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The Sedentary Behavior Research Network has published new guidelines “to provide guidance to parents, educators, policy makers, researchers, and health care providers” on means to reduce school-related sedentary behavior.

The recommendations, published in the International Journal of Behavioral Nutrition and Physical Activity were written by researchers led by Travis J. Saunders, PhD, associate professor of applied human sciences at the University of Prince Edward Island, Charlottetown. Based on work carried out by a panel of international experts and informed by the best available evidence and stakeholder consultation, “these recommendations will be useful in supporting the physical and mental health, well-being, and academic success of school-age children and youth,” according to the authors.

The key strength of their work, they wrote, is that it is based on robust scientific data and specifically refers to school-related sedentary behaviors, whether these occur during lessons in the classroom or while completing assignments at home. “Existing sedentary behavior guidelines for children and youth target overall sedentary behavior and recreational screen time, without any specific recommendations regarding school-related sedentary behaviors.” The article also mentions the impact of the COVID-19 pandemic. Lack of movement was already a problem in these age groups; social distancing and distance learning over such an extended period only made things worse.
 

Risks and benefits

Dr. Saunders and colleagues wrote: “The relationships between sedentary behaviors and student health and academic outcomes are complex and likely differ for specific sedentary behaviors.”

While on one hand sedentary behavior may have a significant negative impact on metabolic outcomes, there is evidence that higher durations of homework and reading are associated with better academic achievement among school-aged children.

Another example of this complexity is that screen-based sedentary behaviors (spending time in front of computer screens, TVs, tablets, smartphones) often demonstrate deleterious associations with a range of health outcomes among school-aged children and youth aged 5-18 years, including body composition, cardiometabolic risk, and self-esteem. Yet screen-based devices may offer opportunities for novel pedagogic approaches and student engagement and may increase access to education for some students, especially during the COVID-19 pandemic.

The researchers noted that “many common sedentary activities ... do not have to be sedentary in nature. These behaviors are only considered to be sedentary when combined with both low energy expenditure and a sitting, reclining, or lying posture.” As an example, they pointed out that “active video gaming, or paper-based work at a standing desk, are both ways that common sedentary behaviors can be made nonsedentary.”

One thing’s for sure: Children and teenagers don’t move around all that much.

Data from the 2019 Eye on Health survey found that one of five children (20.3%) had not engaged in any physical activity the day before the survey, almost half (43.5%) had a TV in their bedroom, and about the same number (44.5%) spent more than 2 hours a day in front of a screen.

As for schools, the survey showed that, while 93% had initiatives to promote physical activity, fewer than 30% of these programs involved parents. It should be kept in mind that these are prepandemic numbers.
 

‘A healthy school day’

The authors recommend the following for reducing school-related sedentary behavior:

• Break up periods of extended sedentary behavior with both scheduled and unscheduled movement breaks: at least once every 30 minutes for ages 5-11 years and at least once every hour for ages 12-18 years. Consider activities that vary in intensity and duration (for example, standing, stretching breaks, moving to another classroom, active lessons, active breaks).
• Incorporate different types of movement into homework whenever possible, and limit sedentary homework to no more than 10 minutes per day per grade level (for example, no more than 10 minutes per day in grade 1, or 60 minutes per day in grade 6).
• Regardless of the location, school-related screen time should be meaningful, mentally or physically active, and serve a specific pedagogic purpose that enhances learning, compared with alternative methods. When school-related screen time is warranted, the following are recommended: limit time on devices, especially for students age 5-11 years; take a device break at least once every 30 minutes; discourage media multitasking in the classroom and while doing homework; and avoid screen-based homework within an hour of bedtime.
• Replace sedentary learning activities with movement-based learning activities (including standing) and replacing screen-based learning activities with non–screen-based learning activities (for example, outdoor lessons) can further support students’ health and well-being.

“Given the important role that schools can play in the promotion of healthy behaviors,” Dr. Saunders and associates wrote, “we encourage national and international public health agencies to consider inclusion of specific recommendations related to the school environment in future sedentary behavior guidelines.”

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

The Sedentary Behavior Research Network has published new guidelines “to provide guidance to parents, educators, policy makers, researchers, and health care providers” on means to reduce school-related sedentary behavior.

The recommendations, published in the International Journal of Behavioral Nutrition and Physical Activity were written by researchers led by Travis J. Saunders, PhD, associate professor of applied human sciences at the University of Prince Edward Island, Charlottetown. Based on work carried out by a panel of international experts and informed by the best available evidence and stakeholder consultation, “these recommendations will be useful in supporting the physical and mental health, well-being, and academic success of school-age children and youth,” according to the authors.

The key strength of their work, they wrote, is that it is based on robust scientific data and specifically refers to school-related sedentary behaviors, whether these occur during lessons in the classroom or while completing assignments at home. “Existing sedentary behavior guidelines for children and youth target overall sedentary behavior and recreational screen time, without any specific recommendations regarding school-related sedentary behaviors.” The article also mentions the impact of the COVID-19 pandemic. Lack of movement was already a problem in these age groups; social distancing and distance learning over such an extended period only made things worse.
 

Risks and benefits

Dr. Saunders and colleagues wrote: “The relationships between sedentary behaviors and student health and academic outcomes are complex and likely differ for specific sedentary behaviors.”

While on one hand sedentary behavior may have a significant negative impact on metabolic outcomes, there is evidence that higher durations of homework and reading are associated with better academic achievement among school-aged children.

Another example of this complexity is that screen-based sedentary behaviors (spending time in front of computer screens, TVs, tablets, smartphones) often demonstrate deleterious associations with a range of health outcomes among school-aged children and youth aged 5-18 years, including body composition, cardiometabolic risk, and self-esteem. Yet screen-based devices may offer opportunities for novel pedagogic approaches and student engagement and may increase access to education for some students, especially during the COVID-19 pandemic.

The researchers noted that “many common sedentary activities ... do not have to be sedentary in nature. These behaviors are only considered to be sedentary when combined with both low energy expenditure and a sitting, reclining, or lying posture.” As an example, they pointed out that “active video gaming, or paper-based work at a standing desk, are both ways that common sedentary behaviors can be made nonsedentary.”

One thing’s for sure: Children and teenagers don’t move around all that much.

Data from the 2019 Eye on Health survey found that one of five children (20.3%) had not engaged in any physical activity the day before the survey, almost half (43.5%) had a TV in their bedroom, and about the same number (44.5%) spent more than 2 hours a day in front of a screen.

As for schools, the survey showed that, while 93% had initiatives to promote physical activity, fewer than 30% of these programs involved parents. It should be kept in mind that these are prepandemic numbers.
 

‘A healthy school day’

The authors recommend the following for reducing school-related sedentary behavior:

• Break up periods of extended sedentary behavior with both scheduled and unscheduled movement breaks: at least once every 30 minutes for ages 5-11 years and at least once every hour for ages 12-18 years. Consider activities that vary in intensity and duration (for example, standing, stretching breaks, moving to another classroom, active lessons, active breaks).
• Incorporate different types of movement into homework whenever possible, and limit sedentary homework to no more than 10 minutes per day per grade level (for example, no more than 10 minutes per day in grade 1, or 60 minutes per day in grade 6).
• Regardless of the location, school-related screen time should be meaningful, mentally or physically active, and serve a specific pedagogic purpose that enhances learning, compared with alternative methods. When school-related screen time is warranted, the following are recommended: limit time on devices, especially for students age 5-11 years; take a device break at least once every 30 minutes; discourage media multitasking in the classroom and while doing homework; and avoid screen-based homework within an hour of bedtime.
• Replace sedentary learning activities with movement-based learning activities (including standing) and replacing screen-based learning activities with non–screen-based learning activities (for example, outdoor lessons) can further support students’ health and well-being.

“Given the important role that schools can play in the promotion of healthy behaviors,” Dr. Saunders and associates wrote, “we encourage national and international public health agencies to consider inclusion of specific recommendations related to the school environment in future sedentary behavior guidelines.”

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

The Sedentary Behavior Research Network has published new guidelines “to provide guidance to parents, educators, policy makers, researchers, and health care providers” on means to reduce school-related sedentary behavior.

The recommendations, published in the International Journal of Behavioral Nutrition and Physical Activity were written by researchers led by Travis J. Saunders, PhD, associate professor of applied human sciences at the University of Prince Edward Island, Charlottetown. Based on work carried out by a panel of international experts and informed by the best available evidence and stakeholder consultation, “these recommendations will be useful in supporting the physical and mental health, well-being, and academic success of school-age children and youth,” according to the authors.

The key strength of their work, they wrote, is that it is based on robust scientific data and specifically refers to school-related sedentary behaviors, whether these occur during lessons in the classroom or while completing assignments at home. “Existing sedentary behavior guidelines for children and youth target overall sedentary behavior and recreational screen time, without any specific recommendations regarding school-related sedentary behaviors.” The article also mentions the impact of the COVID-19 pandemic. Lack of movement was already a problem in these age groups; social distancing and distance learning over such an extended period only made things worse.
 

Risks and benefits

Dr. Saunders and colleagues wrote: “The relationships between sedentary behaviors and student health and academic outcomes are complex and likely differ for specific sedentary behaviors.”

While on one hand sedentary behavior may have a significant negative impact on metabolic outcomes, there is evidence that higher durations of homework and reading are associated with better academic achievement among school-aged children.

Another example of this complexity is that screen-based sedentary behaviors (spending time in front of computer screens, TVs, tablets, smartphones) often demonstrate deleterious associations with a range of health outcomes among school-aged children and youth aged 5-18 years, including body composition, cardiometabolic risk, and self-esteem. Yet screen-based devices may offer opportunities for novel pedagogic approaches and student engagement and may increase access to education for some students, especially during the COVID-19 pandemic.

The researchers noted that “many common sedentary activities ... do not have to be sedentary in nature. These behaviors are only considered to be sedentary when combined with both low energy expenditure and a sitting, reclining, or lying posture.” As an example, they pointed out that “active video gaming, or paper-based work at a standing desk, are both ways that common sedentary behaviors can be made nonsedentary.”

One thing’s for sure: Children and teenagers don’t move around all that much.

Data from the 2019 Eye on Health survey found that one of five children (20.3%) had not engaged in any physical activity the day before the survey, almost half (43.5%) had a TV in their bedroom, and about the same number (44.5%) spent more than 2 hours a day in front of a screen.

As for schools, the survey showed that, while 93% had initiatives to promote physical activity, fewer than 30% of these programs involved parents. It should be kept in mind that these are prepandemic numbers.
 

‘A healthy school day’

The authors recommend the following for reducing school-related sedentary behavior:

• Break up periods of extended sedentary behavior with both scheduled and unscheduled movement breaks: at least once every 30 minutes for ages 5-11 years and at least once every hour for ages 12-18 years. Consider activities that vary in intensity and duration (for example, standing, stretching breaks, moving to another classroom, active lessons, active breaks).
• Incorporate different types of movement into homework whenever possible, and limit sedentary homework to no more than 10 minutes per day per grade level (for example, no more than 10 minutes per day in grade 1, or 60 minutes per day in grade 6).
• Regardless of the location, school-related screen time should be meaningful, mentally or physically active, and serve a specific pedagogic purpose that enhances learning, compared with alternative methods. When school-related screen time is warranted, the following are recommended: limit time on devices, especially for students age 5-11 years; take a device break at least once every 30 minutes; discourage media multitasking in the classroom and while doing homework; and avoid screen-based homework within an hour of bedtime.
• Replace sedentary learning activities with movement-based learning activities (including standing) and replacing screen-based learning activities with non–screen-based learning activities (for example, outdoor lessons) can further support students’ health and well-being.

“Given the important role that schools can play in the promotion of healthy behaviors,” Dr. Saunders and associates wrote, “we encourage national and international public health agencies to consider inclusion of specific recommendations related to the school environment in future sedentary behavior guidelines.”

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. But a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD alone at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said in an interview. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings at the annual scientific sessions of the Heart Rhythm Society.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ont., who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of stroke, myocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler disclosed consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. But a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD alone at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said in an interview. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings at the annual scientific sessions of the Heart Rhythm Society.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ont., who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of stroke, myocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler disclosed consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. But a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD alone at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said in an interview. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings at the annual scientific sessions of the Heart Rhythm Society.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ont., who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of stroke, myocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler disclosed consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

Fat shaming doesn’t work. If it did, obesity as we know it wouldn’t exist because if the one thing society ensures isn’t lacking for people with obesity, it’s shame. We know that fat shaming doesn’t lead to weight loss and that it’s actually correlated with weight gain: More shame leads to more gain (Puhl and Suh; Sutin and Terracciano; Tomiyama et al).

Shaming and weight stigma have far more concerning associations than weight gain. People who report experiencing more weight stigma have an increased risk for depression, anxiety, low self-esteem, poor body image, substance abuse, suicidality, unhealthy eating behaviors, disordered eating, increased caloric intake, exercise avoidance, decreased exercise motivation potentially due to heightened cortisol reactivity, elevated C-reactive protein, and elevated blood pressure.

Meanwhile, people with obesity – likely in part owing to negative weight-biased experiences in health care – are reluctant to discuss weight with their health care providers and are less likely to seek care at all for any conditions. When care is sought, people with obesity are more likely to receive substandard treatment, including receiving fewer preventive health screenings, decreased health education, and decreased time spent in appointments.
 

Remember that obesity is not a conscious choice

A fact that is conveniently forgotten by those who are most prone to fat shaming is that obesity, like every chronic noncommunicable disease, isn’t a choice that is consciously made by patients.

And yes, though there are lifestyle means that might affect weight, there are lifestyle means that might affect all chronic diseases – yet obesity is the only one we seem to moralize about. It’s also worth noting that other chronic diseases’ lifestyle levers tend not to be governed by thousands of genes and dozens of hormones; those trying to “lifestyle” their way out of obesity are swimming against strong physiologic currents that influence our most seminally important survival drive: eating.

But forgetting about physiologic currents, there is also staggering privilege associated with intentional perpetual behavior change around food and fitness in the name of health.

Whereas medicine and the world are right and quick to embrace the fights against racism, sexism, and homophobia, the push to confront weight bias is far rarer, despite the fact that it’s been shown to be rampant among health care professionals.
 

Protecting the rights of people with obesity

Perhaps though, times are changing. Movements are popping up to protect the rights of people with obesity while combating hate.

Of note, Brazil seems to have embraced a campaign to fight gordofobia — the Portuguese term used to describe weight-based discrimination. For instance, laws are being passed to ensure appropriate seating is supplied in schools for children with obesity, an annual day was formalized to promote the rights of people with obesity, preferential seating is provided on subways for people with obesity, and fines have been levied against at least one comedian for making fat jokes on the grounds of the state’s duty to protect minorities.

We need to take this fight to medicine. Given the incredibly depressing prevalence of weight bias among trainees, medical schools and residency programs should ensure countering weight bias is not only part of the curriculum but that it’s explicitly examined. National medical licensing examinations should include weight bias as well.

Though we’re closer than ever before to widely effective treatment options for obesity, it’s likely to still be decades before pharmaceutical options to treat obesity are as effective, accepted, and encouraged as medications to treat hypertension, dyslipidemia, diabetes, and more are today.

If you’re curious about your own implicit weight biases, consider taking Harvard’s Implicit Association Test for Weight. You might also want to take a few moments and review the Strategies to Overcome and Prevent Obesity Alliances’ Weight Can’t Wait guide for advice on the management of obesity in primary care.

Treat patients with obesity the same as you would those with any chronic condition.

Also, consider your physical office space. Do you have chairs suitable for patients with obesity (wide base and with arms to help patients rise)? A scale that measures up to high weights that’s in a private location? Appropriately sized blood pressure cuffs?

If not, do you know who is deserving of shame?

Doctors who fat shame or who treat patients with obesity differently than they would any other patient with a chronic medical condition.

Examples include the family doctor who hadn’t checked my patient’s blood pressure in over a decade because he couldn’t be bothered buying an appropriately sized blood pressure cuff. Or the fertility doctor who told one of my patients that perhaps her weight reflected God’s will that she does not have children.

Finally, if reading this article about treating people with obesity the same as you would patients with other chronic, noncommunicable, lifestyle responsive diseases made you angry, there’s a great chance that you’re part of the problem.
 

Dr. Freedhoff, is associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute, a nonsurgical weight management center. He is one of Canada’s most outspoken obesity experts and the author of The Diet Fix: Why Diets Fail and How to Make Yours Work. He has disclosed the following: He served as a director, officer, partner, employee, adviser, consultant, or trustee for Bariatric Medical Institute and Constant Health; has received research grant from Novo Nordisk, and has publicly shared opinions via Weighty Matters and social media. A version of this article first appeared on Medscape.com.

Fat shaming doesn’t work. If it did, obesity as we know it wouldn’t exist because if the one thing society ensures isn’t lacking for people with obesity, it’s shame. We know that fat shaming doesn’t lead to weight loss and that it’s actually correlated with weight gain: More shame leads to more gain (Puhl and Suh; Sutin and Terracciano; Tomiyama et al).

Shaming and weight stigma have far more concerning associations than weight gain. People who report experiencing more weight stigma have an increased risk for depression, anxiety, low self-esteem, poor body image, substance abuse, suicidality, unhealthy eating behaviors, disordered eating, increased caloric intake, exercise avoidance, decreased exercise motivation potentially due to heightened cortisol reactivity, elevated C-reactive protein, and elevated blood pressure.

Meanwhile, people with obesity – likely in part owing to negative weight-biased experiences in health care – are reluctant to discuss weight with their health care providers and are less likely to seek care at all for any conditions. When care is sought, people with obesity are more likely to receive substandard treatment, including receiving fewer preventive health screenings, decreased health education, and decreased time spent in appointments.
 

Remember that obesity is not a conscious choice

A fact that is conveniently forgotten by those who are most prone to fat shaming is that obesity, like every chronic noncommunicable disease, isn’t a choice that is consciously made by patients.

And yes, though there are lifestyle means that might affect weight, there are lifestyle means that might affect all chronic diseases – yet obesity is the only one we seem to moralize about. It’s also worth noting that other chronic diseases’ lifestyle levers tend not to be governed by thousands of genes and dozens of hormones; those trying to “lifestyle” their way out of obesity are swimming against strong physiologic currents that influence our most seminally important survival drive: eating.

But forgetting about physiologic currents, there is also staggering privilege associated with intentional perpetual behavior change around food and fitness in the name of health.

Whereas medicine and the world are right and quick to embrace the fights against racism, sexism, and homophobia, the push to confront weight bias is far rarer, despite the fact that it’s been shown to be rampant among health care professionals.
 

Protecting the rights of people with obesity

Perhaps though, times are changing. Movements are popping up to protect the rights of people with obesity while combating hate.

Of note, Brazil seems to have embraced a campaign to fight gordofobia — the Portuguese term used to describe weight-based discrimination. For instance, laws are being passed to ensure appropriate seating is supplied in schools for children with obesity, an annual day was formalized to promote the rights of people with obesity, preferential seating is provided on subways for people with obesity, and fines have been levied against at least one comedian for making fat jokes on the grounds of the state’s duty to protect minorities.

We need to take this fight to medicine. Given the incredibly depressing prevalence of weight bias among trainees, medical schools and residency programs should ensure countering weight bias is not only part of the curriculum but that it’s explicitly examined. National medical licensing examinations should include weight bias as well.

Though we’re closer than ever before to widely effective treatment options for obesity, it’s likely to still be decades before pharmaceutical options to treat obesity are as effective, accepted, and encouraged as medications to treat hypertension, dyslipidemia, diabetes, and more are today.

If you’re curious about your own implicit weight biases, consider taking Harvard’s Implicit Association Test for Weight. You might also want to take a few moments and review the Strategies to Overcome and Prevent Obesity Alliances’ Weight Can’t Wait guide for advice on the management of obesity in primary care.

Treat patients with obesity the same as you would those with any chronic condition.

Also, consider your physical office space. Do you have chairs suitable for patients with obesity (wide base and with arms to help patients rise)? A scale that measures up to high weights that’s in a private location? Appropriately sized blood pressure cuffs?

If not, do you know who is deserving of shame?

Doctors who fat shame or who treat patients with obesity differently than they would any other patient with a chronic medical condition.

Examples include the family doctor who hadn’t checked my patient’s blood pressure in over a decade because he couldn’t be bothered buying an appropriately sized blood pressure cuff. Or the fertility doctor who told one of my patients that perhaps her weight reflected God’s will that she does not have children.

Finally, if reading this article about treating people with obesity the same as you would patients with other chronic, noncommunicable, lifestyle responsive diseases made you angry, there’s a great chance that you’re part of the problem.
 

Dr. Freedhoff, is associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute, a nonsurgical weight management center. He is one of Canada’s most outspoken obesity experts and the author of The Diet Fix: Why Diets Fail and How to Make Yours Work. He has disclosed the following: He served as a director, officer, partner, employee, adviser, consultant, or trustee for Bariatric Medical Institute and Constant Health; has received research grant from Novo Nordisk, and has publicly shared opinions via Weighty Matters and social media. A version of this article first appeared on Medscape.com.

Fat shaming doesn’t work. If it did, obesity as we know it wouldn’t exist because if the one thing society ensures isn’t lacking for people with obesity, it’s shame. We know that fat shaming doesn’t lead to weight loss and that it’s actually correlated with weight gain: More shame leads to more gain (Puhl and Suh; Sutin and Terracciano; Tomiyama et al).

Shaming and weight stigma have far more concerning associations than weight gain. People who report experiencing more weight stigma have an increased risk for depression, anxiety, low self-esteem, poor body image, substance abuse, suicidality, unhealthy eating behaviors, disordered eating, increased caloric intake, exercise avoidance, decreased exercise motivation potentially due to heightened cortisol reactivity, elevated C-reactive protein, and elevated blood pressure.

Meanwhile, people with obesity – likely in part owing to negative weight-biased experiences in health care – are reluctant to discuss weight with their health care providers and are less likely to seek care at all for any conditions. When care is sought, people with obesity are more likely to receive substandard treatment, including receiving fewer preventive health screenings, decreased health education, and decreased time spent in appointments.
 

Remember that obesity is not a conscious choice

A fact that is conveniently forgotten by those who are most prone to fat shaming is that obesity, like every chronic noncommunicable disease, isn’t a choice that is consciously made by patients.

And yes, though there are lifestyle means that might affect weight, there are lifestyle means that might affect all chronic diseases – yet obesity is the only one we seem to moralize about. It’s also worth noting that other chronic diseases’ lifestyle levers tend not to be governed by thousands of genes and dozens of hormones; those trying to “lifestyle” their way out of obesity are swimming against strong physiologic currents that influence our most seminally important survival drive: eating.

But forgetting about physiologic currents, there is also staggering privilege associated with intentional perpetual behavior change around food and fitness in the name of health.

Whereas medicine and the world are right and quick to embrace the fights against racism, sexism, and homophobia, the push to confront weight bias is far rarer, despite the fact that it’s been shown to be rampant among health care professionals.
 

Protecting the rights of people with obesity

Perhaps though, times are changing. Movements are popping up to protect the rights of people with obesity while combating hate.

Of note, Brazil seems to have embraced a campaign to fight gordofobia — the Portuguese term used to describe weight-based discrimination. For instance, laws are being passed to ensure appropriate seating is supplied in schools for children with obesity, an annual day was formalized to promote the rights of people with obesity, preferential seating is provided on subways for people with obesity, and fines have been levied against at least one comedian for making fat jokes on the grounds of the state’s duty to protect minorities.

We need to take this fight to medicine. Given the incredibly depressing prevalence of weight bias among trainees, medical schools and residency programs should ensure countering weight bias is not only part of the curriculum but that it’s explicitly examined. National medical licensing examinations should include weight bias as well.

Though we’re closer than ever before to widely effective treatment options for obesity, it’s likely to still be decades before pharmaceutical options to treat obesity are as effective, accepted, and encouraged as medications to treat hypertension, dyslipidemia, diabetes, and more are today.

If you’re curious about your own implicit weight biases, consider taking Harvard’s Implicit Association Test for Weight. You might also want to take a few moments and review the Strategies to Overcome and Prevent Obesity Alliances’ Weight Can’t Wait guide for advice on the management of obesity in primary care.

Treat patients with obesity the same as you would those with any chronic condition.

Also, consider your physical office space. Do you have chairs suitable for patients with obesity (wide base and with arms to help patients rise)? A scale that measures up to high weights that’s in a private location? Appropriately sized blood pressure cuffs?

If not, do you know who is deserving of shame?

Doctors who fat shame or who treat patients with obesity differently than they would any other patient with a chronic medical condition.

Examples include the family doctor who hadn’t checked my patient’s blood pressure in over a decade because he couldn’t be bothered buying an appropriately sized blood pressure cuff. Or the fertility doctor who told one of my patients that perhaps her weight reflected God’s will that she does not have children.

Finally, if reading this article about treating people with obesity the same as you would patients with other chronic, noncommunicable, lifestyle responsive diseases made you angry, there’s a great chance that you’re part of the problem.
 

Dr. Freedhoff, is associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute, a nonsurgical weight management center. He is one of Canada’s most outspoken obesity experts and the author of The Diet Fix: Why Diets Fail and How to Make Yours Work. He has disclosed the following: He served as a director, officer, partner, employee, adviser, consultant, or trustee for Bariatric Medical Institute and Constant Health; has received research grant from Novo Nordisk, and has publicly shared opinions via Weighty Matters and social media. A version of this article first appeared on Medscape.com.

Air traffic controllers face mandatory retirement at age 56, with exceptions up to 61. Commercial airline pilots must bow out at 65; same for foreign service employees. Physicians, however, have no age limit, regardless of specialty.

That doesn’t mean the topic of “how old is too old” hasn’t been one of the profession’s most heated debates for many years now.

As the profession rapidly ages – some 30% of the physician workforce is currently a senior, according to the American Medical Association – the topic of whether or not there should be a standard measure or age for retirement is front and center. The AMA’s Council on Medical Education formed a workgroup to look into the issue in 2015 and 2018, and in 2021, delegates adopted a set of guidelines for screening and assessing physicians, but stopped short of a mandate.

Mark Katlic, MD, chair of surgery at Lifebridge Health System, Baltimore, has devoted a decade to studying this topic. “I’m a bit of an outlier looking into this,” he says. “The public is unaware and seemingly unconcerned about the issue. Even among the medical profession, there’s been a series of fits and starts to develop a cohesive approach.”

One of the reasons guidelines – mandatory or otherwise – have been tough to come by is that aging brings with it a huge degree of variability. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” Dr. Katlic pointed out.

Indeed, some 80-year-olds can easily continue to teach college courses, keep up in 10K running races, or perform delicate surgeries. Yet others in their peer group might struggle to properly button a shirt, walk a flight of stairs, or remember yesterday’s meals. Functional age is not the same as chronological age.

Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist at Stanford (Calif.) University Health, counts himself in the camp opposed to age-based assessments. “It’s age discrimination,” he says. “Physicians receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as doctors reach a certain age.”

Dr. Stockdale suggests that in many cases, malpractice suits are filed against mid-career doctors, not those of advanced age. “If you’re using the argument that there is an accumulation of deficits with age, the fact is that those deficits begin well before your 70s,” he said. “It’s better to have a uniform screening policy and begin at a much younger age.”

At Stanford, in fact, there was a former assessment policy that included cognitive testing, but physicians were successful in seeing that portion of testing eliminated. “It is a physical examination, by a physician of choice, certifying that for the privileges requested there is no physical or mental reason the candidate cannot safely perform them,” Dr. Stockdale explained.

In some cases, medical staffs have filed lawsuits to fight age-related testing. In New Haven, Conn., for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory “late career practitioner policy.”

A similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

James Ellison, MD, MPH, chair in Memory Care and Geriatrics with ChristianaCare in Wilmington, Del., points out that aging can bring benefits for practicing physicians. “Age is very individualized and there are good and bad consequences,” he said. “Experience can build knowledge and confidence and expertise, and it does improve diagnostic accuracy.”

On the flip side, however, age-related brain changes include loss of volume and lower levels of some neurotransmitters, resulting in cognitive changes. “Functional changes occur too,” Dr. Ellison said.

“Just as some aging athletes may lose a degree of speed, strength, and flexibility, and some aging scientists may lose a part of their former cognitive speed, flexibility, and mental strength, aging health care providers can lose some of the physical coordination, strength, and visual acuity necessary to perform demanding surgical operations. They can also lose some of the processing speed, working memory, and executive function that allows them to excel in cognitive professional tasks.”

An estimated 5.8 million Americans age 65 and older have Alzheimer’s dementia, according to the Alzheimer’s Association.

Picking an arbitrary age for mandatory retirement isn’t the right approach for physicians, said Dr. Katlic. Rather, he said, the answer is to establish late-practitioner screening programs. “Very few hospitals have them, however,” he pointed out. “We do [at Lifebridge Health], and so do a few dozen others, but that’s out of hundreds.”

Instead, what typically plays out is that hospital staff might begin to notice a decline in a colleague. Things like a disheveled appearance or lack of hygiene, or trouble with memory, such as getting lost en route back to his or her office. Even dangerous behaviors such as nodding off during a procedure are not unheard of.

There are many examples of physician decline that fly under the radar. “Unfortunately, it’s unusual for cognitively impaired health care providers to recognize and report their own difficulties,” said Dr. Ellison. “Although peers are expected to report cognitively impaired colleagues, they often fail to do so. In some other countries, age-based assessment is an accepted policy. In the U.S., this is not a uniform policy.”

Sometimes physicians can remain on the job in spite of decline thanks to certain “props,” according to Dr. Ellison. “Good procedures, efficient supports, and various workarounds compensate,” he said, “but often are not sufficient to maintain high-quality practice.”

Most often, these situations play out slowly, until the problem becomes glaringly obvious and potentially dangerous, and someone in a position of power must step in.

“Often, it’s hearsay from a nurse or another staff member, and then a hospital president or chief of staff must make a career-affecting decision for the doctor in question,” said Dr. Katlic.

Because there is little self- or colleague policing – and barring official or binding guidelines on the aging physician issue – both Dr. Katlic and Dr. Ellison are proponents of late-career screening.
 

How screening can help  

As it stands, Dr. Katlic maintains that the profession isn’t doing enough to ensure public safety. “We have peer review and recertification processes, but when you get down to it, we don’t police ourselves well,” he said. “All physicians are assessed throughout their careers as part of the hospital accreditation process, which is fair and adequate.”

Dr. Katlic said that there are three main benchmarks that physicians should be able to meet at an agreed upon age: a physical exam, a neurocognitive screening, and an eye exam. “At some reasonable age, I personally believe these exams should take place,” he said. “We can allow doctors to pick their own practitioners for the eye and physical exams, but the neurocognitive exam should be completed by a PhD neuropsychologist.”

At Lifebridge, for instance, these screenings begin at age 75 and take place every 2 years, during the recredentialing process. It applies to all specialties, not just surgeons. “Surgery is a little different in that it requires fine motor skills in addition to the others we test, but you want any physician to be cognitively intact,” Dr. Katlic pointed out. “All doctors need the ability to make decisions quickly, often under noisy, distracting conditions.”

Dr. Ellison supports applying the screenings to all specialties. “Let’s not forget that all physicians must be alert to the many ways in which their patients reveal what needs attention, evaluation, and treatment,” he said. “Some health care tasks could be performed without visual input; for example, perhaps psychotherapy could be provided competently by a clinician who lacks visual acuity. Auditory input might not be necessary for reading x-rays – but the information a health care provider gets from their eyes and ears is important, not just for surgeons.”

University of California San Diego has established what it calls its Physician Assessment and Clinical Education (PACE) program. One of the nation’s oldest and largest such programs, the hospital founded PACE in 1996. Most physicians taking part arrive as a requirement of disciplinary action from the state medical board, but a small percentage self-refers.

PACE involves two phases. The first is a 2-day set of tests and measures core competency knowledge. Phase 2 is more comprehensive and lasts 5 days. Here, within their specialty, physicians participate in the activities of the corresponding residency program. Faculty evaluates the physician, and a multidisciplinary team meets to review all the findings of the combined phases.

Depending on the results, doctors may face remediation steps that range from programs to address performance deficiencies to residency-level clinical experiences. According to a paper on the program published by the institution, “most physicians referred to the PACE program are found to have mild to moderate performance dyscompetence.”

In the case of the 2021 guidelines adopted by AMA delegates, there are nine principles for assessment. They should be evidence-based, ethical, relevant, accountable, fair and equitable, transparent, supportive, and nonburdensome, and should afford physicians due process protections.
 

Looking ahead

Even Dr. Katlic worries about the possibility of Congress intervening to establish federal-level, mandatory retirement age. “This just doesn’t make sense for our profession given the great variability we see,” he said. “My biggest hope is that more individual hospitals will institute these screenings.”

As the physician population ages – and the influx of new doctors shrinks – the slope becomes even more slippery. The AMA is predicting a physician shortage of nearly 40,000 by the year 2034. This strengthens arguments to keep existing physicians practicing for as long as possible and might make institutions less likely to screen.

It’s all a delicate balancing act and a continuing work in progress, said Dr. Ellison. “Ultimately, I believe we need to find a way to understand and address the possible implications for public safety, while at the same time protecting the privacy and dignity of our valued older physicians and other health care providers.”

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

Air traffic controllers face mandatory retirement at age 56, with exceptions up to 61. Commercial airline pilots must bow out at 65; same for foreign service employees. Physicians, however, have no age limit, regardless of specialty.

That doesn’t mean the topic of “how old is too old” hasn’t been one of the profession’s most heated debates for many years now.

As the profession rapidly ages – some 30% of the physician workforce is currently a senior, according to the American Medical Association – the topic of whether or not there should be a standard measure or age for retirement is front and center. The AMA’s Council on Medical Education formed a workgroup to look into the issue in 2015 and 2018, and in 2021, delegates adopted a set of guidelines for screening and assessing physicians, but stopped short of a mandate.

Mark Katlic, MD, chair of surgery at Lifebridge Health System, Baltimore, has devoted a decade to studying this topic. “I’m a bit of an outlier looking into this,” he says. “The public is unaware and seemingly unconcerned about the issue. Even among the medical profession, there’s been a series of fits and starts to develop a cohesive approach.”

One of the reasons guidelines – mandatory or otherwise – have been tough to come by is that aging brings with it a huge degree of variability. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” Dr. Katlic pointed out.

Indeed, some 80-year-olds can easily continue to teach college courses, keep up in 10K running races, or perform delicate surgeries. Yet others in their peer group might struggle to properly button a shirt, walk a flight of stairs, or remember yesterday’s meals. Functional age is not the same as chronological age.

Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist at Stanford (Calif.) University Health, counts himself in the camp opposed to age-based assessments. “It’s age discrimination,” he says. “Physicians receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as doctors reach a certain age.”

Dr. Stockdale suggests that in many cases, malpractice suits are filed against mid-career doctors, not those of advanced age. “If you’re using the argument that there is an accumulation of deficits with age, the fact is that those deficits begin well before your 70s,” he said. “It’s better to have a uniform screening policy and begin at a much younger age.”

At Stanford, in fact, there was a former assessment policy that included cognitive testing, but physicians were successful in seeing that portion of testing eliminated. “It is a physical examination, by a physician of choice, certifying that for the privileges requested there is no physical or mental reason the candidate cannot safely perform them,” Dr. Stockdale explained.

In some cases, medical staffs have filed lawsuits to fight age-related testing. In New Haven, Conn., for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory “late career practitioner policy.”

A similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

James Ellison, MD, MPH, chair in Memory Care and Geriatrics with ChristianaCare in Wilmington, Del., points out that aging can bring benefits for practicing physicians. “Age is very individualized and there are good and bad consequences,” he said. “Experience can build knowledge and confidence and expertise, and it does improve diagnostic accuracy.”

On the flip side, however, age-related brain changes include loss of volume and lower levels of some neurotransmitters, resulting in cognitive changes. “Functional changes occur too,” Dr. Ellison said.

“Just as some aging athletes may lose a degree of speed, strength, and flexibility, and some aging scientists may lose a part of their former cognitive speed, flexibility, and mental strength, aging health care providers can lose some of the physical coordination, strength, and visual acuity necessary to perform demanding surgical operations. They can also lose some of the processing speed, working memory, and executive function that allows them to excel in cognitive professional tasks.”

An estimated 5.8 million Americans age 65 and older have Alzheimer’s dementia, according to the Alzheimer’s Association.

Picking an arbitrary age for mandatory retirement isn’t the right approach for physicians, said Dr. Katlic. Rather, he said, the answer is to establish late-practitioner screening programs. “Very few hospitals have them, however,” he pointed out. “We do [at Lifebridge Health], and so do a few dozen others, but that’s out of hundreds.”

Instead, what typically plays out is that hospital staff might begin to notice a decline in a colleague. Things like a disheveled appearance or lack of hygiene, or trouble with memory, such as getting lost en route back to his or her office. Even dangerous behaviors such as nodding off during a procedure are not unheard of.

There are many examples of physician decline that fly under the radar. “Unfortunately, it’s unusual for cognitively impaired health care providers to recognize and report their own difficulties,” said Dr. Ellison. “Although peers are expected to report cognitively impaired colleagues, they often fail to do so. In some other countries, age-based assessment is an accepted policy. In the U.S., this is not a uniform policy.”

Sometimes physicians can remain on the job in spite of decline thanks to certain “props,” according to Dr. Ellison. “Good procedures, efficient supports, and various workarounds compensate,” he said, “but often are not sufficient to maintain high-quality practice.”

Most often, these situations play out slowly, until the problem becomes glaringly obvious and potentially dangerous, and someone in a position of power must step in.

“Often, it’s hearsay from a nurse or another staff member, and then a hospital president or chief of staff must make a career-affecting decision for the doctor in question,” said Dr. Katlic.

Because there is little self- or colleague policing – and barring official or binding guidelines on the aging physician issue – both Dr. Katlic and Dr. Ellison are proponents of late-career screening.
 

How screening can help  

As it stands, Dr. Katlic maintains that the profession isn’t doing enough to ensure public safety. “We have peer review and recertification processes, but when you get down to it, we don’t police ourselves well,” he said. “All physicians are assessed throughout their careers as part of the hospital accreditation process, which is fair and adequate.”

Dr. Katlic said that there are three main benchmarks that physicians should be able to meet at an agreed upon age: a physical exam, a neurocognitive screening, and an eye exam. “At some reasonable age, I personally believe these exams should take place,” he said. “We can allow doctors to pick their own practitioners for the eye and physical exams, but the neurocognitive exam should be completed by a PhD neuropsychologist.”

At Lifebridge, for instance, these screenings begin at age 75 and take place every 2 years, during the recredentialing process. It applies to all specialties, not just surgeons. “Surgery is a little different in that it requires fine motor skills in addition to the others we test, but you want any physician to be cognitively intact,” Dr. Katlic pointed out. “All doctors need the ability to make decisions quickly, often under noisy, distracting conditions.”

Dr. Ellison supports applying the screenings to all specialties. “Let’s not forget that all physicians must be alert to the many ways in which their patients reveal what needs attention, evaluation, and treatment,” he said. “Some health care tasks could be performed without visual input; for example, perhaps psychotherapy could be provided competently by a clinician who lacks visual acuity. Auditory input might not be necessary for reading x-rays – but the information a health care provider gets from their eyes and ears is important, not just for surgeons.”

University of California San Diego has established what it calls its Physician Assessment and Clinical Education (PACE) program. One of the nation’s oldest and largest such programs, the hospital founded PACE in 1996. Most physicians taking part arrive as a requirement of disciplinary action from the state medical board, but a small percentage self-refers.

PACE involves two phases. The first is a 2-day set of tests and measures core competency knowledge. Phase 2 is more comprehensive and lasts 5 days. Here, within their specialty, physicians participate in the activities of the corresponding residency program. Faculty evaluates the physician, and a multidisciplinary team meets to review all the findings of the combined phases.

Depending on the results, doctors may face remediation steps that range from programs to address performance deficiencies to residency-level clinical experiences. According to a paper on the program published by the institution, “most physicians referred to the PACE program are found to have mild to moderate performance dyscompetence.”

In the case of the 2021 guidelines adopted by AMA delegates, there are nine principles for assessment. They should be evidence-based, ethical, relevant, accountable, fair and equitable, transparent, supportive, and nonburdensome, and should afford physicians due process protections.
 

Looking ahead

Even Dr. Katlic worries about the possibility of Congress intervening to establish federal-level, mandatory retirement age. “This just doesn’t make sense for our profession given the great variability we see,” he said. “My biggest hope is that more individual hospitals will institute these screenings.”

As the physician population ages – and the influx of new doctors shrinks – the slope becomes even more slippery. The AMA is predicting a physician shortage of nearly 40,000 by the year 2034. This strengthens arguments to keep existing physicians practicing for as long as possible and might make institutions less likely to screen.

It’s all a delicate balancing act and a continuing work in progress, said Dr. Ellison. “Ultimately, I believe we need to find a way to understand and address the possible implications for public safety, while at the same time protecting the privacy and dignity of our valued older physicians and other health care providers.”

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

Air traffic controllers face mandatory retirement at age 56, with exceptions up to 61. Commercial airline pilots must bow out at 65; same for foreign service employees. Physicians, however, have no age limit, regardless of specialty.

That doesn’t mean the topic of “how old is too old” hasn’t been one of the profession’s most heated debates for many years now.

As the profession rapidly ages – some 30% of the physician workforce is currently a senior, according to the American Medical Association – the topic of whether or not there should be a standard measure or age for retirement is front and center. The AMA’s Council on Medical Education formed a workgroup to look into the issue in 2015 and 2018, and in 2021, delegates adopted a set of guidelines for screening and assessing physicians, but stopped short of a mandate.

Mark Katlic, MD, chair of surgery at Lifebridge Health System, Baltimore, has devoted a decade to studying this topic. “I’m a bit of an outlier looking into this,” he says. “The public is unaware and seemingly unconcerned about the issue. Even among the medical profession, there’s been a series of fits and starts to develop a cohesive approach.”

One of the reasons guidelines – mandatory or otherwise – have been tough to come by is that aging brings with it a huge degree of variability. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” Dr. Katlic pointed out.

Indeed, some 80-year-olds can easily continue to teach college courses, keep up in 10K running races, or perform delicate surgeries. Yet others in their peer group might struggle to properly button a shirt, walk a flight of stairs, or remember yesterday’s meals. Functional age is not the same as chronological age.

Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist at Stanford (Calif.) University Health, counts himself in the camp opposed to age-based assessments. “It’s age discrimination,” he says. “Physicians receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as doctors reach a certain age.”

Dr. Stockdale suggests that in many cases, malpractice suits are filed against mid-career doctors, not those of advanced age. “If you’re using the argument that there is an accumulation of deficits with age, the fact is that those deficits begin well before your 70s,” he said. “It’s better to have a uniform screening policy and begin at a much younger age.”

At Stanford, in fact, there was a former assessment policy that included cognitive testing, but physicians were successful in seeing that portion of testing eliminated. “It is a physical examination, by a physician of choice, certifying that for the privileges requested there is no physical or mental reason the candidate cannot safely perform them,” Dr. Stockdale explained.

In some cases, medical staffs have filed lawsuits to fight age-related testing. In New Haven, Conn., for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory “late career practitioner policy.”

A similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

James Ellison, MD, MPH, chair in Memory Care and Geriatrics with ChristianaCare in Wilmington, Del., points out that aging can bring benefits for practicing physicians. “Age is very individualized and there are good and bad consequences,” he said. “Experience can build knowledge and confidence and expertise, and it does improve diagnostic accuracy.”

On the flip side, however, age-related brain changes include loss of volume and lower levels of some neurotransmitters, resulting in cognitive changes. “Functional changes occur too,” Dr. Ellison said.

“Just as some aging athletes may lose a degree of speed, strength, and flexibility, and some aging scientists may lose a part of their former cognitive speed, flexibility, and mental strength, aging health care providers can lose some of the physical coordination, strength, and visual acuity necessary to perform demanding surgical operations. They can also lose some of the processing speed, working memory, and executive function that allows them to excel in cognitive professional tasks.”

An estimated 5.8 million Americans age 65 and older have Alzheimer’s dementia, according to the Alzheimer’s Association.

Picking an arbitrary age for mandatory retirement isn’t the right approach for physicians, said Dr. Katlic. Rather, he said, the answer is to establish late-practitioner screening programs. “Very few hospitals have them, however,” he pointed out. “We do [at Lifebridge Health], and so do a few dozen others, but that’s out of hundreds.”

Instead, what typically plays out is that hospital staff might begin to notice a decline in a colleague. Things like a disheveled appearance or lack of hygiene, or trouble with memory, such as getting lost en route back to his or her office. Even dangerous behaviors such as nodding off during a procedure are not unheard of.

There are many examples of physician decline that fly under the radar. “Unfortunately, it’s unusual for cognitively impaired health care providers to recognize and report their own difficulties,” said Dr. Ellison. “Although peers are expected to report cognitively impaired colleagues, they often fail to do so. In some other countries, age-based assessment is an accepted policy. In the U.S., this is not a uniform policy.”

Sometimes physicians can remain on the job in spite of decline thanks to certain “props,” according to Dr. Ellison. “Good procedures, efficient supports, and various workarounds compensate,” he said, “but often are not sufficient to maintain high-quality practice.”

Most often, these situations play out slowly, until the problem becomes glaringly obvious and potentially dangerous, and someone in a position of power must step in.

“Often, it’s hearsay from a nurse or another staff member, and then a hospital president or chief of staff must make a career-affecting decision for the doctor in question,” said Dr. Katlic.

Because there is little self- or colleague policing – and barring official or binding guidelines on the aging physician issue – both Dr. Katlic and Dr. Ellison are proponents of late-career screening.
 

How screening can help  

As it stands, Dr. Katlic maintains that the profession isn’t doing enough to ensure public safety. “We have peer review and recertification processes, but when you get down to it, we don’t police ourselves well,” he said. “All physicians are assessed throughout their careers as part of the hospital accreditation process, which is fair and adequate.”

Dr. Katlic said that there are three main benchmarks that physicians should be able to meet at an agreed upon age: a physical exam, a neurocognitive screening, and an eye exam. “At some reasonable age, I personally believe these exams should take place,” he said. “We can allow doctors to pick their own practitioners for the eye and physical exams, but the neurocognitive exam should be completed by a PhD neuropsychologist.”

At Lifebridge, for instance, these screenings begin at age 75 and take place every 2 years, during the recredentialing process. It applies to all specialties, not just surgeons. “Surgery is a little different in that it requires fine motor skills in addition to the others we test, but you want any physician to be cognitively intact,” Dr. Katlic pointed out. “All doctors need the ability to make decisions quickly, often under noisy, distracting conditions.”

Dr. Ellison supports applying the screenings to all specialties. “Let’s not forget that all physicians must be alert to the many ways in which their patients reveal what needs attention, evaluation, and treatment,” he said. “Some health care tasks could be performed without visual input; for example, perhaps psychotherapy could be provided competently by a clinician who lacks visual acuity. Auditory input might not be necessary for reading x-rays – but the information a health care provider gets from their eyes and ears is important, not just for surgeons.”

University of California San Diego has established what it calls its Physician Assessment and Clinical Education (PACE) program. One of the nation’s oldest and largest such programs, the hospital founded PACE in 1996. Most physicians taking part arrive as a requirement of disciplinary action from the state medical board, but a small percentage self-refers.

PACE involves two phases. The first is a 2-day set of tests and measures core competency knowledge. Phase 2 is more comprehensive and lasts 5 days. Here, within their specialty, physicians participate in the activities of the corresponding residency program. Faculty evaluates the physician, and a multidisciplinary team meets to review all the findings of the combined phases.

Depending on the results, doctors may face remediation steps that range from programs to address performance deficiencies to residency-level clinical experiences. According to a paper on the program published by the institution, “most physicians referred to the PACE program are found to have mild to moderate performance dyscompetence.”

In the case of the 2021 guidelines adopted by AMA delegates, there are nine principles for assessment. They should be evidence-based, ethical, relevant, accountable, fair and equitable, transparent, supportive, and nonburdensome, and should afford physicians due process protections.
 

Looking ahead

Even Dr. Katlic worries about the possibility of Congress intervening to establish federal-level, mandatory retirement age. “This just doesn’t make sense for our profession given the great variability we see,” he said. “My biggest hope is that more individual hospitals will institute these screenings.”

As the physician population ages – and the influx of new doctors shrinks – the slope becomes even more slippery. The AMA is predicting a physician shortage of nearly 40,000 by the year 2034. This strengthens arguments to keep existing physicians practicing for as long as possible and might make institutions less likely to screen.

It’s all a delicate balancing act and a continuing work in progress, said Dr. Ellison. “Ultimately, I believe we need to find a way to understand and address the possible implications for public safety, while at the same time protecting the privacy and dignity of our valued older physicians and other health care providers.”

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

A Canadian woman who officials allege faked being a registered nurse for some 30 years in Canada and the United States is scheduled to appear in court next month after being sentenced to 7 years in prison.

Brigitte Cleroux, 50, is scheduled to appear May 18 on charges in Vancouver, British Columbia, of impersonating a nurse while working inside a local hospital. She was previously sentenced April 22 in an Ontario court after she pled guilty in January to seven offenses, including impersonation, assault with a weapon, and assault, according to CBC Radio-Canada.

Ms. Cleroux, who uses several aliases, had a long history of deception in three provinces in Canada, as well as in Colorado and Florida. The sentencing in Ontario stemmed from incidents at a medical and dental clinic in Ottawa last year, which included administration of medications to patients through needle injections, Ottawa Police reported in a press statement obtained by this news organization.

Authorities charged Ms. Cleroux in September with assault with a weapon and criminal negligence causing bodily harm, along with “personation to gain advantage,” obtaining by false pretense, and using a forged document, this news organization reported.

Ms. Cleroux has been in custody since her arrest by Ottawa Police in August.

The Vancouver Police Department (VPD) charged Ms. Cleroux last year with fraud of over $5,000 and personation with intent. VPD investigated claims that an employee at BC Women’s Hospital fraudulently identified herself as a nurse while working there between June 2020 and June 2021, according to a VPD press release.

Nursing colleges in British Columbia and Ontario issued warnings that she had used aliases and purported to be a registered nurse to gain employment. The aliases included Melanie Thompson, Melanie Smith, and Melanie Cleroux.

Ms. Cleroux was believed to be a student in a nursing school in Colorado, but she only completed 2 years of a 4-year nursing course and was never certified as a nurse, according to CBC. Her criminal record dates back 30 years and includes 67 adult convictions and other convictions in her youth, CBC reported.

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

A Canadian woman who officials allege faked being a registered nurse for some 30 years in Canada and the United States is scheduled to appear in court next month after being sentenced to 7 years in prison.

Brigitte Cleroux, 50, is scheduled to appear May 18 on charges in Vancouver, British Columbia, of impersonating a nurse while working inside a local hospital. She was previously sentenced April 22 in an Ontario court after she pled guilty in January to seven offenses, including impersonation, assault with a weapon, and assault, according to CBC Radio-Canada.

Ms. Cleroux, who uses several aliases, had a long history of deception in three provinces in Canada, as well as in Colorado and Florida. The sentencing in Ontario stemmed from incidents at a medical and dental clinic in Ottawa last year, which included administration of medications to patients through needle injections, Ottawa Police reported in a press statement obtained by this news organization.

Authorities charged Ms. Cleroux in September with assault with a weapon and criminal negligence causing bodily harm, along with “personation to gain advantage,” obtaining by false pretense, and using a forged document, this news organization reported.

Ms. Cleroux has been in custody since her arrest by Ottawa Police in August.

The Vancouver Police Department (VPD) charged Ms. Cleroux last year with fraud of over $5,000 and personation with intent. VPD investigated claims that an employee at BC Women’s Hospital fraudulently identified herself as a nurse while working there between June 2020 and June 2021, according to a VPD press release.

Nursing colleges in British Columbia and Ontario issued warnings that she had used aliases and purported to be a registered nurse to gain employment. The aliases included Melanie Thompson, Melanie Smith, and Melanie Cleroux.

Ms. Cleroux was believed to be a student in a nursing school in Colorado, but she only completed 2 years of a 4-year nursing course and was never certified as a nurse, according to CBC. Her criminal record dates back 30 years and includes 67 adult convictions and other convictions in her youth, CBC reported.

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

A Canadian woman who officials allege faked being a registered nurse for some 30 years in Canada and the United States is scheduled to appear in court next month after being sentenced to 7 years in prison.

Brigitte Cleroux, 50, is scheduled to appear May 18 on charges in Vancouver, British Columbia, of impersonating a nurse while working inside a local hospital. She was previously sentenced April 22 in an Ontario court after she pled guilty in January to seven offenses, including impersonation, assault with a weapon, and assault, according to CBC Radio-Canada.

Ms. Cleroux, who uses several aliases, had a long history of deception in three provinces in Canada, as well as in Colorado and Florida. The sentencing in Ontario stemmed from incidents at a medical and dental clinic in Ottawa last year, which included administration of medications to patients through needle injections, Ottawa Police reported in a press statement obtained by this news organization.

Authorities charged Ms. Cleroux in September with assault with a weapon and criminal negligence causing bodily harm, along with “personation to gain advantage,” obtaining by false pretense, and using a forged document, this news organization reported.

Ms. Cleroux has been in custody since her arrest by Ottawa Police in August.

The Vancouver Police Department (VPD) charged Ms. Cleroux last year with fraud of over $5,000 and personation with intent. VPD investigated claims that an employee at BC Women’s Hospital fraudulently identified herself as a nurse while working there between June 2020 and June 2021, according to a VPD press release.

Nursing colleges in British Columbia and Ontario issued warnings that she had used aliases and purported to be a registered nurse to gain employment. The aliases included Melanie Thompson, Melanie Smith, and Melanie Cleroux.

Ms. Cleroux was believed to be a student in a nursing school in Colorado, but she only completed 2 years of a 4-year nursing course and was never certified as a nurse, according to CBC. Her criminal record dates back 30 years and includes 67 adult convictions and other convictions in her youth, CBC reported.

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