Cardiology

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

Heart failure (HF) is one of the leading causes of hospitalizations and the most expensive Medicare diagnosis. Its prevalence continues to rise with a projected increase of 46% from 2012 to 2030 resulting in > 8 million people aged ≥ 18 years with HF in the United States. Despite improvements in therapy, mortality remains unacceptably high with a 50% mortality rate within 5 years. Early detection strategies are needed to identify patients at risk of developing HF to delay the disease course and improve survival.^1,2

Emerging data indicates that natriuretic peptide biomarker-based screening using B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) and early intervention for patients at risk of HF could prevent development of left ventricular dysfunction or new-onset HF.^3-5 The 2013 St. Vincent’s Screening to Prevent Heart Failure (STOP-HF) trial is the largest study to date to evaluate BNP as a screening tool for patients at risk for HF.⁴ Patients at risk of HF who did not have established left ventricular systolic dysfunction or symptomatic HF were assigned randomly to usual primary care or BNP screening. Patients with BNP levels ≥ 50 pg/mL underwent echocardiogram and were referred to a cardiovascular specialty service for management. The cardiovascular specialty clinic included a team of registered nurses, nurse practitioners, pharmacists, dieticians, palliative care specialists, and cardiologists. Individuals in the intervention group showed increased renin-angiotensin system (RAS) inhibitor use at follow-up (control, 49.6%; intervention, 59.6%; P = .01). All patients received coaching by a nurse who emphasized individual risk, importance of medication adherence, and healthy lifestyle behaviors. After a mean follow-up of 4.2 years, 59 of 677 participants (8.7%) in the control group and 37 of 697 (5.3%) in the intervention group (odds ratio [OR], 0.55; 95% CI, 0.37 to 0.82; P = .003) met the primary end point of left ventricular dysfunction with or without HF. BNP-based screening in conjunction with collaborative care reduced rates of left ventricular dysfunction and HF.

In the 2013 PONTIAC trial, patients with type 2 diabetes mellitus (T2DM) without cardiac disease but with NT-proBNP levels > 125 pg/mL were randomized to usual diabetes care or intensified care at a cardiac outpatient clinic for initiation and increase of RAS inhibitors and β blockers.⁵ After 2 years, patients randomized to the intensified care group showed a 65% risk reduction of the primary endpoint of hospitalization or death from cardiac disease (P = .04).

Based on this evidence, the 2017 focused update of the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) guideline for managing HF added a IIa recommendation for natriuretic peptide biomarker screening in those at risk of developing HF.⁶ The guideline recommends biomarker screening in conjunction with team-based care, including a cardiovascular specialist, and guideline-directed management and therapy to prevent development of left ventricular dysfunction or new-onset HF.

Although ordering a natriuretic peptide biomarker laboratory test is straightforward, the variability of team-based care across institutions and health systems makes it difficult to standardize screening and interventions for patients at risk for HF. We developed and piloted a process using clinical pharmacists in primary care for natriuretic peptide biomarker screening and risk factor reduction within the established patient aligned care team (PACT) framework at a US Department of Veterans Affairs (VA) medical center. In this paper, we describe our implementation process including descriptive preliminary outcomes.

Methods

The PACT team-based approach in primary care clinics is similar to the patient-centered medical home framework. A PACT includes the veteran patient and an interdisciplinary team of health professionals composed of their primary care practitioner (PCP), registered nurse care manager, clinical pharmacist, and other clinical and administrative staff. The PACT clinical pharmacist has prescriptive authority within a scope of practice to provide postdiagnostic chronic disease state management including management of T2DM, hypertension, HF, chronic obstructive pulmonary disease, anticoagulation, tobacco cessation, and atherosclerotic cardiovascular disease (ASCVD) risk reduction. Clinical pharmacists can prescribe and adjust medications and order laboratory tests.

Our institution, Clement J. Zablocki VA Medical Center (CJZVAMC) in Milwaukee, Wisconsin, has a specialty HF clinic that primarily manages ACC/AHA Stage C HF patients. The HF clinic uses a team-based approach to collaborate and coordinate care for the veteran. The HF team is comprised of cardiology specialists, registered nurses, clinical pharmacists, dietitians, and administrative staff. Two PACT clinical pharmacists also staff the HF clinic at CJZVAMC and work collaboratively to initiate, adjust, and optimize veterans’ HF medication regimens.

Two primary care PACT panels were selected for this project. Before implementation, a pharmacy resident and 3 PACT clinical pharmacists (2 of whom also staff the HF clinic) met with a HF cardiology specialist and 2 PACT PCPs to finalize the team-based process and workflow. PCPs were presented with the evidence-based background, purpose, and project design, which included patient identification, NT-proBNP laboratory test ordering, medication adjustment schedules, and protocol for ordering echocardiograms (Figure). Templated notes were created to allow for consistent documentation in patients’ electronic health record. A telephone script also was written for the initial telephone call to patients to explain in patient-friendly terms the implications of an elevated NT-proBNP level, the echocardiogram procedure, and recommendations for risk reduction.

Patient Selection

Patients aged ≥ 18 years with hypertension, taking antihypertensive medication for ≥ 1 month, or diagnosed with T2DM for ≥ 6 months were included. Using the parameters provided in the STOP-HF trial, patients with evidence or history of left ventricular dysfunction, defined as a left ventricular ejection fraction (EF) < 50% or an E/e’ ratio > 15 in the setting of normal EF, or symptomatic HF were excluded. Patients with a diagnosis causing life expectancy < 1 year were excluded, which was determined based on review of the patient’s chart or discussion with the PCP.

A clinical pharmacist screened patients with an upcoming PCP appointment between September 2019 and January 2020 for eligibility. For patients who met criteria, the clinical pharmacist ordered a NT-proBNP laboratory test to their already scheduled tests and entered a templated note into the patient’s chart to alert the PCP of the test. NT-proBNP was used rather than BNP because it was the natriuretic peptide laboratory test available at CJZVAMC during this time. Patients with NT-proBNP < 125 pg/mL received usual care from their PCPs. Patients with NT-proBNP ≥ 125 pg/mL received a follow-up phone call from a clinical pharmacist to discuss the laboratory test result with recommendations for initiation or increase of RAS inhibitors and an echocardiogram. If the patient agreed to an echocardiogram, the PCP was notified to order the test. For patients aged > 80 years with elevated NT-proBNP, risk vs benefit and patient-specific goals of care were discussed with the PCP. For patients whose echocardiograms revealed left ventricular dysfunction, initiation or adjustment of β blockers was considered. During RAS inhibitor increase, the clinical pharmacists provided a review of the patient’s risk factors and optimized management of hypertension, T2DM, ASCVD risk reduction, oral nonsteroidal anti-inflammatory drug (NSAID) reduction, and tobacco cessation.

Outcome Measures

Outcome measures included the percentage of patients who met inclusion/exclusion criteria and had an elevated NT-proBNP level, percent change in RAS inhibitor prescriptions and optimized dosing after intervention, frequency of left ventricular dysfunction visualized with echocardiograms, and quantification of pharmacist interventions in disease state management. Descriptive statistics were used to analyze demographic data, RAS inhibitors prescriptions before and after intervention, echocardiogram results, pharmacist recommendations, and acceptance rates of disease state management.

Results

Between September 2019 and January 2020, 570 patients from 2 PACT teams were screened. Of the 570 patients, 246 met inclusion criteria with upcoming appointments. Of these, 24 were excluded, 10 for EF < 50%, 13 for E/e’ > 15 in setting of normal EF, and 1 for hypertension diagnosis without an antihypertensive regimen or elevated blood pressure. The remaining 222 patients had an NT-proBNP level ordered and drawn and 73 (32.9%) patients had an NT-proBNP ≥ 125 pg/mL. Baseline characteristics are described in Table 1.

Data was collected through March 2020 (due to COVID-19) found that among the 73 patients with elevated NT-proBNP: 14 had an echocardiogram within the past year without evidence of left ventricular dysfunction; 39 had echocardiograms ordered; and 19 had echocardiograms completed by March 2020. Among the 19 echocardiograms, 16 (84%) showed no evidence of left ventricular dysfunction, 2 (11%) revealed mildly reduced EF (40% to 50%), and 1 (5%) revealed a reduced EF (< 40%). These patients were identified early in the disease course before symptom onset and received intervention with RAS inhibitors and disease state management.

Patients prescribed RAS inhibitors increased from 44 to 50. The number of patients who were able to have their RAS inhibitor dosage adjusted increased from 28 to 31. For the 3 patients with mildly reduced or reduced EF, management with β blockers was based on RAS inhibitor adjustment toleration. One patient with mildly reduced EF was switched from metoprolol tartrate to metoprolol succinate.

Discussion

We included patients diagnosed with T2DM and hypertension for several reasons. Most patients (62%) studied in the STOP-HF trial were diagnosed with hypertension. Also, T2DM represented the patient population enrolled in the PONTIAC trial. Guidance from the European Society of Cardiology recommends use of natriuretic peptides in high-risk populations, such as patients with DM and hypertension, to help target initiation of preventive measures.⁷ Lastly, T2DM and hypertension patients were easily identified using population management software available at the VA.

The percentage of patients in this project with risk factors for HF and an elevated NT-proBNP were similar to the elevated levels described in the STOP-HF trial. In our project, 32.9% of patients had elevated NT-proBNP levels, similar to the 41.6% of patients in STOP-HF. Among the completed echocardiograms, 16% revealed mildly reduced or reduced EF. These patients were identified early in the disease course before symptom onset and received intervention with RAS inhibitors and disease state management.

In addition to early identification of reduced EF, this project allowed a targeted approach to identifying patients for risk factor reduction. Between the 2 PACT teams, 246 patients with T2DM and/or hypertension were seen from September 2019 to January 2020. By using natriuretic peptide screening, the clinical pharmacists were able to prioritize and focus risk factor management on patients at higher risk. Pharmacists were then able to intervene for all risk factors assessed: hypertension, T2DM, ASCVD risk reduction, NSAID use reduction, and tobacco cessation.

During the implementation period, VA criteria of use of the angiotensin receptor-neprilysin inhibitor, sacubitril/valsartan, was restricted to VA cardiology. For patients with reduced EF, it was up to the PCP’s discretion to consult cardiology for further follow-up. In November 2020, the VA removed the restriction to cardiology and PCPs were able to order sacubitril/valsartan. Although not included in the Figure at the time of project implementation, the clinical pharmacist could now transition a patient with reduced EF from a RAS inhibitor to sacubitril/valsartan and adjust to target dosages.

Limitations

Participants were identified initially through a computer-generated list of patients with hypertension or T2DM without a HF diagnosis documented in their problem list. This problem list is manually updated by PCPs. Although we reviewed records for exclusion criteria, eligible patients might have been excluded. The use and interpretation of an NT-proBNP level is not specific to cardiac disease. Elevations can be seen with increased age, kidney dysfunction, and pulmonary disease. Additionally, an NT-proBNP level might be falsely low in patients who are overweight or obese. Because of the relatively short period of time, we could not analyze associations with HF diagnosis or progression, hospitalizations due to HF, or mortality. Regarding external validity, because of the pre-established interdisciplinary clinic settings and VA pharmacists’ scope of practice with prescriptive authority, implementing this project might have been better received by PCPs and allowed for higher acceptance rates of pharmacist interventions at the VA compared with a community setting.

Conclusions

The ACC/AHA/HFSA guidelines recommended use of natriuretic peptide biomarker screening in conjunction with team-based care for those at risk of developing HF. We describe our process for implementing team-based care using clinical pharmacists in primary care. Our process provides a targeted approach to identifying patients for risk factor reduction through comprehensive medication management and could be replicated by other primary care clinics using a patient-centered medical home model.

Acknowledgments

We would like to acknowledge Dr. Sara Hariman, Dr. Payal Sanghani, and Dr. Cecilia Scholcoff for their support and collaboration with the project.

Heart failure (HF) is one of the leading causes of hospitalizations and the most expensive Medicare diagnosis. Its prevalence continues to rise with a projected increase of 46% from 2012 to 2030 resulting in > 8 million people aged ≥ 18 years with HF in the United States. Despite improvements in therapy, mortality remains unacceptably high with a 50% mortality rate within 5 years. Early detection strategies are needed to identify patients at risk of developing HF to delay the disease course and improve survival.^1,2

Emerging data indicates that natriuretic peptide biomarker-based screening using B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) and early intervention for patients at risk of HF could prevent development of left ventricular dysfunction or new-onset HF.^3-5 The 2013 St. Vincent’s Screening to Prevent Heart Failure (STOP-HF) trial is the largest study to date to evaluate BNP as a screening tool for patients at risk for HF.⁴ Patients at risk of HF who did not have established left ventricular systolic dysfunction or symptomatic HF were assigned randomly to usual primary care or BNP screening. Patients with BNP levels ≥ 50 pg/mL underwent echocardiogram and were referred to a cardiovascular specialty service for management. The cardiovascular specialty clinic included a team of registered nurses, nurse practitioners, pharmacists, dieticians, palliative care specialists, and cardiologists. Individuals in the intervention group showed increased renin-angiotensin system (RAS) inhibitor use at follow-up (control, 49.6%; intervention, 59.6%; P = .01). All patients received coaching by a nurse who emphasized individual risk, importance of medication adherence, and healthy lifestyle behaviors. After a mean follow-up of 4.2 years, 59 of 677 participants (8.7%) in the control group and 37 of 697 (5.3%) in the intervention group (odds ratio [OR], 0.55; 95% CI, 0.37 to 0.82; P = .003) met the primary end point of left ventricular dysfunction with or without HF. BNP-based screening in conjunction with collaborative care reduced rates of left ventricular dysfunction and HF.

In the 2013 PONTIAC trial, patients with type 2 diabetes mellitus (T2DM) without cardiac disease but with NT-proBNP levels > 125 pg/mL were randomized to usual diabetes care or intensified care at a cardiac outpatient clinic for initiation and increase of RAS inhibitors and β blockers.⁵ After 2 years, patients randomized to the intensified care group showed a 65% risk reduction of the primary endpoint of hospitalization or death from cardiac disease (P = .04).

Based on this evidence, the 2017 focused update of the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) guideline for managing HF added a IIa recommendation for natriuretic peptide biomarker screening in those at risk of developing HF.⁶ The guideline recommends biomarker screening in conjunction with team-based care, including a cardiovascular specialist, and guideline-directed management and therapy to prevent development of left ventricular dysfunction or new-onset HF.

Although ordering a natriuretic peptide biomarker laboratory test is straightforward, the variability of team-based care across institutions and health systems makes it difficult to standardize screening and interventions for patients at risk for HF. We developed and piloted a process using clinical pharmacists in primary care for natriuretic peptide biomarker screening and risk factor reduction within the established patient aligned care team (PACT) framework at a US Department of Veterans Affairs (VA) medical center. In this paper, we describe our implementation process including descriptive preliminary outcomes.

Methods

The PACT team-based approach in primary care clinics is similar to the patient-centered medical home framework. A PACT includes the veteran patient and an interdisciplinary team of health professionals composed of their primary care practitioner (PCP), registered nurse care manager, clinical pharmacist, and other clinical and administrative staff. The PACT clinical pharmacist has prescriptive authority within a scope of practice to provide postdiagnostic chronic disease state management including management of T2DM, hypertension, HF, chronic obstructive pulmonary disease, anticoagulation, tobacco cessation, and atherosclerotic cardiovascular disease (ASCVD) risk reduction. Clinical pharmacists can prescribe and adjust medications and order laboratory tests.

Our institution, Clement J. Zablocki VA Medical Center (CJZVAMC) in Milwaukee, Wisconsin, has a specialty HF clinic that primarily manages ACC/AHA Stage C HF patients. The HF clinic uses a team-based approach to collaborate and coordinate care for the veteran. The HF team is comprised of cardiology specialists, registered nurses, clinical pharmacists, dietitians, and administrative staff. Two PACT clinical pharmacists also staff the HF clinic at CJZVAMC and work collaboratively to initiate, adjust, and optimize veterans’ HF medication regimens.

Two primary care PACT panels were selected for this project. Before implementation, a pharmacy resident and 3 PACT clinical pharmacists (2 of whom also staff the HF clinic) met with a HF cardiology specialist and 2 PACT PCPs to finalize the team-based process and workflow. PCPs were presented with the evidence-based background, purpose, and project design, which included patient identification, NT-proBNP laboratory test ordering, medication adjustment schedules, and protocol for ordering echocardiograms (Figure). Templated notes were created to allow for consistent documentation in patients’ electronic health record. A telephone script also was written for the initial telephone call to patients to explain in patient-friendly terms the implications of an elevated NT-proBNP level, the echocardiogram procedure, and recommendations for risk reduction.

Patient Selection

Patients aged ≥ 18 years with hypertension, taking antihypertensive medication for ≥ 1 month, or diagnosed with T2DM for ≥ 6 months were included. Using the parameters provided in the STOP-HF trial, patients with evidence or history of left ventricular dysfunction, defined as a left ventricular ejection fraction (EF) < 50% or an E/e’ ratio > 15 in the setting of normal EF, or symptomatic HF were excluded. Patients with a diagnosis causing life expectancy < 1 year were excluded, which was determined based on review of the patient’s chart or discussion with the PCP.

A clinical pharmacist screened patients with an upcoming PCP appointment between September 2019 and January 2020 for eligibility. For patients who met criteria, the clinical pharmacist ordered a NT-proBNP laboratory test to their already scheduled tests and entered a templated note into the patient’s chart to alert the PCP of the test. NT-proBNP was used rather than BNP because it was the natriuretic peptide laboratory test available at CJZVAMC during this time. Patients with NT-proBNP < 125 pg/mL received usual care from their PCPs. Patients with NT-proBNP ≥ 125 pg/mL received a follow-up phone call from a clinical pharmacist to discuss the laboratory test result with recommendations for initiation or increase of RAS inhibitors and an echocardiogram. If the patient agreed to an echocardiogram, the PCP was notified to order the test. For patients aged > 80 years with elevated NT-proBNP, risk vs benefit and patient-specific goals of care were discussed with the PCP. For patients whose echocardiograms revealed left ventricular dysfunction, initiation or adjustment of β blockers was considered. During RAS inhibitor increase, the clinical pharmacists provided a review of the patient’s risk factors and optimized management of hypertension, T2DM, ASCVD risk reduction, oral nonsteroidal anti-inflammatory drug (NSAID) reduction, and tobacco cessation.

Outcome Measures

Outcome measures included the percentage of patients who met inclusion/exclusion criteria and had an elevated NT-proBNP level, percent change in RAS inhibitor prescriptions and optimized dosing after intervention, frequency of left ventricular dysfunction visualized with echocardiograms, and quantification of pharmacist interventions in disease state management. Descriptive statistics were used to analyze demographic data, RAS inhibitors prescriptions before and after intervention, echocardiogram results, pharmacist recommendations, and acceptance rates of disease state management.

Results

Between September 2019 and January 2020, 570 patients from 2 PACT teams were screened. Of the 570 patients, 246 met inclusion criteria with upcoming appointments. Of these, 24 were excluded, 10 for EF < 50%, 13 for E/e’ > 15 in setting of normal EF, and 1 for hypertension diagnosis without an antihypertensive regimen or elevated blood pressure. The remaining 222 patients had an NT-proBNP level ordered and drawn and 73 (32.9%) patients had an NT-proBNP ≥ 125 pg/mL. Baseline characteristics are described in Table 1.

Data was collected through March 2020 (due to COVID-19) found that among the 73 patients with elevated NT-proBNP: 14 had an echocardiogram within the past year without evidence of left ventricular dysfunction; 39 had echocardiograms ordered; and 19 had echocardiograms completed by March 2020. Among the 19 echocardiograms, 16 (84%) showed no evidence of left ventricular dysfunction, 2 (11%) revealed mildly reduced EF (40% to 50%), and 1 (5%) revealed a reduced EF (< 40%). These patients were identified early in the disease course before symptom onset and received intervention with RAS inhibitors and disease state management.

Patients prescribed RAS inhibitors increased from 44 to 50. The number of patients who were able to have their RAS inhibitor dosage adjusted increased from 28 to 31. For the 3 patients with mildly reduced or reduced EF, management with β blockers was based on RAS inhibitor adjustment toleration. One patient with mildly reduced EF was switched from metoprolol tartrate to metoprolol succinate.

Discussion

We included patients diagnosed with T2DM and hypertension for several reasons. Most patients (62%) studied in the STOP-HF trial were diagnosed with hypertension. Also, T2DM represented the patient population enrolled in the PONTIAC trial. Guidance from the European Society of Cardiology recommends use of natriuretic peptides in high-risk populations, such as patients with DM and hypertension, to help target initiation of preventive measures.⁷ Lastly, T2DM and hypertension patients were easily identified using population management software available at the VA.

The percentage of patients in this project with risk factors for HF and an elevated NT-proBNP were similar to the elevated levels described in the STOP-HF trial. In our project, 32.9% of patients had elevated NT-proBNP levels, similar to the 41.6% of patients in STOP-HF. Among the completed echocardiograms, 16% revealed mildly reduced or reduced EF. These patients were identified early in the disease course before symptom onset and received intervention with RAS inhibitors and disease state management.

In addition to early identification of reduced EF, this project allowed a targeted approach to identifying patients for risk factor reduction. Between the 2 PACT teams, 246 patients with T2DM and/or hypertension were seen from September 2019 to January 2020. By using natriuretic peptide screening, the clinical pharmacists were able to prioritize and focus risk factor management on patients at higher risk. Pharmacists were then able to intervene for all risk factors assessed: hypertension, T2DM, ASCVD risk reduction, NSAID use reduction, and tobacco cessation.

During the implementation period, VA criteria of use of the angiotensin receptor-neprilysin inhibitor, sacubitril/valsartan, was restricted to VA cardiology. For patients with reduced EF, it was up to the PCP’s discretion to consult cardiology for further follow-up. In November 2020, the VA removed the restriction to cardiology and PCPs were able to order sacubitril/valsartan. Although not included in the Figure at the time of project implementation, the clinical pharmacist could now transition a patient with reduced EF from a RAS inhibitor to sacubitril/valsartan and adjust to target dosages.

Limitations

Participants were identified initially through a computer-generated list of patients with hypertension or T2DM without a HF diagnosis documented in their problem list. This problem list is manually updated by PCPs. Although we reviewed records for exclusion criteria, eligible patients might have been excluded. The use and interpretation of an NT-proBNP level is not specific to cardiac disease. Elevations can be seen with increased age, kidney dysfunction, and pulmonary disease. Additionally, an NT-proBNP level might be falsely low in patients who are overweight or obese. Because of the relatively short period of time, we could not analyze associations with HF diagnosis or progression, hospitalizations due to HF, or mortality. Regarding external validity, because of the pre-established interdisciplinary clinic settings and VA pharmacists’ scope of practice with prescriptive authority, implementing this project might have been better received by PCPs and allowed for higher acceptance rates of pharmacist interventions at the VA compared with a community setting.

Conclusions

The ACC/AHA/HFSA guidelines recommended use of natriuretic peptide biomarker screening in conjunction with team-based care for those at risk of developing HF. We describe our process for implementing team-based care using clinical pharmacists in primary care. Our process provides a targeted approach to identifying patients for risk factor reduction through comprehensive medication management and could be replicated by other primary care clinics using a patient-centered medical home model.

Acknowledgments

We would like to acknowledge Dr. Sara Hariman, Dr. Payal Sanghani, and Dr. Cecilia Scholcoff for their support and collaboration with the project.

Heart failure (HF) is one of the leading causes of hospitalizations and the most expensive Medicare diagnosis. Its prevalence continues to rise with a projected increase of 46% from 2012 to 2030 resulting in > 8 million people aged ≥ 18 years with HF in the United States. Despite improvements in therapy, mortality remains unacceptably high with a 50% mortality rate within 5 years. Early detection strategies are needed to identify patients at risk of developing HF to delay the disease course and improve survival.^1,2

Emerging data indicates that natriuretic peptide biomarker-based screening using B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) and early intervention for patients at risk of HF could prevent development of left ventricular dysfunction or new-onset HF.^3-5 The 2013 St. Vincent’s Screening to Prevent Heart Failure (STOP-HF) trial is the largest study to date to evaluate BNP as a screening tool for patients at risk for HF.⁴ Patients at risk of HF who did not have established left ventricular systolic dysfunction or symptomatic HF were assigned randomly to usual primary care or BNP screening. Patients with BNP levels ≥ 50 pg/mL underwent echocardiogram and were referred to a cardiovascular specialty service for management. The cardiovascular specialty clinic included a team of registered nurses, nurse practitioners, pharmacists, dieticians, palliative care specialists, and cardiologists. Individuals in the intervention group showed increased renin-angiotensin system (RAS) inhibitor use at follow-up (control, 49.6%; intervention, 59.6%; P = .01). All patients received coaching by a nurse who emphasized individual risk, importance of medication adherence, and healthy lifestyle behaviors. After a mean follow-up of 4.2 years, 59 of 677 participants (8.7%) in the control group and 37 of 697 (5.3%) in the intervention group (odds ratio [OR], 0.55; 95% CI, 0.37 to 0.82; P = .003) met the primary end point of left ventricular dysfunction with or without HF. BNP-based screening in conjunction with collaborative care reduced rates of left ventricular dysfunction and HF.

In the 2013 PONTIAC trial, patients with type 2 diabetes mellitus (T2DM) without cardiac disease but with NT-proBNP levels > 125 pg/mL were randomized to usual diabetes care or intensified care at a cardiac outpatient clinic for initiation and increase of RAS inhibitors and β blockers.⁵ After 2 years, patients randomized to the intensified care group showed a 65% risk reduction of the primary endpoint of hospitalization or death from cardiac disease (P = .04).

Based on this evidence, the 2017 focused update of the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) guideline for managing HF added a IIa recommendation for natriuretic peptide biomarker screening in those at risk of developing HF.⁶ The guideline recommends biomarker screening in conjunction with team-based care, including a cardiovascular specialist, and guideline-directed management and therapy to prevent development of left ventricular dysfunction or new-onset HF.

Although ordering a natriuretic peptide biomarker laboratory test is straightforward, the variability of team-based care across institutions and health systems makes it difficult to standardize screening and interventions for patients at risk for HF. We developed and piloted a process using clinical pharmacists in primary care for natriuretic peptide biomarker screening and risk factor reduction within the established patient aligned care team (PACT) framework at a US Department of Veterans Affairs (VA) medical center. In this paper, we describe our implementation process including descriptive preliminary outcomes.

Methods

The PACT team-based approach in primary care clinics is similar to the patient-centered medical home framework. A PACT includes the veteran patient and an interdisciplinary team of health professionals composed of their primary care practitioner (PCP), registered nurse care manager, clinical pharmacist, and other clinical and administrative staff. The PACT clinical pharmacist has prescriptive authority within a scope of practice to provide postdiagnostic chronic disease state management including management of T2DM, hypertension, HF, chronic obstructive pulmonary disease, anticoagulation, tobacco cessation, and atherosclerotic cardiovascular disease (ASCVD) risk reduction. Clinical pharmacists can prescribe and adjust medications and order laboratory tests.

Our institution, Clement J. Zablocki VA Medical Center (CJZVAMC) in Milwaukee, Wisconsin, has a specialty HF clinic that primarily manages ACC/AHA Stage C HF patients. The HF clinic uses a team-based approach to collaborate and coordinate care for the veteran. The HF team is comprised of cardiology specialists, registered nurses, clinical pharmacists, dietitians, and administrative staff. Two PACT clinical pharmacists also staff the HF clinic at CJZVAMC and work collaboratively to initiate, adjust, and optimize veterans’ HF medication regimens.

Two primary care PACT panels were selected for this project. Before implementation, a pharmacy resident and 3 PACT clinical pharmacists (2 of whom also staff the HF clinic) met with a HF cardiology specialist and 2 PACT PCPs to finalize the team-based process and workflow. PCPs were presented with the evidence-based background, purpose, and project design, which included patient identification, NT-proBNP laboratory test ordering, medication adjustment schedules, and protocol for ordering echocardiograms (Figure). Templated notes were created to allow for consistent documentation in patients’ electronic health record. A telephone script also was written for the initial telephone call to patients to explain in patient-friendly terms the implications of an elevated NT-proBNP level, the echocardiogram procedure, and recommendations for risk reduction.

Patient Selection

Patients aged ≥ 18 years with hypertension, taking antihypertensive medication for ≥ 1 month, or diagnosed with T2DM for ≥ 6 months were included. Using the parameters provided in the STOP-HF trial, patients with evidence or history of left ventricular dysfunction, defined as a left ventricular ejection fraction (EF) < 50% or an E/e’ ratio > 15 in the setting of normal EF, or symptomatic HF were excluded. Patients with a diagnosis causing life expectancy < 1 year were excluded, which was determined based on review of the patient’s chart or discussion with the PCP.

A clinical pharmacist screened patients with an upcoming PCP appointment between September 2019 and January 2020 for eligibility. For patients who met criteria, the clinical pharmacist ordered a NT-proBNP laboratory test to their already scheduled tests and entered a templated note into the patient’s chart to alert the PCP of the test. NT-proBNP was used rather than BNP because it was the natriuretic peptide laboratory test available at CJZVAMC during this time. Patients with NT-proBNP < 125 pg/mL received usual care from their PCPs. Patients with NT-proBNP ≥ 125 pg/mL received a follow-up phone call from a clinical pharmacist to discuss the laboratory test result with recommendations for initiation or increase of RAS inhibitors and an echocardiogram. If the patient agreed to an echocardiogram, the PCP was notified to order the test. For patients aged > 80 years with elevated NT-proBNP, risk vs benefit and patient-specific goals of care were discussed with the PCP. For patients whose echocardiograms revealed left ventricular dysfunction, initiation or adjustment of β blockers was considered. During RAS inhibitor increase, the clinical pharmacists provided a review of the patient’s risk factors and optimized management of hypertension, T2DM, ASCVD risk reduction, oral nonsteroidal anti-inflammatory drug (NSAID) reduction, and tobacco cessation.

Outcome Measures

Outcome measures included the percentage of patients who met inclusion/exclusion criteria and had an elevated NT-proBNP level, percent change in RAS inhibitor prescriptions and optimized dosing after intervention, frequency of left ventricular dysfunction visualized with echocardiograms, and quantification of pharmacist interventions in disease state management. Descriptive statistics were used to analyze demographic data, RAS inhibitors prescriptions before and after intervention, echocardiogram results, pharmacist recommendations, and acceptance rates of disease state management.

Results

Between September 2019 and January 2020, 570 patients from 2 PACT teams were screened. Of the 570 patients, 246 met inclusion criteria with upcoming appointments. Of these, 24 were excluded, 10 for EF < 50%, 13 for E/e’ > 15 in setting of normal EF, and 1 for hypertension diagnosis without an antihypertensive regimen or elevated blood pressure. The remaining 222 patients had an NT-proBNP level ordered and drawn and 73 (32.9%) patients had an NT-proBNP ≥ 125 pg/mL. Baseline characteristics are described in Table 1.

Data was collected through March 2020 (due to COVID-19) found that among the 73 patients with elevated NT-proBNP: 14 had an echocardiogram within the past year without evidence of left ventricular dysfunction; 39 had echocardiograms ordered; and 19 had echocardiograms completed by March 2020. Among the 19 echocardiograms, 16 (84%) showed no evidence of left ventricular dysfunction, 2 (11%) revealed mildly reduced EF (40% to 50%), and 1 (5%) revealed a reduced EF (< 40%). These patients were identified early in the disease course before symptom onset and received intervention with RAS inhibitors and disease state management.

Patients prescribed RAS inhibitors increased from 44 to 50. The number of patients who were able to have their RAS inhibitor dosage adjusted increased from 28 to 31. For the 3 patients with mildly reduced or reduced EF, management with β blockers was based on RAS inhibitor adjustment toleration. One patient with mildly reduced EF was switched from metoprolol tartrate to metoprolol succinate.

Discussion

We included patients diagnosed with T2DM and hypertension for several reasons. Most patients (62%) studied in the STOP-HF trial were diagnosed with hypertension. Also, T2DM represented the patient population enrolled in the PONTIAC trial. Guidance from the European Society of Cardiology recommends use of natriuretic peptides in high-risk populations, such as patients with DM and hypertension, to help target initiation of preventive measures.⁷ Lastly, T2DM and hypertension patients were easily identified using population management software available at the VA.

The percentage of patients in this project with risk factors for HF and an elevated NT-proBNP were similar to the elevated levels described in the STOP-HF trial. In our project, 32.9% of patients had elevated NT-proBNP levels, similar to the 41.6% of patients in STOP-HF. Among the completed echocardiograms, 16% revealed mildly reduced or reduced EF. These patients were identified early in the disease course before symptom onset and received intervention with RAS inhibitors and disease state management.

In addition to early identification of reduced EF, this project allowed a targeted approach to identifying patients for risk factor reduction. Between the 2 PACT teams, 246 patients with T2DM and/or hypertension were seen from September 2019 to January 2020. By using natriuretic peptide screening, the clinical pharmacists were able to prioritize and focus risk factor management on patients at higher risk. Pharmacists were then able to intervene for all risk factors assessed: hypertension, T2DM, ASCVD risk reduction, NSAID use reduction, and tobacco cessation.

During the implementation period, VA criteria of use of the angiotensin receptor-neprilysin inhibitor, sacubitril/valsartan, was restricted to VA cardiology. For patients with reduced EF, it was up to the PCP’s discretion to consult cardiology for further follow-up. In November 2020, the VA removed the restriction to cardiology and PCPs were able to order sacubitril/valsartan. Although not included in the Figure at the time of project implementation, the clinical pharmacist could now transition a patient with reduced EF from a RAS inhibitor to sacubitril/valsartan and adjust to target dosages.

Limitations

Participants were identified initially through a computer-generated list of patients with hypertension or T2DM without a HF diagnosis documented in their problem list. This problem list is manually updated by PCPs. Although we reviewed records for exclusion criteria, eligible patients might have been excluded. The use and interpretation of an NT-proBNP level is not specific to cardiac disease. Elevations can be seen with increased age, kidney dysfunction, and pulmonary disease. Additionally, an NT-proBNP level might be falsely low in patients who are overweight or obese. Because of the relatively short period of time, we could not analyze associations with HF diagnosis or progression, hospitalizations due to HF, or mortality. Regarding external validity, because of the pre-established interdisciplinary clinic settings and VA pharmacists’ scope of practice with prescriptive authority, implementing this project might have been better received by PCPs and allowed for higher acceptance rates of pharmacist interventions at the VA compared with a community setting.

Conclusions

The ACC/AHA/HFSA guidelines recommended use of natriuretic peptide biomarker screening in conjunction with team-based care for those at risk of developing HF. We describe our process for implementing team-based care using clinical pharmacists in primary care. Our process provides a targeted approach to identifying patients for risk factor reduction through comprehensive medication management and could be replicated by other primary care clinics using a patient-centered medical home model.

Acknowledgments

We would like to acknowledge Dr. Sara Hariman, Dr. Payal Sanghani, and Dr. Cecilia Scholcoff for their support and collaboration with the project.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

From stubborn high blood pressure to diverticulitis, two deputy editors of the Annals of Internal Medicine reviewed eight recently published articles they feel will influence practice.

1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study

Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.

Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.

To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.

The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.

A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.

“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”

At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.

“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
 

2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis

The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.

However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.

To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.

The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
 

3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study

Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”

The study authors posed two questions:

• How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?  
• Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?

During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.

“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
 

4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study

The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.

The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.

Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.

“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
 

5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial

This study assessed the effects of four doses of vitamin D₃ supplements on the risk of falls.

The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.

“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
 

6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study

This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.

The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
 

7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events

This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.

Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.

“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
 

8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review

Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.

It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.

As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.

“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.

Dr. Wee and Dr. Chang disclosed no relevant financial relationships.

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

From stubborn high blood pressure to diverticulitis, two deputy editors of the Annals of Internal Medicine reviewed eight recently published articles they feel will influence practice.

1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study

Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.

Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.

To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.

The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.

A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.

“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”

At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.

“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
 

2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis

The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.

However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.

To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.

The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
 

3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study

Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”

The study authors posed two questions:

• How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?  
• Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?

During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.

“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
 

4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study

The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.

The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.

Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.

“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
 

5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial

This study assessed the effects of four doses of vitamin D₃ supplements on the risk of falls.

The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.

“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
 

6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study

This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.

The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
 

7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events

This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.

Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.

“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
 

8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review

Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.

It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.

As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.

“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.

Dr. Wee and Dr. Chang disclosed no relevant financial relationships.

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

From stubborn high blood pressure to diverticulitis, two deputy editors of the Annals of Internal Medicine reviewed eight recently published articles they feel will influence practice.

1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study

Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.

Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.

To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.

The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.

A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.

“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”

At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.

“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
 

2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis

The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.

However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.

To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.

The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
 

3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study

Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”

The study authors posed two questions:

• How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?  
• Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?

During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.

“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
 

4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study

The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.

The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.

Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.

“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
 

5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial

This study assessed the effects of four doses of vitamin D₃ supplements on the risk of falls.

The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.

“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
 

6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study

This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.

The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
 

7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events

This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.

Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.

“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
 

8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review

Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.

It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.

As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.

“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.

Dr. Wee and Dr. Chang disclosed no relevant financial relationships.

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

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

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

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

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

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

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

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

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

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

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

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

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

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

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

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

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

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

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

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

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

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

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

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

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

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

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

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

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

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

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

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

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

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

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

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

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

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

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

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

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

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