Cardiology News

What if cardiology were no longer an internal medicine subspecialty? Four leading cardiology societies have announced plans to create a new certification process that is independent of the American Board of Internal Medicine maintenance of certification (MOC) system.

As envisioned, the new “independent, self-governed” entity would supplant the ABIM’s long-standing and widely criticized MOC system and establish cardiology as its own specialty with its own subspecialties. Long in coming, it is only the latest response to many in the field who for years have charged that the MOC system is needlessly burdensome and expensive.

“It’s time to have a dedicated cardiovascular medicine board of our own,” said B. Hadley Wilson, MD, in the group’s announcement. “Cardiology is a distinct medical specialty, and physicians want and deserve a clinical competency and continuous certification program that is meaningful to their practice and patients.”

Hadley Wilson, Sanger Heart & Vascular Institute Vascular Kenilworth, Charlotte, N.C., is president of the American College of Cardiology, one of the four societies spearheading the initiative along with the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions.

Their Sept. 21 statement says that the consortium will apply to the American Board of Medical Specialties to request an independent cardiology board that follows a “new competency-based approach to continuous certification – one that harnesses the knowledge, skills, and attitudes required to sustain professional excellence and care for cardiovascular patients effectively.”

It continues, “The new board requirements will de-emphasize timed, high stakes performance exams in the continuous certification process and instead will focus on learning assessments to identify gaps in current knowledge or skills.”

“The new board’s focus on competence in the pursuit of continuous certification is a needed paradigm shift for the field,” states HFSA President John R. Teerlink, MD, University of California, San Francisco, and the San Francisco VA Medical Center, in the announcement.

“I commend these professional cardiovascular societies for taking on this important challenge,” Deepak L. Bhatt, MD, MPH, Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai, New York City, told this news organization by email.

“This is an incredible opportunity to redefine what ongoing cardiovascular education means to the contemporary practicing cardiologist in a way that is relevant to improving the care of actual patients,” said Dr. Bhatt, who chairs the ACC Accreditation Oversight Committee.

“There needs to be an agile, personalized, convenient, and effective system to assist practitioners to stay current with new knowledge and demonstrate the necessary competencies,” Harlan Krumholz, MD, said in an email.

“There is a deep sense in the profession that the current approaches do not meet the needs of clinicians or society,” said Dr. Krumholz, Yale School of Medicine, New Haven, Conn., who has sat on the ABIM board of directors.

“This effort, which now will create competition, has the potential to spark innovation,” he said. “The key is that any approach needs to ask the question, ‘Is the cost and effort producing benefit for patients and society?’ If it is not, we have not found the right system.”

In a statement in response to the new development, ABIM said it plans to continue “offering and administering” its existing MOC programs across all specialties.

“Any physician choosing to maintain their ABIM certification in these disciplines will continue to have a pathway with ABIM to do so,” it says. “Questions about the cardiovascular organizations’ announcement and how it may affect individual physicians are best answered by those organizations.”

The process of approving the heart societies’ application to ABMS “is expected to take several months,” their announcement states. If approval is granted, “it will then take several additional months before initial certification and continuous certification and competency programs would begin.”

Medscape provides educational content including MOC. Medscape’s editorial content, including news and features, is developed independently of the educational content available on Medscape.

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

What if cardiology were no longer an internal medicine subspecialty? Four leading cardiology societies have announced plans to create a new certification process that is independent of the American Board of Internal Medicine maintenance of certification (MOC) system.

As envisioned, the new “independent, self-governed” entity would supplant the ABIM’s long-standing and widely criticized MOC system and establish cardiology as its own specialty with its own subspecialties. Long in coming, it is only the latest response to many in the field who for years have charged that the MOC system is needlessly burdensome and expensive.

“It’s time to have a dedicated cardiovascular medicine board of our own,” said B. Hadley Wilson, MD, in the group’s announcement. “Cardiology is a distinct medical specialty, and physicians want and deserve a clinical competency and continuous certification program that is meaningful to their practice and patients.”

Hadley Wilson, Sanger Heart & Vascular Institute Vascular Kenilworth, Charlotte, N.C., is president of the American College of Cardiology, one of the four societies spearheading the initiative along with the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions.

Their Sept. 21 statement says that the consortium will apply to the American Board of Medical Specialties to request an independent cardiology board that follows a “new competency-based approach to continuous certification – one that harnesses the knowledge, skills, and attitudes required to sustain professional excellence and care for cardiovascular patients effectively.”

It continues, “The new board requirements will de-emphasize timed, high stakes performance exams in the continuous certification process and instead will focus on learning assessments to identify gaps in current knowledge or skills.”

“The new board’s focus on competence in the pursuit of continuous certification is a needed paradigm shift for the field,” states HFSA President John R. Teerlink, MD, University of California, San Francisco, and the San Francisco VA Medical Center, in the announcement.

“I commend these professional cardiovascular societies for taking on this important challenge,” Deepak L. Bhatt, MD, MPH, Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai, New York City, told this news organization by email.

“This is an incredible opportunity to redefine what ongoing cardiovascular education means to the contemporary practicing cardiologist in a way that is relevant to improving the care of actual patients,” said Dr. Bhatt, who chairs the ACC Accreditation Oversight Committee.

“There needs to be an agile, personalized, convenient, and effective system to assist practitioners to stay current with new knowledge and demonstrate the necessary competencies,” Harlan Krumholz, MD, said in an email.

“There is a deep sense in the profession that the current approaches do not meet the needs of clinicians or society,” said Dr. Krumholz, Yale School of Medicine, New Haven, Conn., who has sat on the ABIM board of directors.

“This effort, which now will create competition, has the potential to spark innovation,” he said. “The key is that any approach needs to ask the question, ‘Is the cost and effort producing benefit for patients and society?’ If it is not, we have not found the right system.”

In a statement in response to the new development, ABIM said it plans to continue “offering and administering” its existing MOC programs across all specialties.

“Any physician choosing to maintain their ABIM certification in these disciplines will continue to have a pathway with ABIM to do so,” it says. “Questions about the cardiovascular organizations’ announcement and how it may affect individual physicians are best answered by those organizations.”

The process of approving the heart societies’ application to ABMS “is expected to take several months,” their announcement states. If approval is granted, “it will then take several additional months before initial certification and continuous certification and competency programs would begin.”

Medscape provides educational content including MOC. Medscape’s editorial content, including news and features, is developed independently of the educational content available on Medscape.

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

What if cardiology were no longer an internal medicine subspecialty? Four leading cardiology societies have announced plans to create a new certification process that is independent of the American Board of Internal Medicine maintenance of certification (MOC) system.

As envisioned, the new “independent, self-governed” entity would supplant the ABIM’s long-standing and widely criticized MOC system and establish cardiology as its own specialty with its own subspecialties. Long in coming, it is only the latest response to many in the field who for years have charged that the MOC system is needlessly burdensome and expensive.

“It’s time to have a dedicated cardiovascular medicine board of our own,” said B. Hadley Wilson, MD, in the group’s announcement. “Cardiology is a distinct medical specialty, and physicians want and deserve a clinical competency and continuous certification program that is meaningful to their practice and patients.”

Hadley Wilson, Sanger Heart & Vascular Institute Vascular Kenilworth, Charlotte, N.C., is president of the American College of Cardiology, one of the four societies spearheading the initiative along with the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions.

Their Sept. 21 statement says that the consortium will apply to the American Board of Medical Specialties to request an independent cardiology board that follows a “new competency-based approach to continuous certification – one that harnesses the knowledge, skills, and attitudes required to sustain professional excellence and care for cardiovascular patients effectively.”

It continues, “The new board requirements will de-emphasize timed, high stakes performance exams in the continuous certification process and instead will focus on learning assessments to identify gaps in current knowledge or skills.”

“The new board’s focus on competence in the pursuit of continuous certification is a needed paradigm shift for the field,” states HFSA President John R. Teerlink, MD, University of California, San Francisco, and the San Francisco VA Medical Center, in the announcement.

“I commend these professional cardiovascular societies for taking on this important challenge,” Deepak L. Bhatt, MD, MPH, Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai, New York City, told this news organization by email.

“This is an incredible opportunity to redefine what ongoing cardiovascular education means to the contemporary practicing cardiologist in a way that is relevant to improving the care of actual patients,” said Dr. Bhatt, who chairs the ACC Accreditation Oversight Committee.

“There needs to be an agile, personalized, convenient, and effective system to assist practitioners to stay current with new knowledge and demonstrate the necessary competencies,” Harlan Krumholz, MD, said in an email.

“There is a deep sense in the profession that the current approaches do not meet the needs of clinicians or society,” said Dr. Krumholz, Yale School of Medicine, New Haven, Conn., who has sat on the ABIM board of directors.

“This effort, which now will create competition, has the potential to spark innovation,” he said. “The key is that any approach needs to ask the question, ‘Is the cost and effort producing benefit for patients and society?’ If it is not, we have not found the right system.”

In a statement in response to the new development, ABIM said it plans to continue “offering and administering” its existing MOC programs across all specialties.

“Any physician choosing to maintain their ABIM certification in these disciplines will continue to have a pathway with ABIM to do so,” it says. “Questions about the cardiovascular organizations’ announcement and how it may affect individual physicians are best answered by those organizations.”

The process of approving the heart societies’ application to ABMS “is expected to take several months,” their announcement states. If approval is granted, “it will then take several additional months before initial certification and continuous certification and competency programs would begin.”

Medscape provides educational content including MOC. Medscape’s editorial content, including news and features, is developed independently of the educational content available on Medscape.

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

AMSTERDAM – Calculating a patient’s myocardial performance index (MPI) and adding it to a standard risk-prediction model significantly increased prognostic accuracy for major adverse cardiovascular events (MACE), especially heart failure, in people with type 1 but not type 2 diabetes, an analysis of data from about 2,000 Danish patients shows.

“MPI provides incremental prognostic information” in people with type 1 diabetes that “may enhance risk prediction” for their future risk of all-cause death, acute coronary syndrome, heart failure, or stroke, Hashmat S.Z. Bahrami, MD, said at the annual congress of the European Society of Cardiology.

The primary analysis he reported showed a significantly elevated adjusted hazard ratio of 1.2 among people with either type 1 or type 2 diabetes and an elevated MPI, compared with those with diabetes but a lower MPI value.

Further analysis divided the study cohort into the 1,093 people with type 1 diabetes and the 1,030 with type 2 diabetes and showed that the significant association of elevated MPI with increased MACE was entirely confined to the type 1 diabetes subgroup, again with a hazard ratio of 1.2, but without any significant association among those with type 2 diabetes, said Dr. Bahrami, a cardiology researcher at Copenhagen University Hospital.
 

‘Trying to figure out’ the type 1 diabetes link

“We’re still trying to figure out” the explanation for this difference based on diabetes type, Dr. Bahrami said. He speculated that it might relate to a higher incidence of heart failure among those with type 1 diabetes, or to longer duration of diabetes in the type 1 subgroup.

The ability of elevated MPI to predict an increased risk specifically for heart failure was apparent in another analysis he presented that divided MACE events into the individual components of this composite. Elevated MPI significantly linked with a 1.3-fold elevated risk for heart failure in those with type 1 diabetes, but high MPI had no significant association with any of the other event types included in the MACE composite.

The researchers also assessed the incremental impact from adding MPI data to an established cardiovascular disease (CVD) risk calculator for people with type 1 diabetes, the Steno Type 1 Risk Engine, which includes nine parameters such as age, sex, blood pressure, diabetes duration, and two different measures of renal function.

This analysis showed that adding MPI significantly boosted the attributable CVD risk from an area-under-the-curve of 0.77 to an AUC of 0.79. Including MPI also boosted the AUC for risk of future heart failure from 0.77 with the existing Steno Type 1 Risk Engine to 0.83, also a significant increase.

Simultaneously with his talk at the Congress, a report on the findings was published online in the European Heart Journal Cardiovascular Imaging.
 

MPI reflects left ventricular function

MPI is calculated by adding a person’s isovolumic cardiac relaxation time to their isovolumic cardiac contraction time and dividing this by their ejection time. These time measurements come from examination with tissue Doppler M-mode echocardiography, Dr. Bahrami explained, and when assessed together reflect left ventricular function during both systolic and diastolic phases.

“MPI has been around for many years, but our technique is rather novel” and has high intra- and inter-observer reproducibility, he said. “It’s highly reproducible and feasible.”

The study included data collected prospectively from Danish adults without any known CVD enrolled in the Thousand & 1 study of people with type 1 diabetes and the Thousand & 2 study of people with type 2 diabetes. The analyses that Dr. Bahrami reported included CVD events during a median 5.3 years of follow-up.

The study received funding from Novo Nordisk. Dr. Bahrami has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

AMSTERDAM – Calculating a patient’s myocardial performance index (MPI) and adding it to a standard risk-prediction model significantly increased prognostic accuracy for major adverse cardiovascular events (MACE), especially heart failure, in people with type 1 but not type 2 diabetes, an analysis of data from about 2,000 Danish patients shows.

“MPI provides incremental prognostic information” in people with type 1 diabetes that “may enhance risk prediction” for their future risk of all-cause death, acute coronary syndrome, heart failure, or stroke, Hashmat S.Z. Bahrami, MD, said at the annual congress of the European Society of Cardiology.

The primary analysis he reported showed a significantly elevated adjusted hazard ratio of 1.2 among people with either type 1 or type 2 diabetes and an elevated MPI, compared with those with diabetes but a lower MPI value.

Further analysis divided the study cohort into the 1,093 people with type 1 diabetes and the 1,030 with type 2 diabetes and showed that the significant association of elevated MPI with increased MACE was entirely confined to the type 1 diabetes subgroup, again with a hazard ratio of 1.2, but without any significant association among those with type 2 diabetes, said Dr. Bahrami, a cardiology researcher at Copenhagen University Hospital.
 

‘Trying to figure out’ the type 1 diabetes link

“We’re still trying to figure out” the explanation for this difference based on diabetes type, Dr. Bahrami said. He speculated that it might relate to a higher incidence of heart failure among those with type 1 diabetes, or to longer duration of diabetes in the type 1 subgroup.

The ability of elevated MPI to predict an increased risk specifically for heart failure was apparent in another analysis he presented that divided MACE events into the individual components of this composite. Elevated MPI significantly linked with a 1.3-fold elevated risk for heart failure in those with type 1 diabetes, but high MPI had no significant association with any of the other event types included in the MACE composite.

The researchers also assessed the incremental impact from adding MPI data to an established cardiovascular disease (CVD) risk calculator for people with type 1 diabetes, the Steno Type 1 Risk Engine, which includes nine parameters such as age, sex, blood pressure, diabetes duration, and two different measures of renal function.

This analysis showed that adding MPI significantly boosted the attributable CVD risk from an area-under-the-curve of 0.77 to an AUC of 0.79. Including MPI also boosted the AUC for risk of future heart failure from 0.77 with the existing Steno Type 1 Risk Engine to 0.83, also a significant increase.

Simultaneously with his talk at the Congress, a report on the findings was published online in the European Heart Journal Cardiovascular Imaging.
 

MPI reflects left ventricular function

MPI is calculated by adding a person’s isovolumic cardiac relaxation time to their isovolumic cardiac contraction time and dividing this by their ejection time. These time measurements come from examination with tissue Doppler M-mode echocardiography, Dr. Bahrami explained, and when assessed together reflect left ventricular function during both systolic and diastolic phases.

“MPI has been around for many years, but our technique is rather novel” and has high intra- and inter-observer reproducibility, he said. “It’s highly reproducible and feasible.”

The study included data collected prospectively from Danish adults without any known CVD enrolled in the Thousand & 1 study of people with type 1 diabetes and the Thousand & 2 study of people with type 2 diabetes. The analyses that Dr. Bahrami reported included CVD events during a median 5.3 years of follow-up.

The study received funding from Novo Nordisk. Dr. Bahrami has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

AMSTERDAM – Calculating a patient’s myocardial performance index (MPI) and adding it to a standard risk-prediction model significantly increased prognostic accuracy for major adverse cardiovascular events (MACE), especially heart failure, in people with type 1 but not type 2 diabetes, an analysis of data from about 2,000 Danish patients shows.

“MPI provides incremental prognostic information” in people with type 1 diabetes that “may enhance risk prediction” for their future risk of all-cause death, acute coronary syndrome, heart failure, or stroke, Hashmat S.Z. Bahrami, MD, said at the annual congress of the European Society of Cardiology.

The primary analysis he reported showed a significantly elevated adjusted hazard ratio of 1.2 among people with either type 1 or type 2 diabetes and an elevated MPI, compared with those with diabetes but a lower MPI value.

Further analysis divided the study cohort into the 1,093 people with type 1 diabetes and the 1,030 with type 2 diabetes and showed that the significant association of elevated MPI with increased MACE was entirely confined to the type 1 diabetes subgroup, again with a hazard ratio of 1.2, but without any significant association among those with type 2 diabetes, said Dr. Bahrami, a cardiology researcher at Copenhagen University Hospital.
 

‘Trying to figure out’ the type 1 diabetes link

“We’re still trying to figure out” the explanation for this difference based on diabetes type, Dr. Bahrami said. He speculated that it might relate to a higher incidence of heart failure among those with type 1 diabetes, or to longer duration of diabetes in the type 1 subgroup.

The ability of elevated MPI to predict an increased risk specifically for heart failure was apparent in another analysis he presented that divided MACE events into the individual components of this composite. Elevated MPI significantly linked with a 1.3-fold elevated risk for heart failure in those with type 1 diabetes, but high MPI had no significant association with any of the other event types included in the MACE composite.

The researchers also assessed the incremental impact from adding MPI data to an established cardiovascular disease (CVD) risk calculator for people with type 1 diabetes, the Steno Type 1 Risk Engine, which includes nine parameters such as age, sex, blood pressure, diabetes duration, and two different measures of renal function.

This analysis showed that adding MPI significantly boosted the attributable CVD risk from an area-under-the-curve of 0.77 to an AUC of 0.79. Including MPI also boosted the AUC for risk of future heart failure from 0.77 with the existing Steno Type 1 Risk Engine to 0.83, also a significant increase.

Simultaneously with his talk at the Congress, a report on the findings was published online in the European Heart Journal Cardiovascular Imaging.
 

MPI reflects left ventricular function

MPI is calculated by adding a person’s isovolumic cardiac relaxation time to their isovolumic cardiac contraction time and dividing this by their ejection time. These time measurements come from examination with tissue Doppler M-mode echocardiography, Dr. Bahrami explained, and when assessed together reflect left ventricular function during both systolic and diastolic phases.

“MPI has been around for many years, but our technique is rather novel” and has high intra- and inter-observer reproducibility, he said. “It’s highly reproducible and feasible.”

The study included data collected prospectively from Danish adults without any known CVD enrolled in the Thousand & 1 study of people with type 1 diabetes and the Thousand & 2 study of people with type 2 diabetes. The analyses that Dr. Bahrami reported included CVD events during a median 5.3 years of follow-up.

The study received funding from Novo Nordisk. Dr. Bahrami has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

All pregnant women should undergo screening for hypertensive disorders, with evidence-based management for those screening positive, according to a new recommendation from the U.S. Preventive Services Task Force.

Hypertensive disorders of pregnancy in the United States increased from approximately 500 cases per 10,000 deliveries to 1,021 cases per 10,000 deliveries from 1993 to 2016-2017, and remain a leading cause of maternal morbidity and mortality, wrote Task Force Chair Michael J. Barry, MD, of Massachusetts General Hospital, Boston, and colleagues in the final recommendation statement published in JAMA.

The USPSTF commissioned a systematic review to assess the risks and benefits of hypertensive screening for asymptomatic pregnant women. The resulting grade B recommendation indicates that screening for hypertensive disorders in pregnancy using blood pressure measurements yields a substantial net benefit.

The recommendation applies to “all pregnant women and pregnant persons of all genders without a known diagnosis of a hypertensive disorder of pregnancy or chronic hypertension,” the authors said.

The recommendation calls for the use of blood pressure measurements to evaluate hypertensive disorders, with measurements taken at each prenatal visit. A positive result for new-onset hypertension was defined as systolic blood pressure of 140 mm Hg or diastolic blood pressure 90 mm Hg in the absence of chronic hypertension, based on two measurements at least 4 hours apart. Regular review of blood pressure can help identify and manage potentially fatal conditions.

However, screening alone is insufficient to improve inequities in health outcomes associated with hypertensive disorders of pregnancy, the authors emphasized. Data from previous studies have shown that Black patients are at increased risk for hypertensive disorders of pregnancy and severe complications, and that Black and Hispanic patients have twice the risk of stroke with hypertensive disorders of pregnancy as White patients.

In the evidence report that supported the recommendation, Jillian T. Henderson, PhD, of Kaiser Permanente in Portland, Ore., and colleagues reviewed six studies including 10,165 individuals. The studies (five clinical trials and one nonrandomized study) compared changes in prenatal screening with usual care.

Overall, the review yielded no evidence that any other screening strategies were more useful than routine blood pressure measurement to identify hypertensive disorders of pregnancy in asymptomatic women.

The findings cited to support the recommendation were limited by several factors, including the lack of power to detect pregnancy health outcomes and potential harms of different screening programs, and the lack of power to evaluate outcomes for American Indian, Alaska Native, or Black individuals, who have disproportionately high rates of hypertensive disorders of pregnancy, the authors said.

More research is needed to identify which screening approaches may lead to improved disease detection and better health outcomes, but the results of the review support the grade B recommendation for hypertensive screening of all pregnant women, they concluded.
 

Early identification makes a difference

The new recommendation is important because it can help all moms and babies to be healthier, said Wanda Nicholson, MD, vice chair of the task force, in an interview.

“We are recommending that all pregnant persons have a blood pressure check at every visit throughout pregnancy,” said Dr. Nicholson, an ob.gyn. by training who also serves as professor of prevention and community health at George Washington University in Washington. “We know that there is a maternal health crisis in this country, and we know that hypertensive disorders of pregnancy are one of the key factors related to that,” she said.

Unfortunately, barriers to routine screening for hypertensive disorders of pregnancy persist, said Dr. Nicholson. The incidence of hypertensive disorders of pregnancy is higher in many of the same populations who also have challenges in accessing regular prenatal care, notably those who are Black, Native American, or Alaska Native, she noted.

The new recommendation also serves as an opportunity to call attention to the health care disparities for these populations, not only during pregnancy, but in general, she emphasized.

In clinical practice, the definition of hypertensive disorders of pregnancy involves three different diagnoses – gestational hypertension, preeclampsia, and eclampsia – that can be seen as points on a continuum, said Dr. Nicholson. The sooner patients are identified with hypertensive disorders of pregnancy, the sooner intervention and treatment can begin, she said. To that end, she added the clinical pearl of using a properly sized blood pressure cuff to obtain an accurate reading and avoid missed diagnoses.

The task force also outlined several key areas for additional research, said Dr. Nicholson. First, more research is needed on alternative screening strategies, such as at-home blood pressure monitoring for patients, as well as teleheath visits. Second, more studies are needed to address the disparities in prenatal care and include more diverse populations in clinical research. Third, future studies need to consider social determinants of health and other factors that might impact maternal health outcomes. “These steps will help achieve the larger goal of healthier mothers and babies,” Dr. Nicholson said.
 

Back to basics to improve women’s health

Some clinicians may be disappointed by the Evidence Report’s primary finding that no alternative screening strategies outperformed routine blood pressure measurement, wrote Anne E. Denoble, MD, and Christian M. Pettker, MD, both of Yale University, New Haven, Conn., in an accompanying editorial.

While potentially frustrating at first glance, the findings of the Evidence Report provide a foundation for improvement and reassurance that the best existing screening methods are basic and fundamental: regular prenatal visits with routine, in-office blood pressure measurements, and urine protein screening when clinically indicated, they said.

However, the USPSTF review also noted persistent research gaps that must be addressed to significantly improve maternal health outcomes, they said. Notable gaps include the disproportionately low numbers of Black patients in current studies, and the need for studies of alternate models of prenatal care, including the use of remote blood pressure monitoring, and the use of biomarkers to screen for and predict hypertensive disorders of pregnancy.

The most striking limitation may be the focus on prenatal care, with lack of attention to postpartum mortality risk, given that more than half of pregnancy-related deaths occur postpartum, the authors noted.

Although current screening tools may be used in practice “with skill and might,” more effort at multiple levels is needed to address the larger maternal health crisis in the United States, they said.
 

Expand screening, engage primary care for long-term benefits

Screening for hypertensive disorders of pregnancy “can and should be within the purview of internists,” wrote Srilakshmi Mitta, MD; Cary P. Gross, MD; Melissa A. Simon, MD, of Brown University, Yale University, and Northwestern University, respectively, in a separate editorial. The recommendation to extend screening beyond preeclampsia is timely, given the consistent increase in all hypertensive disorders of pregnancy since 1990, the authors said.

Pregnancy is not the only time for screening, counseling, and management of hypertensive disorders, they emphasized. “All persons who have reproductive capacity and/or are planning pregnancy, along with those who are post partum, should be screened for hypertensive disorders, aligning the USPSTF with guidelines from the American College of Obstetricians and Gynecologists, the American College of Cardiology, and the American Heart Association,” they said, and all clinicians should be on board to identify and treat hypertensive disorders of pregnancy, especially in underserved racial and ethnic minorities for whom primary care may be their only source of health care.

“Pregnancy is a window of opportunity to influence current and future life course, not just of the individual, but also of the fetus(es),other children, and family,” and timely intervention has the potential for great public health impact, they said.

Dr. Denoble disclosed grants from the HealthPartners Institute for Education and Research and from the Patient-Centered Outcomes Research Institute. Dr. Simon serves on the Advisory Committee for Research on Women’s Health for the National Institutes of Health Office of Research on Women’s Health and serves as a member of the Centers for Disease Control and Prevention Community Preventive Services Task Force; she was a member of the USPSTF from 2017 to 2020. Dr. Gross disclosed grants from Johnson and Johnson and the National Comprehensive Cancer Network (through a grant to the NCCN from AstraZeneca) and personal fees from Genentech.

All pregnant women should undergo screening for hypertensive disorders, with evidence-based management for those screening positive, according to a new recommendation from the U.S. Preventive Services Task Force.

Hypertensive disorders of pregnancy in the United States increased from approximately 500 cases per 10,000 deliveries to 1,021 cases per 10,000 deliveries from 1993 to 2016-2017, and remain a leading cause of maternal morbidity and mortality, wrote Task Force Chair Michael J. Barry, MD, of Massachusetts General Hospital, Boston, and colleagues in the final recommendation statement published in JAMA.

The USPSTF commissioned a systematic review to assess the risks and benefits of hypertensive screening for asymptomatic pregnant women. The resulting grade B recommendation indicates that screening for hypertensive disorders in pregnancy using blood pressure measurements yields a substantial net benefit.

The recommendation applies to “all pregnant women and pregnant persons of all genders without a known diagnosis of a hypertensive disorder of pregnancy or chronic hypertension,” the authors said.

The recommendation calls for the use of blood pressure measurements to evaluate hypertensive disorders, with measurements taken at each prenatal visit. A positive result for new-onset hypertension was defined as systolic blood pressure of 140 mm Hg or diastolic blood pressure 90 mm Hg in the absence of chronic hypertension, based on two measurements at least 4 hours apart. Regular review of blood pressure can help identify and manage potentially fatal conditions.

However, screening alone is insufficient to improve inequities in health outcomes associated with hypertensive disorders of pregnancy, the authors emphasized. Data from previous studies have shown that Black patients are at increased risk for hypertensive disorders of pregnancy and severe complications, and that Black and Hispanic patients have twice the risk of stroke with hypertensive disorders of pregnancy as White patients.

In the evidence report that supported the recommendation, Jillian T. Henderson, PhD, of Kaiser Permanente in Portland, Ore., and colleagues reviewed six studies including 10,165 individuals. The studies (five clinical trials and one nonrandomized study) compared changes in prenatal screening with usual care.

Overall, the review yielded no evidence that any other screening strategies were more useful than routine blood pressure measurement to identify hypertensive disorders of pregnancy in asymptomatic women.

The findings cited to support the recommendation were limited by several factors, including the lack of power to detect pregnancy health outcomes and potential harms of different screening programs, and the lack of power to evaluate outcomes for American Indian, Alaska Native, or Black individuals, who have disproportionately high rates of hypertensive disorders of pregnancy, the authors said.

More research is needed to identify which screening approaches may lead to improved disease detection and better health outcomes, but the results of the review support the grade B recommendation for hypertensive screening of all pregnant women, they concluded.
 

Early identification makes a difference

The new recommendation is important because it can help all moms and babies to be healthier, said Wanda Nicholson, MD, vice chair of the task force, in an interview.

“We are recommending that all pregnant persons have a blood pressure check at every visit throughout pregnancy,” said Dr. Nicholson, an ob.gyn. by training who also serves as professor of prevention and community health at George Washington University in Washington. “We know that there is a maternal health crisis in this country, and we know that hypertensive disorders of pregnancy are one of the key factors related to that,” she said.

Unfortunately, barriers to routine screening for hypertensive disorders of pregnancy persist, said Dr. Nicholson. The incidence of hypertensive disorders of pregnancy is higher in many of the same populations who also have challenges in accessing regular prenatal care, notably those who are Black, Native American, or Alaska Native, she noted.

The new recommendation also serves as an opportunity to call attention to the health care disparities for these populations, not only during pregnancy, but in general, she emphasized.

In clinical practice, the definition of hypertensive disorders of pregnancy involves three different diagnoses – gestational hypertension, preeclampsia, and eclampsia – that can be seen as points on a continuum, said Dr. Nicholson. The sooner patients are identified with hypertensive disorders of pregnancy, the sooner intervention and treatment can begin, she said. To that end, she added the clinical pearl of using a properly sized blood pressure cuff to obtain an accurate reading and avoid missed diagnoses.

The task force also outlined several key areas for additional research, said Dr. Nicholson. First, more research is needed on alternative screening strategies, such as at-home blood pressure monitoring for patients, as well as teleheath visits. Second, more studies are needed to address the disparities in prenatal care and include more diverse populations in clinical research. Third, future studies need to consider social determinants of health and other factors that might impact maternal health outcomes. “These steps will help achieve the larger goal of healthier mothers and babies,” Dr. Nicholson said.
 

Back to basics to improve women’s health

Some clinicians may be disappointed by the Evidence Report’s primary finding that no alternative screening strategies outperformed routine blood pressure measurement, wrote Anne E. Denoble, MD, and Christian M. Pettker, MD, both of Yale University, New Haven, Conn., in an accompanying editorial.

While potentially frustrating at first glance, the findings of the Evidence Report provide a foundation for improvement and reassurance that the best existing screening methods are basic and fundamental: regular prenatal visits with routine, in-office blood pressure measurements, and urine protein screening when clinically indicated, they said.

However, the USPSTF review also noted persistent research gaps that must be addressed to significantly improve maternal health outcomes, they said. Notable gaps include the disproportionately low numbers of Black patients in current studies, and the need for studies of alternate models of prenatal care, including the use of remote blood pressure monitoring, and the use of biomarkers to screen for and predict hypertensive disorders of pregnancy.

The most striking limitation may be the focus on prenatal care, with lack of attention to postpartum mortality risk, given that more than half of pregnancy-related deaths occur postpartum, the authors noted.

Although current screening tools may be used in practice “with skill and might,” more effort at multiple levels is needed to address the larger maternal health crisis in the United States, they said.
 

Expand screening, engage primary care for long-term benefits

Screening for hypertensive disorders of pregnancy “can and should be within the purview of internists,” wrote Srilakshmi Mitta, MD; Cary P. Gross, MD; Melissa A. Simon, MD, of Brown University, Yale University, and Northwestern University, respectively, in a separate editorial. The recommendation to extend screening beyond preeclampsia is timely, given the consistent increase in all hypertensive disorders of pregnancy since 1990, the authors said.

Pregnancy is not the only time for screening, counseling, and management of hypertensive disorders, they emphasized. “All persons who have reproductive capacity and/or are planning pregnancy, along with those who are post partum, should be screened for hypertensive disorders, aligning the USPSTF with guidelines from the American College of Obstetricians and Gynecologists, the American College of Cardiology, and the American Heart Association,” they said, and all clinicians should be on board to identify and treat hypertensive disorders of pregnancy, especially in underserved racial and ethnic minorities for whom primary care may be their only source of health care.

“Pregnancy is a window of opportunity to influence current and future life course, not just of the individual, but also of the fetus(es),other children, and family,” and timely intervention has the potential for great public health impact, they said.

Dr. Denoble disclosed grants from the HealthPartners Institute for Education and Research and from the Patient-Centered Outcomes Research Institute. Dr. Simon serves on the Advisory Committee for Research on Women’s Health for the National Institutes of Health Office of Research on Women’s Health and serves as a member of the Centers for Disease Control and Prevention Community Preventive Services Task Force; she was a member of the USPSTF from 2017 to 2020. Dr. Gross disclosed grants from Johnson and Johnson and the National Comprehensive Cancer Network (through a grant to the NCCN from AstraZeneca) and personal fees from Genentech.

All pregnant women should undergo screening for hypertensive disorders, with evidence-based management for those screening positive, according to a new recommendation from the U.S. Preventive Services Task Force.

Hypertensive disorders of pregnancy in the United States increased from approximately 500 cases per 10,000 deliveries to 1,021 cases per 10,000 deliveries from 1993 to 2016-2017, and remain a leading cause of maternal morbidity and mortality, wrote Task Force Chair Michael J. Barry, MD, of Massachusetts General Hospital, Boston, and colleagues in the final recommendation statement published in JAMA.

The USPSTF commissioned a systematic review to assess the risks and benefits of hypertensive screening for asymptomatic pregnant women. The resulting grade B recommendation indicates that screening for hypertensive disorders in pregnancy using blood pressure measurements yields a substantial net benefit.

The recommendation applies to “all pregnant women and pregnant persons of all genders without a known diagnosis of a hypertensive disorder of pregnancy or chronic hypertension,” the authors said.

The recommendation calls for the use of blood pressure measurements to evaluate hypertensive disorders, with measurements taken at each prenatal visit. A positive result for new-onset hypertension was defined as systolic blood pressure of 140 mm Hg or diastolic blood pressure 90 mm Hg in the absence of chronic hypertension, based on two measurements at least 4 hours apart. Regular review of blood pressure can help identify and manage potentially fatal conditions.

However, screening alone is insufficient to improve inequities in health outcomes associated with hypertensive disorders of pregnancy, the authors emphasized. Data from previous studies have shown that Black patients are at increased risk for hypertensive disorders of pregnancy and severe complications, and that Black and Hispanic patients have twice the risk of stroke with hypertensive disorders of pregnancy as White patients.

In the evidence report that supported the recommendation, Jillian T. Henderson, PhD, of Kaiser Permanente in Portland, Ore., and colleagues reviewed six studies including 10,165 individuals. The studies (five clinical trials and one nonrandomized study) compared changes in prenatal screening with usual care.

Overall, the review yielded no evidence that any other screening strategies were more useful than routine blood pressure measurement to identify hypertensive disorders of pregnancy in asymptomatic women.

The findings cited to support the recommendation were limited by several factors, including the lack of power to detect pregnancy health outcomes and potential harms of different screening programs, and the lack of power to evaluate outcomes for American Indian, Alaska Native, or Black individuals, who have disproportionately high rates of hypertensive disorders of pregnancy, the authors said.

More research is needed to identify which screening approaches may lead to improved disease detection and better health outcomes, but the results of the review support the grade B recommendation for hypertensive screening of all pregnant women, they concluded.
 

Early identification makes a difference

The new recommendation is important because it can help all moms and babies to be healthier, said Wanda Nicholson, MD, vice chair of the task force, in an interview.

“We are recommending that all pregnant persons have a blood pressure check at every visit throughout pregnancy,” said Dr. Nicholson, an ob.gyn. by training who also serves as professor of prevention and community health at George Washington University in Washington. “We know that there is a maternal health crisis in this country, and we know that hypertensive disorders of pregnancy are one of the key factors related to that,” she said.

Unfortunately, barriers to routine screening for hypertensive disorders of pregnancy persist, said Dr. Nicholson. The incidence of hypertensive disorders of pregnancy is higher in many of the same populations who also have challenges in accessing regular prenatal care, notably those who are Black, Native American, or Alaska Native, she noted.

The new recommendation also serves as an opportunity to call attention to the health care disparities for these populations, not only during pregnancy, but in general, she emphasized.

In clinical practice, the definition of hypertensive disorders of pregnancy involves three different diagnoses – gestational hypertension, preeclampsia, and eclampsia – that can be seen as points on a continuum, said Dr. Nicholson. The sooner patients are identified with hypertensive disorders of pregnancy, the sooner intervention and treatment can begin, she said. To that end, she added the clinical pearl of using a properly sized blood pressure cuff to obtain an accurate reading and avoid missed diagnoses.

The task force also outlined several key areas for additional research, said Dr. Nicholson. First, more research is needed on alternative screening strategies, such as at-home blood pressure monitoring for patients, as well as teleheath visits. Second, more studies are needed to address the disparities in prenatal care and include more diverse populations in clinical research. Third, future studies need to consider social determinants of health and other factors that might impact maternal health outcomes. “These steps will help achieve the larger goal of healthier mothers and babies,” Dr. Nicholson said.
 

Back to basics to improve women’s health

Some clinicians may be disappointed by the Evidence Report’s primary finding that no alternative screening strategies outperformed routine blood pressure measurement, wrote Anne E. Denoble, MD, and Christian M. Pettker, MD, both of Yale University, New Haven, Conn., in an accompanying editorial.

While potentially frustrating at first glance, the findings of the Evidence Report provide a foundation for improvement and reassurance that the best existing screening methods are basic and fundamental: regular prenatal visits with routine, in-office blood pressure measurements, and urine protein screening when clinically indicated, they said.

However, the USPSTF review also noted persistent research gaps that must be addressed to significantly improve maternal health outcomes, they said. Notable gaps include the disproportionately low numbers of Black patients in current studies, and the need for studies of alternate models of prenatal care, including the use of remote blood pressure monitoring, and the use of biomarkers to screen for and predict hypertensive disorders of pregnancy.

The most striking limitation may be the focus on prenatal care, with lack of attention to postpartum mortality risk, given that more than half of pregnancy-related deaths occur postpartum, the authors noted.

Although current screening tools may be used in practice “with skill and might,” more effort at multiple levels is needed to address the larger maternal health crisis in the United States, they said.
 

Expand screening, engage primary care for long-term benefits

Screening for hypertensive disorders of pregnancy “can and should be within the purview of internists,” wrote Srilakshmi Mitta, MD; Cary P. Gross, MD; Melissa A. Simon, MD, of Brown University, Yale University, and Northwestern University, respectively, in a separate editorial. The recommendation to extend screening beyond preeclampsia is timely, given the consistent increase in all hypertensive disorders of pregnancy since 1990, the authors said.

Pregnancy is not the only time for screening, counseling, and management of hypertensive disorders, they emphasized. “All persons who have reproductive capacity and/or are planning pregnancy, along with those who are post partum, should be screened for hypertensive disorders, aligning the USPSTF with guidelines from the American College of Obstetricians and Gynecologists, the American College of Cardiology, and the American Heart Association,” they said, and all clinicians should be on board to identify and treat hypertensive disorders of pregnancy, especially in underserved racial and ethnic minorities for whom primary care may be their only source of health care.

“Pregnancy is a window of opportunity to influence current and future life course, not just of the individual, but also of the fetus(es),other children, and family,” and timely intervention has the potential for great public health impact, they said.

Dr. Denoble disclosed grants from the HealthPartners Institute for Education and Research and from the Patient-Centered Outcomes Research Institute. Dr. Simon serves on the Advisory Committee for Research on Women’s Health for the National Institutes of Health Office of Research on Women’s Health and serves as a member of the Centers for Disease Control and Prevention Community Preventive Services Task Force; she was a member of the USPSTF from 2017 to 2020. Dr. Gross disclosed grants from Johnson and Johnson and the National Comprehensive Cancer Network (through a grant to the NCCN from AstraZeneca) and personal fees from Genentech.

A significant mortality gap persists between patients with type 2 diabetes and cardiovascular disease and similarly aged patients with neither condition. Data from the Emerging Risk Factors Collaboration showed that on average, a 60-year-old female patient with type 2 diabetes and a history of myocardial infarction dies around 14 years earlier than a similarly aged patient with neither of these conditions.

Therefore, I was keen to hear the key new recommendations from the 2023 European Society of Cardiology (ESC) guidelines for the management of cardiovascular disease in patients with diabetes. These recommendations were presented at the recent ESC 2023 congress in Amsterdam, which I was fortunate enough to attend.

The comprehensive guideline cemented the fact that our primary goal in type 2 diabetes management is a reduction in cardiovascular events and mortality, rather than the glucocentric goals that have been followed previously. Of course, good glycemic control remains important to protect against the microvascular complications of diabetes, but glycemic control has only a modest impact on macrovascular complications such as cardiovascular disease.

The updated guideline recommends that all patients with type 2 diabetes without symptomatic atherosclerotic cardiovascular disease or severe target-organ damage be screened for the risk for cardiovascular disease using a new 10-year cardiovascular risk calculator called SCORE2-Diabetes. This calculator extends the well-established SCORE2 cardiovascular risk-prediction tool with added predictors specifically related to type 2 diabetes. It also accounts for variation in risk across Europe.

Using SCORE2 Diabetes will be a change in practice for me, as I have been using QRISK3, which is a United Kingdom–based cardiovascular risk tool that has been less extensively validated in patients with type 2 diabetes. Helpfully, an ESC CVD Risk Calculation app is available and can be tailored to your geographical region to calculate a SCORE2-Diabetes risk score easily. For example, Eastern Europe has a higher cardiovascular risk profile than Western Europe.

Cardiovascular risk categories are now defined on the basis of the presence of atherosclerotic cardiovascular disease, severe target-organ damage, or the 10-year cardiovascular risk using SCORE2-Diabetes.

For patients at very high cardiovascular risk (for example, those with type 2 diabetes and established atherosclerotic cardiovascular disease), the ESC guidance recommends dual therapy with a GLP-1 receptor agonist and an SGLT2 inhibitor to reduce cardiovascular risk independent of glucose control (that is, A1c). This dual therapy is recommended in addition to standard-of-care antiplatelet, antihypertensive, and lipid-lowering therapies.

There is no doubt that the evidence for GLP-1 receptor agonist use and reduction in atherosclerotic cardiovascular disease in type 2 diabetes is compelling, perhaps more so than the evidence for SGLT2 inhibitor use. However, this recommendation will be challenging to implement, given the current global supply issues with GLP-1 receptor agonists, which are driven by the off-label use of these medications for the management of obesity. GLP-1 receptor agonist supplies are not expected to stabilize until mid-2024.

Controversially, the updated ESC guidance suggests the use of metformin only in patients with type 2 diabetes and atherosclerotic cardiovascular disease if additional glucose control is required. This is a misstep, in my opinion, as insulin resistance is one of the key pathophysiologic abnormalities in patients with type 2 diabetes. One of the key advantages of metformin is an improvement in insulin sensitivity. This recommendation will not change my practice, and I will continue to prescribe metformin alongside GLP-1 receptor agonists or SGLT2 inhibitors for my patients at highest cardiovascular risk.

The updated ESC guidance also explicitly reminds healthcare professionals to look for significant comorbidities, such as heart failure of all subtypes and chronic kidney disease.

The ESC guidance recommends a systematic survey for heart failure symptoms and signs at each clinical encounter in all patients with type 2 diabetes. Although I agree that heart failure is underdiagnosed in this population, the recommendation will be challenging to implement and has significant workload implications, as heart failure often presents in insidious, nonspecific ways in primary care.

For patients with type 2 diabetes and heart failure with reduced ejection fraction, SGLT2 inhibitors are recommended to reduce the risk for heart failure hospitalization and cardiovascular death. Again, this recommendation is independent of glycemic control. In addition, for patients with type 2 diabetes and heart failure with mid-range ejection fraction or heart failure with preserved ejection fraction (that is, left ventricular ejection fraction > 40%), SGLT2 inhibitors are also recommended to reduce the risk for heart failure hospitalization or cardiovascular death independent of glycemic control. This recommendation is consistent with other updated global heart failure guidance. Increasingly, the pillars of heart failure therapy are being challenged with the early initiation of SGLT2 inhibitors, given their compelling evidence base, early symptomatic benefit, and ease of use, with less requirement of routine blood monitoring.

Finally, for patients with type 2 diabetes and chronic kidney disease, SGLT2 inhibitors and finerenone are now recommended to reduce the risk for kidney failure and cardiovascular disease, independent of glycemic control and in addition to standard of care.

Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist with quite different pharmacokinetics and clinical effects, compared with those of spironolactone and eplerenone, which are steroidal MRAs. Specifically, finerenone does not significantly lower blood pressure and has fewer steroid-induced adverse effects such as gynecomastia, impotence, and low libido. However, like steroidal MRAs, finerenone can result in hyperkalemia.

Finerenone has demonstrated significant kidney and cardiovascular benefits across the spectrum of chronic kidney disease in patients with type 2 diabetes. It entails no significant imbalance in adverse events, hence this recommendation. This observation reinforces the importance of measuring urinary albumin–creatinine ratio in patients with type 2 diabetes and preserved kidney function.

In conclusion, the 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes are forward-thinking recommendations. They look beyond glycemia and reflect the current evidence for newer glucose-lowering therapies with proven cardiorenal benefits. Nevertheless, the implementation of these guidelines will be challenging, given their workload implications, the unstable supply of GLP-1 receptor agonists, and a persisting glucocentric approach to type 2 diabetes care in some areas. Implementation will require ongoing education for health care professionals about the risk-benefit ratios of SGLT2 inhibitors and GLP-1 receptor agonists. It also will require a re-evaluation of workforce strategy to support the development of a skilled and sustainable workforce.

Dr. Fernando is a general practitioner partner with North Berwick (Scotland) Health Centre, with a specialist interest in diabetes; cardiovascular, renal, and metabolic diseases; and medical education. He disclosed receiving speakers’ fees from Eli Lilly and Novo Nordisk.

A version of this article appeared on Medscape.com.

A significant mortality gap persists between patients with type 2 diabetes and cardiovascular disease and similarly aged patients with neither condition. Data from the Emerging Risk Factors Collaboration showed that on average, a 60-year-old female patient with type 2 diabetes and a history of myocardial infarction dies around 14 years earlier than a similarly aged patient with neither of these conditions.

Therefore, I was keen to hear the key new recommendations from the 2023 European Society of Cardiology (ESC) guidelines for the management of cardiovascular disease in patients with diabetes. These recommendations were presented at the recent ESC 2023 congress in Amsterdam, which I was fortunate enough to attend.

The comprehensive guideline cemented the fact that our primary goal in type 2 diabetes management is a reduction in cardiovascular events and mortality, rather than the glucocentric goals that have been followed previously. Of course, good glycemic control remains important to protect against the microvascular complications of diabetes, but glycemic control has only a modest impact on macrovascular complications such as cardiovascular disease.

The updated guideline recommends that all patients with type 2 diabetes without symptomatic atherosclerotic cardiovascular disease or severe target-organ damage be screened for the risk for cardiovascular disease using a new 10-year cardiovascular risk calculator called SCORE2-Diabetes. This calculator extends the well-established SCORE2 cardiovascular risk-prediction tool with added predictors specifically related to type 2 diabetes. It also accounts for variation in risk across Europe.

Using SCORE2 Diabetes will be a change in practice for me, as I have been using QRISK3, which is a United Kingdom–based cardiovascular risk tool that has been less extensively validated in patients with type 2 diabetes. Helpfully, an ESC CVD Risk Calculation app is available and can be tailored to your geographical region to calculate a SCORE2-Diabetes risk score easily. For example, Eastern Europe has a higher cardiovascular risk profile than Western Europe.

Cardiovascular risk categories are now defined on the basis of the presence of atherosclerotic cardiovascular disease, severe target-organ damage, or the 10-year cardiovascular risk using SCORE2-Diabetes.

For patients at very high cardiovascular risk (for example, those with type 2 diabetes and established atherosclerotic cardiovascular disease), the ESC guidance recommends dual therapy with a GLP-1 receptor agonist and an SGLT2 inhibitor to reduce cardiovascular risk independent of glucose control (that is, A1c). This dual therapy is recommended in addition to standard-of-care antiplatelet, antihypertensive, and lipid-lowering therapies.

There is no doubt that the evidence for GLP-1 receptor agonist use and reduction in atherosclerotic cardiovascular disease in type 2 diabetes is compelling, perhaps more so than the evidence for SGLT2 inhibitor use. However, this recommendation will be challenging to implement, given the current global supply issues with GLP-1 receptor agonists, which are driven by the off-label use of these medications for the management of obesity. GLP-1 receptor agonist supplies are not expected to stabilize until mid-2024.

Controversially, the updated ESC guidance suggests the use of metformin only in patients with type 2 diabetes and atherosclerotic cardiovascular disease if additional glucose control is required. This is a misstep, in my opinion, as insulin resistance is one of the key pathophysiologic abnormalities in patients with type 2 diabetes. One of the key advantages of metformin is an improvement in insulin sensitivity. This recommendation will not change my practice, and I will continue to prescribe metformin alongside GLP-1 receptor agonists or SGLT2 inhibitors for my patients at highest cardiovascular risk.

The updated ESC guidance also explicitly reminds healthcare professionals to look for significant comorbidities, such as heart failure of all subtypes and chronic kidney disease.

The ESC guidance recommends a systematic survey for heart failure symptoms and signs at each clinical encounter in all patients with type 2 diabetes. Although I agree that heart failure is underdiagnosed in this population, the recommendation will be challenging to implement and has significant workload implications, as heart failure often presents in insidious, nonspecific ways in primary care.

For patients with type 2 diabetes and heart failure with reduced ejection fraction, SGLT2 inhibitors are recommended to reduce the risk for heart failure hospitalization and cardiovascular death. Again, this recommendation is independent of glycemic control. In addition, for patients with type 2 diabetes and heart failure with mid-range ejection fraction or heart failure with preserved ejection fraction (that is, left ventricular ejection fraction > 40%), SGLT2 inhibitors are also recommended to reduce the risk for heart failure hospitalization or cardiovascular death independent of glycemic control. This recommendation is consistent with other updated global heart failure guidance. Increasingly, the pillars of heart failure therapy are being challenged with the early initiation of SGLT2 inhibitors, given their compelling evidence base, early symptomatic benefit, and ease of use, with less requirement of routine blood monitoring.

Finally, for patients with type 2 diabetes and chronic kidney disease, SGLT2 inhibitors and finerenone are now recommended to reduce the risk for kidney failure and cardiovascular disease, independent of glycemic control and in addition to standard of care.

Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist with quite different pharmacokinetics and clinical effects, compared with those of spironolactone and eplerenone, which are steroidal MRAs. Specifically, finerenone does not significantly lower blood pressure and has fewer steroid-induced adverse effects such as gynecomastia, impotence, and low libido. However, like steroidal MRAs, finerenone can result in hyperkalemia.

Finerenone has demonstrated significant kidney and cardiovascular benefits across the spectrum of chronic kidney disease in patients with type 2 diabetes. It entails no significant imbalance in adverse events, hence this recommendation. This observation reinforces the importance of measuring urinary albumin–creatinine ratio in patients with type 2 diabetes and preserved kidney function.

In conclusion, the 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes are forward-thinking recommendations. They look beyond glycemia and reflect the current evidence for newer glucose-lowering therapies with proven cardiorenal benefits. Nevertheless, the implementation of these guidelines will be challenging, given their workload implications, the unstable supply of GLP-1 receptor agonists, and a persisting glucocentric approach to type 2 diabetes care in some areas. Implementation will require ongoing education for health care professionals about the risk-benefit ratios of SGLT2 inhibitors and GLP-1 receptor agonists. It also will require a re-evaluation of workforce strategy to support the development of a skilled and sustainable workforce.

Dr. Fernando is a general practitioner partner with North Berwick (Scotland) Health Centre, with a specialist interest in diabetes; cardiovascular, renal, and metabolic diseases; and medical education. He disclosed receiving speakers’ fees from Eli Lilly and Novo Nordisk.

A version of this article appeared on Medscape.com.

A significant mortality gap persists between patients with type 2 diabetes and cardiovascular disease and similarly aged patients with neither condition. Data from the Emerging Risk Factors Collaboration showed that on average, a 60-year-old female patient with type 2 diabetes and a history of myocardial infarction dies around 14 years earlier than a similarly aged patient with neither of these conditions.

Therefore, I was keen to hear the key new recommendations from the 2023 European Society of Cardiology (ESC) guidelines for the management of cardiovascular disease in patients with diabetes. These recommendations were presented at the recent ESC 2023 congress in Amsterdam, which I was fortunate enough to attend.

The comprehensive guideline cemented the fact that our primary goal in type 2 diabetes management is a reduction in cardiovascular events and mortality, rather than the glucocentric goals that have been followed previously. Of course, good glycemic control remains important to protect against the microvascular complications of diabetes, but glycemic control has only a modest impact on macrovascular complications such as cardiovascular disease.

The updated guideline recommends that all patients with type 2 diabetes without symptomatic atherosclerotic cardiovascular disease or severe target-organ damage be screened for the risk for cardiovascular disease using a new 10-year cardiovascular risk calculator called SCORE2-Diabetes. This calculator extends the well-established SCORE2 cardiovascular risk-prediction tool with added predictors specifically related to type 2 diabetes. It also accounts for variation in risk across Europe.

Using SCORE2 Diabetes will be a change in practice for me, as I have been using QRISK3, which is a United Kingdom–based cardiovascular risk tool that has been less extensively validated in patients with type 2 diabetes. Helpfully, an ESC CVD Risk Calculation app is available and can be tailored to your geographical region to calculate a SCORE2-Diabetes risk score easily. For example, Eastern Europe has a higher cardiovascular risk profile than Western Europe.

Cardiovascular risk categories are now defined on the basis of the presence of atherosclerotic cardiovascular disease, severe target-organ damage, or the 10-year cardiovascular risk using SCORE2-Diabetes.

For patients at very high cardiovascular risk (for example, those with type 2 diabetes and established atherosclerotic cardiovascular disease), the ESC guidance recommends dual therapy with a GLP-1 receptor agonist and an SGLT2 inhibitor to reduce cardiovascular risk independent of glucose control (that is, A1c). This dual therapy is recommended in addition to standard-of-care antiplatelet, antihypertensive, and lipid-lowering therapies.

There is no doubt that the evidence for GLP-1 receptor agonist use and reduction in atherosclerotic cardiovascular disease in type 2 diabetes is compelling, perhaps more so than the evidence for SGLT2 inhibitor use. However, this recommendation will be challenging to implement, given the current global supply issues with GLP-1 receptor agonists, which are driven by the off-label use of these medications for the management of obesity. GLP-1 receptor agonist supplies are not expected to stabilize until mid-2024.

Controversially, the updated ESC guidance suggests the use of metformin only in patients with type 2 diabetes and atherosclerotic cardiovascular disease if additional glucose control is required. This is a misstep, in my opinion, as insulin resistance is one of the key pathophysiologic abnormalities in patients with type 2 diabetes. One of the key advantages of metformin is an improvement in insulin sensitivity. This recommendation will not change my practice, and I will continue to prescribe metformin alongside GLP-1 receptor agonists or SGLT2 inhibitors for my patients at highest cardiovascular risk.

The updated ESC guidance also explicitly reminds healthcare professionals to look for significant comorbidities, such as heart failure of all subtypes and chronic kidney disease.

The ESC guidance recommends a systematic survey for heart failure symptoms and signs at each clinical encounter in all patients with type 2 diabetes. Although I agree that heart failure is underdiagnosed in this population, the recommendation will be challenging to implement and has significant workload implications, as heart failure often presents in insidious, nonspecific ways in primary care.

For patients with type 2 diabetes and heart failure with reduced ejection fraction, SGLT2 inhibitors are recommended to reduce the risk for heart failure hospitalization and cardiovascular death. Again, this recommendation is independent of glycemic control. In addition, for patients with type 2 diabetes and heart failure with mid-range ejection fraction or heart failure with preserved ejection fraction (that is, left ventricular ejection fraction > 40%), SGLT2 inhibitors are also recommended to reduce the risk for heart failure hospitalization or cardiovascular death independent of glycemic control. This recommendation is consistent with other updated global heart failure guidance. Increasingly, the pillars of heart failure therapy are being challenged with the early initiation of SGLT2 inhibitors, given their compelling evidence base, early symptomatic benefit, and ease of use, with less requirement of routine blood monitoring.

Finally, for patients with type 2 diabetes and chronic kidney disease, SGLT2 inhibitors and finerenone are now recommended to reduce the risk for kidney failure and cardiovascular disease, independent of glycemic control and in addition to standard of care.

Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist with quite different pharmacokinetics and clinical effects, compared with those of spironolactone and eplerenone, which are steroidal MRAs. Specifically, finerenone does not significantly lower blood pressure and has fewer steroid-induced adverse effects such as gynecomastia, impotence, and low libido. However, like steroidal MRAs, finerenone can result in hyperkalemia.

Finerenone has demonstrated significant kidney and cardiovascular benefits across the spectrum of chronic kidney disease in patients with type 2 diabetes. It entails no significant imbalance in adverse events, hence this recommendation. This observation reinforces the importance of measuring urinary albumin–creatinine ratio in patients with type 2 diabetes and preserved kidney function.

In conclusion, the 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes are forward-thinking recommendations. They look beyond glycemia and reflect the current evidence for newer glucose-lowering therapies with proven cardiorenal benefits. Nevertheless, the implementation of these guidelines will be challenging, given their workload implications, the unstable supply of GLP-1 receptor agonists, and a persisting glucocentric approach to type 2 diabetes care in some areas. Implementation will require ongoing education for health care professionals about the risk-benefit ratios of SGLT2 inhibitors and GLP-1 receptor agonists. It also will require a re-evaluation of workforce strategy to support the development of a skilled and sustainable workforce.

Dr. Fernando is a general practitioner partner with North Berwick (Scotland) Health Centre, with a specialist interest in diabetes; cardiovascular, renal, and metabolic diseases; and medical education. He disclosed receiving speakers’ fees from Eli Lilly and Novo Nordisk.

A version of this article appeared on Medscape.com.

TOPLINE:

The drug mirabegron, used to treat overactive bladder disease, when added to standard treatment did not improve either left ventricular mass index or diastolic function over 12 months among patients with pre–heart failure (pre-HF) structural heart disease who were at risk of developing or worsening HF.

METHODOLOGY:

• Interventions for patients with asymptomatic pre-HF may be important in reducing the incidence of clinically overt HF, including HF with preserved ejection fraction (HFpEF).
• Mirabegron activates the cardiac beta-3 adrenergic receptor, which may offer an alternative activation of the cyclic guanosine monophosphate protein/kinase G (cGMP/PKG) pathway for patients at risk of or with mild HF and protect against worsening left ventricular hypertrophy (LVH) and/or diastolic dysfunction, but few clinical trials have evaluated the effect of mirabegron on cardiovascular outcomes.
• The phase 2b Beta3_LVH trial included 296 patients, some with and some without HF symptoms (mean age, 63 years), at 10 centers in Europe and the United Kingdom. All had an increased LV mass index (LVMI) (≥ 115 g/m² for men and ≥ 95 g/m² for women) or end-diastolic wall thickness of ≥ 13 mm in at least one wall segment.
• Patients, many of whom had risk factors, including hypertension, and were receiving cardiovascular therapies, were randomly assigned to receive mirabegron 50 mg/day or placebo and underwent various tests, including cardiac MRI, Doppler echocardiography, and urine and blood sampling for fasting glucose, insulin, hemoglobin A1c, serum lipids, and other measures.
• The two primary endpoints were change in left ventricular mass index (LVMI), expressed in grams per meters squared, and change in diastolic function, assessed as the ratio of peak early transmitral ventricular filling velocity to early diastolic tissue Doppler velocity (E/e´).

TAKEAWAY:

• Neither primary outcome reached statistical significance at 12 months; adjusted differences between groups included a 1.3g/m² increase in LVMI (95% confidence interval, −0.15 to 2.74; P = .08) and a −0.15 decrease in E/e´ (95% CI, −0.69 to 0.4; P = .60).
• There was no statistically significant effect of mirabegron, in comparison with placebo, on lipids, glycemic control, or insulin sensitivity.
• The effect of mirabegron remained neutral in exploratory subgroup analyses, including age (≤ 65 years or > 65 years at baseline), sex (men or women), body mass index (≤ 30 kg/m² or > 30 at baseline), presence of type 2 diabetes, atrial fibrillation, beta-blocker use, and geographic region.
• There were no deaths. There was a total of 428 adverse events (AEs), but there were no statistically significant between-group differences in the occurrence of these AEs.

IN PRACTICE:

While this study showed that mirabegron had a neutral effect on LV mass and diastolic function for patients with pre-HF or mild HF, the researchers suggest that longer-term effects of beta-3 adrenergic stimulation on myocardial remodeling and function “need to be tested in patients with established HFpEF, including with recent, more potent agonists.”

SOURCE:

The study was conducted by Jean-Luc Balligand, MD, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, and colleagues. It was published online in JAMA Cardiology.

LIMITATIONS:

Inclusion of patients with mild HF and use of a single standard mirabegron dosage (50 mg/day) may have prevented detection of a treatment effect. More advanced techniques than measurements of E/e´, such as cardiac strain, may have been better for assessing early changes in diastolic function. Although missing data and dropouts were relatively infrequent and were compensated for in the study, these remain limitations.

DISCLOSURES:

The study was funded by European Commission Horizon 2020 Framework Programme. Dr. Balligand reported receiving grants from the European Commission during the conduct of the study, grants from Novartis and Daiichi Sankyo outside the submitted work, and consulting fees from Amgen, Novartis, and Daiichi Sankyo outside the submitted work; he also reported being a minor shareholder of Spinovit and serving as a board member for the Wallonia Health and Biotech Cluster, Biowin, and the AstraZeneca Foundation.

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

TOPLINE:

The drug mirabegron, used to treat overactive bladder disease, when added to standard treatment did not improve either left ventricular mass index or diastolic function over 12 months among patients with pre–heart failure (pre-HF) structural heart disease who were at risk of developing or worsening HF.

METHODOLOGY:

• Interventions for patients with asymptomatic pre-HF may be important in reducing the incidence of clinically overt HF, including HF with preserved ejection fraction (HFpEF).
• Mirabegron activates the cardiac beta-3 adrenergic receptor, which may offer an alternative activation of the cyclic guanosine monophosphate protein/kinase G (cGMP/PKG) pathway for patients at risk of or with mild HF and protect against worsening left ventricular hypertrophy (LVH) and/or diastolic dysfunction, but few clinical trials have evaluated the effect of mirabegron on cardiovascular outcomes.
• The phase 2b Beta3_LVH trial included 296 patients, some with and some without HF symptoms (mean age, 63 years), at 10 centers in Europe and the United Kingdom. All had an increased LV mass index (LVMI) (≥ 115 g/m² for men and ≥ 95 g/m² for women) or end-diastolic wall thickness of ≥ 13 mm in at least one wall segment.
• Patients, many of whom had risk factors, including hypertension, and were receiving cardiovascular therapies, were randomly assigned to receive mirabegron 50 mg/day or placebo and underwent various tests, including cardiac MRI, Doppler echocardiography, and urine and blood sampling for fasting glucose, insulin, hemoglobin A1c, serum lipids, and other measures.
• The two primary endpoints were change in left ventricular mass index (LVMI), expressed in grams per meters squared, and change in diastolic function, assessed as the ratio of peak early transmitral ventricular filling velocity to early diastolic tissue Doppler velocity (E/e´).

TAKEAWAY:

• Neither primary outcome reached statistical significance at 12 months; adjusted differences between groups included a 1.3g/m² increase in LVMI (95% confidence interval, −0.15 to 2.74; P = .08) and a −0.15 decrease in E/e´ (95% CI, −0.69 to 0.4; P = .60).
• There was no statistically significant effect of mirabegron, in comparison with placebo, on lipids, glycemic control, or insulin sensitivity.
• The effect of mirabegron remained neutral in exploratory subgroup analyses, including age (≤ 65 years or > 65 years at baseline), sex (men or women), body mass index (≤ 30 kg/m² or > 30 at baseline), presence of type 2 diabetes, atrial fibrillation, beta-blocker use, and geographic region.
• There were no deaths. There was a total of 428 adverse events (AEs), but there were no statistically significant between-group differences in the occurrence of these AEs.

IN PRACTICE:

While this study showed that mirabegron had a neutral effect on LV mass and diastolic function for patients with pre-HF or mild HF, the researchers suggest that longer-term effects of beta-3 adrenergic stimulation on myocardial remodeling and function “need to be tested in patients with established HFpEF, including with recent, more potent agonists.”

SOURCE:

The study was conducted by Jean-Luc Balligand, MD, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, and colleagues. It was published online in JAMA Cardiology.

LIMITATIONS:

Inclusion of patients with mild HF and use of a single standard mirabegron dosage (50 mg/day) may have prevented detection of a treatment effect. More advanced techniques than measurements of E/e´, such as cardiac strain, may have been better for assessing early changes in diastolic function. Although missing data and dropouts were relatively infrequent and were compensated for in the study, these remain limitations.

DISCLOSURES:

The study was funded by European Commission Horizon 2020 Framework Programme. Dr. Balligand reported receiving grants from the European Commission during the conduct of the study, grants from Novartis and Daiichi Sankyo outside the submitted work, and consulting fees from Amgen, Novartis, and Daiichi Sankyo outside the submitted work; he also reported being a minor shareholder of Spinovit and serving as a board member for the Wallonia Health and Biotech Cluster, Biowin, and the AstraZeneca Foundation.

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

TOPLINE:

The drug mirabegron, used to treat overactive bladder disease, when added to standard treatment did not improve either left ventricular mass index or diastolic function over 12 months among patients with pre–heart failure (pre-HF) structural heart disease who were at risk of developing or worsening HF.

METHODOLOGY:

• Interventions for patients with asymptomatic pre-HF may be important in reducing the incidence of clinically overt HF, including HF with preserved ejection fraction (HFpEF).
• Mirabegron activates the cardiac beta-3 adrenergic receptor, which may offer an alternative activation of the cyclic guanosine monophosphate protein/kinase G (cGMP/PKG) pathway for patients at risk of or with mild HF and protect against worsening left ventricular hypertrophy (LVH) and/or diastolic dysfunction, but few clinical trials have evaluated the effect of mirabegron on cardiovascular outcomes.
• The phase 2b Beta3_LVH trial included 296 patients, some with and some without HF symptoms (mean age, 63 years), at 10 centers in Europe and the United Kingdom. All had an increased LV mass index (LVMI) (≥ 115 g/m² for men and ≥ 95 g/m² for women) or end-diastolic wall thickness of ≥ 13 mm in at least one wall segment.
• Patients, many of whom had risk factors, including hypertension, and were receiving cardiovascular therapies, were randomly assigned to receive mirabegron 50 mg/day or placebo and underwent various tests, including cardiac MRI, Doppler echocardiography, and urine and blood sampling for fasting glucose, insulin, hemoglobin A1c, serum lipids, and other measures.
• The two primary endpoints were change in left ventricular mass index (LVMI), expressed in grams per meters squared, and change in diastolic function, assessed as the ratio of peak early transmitral ventricular filling velocity to early diastolic tissue Doppler velocity (E/e´).

TAKEAWAY:

• Neither primary outcome reached statistical significance at 12 months; adjusted differences between groups included a 1.3g/m² increase in LVMI (95% confidence interval, −0.15 to 2.74; P = .08) and a −0.15 decrease in E/e´ (95% CI, −0.69 to 0.4; P = .60).
• There was no statistically significant effect of mirabegron, in comparison with placebo, on lipids, glycemic control, or insulin sensitivity.
• The effect of mirabegron remained neutral in exploratory subgroup analyses, including age (≤ 65 years or > 65 years at baseline), sex (men or women), body mass index (≤ 30 kg/m² or > 30 at baseline), presence of type 2 diabetes, atrial fibrillation, beta-blocker use, and geographic region.
• There were no deaths. There was a total of 428 adverse events (AEs), but there were no statistically significant between-group differences in the occurrence of these AEs.

IN PRACTICE:

While this study showed that mirabegron had a neutral effect on LV mass and diastolic function for patients with pre-HF or mild HF, the researchers suggest that longer-term effects of beta-3 adrenergic stimulation on myocardial remodeling and function “need to be tested in patients with established HFpEF, including with recent, more potent agonists.”

SOURCE:

The study was conducted by Jean-Luc Balligand, MD, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, and colleagues. It was published online in JAMA Cardiology.

LIMITATIONS:

Inclusion of patients with mild HF and use of a single standard mirabegron dosage (50 mg/day) may have prevented detection of a treatment effect. More advanced techniques than measurements of E/e´, such as cardiac strain, may have been better for assessing early changes in diastolic function. Although missing data and dropouts were relatively infrequent and were compensated for in the study, these remain limitations.

DISCLOSURES:

The study was funded by European Commission Horizon 2020 Framework Programme. Dr. Balligand reported receiving grants from the European Commission during the conduct of the study, grants from Novartis and Daiichi Sankyo outside the submitted work, and consulting fees from Amgen, Novartis, and Daiichi Sankyo outside the submitted work; he also reported being a minor shareholder of Spinovit and serving as a board member for the Wallonia Health and Biotech Cluster, Biowin, and the AstraZeneca Foundation.

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

Successful catheter ablation in a recent study may have helped alleviate anxiety or depression in patients with atrial fibrillation (AFib) who had initially tested high for such psychological distress.

The finding, said the researchers, may point to an overlooked potential benefit of ablation that can be discussed with patients considering whether to have the procedure.

Importantly, the 100 adults with symptomatic paroxysmal or persistent AFib in the randomized trial weren’t blinded to treatment assignment, which was either ablation or continued medical therapy.

That leaves open the possibility that psychological distress improved in the ablation group not from any unique effect of ablation itself but because patients expected to benefit from the procedure.

The investigators acknowledged that their trial, called REMEDIAL, can’t rule out a placebo effect as part of the observed benefit. Indeed, studies suggest that there is a substantial placebo component of AFib ablation – which, notably, is usually done to make patients feel better.

But the current findings are more consistent with the conventional view that patients feel better primarily because ablation reduces the AFib causing their symptoms, the group said.

Psychological stress in the study started to fall early after the procedure and continued to decline consistently over the next 6 months (P = .006) and 12 months (P = .005), not a typical pattern for placebo, they wrote.

Moreover, the mental health benefits “correlated very strongly” with less recurrent AFib, reduced AFib burden, and withdrawal of beta-blockers and antiarrhythmic agents, outcomes that might be expected from ablation, said Jonathan M. Kalman, MBBS, PhD.

“Of course, I cannot say there is no placebo effect from having had the procedure, and maybe that something to consider,” but it’s probably not the main driver of benefit, he said in an interview. The relationship between successful AFib ablation “and improvements in physical and now mental health is overwhelming.”

Dr. Kalman, who is affiliated with Royal Melbourne Hospital, is senior author on the study, published in JAMA.

The findings add to “strong, reproducible evidence that ablation is the best way to tackle rhythm control in [AFib] populations” regardless of age, mental health status, or AFib burden, said Auroa Badin, MD, who wasn’t involved in REMEDIAL but has studied the psychological effects of arrhythmia ablation.

For example, there is “very good evidence” from CABANA and other trials that AFib ablation “considerably improves quality of life,” Dr. Badin, of OhioHealth Heart & Vascular Physicians, Columbus, said in an interview. The current study “just emphasizes that there’s also a psychological effect.”

Some of that response could be a placebo or even a nocebo effect. Most of the patients assigned to the medical arm had already been on medications that failed at rhythm control. And their management in the trial, he said, “even if you optimize it, was still drug therapy.”

Patients in the control group, therefore, could have been “disappointed” at the prospect of continued ineffective therapy in a way that influenced their outcomes. “That is another confounding factor,” Dr. Badin said.

But if the psychological results of ablation in the trial were predominantly a placebo effect, early differences in psychological test scores would not have persisted for long, certainly not for a year, he observed. Moreover, the ablation group had better test scores at 12 months than at 6 months, “indicating a likelihood of improvement over time.”

Differences between the groups would probably have been less pronounced if the control group had received a sham procedure, Dr. Badin proposed. That would potentially differentiate ablation’s clinical and placebo contributions to the outcomes.

Still, he said, any observed placebo effect in a sham-controlled trial would probably have been limited. “I think it still would have been a positive trial. It may not show the same difference, but I don’t think you would have a neutral trial just by doing a sham.”

REMEDIAL has “good data,” and its conclusions about ablation’s potential psychological benefits are “reasonable” and worth bringing up when discussing the procedure with patients, Dr. Badin said.

Indeed, psychological distress is “important and often overlooked” in patients with AFib, Dr. Kalman observed. “The dominant indication for atrial fibrillation ablation is symptomatic impact on quality of life. We should think about that broadly, about not just the physical symptoms but the impact on their mental health.”

The trial was conducted at two centers in Australia. It enrolled patients, one-third of whom were women, who were on medical management for AFib. Patients receiving treatment for severe depression were excluded. The included patients were randomly assigned to undergo catheter ablation or to continue on closely managed rhythm-control medication, with cardioversion as indicated.

Psychological distress was measured at baseline and throughout follow-up by a battery of self-administered, validated questionnaires. Baseline test scores for the two groups were similar.

Recurrence and burden of AFib were tracked primarily by daily KardiaMobile (AliveCor) ECG monitoring. A few patients were followed using already implanted cardiac rhythm devices or by 24-hour Holter monitor every 3 months, Dr. Kalman said.

Composite scores on the Hospital Anxiety and Depression Scale (HADS) at 12 months, the primary endpoint, were 7.6 and 11.8 (P = .005) for the ablation and medical groups, respectively. They were 8.2 and 11.9 (P = .006), respectively, at 6 months.

The prevalence of severe psychological distress, defined as a HADS score greater than 15, was lower in the ablation group at 6 months (14.2% vs. 34%; P = .02) and 12 months (10.2% vs. 31.9%; P = .01).

Scores on the Beck Depression Inventory–II questionnaire were also consistently and significantly better for the ablation group at 6 and at 12 months (P = .01 for both).

Monitoring picked up AFib in 47% of the ablation group and 96% of the control group (P < .001) over 12 months. Their median AFib burdens were 0% (interquartile range, 0%-3.2%) and 15.5% (IQR, 1%-46%), respectively (P < .001).

Antiarrhythmic drug use fell from a baseline of 90% to 53% 3 months after ablation and 30% at 12 months (P = .003). Use of these drugs in the control group was 89% at baseline and remained essentially the same, 85%, at 12 months.

AFib symptom severity scores were significantly lower after ablation, compared with medical management at 3, 6, and 12 months.

The observed effect of ablation on psychological stress “clearly speaks in favor of effective rhythm control, and moreover catheter ablation” and is a “novel argument” in support of catheter ablation for AFib, Julia Lurz, MD, Heart Center Leipzig (Germany) at University Leipzig, and Karl-Heinz Ladwig, MD, PhD, Technical University Munich (Germany), wrote in an editorial accompanying publication of REMEDIAL.

But the findings also “raise the question of why rhythm control was so ineffective in the medical treatment group,” they wrote.

They agreed that the randomization process itself may have had its own psychological effects. “Potential disappointment” in the medical group and “high expectations” among patients who received ablation “could have fueled the success of catheter ablation” with respect to mental health endpoints.

Dr. Kalman reported receiving grants from the National Health and Medical Research Council of Australia, Medtronic, Mooney, and Biosense Webster. Dr. Badin, Dr. Lurz, and Dr. Ladwig reported no conflicts of interest.

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

Successful catheter ablation in a recent study may have helped alleviate anxiety or depression in patients with atrial fibrillation (AFib) who had initially tested high for such psychological distress.

The finding, said the researchers, may point to an overlooked potential benefit of ablation that can be discussed with patients considering whether to have the procedure.

Importantly, the 100 adults with symptomatic paroxysmal or persistent AFib in the randomized trial weren’t blinded to treatment assignment, which was either ablation or continued medical therapy.

That leaves open the possibility that psychological distress improved in the ablation group not from any unique effect of ablation itself but because patients expected to benefit from the procedure.

The investigators acknowledged that their trial, called REMEDIAL, can’t rule out a placebo effect as part of the observed benefit. Indeed, studies suggest that there is a substantial placebo component of AFib ablation – which, notably, is usually done to make patients feel better.

But the current findings are more consistent with the conventional view that patients feel better primarily because ablation reduces the AFib causing their symptoms, the group said.

Psychological stress in the study started to fall early after the procedure and continued to decline consistently over the next 6 months (P = .006) and 12 months (P = .005), not a typical pattern for placebo, they wrote.

Moreover, the mental health benefits “correlated very strongly” with less recurrent AFib, reduced AFib burden, and withdrawal of beta-blockers and antiarrhythmic agents, outcomes that might be expected from ablation, said Jonathan M. Kalman, MBBS, PhD.

“Of course, I cannot say there is no placebo effect from having had the procedure, and maybe that something to consider,” but it’s probably not the main driver of benefit, he said in an interview. The relationship between successful AFib ablation “and improvements in physical and now mental health is overwhelming.”

Dr. Kalman, who is affiliated with Royal Melbourne Hospital, is senior author on the study, published in JAMA.

The findings add to “strong, reproducible evidence that ablation is the best way to tackle rhythm control in [AFib] populations” regardless of age, mental health status, or AFib burden, said Auroa Badin, MD, who wasn’t involved in REMEDIAL but has studied the psychological effects of arrhythmia ablation.

For example, there is “very good evidence” from CABANA and other trials that AFib ablation “considerably improves quality of life,” Dr. Badin, of OhioHealth Heart & Vascular Physicians, Columbus, said in an interview. The current study “just emphasizes that there’s also a psychological effect.”

Some of that response could be a placebo or even a nocebo effect. Most of the patients assigned to the medical arm had already been on medications that failed at rhythm control. And their management in the trial, he said, “even if you optimize it, was still drug therapy.”

Patients in the control group, therefore, could have been “disappointed” at the prospect of continued ineffective therapy in a way that influenced their outcomes. “That is another confounding factor,” Dr. Badin said.

But if the psychological results of ablation in the trial were predominantly a placebo effect, early differences in psychological test scores would not have persisted for long, certainly not for a year, he observed. Moreover, the ablation group had better test scores at 12 months than at 6 months, “indicating a likelihood of improvement over time.”

Differences between the groups would probably have been less pronounced if the control group had received a sham procedure, Dr. Badin proposed. That would potentially differentiate ablation’s clinical and placebo contributions to the outcomes.

Still, he said, any observed placebo effect in a sham-controlled trial would probably have been limited. “I think it still would have been a positive trial. It may not show the same difference, but I don’t think you would have a neutral trial just by doing a sham.”

REMEDIAL has “good data,” and its conclusions about ablation’s potential psychological benefits are “reasonable” and worth bringing up when discussing the procedure with patients, Dr. Badin said.

Indeed, psychological distress is “important and often overlooked” in patients with AFib, Dr. Kalman observed. “The dominant indication for atrial fibrillation ablation is symptomatic impact on quality of life. We should think about that broadly, about not just the physical symptoms but the impact on their mental health.”

The trial was conducted at two centers in Australia. It enrolled patients, one-third of whom were women, who were on medical management for AFib. Patients receiving treatment for severe depression were excluded. The included patients were randomly assigned to undergo catheter ablation or to continue on closely managed rhythm-control medication, with cardioversion as indicated.

Psychological distress was measured at baseline and throughout follow-up by a battery of self-administered, validated questionnaires. Baseline test scores for the two groups were similar.

Recurrence and burden of AFib were tracked primarily by daily KardiaMobile (AliveCor) ECG monitoring. A few patients were followed using already implanted cardiac rhythm devices or by 24-hour Holter monitor every 3 months, Dr. Kalman said.

Composite scores on the Hospital Anxiety and Depression Scale (HADS) at 12 months, the primary endpoint, were 7.6 and 11.8 (P = .005) for the ablation and medical groups, respectively. They were 8.2 and 11.9 (P = .006), respectively, at 6 months.

The prevalence of severe psychological distress, defined as a HADS score greater than 15, was lower in the ablation group at 6 months (14.2% vs. 34%; P = .02) and 12 months (10.2% vs. 31.9%; P = .01).

Scores on the Beck Depression Inventory–II questionnaire were also consistently and significantly better for the ablation group at 6 and at 12 months (P = .01 for both).

Monitoring picked up AFib in 47% of the ablation group and 96% of the control group (P < .001) over 12 months. Their median AFib burdens were 0% (interquartile range, 0%-3.2%) and 15.5% (IQR, 1%-46%), respectively (P < .001).

Antiarrhythmic drug use fell from a baseline of 90% to 53% 3 months after ablation and 30% at 12 months (P = .003). Use of these drugs in the control group was 89% at baseline and remained essentially the same, 85%, at 12 months.

AFib symptom severity scores were significantly lower after ablation, compared with medical management at 3, 6, and 12 months.

The observed effect of ablation on psychological stress “clearly speaks in favor of effective rhythm control, and moreover catheter ablation” and is a “novel argument” in support of catheter ablation for AFib, Julia Lurz, MD, Heart Center Leipzig (Germany) at University Leipzig, and Karl-Heinz Ladwig, MD, PhD, Technical University Munich (Germany), wrote in an editorial accompanying publication of REMEDIAL.

But the findings also “raise the question of why rhythm control was so ineffective in the medical treatment group,” they wrote.

They agreed that the randomization process itself may have had its own psychological effects. “Potential disappointment” in the medical group and “high expectations” among patients who received ablation “could have fueled the success of catheter ablation” with respect to mental health endpoints.

Dr. Kalman reported receiving grants from the National Health and Medical Research Council of Australia, Medtronic, Mooney, and Biosense Webster. Dr. Badin, Dr. Lurz, and Dr. Ladwig reported no conflicts of interest.

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

Successful catheter ablation in a recent study may have helped alleviate anxiety or depression in patients with atrial fibrillation (AFib) who had initially tested high for such psychological distress.

The finding, said the researchers, may point to an overlooked potential benefit of ablation that can be discussed with patients considering whether to have the procedure.

Importantly, the 100 adults with symptomatic paroxysmal or persistent AFib in the randomized trial weren’t blinded to treatment assignment, which was either ablation or continued medical therapy.

That leaves open the possibility that psychological distress improved in the ablation group not from any unique effect of ablation itself but because patients expected to benefit from the procedure.

The investigators acknowledged that their trial, called REMEDIAL, can’t rule out a placebo effect as part of the observed benefit. Indeed, studies suggest that there is a substantial placebo component of AFib ablation – which, notably, is usually done to make patients feel better.

But the current findings are more consistent with the conventional view that patients feel better primarily because ablation reduces the AFib causing their symptoms, the group said.

Psychological stress in the study started to fall early after the procedure and continued to decline consistently over the next 6 months (P = .006) and 12 months (P = .005), not a typical pattern for placebo, they wrote.

Moreover, the mental health benefits “correlated very strongly” with less recurrent AFib, reduced AFib burden, and withdrawal of beta-blockers and antiarrhythmic agents, outcomes that might be expected from ablation, said Jonathan M. Kalman, MBBS, PhD.

“Of course, I cannot say there is no placebo effect from having had the procedure, and maybe that something to consider,” but it’s probably not the main driver of benefit, he said in an interview. The relationship between successful AFib ablation “and improvements in physical and now mental health is overwhelming.”

Dr. Kalman, who is affiliated with Royal Melbourne Hospital, is senior author on the study, published in JAMA.

The findings add to “strong, reproducible evidence that ablation is the best way to tackle rhythm control in [AFib] populations” regardless of age, mental health status, or AFib burden, said Auroa Badin, MD, who wasn’t involved in REMEDIAL but has studied the psychological effects of arrhythmia ablation.

For example, there is “very good evidence” from CABANA and other trials that AFib ablation “considerably improves quality of life,” Dr. Badin, of OhioHealth Heart & Vascular Physicians, Columbus, said in an interview. The current study “just emphasizes that there’s also a psychological effect.”

Some of that response could be a placebo or even a nocebo effect. Most of the patients assigned to the medical arm had already been on medications that failed at rhythm control. And their management in the trial, he said, “even if you optimize it, was still drug therapy.”

Patients in the control group, therefore, could have been “disappointed” at the prospect of continued ineffective therapy in a way that influenced their outcomes. “That is another confounding factor,” Dr. Badin said.

But if the psychological results of ablation in the trial were predominantly a placebo effect, early differences in psychological test scores would not have persisted for long, certainly not for a year, he observed. Moreover, the ablation group had better test scores at 12 months than at 6 months, “indicating a likelihood of improvement over time.”

Differences between the groups would probably have been less pronounced if the control group had received a sham procedure, Dr. Badin proposed. That would potentially differentiate ablation’s clinical and placebo contributions to the outcomes.

Still, he said, any observed placebo effect in a sham-controlled trial would probably have been limited. “I think it still would have been a positive trial. It may not show the same difference, but I don’t think you would have a neutral trial just by doing a sham.”

REMEDIAL has “good data,” and its conclusions about ablation’s potential psychological benefits are “reasonable” and worth bringing up when discussing the procedure with patients, Dr. Badin said.

Indeed, psychological distress is “important and often overlooked” in patients with AFib, Dr. Kalman observed. “The dominant indication for atrial fibrillation ablation is symptomatic impact on quality of life. We should think about that broadly, about not just the physical symptoms but the impact on their mental health.”

The trial was conducted at two centers in Australia. It enrolled patients, one-third of whom were women, who were on medical management for AFib. Patients receiving treatment for severe depression were excluded. The included patients were randomly assigned to undergo catheter ablation or to continue on closely managed rhythm-control medication, with cardioversion as indicated.

Psychological distress was measured at baseline and throughout follow-up by a battery of self-administered, validated questionnaires. Baseline test scores for the two groups were similar.

Recurrence and burden of AFib were tracked primarily by daily KardiaMobile (AliveCor) ECG monitoring. A few patients were followed using already implanted cardiac rhythm devices or by 24-hour Holter monitor every 3 months, Dr. Kalman said.

Composite scores on the Hospital Anxiety and Depression Scale (HADS) at 12 months, the primary endpoint, were 7.6 and 11.8 (P = .005) for the ablation and medical groups, respectively. They were 8.2 and 11.9 (P = .006), respectively, at 6 months.

The prevalence of severe psychological distress, defined as a HADS score greater than 15, was lower in the ablation group at 6 months (14.2% vs. 34%; P = .02) and 12 months (10.2% vs. 31.9%; P = .01).

Scores on the Beck Depression Inventory–II questionnaire were also consistently and significantly better for the ablation group at 6 and at 12 months (P = .01 for both).

Monitoring picked up AFib in 47% of the ablation group and 96% of the control group (P < .001) over 12 months. Their median AFib burdens were 0% (interquartile range, 0%-3.2%) and 15.5% (IQR, 1%-46%), respectively (P < .001).

Antiarrhythmic drug use fell from a baseline of 90% to 53% 3 months after ablation and 30% at 12 months (P = .003). Use of these drugs in the control group was 89% at baseline and remained essentially the same, 85%, at 12 months.

AFib symptom severity scores were significantly lower after ablation, compared with medical management at 3, 6, and 12 months.

The observed effect of ablation on psychological stress “clearly speaks in favor of effective rhythm control, and moreover catheter ablation” and is a “novel argument” in support of catheter ablation for AFib, Julia Lurz, MD, Heart Center Leipzig (Germany) at University Leipzig, and Karl-Heinz Ladwig, MD, PhD, Technical University Munich (Germany), wrote in an editorial accompanying publication of REMEDIAL.

But the findings also “raise the question of why rhythm control was so ineffective in the medical treatment group,” they wrote.

They agreed that the randomization process itself may have had its own psychological effects. “Potential disappointment” in the medical group and “high expectations” among patients who received ablation “could have fueled the success of catheter ablation” with respect to mental health endpoints.

Dr. Kalman reported receiving grants from the National Health and Medical Research Council of Australia, Medtronic, Mooney, and Biosense Webster. Dr. Badin, Dr. Lurz, and Dr. Ladwig reported no conflicts of interest.

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

TOPLINE:

In a large cross-sectional study, nearly one-third of patients with severe psoriasis met criteria for coronary microvascular dysfunction (CMD).

METHODOLOGY:

• Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
• In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
• The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
• The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.

TAKEAWAY:

• Of the 448 patients, 141 (31.5%) showed CMD.
• Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
• An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.

IN PRACTICE:

“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.

SOURCE:

Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.

LIMITATIONS:

A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.

DISCLOSURES:

The authors reported having no relevant financial disclosures.

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

TOPLINE:

In a large cross-sectional study, nearly one-third of patients with severe psoriasis met criteria for coronary microvascular dysfunction (CMD).

METHODOLOGY:

• Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
• In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
• The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
• The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.

TAKEAWAY:

• Of the 448 patients, 141 (31.5%) showed CMD.
• Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
• An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.

IN PRACTICE:

“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.

SOURCE:

Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.

LIMITATIONS:

A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.

DISCLOSURES:

The authors reported having no relevant financial disclosures.

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

TOPLINE:

In a large cross-sectional study, nearly one-third of patients with severe psoriasis met criteria for coronary microvascular dysfunction (CMD).

METHODOLOGY:

• Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
• In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
• The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
• The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.

TAKEAWAY:

• Of the 448 patients, 141 (31.5%) showed CMD.
• Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
• An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.

IN PRACTICE:

“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.

SOURCE:

Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.

LIMITATIONS:

A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.

DISCLOSURES:

The authors reported having no relevant financial disclosures.

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

A phase 2 trial of the investigational factor XI inhibitor abelacimab, used in patients with atrial fibrillation (AFib) who are at moderate to high risk for stroke, has been stopped early due to “an overwhelming reduction” in the primary endpoint – major and clinically relevant nonmajor bleeding – in patients taking abelacimab versus those on rivaroxaban.

The announcement of topline results of the AZALEA-TIMI 71 trial was made by Anthos Therapeutics, the company developing abelacimab.

“The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant,” Marc Sabatine, MD, chair of cardiovascular medicine at Brigham and Women’s Hospital and chair of the TIMI study group, both in Boston, stated in the Anthos press release.

“With a median of 21 months of follow-up, spanning more than 2,000 patient years, AZALEA-TIMI 71 represents a landmark study confirming the promise of Factor XI inhibition as causing substantially less bleeding than a current standard-of-care,” Dr. Sabatine added.

Abelacimab is a novel, highly selective, fully human monoclonal antibody with dual inhibitory activity against factor XI and its active form, factor XIa. At the 150-mg dose given subcutaneously once monthly, the drug maintains around 98% inhibition of factor XI, in line with the benign bleeding profile of patients with genetic factor XI deficiency, the company notes.

The AZALEA-TIMI 71 study is an event-driven, randomized study comparing two blinded doses of abelacimab (90 mg or 150 mg given by subcutaneous injection once-monthly) with rivaroxaban 20 mg daily in 1,287 patients with AFib who are at moderate to high risk for stroke. Full results of the study will be presented at an upcoming scientific congress.

Patients in the rivaroxaban arm can transition to abelacimab in an extension study.

In a previous proof-of-concept study published in The New England Journal of Medicine, a single IV dose of abelacimab achieved a large reduction in venous thromboembolism versus enoxaparin in patients undergoing knee surgery.

A phase 3 trial in AFib patients is now planned. The LILAC-TIMI 76 study is an event-driven, randomized trial to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism in AFib patients who have been deemed to be unsuitable for currently available anticoagulation therapy. Patients will be randomized to receive abelacimab 150 mg subcutaneously or matching placebo once monthly. The researchers aim to enroll approximately 1,900 patients from North America, Europe, Latin America, the Middle East, and Asia.

Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics, said that, “Abelacimab embodies its promise as a hemostasis-sparing anticoagulant and represents a paradigm shift in the prevention of stroke and other thrombotic conditions.”

It is estimated that 12.1 million people in the United States will have AFib by 2030, but 40%-60% of patients with AFib are not prescribed anticoagulants today, one of the main reasons being concerns about bleeding, the company notes.

“Abelacimab has the potential to provide a game-changing treatment option for all those patients who live with the daily fear of bleeding while taking current anticoagulants,” said Leslie Lake, president of the National Blood Clot Alliance.

Abelacimab has been granted a fast-track designation by the U.S. Food and Drug Administration for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Several other Factor XI inhibitors are in development and have also shown promising results in terms of a more benign bleeding profile than current standard-of-care anticoagulants.

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

A phase 2 trial of the investigational factor XI inhibitor abelacimab, used in patients with atrial fibrillation (AFib) who are at moderate to high risk for stroke, has been stopped early due to “an overwhelming reduction” in the primary endpoint – major and clinically relevant nonmajor bleeding – in patients taking abelacimab versus those on rivaroxaban.

The announcement of topline results of the AZALEA-TIMI 71 trial was made by Anthos Therapeutics, the company developing abelacimab.

“The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant,” Marc Sabatine, MD, chair of cardiovascular medicine at Brigham and Women’s Hospital and chair of the TIMI study group, both in Boston, stated in the Anthos press release.

“With a median of 21 months of follow-up, spanning more than 2,000 patient years, AZALEA-TIMI 71 represents a landmark study confirming the promise of Factor XI inhibition as causing substantially less bleeding than a current standard-of-care,” Dr. Sabatine added.

Abelacimab is a novel, highly selective, fully human monoclonal antibody with dual inhibitory activity against factor XI and its active form, factor XIa. At the 150-mg dose given subcutaneously once monthly, the drug maintains around 98% inhibition of factor XI, in line with the benign bleeding profile of patients with genetic factor XI deficiency, the company notes.

The AZALEA-TIMI 71 study is an event-driven, randomized study comparing two blinded doses of abelacimab (90 mg or 150 mg given by subcutaneous injection once-monthly) with rivaroxaban 20 mg daily in 1,287 patients with AFib who are at moderate to high risk for stroke. Full results of the study will be presented at an upcoming scientific congress.

Patients in the rivaroxaban arm can transition to abelacimab in an extension study.

In a previous proof-of-concept study published in The New England Journal of Medicine, a single IV dose of abelacimab achieved a large reduction in venous thromboembolism versus enoxaparin in patients undergoing knee surgery.

A phase 3 trial in AFib patients is now planned. The LILAC-TIMI 76 study is an event-driven, randomized trial to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism in AFib patients who have been deemed to be unsuitable for currently available anticoagulation therapy. Patients will be randomized to receive abelacimab 150 mg subcutaneously or matching placebo once monthly. The researchers aim to enroll approximately 1,900 patients from North America, Europe, Latin America, the Middle East, and Asia.

Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics, said that, “Abelacimab embodies its promise as a hemostasis-sparing anticoagulant and represents a paradigm shift in the prevention of stroke and other thrombotic conditions.”

It is estimated that 12.1 million people in the United States will have AFib by 2030, but 40%-60% of patients with AFib are not prescribed anticoagulants today, one of the main reasons being concerns about bleeding, the company notes.

“Abelacimab has the potential to provide a game-changing treatment option for all those patients who live with the daily fear of bleeding while taking current anticoagulants,” said Leslie Lake, president of the National Blood Clot Alliance.

Abelacimab has been granted a fast-track designation by the U.S. Food and Drug Administration for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Several other Factor XI inhibitors are in development and have also shown promising results in terms of a more benign bleeding profile than current standard-of-care anticoagulants.

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

A phase 2 trial of the investigational factor XI inhibitor abelacimab, used in patients with atrial fibrillation (AFib) who are at moderate to high risk for stroke, has been stopped early due to “an overwhelming reduction” in the primary endpoint – major and clinically relevant nonmajor bleeding – in patients taking abelacimab versus those on rivaroxaban.

The announcement of topline results of the AZALEA-TIMI 71 trial was made by Anthos Therapeutics, the company developing abelacimab.

“The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant,” Marc Sabatine, MD, chair of cardiovascular medicine at Brigham and Women’s Hospital and chair of the TIMI study group, both in Boston, stated in the Anthos press release.

“With a median of 21 months of follow-up, spanning more than 2,000 patient years, AZALEA-TIMI 71 represents a landmark study confirming the promise of Factor XI inhibition as causing substantially less bleeding than a current standard-of-care,” Dr. Sabatine added.

Abelacimab is a novel, highly selective, fully human monoclonal antibody with dual inhibitory activity against factor XI and its active form, factor XIa. At the 150-mg dose given subcutaneously once monthly, the drug maintains around 98% inhibition of factor XI, in line with the benign bleeding profile of patients with genetic factor XI deficiency, the company notes.

The AZALEA-TIMI 71 study is an event-driven, randomized study comparing two blinded doses of abelacimab (90 mg or 150 mg given by subcutaneous injection once-monthly) with rivaroxaban 20 mg daily in 1,287 patients with AFib who are at moderate to high risk for stroke. Full results of the study will be presented at an upcoming scientific congress.

Patients in the rivaroxaban arm can transition to abelacimab in an extension study.

In a previous proof-of-concept study published in The New England Journal of Medicine, a single IV dose of abelacimab achieved a large reduction in venous thromboembolism versus enoxaparin in patients undergoing knee surgery.

A phase 3 trial in AFib patients is now planned. The LILAC-TIMI 76 study is an event-driven, randomized trial to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism in AFib patients who have been deemed to be unsuitable for currently available anticoagulation therapy. Patients will be randomized to receive abelacimab 150 mg subcutaneously or matching placebo once monthly. The researchers aim to enroll approximately 1,900 patients from North America, Europe, Latin America, the Middle East, and Asia.

Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics, said that, “Abelacimab embodies its promise as a hemostasis-sparing anticoagulant and represents a paradigm shift in the prevention of stroke and other thrombotic conditions.”

It is estimated that 12.1 million people in the United States will have AFib by 2030, but 40%-60% of patients with AFib are not prescribed anticoagulants today, one of the main reasons being concerns about bleeding, the company notes.

“Abelacimab has the potential to provide a game-changing treatment option for all those patients who live with the daily fear of bleeding while taking current anticoagulants,” said Leslie Lake, president of the National Blood Clot Alliance.

Abelacimab has been granted a fast-track designation by the U.S. Food and Drug Administration for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Several other Factor XI inhibitors are in development and have also shown promising results in terms of a more benign bleeding profile than current standard-of-care anticoagulants.

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

TOPLINE:

Men exposed to either job-related stress or an imbalance between the effort they put in and the rewards they reap at work have a 50% increased risk for coronary heart disease (CHD), and those facing both stressors have double the risk compared with colleagues not suffering from these stressors, new research shows. Results in women were inconclusive, suggesting a more complex relationship of these factors, the researchers noted.

METHODOLOGY:

• Evidence suggests psychosocial stressors at work, from job strain related to level of demand and control in workload and decision-making responsibilities, and an effort-reward imbalance (ERI) in areas such as salary, promotion, and job stability, increase CHD risk, with the effect of both types of stressors together possibly being especially harmful.
• The study, which included 6,465 participants in the cardiovascular component of PROQ, a Canadian prospective cohort of white-collar workers initially free of cardiovascular disease, mean age 45 years, estimated that the separate and combined effect of job strain and ERI on CHD incidence.
• Researchers used the Job Content Questionnaire to assess psychological demands and job control; various measures; scales to determine job strain, reward, and effort at work; and the sum of both effort and reward to calculate the ERI ratio.
• They assessed CHD using medico-administrative databases and an algorithm validated by medical records.

TAKEAWAY:

• After a median follow-up of 18.7 years, there were 571 and 265 incident CHD cases among men and women, respectively.
• Men with either job strain or ERI had a 49% increased risk for CHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.07-2.09), an estimate comparable to that of several lifestyle risk factors for CHD.
• Male workers facing both job strain and ERI had a 103% increased risk for CHD (HR, 2.03; 95% CI, 1.38-2.97), which is comparable to the increased risk associated with obesity.
• Associations were robust to adjustments for demographic, socioeconomic, psychosocial, personality, stressful life events, and biomedical and lifestyle factors.
• Among women, results were inconclusive because the CIs were wide enough to encompass both protective and detrimental effects, suggesting more research is needed into the complex interplay of various stressors and women’s heart health.

IN PRACTICE:

“Integrative and interdisciplinary approaches should be used to tackle psychosocial stressors at work,” the authors wrote, adding this involves “going beyond traditional modifiable individual behaviors” and should include “population-based prevention strategies taking into consideration both the individual and their work environment.” 

SOURCE:

The study was conducted by Mathilde Lavigne-Robichaud, Population Health and Optimal Health Practices Research Unit, CHU de Québec-Laval University, Quebec City, Canada. It was published online in Circulation: Cardiovascular Quality and Outcomes. 

LIMITATIONS:

There was a risk for chance associations due to multiple testing. The exposure may have changed over the course of the study. Using medical databases for CHD event definition may have led to misclassification and underestimation of outcomes. The study population is limited to white-collar workers.

DISCLOSURES:

The study received funding from the Canadian Institute of Health Research. Lavigne-Robichaud was supported by a PhD grant from les Fonds de Recherche du Québec-Santé. See paper for disclosures of other authors.

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

TOPLINE:

Men exposed to either job-related stress or an imbalance between the effort they put in and the rewards they reap at work have a 50% increased risk for coronary heart disease (CHD), and those facing both stressors have double the risk compared with colleagues not suffering from these stressors, new research shows. Results in women were inconclusive, suggesting a more complex relationship of these factors, the researchers noted.

METHODOLOGY:

• Evidence suggests psychosocial stressors at work, from job strain related to level of demand and control in workload and decision-making responsibilities, and an effort-reward imbalance (ERI) in areas such as salary, promotion, and job stability, increase CHD risk, with the effect of both types of stressors together possibly being especially harmful.
• The study, which included 6,465 participants in the cardiovascular component of PROQ, a Canadian prospective cohort of white-collar workers initially free of cardiovascular disease, mean age 45 years, estimated that the separate and combined effect of job strain and ERI on CHD incidence.
• Researchers used the Job Content Questionnaire to assess psychological demands and job control; various measures; scales to determine job strain, reward, and effort at work; and the sum of both effort and reward to calculate the ERI ratio.
• They assessed CHD using medico-administrative databases and an algorithm validated by medical records.

TAKEAWAY:

• After a median follow-up of 18.7 years, there were 571 and 265 incident CHD cases among men and women, respectively.
• Men with either job strain or ERI had a 49% increased risk for CHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.07-2.09), an estimate comparable to that of several lifestyle risk factors for CHD.
• Male workers facing both job strain and ERI had a 103% increased risk for CHD (HR, 2.03; 95% CI, 1.38-2.97), which is comparable to the increased risk associated with obesity.
• Associations were robust to adjustments for demographic, socioeconomic, psychosocial, personality, stressful life events, and biomedical and lifestyle factors.
• Among women, results were inconclusive because the CIs were wide enough to encompass both protective and detrimental effects, suggesting more research is needed into the complex interplay of various stressors and women’s heart health.

IN PRACTICE:

“Integrative and interdisciplinary approaches should be used to tackle psychosocial stressors at work,” the authors wrote, adding this involves “going beyond traditional modifiable individual behaviors” and should include “population-based prevention strategies taking into consideration both the individual and their work environment.” 

SOURCE:

The study was conducted by Mathilde Lavigne-Robichaud, Population Health and Optimal Health Practices Research Unit, CHU de Québec-Laval University, Quebec City, Canada. It was published online in Circulation: Cardiovascular Quality and Outcomes. 

LIMITATIONS:

There was a risk for chance associations due to multiple testing. The exposure may have changed over the course of the study. Using medical databases for CHD event definition may have led to misclassification and underestimation of outcomes. The study population is limited to white-collar workers.

DISCLOSURES:

The study received funding from the Canadian Institute of Health Research. Lavigne-Robichaud was supported by a PhD grant from les Fonds de Recherche du Québec-Santé. See paper for disclosures of other authors.

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

TOPLINE:

Men exposed to either job-related stress or an imbalance between the effort they put in and the rewards they reap at work have a 50% increased risk for coronary heart disease (CHD), and those facing both stressors have double the risk compared with colleagues not suffering from these stressors, new research shows. Results in women were inconclusive, suggesting a more complex relationship of these factors, the researchers noted.

METHODOLOGY:

• Evidence suggests psychosocial stressors at work, from job strain related to level of demand and control in workload and decision-making responsibilities, and an effort-reward imbalance (ERI) in areas such as salary, promotion, and job stability, increase CHD risk, with the effect of both types of stressors together possibly being especially harmful.
• The study, which included 6,465 participants in the cardiovascular component of PROQ, a Canadian prospective cohort of white-collar workers initially free of cardiovascular disease, mean age 45 years, estimated that the separate and combined effect of job strain and ERI on CHD incidence.
• Researchers used the Job Content Questionnaire to assess psychological demands and job control; various measures; scales to determine job strain, reward, and effort at work; and the sum of both effort and reward to calculate the ERI ratio.
• They assessed CHD using medico-administrative databases and an algorithm validated by medical records.

TAKEAWAY:

• After a median follow-up of 18.7 years, there were 571 and 265 incident CHD cases among men and women, respectively.
• Men with either job strain or ERI had a 49% increased risk for CHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.07-2.09), an estimate comparable to that of several lifestyle risk factors for CHD.
• Male workers facing both job strain and ERI had a 103% increased risk for CHD (HR, 2.03; 95% CI, 1.38-2.97), which is comparable to the increased risk associated with obesity.
• Associations were robust to adjustments for demographic, socioeconomic, psychosocial, personality, stressful life events, and biomedical and lifestyle factors.
• Among women, results were inconclusive because the CIs were wide enough to encompass both protective and detrimental effects, suggesting more research is needed into the complex interplay of various stressors and women’s heart health.

IN PRACTICE:

“Integrative and interdisciplinary approaches should be used to tackle psychosocial stressors at work,” the authors wrote, adding this involves “going beyond traditional modifiable individual behaviors” and should include “population-based prevention strategies taking into consideration both the individual and their work environment.” 

SOURCE:

The study was conducted by Mathilde Lavigne-Robichaud, Population Health and Optimal Health Practices Research Unit, CHU de Québec-Laval University, Quebec City, Canada. It was published online in Circulation: Cardiovascular Quality and Outcomes. 

LIMITATIONS:

There was a risk for chance associations due to multiple testing. The exposure may have changed over the course of the study. Using medical databases for CHD event definition may have led to misclassification and underestimation of outcomes. The study population is limited to white-collar workers.

DISCLOSURES:

The study received funding from the Canadian Institute of Health Research. Lavigne-Robichaud was supported by a PhD grant from les Fonds de Recherche du Québec-Santé. See paper for disclosures of other authors.

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

Multiple emerging risk factors for cardiovascular disease in women must be recognized and assessed to provide timely diagnosis and treatment, according to Dipti N. Itchhaporia, MD, an interventional cardiologist in southern California. These risk factors include pregnancy complications, autoimmune diseases, depression, breast cancer, and breast arterial calcification.

During the session titled “Cardiac Care in Women: Emerging Risk Factors” at CardioAcademic 2023, the former president of the American College of Cardiology emphasized that gender equity in care for cardiovascular disease will be achieved only when risk factors are evaluated from a gender-dependent perspective and when assessments are broadened to include novel and unrecognized risk factors, not just traditional risk factors.

Dr. Itchhaporia also remarked that women and primary care clinicians must be educated on the symptoms of heart disease so that they can be on the alert and provide patients with comprehensive treatments when necessary.

“Cardiovascular disease remains the leading cause of death in women, at least in the United States, and globally the outlook is similar,” she explained. “That’s why we need to provide our patients with guidance and carefully investigate when they experience chest pain. We need to remember that smoking and obesity pose a higher risk for cardiovascular disease in women than in men. Taking these risk factors into account will really make a difference by allowing us to provide more timely and targeted care.”

In her presentation, Dr. Itchhaporia noted that cardiovascular disease accounts for 35% of deaths in women worldwide. She reminded her audience that, according to The Lancet Women and Cardiovascular Disease Commission, heart diseases in this population remain “understudied, underrecognized, underdiagnosed, and undertreated. Furthermore, women are underrepresented in cardiovascular [clinical practice].”

She mentioned this because, despite U.S. legislation enacted between 1980 and 1990 that mandated the inclusion of women in clinical trials, women accounted for less than 39% of participants in cardiovascular clinical trials between 2010 and 2017. According to Dr. Itchhaporia, this situation limits the potential for developing tailored strategies and recommendations to treat the cardiovascular diseases affecting women.
 

Emerging risk factors

Dr. Itchhaporia pointed out that traditional risk factors have been known for many years. For example, 80% of women aged 75 years or younger have arterial hypertension. Only 29% receive adequate blood pressure control, those living with diabetes have a 45% greater risk of suffering ischemic heart disease, and obesity confers a 64% higher risk of developing ischemic heart disease in women versus 46% in men.

In addition to these factors, she noted that emerging factors must be assessed carefully. For example, women who experience pregnancy complications like gestational diabetes have a higher risk for ischemic heart disease and type 2 diabetes. Women with hypertension and preeclampsia are at a threefold higher risk of developing ischemic heart disease.

“Pregnancy can really be a major stress test for the heart, and I believe that, as health care professionals, we should all be asking women if they have had pregnancy-related complications. I don’t think that’s something we’ve been doing on a regular basis. Statistically, we know that 10%-20% of pregnant women report complications during pregnancy, and strong associations have been shown between gestational hypertension [and] preeclampsia.”

Dr. Itchhaporia explained that depression, a condition that globally affects women twice as much as men, is another emerging factor (though it has received some increased recognition). She explained that, in women, depression is a significant risk factor for developing a major adverse cardiovascular event or a combined event of cardiac death and myocardial infarction related to the target lesion and revascularization of the target lesion because of ischemia. Furthermore, women who have experienced a cardiac-related event are more likely to have depression than men.

“If we look into it in more detail, depression leads to changes in behavioral habits and physiological mechanisms,” she said. “Women living with depression are at higher risk of smoking, not exercising as much, are perhaps less careful with their hygiene, are not likely to adhere to their medications, and don’t sleep as well. All this moves them in the direction of heart disease.”

Added to these factors are autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus, where the female-to-male ratio for rheumatoid arthritis is 2½:1 and for lupus it’s 9:1. Dr. Itchhaporia explained that patients with rheumatoid arthritis are at two- to threefold greater risk for myocardial infarction and have a 50% higher risk for stroke. In the case of systemic lupus, the risk of myocardial infarction is 7-50 times greater than in the general population. She noted that cardiovascular risk calculators underestimate the burden of risk in patients with these diseases.

Lastly, she brought up breast cancer and breast arterial calcification as additional emerging risk factors. She explained that women with breast cancer are more likely to develop hypertension and diabetes, compared with women without this diagnosis. Women with hypertension or diabetes before developing breast cancer have twice the risk for heart problems after cancer.

She added that 12.7% of women screened for breast cancer have some degree of breast calcification. She explained that this occurs when calcium accumulates in the middle layer of artery walls in the breast, which is linked to aging, type 2 diabetes, or arterial hypertension and may be a marker of arterial stiffening, which is a cardiovascular disease.

“It’s extremely important to take into consideration data suggesting a strong association between breast calcifications and cardiovascular disease, independent of other known risk factors of cardiovascular disease. We need to improve our tests for detecting cardiovascular disease in women and we need to ask specific questions and not overlook these emerging factors,” she noted.
 

Improving health outcomes

Panelist María Guadalupe Parra Machuca, MD, a cardiologist in Guadalajara, Mexico, specializing in women’s heart disease, agreed that it is high time that clinical practice reflect public health policies, so that efforts to diagnose and treat cardiovascular diseases in women more effectively can transition from theory to reality.

“As physicians, we cannot allow public policy to remain outside of the reality we face,” she stressed. “We need to let it impact the decisions we make. Everything we see day to day, the things we learn at these conferences – let’s put it into practice. Otherwise, all our discussions and all the steps taken to improve care, from primary to highly specialized care and to detect and treat cardiovascular disease in women, will be nothing but rhetoric.”

Clinical cardiology specialist Victor Leal, MD, noted that, according to preliminary results from the national survey of cardiovascular risk factors in Mexican women, Mexico is no exception to these emerging risk factors for cardiovascular disease in women. More than 50% of women in Mexico have traditional risk factors, most notably hypertension, obesity, and diabetes, while hypertensive disorders of pregnancy top the list of other sex-specific risk factors.

“Not only are these factors increasing, but also having them increases the risk of a worse prognosis, leaving us with a very challenging scenario,” said Dr. Leal. “Not only do we need to educate patients about the traditional risk factors, but also about factors that might not be on our radar. We need to get women to link these factors to cardiovascular disease and to the possibility of developing much more adverse outcomes. This will reinforce our diagnosis and treatment.”

In an interview, Dr. Itchhaporia emphasized the changing face of cardiovascular disease for women, who have worse short- and long-term outcomes than men because they are not asked sex-specific questions during initial encounters and they experience greater prehospital delays.

She noted that, while experts need to raise awareness of the emerging risk factors among health care professionals, they also need to use information campaigns to make women aware of what the risks are. Then, if they experience any of the emerging risk factors, they can discuss it with their treating physicians.

“We need to assess both the traditional risk factors and the novel ones, those that are underrecognized. We need to include the history of pregnancy and complications during this period and we need to educate women about symptoms of heart disease like chest pain, difficulty breathing, and increasing fatigue,” she emphasized. “We must also provide guidance as to lifestyle, diet, and levels of physical activity and be aware of stress and symptoms of depression. Only then will we bring greater awareness to the fact that cardiovascular disease is the leading cause of death among women, and then we can reverse these trends.”

Dr. Itchhaporia, Dr. Parra, and Dr. Leal reported no relevant financial relationships.

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

Multiple emerging risk factors for cardiovascular disease in women must be recognized and assessed to provide timely diagnosis and treatment, according to Dipti N. Itchhaporia, MD, an interventional cardiologist in southern California. These risk factors include pregnancy complications, autoimmune diseases, depression, breast cancer, and breast arterial calcification.

During the session titled “Cardiac Care in Women: Emerging Risk Factors” at CardioAcademic 2023, the former president of the American College of Cardiology emphasized that gender equity in care for cardiovascular disease will be achieved only when risk factors are evaluated from a gender-dependent perspective and when assessments are broadened to include novel and unrecognized risk factors, not just traditional risk factors.

Dr. Itchhaporia also remarked that women and primary care clinicians must be educated on the symptoms of heart disease so that they can be on the alert and provide patients with comprehensive treatments when necessary.

“Cardiovascular disease remains the leading cause of death in women, at least in the United States, and globally the outlook is similar,” she explained. “That’s why we need to provide our patients with guidance and carefully investigate when they experience chest pain. We need to remember that smoking and obesity pose a higher risk for cardiovascular disease in women than in men. Taking these risk factors into account will really make a difference by allowing us to provide more timely and targeted care.”

In her presentation, Dr. Itchhaporia noted that cardiovascular disease accounts for 35% of deaths in women worldwide. She reminded her audience that, according to The Lancet Women and Cardiovascular Disease Commission, heart diseases in this population remain “understudied, underrecognized, underdiagnosed, and undertreated. Furthermore, women are underrepresented in cardiovascular [clinical practice].”

She mentioned this because, despite U.S. legislation enacted between 1980 and 1990 that mandated the inclusion of women in clinical trials, women accounted for less than 39% of participants in cardiovascular clinical trials between 2010 and 2017. According to Dr. Itchhaporia, this situation limits the potential for developing tailored strategies and recommendations to treat the cardiovascular diseases affecting women.
 

Emerging risk factors

Dr. Itchhaporia pointed out that traditional risk factors have been known for many years. For example, 80% of women aged 75 years or younger have arterial hypertension. Only 29% receive adequate blood pressure control, those living with diabetes have a 45% greater risk of suffering ischemic heart disease, and obesity confers a 64% higher risk of developing ischemic heart disease in women versus 46% in men.

In addition to these factors, she noted that emerging factors must be assessed carefully. For example, women who experience pregnancy complications like gestational diabetes have a higher risk for ischemic heart disease and type 2 diabetes. Women with hypertension and preeclampsia are at a threefold higher risk of developing ischemic heart disease.

“Pregnancy can really be a major stress test for the heart, and I believe that, as health care professionals, we should all be asking women if they have had pregnancy-related complications. I don’t think that’s something we’ve been doing on a regular basis. Statistically, we know that 10%-20% of pregnant women report complications during pregnancy, and strong associations have been shown between gestational hypertension [and] preeclampsia.”

Dr. Itchhaporia explained that depression, a condition that globally affects women twice as much as men, is another emerging factor (though it has received some increased recognition). She explained that, in women, depression is a significant risk factor for developing a major adverse cardiovascular event or a combined event of cardiac death and myocardial infarction related to the target lesion and revascularization of the target lesion because of ischemia. Furthermore, women who have experienced a cardiac-related event are more likely to have depression than men.

“If we look into it in more detail, depression leads to changes in behavioral habits and physiological mechanisms,” she said. “Women living with depression are at higher risk of smoking, not exercising as much, are perhaps less careful with their hygiene, are not likely to adhere to their medications, and don’t sleep as well. All this moves them in the direction of heart disease.”

Added to these factors are autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus, where the female-to-male ratio for rheumatoid arthritis is 2½:1 and for lupus it’s 9:1. Dr. Itchhaporia explained that patients with rheumatoid arthritis are at two- to threefold greater risk for myocardial infarction and have a 50% higher risk for stroke. In the case of systemic lupus, the risk of myocardial infarction is 7-50 times greater than in the general population. She noted that cardiovascular risk calculators underestimate the burden of risk in patients with these diseases.

Lastly, she brought up breast cancer and breast arterial calcification as additional emerging risk factors. She explained that women with breast cancer are more likely to develop hypertension and diabetes, compared with women without this diagnosis. Women with hypertension or diabetes before developing breast cancer have twice the risk for heart problems after cancer.

She added that 12.7% of women screened for breast cancer have some degree of breast calcification. She explained that this occurs when calcium accumulates in the middle layer of artery walls in the breast, which is linked to aging, type 2 diabetes, or arterial hypertension and may be a marker of arterial stiffening, which is a cardiovascular disease.

“It’s extremely important to take into consideration data suggesting a strong association between breast calcifications and cardiovascular disease, independent of other known risk factors of cardiovascular disease. We need to improve our tests for detecting cardiovascular disease in women and we need to ask specific questions and not overlook these emerging factors,” she noted.
 

Improving health outcomes

Panelist María Guadalupe Parra Machuca, MD, a cardiologist in Guadalajara, Mexico, specializing in women’s heart disease, agreed that it is high time that clinical practice reflect public health policies, so that efforts to diagnose and treat cardiovascular diseases in women more effectively can transition from theory to reality.

“As physicians, we cannot allow public policy to remain outside of the reality we face,” she stressed. “We need to let it impact the decisions we make. Everything we see day to day, the things we learn at these conferences – let’s put it into practice. Otherwise, all our discussions and all the steps taken to improve care, from primary to highly specialized care and to detect and treat cardiovascular disease in women, will be nothing but rhetoric.”

Clinical cardiology specialist Victor Leal, MD, noted that, according to preliminary results from the national survey of cardiovascular risk factors in Mexican women, Mexico is no exception to these emerging risk factors for cardiovascular disease in women. More than 50% of women in Mexico have traditional risk factors, most notably hypertension, obesity, and diabetes, while hypertensive disorders of pregnancy top the list of other sex-specific risk factors.

“Not only are these factors increasing, but also having them increases the risk of a worse prognosis, leaving us with a very challenging scenario,” said Dr. Leal. “Not only do we need to educate patients about the traditional risk factors, but also about factors that might not be on our radar. We need to get women to link these factors to cardiovascular disease and to the possibility of developing much more adverse outcomes. This will reinforce our diagnosis and treatment.”

In an interview, Dr. Itchhaporia emphasized the changing face of cardiovascular disease for women, who have worse short- and long-term outcomes than men because they are not asked sex-specific questions during initial encounters and they experience greater prehospital delays.

She noted that, while experts need to raise awareness of the emerging risk factors among health care professionals, they also need to use information campaigns to make women aware of what the risks are. Then, if they experience any of the emerging risk factors, they can discuss it with their treating physicians.

“We need to assess both the traditional risk factors and the novel ones, those that are underrecognized. We need to include the history of pregnancy and complications during this period and we need to educate women about symptoms of heart disease like chest pain, difficulty breathing, and increasing fatigue,” she emphasized. “We must also provide guidance as to lifestyle, diet, and levels of physical activity and be aware of stress and symptoms of depression. Only then will we bring greater awareness to the fact that cardiovascular disease is the leading cause of death among women, and then we can reverse these trends.”

Dr. Itchhaporia, Dr. Parra, and Dr. Leal reported no relevant financial relationships.

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

Multiple emerging risk factors for cardiovascular disease in women must be recognized and assessed to provide timely diagnosis and treatment, according to Dipti N. Itchhaporia, MD, an interventional cardiologist in southern California. These risk factors include pregnancy complications, autoimmune diseases, depression, breast cancer, and breast arterial calcification.

During the session titled “Cardiac Care in Women: Emerging Risk Factors” at CardioAcademic 2023, the former president of the American College of Cardiology emphasized that gender equity in care for cardiovascular disease will be achieved only when risk factors are evaluated from a gender-dependent perspective and when assessments are broadened to include novel and unrecognized risk factors, not just traditional risk factors.

Dr. Itchhaporia also remarked that women and primary care clinicians must be educated on the symptoms of heart disease so that they can be on the alert and provide patients with comprehensive treatments when necessary.

“Cardiovascular disease remains the leading cause of death in women, at least in the United States, and globally the outlook is similar,” she explained. “That’s why we need to provide our patients with guidance and carefully investigate when they experience chest pain. We need to remember that smoking and obesity pose a higher risk for cardiovascular disease in women than in men. Taking these risk factors into account will really make a difference by allowing us to provide more timely and targeted care.”

In her presentation, Dr. Itchhaporia noted that cardiovascular disease accounts for 35% of deaths in women worldwide. She reminded her audience that, according to The Lancet Women and Cardiovascular Disease Commission, heart diseases in this population remain “understudied, underrecognized, underdiagnosed, and undertreated. Furthermore, women are underrepresented in cardiovascular [clinical practice].”

She mentioned this because, despite U.S. legislation enacted between 1980 and 1990 that mandated the inclusion of women in clinical trials, women accounted for less than 39% of participants in cardiovascular clinical trials between 2010 and 2017. According to Dr. Itchhaporia, this situation limits the potential for developing tailored strategies and recommendations to treat the cardiovascular diseases affecting women.
 

Emerging risk factors

Dr. Itchhaporia pointed out that traditional risk factors have been known for many years. For example, 80% of women aged 75 years or younger have arterial hypertension. Only 29% receive adequate blood pressure control, those living with diabetes have a 45% greater risk of suffering ischemic heart disease, and obesity confers a 64% higher risk of developing ischemic heart disease in women versus 46% in men.

In addition to these factors, she noted that emerging factors must be assessed carefully. For example, women who experience pregnancy complications like gestational diabetes have a higher risk for ischemic heart disease and type 2 diabetes. Women with hypertension and preeclampsia are at a threefold higher risk of developing ischemic heart disease.

“Pregnancy can really be a major stress test for the heart, and I believe that, as health care professionals, we should all be asking women if they have had pregnancy-related complications. I don’t think that’s something we’ve been doing on a regular basis. Statistically, we know that 10%-20% of pregnant women report complications during pregnancy, and strong associations have been shown between gestational hypertension [and] preeclampsia.”

Dr. Itchhaporia explained that depression, a condition that globally affects women twice as much as men, is another emerging factor (though it has received some increased recognition). She explained that, in women, depression is a significant risk factor for developing a major adverse cardiovascular event or a combined event of cardiac death and myocardial infarction related to the target lesion and revascularization of the target lesion because of ischemia. Furthermore, women who have experienced a cardiac-related event are more likely to have depression than men.

“If we look into it in more detail, depression leads to changes in behavioral habits and physiological mechanisms,” she said. “Women living with depression are at higher risk of smoking, not exercising as much, are perhaps less careful with their hygiene, are not likely to adhere to their medications, and don’t sleep as well. All this moves them in the direction of heart disease.”

Added to these factors are autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus, where the female-to-male ratio for rheumatoid arthritis is 2½:1 and for lupus it’s 9:1. Dr. Itchhaporia explained that patients with rheumatoid arthritis are at two- to threefold greater risk for myocardial infarction and have a 50% higher risk for stroke. In the case of systemic lupus, the risk of myocardial infarction is 7-50 times greater than in the general population. She noted that cardiovascular risk calculators underestimate the burden of risk in patients with these diseases.

Lastly, she brought up breast cancer and breast arterial calcification as additional emerging risk factors. She explained that women with breast cancer are more likely to develop hypertension and diabetes, compared with women without this diagnosis. Women with hypertension or diabetes before developing breast cancer have twice the risk for heart problems after cancer.

She added that 12.7% of women screened for breast cancer have some degree of breast calcification. She explained that this occurs when calcium accumulates in the middle layer of artery walls in the breast, which is linked to aging, type 2 diabetes, or arterial hypertension and may be a marker of arterial stiffening, which is a cardiovascular disease.

“It’s extremely important to take into consideration data suggesting a strong association between breast calcifications and cardiovascular disease, independent of other known risk factors of cardiovascular disease. We need to improve our tests for detecting cardiovascular disease in women and we need to ask specific questions and not overlook these emerging factors,” she noted.
 

Improving health outcomes

Panelist María Guadalupe Parra Machuca, MD, a cardiologist in Guadalajara, Mexico, specializing in women’s heart disease, agreed that it is high time that clinical practice reflect public health policies, so that efforts to diagnose and treat cardiovascular diseases in women more effectively can transition from theory to reality.

“As physicians, we cannot allow public policy to remain outside of the reality we face,” she stressed. “We need to let it impact the decisions we make. Everything we see day to day, the things we learn at these conferences – let’s put it into practice. Otherwise, all our discussions and all the steps taken to improve care, from primary to highly specialized care and to detect and treat cardiovascular disease in women, will be nothing but rhetoric.”

Clinical cardiology specialist Victor Leal, MD, noted that, according to preliminary results from the national survey of cardiovascular risk factors in Mexican women, Mexico is no exception to these emerging risk factors for cardiovascular disease in women. More than 50% of women in Mexico have traditional risk factors, most notably hypertension, obesity, and diabetes, while hypertensive disorders of pregnancy top the list of other sex-specific risk factors.

“Not only are these factors increasing, but also having them increases the risk of a worse prognosis, leaving us with a very challenging scenario,” said Dr. Leal. “Not only do we need to educate patients about the traditional risk factors, but also about factors that might not be on our radar. We need to get women to link these factors to cardiovascular disease and to the possibility of developing much more adverse outcomes. This will reinforce our diagnosis and treatment.”

In an interview, Dr. Itchhaporia emphasized the changing face of cardiovascular disease for women, who have worse short- and long-term outcomes than men because they are not asked sex-specific questions during initial encounters and they experience greater prehospital delays.

She noted that, while experts need to raise awareness of the emerging risk factors among health care professionals, they also need to use information campaigns to make women aware of what the risks are. Then, if they experience any of the emerging risk factors, they can discuss it with their treating physicians.

“We need to assess both the traditional risk factors and the novel ones, those that are underrecognized. We need to include the history of pregnancy and complications during this period and we need to educate women about symptoms of heart disease like chest pain, difficulty breathing, and increasing fatigue,” she emphasized. “We must also provide guidance as to lifestyle, diet, and levels of physical activity and be aware of stress and symptoms of depression. Only then will we bring greater awareness to the fact that cardiovascular disease is the leading cause of death among women, and then we can reverse these trends.”

Dr. Itchhaporia, Dr. Parra, and Dr. Leal reported no relevant financial relationships.

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