstraZeneca, Biosensors, and Idorsia.

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

After taking it on the chin for previously reporting Bayesian estimates, actual 2-year data from the EVOLUT Low Risk trial confirm that transcatheter aortic valve replacement (TAVR) is noninferior to surgery for the primary endpoint of death or disabling stroke.

Among 1,414 as-treated patients, Kaplan-Meier rates for all-cause death or disabling stroke at 24 months were 4.3% with TAVR and 6.3% with surgery (P = .084).

There was also no difference in the individual components of all-cause death (3.5% vs. 4.4%; log-rank P = .366) and disabling stroke (1.5% vs. 2.7%; log-rank P = .119).

Recent low-risk TAVR studies have raised questions about whether there’s a possible catch-up for surgery between 12 and 24 months, given the early mortality benefit from the less-invasive transcatheter procedure, prompting a landmark analysis, John K. Forrest, MD, said during the virtual presentation at the 2021 Congress of European Association of Percutaneous Cardiovascular Interventions, EuroPCR 2021.

“Between 1 and 2 years, there was no convergence of the Kaplan-Meier curves for death or disabling stroke,” with an incidence of 1.9% for the TAVR group and 2.1% for the surgery group (log-rank P = .742), said Dr. Forrest, of Yale University, New Haven, Conn. “The lines were almost superimposed upon each other.”

Session moderator Bernard Prendergast, MD, observed that the Bayesian analysis, which was reported in 2019 and used 12-month follow-up to predict 2-year outcomes, generated questions and criticism over whether this was an appropriate method, compared with traditional Kaplan-Meier analysis. “Indeed, some people accused the investigators of gaming it with this form of statistical analysis.”

To act as a “fact checker,” Dr. Prendergast called in Christopher Cook, MRC, from the PCR Clinical Research Group and Imperial College London. The key methodologic question, Dr. Cook said, is whether Bayesian methods accurately predict actual clinical outcomes in this randomized clinical trial. “The simple answer to this for me, is yes.”

He pointed out that the Kaplan-Meier data for the primary outcome at 2 years were, in fact, numerically better than Bayesian estimates of 5.3% in the TAVR group and 6.7% in the surgery group.

“This validates the use of the original Bayesian methods to estimate patient outcomes in low-risk TAVI patients and, indeed, it may act as an example of where Bayesian methods can be safely applied in order to fast track potentially transformative procedures and technologies to our patients,” Dr. Cook said.

The rate of disabling stroke with TAVR was 1.5% in the new analysis, up from 1.1% in the Bayesian analysis, and 2.7% with surgery, down from 3.5% in the Bayesian analysis.

All-cause mortality, also noted earlier, was 3.5% with TAVR and 4.4% with surgery, whereas the Bayesian estimate was 4.5% for each group.

Dr. Prendergast of St. Thomas’ Hospital, London, said the actual 2-year data are reassuring regarding the statistical tools used and supplement those recently reported from low-risk patients in PARTNER 3.

But, he asked, “what does this mean for practice, what does it mean for guidelines, and how long do we need to wait until we are comfortable and reassured that we can apply TAVI in younger and low-risk patients with a durable outcome?”

Dr. Forrest said that clinicians can be reassured that these patients “are doing very well” but that long-term follow-up is critical.

“We need to be realistic here. We’re really going to be interested in 5- and 10-year outcomes and potentially even thereafter,” he said. “What happens to these valves when they eventually fail? Are superior hemodynamics going to give us longer valve durability in some way or are there going to be other unforeseen things that come up 10 years out? We don’t know those answers.”

TAVR with a supra-annular, self-expanding valve (CoreValve , Evolut R, or Evolut PRO) had superior hemodynamics in the new 2-year analysis with lower aortic valve gradients (9.0 vs. 11.7 mm Hg) and larger valve areas (2.2 vs. 2.0 cm²).

Prosthesis-patient mismatch also favored TAVR, with moderate or severe mismatch occurring in 7.2% and 2.1%, respectively, compared with 19.1% and 4.9%, respectively, with surgery. “We know that this has an impact on long-term outcomes, so it’s important to note that significant difference here,” Dr. Forrest said.

The chink in TAVR’s armor remains paravalvular leak, particularly mild leak, which was significantly higher at 26.6%, compared with only 2.6% with surgery. Moderate to severe leaks were seen in 1.7% and 0.4%, respectively, reflecting the improvement in TAVR with new iterations, he said.

Surgery was also superior to TAVR with regard to the need for permanent pacemaker implantation (7.9% vs. 21.1%). This compares with Bayesian estimates of 6.7% and 23.0%, respectively.

Rates of myocardial infarction remained constant in the two analyses for the TAVR (2.2%) and surgery (1.6%) groups, whereas heart failure hospitalizations improved slightly, from 5.4% versus 7.9%, respectively, in the Bayesian analysis to 5.3% versus 7.1%, respectively, in the new analysis.

Fellow discussant Marie-Claude Morice, MD, Institute Hospitalier Jacques Cartier, Massy, France, highlighted several meta-analyses in different risk patients showing “a lot of good news,” including decreased stroke and mortality rates and the combined outcome clearly favoring TAVR.

“The remaining question is the longevity of the valve, but with 5 years’ follow-up we have for comparison [in high-risk patients], it is the same,” she said. “What this illustrates is that the tidal wave of TAVR is continuing, and we can look optimistically to the future. Is it the nonsymptomatic patients?”

Medtronic funded the study. Dr. Forrest reported grant support from, serving on the advisory board, and proctoring for Edwards Lifesciences and Medtronic. Dr. Prendergast has received grants from Edwards Lifesciences; and speaker/consultancy fees from Abbott, Anteris, and Edwards.

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

After taking it on the chin for previously reporting Bayesian estimates, actual 2-year data from the EVOLUT Low Risk trial confirm that transcatheter aortic valve replacement (TAVR) is noninferior to surgery for the primary endpoint of death or disabling stroke.

Among 1,414 as-treated patients, Kaplan-Meier rates for all-cause death or disabling stroke at 24 months were 4.3% with TAVR and 6.3% with surgery (P = .084).

There was also no difference in the individual components of all-cause death (3.5% vs. 4.4%; log-rank P = .366) and disabling stroke (1.5% vs. 2.7%; log-rank P = .119).

Recent low-risk TAVR studies have raised questions about whether there’s a possible catch-up for surgery between 12 and 24 months, given the early mortality benefit from the less-invasive transcatheter procedure, prompting a landmark analysis, John K. Forrest, MD, said during the virtual presentation at the 2021 Congress of European Association of Percutaneous Cardiovascular Interventions, EuroPCR 2021.

“Between 1 and 2 years, there was no convergence of the Kaplan-Meier curves for death or disabling stroke,” with an incidence of 1.9% for the TAVR group and 2.1% for the surgery group (log-rank P = .742), said Dr. Forrest, of Yale University, New Haven, Conn. “The lines were almost superimposed upon each other.”

Session moderator Bernard Prendergast, MD, observed that the Bayesian analysis, which was reported in 2019 and used 12-month follow-up to predict 2-year outcomes, generated questions and criticism over whether this was an appropriate method, compared with traditional Kaplan-Meier analysis. “Indeed, some people accused the investigators of gaming it with this form of statistical analysis.”

To act as a “fact checker,” Dr. Prendergast called in Christopher Cook, MRC, from the PCR Clinical Research Group and Imperial College London. The key methodologic question, Dr. Cook said, is whether Bayesian methods accurately predict actual clinical outcomes in this randomized clinical trial. “The simple answer to this for me, is yes.”

He pointed out that the Kaplan-Meier data for the primary outcome at 2 years were, in fact, numerically better than Bayesian estimates of 5.3% in the TAVR group and 6.7% in the surgery group.

“This validates the use of the original Bayesian methods to estimate patient outcomes in low-risk TAVI patients and, indeed, it may act as an example of where Bayesian methods can be safely applied in order to fast track potentially transformative procedures and technologies to our patients,” Dr. Cook said.

The rate of disabling stroke with TAVR was 1.5% in the new analysis, up from 1.1% in the Bayesian analysis, and 2.7% with surgery, down from 3.5% in the Bayesian analysis.

All-cause mortality, also noted earlier, was 3.5% with TAVR and 4.4% with surgery, whereas the Bayesian estimate was 4.5% for each group.

Dr. Prendergast of St. Thomas’ Hospital, London, said the actual 2-year data are reassuring regarding the statistical tools used and supplement those recently reported from low-risk patients in PARTNER 3.

But, he asked, “what does this mean for practice, what does it mean for guidelines, and how long do we need to wait until we are comfortable and reassured that we can apply TAVI in younger and low-risk patients with a durable outcome?”

Dr. Forrest said that clinicians can be reassured that these patients “are doing very well” but that long-term follow-up is critical.

“We need to be realistic here. We’re really going to be interested in 5- and 10-year outcomes and potentially even thereafter,” he said. “What happens to these valves when they eventually fail? Are superior hemodynamics going to give us longer valve durability in some way or are there going to be other unforeseen things that come up 10 years out? We don’t know those answers.”

TAVR with a supra-annular, self-expanding valve (CoreValve , Evolut R, or Evolut PRO) had superior hemodynamics in the new 2-year analysis with lower aortic valve gradients (9.0 vs. 11.7 mm Hg) and larger valve areas (2.2 vs. 2.0 cm²).

Prosthesis-patient mismatch also favored TAVR, with moderate or severe mismatch occurring in 7.2% and 2.1%, respectively, compared with 19.1% and 4.9%, respectively, with surgery. “We know that this has an impact on long-term outcomes, so it’s important to note that significant difference here,” Dr. Forrest said.

The chink in TAVR’s armor remains paravalvular leak, particularly mild leak, which was significantly higher at 26.6%, compared with only 2.6% with surgery. Moderate to severe leaks were seen in 1.7% and 0.4%, respectively, reflecting the improvement in TAVR with new iterations, he said.

Surgery was also superior to TAVR with regard to the need for permanent pacemaker implantation (7.9% vs. 21.1%). This compares with Bayesian estimates of 6.7% and 23.0%, respectively.

Rates of myocardial infarction remained constant in the two analyses for the TAVR (2.2%) and surgery (1.6%) groups, whereas heart failure hospitalizations improved slightly, from 5.4% versus 7.9%, respectively, in the Bayesian analysis to 5.3% versus 7.1%, respectively, in the new analysis.

Fellow discussant Marie-Claude Morice, MD, Institute Hospitalier Jacques Cartier, Massy, France, highlighted several meta-analyses in different risk patients showing “a lot of good news,” including decreased stroke and mortality rates and the combined outcome clearly favoring TAVR.

“The remaining question is the longevity of the valve, but with 5 years’ follow-up we have for comparison [in high-risk patients], it is the same,” she said. “What this illustrates is that the tidal wave of TAVR is continuing, and we can look optimistically to the future. Is it the nonsymptomatic patients?”

Medtronic funded the study. Dr. Forrest reported grant support from, serving on the advisory board, and proctoring for Edwards Lifesciences and Medtronic. Dr. Prendergast has received grants from Edwards Lifesciences; and speaker/consultancy fees from Abbott, Anteris, and Edwards.

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

After taking it on the chin for previously reporting Bayesian estimates, actual 2-year data from the EVOLUT Low Risk trial confirm that transcatheter aortic valve replacement (TAVR) is noninferior to surgery for the primary endpoint of death or disabling stroke.

Among 1,414 as-treated patients, Kaplan-Meier rates for all-cause death or disabling stroke at 24 months were 4.3% with TAVR and 6.3% with surgery (P = .084).

There was also no difference in the individual components of all-cause death (3.5% vs. 4.4%; log-rank P = .366) and disabling stroke (1.5% vs. 2.7%; log-rank P = .119).

Recent low-risk TAVR studies have raised questions about whether there’s a possible catch-up for surgery between 12 and 24 months, given the early mortality benefit from the less-invasive transcatheter procedure, prompting a landmark analysis, John K. Forrest, MD, said during the virtual presentation at the 2021 Congress of European Association of Percutaneous Cardiovascular Interventions, EuroPCR 2021.

“Between 1 and 2 years, there was no convergence of the Kaplan-Meier curves for death or disabling stroke,” with an incidence of 1.9% for the TAVR group and 2.1% for the surgery group (log-rank P = .742), said Dr. Forrest, of Yale University, New Haven, Conn. “The lines were almost superimposed upon each other.”

Session moderator Bernard Prendergast, MD, observed that the Bayesian analysis, which was reported in 2019 and used 12-month follow-up to predict 2-year outcomes, generated questions and criticism over whether this was an appropriate method, compared with traditional Kaplan-Meier analysis. “Indeed, some people accused the investigators of gaming it with this form of statistical analysis.”

To act as a “fact checker,” Dr. Prendergast called in Christopher Cook, MRC, from the PCR Clinical Research Group and Imperial College London. The key methodologic question, Dr. Cook said, is whether Bayesian methods accurately predict actual clinical outcomes in this randomized clinical trial. “The simple answer to this for me, is yes.”

He pointed out that the Kaplan-Meier data for the primary outcome at 2 years were, in fact, numerically better than Bayesian estimates of 5.3% in the TAVR group and 6.7% in the surgery group.

“This validates the use of the original Bayesian methods to estimate patient outcomes in low-risk TAVI patients and, indeed, it may act as an example of where Bayesian methods can be safely applied in order to fast track potentially transformative procedures and technologies to our patients,” Dr. Cook said.

The rate of disabling stroke with TAVR was 1.5% in the new analysis, up from 1.1% in the Bayesian analysis, and 2.7% with surgery, down from 3.5% in the Bayesian analysis.

All-cause mortality, also noted earlier, was 3.5% with TAVR and 4.4% with surgery, whereas the Bayesian estimate was 4.5% for each group.

Dr. Prendergast of St. Thomas’ Hospital, London, said the actual 2-year data are reassuring regarding the statistical tools used and supplement those recently reported from low-risk patients in PARTNER 3.

But, he asked, “what does this mean for practice, what does it mean for guidelines, and how long do we need to wait until we are comfortable and reassured that we can apply TAVI in younger and low-risk patients with a durable outcome?”

Dr. Forrest said that clinicians can be reassured that these patients “are doing very well” but that long-term follow-up is critical.

“We need to be realistic here. We’re really going to be interested in 5- and 10-year outcomes and potentially even thereafter,” he said. “What happens to these valves when they eventually fail? Are superior hemodynamics going to give us longer valve durability in some way or are there going to be other unforeseen things that come up 10 years out? We don’t know those answers.”

TAVR with a supra-annular, self-expanding valve (CoreValve , Evolut R, or Evolut PRO) had superior hemodynamics in the new 2-year analysis with lower aortic valve gradients (9.0 vs. 11.7 mm Hg) and larger valve areas (2.2 vs. 2.0 cm²).

Prosthesis-patient mismatch also favored TAVR, with moderate or severe mismatch occurring in 7.2% and 2.1%, respectively, compared with 19.1% and 4.9%, respectively, with surgery. “We know that this has an impact on long-term outcomes, so it’s important to note that significant difference here,” Dr. Forrest said.

The chink in TAVR’s armor remains paravalvular leak, particularly mild leak, which was significantly higher at 26.6%, compared with only 2.6% with surgery. Moderate to severe leaks were seen in 1.7% and 0.4%, respectively, reflecting the improvement in TAVR with new iterations, he said.

Surgery was also superior to TAVR with regard to the need for permanent pacemaker implantation (7.9% vs. 21.1%). This compares with Bayesian estimates of 6.7% and 23.0%, respectively.

Rates of myocardial infarction remained constant in the two analyses for the TAVR (2.2%) and surgery (1.6%) groups, whereas heart failure hospitalizations improved slightly, from 5.4% versus 7.9%, respectively, in the Bayesian analysis to 5.3% versus 7.1%, respectively, in the new analysis.

Fellow discussant Marie-Claude Morice, MD, Institute Hospitalier Jacques Cartier, Massy, France, highlighted several meta-analyses in different risk patients showing “a lot of good news,” including decreased stroke and mortality rates and the combined outcome clearly favoring TAVR.

“The remaining question is the longevity of the valve, but with 5 years’ follow-up we have for comparison [in high-risk patients], it is the same,” she said. “What this illustrates is that the tidal wave of TAVR is continuing, and we can look optimistically to the future. Is it the nonsymptomatic patients?”

Medtronic funded the study. Dr. Forrest reported grant support from, serving on the advisory board, and proctoring for Edwards Lifesciences and Medtronic. Dr. Prendergast has received grants from Edwards Lifesciences; and speaker/consultancy fees from Abbott, Anteris, and Edwards.

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

William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.

In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”

By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.

“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
 

A way to heal

For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.

Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.

Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.

Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.

He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.

A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.

The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”

For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
 

Why physicians die by suicide

Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”

Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.

Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.

A 2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.

The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.

The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.

Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
 

Every story is different

It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.

Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started. “What I can tell you is that this is a serious subject,” Dr. Myers said. “And it’s not going away.”

Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.

After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.

The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.

Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.

Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.

His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.

Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
 

A real gift

Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.

“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”

Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.

Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.

A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.

Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.

In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”

Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.

“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
 

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

William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.

In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”

By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.

“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
 

A way to heal

For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.

Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.

Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.

Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.

He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.

A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.

The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”

For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
 

Why physicians die by suicide

Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”

Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.

Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.

A 2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.

The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.

The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.

Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
 

Every story is different

It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.

Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started. “What I can tell you is that this is a serious subject,” Dr. Myers said. “And it’s not going away.”

Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.

After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.

The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.

Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.

Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.

His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.

Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
 

A real gift

Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.

“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”

Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.

Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.

A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.

Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.

In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”

Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.

“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
 

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

William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.

In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”

By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.

“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
 

A way to heal

For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.

Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.

Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.

Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.

He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.

A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.

The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”

For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
 

Why physicians die by suicide

Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”

Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.

Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.

A 2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.

The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.

The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.

Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
 

Every story is different

It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.

Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started. “What I can tell you is that this is a serious subject,” Dr. Myers said. “And it’s not going away.”

Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.

After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.

The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.

Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.

Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.

His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.

Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
 

A real gift

Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.

“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”

Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.

Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.

A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.

Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.

In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”

Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.

“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
 

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

New data show for the first time that combining the DASH (Dietary Approaches to Stop Hypertension) diet with sodium restriction decreases myocardial injury and cardiac strain, which are associated with subclinical cardiac damage and long-term cardiovascular risk.

“The benefits of healthy eating are swift and direct. High sodium is not just about taste, it causes heart strain,” Stephen Juraschek, MD, PhD, from Beth Israel Deaconess Medical Center, Boston, said in an interview.

“We should consciously follow a diet enriched with fruit and vegetables and low in sodium. Collectively, we should think about how foods are promoted in society and what is an acceptable amount of sodium for food supplies,” said Dr. Juraschek.

The findings, from a secondary analysis of the DASH-Sodium trial, were published the Journal of the American College of Cardiology.
 

Renewed focus on diet

“These data should spur a renewed focus on the critical need for widespread adoption of the DASH–low-sodium diet in the United States,” wrote the coauthors of a linked editorial.

“The challenge remains moving the DASH–low-sodium diet from the research world into the real world, where its significant health benefits can be fully realized,” they added.

The researchers evaluated the impact of the DASH diet and sodium restriction, individually and combined, on biomarkers of cardiac injury (high-sensitivity cardiac troponin I [hs-cTnI]), cardiac strain (N-terminal of the prohormone brain natriuretic peptide [NT-proBNP]), and inflammation (high-sensitivity C-reactive protein [hs-CRP]).

The DASH-Sodium trial was a controlled feeding study that enrolled 412 adults (mean age, 48 years; 56% women, 56% Black) with untreated systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure between 80 and 95 mm Hg. Mean baseline BP was 135/86 mm Hg.

Participants were randomly allocated to a typical American diet (control) or the heart-healthy DASH diet. Further, participants in both groups were assigned to each of three sodium intake levels: low (0.5 mg/kcal), medium (1.1 mg/kcal) or high (1.6 mg/kcal) for 30 days using a crossover design with washout periods in between.

Compared with the control diet, the DASH diet reduced hs-cTnI by 18% and hs-CRP by 13% with no impact on NT-proBNP.

In contrast, lowering sodium from high to low levels reduced NT-proBNP independent of diet by 19%, but did not alter hs-cTnI and mildly increased hs-CRP (9%).

Combining the DASH diet with sodium reduction lowered hs-cTnI by 20% and NT-proBNP by 23%, with no significant change in hs-CRP, compared with the high-sodium-control diet.

“Together, these findings imply that two distinct dietary strategies might improve two key pathways of subclinical cardiac damage: injury and strain,” Dr. Juraschek and colleagues wrote.

“These findings should strengthen public resolve for public policies that promote the DASH dietary pattern and lower sodium intake in the United States and globally,” they concluded.

“We need to talk about DASH more. Most adults in the U.S. have never heard of it,” Dr. Juraschek said in an interview.

“We need to promote nutrition literacy with regard to nutrition facts. Labeling is not very transparent and hard to understand. Many people don’t know where salt is hiding in their diet,” he added.

It will also be important to address disparities in access to healthy foods and food insecurity, Dr. Juraschek said.

“If we don’t address food costs and access, disparities in healthy eating will persist. Greater equity is key. We should also be mindful about populations dependent on others for meal preparation [children in schools or older adults on meal plans]. This might be regulated in ways that promote healthier eating population wide, but for these patients, they may not have autonomy to choose what they eat,” Dr. Juraschek said.

In their editorial, Neha J. Pagidipati, MD, and Laura P. Svetkey, MD, from Duke University and Duke Clinical Research Institute, Durham, N.C., said an important caveat is that the beneficial effects of diet and sodium restriction on cardiac injury and strain occurred in people without any clinical evidence of coronary artery disease or heart failure at baseline, “suggesting that this dietary combination can improve subclinical metrics of cardiac health.”

“Further, the impact on these markers was seen within weeks, indicating a relatively rapid impact on cardiac damage,” they added.

The measurement of cardiac biomarkers was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute. The original DASH trial was supported by the NHLBI, the Office of Research on Minority Health, and the National Center for Research Resources. Dr. Juraschek and coauthors disclosed no relevant conflicts of interest. Dr. Pagidipati has received research support to the institution from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Regeneron, Sanofi, and Verily Life Sciences; and has received consultation fees from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Novo Nordisk. Dr. Svetkey has no relevant disclosures.

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

New data show for the first time that combining the DASH (Dietary Approaches to Stop Hypertension) diet with sodium restriction decreases myocardial injury and cardiac strain, which are associated with subclinical cardiac damage and long-term cardiovascular risk.

“The benefits of healthy eating are swift and direct. High sodium is not just about taste, it causes heart strain,” Stephen Juraschek, MD, PhD, from Beth Israel Deaconess Medical Center, Boston, said in an interview.

“We should consciously follow a diet enriched with fruit and vegetables and low in sodium. Collectively, we should think about how foods are promoted in society and what is an acceptable amount of sodium for food supplies,” said Dr. Juraschek.

The findings, from a secondary analysis of the DASH-Sodium trial, were published the Journal of the American College of Cardiology.
 

Renewed focus on diet

“These data should spur a renewed focus on the critical need for widespread adoption of the DASH–low-sodium diet in the United States,” wrote the coauthors of a linked editorial.

“The challenge remains moving the DASH–low-sodium diet from the research world into the real world, where its significant health benefits can be fully realized,” they added.

The researchers evaluated the impact of the DASH diet and sodium restriction, individually and combined, on biomarkers of cardiac injury (high-sensitivity cardiac troponin I [hs-cTnI]), cardiac strain (N-terminal of the prohormone brain natriuretic peptide [NT-proBNP]), and inflammation (high-sensitivity C-reactive protein [hs-CRP]).

The DASH-Sodium trial was a controlled feeding study that enrolled 412 adults (mean age, 48 years; 56% women, 56% Black) with untreated systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure between 80 and 95 mm Hg. Mean baseline BP was 135/86 mm Hg.

Participants were randomly allocated to a typical American diet (control) or the heart-healthy DASH diet. Further, participants in both groups were assigned to each of three sodium intake levels: low (0.5 mg/kcal), medium (1.1 mg/kcal) or high (1.6 mg/kcal) for 30 days using a crossover design with washout periods in between.

Compared with the control diet, the DASH diet reduced hs-cTnI by 18% and hs-CRP by 13% with no impact on NT-proBNP.

In contrast, lowering sodium from high to low levels reduced NT-proBNP independent of diet by 19%, but did not alter hs-cTnI and mildly increased hs-CRP (9%).

Combining the DASH diet with sodium reduction lowered hs-cTnI by 20% and NT-proBNP by 23%, with no significant change in hs-CRP, compared with the high-sodium-control diet.

“Together, these findings imply that two distinct dietary strategies might improve two key pathways of subclinical cardiac damage: injury and strain,” Dr. Juraschek and colleagues wrote.

“These findings should strengthen public resolve for public policies that promote the DASH dietary pattern and lower sodium intake in the United States and globally,” they concluded.

“We need to talk about DASH more. Most adults in the U.S. have never heard of it,” Dr. Juraschek said in an interview.

“We need to promote nutrition literacy with regard to nutrition facts. Labeling is not very transparent and hard to understand. Many people don’t know where salt is hiding in their diet,” he added.

It will also be important to address disparities in access to healthy foods and food insecurity, Dr. Juraschek said.

“If we don’t address food costs and access, disparities in healthy eating will persist. Greater equity is key. We should also be mindful about populations dependent on others for meal preparation [children in schools or older adults on meal plans]. This might be regulated in ways that promote healthier eating population wide, but for these patients, they may not have autonomy to choose what they eat,” Dr. Juraschek said.

In their editorial, Neha J. Pagidipati, MD, and Laura P. Svetkey, MD, from Duke University and Duke Clinical Research Institute, Durham, N.C., said an important caveat is that the beneficial effects of diet and sodium restriction on cardiac injury and strain occurred in people without any clinical evidence of coronary artery disease or heart failure at baseline, “suggesting that this dietary combination can improve subclinical metrics of cardiac health.”

“Further, the impact on these markers was seen within weeks, indicating a relatively rapid impact on cardiac damage,” they added.

The measurement of cardiac biomarkers was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute. The original DASH trial was supported by the NHLBI, the Office of Research on Minority Health, and the National Center for Research Resources. Dr. Juraschek and coauthors disclosed no relevant conflicts of interest. Dr. Pagidipati has received research support to the institution from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Regeneron, Sanofi, and Verily Life Sciences; and has received consultation fees from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Novo Nordisk. Dr. Svetkey has no relevant disclosures.

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

New data show for the first time that combining the DASH (Dietary Approaches to Stop Hypertension) diet with sodium restriction decreases myocardial injury and cardiac strain, which are associated with subclinical cardiac damage and long-term cardiovascular risk.

“The benefits of healthy eating are swift and direct. High sodium is not just about taste, it causes heart strain,” Stephen Juraschek, MD, PhD, from Beth Israel Deaconess Medical Center, Boston, said in an interview.

“We should consciously follow a diet enriched with fruit and vegetables and low in sodium. Collectively, we should think about how foods are promoted in society and what is an acceptable amount of sodium for food supplies,” said Dr. Juraschek.

The findings, from a secondary analysis of the DASH-Sodium trial, were published the Journal of the American College of Cardiology.
 

Renewed focus on diet

“These data should spur a renewed focus on the critical need for widespread adoption of the DASH–low-sodium diet in the United States,” wrote the coauthors of a linked editorial.

“The challenge remains moving the DASH–low-sodium diet from the research world into the real world, where its significant health benefits can be fully realized,” they added.

The researchers evaluated the impact of the DASH diet and sodium restriction, individually and combined, on biomarkers of cardiac injury (high-sensitivity cardiac troponin I [hs-cTnI]), cardiac strain (N-terminal of the prohormone brain natriuretic peptide [NT-proBNP]), and inflammation (high-sensitivity C-reactive protein [hs-CRP]).

The DASH-Sodium trial was a controlled feeding study that enrolled 412 adults (mean age, 48 years; 56% women, 56% Black) with untreated systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure between 80 and 95 mm Hg. Mean baseline BP was 135/86 mm Hg.

Participants were randomly allocated to a typical American diet (control) or the heart-healthy DASH diet. Further, participants in both groups were assigned to each of three sodium intake levels: low (0.5 mg/kcal), medium (1.1 mg/kcal) or high (1.6 mg/kcal) for 30 days using a crossover design with washout periods in between.

Compared with the control diet, the DASH diet reduced hs-cTnI by 18% and hs-CRP by 13% with no impact on NT-proBNP.

In contrast, lowering sodium from high to low levels reduced NT-proBNP independent of diet by 19%, but did not alter hs-cTnI and mildly increased hs-CRP (9%).

Combining the DASH diet with sodium reduction lowered hs-cTnI by 20% and NT-proBNP by 23%, with no significant change in hs-CRP, compared with the high-sodium-control diet.

“Together, these findings imply that two distinct dietary strategies might improve two key pathways of subclinical cardiac damage: injury and strain,” Dr. Juraschek and colleagues wrote.

“These findings should strengthen public resolve for public policies that promote the DASH dietary pattern and lower sodium intake in the United States and globally,” they concluded.

“We need to talk about DASH more. Most adults in the U.S. have never heard of it,” Dr. Juraschek said in an interview.

“We need to promote nutrition literacy with regard to nutrition facts. Labeling is not very transparent and hard to understand. Many people don’t know where salt is hiding in their diet,” he added.

It will also be important to address disparities in access to healthy foods and food insecurity, Dr. Juraschek said.

“If we don’t address food costs and access, disparities in healthy eating will persist. Greater equity is key. We should also be mindful about populations dependent on others for meal preparation [children in schools or older adults on meal plans]. This might be regulated in ways that promote healthier eating population wide, but for these patients, they may not have autonomy to choose what they eat,” Dr. Juraschek said.

In their editorial, Neha J. Pagidipati, MD, and Laura P. Svetkey, MD, from Duke University and Duke Clinical Research Institute, Durham, N.C., said an important caveat is that the beneficial effects of diet and sodium restriction on cardiac injury and strain occurred in people without any clinical evidence of coronary artery disease or heart failure at baseline, “suggesting that this dietary combination can improve subclinical metrics of cardiac health.”

“Further, the impact on these markers was seen within weeks, indicating a relatively rapid impact on cardiac damage,” they added.

The measurement of cardiac biomarkers was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute. The original DASH trial was supported by the NHLBI, the Office of Research on Minority Health, and the National Center for Research Resources. Dr. Juraschek and coauthors disclosed no relevant conflicts of interest. Dr. Pagidipati has received research support to the institution from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Regeneron, Sanofi, and Verily Life Sciences; and has received consultation fees from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Novo Nordisk. Dr. Svetkey has no relevant disclosures.

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

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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