Cardiology

TOPLINE:

Stimulating the vagus nerve reduced orthostatic tachycardia in patients with postural tachycardia syndrome (POTS), possibly through decreased antiadrenergic autoantibodies and inflammatory cytokines, and improved cardiac autonomic function, in a small proof-of-concept study.

METHODOLOGY:

The double-blind study included 25 female patients with POTS, a syndrome of orthostatic intolerance (mean age 31 years and 81% Caucasian), who were randomly assigned to transcutaneous vagus nerve stimulation (tVNS) to the right tragus or sham stimulation to the earlobe, a site devoid of vagal innervation.

After training, patients delivered the tVNS themselves at a frequency of 20 Hz and pulse width of 200 ms during 1-hour daily sessions over 2 months.

At baseline and 2 months, patients underwent a tilt test to determine postural tachycardia; they remained supine for 25 minutes, followed by 10 minutes of standing, as tolerated.

Researchers used electrocardiogram data to examine heart rate and blood samples to assess serum cytokines and antiautonomic autoantibodies.

The primary outcome was a comparison of orthostatic tachycardia (standing – supine) between the two arms at 2 months.

TAKEAWAY:

At 2 months, postural tachycardia was significantly less in the active vs sham arm (mean postural increase in heart rate 17.6 beats/min vs 31.7 beats/min; P = .01).

There was a significant decrease in beta 1-adrenergic receptor (beta 1-AR; P = .01) and alpha-1-AR (P = .04) autoantibody activity in the active vs sham group, which may account at least in part for the reduced orthostatic tachycardia, although the exact mechanisms for this effect have not been clearly defined, the authors said.

Serum tumor necrosis factor-alpha (TNF-alpha) levels were significantly decreased in the active group relative to the sham group (8.3 pg/mL vs 13.9 pg/mL; P = .01).

As for heart rate variability, change in low frequency (LF) and high frequency (HF) from supine to standing was significantly decreased, and postural change in LF/HF ratio, a surrogate for sympathovagal balance, was significantly lower in the active group compared with the sham group.

IN PRACTICE:

“Collectively, these data suggest that tVNS, a low-cost, low-risk intervention, applied for a short period of time in selected patients with POTS, may result in a significant amelioration of their disease,” the authors conclude.

SOURCE:

The study was led by Stavros Stavrakis, MD, PhD, University of Oklahoma Health Sciences Center, Oklahoma City. It was published online in JACC: Clinical Electrophysiology..

LIMITATIONS:

The study had a small sample size, included only females, and extended only up to 2 months. As there was no improvement on the overall score from the Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire, researchers can’t conclude tVNS improved patient reported outcomes. The study used 1 hour of daily stimulation but the optimal duration and ideal timing of tVNS is yet to be determined.

DISCLOSURES:

The study was supported by the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute, NIH/National Institute of General Medical Sciences, and individual donations from Francie Fitzgerald and family through the OU Foundation Fund. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Stimulating the vagus nerve reduced orthostatic tachycardia in patients with postural tachycardia syndrome (POTS), possibly through decreased antiadrenergic autoantibodies and inflammatory cytokines, and improved cardiac autonomic function, in a small proof-of-concept study.

METHODOLOGY:

The double-blind study included 25 female patients with POTS, a syndrome of orthostatic intolerance (mean age 31 years and 81% Caucasian), who were randomly assigned to transcutaneous vagus nerve stimulation (tVNS) to the right tragus or sham stimulation to the earlobe, a site devoid of vagal innervation.

After training, patients delivered the tVNS themselves at a frequency of 20 Hz and pulse width of 200 ms during 1-hour daily sessions over 2 months.

At baseline and 2 months, patients underwent a tilt test to determine postural tachycardia; they remained supine for 25 minutes, followed by 10 minutes of standing, as tolerated.

Researchers used electrocardiogram data to examine heart rate and blood samples to assess serum cytokines and antiautonomic autoantibodies.

The primary outcome was a comparison of orthostatic tachycardia (standing – supine) between the two arms at 2 months.

TAKEAWAY:

At 2 months, postural tachycardia was significantly less in the active vs sham arm (mean postural increase in heart rate 17.6 beats/min vs 31.7 beats/min; P = .01).

There was a significant decrease in beta 1-adrenergic receptor (beta 1-AR; P = .01) and alpha-1-AR (P = .04) autoantibody activity in the active vs sham group, which may account at least in part for the reduced orthostatic tachycardia, although the exact mechanisms for this effect have not been clearly defined, the authors said.

Serum tumor necrosis factor-alpha (TNF-alpha) levels were significantly decreased in the active group relative to the sham group (8.3 pg/mL vs 13.9 pg/mL; P = .01).

As for heart rate variability, change in low frequency (LF) and high frequency (HF) from supine to standing was significantly decreased, and postural change in LF/HF ratio, a surrogate for sympathovagal balance, was significantly lower in the active group compared with the sham group.

IN PRACTICE:

“Collectively, these data suggest that tVNS, a low-cost, low-risk intervention, applied for a short period of time in selected patients with POTS, may result in a significant amelioration of their disease,” the authors conclude.

SOURCE:

The study was led by Stavros Stavrakis, MD, PhD, University of Oklahoma Health Sciences Center, Oklahoma City. It was published online in JACC: Clinical Electrophysiology..

LIMITATIONS:

The study had a small sample size, included only females, and extended only up to 2 months. As there was no improvement on the overall score from the Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire, researchers can’t conclude tVNS improved patient reported outcomes. The study used 1 hour of daily stimulation but the optimal duration and ideal timing of tVNS is yet to be determined.

DISCLOSURES:

The study was supported by the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute, NIH/National Institute of General Medical Sciences, and individual donations from Francie Fitzgerald and family through the OU Foundation Fund. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Stimulating the vagus nerve reduced orthostatic tachycardia in patients with postural tachycardia syndrome (POTS), possibly through decreased antiadrenergic autoantibodies and inflammatory cytokines, and improved cardiac autonomic function, in a small proof-of-concept study.

METHODOLOGY:

The double-blind study included 25 female patients with POTS, a syndrome of orthostatic intolerance (mean age 31 years and 81% Caucasian), who were randomly assigned to transcutaneous vagus nerve stimulation (tVNS) to the right tragus or sham stimulation to the earlobe, a site devoid of vagal innervation.

After training, patients delivered the tVNS themselves at a frequency of 20 Hz and pulse width of 200 ms during 1-hour daily sessions over 2 months.

At baseline and 2 months, patients underwent a tilt test to determine postural tachycardia; they remained supine for 25 minutes, followed by 10 minutes of standing, as tolerated.

Researchers used electrocardiogram data to examine heart rate and blood samples to assess serum cytokines and antiautonomic autoantibodies.

The primary outcome was a comparison of orthostatic tachycardia (standing – supine) between the two arms at 2 months.

TAKEAWAY:

At 2 months, postural tachycardia was significantly less in the active vs sham arm (mean postural increase in heart rate 17.6 beats/min vs 31.7 beats/min; P = .01).

There was a significant decrease in beta 1-adrenergic receptor (beta 1-AR; P = .01) and alpha-1-AR (P = .04) autoantibody activity in the active vs sham group, which may account at least in part for the reduced orthostatic tachycardia, although the exact mechanisms for this effect have not been clearly defined, the authors said.

Serum tumor necrosis factor-alpha (TNF-alpha) levels were significantly decreased in the active group relative to the sham group (8.3 pg/mL vs 13.9 pg/mL; P = .01).

As for heart rate variability, change in low frequency (LF) and high frequency (HF) from supine to standing was significantly decreased, and postural change in LF/HF ratio, a surrogate for sympathovagal balance, was significantly lower in the active group compared with the sham group.

IN PRACTICE:

“Collectively, these data suggest that tVNS, a low-cost, low-risk intervention, applied for a short period of time in selected patients with POTS, may result in a significant amelioration of their disease,” the authors conclude.

SOURCE:

The study was led by Stavros Stavrakis, MD, PhD, University of Oklahoma Health Sciences Center, Oklahoma City. It was published online in JACC: Clinical Electrophysiology..

LIMITATIONS:

The study had a small sample size, included only females, and extended only up to 2 months. As there was no improvement on the overall score from the Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire, researchers can’t conclude tVNS improved patient reported outcomes. The study used 1 hour of daily stimulation but the optimal duration and ideal timing of tVNS is yet to be determined.

DISCLOSURES:

The study was supported by the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute, NIH/National Institute of General Medical Sciences, and individual donations from Francie Fitzgerald and family through the OU Foundation Fund. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Posttraumatic stress disorder (PTSD) symptoms are associated with poorer cardiovascular and neurocognitive health among midlife women, particularly those who are APOEε4 carriers, new research suggests.

METHODOLOGY:

• Researchers conducted a cross-sectional study of 274 women (mean age, 59 years) participating in the MsBrain study of menopause and brain health.
• As part of the study, the women completed the PTSD Checklist–Civilian Version and underwent physical and neuropsychological testing, as well as carotid artery ultrasonography and brain MRI.
• Outcomes of interest were associations of PTSD symptoms with carotid intima media thickness (IMT), brain white matter hyperintensity volume (WMHV), and cognition, assessed in linear regression models.
• Interactions by APOEε4 were assessed; covariates included age, race/ethnicity, education, and CVD risk factors.

TAKEAWAY:

• Higher PTSD symptoms were associated with greater carotid IMT (P = .03); associations of PTSD symptoms with neurocognitive outcomes varied significantly by APOEε4 status.
• Among APOEε4 carriers, PTSD symptoms were associated with greater whole-brain WMHV (P = .009), periventricular WMHV (P = .02), deep WMHV (P = .01), and frontal WMHV (P = .04) in multivariable models.
• APOEε4 carriers with PTSD symptoms also had poorer cognition, specifically attention and working memory (P = .02), semantic fluency (P = .01), perceptual speed (P = .002) and processing speed (P = .002), in multivariable models.

IN PRACTICE:

“This study sheds important insight on the implications of PTSD symptoms to women’s cardiovascular and neurocognitive health. Our findings indicate that the APOEε4 genotype may identify a group of women with PTSD symptoms at particular risk for poor neurocognitive health,” the authors wrote.

SOURCE:

The study, with first author Rebecca Thurston, PhD, of the department of psychiatry, University of Pittsburgh, was published online  in JAMA Network Open.

LIMITATIONS:

No diagnostic clinical interviews were conducted, and PTSD treatment was not assessed. All participants identified as cisgender, and most were non-Hispanic Black or White. The study was observational and cross-sectional, precluding assertions about directionality or causality.

DISCLOSURES:

The study was funded by the National Institutes of Health, the University of Pittsburgh Clinical and Translational Science Institute, and the University of Pittsburgh Small Molecule Biomarker Core. Dr. Thurston reported receiving personal fees from Astellas Pharma, Bayer, Hello Therapeutics, Vira Health, and Happify Health outside the submitted work.

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

TOPLINE:

Posttraumatic stress disorder (PTSD) symptoms are associated with poorer cardiovascular and neurocognitive health among midlife women, particularly those who are APOEε4 carriers, new research suggests.

METHODOLOGY:

• Researchers conducted a cross-sectional study of 274 women (mean age, 59 years) participating in the MsBrain study of menopause and brain health.
• As part of the study, the women completed the PTSD Checklist–Civilian Version and underwent physical and neuropsychological testing, as well as carotid artery ultrasonography and brain MRI.
• Outcomes of interest were associations of PTSD symptoms with carotid intima media thickness (IMT), brain white matter hyperintensity volume (WMHV), and cognition, assessed in linear regression models.
• Interactions by APOEε4 were assessed; covariates included age, race/ethnicity, education, and CVD risk factors.

TAKEAWAY:

• Higher PTSD symptoms were associated with greater carotid IMT (P = .03); associations of PTSD symptoms with neurocognitive outcomes varied significantly by APOEε4 status.
• Among APOEε4 carriers, PTSD symptoms were associated with greater whole-brain WMHV (P = .009), periventricular WMHV (P = .02), deep WMHV (P = .01), and frontal WMHV (P = .04) in multivariable models.
• APOEε4 carriers with PTSD symptoms also had poorer cognition, specifically attention and working memory (P = .02), semantic fluency (P = .01), perceptual speed (P = .002) and processing speed (P = .002), in multivariable models.

IN PRACTICE:

“This study sheds important insight on the implications of PTSD symptoms to women’s cardiovascular and neurocognitive health. Our findings indicate that the APOEε4 genotype may identify a group of women with PTSD symptoms at particular risk for poor neurocognitive health,” the authors wrote.

SOURCE:

The study, with first author Rebecca Thurston, PhD, of the department of psychiatry, University of Pittsburgh, was published online  in JAMA Network Open.

LIMITATIONS:

No diagnostic clinical interviews were conducted, and PTSD treatment was not assessed. All participants identified as cisgender, and most were non-Hispanic Black or White. The study was observational and cross-sectional, precluding assertions about directionality or causality.

DISCLOSURES:

The study was funded by the National Institutes of Health, the University of Pittsburgh Clinical and Translational Science Institute, and the University of Pittsburgh Small Molecule Biomarker Core. Dr. Thurston reported receiving personal fees from Astellas Pharma, Bayer, Hello Therapeutics, Vira Health, and Happify Health outside the submitted work.

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

TOPLINE:

Posttraumatic stress disorder (PTSD) symptoms are associated with poorer cardiovascular and neurocognitive health among midlife women, particularly those who are APOEε4 carriers, new research suggests.

METHODOLOGY:

• Researchers conducted a cross-sectional study of 274 women (mean age, 59 years) participating in the MsBrain study of menopause and brain health.
• As part of the study, the women completed the PTSD Checklist–Civilian Version and underwent physical and neuropsychological testing, as well as carotid artery ultrasonography and brain MRI.
• Outcomes of interest were associations of PTSD symptoms with carotid intima media thickness (IMT), brain white matter hyperintensity volume (WMHV), and cognition, assessed in linear regression models.
• Interactions by APOEε4 were assessed; covariates included age, race/ethnicity, education, and CVD risk factors.

TAKEAWAY:

• Higher PTSD symptoms were associated with greater carotid IMT (P = .03); associations of PTSD symptoms with neurocognitive outcomes varied significantly by APOEε4 status.
• Among APOEε4 carriers, PTSD symptoms were associated with greater whole-brain WMHV (P = .009), periventricular WMHV (P = .02), deep WMHV (P = .01), and frontal WMHV (P = .04) in multivariable models.
• APOEε4 carriers with PTSD symptoms also had poorer cognition, specifically attention and working memory (P = .02), semantic fluency (P = .01), perceptual speed (P = .002) and processing speed (P = .002), in multivariable models.

IN PRACTICE:

“This study sheds important insight on the implications of PTSD symptoms to women’s cardiovascular and neurocognitive health. Our findings indicate that the APOEε4 genotype may identify a group of women with PTSD symptoms at particular risk for poor neurocognitive health,” the authors wrote.

SOURCE:

The study, with first author Rebecca Thurston, PhD, of the department of psychiatry, University of Pittsburgh, was published online  in JAMA Network Open.

LIMITATIONS:

No diagnostic clinical interviews were conducted, and PTSD treatment was not assessed. All participants identified as cisgender, and most were non-Hispanic Black or White. The study was observational and cross-sectional, precluding assertions about directionality or causality.

DISCLOSURES:

The study was funded by the National Institutes of Health, the University of Pittsburgh Clinical and Translational Science Institute, and the University of Pittsburgh Small Molecule Biomarker Core. Dr. Thurston reported receiving personal fees from Astellas Pharma, Bayer, Hello Therapeutics, Vira Health, and Happify Health outside the submitted work.

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

Bariatric surgery continues to play a major role in obesity management despite the emergence of potent new weight-loss medications, according to two experts who spoke at an Endocrine Society science writers briefing.

“Bariatric surgery is safe, effective, and unfortunately underutilized for treating obesity and its complications,” said Jaime Almandoz, MD, medical director of the Weight Wellness Program at the University of Texas Southwestern Medical Center, Dallas.

Added Dr. Almandoz, who is triple board-certified in internal medicine, endocrinology, and obesity medicine, “Sometimes this gets presented in a linear fashion. ‘We’ll try lifestyle first, and if that doesn’t work, we’ll try medications, and if that doesn’t work, we’ll try surgery.’ But sometimes we might need to go straight to surgery instead of going through medications first, because it may be the most effective and evidence-based treatment for the person in the office in front of you.”

Moreover, he pointed out that currently, Medicare and many private insurers don’t cover antiobesity medications but do cover bariatric surgery.

Indeed, Srividya Kidambi, MD, professor and chief of endocrinology and molecular medicine at the Medical College of Wisconsin/Froedtert Hospital, Milwaukee, said there are certain types of patients for whom she might consider bariatric surgery first. One would be a person with a body mass index (BMI) greater than 40 kg/m² or with a BMI greater than 35 kg/m² and severe comorbidities.

Another, she said, would be young, relatively healthy people with obesity who have no comorbid conditions. “We know that if we stop the medication, the weight comes back. So, if I see a 20- to 25-year-old, am I really to commit them to lifelong therapy, or is bariatric surgery a better option in these cases? These drugs have not been around that long ... so I tend to recommend bariatric surgery in some patients.”

During the recent briefing, Dr. Almandoz summarized the evidence base for the benefits of bariatric surgery beyond weight loss, which include remission of type 2 diabetes and fatty liver disease, reduction of the risks of cardiovascular disease and cancer, and increased life expectancy.

“Everyone seems to be talking about GLP-1s for facilitating weight loss and treating obesity. ... What I want to do is provide a counterpoint to accessible therapies that are covered by more insurance plans and that may, in fact, have a better evidence base for treating obesity and its related complications,” he said in his introduction.

Bariatric surgery has been used for decades, and many centers of excellence perform it, with greatly reduced complication rates seen today than in the past. “It’s comparable to having a gallbladder surgery in terms of perioperative risk,” he noted.

Medicare and private insurers generally cover bariatric surgery for people with BMI greater than 40 kg/m2 or 35-39 kg/m² and at least one weight-related comorbidity, including type 2 diabetes, obstructive sleep apnea, hypertension, atherosclerotic disease, hyperlipidemia, and fatty liver disease.

Data suggest that weight reduction of about 3% can lead to meaningful reductions in blood glucose and triglyceride levels, but weight loss of 15% or greater is associated with reductions in cardiovascular events and type 2 diabetes remission. Lifestyle modification typically produces about 5% weight loss, compared with 20%-35% with bariatric surgery with sleeve gastrectomy or gastric bypass.

Older weight loss medications produced weight loss of 5%-10%; only the newer medications, semaglutide 2.4 mg and tirzepatide, come close to that. Weight loss with semaglutide is about 15%, while tirzepatide can produce weight loss of up to 22%. But, there are still issues with affordability, access, and lack of coverage, Dr. Almandoz noted.

One recent randomized trial of more than 400 individuals showed that bariatric surgery was more effective than lifestyle and medical therapies for treating metabolic-associated steatohepatitis without worsening of fibrosis.

Another showed that the surgery was associated with fewer major adverse liver outcomes among people who already had MASH. That same study showed a 70% reduction in cardiovascular events with bariatric surgery.

For patients with type 2 diabetes, numerous trials have demonstrated long-term remission and reduced A1c at 5 years and 10 years post surgery, along with reductions in microvascular and macrovascular complications.

Other data suggest that a shorter history of type 2 diabetes is among the factors predicting remission with bariatric surgery. “Oftentimes, both patients and providers will wait until the diabetes is quite advanced before they even have the conversation about weight loss or even bariatric surgery. This suggests that if we intervene earlier in the course of disease, when it is less severe and less advanced, we have a higher rate of causing remission in the diabetes,” Dr. Almandoz said.

The American Diabetes Association’s Standards of Care incorporate bariatric surgery as either “recommended” or “may be considered” to treat type 2 diabetes, depending on BMI level, for those who don’t achieve durable weight loss with nonsurgical methods, he noted.

A retrospective cohort study showed significant reductions in cardiovascular outcomes with bariatric surgery among people with baseline cardiovascular disease. “This is not just about bariatric surgery to cause weight loss. This is about the multitude of effects that happen when we treat obesity as a disease with highly effective therapies such as surgery,” he said.

Even cancer risk and cancer-related mortality were significantly reduced with bariatric surgery, another study found.

And in the long-term Swedish Obese Subjects Study, among people with obesity, bariatric surgery was associated with a 3-year increase in life expectancy, compared with not undergoing surgery.

However, Dr. Almandoz also pointed out that some patients may benefit from both weight-loss medication and bariatric surgery. “Once someone has undergone pharmacotherapy, there may still be a role for bariatric procedures in helping to optimize body weight and control body weight long term. And likewise for those who have undergone bariatric surgery, there’s also a role for pharmacotherapy in terms of treating insufficient weight loss or weight recurrence after bariatric surgery. ... So I think there’s clearly a role for integration of therapies.”

Dr. Almandoz serves as consultant/advisory board member for Novo Nordisk, Boehringer Ingelheim, and Eli Lilly. Dr. Kidambi is director of TOPS Center for Metabolic Research and is medical editor of TOPS Magazine, for which her institution receives an honorarium.

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

Bariatric surgery continues to play a major role in obesity management despite the emergence of potent new weight-loss medications, according to two experts who spoke at an Endocrine Society science writers briefing.

“Bariatric surgery is safe, effective, and unfortunately underutilized for treating obesity and its complications,” said Jaime Almandoz, MD, medical director of the Weight Wellness Program at the University of Texas Southwestern Medical Center, Dallas.

Added Dr. Almandoz, who is triple board-certified in internal medicine, endocrinology, and obesity medicine, “Sometimes this gets presented in a linear fashion. ‘We’ll try lifestyle first, and if that doesn’t work, we’ll try medications, and if that doesn’t work, we’ll try surgery.’ But sometimes we might need to go straight to surgery instead of going through medications first, because it may be the most effective and evidence-based treatment for the person in the office in front of you.”

Moreover, he pointed out that currently, Medicare and many private insurers don’t cover antiobesity medications but do cover bariatric surgery.

Indeed, Srividya Kidambi, MD, professor and chief of endocrinology and molecular medicine at the Medical College of Wisconsin/Froedtert Hospital, Milwaukee, said there are certain types of patients for whom she might consider bariatric surgery first. One would be a person with a body mass index (BMI) greater than 40 kg/m² or with a BMI greater than 35 kg/m² and severe comorbidities.

Another, she said, would be young, relatively healthy people with obesity who have no comorbid conditions. “We know that if we stop the medication, the weight comes back. So, if I see a 20- to 25-year-old, am I really to commit them to lifelong therapy, or is bariatric surgery a better option in these cases? These drugs have not been around that long ... so I tend to recommend bariatric surgery in some patients.”

During the recent briefing, Dr. Almandoz summarized the evidence base for the benefits of bariatric surgery beyond weight loss, which include remission of type 2 diabetes and fatty liver disease, reduction of the risks of cardiovascular disease and cancer, and increased life expectancy.

“Everyone seems to be talking about GLP-1s for facilitating weight loss and treating obesity. ... What I want to do is provide a counterpoint to accessible therapies that are covered by more insurance plans and that may, in fact, have a better evidence base for treating obesity and its related complications,” he said in his introduction.

Bariatric surgery has been used for decades, and many centers of excellence perform it, with greatly reduced complication rates seen today than in the past. “It’s comparable to having a gallbladder surgery in terms of perioperative risk,” he noted.

Medicare and private insurers generally cover bariatric surgery for people with BMI greater than 40 kg/m2 or 35-39 kg/m² and at least one weight-related comorbidity, including type 2 diabetes, obstructive sleep apnea, hypertension, atherosclerotic disease, hyperlipidemia, and fatty liver disease.

Data suggest that weight reduction of about 3% can lead to meaningful reductions in blood glucose and triglyceride levels, but weight loss of 15% or greater is associated with reductions in cardiovascular events and type 2 diabetes remission. Lifestyle modification typically produces about 5% weight loss, compared with 20%-35% with bariatric surgery with sleeve gastrectomy or gastric bypass.

Older weight loss medications produced weight loss of 5%-10%; only the newer medications, semaglutide 2.4 mg and tirzepatide, come close to that. Weight loss with semaglutide is about 15%, while tirzepatide can produce weight loss of up to 22%. But, there are still issues with affordability, access, and lack of coverage, Dr. Almandoz noted.

One recent randomized trial of more than 400 individuals showed that bariatric surgery was more effective than lifestyle and medical therapies for treating metabolic-associated steatohepatitis without worsening of fibrosis.

Another showed that the surgery was associated with fewer major adverse liver outcomes among people who already had MASH. That same study showed a 70% reduction in cardiovascular events with bariatric surgery.

For patients with type 2 diabetes, numerous trials have demonstrated long-term remission and reduced A1c at 5 years and 10 years post surgery, along with reductions in microvascular and macrovascular complications.

Other data suggest that a shorter history of type 2 diabetes is among the factors predicting remission with bariatric surgery. “Oftentimes, both patients and providers will wait until the diabetes is quite advanced before they even have the conversation about weight loss or even bariatric surgery. This suggests that if we intervene earlier in the course of disease, when it is less severe and less advanced, we have a higher rate of causing remission in the diabetes,” Dr. Almandoz said.

The American Diabetes Association’s Standards of Care incorporate bariatric surgery as either “recommended” or “may be considered” to treat type 2 diabetes, depending on BMI level, for those who don’t achieve durable weight loss with nonsurgical methods, he noted.

A retrospective cohort study showed significant reductions in cardiovascular outcomes with bariatric surgery among people with baseline cardiovascular disease. “This is not just about bariatric surgery to cause weight loss. This is about the multitude of effects that happen when we treat obesity as a disease with highly effective therapies such as surgery,” he said.

Even cancer risk and cancer-related mortality were significantly reduced with bariatric surgery, another study found.

And in the long-term Swedish Obese Subjects Study, among people with obesity, bariatric surgery was associated with a 3-year increase in life expectancy, compared with not undergoing surgery.

However, Dr. Almandoz also pointed out that some patients may benefit from both weight-loss medication and bariatric surgery. “Once someone has undergone pharmacotherapy, there may still be a role for bariatric procedures in helping to optimize body weight and control body weight long term. And likewise for those who have undergone bariatric surgery, there’s also a role for pharmacotherapy in terms of treating insufficient weight loss or weight recurrence after bariatric surgery. ... So I think there’s clearly a role for integration of therapies.”

Dr. Almandoz serves as consultant/advisory board member for Novo Nordisk, Boehringer Ingelheim, and Eli Lilly. Dr. Kidambi is director of TOPS Center for Metabolic Research and is medical editor of TOPS Magazine, for which her institution receives an honorarium.

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

Bariatric surgery continues to play a major role in obesity management despite the emergence of potent new weight-loss medications, according to two experts who spoke at an Endocrine Society science writers briefing.

“Bariatric surgery is safe, effective, and unfortunately underutilized for treating obesity and its complications,” said Jaime Almandoz, MD, medical director of the Weight Wellness Program at the University of Texas Southwestern Medical Center, Dallas.

Added Dr. Almandoz, who is triple board-certified in internal medicine, endocrinology, and obesity medicine, “Sometimes this gets presented in a linear fashion. ‘We’ll try lifestyle first, and if that doesn’t work, we’ll try medications, and if that doesn’t work, we’ll try surgery.’ But sometimes we might need to go straight to surgery instead of going through medications first, because it may be the most effective and evidence-based treatment for the person in the office in front of you.”

Moreover, he pointed out that currently, Medicare and many private insurers don’t cover antiobesity medications but do cover bariatric surgery.

Indeed, Srividya Kidambi, MD, professor and chief of endocrinology and molecular medicine at the Medical College of Wisconsin/Froedtert Hospital, Milwaukee, said there are certain types of patients for whom she might consider bariatric surgery first. One would be a person with a body mass index (BMI) greater than 40 kg/m² or with a BMI greater than 35 kg/m² and severe comorbidities.

Another, she said, would be young, relatively healthy people with obesity who have no comorbid conditions. “We know that if we stop the medication, the weight comes back. So, if I see a 20- to 25-year-old, am I really to commit them to lifelong therapy, or is bariatric surgery a better option in these cases? These drugs have not been around that long ... so I tend to recommend bariatric surgery in some patients.”

During the recent briefing, Dr. Almandoz summarized the evidence base for the benefits of bariatric surgery beyond weight loss, which include remission of type 2 diabetes and fatty liver disease, reduction of the risks of cardiovascular disease and cancer, and increased life expectancy.

“Everyone seems to be talking about GLP-1s for facilitating weight loss and treating obesity. ... What I want to do is provide a counterpoint to accessible therapies that are covered by more insurance plans and that may, in fact, have a better evidence base for treating obesity and its related complications,” he said in his introduction.

Bariatric surgery has been used for decades, and many centers of excellence perform it, with greatly reduced complication rates seen today than in the past. “It’s comparable to having a gallbladder surgery in terms of perioperative risk,” he noted.

Medicare and private insurers generally cover bariatric surgery for people with BMI greater than 40 kg/m2 or 35-39 kg/m² and at least one weight-related comorbidity, including type 2 diabetes, obstructive sleep apnea, hypertension, atherosclerotic disease, hyperlipidemia, and fatty liver disease.

Data suggest that weight reduction of about 3% can lead to meaningful reductions in blood glucose and triglyceride levels, but weight loss of 15% or greater is associated with reductions in cardiovascular events and type 2 diabetes remission. Lifestyle modification typically produces about 5% weight loss, compared with 20%-35% with bariatric surgery with sleeve gastrectomy or gastric bypass.

Older weight loss medications produced weight loss of 5%-10%; only the newer medications, semaglutide 2.4 mg and tirzepatide, come close to that. Weight loss with semaglutide is about 15%, while tirzepatide can produce weight loss of up to 22%. But, there are still issues with affordability, access, and lack of coverage, Dr. Almandoz noted.

One recent randomized trial of more than 400 individuals showed that bariatric surgery was more effective than lifestyle and medical therapies for treating metabolic-associated steatohepatitis without worsening of fibrosis.

Another showed that the surgery was associated with fewer major adverse liver outcomes among people who already had MASH. That same study showed a 70% reduction in cardiovascular events with bariatric surgery.

For patients with type 2 diabetes, numerous trials have demonstrated long-term remission and reduced A1c at 5 years and 10 years post surgery, along with reductions in microvascular and macrovascular complications.

Other data suggest that a shorter history of type 2 diabetes is among the factors predicting remission with bariatric surgery. “Oftentimes, both patients and providers will wait until the diabetes is quite advanced before they even have the conversation about weight loss or even bariatric surgery. This suggests that if we intervene earlier in the course of disease, when it is less severe and less advanced, we have a higher rate of causing remission in the diabetes,” Dr. Almandoz said.

The American Diabetes Association’s Standards of Care incorporate bariatric surgery as either “recommended” or “may be considered” to treat type 2 diabetes, depending on BMI level, for those who don’t achieve durable weight loss with nonsurgical methods, he noted.

A retrospective cohort study showed significant reductions in cardiovascular outcomes with bariatric surgery among people with baseline cardiovascular disease. “This is not just about bariatric surgery to cause weight loss. This is about the multitude of effects that happen when we treat obesity as a disease with highly effective therapies such as surgery,” he said.

Even cancer risk and cancer-related mortality were significantly reduced with bariatric surgery, another study found.

And in the long-term Swedish Obese Subjects Study, among people with obesity, bariatric surgery was associated with a 3-year increase in life expectancy, compared with not undergoing surgery.

However, Dr. Almandoz also pointed out that some patients may benefit from both weight-loss medication and bariatric surgery. “Once someone has undergone pharmacotherapy, there may still be a role for bariatric procedures in helping to optimize body weight and control body weight long term. And likewise for those who have undergone bariatric surgery, there’s also a role for pharmacotherapy in terms of treating insufficient weight loss or weight recurrence after bariatric surgery. ... So I think there’s clearly a role for integration of therapies.”

Dr. Almandoz serves as consultant/advisory board member for Novo Nordisk, Boehringer Ingelheim, and Eli Lilly. Dr. Kidambi is director of TOPS Center for Metabolic Research and is medical editor of TOPS Magazine, for which her institution receives an honorarium.

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

Longer cumulative use of medication to treat attention-deficit/hyperactivity disorder (ADHD) is associated with a small, but statistically significant, increased risk for cardiovascular disease (CVD), results of a large Swedish nested case-control study suggest.

The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.

“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.

“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.

The study was published online in JAMA Psychiatry

Filling in the research gaps

The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.

In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.

Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.

Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.

When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.

For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
 

Stimulants confer greatest risk

Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.

Similar risks were observed in children and adults, as well as in females and males.

When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).

The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).

In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).

The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.

The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.

‘Tricky trade-offs’

The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”

Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).

“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.

Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”

“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”

The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.

This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Longer cumulative use of medication to treat attention-deficit/hyperactivity disorder (ADHD) is associated with a small, but statistically significant, increased risk for cardiovascular disease (CVD), results of a large Swedish nested case-control study suggest.

The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.

“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.

“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.

The study was published online in JAMA Psychiatry

Filling in the research gaps

The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.

In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.

Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.

Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.

When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.

For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
 

Stimulants confer greatest risk

Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.

Similar risks were observed in children and adults, as well as in females and males.

When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).

The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).

In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).

The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.

The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.

‘Tricky trade-offs’

The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”

Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).

“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.

Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”

“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”

The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.

This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Longer cumulative use of medication to treat attention-deficit/hyperactivity disorder (ADHD) is associated with a small, but statistically significant, increased risk for cardiovascular disease (CVD), results of a large Swedish nested case-control study suggest.

The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.

“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.

“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.

The study was published online in JAMA Psychiatry

Filling in the research gaps

The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.

In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.

Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.

Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.

When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.

For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
 

Stimulants confer greatest risk

Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.

Similar risks were observed in children and adults, as well as in females and males.

When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).

The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).

In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).

The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.

The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.

‘Tricky trade-offs’

The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”

Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).

“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.

Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”

“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”

The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.

This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Screening with a “smart,” artificial-intelligence (AI)–enhanced investigational digital stethoscope (Eko Duo) that provides phonocardiogram and electrocardiogram (ECG) readings doubled the detection of peripartum cardiomyopathy in a large study of obstetric patients in Nigeria.

Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.

“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”

If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.

Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.

“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.

Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.

“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.

This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.

Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.

A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
 

Findings ‘absolutely startling’

The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”

Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.

“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.

“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”

“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.

The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.

With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.

“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?

“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”

However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.

Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.

“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
 

AI-guided screening study

Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.

In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.

The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).

In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.

In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.

The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.

The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).

For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.

Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.

A version of this article appeared on Medscape.com.

Screening with a “smart,” artificial-intelligence (AI)–enhanced investigational digital stethoscope (Eko Duo) that provides phonocardiogram and electrocardiogram (ECG) readings doubled the detection of peripartum cardiomyopathy in a large study of obstetric patients in Nigeria.

Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.

“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”

If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.

Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.

“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.

Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.

“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.

This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.

Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.

A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
 

Findings ‘absolutely startling’

The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”

Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.

“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.

“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”

“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.

The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.

With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.

“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?

“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”

However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.

Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.

“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
 

AI-guided screening study

Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.

In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.

The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).

In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.

In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.

The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.

The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).

For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.

Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.

A version of this article appeared on Medscape.com.

Screening with a “smart,” artificial-intelligence (AI)–enhanced investigational digital stethoscope (Eko Duo) that provides phonocardiogram and electrocardiogram (ECG) readings doubled the detection of peripartum cardiomyopathy in a large study of obstetric patients in Nigeria.

Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.

“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”

If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.

Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.

“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.

Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.

“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.

This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.

Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.

A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
 

Findings ‘absolutely startling’

The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”

Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.

“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.

“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”

“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.

The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.

With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.

“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?

“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”

However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.

Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.

“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
 

AI-guided screening study

Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.

In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.

The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).

In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.

In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.

The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.

The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).

For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.

Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.

A version of this article appeared on Medscape.com.

Despite higher upfront costs, enhanced home blood pressure monitoring by hypertension patients could be cost-effective compared with standard clinical care over the longer term, a systematic review in JAMA Network Open found.

In an analysis of 16 studies, at-home blood pressure (HBPM) monitoring, particularly using automatic 24-hour continuous measurements alone or combined with additional support or team-based care, appeared to be economical over a minimum 10-year period compared with usual care – higher expenditures for equipment and training notwithstanding.

Texas A&amp;M University

“Our findings suggest that clinicians, hospitals, health care systems, third-party payers, and other stakeholders should consider the long-term incremental benefits and improvements in patients’ blood pressure, quality of life, and reductions in adverse outcomes,” wrote Michelle A. Hayek, of the Population Informatics Lab, department of industrial and systems engineering, at Texas A&M University, College Station, Tex., and colleagues.

HBPM increased considerably during the COVID pandemic and is expected to increase further in the next decade, according to lead author Theodoros Giannouchos, PhD, MS, MPharm, assistant professor in the department of health policy and organization in the School of Public Health at the University of Alabama at Birmingham. “Because home blood pressure monitoring might add costs to insurers, patients, and the health care system – at least short term – we noticed a gap in the updated literature on whether this method is cost-effective relative to in-office monitoring. Hence, we conducted this review.”

University of Alabama at Birmingham

Six of the 16 studies were conducted in the United States and six in the United Kingdom; 14 used a health care insurance system perspective to determine costs. In nearly half, quality-adjusted life-years gained and cost per 1–mm Hg reduction in blood pressure were used as outcomes.

Self-monitoring included self measurements transmitted to health care professionals and involved either periodic readings, such as twice each morning and evening during the first week of every month, 3 times per week, or 24-hour ambulatory readings with a portable device every 20 or 30 minutes. Among studies comparing HBPM alone versus 24-hour ambulatory BP monitoring (ABPM) or HBPM combined with additional support or team-based care, the latter two approaches were more cost effective. The benefits would appear to offset the costs of more resource-intensive at-home self-monitoring methods over office care and traditional at-home monitoring only.

In addition, the authors noted, ABPM in particular might detect elevated in-office, or white-coat hypertension, and masked hypertension, the latter referring to normal BP readings measured in the office but actual elevated pressures in the everyday home setting. An estimated 17.1 million adults in the United States have masked hypertension, and the authors say the new approach would allow early tailored interventions to mitigate the risk of masked hypertension or prevent unnecessary treatment because of white-coat hypertension. “Because of the growing market in blood pressure monitors, the technology and accuracy of monitors is expected to improve even more,” Dr. Giannouchos said. “If these technologies are properly used, they can improve patients’ quality of life and health outcomes at a justified level of cost.”

The findings align with previous research that synthesized costs and benefits of self-monitoring methods across various diseases and settings.

“Future work is needed to compare these alternatives directly from a cost-effectiveness standpoint and to provide clinicians, stakeholders, and patients with more evidence to prioritize specific home-based BP programs,” the authors wrote.

This research was supported by the Texas A&M President’s Office X-grant initiative, National Science Foundation PATHS-UP, and Population Informatics Lab. A study coauthor reported grants from National Science Foundation during the conduct of the study.

Despite higher upfront costs, enhanced home blood pressure monitoring by hypertension patients could be cost-effective compared with standard clinical care over the longer term, a systematic review in JAMA Network Open found.

In an analysis of 16 studies, at-home blood pressure (HBPM) monitoring, particularly using automatic 24-hour continuous measurements alone or combined with additional support or team-based care, appeared to be economical over a minimum 10-year period compared with usual care – higher expenditures for equipment and training notwithstanding.

Texas A&amp;M University

“Our findings suggest that clinicians, hospitals, health care systems, third-party payers, and other stakeholders should consider the long-term incremental benefits and improvements in patients’ blood pressure, quality of life, and reductions in adverse outcomes,” wrote Michelle A. Hayek, of the Population Informatics Lab, department of industrial and systems engineering, at Texas A&M University, College Station, Tex., and colleagues.

HBPM increased considerably during the COVID pandemic and is expected to increase further in the next decade, according to lead author Theodoros Giannouchos, PhD, MS, MPharm, assistant professor in the department of health policy and organization in the School of Public Health at the University of Alabama at Birmingham. “Because home blood pressure monitoring might add costs to insurers, patients, and the health care system – at least short term – we noticed a gap in the updated literature on whether this method is cost-effective relative to in-office monitoring. Hence, we conducted this review.”

University of Alabama at Birmingham

Six of the 16 studies were conducted in the United States and six in the United Kingdom; 14 used a health care insurance system perspective to determine costs. In nearly half, quality-adjusted life-years gained and cost per 1–mm Hg reduction in blood pressure were used as outcomes.

Self-monitoring included self measurements transmitted to health care professionals and involved either periodic readings, such as twice each morning and evening during the first week of every month, 3 times per week, or 24-hour ambulatory readings with a portable device every 20 or 30 minutes. Among studies comparing HBPM alone versus 24-hour ambulatory BP monitoring (ABPM) or HBPM combined with additional support or team-based care, the latter two approaches were more cost effective. The benefits would appear to offset the costs of more resource-intensive at-home self-monitoring methods over office care and traditional at-home monitoring only.

In addition, the authors noted, ABPM in particular might detect elevated in-office, or white-coat hypertension, and masked hypertension, the latter referring to normal BP readings measured in the office but actual elevated pressures in the everyday home setting. An estimated 17.1 million adults in the United States have masked hypertension, and the authors say the new approach would allow early tailored interventions to mitigate the risk of masked hypertension or prevent unnecessary treatment because of white-coat hypertension. “Because of the growing market in blood pressure monitors, the technology and accuracy of monitors is expected to improve even more,” Dr. Giannouchos said. “If these technologies are properly used, they can improve patients’ quality of life and health outcomes at a justified level of cost.”

The findings align with previous research that synthesized costs and benefits of self-monitoring methods across various diseases and settings.

“Future work is needed to compare these alternatives directly from a cost-effectiveness standpoint and to provide clinicians, stakeholders, and patients with more evidence to prioritize specific home-based BP programs,” the authors wrote.

This research was supported by the Texas A&M President’s Office X-grant initiative, National Science Foundation PATHS-UP, and Population Informatics Lab. A study coauthor reported grants from National Science Foundation during the conduct of the study.

Despite higher upfront costs, enhanced home blood pressure monitoring by hypertension patients could be cost-effective compared with standard clinical care over the longer term, a systematic review in JAMA Network Open found.

In an analysis of 16 studies, at-home blood pressure (HBPM) monitoring, particularly using automatic 24-hour continuous measurements alone or combined with additional support or team-based care, appeared to be economical over a minimum 10-year period compared with usual care – higher expenditures for equipment and training notwithstanding.

Texas A&amp;M University

“Our findings suggest that clinicians, hospitals, health care systems, third-party payers, and other stakeholders should consider the long-term incremental benefits and improvements in patients’ blood pressure, quality of life, and reductions in adverse outcomes,” wrote Michelle A. Hayek, of the Population Informatics Lab, department of industrial and systems engineering, at Texas A&M University, College Station, Tex., and colleagues.

HBPM increased considerably during the COVID pandemic and is expected to increase further in the next decade, according to lead author Theodoros Giannouchos, PhD, MS, MPharm, assistant professor in the department of health policy and organization in the School of Public Health at the University of Alabama at Birmingham. “Because home blood pressure monitoring might add costs to insurers, patients, and the health care system – at least short term – we noticed a gap in the updated literature on whether this method is cost-effective relative to in-office monitoring. Hence, we conducted this review.”

University of Alabama at Birmingham

Six of the 16 studies were conducted in the United States and six in the United Kingdom; 14 used a health care insurance system perspective to determine costs. In nearly half, quality-adjusted life-years gained and cost per 1–mm Hg reduction in blood pressure were used as outcomes.

Self-monitoring included self measurements transmitted to health care professionals and involved either periodic readings, such as twice each morning and evening during the first week of every month, 3 times per week, or 24-hour ambulatory readings with a portable device every 20 or 30 minutes. Among studies comparing HBPM alone versus 24-hour ambulatory BP monitoring (ABPM) or HBPM combined with additional support or team-based care, the latter two approaches were more cost effective. The benefits would appear to offset the costs of more resource-intensive at-home self-monitoring methods over office care and traditional at-home monitoring only.

In addition, the authors noted, ABPM in particular might detect elevated in-office, or white-coat hypertension, and masked hypertension, the latter referring to normal BP readings measured in the office but actual elevated pressures in the everyday home setting. An estimated 17.1 million adults in the United States have masked hypertension, and the authors say the new approach would allow early tailored interventions to mitigate the risk of masked hypertension or prevent unnecessary treatment because of white-coat hypertension. “Because of the growing market in blood pressure monitors, the technology and accuracy of monitors is expected to improve even more,” Dr. Giannouchos said. “If these technologies are properly used, they can improve patients’ quality of life and health outcomes at a justified level of cost.”

The findings align with previous research that synthesized costs and benefits of self-monitoring methods across various diseases and settings.

“Future work is needed to compare these alternatives directly from a cost-effectiveness standpoint and to provide clinicians, stakeholders, and patients with more evidence to prioritize specific home-based BP programs,” the authors wrote.

This research was supported by the Texas A&M President’s Office X-grant initiative, National Science Foundation PATHS-UP, and Population Informatics Lab. A study coauthor reported grants from National Science Foundation during the conduct of the study.

The Food and Drug Administration has approved Medtronic’s Symplicity Spyral renal denervation system for the treatment of hypertension, the company has announced.

The Symplicity Spyral system, also known as the Symplicity blood pressure procedure, provides a catheter-based approach to denervate the renal arteries using radiofrequency energy.

Back in August, the FDA’s Circulatory System Devices Panel unanimously agreed that the Symplicity Spyral system is safe, but the panel was split on its efficacy and whether the benefits outweighed the risks associated with its use.

As part of the Medtronic SPYRAL HTN Global Clinical Program, more than 25,000 patients have been treated worldwide, both in the presence and absence of medication, and in patients with high baseline cardiovascular risk.

The SPYRAL HTN-OFF study enrolled patients with hypertension whose medications could be stopped at the start of the trial.

The primary effectiveness endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure (ASBP) from baseline to 3 months after renal denervation or sham procedure. The study showed a statistically significant reduction of 3.9 mm Hg ASBP in patients who received the device, compared with sham-control patients.

The SPYRAL HTN-ON study evaluated patients with uncontrolled hypertension who continued taking their BP medications during treatment with either the Spyral renal denervation device or a sham device.

The primary endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure at 6 months. The study showed a nonsignificant 24-hour 0.03 mm Hg reduction in ASBP in active-treatment patients, compared with sham-control patients.

“The Symplicity blood pressure procedure is safe and effective, providing significant ‘always-on’ blood pressure reductions for patients,” David Kandzari, MD, chief, Piedmont Heart Institute, Atlanta, and co–principal investigator of the SPYRAL clinical program, said in the news release.

“This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes,” added co–principal investigator Raymond Townsend, MD, with University of Pennsylvania, Philadelphia.

Medtronic notes that patient preference and shared decision-making are key components when considering the Symplicity blood pressure procedure.

In a patient preference study led by Medtronic, when presented with an interventional treatment with BP reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one-third of patients were likely to choose the interventional treatment.

Earlier in November, the FDA also approved the Paradise Ultrasound Renal Denervation system (Recor Medical, Otsuka Medical Devices) for the treatment of hypertension.

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

The Food and Drug Administration has approved Medtronic’s Symplicity Spyral renal denervation system for the treatment of hypertension, the company has announced.

The Symplicity Spyral system, also known as the Symplicity blood pressure procedure, provides a catheter-based approach to denervate the renal arteries using radiofrequency energy.

Back in August, the FDA’s Circulatory System Devices Panel unanimously agreed that the Symplicity Spyral system is safe, but the panel was split on its efficacy and whether the benefits outweighed the risks associated with its use.

As part of the Medtronic SPYRAL HTN Global Clinical Program, more than 25,000 patients have been treated worldwide, both in the presence and absence of medication, and in patients with high baseline cardiovascular risk.

The SPYRAL HTN-OFF study enrolled patients with hypertension whose medications could be stopped at the start of the trial.

The primary effectiveness endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure (ASBP) from baseline to 3 months after renal denervation or sham procedure. The study showed a statistically significant reduction of 3.9 mm Hg ASBP in patients who received the device, compared with sham-control patients.

The SPYRAL HTN-ON study evaluated patients with uncontrolled hypertension who continued taking their BP medications during treatment with either the Spyral renal denervation device or a sham device.

The primary endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure at 6 months. The study showed a nonsignificant 24-hour 0.03 mm Hg reduction in ASBP in active-treatment patients, compared with sham-control patients.

“The Symplicity blood pressure procedure is safe and effective, providing significant ‘always-on’ blood pressure reductions for patients,” David Kandzari, MD, chief, Piedmont Heart Institute, Atlanta, and co–principal investigator of the SPYRAL clinical program, said in the news release.

“This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes,” added co–principal investigator Raymond Townsend, MD, with University of Pennsylvania, Philadelphia.

Medtronic notes that patient preference and shared decision-making are key components when considering the Symplicity blood pressure procedure.

In a patient preference study led by Medtronic, when presented with an interventional treatment with BP reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one-third of patients were likely to choose the interventional treatment.

Earlier in November, the FDA also approved the Paradise Ultrasound Renal Denervation system (Recor Medical, Otsuka Medical Devices) for the treatment of hypertension.

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

The Food and Drug Administration has approved Medtronic’s Symplicity Spyral renal denervation system for the treatment of hypertension, the company has announced.

The Symplicity Spyral system, also known as the Symplicity blood pressure procedure, provides a catheter-based approach to denervate the renal arteries using radiofrequency energy.

Back in August, the FDA’s Circulatory System Devices Panel unanimously agreed that the Symplicity Spyral system is safe, but the panel was split on its efficacy and whether the benefits outweighed the risks associated with its use.

As part of the Medtronic SPYRAL HTN Global Clinical Program, more than 25,000 patients have been treated worldwide, both in the presence and absence of medication, and in patients with high baseline cardiovascular risk.

The SPYRAL HTN-OFF study enrolled patients with hypertension whose medications could be stopped at the start of the trial.

The primary effectiveness endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure (ASBP) from baseline to 3 months after renal denervation or sham procedure. The study showed a statistically significant reduction of 3.9 mm Hg ASBP in patients who received the device, compared with sham-control patients.

The SPYRAL HTN-ON study evaluated patients with uncontrolled hypertension who continued taking their BP medications during treatment with either the Spyral renal denervation device or a sham device.

The primary endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure at 6 months. The study showed a nonsignificant 24-hour 0.03 mm Hg reduction in ASBP in active-treatment patients, compared with sham-control patients.

“The Symplicity blood pressure procedure is safe and effective, providing significant ‘always-on’ blood pressure reductions for patients,” David Kandzari, MD, chief, Piedmont Heart Institute, Atlanta, and co–principal investigator of the SPYRAL clinical program, said in the news release.

“This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes,” added co–principal investigator Raymond Townsend, MD, with University of Pennsylvania, Philadelphia.

Medtronic notes that patient preference and shared decision-making are key components when considering the Symplicity blood pressure procedure.

In a patient preference study led by Medtronic, when presented with an interventional treatment with BP reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one-third of patients were likely to choose the interventional treatment.

Earlier in November, the FDA also approved the Paradise Ultrasound Renal Denervation system (Recor Medical, Otsuka Medical Devices) for the treatment of hypertension.

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

A single injection of the investigational antihypertensive agent zilebesiran (Alnylam Pharmaceuticals) effectively lowered blood pressure in adults with mild to moderate hypertension for up to 6 months, with what appeared to be an encouraging side-effect profile, in the phase 2 dose-ranging KARDIA-1 study.

“Our study demonstrates that either quarterly or biannual doses of zilebesiran can effectively and safely lower blood pressure in patients with uncontrolled hypertension,” said senior study investigator George Bakris, MD.

“Based on these results, zilebesiran has the potential to improve medication adherence, which will, in turn, reduce cardiovascular risk in people with hypertension,” added Dr. Bakris, who is professor of medicine and director of the Comprehensive Hypertension Center at the University of Chicago Medicine.

The KARDIA-1 study was presented at the American Heart Association scientific sessions.

Dr. Bakris noted that uncontrolled hypertension is a leading cause of morbidity and mortality, and despite availability of effective antihypertensives, many adults with hypertension are untreated, and up to 80% have uncontrolled disease, both globally and in the United States.

Zilebesiran is a subcutaneous RNA interference therapeutic that binds with high affinity to the hepatic asialoglycoprotein receptor, bringing about a reduction in the synthesis of angiotensinogen, the sole precursor of all angiotensin peptides. It is hoped that its hepatocyte-targeted delivery may allow extrahepatic angiotensinogen expression to be preserved, which could limit off-target effects in the kidney and other tissues.

The KARDIA-1 trial investigated the safety and efficacy of different doses of zilebesiran in patients with mild to moderate hypertension (systolic BP of 135-160 mm Hg), who are untreated or on stable therapy with up to two antihypertensive medications.

The study included 394 such patients (average baseline systolic BP was 142 mm Hg) who were randomly assigned to receive one of four different zilebesiran doses (150 mg, 300 mg, or 600 mg once every 6 months or 300 mg once every 2 months) or a placebo. The final analysis included 377 patients (56% men, 25% Black).

Results showed sustained reductions in serum angiotensinogen (between 88% and 98%) over the 6-month follow-up period.

Ambulatory systolic BP measured over 24 hours was significantly decreased with all zilebesiran regimens, with a mean reduction from baseline to month 6 of around 10 mm Hg in the three top doses studied and by around 14 mm Hg compared with placebo.

Patients receiving zilebesiran were more likely to achieve 24-hour average systolic BP measurements of 130 mm Hg or less at 6 months.

In addition, participants in all four zilebesiran groups consistently experienced significantly greater reductions in both daytime and nighttime systolic BP.

There were four nonserious adverse reactions leading to discontinuation in the zilebesiran groups: two instances of orthostatic hypotension, one of BP elevation, and one of injection site reaction.

Most hyperkalemia adverse events, which occurred in 6% of patients, were mild, did not require intervention, and generally resolved with repeat measurement; none were associated with acute kidney injury or led to study drug discontinuation. The incidence of hypotension events was low, and no clinically relevant changes in renal or hepatic function were observed, Dr. Bakris reported.

There was one death caused by cardiopulmonary arrest in a patient receiving zilebesiran 300 mg every 3 months, but this was not classified as drug related.

Zilebesiran is being further evaluated as an add-on therapy for treatment of hypertension in the ongoing KARDIA-2 phase 2 study.

Moderator of an AHA press conference at which the study was discussed, Sandra Taler, MD, professor of medicine at the Mayo Clinic, Rochester, Minn., said that “to have an injectable medicine that gives long-term blood pressure lowering is extremely exciting.”

Dr. Taler raised the point that some patients may not return for subsequent doses, but added that with subcutaneous dosing, administration at home may be a possibility.

Also commenting at the press conference, Keith Ferdinand, MD, professor of clinical medicine at Tulane University, New Orleans, said that this study “suggests we can now target the first step in the renin-angiotensin system – angiotensinogen – which then appears to lead to robust and continued blood pressure lowering for up to 6 months, which should improve adherence.”

Noting that only 50% of patients continue to take antihypertensive drugs after 1 year, Dr. Ferdinand added: “If we can increase adherence, we will increase efficacy and perhaps protect against some of the target organ damage.”

Designated discussant of the KARDIA-1 study at the AHA late-breaking clinical trial session, Anna Dominiczak, MD, University of Glasgow, noted that hypertension affects one in three adults worldwide, but only around 20% of people have it under control.

“An increase in the number of patients effectively treated for hypertension to levels observed in high-performing countries could prevent 76 million deaths, 120 million strokes, 79 million heart attacks, and 17 million cases of heart failure between now and 2050,” she said.

Dr. Bakris has received consulting fees from Alnylam Pharmaceuticals.

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

A single injection of the investigational antihypertensive agent zilebesiran (Alnylam Pharmaceuticals) effectively lowered blood pressure in adults with mild to moderate hypertension for up to 6 months, with what appeared to be an encouraging side-effect profile, in the phase 2 dose-ranging KARDIA-1 study.

“Our study demonstrates that either quarterly or biannual doses of zilebesiran can effectively and safely lower blood pressure in patients with uncontrolled hypertension,” said senior study investigator George Bakris, MD.

“Based on these results, zilebesiran has the potential to improve medication adherence, which will, in turn, reduce cardiovascular risk in people with hypertension,” added Dr. Bakris, who is professor of medicine and director of the Comprehensive Hypertension Center at the University of Chicago Medicine.

The KARDIA-1 study was presented at the American Heart Association scientific sessions.

Dr. Bakris noted that uncontrolled hypertension is a leading cause of morbidity and mortality, and despite availability of effective antihypertensives, many adults with hypertension are untreated, and up to 80% have uncontrolled disease, both globally and in the United States.

Zilebesiran is a subcutaneous RNA interference therapeutic that binds with high affinity to the hepatic asialoglycoprotein receptor, bringing about a reduction in the synthesis of angiotensinogen, the sole precursor of all angiotensin peptides. It is hoped that its hepatocyte-targeted delivery may allow extrahepatic angiotensinogen expression to be preserved, which could limit off-target effects in the kidney and other tissues.

The KARDIA-1 trial investigated the safety and efficacy of different doses of zilebesiran in patients with mild to moderate hypertension (systolic BP of 135-160 mm Hg), who are untreated or on stable therapy with up to two antihypertensive medications.

The study included 394 such patients (average baseline systolic BP was 142 mm Hg) who were randomly assigned to receive one of four different zilebesiran doses (150 mg, 300 mg, or 600 mg once every 6 months or 300 mg once every 2 months) or a placebo. The final analysis included 377 patients (56% men, 25% Black).

Results showed sustained reductions in serum angiotensinogen (between 88% and 98%) over the 6-month follow-up period.

Ambulatory systolic BP measured over 24 hours was significantly decreased with all zilebesiran regimens, with a mean reduction from baseline to month 6 of around 10 mm Hg in the three top doses studied and by around 14 mm Hg compared with placebo.

Patients receiving zilebesiran were more likely to achieve 24-hour average systolic BP measurements of 130 mm Hg or less at 6 months.

In addition, participants in all four zilebesiran groups consistently experienced significantly greater reductions in both daytime and nighttime systolic BP.

There were four nonserious adverse reactions leading to discontinuation in the zilebesiran groups: two instances of orthostatic hypotension, one of BP elevation, and one of injection site reaction.

Most hyperkalemia adverse events, which occurred in 6% of patients, were mild, did not require intervention, and generally resolved with repeat measurement; none were associated with acute kidney injury or led to study drug discontinuation. The incidence of hypotension events was low, and no clinically relevant changes in renal or hepatic function were observed, Dr. Bakris reported.

There was one death caused by cardiopulmonary arrest in a patient receiving zilebesiran 300 mg every 3 months, but this was not classified as drug related.

Zilebesiran is being further evaluated as an add-on therapy for treatment of hypertension in the ongoing KARDIA-2 phase 2 study.

Moderator of an AHA press conference at which the study was discussed, Sandra Taler, MD, professor of medicine at the Mayo Clinic, Rochester, Minn., said that “to have an injectable medicine that gives long-term blood pressure lowering is extremely exciting.”

Dr. Taler raised the point that some patients may not return for subsequent doses, but added that with subcutaneous dosing, administration at home may be a possibility.

Also commenting at the press conference, Keith Ferdinand, MD, professor of clinical medicine at Tulane University, New Orleans, said that this study “suggests we can now target the first step in the renin-angiotensin system – angiotensinogen – which then appears to lead to robust and continued blood pressure lowering for up to 6 months, which should improve adherence.”

Noting that only 50% of patients continue to take antihypertensive drugs after 1 year, Dr. Ferdinand added: “If we can increase adherence, we will increase efficacy and perhaps protect against some of the target organ damage.”

Designated discussant of the KARDIA-1 study at the AHA late-breaking clinical trial session, Anna Dominiczak, MD, University of Glasgow, noted that hypertension affects one in three adults worldwide, but only around 20% of people have it under control.

“An increase in the number of patients effectively treated for hypertension to levels observed in high-performing countries could prevent 76 million deaths, 120 million strokes, 79 million heart attacks, and 17 million cases of heart failure between now and 2050,” she said.

Dr. Bakris has received consulting fees from Alnylam Pharmaceuticals.

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

A single injection of the investigational antihypertensive agent zilebesiran (Alnylam Pharmaceuticals) effectively lowered blood pressure in adults with mild to moderate hypertension for up to 6 months, with what appeared to be an encouraging side-effect profile, in the phase 2 dose-ranging KARDIA-1 study.

“Our study demonstrates that either quarterly or biannual doses of zilebesiran can effectively and safely lower blood pressure in patients with uncontrolled hypertension,” said senior study investigator George Bakris, MD.

“Based on these results, zilebesiran has the potential to improve medication adherence, which will, in turn, reduce cardiovascular risk in people with hypertension,” added Dr. Bakris, who is professor of medicine and director of the Comprehensive Hypertension Center at the University of Chicago Medicine.

The KARDIA-1 study was presented at the American Heart Association scientific sessions.

Dr. Bakris noted that uncontrolled hypertension is a leading cause of morbidity and mortality, and despite availability of effective antihypertensives, many adults with hypertension are untreated, and up to 80% have uncontrolled disease, both globally and in the United States.

Zilebesiran is a subcutaneous RNA interference therapeutic that binds with high affinity to the hepatic asialoglycoprotein receptor, bringing about a reduction in the synthesis of angiotensinogen, the sole precursor of all angiotensin peptides. It is hoped that its hepatocyte-targeted delivery may allow extrahepatic angiotensinogen expression to be preserved, which could limit off-target effects in the kidney and other tissues.

The KARDIA-1 trial investigated the safety and efficacy of different doses of zilebesiran in patients with mild to moderate hypertension (systolic BP of 135-160 mm Hg), who are untreated or on stable therapy with up to two antihypertensive medications.

The study included 394 such patients (average baseline systolic BP was 142 mm Hg) who were randomly assigned to receive one of four different zilebesiran doses (150 mg, 300 mg, or 600 mg once every 6 months or 300 mg once every 2 months) or a placebo. The final analysis included 377 patients (56% men, 25% Black).

Results showed sustained reductions in serum angiotensinogen (between 88% and 98%) over the 6-month follow-up period.

Ambulatory systolic BP measured over 24 hours was significantly decreased with all zilebesiran regimens, with a mean reduction from baseline to month 6 of around 10 mm Hg in the three top doses studied and by around 14 mm Hg compared with placebo.

Patients receiving zilebesiran were more likely to achieve 24-hour average systolic BP measurements of 130 mm Hg or less at 6 months.

In addition, participants in all four zilebesiran groups consistently experienced significantly greater reductions in both daytime and nighttime systolic BP.

There were four nonserious adverse reactions leading to discontinuation in the zilebesiran groups: two instances of orthostatic hypotension, one of BP elevation, and one of injection site reaction.

Most hyperkalemia adverse events, which occurred in 6% of patients, were mild, did not require intervention, and generally resolved with repeat measurement; none were associated with acute kidney injury or led to study drug discontinuation. The incidence of hypotension events was low, and no clinically relevant changes in renal or hepatic function were observed, Dr. Bakris reported.

There was one death caused by cardiopulmonary arrest in a patient receiving zilebesiran 300 mg every 3 months, but this was not classified as drug related.

Zilebesiran is being further evaluated as an add-on therapy for treatment of hypertension in the ongoing KARDIA-2 phase 2 study.

Moderator of an AHA press conference at which the study was discussed, Sandra Taler, MD, professor of medicine at the Mayo Clinic, Rochester, Minn., said that “to have an injectable medicine that gives long-term blood pressure lowering is extremely exciting.”

Dr. Taler raised the point that some patients may not return for subsequent doses, but added that with subcutaneous dosing, administration at home may be a possibility.

Also commenting at the press conference, Keith Ferdinand, MD, professor of clinical medicine at Tulane University, New Orleans, said that this study “suggests we can now target the first step in the renin-angiotensin system – angiotensinogen – which then appears to lead to robust and continued blood pressure lowering for up to 6 months, which should improve adherence.”

Noting that only 50% of patients continue to take antihypertensive drugs after 1 year, Dr. Ferdinand added: “If we can increase adherence, we will increase efficacy and perhaps protect against some of the target organ damage.”

Designated discussant of the KARDIA-1 study at the AHA late-breaking clinical trial session, Anna Dominiczak, MD, University of Glasgow, noted that hypertension affects one in three adults worldwide, but only around 20% of people have it under control.

“An increase in the number of patients effectively treated for hypertension to levels observed in high-performing countries could prevent 76 million deaths, 120 million strokes, 79 million heart attacks, and 17 million cases of heart failure between now and 2050,” she said.

Dr. Bakris has received consulting fees from Alnylam Pharmaceuticals.

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

The American Heart Association (AHA) has unveiled a new heart disease risk calculator that aims to estimate an individual’s long-term risk for cardiovascular disease (CVD).

The new Predicting Risk of CVD Events (PREVENT) calculator is the first risk calculator that combines measures of cardiovascular, kidney, and metabolic health to estimate risk for CVD.

It follows an AHA presidential advisory and scientific statement published in October, formally defining cardiovascular-kidney-metabolic (CKM) syndrome.

The PREVENT calculator also “starts earlier and goes longer” than the pooled cohort equations (PCE), Sadiya Khan, MD, MSc, chair of the statement writing committee, told this news organization.

PREVENT is for use in adults aged 30-79 years and estimates the 10- and 30-year risk of total CVD including, for the first time, heart failure. The PCE were designed to assess 10-year risk of only myocardial infarction and stroke and only in adults aged 40-79 years.

“The new PREVENT equations are important for doctors because they allow us to start conversations earlier and more comprehensively and accurately calculate risk for our patients,” said Dr. Khan, preventive cardiologist at Northwestern Medicine and associate professor at Northwestern University in Chicago.

“We want to support clinicians in starting these conversations around optimizing CKM health earlier and begin to engage in discussions on ways to optimize health,” Dr. Khan added.

The AHA scientific statement on the PREVENT calculator, with Dr. Khan as lead author, was published online in Circulation, with an accompanying article that describes development and validation of the tool. 

Going beyond the PCE

The new calculator was developed using health information from more than 6 million adults from diverse racial and ethnic, socioeconomic, and geographic backgrounds.

In addition to blood pressure and cholesterol levels, the PREVENT equations allow for inclusion of hemoglobin A1c, if necessary, to monitor metabolic health.

It also includes estimated glomerular filtration rate (eGFR), a measure of kidney function, and allows for use of albumin excretion to monitor kidney disease to further individualize risk assessment and help inform personalized treatment options.

The new calculator also asks about tobacco use and use of medications for CVD risk factors and factors in age and sex, and it removes race from the risk calculations.

“The inclusion of race in risk prediction may imply that differences by race are not modifiable and may reify race as a biological construct, which may worsen health disparities. Therefore, it was decided a priori not to include race as a predictor in the development of PREVENT,” the writing group said.

They emphasized that the PREVENT calculator has similar accuracy among varied racial and ethnic groups.

The equations include an option to use the Social Deprivation Index, which incorporates measures of adverse social determinants of health such as education, poverty, unemployment, and factors based on a person’s environment.

The PREVENT equations are a “critical first step” toward including CKM health and social factors in risk prediction for CVD, Dr. Khan said in a news release.

“We are working on finalizing the online tool and it should be available soon – hopefully in a few weeks,” Dr. Khan told this news organization.
 

Knowledge gaps

The scientific statement lists several knowledge gaps and areas for more research. These include:

• Incorporating “net benefit” to identify the expected benefit of treatment recommendations based on an individual’s level of risk.
• Collecting more data from people of diverse race and ethnic backgrounds to better represent the increasing diversity in the United States. The number of Hispanic and Asian people included in the PREVENT datasets is lower than national estimates in the general U.S. population, so risk estimations in these populations may be less precise.
• Expanding the collection, reporting, and standardization of social determinants of health data, such as individual information rather than neighborhood information.
• Expanding risk assessment and prevention to earlier in life (childhood and/or adolescence) and in key life periods, such as during the peripartum period, since adverse pregnancy outcomes are associated with increased CVD risk.
• Investigating whether predicting adverse kidney outcomes, particularly among people with and without type 2 diabetes, may further optimize cardiovascular risk prediction.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA. Dr. Khan reports no relevant financial relationships.

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

The American Heart Association (AHA) has unveiled a new heart disease risk calculator that aims to estimate an individual’s long-term risk for cardiovascular disease (CVD).

The new Predicting Risk of CVD Events (PREVENT) calculator is the first risk calculator that combines measures of cardiovascular, kidney, and metabolic health to estimate risk for CVD.

It follows an AHA presidential advisory and scientific statement published in October, formally defining cardiovascular-kidney-metabolic (CKM) syndrome.

The PREVENT calculator also “starts earlier and goes longer” than the pooled cohort equations (PCE), Sadiya Khan, MD, MSc, chair of the statement writing committee, told this news organization.

PREVENT is for use in adults aged 30-79 years and estimates the 10- and 30-year risk of total CVD including, for the first time, heart failure. The PCE were designed to assess 10-year risk of only myocardial infarction and stroke and only in adults aged 40-79 years.

“The new PREVENT equations are important for doctors because they allow us to start conversations earlier and more comprehensively and accurately calculate risk for our patients,” said Dr. Khan, preventive cardiologist at Northwestern Medicine and associate professor at Northwestern University in Chicago.

“We want to support clinicians in starting these conversations around optimizing CKM health earlier and begin to engage in discussions on ways to optimize health,” Dr. Khan added.

The AHA scientific statement on the PREVENT calculator, with Dr. Khan as lead author, was published online in Circulation, with an accompanying article that describes development and validation of the tool. 

Going beyond the PCE

The new calculator was developed using health information from more than 6 million adults from diverse racial and ethnic, socioeconomic, and geographic backgrounds.

In addition to blood pressure and cholesterol levels, the PREVENT equations allow for inclusion of hemoglobin A1c, if necessary, to monitor metabolic health.

It also includes estimated glomerular filtration rate (eGFR), a measure of kidney function, and allows for use of albumin excretion to monitor kidney disease to further individualize risk assessment and help inform personalized treatment options.

The new calculator also asks about tobacco use and use of medications for CVD risk factors and factors in age and sex, and it removes race from the risk calculations.

“The inclusion of race in risk prediction may imply that differences by race are not modifiable and may reify race as a biological construct, which may worsen health disparities. Therefore, it was decided a priori not to include race as a predictor in the development of PREVENT,” the writing group said.

They emphasized that the PREVENT calculator has similar accuracy among varied racial and ethnic groups.

The equations include an option to use the Social Deprivation Index, which incorporates measures of adverse social determinants of health such as education, poverty, unemployment, and factors based on a person’s environment.

The PREVENT equations are a “critical first step” toward including CKM health and social factors in risk prediction for CVD, Dr. Khan said in a news release.

“We are working on finalizing the online tool and it should be available soon – hopefully in a few weeks,” Dr. Khan told this news organization.
 

Knowledge gaps

The scientific statement lists several knowledge gaps and areas for more research. These include:

• Incorporating “net benefit” to identify the expected benefit of treatment recommendations based on an individual’s level of risk.
• Collecting more data from people of diverse race and ethnic backgrounds to better represent the increasing diversity in the United States. The number of Hispanic and Asian people included in the PREVENT datasets is lower than national estimates in the general U.S. population, so risk estimations in these populations may be less precise.
• Expanding the collection, reporting, and standardization of social determinants of health data, such as individual information rather than neighborhood information.
• Expanding risk assessment and prevention to earlier in life (childhood and/or adolescence) and in key life periods, such as during the peripartum period, since adverse pregnancy outcomes are associated with increased CVD risk.
• Investigating whether predicting adverse kidney outcomes, particularly among people with and without type 2 diabetes, may further optimize cardiovascular risk prediction.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA. Dr. Khan reports no relevant financial relationships.

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

The American Heart Association (AHA) has unveiled a new heart disease risk calculator that aims to estimate an individual’s long-term risk for cardiovascular disease (CVD).

The new Predicting Risk of CVD Events (PREVENT) calculator is the first risk calculator that combines measures of cardiovascular, kidney, and metabolic health to estimate risk for CVD.

It follows an AHA presidential advisory and scientific statement published in October, formally defining cardiovascular-kidney-metabolic (CKM) syndrome.

The PREVENT calculator also “starts earlier and goes longer” than the pooled cohort equations (PCE), Sadiya Khan, MD, MSc, chair of the statement writing committee, told this news organization.

PREVENT is for use in adults aged 30-79 years and estimates the 10- and 30-year risk of total CVD including, for the first time, heart failure. The PCE were designed to assess 10-year risk of only myocardial infarction and stroke and only in adults aged 40-79 years.

“The new PREVENT equations are important for doctors because they allow us to start conversations earlier and more comprehensively and accurately calculate risk for our patients,” said Dr. Khan, preventive cardiologist at Northwestern Medicine and associate professor at Northwestern University in Chicago.

“We want to support clinicians in starting these conversations around optimizing CKM health earlier and begin to engage in discussions on ways to optimize health,” Dr. Khan added.

The AHA scientific statement on the PREVENT calculator, with Dr. Khan as lead author, was published online in Circulation, with an accompanying article that describes development and validation of the tool. 

Going beyond the PCE

The new calculator was developed using health information from more than 6 million adults from diverse racial and ethnic, socioeconomic, and geographic backgrounds.

In addition to blood pressure and cholesterol levels, the PREVENT equations allow for inclusion of hemoglobin A1c, if necessary, to monitor metabolic health.

It also includes estimated glomerular filtration rate (eGFR), a measure of kidney function, and allows for use of albumin excretion to monitor kidney disease to further individualize risk assessment and help inform personalized treatment options.

The new calculator also asks about tobacco use and use of medications for CVD risk factors and factors in age and sex, and it removes race from the risk calculations.

“The inclusion of race in risk prediction may imply that differences by race are not modifiable and may reify race as a biological construct, which may worsen health disparities. Therefore, it was decided a priori not to include race as a predictor in the development of PREVENT,” the writing group said.

They emphasized that the PREVENT calculator has similar accuracy among varied racial and ethnic groups.

The equations include an option to use the Social Deprivation Index, which incorporates measures of adverse social determinants of health such as education, poverty, unemployment, and factors based on a person’s environment.

The PREVENT equations are a “critical first step” toward including CKM health and social factors in risk prediction for CVD, Dr. Khan said in a news release.

“We are working on finalizing the online tool and it should be available soon – hopefully in a few weeks,” Dr. Khan told this news organization.
 

Knowledge gaps

The scientific statement lists several knowledge gaps and areas for more research. These include:

• Incorporating “net benefit” to identify the expected benefit of treatment recommendations based on an individual’s level of risk.
• Collecting more data from people of diverse race and ethnic backgrounds to better represent the increasing diversity in the United States. The number of Hispanic and Asian people included in the PREVENT datasets is lower than national estimates in the general U.S. population, so risk estimations in these populations may be less precise.
• Expanding the collection, reporting, and standardization of social determinants of health data, such as individual information rather than neighborhood information.
• Expanding risk assessment and prevention to earlier in life (childhood and/or adolescence) and in key life periods, such as during the peripartum period, since adverse pregnancy outcomes are associated with increased CVD risk.
• Investigating whether predicting adverse kidney outcomes, particularly among people with and without type 2 diabetes, may further optimize cardiovascular risk prediction.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA. Dr. Khan reports no relevant financial relationships.

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

Earlier this year, I stumbled across a podcast in a content update email from the Journal of the American Medical Association. The moderator was interviewing the first author of a study comparing hydrocortisone and fludrocortisone (hydro/fludro) to hydrocortisone alone for treatment of septic shock. In the introduction, the author commented on the discordance in practice among his peers at his hospital. It seemed that there was no consensus on whether fludrocortisone was necessary.

I thought this issue had been settled with publication of the COIITSS trial in 2010. This study randomly assigned 509 patients with septic shock to hydro/fludro versus hydrocortisone alone. There was a nonsignificant reduction in mortality with hydro/fludro and everyone I knew stopped adding fludrocortisone for septic shock. It wasn’t included in guidelines (and still isn›t). I figured the only docs still using it were also prescribing ivermectin and vitamin C – another treatment touted to work in an apocryphal podcast.

It wasn’t just COIITSS that killed fludrocortisone for me. Back in 2002, I was a loyal adherent. That year, a randomized controlled trial (RCT) published by “the lord of corticosteroids for critical illness” doctor, Djillali Annane, found benefit to hydro/fludro in septic shock . Everyone in that study had a cosyntropin stim test and only certain subgroups had better outcomes. As a medical resident paying obeisance to all things evidence-based medicine, I rigidly adopted their protocol for all septic patients. I also kept their insulin between 80 and 110 mg/dL, prescribed drotrecogin alfa, and made sure they were floating in crystalloid. But those are topics for another time.

Subsequent trials and meta-analyses cast doubt on the need for the stim test, and a consensus around hydrocortisone at moderate doses for patients with septic shock emerged. Because one part of the Annane protocol was already deemed unnecessary (the cosyntropin stim test), it was easy to dismiss fludrocortisone after COIITTS was published. Yes, I read Annane’s 2018 APROCCHSS trial, and I’m aware that it found that hydro/fludro reduced 90-day mortality. Like others, I rationalized this finding by framing it as a function of baseline mortality. The two Annane RCTs that found that hydro/fludro reduced mortality in enrolled patients who were considerably more likely to die than those enrolled in RCTs of hydrocortisone alone were negative. It was the target population mortality rate and not the addition of fludrocortisone that made the difference, right?
 

Rethinking hydro/fludro

The author interviewed for the recent JAMA podcast forced me to rethink my blithe dismissal of fludrocortisone. He contended that the COIITTS trial was underpowered and the two Annane RCTs that used fludrocortisone supply the evidence that shows corticosteroids reduce septic shock mortality. As discussed earlier, he found clinical equipoise among his colleagues. Last, he invoked pleiotropic mineralocorticoid effects, such as activation of innate immunity and clearance of alveolar fluid, to support the need to reexamine hydro/fludro.

In his study, he used Big Data to compare hospital records from 2016 to 2020. He analyzed a total of 88,275 patients with septic shock. Most were prescribed hydrocortisone alone (85,995 [97.4%] vs. only 2.6% hydro/fludro). After a number of statistical adjustments and sensitivity analyses, the authors concluded that the addition of fludrocortisone to hydrocortisone for patients with septic shock provides a 3.7% absolute risk reduction in mortality (or discharge to hospice) when compared with hydrocortisone alone. That’s a number needed to treat of 28 to prevent one death (or discharge to hospice).
 

Key takeaways

The study isn’t perfect. In their methods section they use terms like “ensemble machine learner (super learner)” and “immortal time bias.” The first is a fancy way of saying they did a form of propensity scoring, which in turn is a fancy way of saying they tried to control for confounding. The second is a way to adjust for time delays between drug administration. Both are attempts to compensate for the observational design, as is their argument for biologic plausibility. Here they’re on particularly thin ice when trying to prove causal inference. Biologic plausibility is never hard to find; after all, what compound doesn’t have pleiotropic effects? Furthermore, the analysis lacks any data to support their biologic plausibility hypothesis that fludrocortisone’s effect on mortality is mediated via activation of innate immunity and/or clearance of alveolar fluid.

The editorial accompanying this Big Data study endorsed adding fludrocortisone. We have very little that reduces ICU mortality so the low number needed to treat is enticing, especially in light of the low risk from adverse events, so I’m going to start using it. Do I think I’ll save one life for every 28 patients with septic shock to whom I give hydro/fludro instead of hydrocortisone alone? I sure don’t. No way an oral mineralocorticoid at that dose has that type of impact on top of hydrocortisone alone. I still believe that the Annane studies are positive because of the mortality rate in the population enrolled and not because fludrocortisone was added. It all comes full circle, though – 20 years after I abandoned hydro/fludro, I’m going back to it.

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/critical care and sleep medicine physician at MedStar Washington Hospital Center in Washington, D.C.

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

Earlier this year, I stumbled across a podcast in a content update email from the Journal of the American Medical Association. The moderator was interviewing the first author of a study comparing hydrocortisone and fludrocortisone (hydro/fludro) to hydrocortisone alone for treatment of septic shock. In the introduction, the author commented on the discordance in practice among his peers at his hospital. It seemed that there was no consensus on whether fludrocortisone was necessary.

I thought this issue had been settled with publication of the COIITSS trial in 2010. This study randomly assigned 509 patients with septic shock to hydro/fludro versus hydrocortisone alone. There was a nonsignificant reduction in mortality with hydro/fludro and everyone I knew stopped adding fludrocortisone for septic shock. It wasn’t included in guidelines (and still isn›t). I figured the only docs still using it were also prescribing ivermectin and vitamin C – another treatment touted to work in an apocryphal podcast.

It wasn’t just COIITSS that killed fludrocortisone for me. Back in 2002, I was a loyal adherent. That year, a randomized controlled trial (RCT) published by “the lord of corticosteroids for critical illness” doctor, Djillali Annane, found benefit to hydro/fludro in septic shock . Everyone in that study had a cosyntropin stim test and only certain subgroups had better outcomes. As a medical resident paying obeisance to all things evidence-based medicine, I rigidly adopted their protocol for all septic patients. I also kept their insulin between 80 and 110 mg/dL, prescribed drotrecogin alfa, and made sure they were floating in crystalloid. But those are topics for another time.

Subsequent trials and meta-analyses cast doubt on the need for the stim test, and a consensus around hydrocortisone at moderate doses for patients with septic shock emerged. Because one part of the Annane protocol was already deemed unnecessary (the cosyntropin stim test), it was easy to dismiss fludrocortisone after COIITTS was published. Yes, I read Annane’s 2018 APROCCHSS trial, and I’m aware that it found that hydro/fludro reduced 90-day mortality. Like others, I rationalized this finding by framing it as a function of baseline mortality. The two Annane RCTs that found that hydro/fludro reduced mortality in enrolled patients who were considerably more likely to die than those enrolled in RCTs of hydrocortisone alone were negative. It was the target population mortality rate and not the addition of fludrocortisone that made the difference, right?
 

Rethinking hydro/fludro

The author interviewed for the recent JAMA podcast forced me to rethink my blithe dismissal of fludrocortisone. He contended that the COIITTS trial was underpowered and the two Annane RCTs that used fludrocortisone supply the evidence that shows corticosteroids reduce septic shock mortality. As discussed earlier, he found clinical equipoise among his colleagues. Last, he invoked pleiotropic mineralocorticoid effects, such as activation of innate immunity and clearance of alveolar fluid, to support the need to reexamine hydro/fludro.

In his study, he used Big Data to compare hospital records from 2016 to 2020. He analyzed a total of 88,275 patients with septic shock. Most were prescribed hydrocortisone alone (85,995 [97.4%] vs. only 2.6% hydro/fludro). After a number of statistical adjustments and sensitivity analyses, the authors concluded that the addition of fludrocortisone to hydrocortisone for patients with septic shock provides a 3.7% absolute risk reduction in mortality (or discharge to hospice) when compared with hydrocortisone alone. That’s a number needed to treat of 28 to prevent one death (or discharge to hospice).
 

Key takeaways

The study isn’t perfect. In their methods section they use terms like “ensemble machine learner (super learner)” and “immortal time bias.” The first is a fancy way of saying they did a form of propensity scoring, which in turn is a fancy way of saying they tried to control for confounding. The second is a way to adjust for time delays between drug administration. Both are attempts to compensate for the observational design, as is their argument for biologic plausibility. Here they’re on particularly thin ice when trying to prove causal inference. Biologic plausibility is never hard to find; after all, what compound doesn’t have pleiotropic effects? Furthermore, the analysis lacks any data to support their biologic plausibility hypothesis that fludrocortisone’s effect on mortality is mediated via activation of innate immunity and/or clearance of alveolar fluid.

The editorial accompanying this Big Data study endorsed adding fludrocortisone. We have very little that reduces ICU mortality so the low number needed to treat is enticing, especially in light of the low risk from adverse events, so I’m going to start using it. Do I think I’ll save one life for every 28 patients with septic shock to whom I give hydro/fludro instead of hydrocortisone alone? I sure don’t. No way an oral mineralocorticoid at that dose has that type of impact on top of hydrocortisone alone. I still believe that the Annane studies are positive because of the mortality rate in the population enrolled and not because fludrocortisone was added. It all comes full circle, though – 20 years after I abandoned hydro/fludro, I’m going back to it.

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/critical care and sleep medicine physician at MedStar Washington Hospital Center in Washington, D.C.

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

Earlier this year, I stumbled across a podcast in a content update email from the Journal of the American Medical Association. The moderator was interviewing the first author of a study comparing hydrocortisone and fludrocortisone (hydro/fludro) to hydrocortisone alone for treatment of septic shock. In the introduction, the author commented on the discordance in practice among his peers at his hospital. It seemed that there was no consensus on whether fludrocortisone was necessary.

I thought this issue had been settled with publication of the COIITSS trial in 2010. This study randomly assigned 509 patients with septic shock to hydro/fludro versus hydrocortisone alone. There was a nonsignificant reduction in mortality with hydro/fludro and everyone I knew stopped adding fludrocortisone for septic shock. It wasn’t included in guidelines (and still isn›t). I figured the only docs still using it were also prescribing ivermectin and vitamin C – another treatment touted to work in an apocryphal podcast.

It wasn’t just COIITSS that killed fludrocortisone for me. Back in 2002, I was a loyal adherent. That year, a randomized controlled trial (RCT) published by “the lord of corticosteroids for critical illness” doctor, Djillali Annane, found benefit to hydro/fludro in septic shock . Everyone in that study had a cosyntropin stim test and only certain subgroups had better outcomes. As a medical resident paying obeisance to all things evidence-based medicine, I rigidly adopted their protocol for all septic patients. I also kept their insulin between 80 and 110 mg/dL, prescribed drotrecogin alfa, and made sure they were floating in crystalloid. But those are topics for another time.

Subsequent trials and meta-analyses cast doubt on the need for the stim test, and a consensus around hydrocortisone at moderate doses for patients with septic shock emerged. Because one part of the Annane protocol was already deemed unnecessary (the cosyntropin stim test), it was easy to dismiss fludrocortisone after COIITTS was published. Yes, I read Annane’s 2018 APROCCHSS trial, and I’m aware that it found that hydro/fludro reduced 90-day mortality. Like others, I rationalized this finding by framing it as a function of baseline mortality. The two Annane RCTs that found that hydro/fludro reduced mortality in enrolled patients who were considerably more likely to die than those enrolled in RCTs of hydrocortisone alone were negative. It was the target population mortality rate and not the addition of fludrocortisone that made the difference, right?
 

Rethinking hydro/fludro

The author interviewed for the recent JAMA podcast forced me to rethink my blithe dismissal of fludrocortisone. He contended that the COIITTS trial was underpowered and the two Annane RCTs that used fludrocortisone supply the evidence that shows corticosteroids reduce septic shock mortality. As discussed earlier, he found clinical equipoise among his colleagues. Last, he invoked pleiotropic mineralocorticoid effects, such as activation of innate immunity and clearance of alveolar fluid, to support the need to reexamine hydro/fludro.

In his study, he used Big Data to compare hospital records from 2016 to 2020. He analyzed a total of 88,275 patients with septic shock. Most were prescribed hydrocortisone alone (85,995 [97.4%] vs. only 2.6% hydro/fludro). After a number of statistical adjustments and sensitivity analyses, the authors concluded that the addition of fludrocortisone to hydrocortisone for patients with septic shock provides a 3.7% absolute risk reduction in mortality (or discharge to hospice) when compared with hydrocortisone alone. That’s a number needed to treat of 28 to prevent one death (or discharge to hospice).
 

Key takeaways

The study isn’t perfect. In their methods section they use terms like “ensemble machine learner (super learner)” and “immortal time bias.” The first is a fancy way of saying they did a form of propensity scoring, which in turn is a fancy way of saying they tried to control for confounding. The second is a way to adjust for time delays between drug administration. Both are attempts to compensate for the observational design, as is their argument for biologic plausibility. Here they’re on particularly thin ice when trying to prove causal inference. Biologic plausibility is never hard to find; after all, what compound doesn’t have pleiotropic effects? Furthermore, the analysis lacks any data to support their biologic plausibility hypothesis that fludrocortisone’s effect on mortality is mediated via activation of innate immunity and/or clearance of alveolar fluid.

The editorial accompanying this Big Data study endorsed adding fludrocortisone. We have very little that reduces ICU mortality so the low number needed to treat is enticing, especially in light of the low risk from adverse events, so I’m going to start using it. Do I think I’ll save one life for every 28 patients with septic shock to whom I give hydro/fludro instead of hydrocortisone alone? I sure don’t. No way an oral mineralocorticoid at that dose has that type of impact on top of hydrocortisone alone. I still believe that the Annane studies are positive because of the mortality rate in the population enrolled and not because fludrocortisone was added. It all comes full circle, though – 20 years after I abandoned hydro/fludro, I’m going back to it.

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/critical care and sleep medicine physician at MedStar Washington Hospital Center in Washington, D.C.

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