Cardiology News

The average life expectancy in the United States is expected to drop by 2.26 years from 2019 to 2021, the sharpest decrease during that time among high-income nations, according to a new study.

The study, published in medRxiv, said U.S. life expectancy went from 78.86 years in 2019 to 76.99 years in 2020, during the thick of the global COVID-19 pandemic. Though vaccines were widely available in 2021, the U.S. life expectancy was expected to keep going down, to 76.60 years.

In “peer countries” – Austria, Belgium, Denmark, England and Wales, Finland, France, Germany, Israel, Italy, the Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Scotland, South Korea, Spain, Sweden, and Switzerland – life expectancy went down only 0.57 years from 2019 to 2020 and increased by 0.28 years in 2021, the study said. The peer countries now have a life expectancy that’s 5 years longer than in the United States.

“The fact the U.S. lost so many more lives than other high-income countries speaks not only to how we managed the pandemic, but also to more deeply rooted problems that predated the pandemic,” said Steven H. Woolf, MD, one of the study authors and a professor of family medicine and population health at Virginia Commonwealth University, Richmond, according to Reuters.

“U.S. life expectancy has been falling behind other countries since the 1980s, and the gap has widened over time, especially in the last decade.”

Lack of universal health care, income and educational inequality, and less-healthy physical and social environments helped lead to the decline in American life expectancy, according to Dr. Woolf.

The life expectancy drop from 2019 to 2020 hit Black and Hispanic people hardest, according to the study. But the drop from 2020 to 2021 affected White people the most, with average life expectancy among them going down about a third of a year.

Researchers looked at death data from the National Center for Health Statistics, the Human Mortality Database, and overseas statistical agencies. Life expectancy for 2021 was estimated “using a previously validated modeling method,” the study said.

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

The average life expectancy in the United States is expected to drop by 2.26 years from 2019 to 2021, the sharpest decrease during that time among high-income nations, according to a new study.

The study, published in medRxiv, said U.S. life expectancy went from 78.86 years in 2019 to 76.99 years in 2020, during the thick of the global COVID-19 pandemic. Though vaccines were widely available in 2021, the U.S. life expectancy was expected to keep going down, to 76.60 years.

In “peer countries” – Austria, Belgium, Denmark, England and Wales, Finland, France, Germany, Israel, Italy, the Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Scotland, South Korea, Spain, Sweden, and Switzerland – life expectancy went down only 0.57 years from 2019 to 2020 and increased by 0.28 years in 2021, the study said. The peer countries now have a life expectancy that’s 5 years longer than in the United States.

“The fact the U.S. lost so many more lives than other high-income countries speaks not only to how we managed the pandemic, but also to more deeply rooted problems that predated the pandemic,” said Steven H. Woolf, MD, one of the study authors and a professor of family medicine and population health at Virginia Commonwealth University, Richmond, according to Reuters.

“U.S. life expectancy has been falling behind other countries since the 1980s, and the gap has widened over time, especially in the last decade.”

Lack of universal health care, income and educational inequality, and less-healthy physical and social environments helped lead to the decline in American life expectancy, according to Dr. Woolf.

The life expectancy drop from 2019 to 2020 hit Black and Hispanic people hardest, according to the study. But the drop from 2020 to 2021 affected White people the most, with average life expectancy among them going down about a third of a year.

Researchers looked at death data from the National Center for Health Statistics, the Human Mortality Database, and overseas statistical agencies. Life expectancy for 2021 was estimated “using a previously validated modeling method,” the study said.

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

The average life expectancy in the United States is expected to drop by 2.26 years from 2019 to 2021, the sharpest decrease during that time among high-income nations, according to a new study.

The study, published in medRxiv, said U.S. life expectancy went from 78.86 years in 2019 to 76.99 years in 2020, during the thick of the global COVID-19 pandemic. Though vaccines were widely available in 2021, the U.S. life expectancy was expected to keep going down, to 76.60 years.

In “peer countries” – Austria, Belgium, Denmark, England and Wales, Finland, France, Germany, Israel, Italy, the Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Scotland, South Korea, Spain, Sweden, and Switzerland – life expectancy went down only 0.57 years from 2019 to 2020 and increased by 0.28 years in 2021, the study said. The peer countries now have a life expectancy that’s 5 years longer than in the United States.

“The fact the U.S. lost so many more lives than other high-income countries speaks not only to how we managed the pandemic, but also to more deeply rooted problems that predated the pandemic,” said Steven H. Woolf, MD, one of the study authors and a professor of family medicine and population health at Virginia Commonwealth University, Richmond, according to Reuters.

“U.S. life expectancy has been falling behind other countries since the 1980s, and the gap has widened over time, especially in the last decade.”

Lack of universal health care, income and educational inequality, and less-healthy physical and social environments helped lead to the decline in American life expectancy, according to Dr. Woolf.

The life expectancy drop from 2019 to 2020 hit Black and Hispanic people hardest, according to the study. But the drop from 2020 to 2021 affected White people the most, with average life expectancy among them going down about a third of a year.

Researchers looked at death data from the National Center for Health Statistics, the Human Mortality Database, and overseas statistical agencies. Life expectancy for 2021 was estimated “using a previously validated modeling method,” the study said.

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

The addition of aspirin to standard guideline management for blood pressure did not reduce the risk of cardiovascular events among adults with hypertension and controlled systolic blood pressure in a study.

The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.

In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.

The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.

“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.

The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.

The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.

In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.

An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.

The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.

Findings confirm value of preventive care

“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.

Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.

As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”

Data support shared decision-making

“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”

“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized. 

Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.

Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.

The addition of aspirin to standard guideline management for blood pressure did not reduce the risk of cardiovascular events among adults with hypertension and controlled systolic blood pressure in a study.

The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.

In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.

The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.

“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.

The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.

The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.

In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.

An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.

The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.

Findings confirm value of preventive care

“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.

Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.

As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”

Data support shared decision-making

“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”

“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized. 

Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.

Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.

The addition of aspirin to standard guideline management for blood pressure did not reduce the risk of cardiovascular events among adults with hypertension and controlled systolic blood pressure in a study.

The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.

In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.

The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.

“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.

The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.

The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.

In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.

An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.

The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.

Findings confirm value of preventive care

“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.

Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.

As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”

Data support shared decision-making

“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”

“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized. 

Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.

Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.

It may seem like déjà vu, as not much has changed regarding the rankings of top U.S. medical schools over the past 2 years.

The University of Washington, Seattle retained its ranking from the U.S. News & World Report as the top medical school for primary care for 2023. Also repeating its 2022 standing as the top medical school for research is Harvard University. Both schools ranked in the top 10 for primary care and research, with Harvard also ranking in the top spot for half of eight specialties reported.

In the primary care ranking, the top 10 schools after the University of Washington were the University of California, San Francisco; the University of Minnesota; Oregon Health and Science University; the University of North Carolina at Chapel Hill; the University of Colorado; the University of Nebraska Medical Center; the University of California, Davis; and Harvard. Three schools tied for the no. 10 slot: the University of Kansas Medical Center, the University of Massachusetts Chan Medical Center, and the University of Pittsburgh.

The top five schools with the most graduates practicing in primary care specialties are Des Moines University, Iowa (50.6%); the University of Pikeville (Ky.) (46.8%); Western University of Health Sciences, Pomona, California (46%); William Carey University College of Osteopathic Medicine, Hattiesburg, Mississippi (44.7%); and A.T. Still University of Health Sciences, Kirksville, Missouri (44.3%).
 

Best for research

When it comes to schools ranking the highest for research, the Grossman School of Medicine at New York University takes the no. 2 spot after Harvard. Three schools were tied for the no. 3 spot: Columbia University, Johns Hopkins University, and the University of California, San Francisco; and two schools for no. 6: Duke University and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. No. 8 goes to Stanford University, followed by the University of Washington. Rounding out the top 10 is Yale University.

Specialty ranks

The top-ranked schools in eight specialties are as follows:

• Anesthesiology: Harvard
• Family medicine: the University of Washington
• Internal medicine: Johns Hopkins
• Obstetrics/gynecology: Harvard
• Pediatrics: the University of Pennsylvania (Perelman)
• Psychiatry: Harvard
• Radiology: Johns Hopkins
• Surgery: Harvard

Most diverse student body

If you’re looking for a school with significant minority representation, Howard University, Washington, D.C., ranked highest (76.8%), followed by the Wertheim College of Medicine at Florida International University, Miami (43.2%). The University of California, Davis (40%), Sacramento, California, and the University of Vermont (Larner), Burlington (14.1%), tied for third.

Three southern schools take top honors for the most graduates practicing in underserved areas, starting with the University of South Carolina (70.9%), followed by the University of Mississippi (66.2%), and East Tennessee State University (Quillen), Johnson City, Tennessee (65.8%).

The colleges with the most graduates practicing in rural areas are William Carey University College of Osteopathic Medicine (28%), the University of Pikesville (25.6%), and the University of Mississippi (22.1%).
 

College debt

The medical school where graduates have the most debt is Nova Southeastern University Patel College of Osteopathic Medicine, Fort Lauderdale, Florida. Graduates incurred an average debt of $309,206. Western University of Health Sciences graduates racked up $276,840 in debt, followed by graduates of West Virginia School of Osteopathic Medicine, owing $268,416.

Ranking criteria

Each year, U.S. News ranks hundreds of U.S. colleges and universities. Medical schools fall under the rankings for best graduate schools.

U.S. News surveyed 192 medical and osteopathic schools accredited in 2021 by the Liaison Committee on Medical Education or the American Osteopathic Association. Among the schools surveyed in fall 2021 and early 2022, 130 schools responded. Of those, 124 were included in both the research and primary care rankings.

The criteria for ranking include faculty resources, academic achievements of entering students, and qualitative assessments by schools and residency directors.

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

It may seem like déjà vu, as not much has changed regarding the rankings of top U.S. medical schools over the past 2 years.

The University of Washington, Seattle retained its ranking from the U.S. News & World Report as the top medical school for primary care for 2023. Also repeating its 2022 standing as the top medical school for research is Harvard University. Both schools ranked in the top 10 for primary care and research, with Harvard also ranking in the top spot for half of eight specialties reported.

In the primary care ranking, the top 10 schools after the University of Washington were the University of California, San Francisco; the University of Minnesota; Oregon Health and Science University; the University of North Carolina at Chapel Hill; the University of Colorado; the University of Nebraska Medical Center; the University of California, Davis; and Harvard. Three schools tied for the no. 10 slot: the University of Kansas Medical Center, the University of Massachusetts Chan Medical Center, and the University of Pittsburgh.

The top five schools with the most graduates practicing in primary care specialties are Des Moines University, Iowa (50.6%); the University of Pikeville (Ky.) (46.8%); Western University of Health Sciences, Pomona, California (46%); William Carey University College of Osteopathic Medicine, Hattiesburg, Mississippi (44.7%); and A.T. Still University of Health Sciences, Kirksville, Missouri (44.3%).
 

Best for research

When it comes to schools ranking the highest for research, the Grossman School of Medicine at New York University takes the no. 2 spot after Harvard. Three schools were tied for the no. 3 spot: Columbia University, Johns Hopkins University, and the University of California, San Francisco; and two schools for no. 6: Duke University and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. No. 8 goes to Stanford University, followed by the University of Washington. Rounding out the top 10 is Yale University.

Specialty ranks

The top-ranked schools in eight specialties are as follows:

• Anesthesiology: Harvard
• Family medicine: the University of Washington
• Internal medicine: Johns Hopkins
• Obstetrics/gynecology: Harvard
• Pediatrics: the University of Pennsylvania (Perelman)
• Psychiatry: Harvard
• Radiology: Johns Hopkins
• Surgery: Harvard

Most diverse student body

If you’re looking for a school with significant minority representation, Howard University, Washington, D.C., ranked highest (76.8%), followed by the Wertheim College of Medicine at Florida International University, Miami (43.2%). The University of California, Davis (40%), Sacramento, California, and the University of Vermont (Larner), Burlington (14.1%), tied for third.

Three southern schools take top honors for the most graduates practicing in underserved areas, starting with the University of South Carolina (70.9%), followed by the University of Mississippi (66.2%), and East Tennessee State University (Quillen), Johnson City, Tennessee (65.8%).

The colleges with the most graduates practicing in rural areas are William Carey University College of Osteopathic Medicine (28%), the University of Pikesville (25.6%), and the University of Mississippi (22.1%).
 

College debt

The medical school where graduates have the most debt is Nova Southeastern University Patel College of Osteopathic Medicine, Fort Lauderdale, Florida. Graduates incurred an average debt of $309,206. Western University of Health Sciences graduates racked up $276,840 in debt, followed by graduates of West Virginia School of Osteopathic Medicine, owing $268,416.

Ranking criteria

Each year, U.S. News ranks hundreds of U.S. colleges and universities. Medical schools fall under the rankings for best graduate schools.

U.S. News surveyed 192 medical and osteopathic schools accredited in 2021 by the Liaison Committee on Medical Education or the American Osteopathic Association. Among the schools surveyed in fall 2021 and early 2022, 130 schools responded. Of those, 124 were included in both the research and primary care rankings.

The criteria for ranking include faculty resources, academic achievements of entering students, and qualitative assessments by schools and residency directors.

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

It may seem like déjà vu, as not much has changed regarding the rankings of top U.S. medical schools over the past 2 years.

The University of Washington, Seattle retained its ranking from the U.S. News & World Report as the top medical school for primary care for 2023. Also repeating its 2022 standing as the top medical school for research is Harvard University. Both schools ranked in the top 10 for primary care and research, with Harvard also ranking in the top spot for half of eight specialties reported.

In the primary care ranking, the top 10 schools after the University of Washington were the University of California, San Francisco; the University of Minnesota; Oregon Health and Science University; the University of North Carolina at Chapel Hill; the University of Colorado; the University of Nebraska Medical Center; the University of California, Davis; and Harvard. Three schools tied for the no. 10 slot: the University of Kansas Medical Center, the University of Massachusetts Chan Medical Center, and the University of Pittsburgh.

The top five schools with the most graduates practicing in primary care specialties are Des Moines University, Iowa (50.6%); the University of Pikeville (Ky.) (46.8%); Western University of Health Sciences, Pomona, California (46%); William Carey University College of Osteopathic Medicine, Hattiesburg, Mississippi (44.7%); and A.T. Still University of Health Sciences, Kirksville, Missouri (44.3%).
 

Best for research

When it comes to schools ranking the highest for research, the Grossman School of Medicine at New York University takes the no. 2 spot after Harvard. Three schools were tied for the no. 3 spot: Columbia University, Johns Hopkins University, and the University of California, San Francisco; and two schools for no. 6: Duke University and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. No. 8 goes to Stanford University, followed by the University of Washington. Rounding out the top 10 is Yale University.

Specialty ranks

The top-ranked schools in eight specialties are as follows:

• Anesthesiology: Harvard
• Family medicine: the University of Washington
• Internal medicine: Johns Hopkins
• Obstetrics/gynecology: Harvard
• Pediatrics: the University of Pennsylvania (Perelman)
• Psychiatry: Harvard
• Radiology: Johns Hopkins
• Surgery: Harvard

Most diverse student body

If you’re looking for a school with significant minority representation, Howard University, Washington, D.C., ranked highest (76.8%), followed by the Wertheim College of Medicine at Florida International University, Miami (43.2%). The University of California, Davis (40%), Sacramento, California, and the University of Vermont (Larner), Burlington (14.1%), tied for third.

Three southern schools take top honors for the most graduates practicing in underserved areas, starting with the University of South Carolina (70.9%), followed by the University of Mississippi (66.2%), and East Tennessee State University (Quillen), Johnson City, Tennessee (65.8%).

The colleges with the most graduates practicing in rural areas are William Carey University College of Osteopathic Medicine (28%), the University of Pikesville (25.6%), and the University of Mississippi (22.1%).
 

College debt

The medical school where graduates have the most debt is Nova Southeastern University Patel College of Osteopathic Medicine, Fort Lauderdale, Florida. Graduates incurred an average debt of $309,206. Western University of Health Sciences graduates racked up $276,840 in debt, followed by graduates of West Virginia School of Osteopathic Medicine, owing $268,416.

Ranking criteria

Each year, U.S. News ranks hundreds of U.S. colleges and universities. Medical schools fall under the rankings for best graduate schools.

U.S. News surveyed 192 medical and osteopathic schools accredited in 2021 by the Liaison Committee on Medical Education or the American Osteopathic Association. Among the schools surveyed in fall 2021 and early 2022, 130 schools responded. Of those, 124 were included in both the research and primary care rankings.

The criteria for ranking include faculty resources, academic achievements of entering students, and qualitative assessments by schools and residency directors.

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

WASHINGTON – Patients with type 2 diabetes and established atherosclerotic cardiovascular disease treated with both an sodium-glucose transporter 2 inhibitor and a glucagonlike peptide–1 receptor agonist had a significant 80% cut in their rate of all-cause death during 1-year follow-up, compared with matched patients treated with an agent from either class alone in an observational, retrospective study of more than 15,000 people in the U.S. Veterans Affairs health system.

For the study’s primary endpoint, the combined rate of all-cause death, nonfatal MI, or nonfatal stroke, combined treatment with both an agent from the sodium-glucose transporter 2 (SGLT2) inhibitor class and from the glucagonlike peptide–1 receptor agonist (GLP-1 RA) class linked with a significant, roughly 50% cut in events during 1-year follow-up, compared with patients treated with an agent from just one of these two classes, Persio D. Lopez, MD, reported at the annual scientific sessions of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

This improvement in the combined endpoint outcome resulted entirely from reduced all-cause mortality. Dual treatment showed no significant association with the incidence of nonfatal MIs or strokes, compared with monotherapy, with rates that were nearly identical regardless of whether patients took one of the agents or both, said Dr. Lopez, a cardiologist at Mount Sinai Morningside and the James J. Peters VA Medical Center, both in New York.
 

Combining classes for hard-to-control diabetes

“We’re not sure what drives combined use” of agents from both drug classes in these types of patients, admitted Dr. Lopez during his talk. “Our hypothesis is that dual treatment is used in patients with harder-to-control diabetes.”

Salim S. Virani, MD, PhD, who practices in the VA system but was not involved with the study, agreed that this is the likely explanation for most instances of high-risk VA patients with diabetes who receive agents from both classes.

Mitchel L. Zoler/MDedge News

“I have a few patients” on both classes, usually “patients with higher starting A1c levels who need greater glycemic control,” said Dr. Virani, professor of medicine at Baylor College of Medicine and a cardiologist at the Michael E. DeBakey VA Medical Center, both in Houston.

U.S. use of either drug class, let alone both, in patients with type 2 diabetes is still struggling to gain traction in U.S. practice and remains limited to a minority of these patients, a prescribing pattern reflected in recent VA data. Analysis of more than half a million patients in the VA system with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) who received treatment at any of 130 VA medical centers throughout 2020 showed that 11% had received an SGLT2 inhibitor, and 8% a GLP-1 RA.

The most frequently used antidiabetes drug classes in these patients were insulin in 36%, biguanides in 47%, and sulfonylureas in 22%.

These data also showed a striking level of variability among the 130 VA centers, with some of the sites prescribing either an SGLT2 inhibitor or a GLP-1 RA to as few as about 3% each of these patients, while other centers had a roughly 10-fold higher prescription rate for each of about 25%-30% of their patients with type 2 diabetes and ASCVD.

Despite the overall modest level of use of both classes in these types of patients as recently as 2020, no barriers exist at the VA to prescribing an agent from one or both classes “if you provide a good reason” for a patient to receive the drugs, Dr. Virani said in an interview. He also predicted that use of both classes in these patients, including combination treatment, will likely soon expand.
 

‘A lot of interest’ in combining an SGLT2 inhibitor and a GLP-1 RA

“There will be a lot of interest in combing the two classes. It makes intuitive sense [to treat with both classes] because most patients with diabetes need more than one drug” for glycemic control, he noted. “Why not use two classes that each reduce a patient’s risk” for adverse outcomes involving ASCVD, heart failure, and renal dysfunction, added Dr. Virani.

The study run by Dr. Lopez and his associates used data collected in the National VA Database and included 121,156 patients with both type 2 diabetes and established ASCVD. Using propensity-score matching the researchers compiled three subgroups that each included 5,277 matched patients. One subgroup had patients prescribed an SGLT2 inhibitor, a second subgroup included patients on a GLP-1 RA, and a third subgroup had patients on agents from both classes. Patient matching relied on age, sex, left ventricular ejection fraction, hemoglobin A1c level, systolic blood pressure, and the presence of coronary artery disease or peripheral artery disease.

Patients included in the analysis averaged about 67 years of age; 97% were men, their average body mass index was about 34 kg/m², their average A1c was about 7.9%, their average estimated glomerular filtration rate was about 55-66 mL/min per 1.73 m², and their average left ventricular ejection fraction was about 55%. The database provided a median follow-up of 902 days (about 2.5 years). The prespecified primary endpoint focused on events that occurred during the first year of follow-up, but the investigators also ran a 3-year follow-up analysis on a post hoc basis.

The most common SGLT2 inhibitor received by these patients was empagliflozin (Jardiance), used on virtually everyone who received an agent from this class. In contrast, the GLP-1 RA drugs that patients received split more widely. The most prescribed agent was liraglutide (Victoza), followed by semaglutide (Ozempic), and dulaglutide (Trulicity), with fewer than 5% receiving exenatide (Bydureon, Byetta).

Regarding other treatments, about 97% of all patients received a statin, about 94% were on a renin-angiotensin system inhibitor, about 90% were on metformin, and roughly 75% were on insulin, aspirin, and a beta-blocker, with smaller numbers on other types of agents.

For the study’s primary endpoint, the 1-year incidence of combined ASCVD events including all-cause death, patients on agents from both classes had a significant 46% reduced rate compared with those on an SGLT2 inhibitor only, and a significant 49% reduced rate, compared with those on a GLP-1 RA only. These between-group separations broadened slightly during 3-year follow-up. Dr. Lopez did not report results of a direct comparison between patients on just an SGLT2 inhibitor and those on just a GLP-1 RA.

For the endpoint of all-cause death, those on combined treatment had a 1-year rate that was 83% below the rate among patients on only an SGLT2 inhibitor, and 81% below the rate among patients who received a GLP-1 RA but not the other class.

Dr. Lopez cautioned that selection bias could have influenced the outcomes of patients who received both classes rather than one or the other, and he also highlighted that the analysis relied on administrative data rather than information gleaned from more detailed medical records or prospectively collected findings and was limited by only including a very small number of women.

“Our results need to be validated in prospective studies,” he declared.

Dr. Lopez and Dr. Virani had no commercial disclosures.

WASHINGTON – Patients with type 2 diabetes and established atherosclerotic cardiovascular disease treated with both an sodium-glucose transporter 2 inhibitor and a glucagonlike peptide–1 receptor agonist had a significant 80% cut in their rate of all-cause death during 1-year follow-up, compared with matched patients treated with an agent from either class alone in an observational, retrospective study of more than 15,000 people in the U.S. Veterans Affairs health system.

For the study’s primary endpoint, the combined rate of all-cause death, nonfatal MI, or nonfatal stroke, combined treatment with both an agent from the sodium-glucose transporter 2 (SGLT2) inhibitor class and from the glucagonlike peptide–1 receptor agonist (GLP-1 RA) class linked with a significant, roughly 50% cut in events during 1-year follow-up, compared with patients treated with an agent from just one of these two classes, Persio D. Lopez, MD, reported at the annual scientific sessions of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

This improvement in the combined endpoint outcome resulted entirely from reduced all-cause mortality. Dual treatment showed no significant association with the incidence of nonfatal MIs or strokes, compared with monotherapy, with rates that were nearly identical regardless of whether patients took one of the agents or both, said Dr. Lopez, a cardiologist at Mount Sinai Morningside and the James J. Peters VA Medical Center, both in New York.
 

Combining classes for hard-to-control diabetes

“We’re not sure what drives combined use” of agents from both drug classes in these types of patients, admitted Dr. Lopez during his talk. “Our hypothesis is that dual treatment is used in patients with harder-to-control diabetes.”

Salim S. Virani, MD, PhD, who practices in the VA system but was not involved with the study, agreed that this is the likely explanation for most instances of high-risk VA patients with diabetes who receive agents from both classes.

Mitchel L. Zoler/MDedge News

“I have a few patients” on both classes, usually “patients with higher starting A1c levels who need greater glycemic control,” said Dr. Virani, professor of medicine at Baylor College of Medicine and a cardiologist at the Michael E. DeBakey VA Medical Center, both in Houston.

U.S. use of either drug class, let alone both, in patients with type 2 diabetes is still struggling to gain traction in U.S. practice and remains limited to a minority of these patients, a prescribing pattern reflected in recent VA data. Analysis of more than half a million patients in the VA system with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) who received treatment at any of 130 VA medical centers throughout 2020 showed that 11% had received an SGLT2 inhibitor, and 8% a GLP-1 RA.

The most frequently used antidiabetes drug classes in these patients were insulin in 36%, biguanides in 47%, and sulfonylureas in 22%.

These data also showed a striking level of variability among the 130 VA centers, with some of the sites prescribing either an SGLT2 inhibitor or a GLP-1 RA to as few as about 3% each of these patients, while other centers had a roughly 10-fold higher prescription rate for each of about 25%-30% of their patients with type 2 diabetes and ASCVD.

Despite the overall modest level of use of both classes in these types of patients as recently as 2020, no barriers exist at the VA to prescribing an agent from one or both classes “if you provide a good reason” for a patient to receive the drugs, Dr. Virani said in an interview. He also predicted that use of both classes in these patients, including combination treatment, will likely soon expand.
 

‘A lot of interest’ in combining an SGLT2 inhibitor and a GLP-1 RA

“There will be a lot of interest in combing the two classes. It makes intuitive sense [to treat with both classes] because most patients with diabetes need more than one drug” for glycemic control, he noted. “Why not use two classes that each reduce a patient’s risk” for adverse outcomes involving ASCVD, heart failure, and renal dysfunction, added Dr. Virani.

The study run by Dr. Lopez and his associates used data collected in the National VA Database and included 121,156 patients with both type 2 diabetes and established ASCVD. Using propensity-score matching the researchers compiled three subgroups that each included 5,277 matched patients. One subgroup had patients prescribed an SGLT2 inhibitor, a second subgroup included patients on a GLP-1 RA, and a third subgroup had patients on agents from both classes. Patient matching relied on age, sex, left ventricular ejection fraction, hemoglobin A1c level, systolic blood pressure, and the presence of coronary artery disease or peripheral artery disease.

Patients included in the analysis averaged about 67 years of age; 97% were men, their average body mass index was about 34 kg/m², their average A1c was about 7.9%, their average estimated glomerular filtration rate was about 55-66 mL/min per 1.73 m², and their average left ventricular ejection fraction was about 55%. The database provided a median follow-up of 902 days (about 2.5 years). The prespecified primary endpoint focused on events that occurred during the first year of follow-up, but the investigators also ran a 3-year follow-up analysis on a post hoc basis.

The most common SGLT2 inhibitor received by these patients was empagliflozin (Jardiance), used on virtually everyone who received an agent from this class. In contrast, the GLP-1 RA drugs that patients received split more widely. The most prescribed agent was liraglutide (Victoza), followed by semaglutide (Ozempic), and dulaglutide (Trulicity), with fewer than 5% receiving exenatide (Bydureon, Byetta).

Regarding other treatments, about 97% of all patients received a statin, about 94% were on a renin-angiotensin system inhibitor, about 90% were on metformin, and roughly 75% were on insulin, aspirin, and a beta-blocker, with smaller numbers on other types of agents.

For the study’s primary endpoint, the 1-year incidence of combined ASCVD events including all-cause death, patients on agents from both classes had a significant 46% reduced rate compared with those on an SGLT2 inhibitor only, and a significant 49% reduced rate, compared with those on a GLP-1 RA only. These between-group separations broadened slightly during 3-year follow-up. Dr. Lopez did not report results of a direct comparison between patients on just an SGLT2 inhibitor and those on just a GLP-1 RA.

For the endpoint of all-cause death, those on combined treatment had a 1-year rate that was 83% below the rate among patients on only an SGLT2 inhibitor, and 81% below the rate among patients who received a GLP-1 RA but not the other class.

Dr. Lopez cautioned that selection bias could have influenced the outcomes of patients who received both classes rather than one or the other, and he also highlighted that the analysis relied on administrative data rather than information gleaned from more detailed medical records or prospectively collected findings and was limited by only including a very small number of women.

“Our results need to be validated in prospective studies,” he declared.

Dr. Lopez and Dr. Virani had no commercial disclosures.

WASHINGTON – Patients with type 2 diabetes and established atherosclerotic cardiovascular disease treated with both an sodium-glucose transporter 2 inhibitor and a glucagonlike peptide–1 receptor agonist had a significant 80% cut in their rate of all-cause death during 1-year follow-up, compared with matched patients treated with an agent from either class alone in an observational, retrospective study of more than 15,000 people in the U.S. Veterans Affairs health system.

For the study’s primary endpoint, the combined rate of all-cause death, nonfatal MI, or nonfatal stroke, combined treatment with both an agent from the sodium-glucose transporter 2 (SGLT2) inhibitor class and from the glucagonlike peptide–1 receptor agonist (GLP-1 RA) class linked with a significant, roughly 50% cut in events during 1-year follow-up, compared with patients treated with an agent from just one of these two classes, Persio D. Lopez, MD, reported at the annual scientific sessions of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

This improvement in the combined endpoint outcome resulted entirely from reduced all-cause mortality. Dual treatment showed no significant association with the incidence of nonfatal MIs or strokes, compared with monotherapy, with rates that were nearly identical regardless of whether patients took one of the agents or both, said Dr. Lopez, a cardiologist at Mount Sinai Morningside and the James J. Peters VA Medical Center, both in New York.
 

Combining classes for hard-to-control diabetes

“We’re not sure what drives combined use” of agents from both drug classes in these types of patients, admitted Dr. Lopez during his talk. “Our hypothesis is that dual treatment is used in patients with harder-to-control diabetes.”

Salim S. Virani, MD, PhD, who practices in the VA system but was not involved with the study, agreed that this is the likely explanation for most instances of high-risk VA patients with diabetes who receive agents from both classes.

Mitchel L. Zoler/MDedge News

“I have a few patients” on both classes, usually “patients with higher starting A1c levels who need greater glycemic control,” said Dr. Virani, professor of medicine at Baylor College of Medicine and a cardiologist at the Michael E. DeBakey VA Medical Center, both in Houston.

U.S. use of either drug class, let alone both, in patients with type 2 diabetes is still struggling to gain traction in U.S. practice and remains limited to a minority of these patients, a prescribing pattern reflected in recent VA data. Analysis of more than half a million patients in the VA system with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) who received treatment at any of 130 VA medical centers throughout 2020 showed that 11% had received an SGLT2 inhibitor, and 8% a GLP-1 RA.

The most frequently used antidiabetes drug classes in these patients were insulin in 36%, biguanides in 47%, and sulfonylureas in 22%.

These data also showed a striking level of variability among the 130 VA centers, with some of the sites prescribing either an SGLT2 inhibitor or a GLP-1 RA to as few as about 3% each of these patients, while other centers had a roughly 10-fold higher prescription rate for each of about 25%-30% of their patients with type 2 diabetes and ASCVD.

Despite the overall modest level of use of both classes in these types of patients as recently as 2020, no barriers exist at the VA to prescribing an agent from one or both classes “if you provide a good reason” for a patient to receive the drugs, Dr. Virani said in an interview. He also predicted that use of both classes in these patients, including combination treatment, will likely soon expand.
 

‘A lot of interest’ in combining an SGLT2 inhibitor and a GLP-1 RA

“There will be a lot of interest in combing the two classes. It makes intuitive sense [to treat with both classes] because most patients with diabetes need more than one drug” for glycemic control, he noted. “Why not use two classes that each reduce a patient’s risk” for adverse outcomes involving ASCVD, heart failure, and renal dysfunction, added Dr. Virani.

The study run by Dr. Lopez and his associates used data collected in the National VA Database and included 121,156 patients with both type 2 diabetes and established ASCVD. Using propensity-score matching the researchers compiled three subgroups that each included 5,277 matched patients. One subgroup had patients prescribed an SGLT2 inhibitor, a second subgroup included patients on a GLP-1 RA, and a third subgroup had patients on agents from both classes. Patient matching relied on age, sex, left ventricular ejection fraction, hemoglobin A1c level, systolic blood pressure, and the presence of coronary artery disease or peripheral artery disease.

Patients included in the analysis averaged about 67 years of age; 97% were men, their average body mass index was about 34 kg/m², their average A1c was about 7.9%, their average estimated glomerular filtration rate was about 55-66 mL/min per 1.73 m², and their average left ventricular ejection fraction was about 55%. The database provided a median follow-up of 902 days (about 2.5 years). The prespecified primary endpoint focused on events that occurred during the first year of follow-up, but the investigators also ran a 3-year follow-up analysis on a post hoc basis.

The most common SGLT2 inhibitor received by these patients was empagliflozin (Jardiance), used on virtually everyone who received an agent from this class. In contrast, the GLP-1 RA drugs that patients received split more widely. The most prescribed agent was liraglutide (Victoza), followed by semaglutide (Ozempic), and dulaglutide (Trulicity), with fewer than 5% receiving exenatide (Bydureon, Byetta).

Regarding other treatments, about 97% of all patients received a statin, about 94% were on a renin-angiotensin system inhibitor, about 90% were on metformin, and roughly 75% were on insulin, aspirin, and a beta-blocker, with smaller numbers on other types of agents.

For the study’s primary endpoint, the 1-year incidence of combined ASCVD events including all-cause death, patients on agents from both classes had a significant 46% reduced rate compared with those on an SGLT2 inhibitor only, and a significant 49% reduced rate, compared with those on a GLP-1 RA only. These between-group separations broadened slightly during 3-year follow-up. Dr. Lopez did not report results of a direct comparison between patients on just an SGLT2 inhibitor and those on just a GLP-1 RA.

For the endpoint of all-cause death, those on combined treatment had a 1-year rate that was 83% below the rate among patients on only an SGLT2 inhibitor, and 81% below the rate among patients who received a GLP-1 RA but not the other class.

Dr. Lopez cautioned that selection bias could have influenced the outcomes of patients who received both classes rather than one or the other, and he also highlighted that the analysis relied on administrative data rather than information gleaned from more detailed medical records or prospectively collected findings and was limited by only including a very small number of women.

“Our results need to be validated in prospective studies,” he declared.

Dr. Lopez and Dr. Virani had no commercial disclosures.

Screening for heart rhythm disorders with a smartphone app and a wearable device had a high rate of correctly detecting atrial fibrillation (AFib) in a large new study.

The mAFA II study, conducted in a mass low-risk population in China, showed that more than 93% of possible AFib episodes detected by the smartphone app were confirmed to be AFib on further monitoring.

wildpixel/iStock/Getty Images

Over the course of 4 years of the study, 12,244 (0.4%) of users received a notification of suspected AFib. Among 5,227 people who chose to follow up with a clinician, AFib was confirmed in 93.8% of patients using standard AFib diagnostic tools, including clinical evaluation, an electrocardiogram, and 24-hour Holter monitoring.

In this study, a subset of the individuals screened for AFib were also screened for signs of sleep apnea using the same PPG technology to detect physiological changes in parameters including oxygenation and respiratory rates. The app is also able to determine whether the individual is awake or asleep. Dr. Guo noted that the PPG algorithm for obstructive sleep apnea risk has been validated, compared with polysomnography or home sleep apnea tests.

Using measurements of apnea (signalled by a reduced respiratory rate) and hypopnea (when oxygenation would decrease), the apnea–hypopnea index (AHI) is calculated to determine the severity of the sleep apnea.

Of the 961,931 participants screened for sleep apnea, about 18,000 were notified they may have the condition.  

Obstructive sleep apnea was the most reported common risk factor associated with increased AFib susceptibility, and those individuals with the highest risk sleep apnea (more than 80% monitoring measures with AHI greater than or equal to 30 during sleep) resulted in a 1.5-fold increase in prevalent AFib, Dr. Guo reported.

The mAFA II is the latest of several studies to show that AFib can be detected with various smartphone apps and wearable devices. Previous studies have included the Fitbit Heart Study and the Apple Heart Study.

Dr. Hurwitz told this news organization that the electrophysiologist community is enthusiastic about this new smart device technology.

“I sent my sister one so she could determine if she develops AFib: That’s a pretty good endorsement,” she commented, but added that there are still concerns about the rate of false-positive results.

Dr. Hurwitz said she suspected that there will probably be meaningful differences between the different apps and devices, but the algorithms are all proprietary, and the use of photoplethysmography seems to make a big difference.

She noted that the detection of sleep apnea in the current study was a novel approach. “This is important, as sleep apnea is felt to contribute to AFib, and treating it is felt to decrease the frequency of AFib. Perhaps if patients with sleep apnea were treated before they had documented AFib, the AFib burden could be reduced,” she said.

She added that further studies were needed to fine tune the algorithms and to try and identify other factors or heart rate variabilities that may predict future risk of AFib.

The study was funded by the National Natural Science Foundation of China. Dr. Guo reports no disclosures.

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

Screening for heart rhythm disorders with a smartphone app and a wearable device had a high rate of correctly detecting atrial fibrillation (AFib) in a large new study.

The mAFA II study, conducted in a mass low-risk population in China, showed that more than 93% of possible AFib episodes detected by the smartphone app were confirmed to be AFib on further monitoring.

wildpixel/iStock/Getty Images

Over the course of 4 years of the study, 12,244 (0.4%) of users received a notification of suspected AFib. Among 5,227 people who chose to follow up with a clinician, AFib was confirmed in 93.8% of patients using standard AFib diagnostic tools, including clinical evaluation, an electrocardiogram, and 24-hour Holter monitoring.

In this study, a subset of the individuals screened for AFib were also screened for signs of sleep apnea using the same PPG technology to detect physiological changes in parameters including oxygenation and respiratory rates. The app is also able to determine whether the individual is awake or asleep. Dr. Guo noted that the PPG algorithm for obstructive sleep apnea risk has been validated, compared with polysomnography or home sleep apnea tests.

Using measurements of apnea (signalled by a reduced respiratory rate) and hypopnea (when oxygenation would decrease), the apnea–hypopnea index (AHI) is calculated to determine the severity of the sleep apnea.

Of the 961,931 participants screened for sleep apnea, about 18,000 were notified they may have the condition.  

Obstructive sleep apnea was the most reported common risk factor associated with increased AFib susceptibility, and those individuals with the highest risk sleep apnea (more than 80% monitoring measures with AHI greater than or equal to 30 during sleep) resulted in a 1.5-fold increase in prevalent AFib, Dr. Guo reported.

The mAFA II is the latest of several studies to show that AFib can be detected with various smartphone apps and wearable devices. Previous studies have included the Fitbit Heart Study and the Apple Heart Study.

Dr. Hurwitz told this news organization that the electrophysiologist community is enthusiastic about this new smart device technology.

“I sent my sister one so she could determine if she develops AFib: That’s a pretty good endorsement,” she commented, but added that there are still concerns about the rate of false-positive results.

Dr. Hurwitz said she suspected that there will probably be meaningful differences between the different apps and devices, but the algorithms are all proprietary, and the use of photoplethysmography seems to make a big difference.

She noted that the detection of sleep apnea in the current study was a novel approach. “This is important, as sleep apnea is felt to contribute to AFib, and treating it is felt to decrease the frequency of AFib. Perhaps if patients with sleep apnea were treated before they had documented AFib, the AFib burden could be reduced,” she said.

She added that further studies were needed to fine tune the algorithms and to try and identify other factors or heart rate variabilities that may predict future risk of AFib.

The study was funded by the National Natural Science Foundation of China. Dr. Guo reports no disclosures.

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

Screening for heart rhythm disorders with a smartphone app and a wearable device had a high rate of correctly detecting atrial fibrillation (AFib) in a large new study.

The mAFA II study, conducted in a mass low-risk population in China, showed that more than 93% of possible AFib episodes detected by the smartphone app were confirmed to be AFib on further monitoring.

wildpixel/iStock/Getty Images

Over the course of 4 years of the study, 12,244 (0.4%) of users received a notification of suspected AFib. Among 5,227 people who chose to follow up with a clinician, AFib was confirmed in 93.8% of patients using standard AFib diagnostic tools, including clinical evaluation, an electrocardiogram, and 24-hour Holter monitoring.

In this study, a subset of the individuals screened for AFib were also screened for signs of sleep apnea using the same PPG technology to detect physiological changes in parameters including oxygenation and respiratory rates. The app is also able to determine whether the individual is awake or asleep. Dr. Guo noted that the PPG algorithm for obstructive sleep apnea risk has been validated, compared with polysomnography or home sleep apnea tests.

Using measurements of apnea (signalled by a reduced respiratory rate) and hypopnea (when oxygenation would decrease), the apnea–hypopnea index (AHI) is calculated to determine the severity of the sleep apnea.

Of the 961,931 participants screened for sleep apnea, about 18,000 were notified they may have the condition.  

Obstructive sleep apnea was the most reported common risk factor associated with increased AFib susceptibility, and those individuals with the highest risk sleep apnea (more than 80% monitoring measures with AHI greater than or equal to 30 during sleep) resulted in a 1.5-fold increase in prevalent AFib, Dr. Guo reported.

The mAFA II is the latest of several studies to show that AFib can be detected with various smartphone apps and wearable devices. Previous studies have included the Fitbit Heart Study and the Apple Heart Study.

Dr. Hurwitz told this news organization that the electrophysiologist community is enthusiastic about this new smart device technology.

“I sent my sister one so she could determine if she develops AFib: That’s a pretty good endorsement,” she commented, but added that there are still concerns about the rate of false-positive results.

Dr. Hurwitz said she suspected that there will probably be meaningful differences between the different apps and devices, but the algorithms are all proprietary, and the use of photoplethysmography seems to make a big difference.

She noted that the detection of sleep apnea in the current study was a novel approach. “This is important, as sleep apnea is felt to contribute to AFib, and treating it is felt to decrease the frequency of AFib. Perhaps if patients with sleep apnea were treated before they had documented AFib, the AFib burden could be reduced,” she said.

She added that further studies were needed to fine tune the algorithms and to try and identify other factors or heart rate variabilities that may predict future risk of AFib.

The study was funded by the National Natural Science Foundation of China. Dr. Guo reports no disclosures.

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

Heart rate variability (HRV), as assessed during a deep breathing test, may lead to improved diagnosis of post-traumatic stress disorder, according to a study published in Frontiers in Psychiatry.

It is estimated that between 8% and 15% of clinically recognized pregnancies and up to 30% of all pregnancies result in miscarriage – a loss that can be devastating for everyone. There are limited data on the strength of the association between perinatal loss and subsequent common mental health disorders, such as anxiety, depression, and PTSD. The prevalence of PTSD among this group is still unknown, and one of the factors that contribute to the absence of data is that diagnostic evaluation is subjective.

To address this issue, researchers from Anhembi Morumbi University (UAM) in São José dos Campos, Brazil, along with teams in the United States and United Arab Emirates (UAE), investigated biomarkers for the severity of PTSD. The hope is that the research will enable psychiatrists to assess women who experience pregnancy loss more objectively. Study author Ovidiu Constantin Baltatu, MD, PhD, a professor at Brazil’s UAM and the UAE’s Khalifa University, spoke to this news organization about the study.

Under the guidance of Dr. Baltatu, psychologist Cláudia de Faria Cardoso carried out the research as part of her studies in biomedical engineering at UAM. Fifty-three women were recruited; the average age of the cohort was 33 years. All participants had a history of at least one perinatal loss. Pregnancy loss intervals ranged from less than 40 days to more than 6 months.

Participants completed a clinical interview and a questionnaire; PTSD symptoms were assessed on the basis of criteria in the DSM-5. The instrument used for the assessment was the Brazilian version of the Post-traumatic Stress Disorder Checklist (PCL-5). In addition, to evaluate general autonomic dysfunction, patients completed the Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire.

HRV was assessed during a deep breathing test using an HRV scanner system with wireless electrocardiography that enabled real-time data analysis and visualization. The investigators examined the following HRV measures: standard deviation (SD) of normal R-R wave intervals (SDNN), square root of the mean of the sum of the squares of differences between adjacent normal R wave intervals, and the number of all R-R intervals in which the change in consecutive normal sinus intervals exceeds 50 ms divided by the total number of R-R intervals measured.

Of the 53 participants, 25 had been diagnosed with pregnancy loss–induced PTSD. The results indicated a significant association between PCL-5 scores and HRV indices. The SDNN index effectively distinguished between patients with PTSD and those without.

To Dr. Baltatu, HRV indices reflect dysfunction of the autonomic nervous system (ANS), one of the major neural pathways activated by stress.

Although the deep breathing test has been around for a long time, it’s not widely used in current clinical practice, he said. According to him, maximum and minimum heart rates during breathing at six cycles per minute can typically be used to calculate the inspiratory-to-expiratory ratio, thus providing an indication of ANS function. “Our group introduced the study of HRV during deep breathing test, which is a step forward,” he said.

The methodology used by the team was well received by the participants. “With the deep breathing test, the women were able to look at a screen and see real-time graphics displaying the stress that they were experiencing after having suffered trauma. This visualization of objective measures was perceived as an improved care,” said Dr. Baltatu.

In general, HRV provides a more objective means of diagnosing PTSD. “Normally, PTSD is assessed through a questionnaire and an interview with psychologists,” said Dr. Baltatu. The subjectivity of the assessment is one of the main factors associated with the underdiagnosis of this condition, he explained.

It is important to remember that other factors, such as a lack of awareness about the problem, also hinder the diagnosis of PTSD in this population, Dr. Baltatu added. Women who have had a miscarriage often don’t think that their symptoms may result from PTSD. This fact highlights why it is so important that hospitals have a clinical psychologist on staff. In addition, Dr. Baltatu pointed out that a woman who experiences a pregnancy loss usually has negative memories of the hospital and is therefore reluctant to reach out for professional help. “In our study, all psychological care and assessments took place outside of a hospital setting, which the participants seemed to appreciate,” he emphasized.

Dr. Baltatu and his team are conducting follow-up research. The preliminary results indicate that the biomarkers identified in the study are promising in the assessment of patients’ clinical progress. This finding may reflect the fact that the HRV indices have proven useful not only in diagnosing but also in monitoring women in treatment, because they are able to identify which patients are responding better to treatment.

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

Heart rate variability (HRV), as assessed during a deep breathing test, may lead to improved diagnosis of post-traumatic stress disorder, according to a study published in Frontiers in Psychiatry.

It is estimated that between 8% and 15% of clinically recognized pregnancies and up to 30% of all pregnancies result in miscarriage – a loss that can be devastating for everyone. There are limited data on the strength of the association between perinatal loss and subsequent common mental health disorders, such as anxiety, depression, and PTSD. The prevalence of PTSD among this group is still unknown, and one of the factors that contribute to the absence of data is that diagnostic evaluation is subjective.

To address this issue, researchers from Anhembi Morumbi University (UAM) in São José dos Campos, Brazil, along with teams in the United States and United Arab Emirates (UAE), investigated biomarkers for the severity of PTSD. The hope is that the research will enable psychiatrists to assess women who experience pregnancy loss more objectively. Study author Ovidiu Constantin Baltatu, MD, PhD, a professor at Brazil’s UAM and the UAE’s Khalifa University, spoke to this news organization about the study.

Under the guidance of Dr. Baltatu, psychologist Cláudia de Faria Cardoso carried out the research as part of her studies in biomedical engineering at UAM. Fifty-three women were recruited; the average age of the cohort was 33 years. All participants had a history of at least one perinatal loss. Pregnancy loss intervals ranged from less than 40 days to more than 6 months.

Participants completed a clinical interview and a questionnaire; PTSD symptoms were assessed on the basis of criteria in the DSM-5. The instrument used for the assessment was the Brazilian version of the Post-traumatic Stress Disorder Checklist (PCL-5). In addition, to evaluate general autonomic dysfunction, patients completed the Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire.

HRV was assessed during a deep breathing test using an HRV scanner system with wireless electrocardiography that enabled real-time data analysis and visualization. The investigators examined the following HRV measures: standard deviation (SD) of normal R-R wave intervals (SDNN), square root of the mean of the sum of the squares of differences between adjacent normal R wave intervals, and the number of all R-R intervals in which the change in consecutive normal sinus intervals exceeds 50 ms divided by the total number of R-R intervals measured.

Of the 53 participants, 25 had been diagnosed with pregnancy loss–induced PTSD. The results indicated a significant association between PCL-5 scores and HRV indices. The SDNN index effectively distinguished between patients with PTSD and those without.

To Dr. Baltatu, HRV indices reflect dysfunction of the autonomic nervous system (ANS), one of the major neural pathways activated by stress.

Although the deep breathing test has been around for a long time, it’s not widely used in current clinical practice, he said. According to him, maximum and minimum heart rates during breathing at six cycles per minute can typically be used to calculate the inspiratory-to-expiratory ratio, thus providing an indication of ANS function. “Our group introduced the study of HRV during deep breathing test, which is a step forward,” he said.

The methodology used by the team was well received by the participants. “With the deep breathing test, the women were able to look at a screen and see real-time graphics displaying the stress that they were experiencing after having suffered trauma. This visualization of objective measures was perceived as an improved care,” said Dr. Baltatu.

In general, HRV provides a more objective means of diagnosing PTSD. “Normally, PTSD is assessed through a questionnaire and an interview with psychologists,” said Dr. Baltatu. The subjectivity of the assessment is one of the main factors associated with the underdiagnosis of this condition, he explained.

It is important to remember that other factors, such as a lack of awareness about the problem, also hinder the diagnosis of PTSD in this population, Dr. Baltatu added. Women who have had a miscarriage often don’t think that their symptoms may result from PTSD. This fact highlights why it is so important that hospitals have a clinical psychologist on staff. In addition, Dr. Baltatu pointed out that a woman who experiences a pregnancy loss usually has negative memories of the hospital and is therefore reluctant to reach out for professional help. “In our study, all psychological care and assessments took place outside of a hospital setting, which the participants seemed to appreciate,” he emphasized.

Dr. Baltatu and his team are conducting follow-up research. The preliminary results indicate that the biomarkers identified in the study are promising in the assessment of patients’ clinical progress. This finding may reflect the fact that the HRV indices have proven useful not only in diagnosing but also in monitoring women in treatment, because they are able to identify which patients are responding better to treatment.

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

Heart rate variability (HRV), as assessed during a deep breathing test, may lead to improved diagnosis of post-traumatic stress disorder, according to a study published in Frontiers in Psychiatry.

It is estimated that between 8% and 15% of clinically recognized pregnancies and up to 30% of all pregnancies result in miscarriage – a loss that can be devastating for everyone. There are limited data on the strength of the association between perinatal loss and subsequent common mental health disorders, such as anxiety, depression, and PTSD. The prevalence of PTSD among this group is still unknown, and one of the factors that contribute to the absence of data is that diagnostic evaluation is subjective.

To address this issue, researchers from Anhembi Morumbi University (UAM) in São José dos Campos, Brazil, along with teams in the United States and United Arab Emirates (UAE), investigated biomarkers for the severity of PTSD. The hope is that the research will enable psychiatrists to assess women who experience pregnancy loss more objectively. Study author Ovidiu Constantin Baltatu, MD, PhD, a professor at Brazil’s UAM and the UAE’s Khalifa University, spoke to this news organization about the study.

Under the guidance of Dr. Baltatu, psychologist Cláudia de Faria Cardoso carried out the research as part of her studies in biomedical engineering at UAM. Fifty-three women were recruited; the average age of the cohort was 33 years. All participants had a history of at least one perinatal loss. Pregnancy loss intervals ranged from less than 40 days to more than 6 months.

Participants completed a clinical interview and a questionnaire; PTSD symptoms were assessed on the basis of criteria in the DSM-5. The instrument used for the assessment was the Brazilian version of the Post-traumatic Stress Disorder Checklist (PCL-5). In addition, to evaluate general autonomic dysfunction, patients completed the Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire.

HRV was assessed during a deep breathing test using an HRV scanner system with wireless electrocardiography that enabled real-time data analysis and visualization. The investigators examined the following HRV measures: standard deviation (SD) of normal R-R wave intervals (SDNN), square root of the mean of the sum of the squares of differences between adjacent normal R wave intervals, and the number of all R-R intervals in which the change in consecutive normal sinus intervals exceeds 50 ms divided by the total number of R-R intervals measured.

Of the 53 participants, 25 had been diagnosed with pregnancy loss–induced PTSD. The results indicated a significant association between PCL-5 scores and HRV indices. The SDNN index effectively distinguished between patients with PTSD and those without.

To Dr. Baltatu, HRV indices reflect dysfunction of the autonomic nervous system (ANS), one of the major neural pathways activated by stress.

Although the deep breathing test has been around for a long time, it’s not widely used in current clinical practice, he said. According to him, maximum and minimum heart rates during breathing at six cycles per minute can typically be used to calculate the inspiratory-to-expiratory ratio, thus providing an indication of ANS function. “Our group introduced the study of HRV during deep breathing test, which is a step forward,” he said.

The methodology used by the team was well received by the participants. “With the deep breathing test, the women were able to look at a screen and see real-time graphics displaying the stress that they were experiencing after having suffered trauma. This visualization of objective measures was perceived as an improved care,” said Dr. Baltatu.

In general, HRV provides a more objective means of diagnosing PTSD. “Normally, PTSD is assessed through a questionnaire and an interview with psychologists,” said Dr. Baltatu. The subjectivity of the assessment is one of the main factors associated with the underdiagnosis of this condition, he explained.

It is important to remember that other factors, such as a lack of awareness about the problem, also hinder the diagnosis of PTSD in this population, Dr. Baltatu added. Women who have had a miscarriage often don’t think that their symptoms may result from PTSD. This fact highlights why it is so important that hospitals have a clinical psychologist on staff. In addition, Dr. Baltatu pointed out that a woman who experiences a pregnancy loss usually has negative memories of the hospital and is therefore reluctant to reach out for professional help. “In our study, all psychological care and assessments took place outside of a hospital setting, which the participants seemed to appreciate,” he emphasized.

Dr. Baltatu and his team are conducting follow-up research. The preliminary results indicate that the biomarkers identified in the study are promising in the assessment of patients’ clinical progress. This finding may reflect the fact that the HRV indices have proven useful not only in diagnosing but also in monitoring women in treatment, because they are able to identify which patients are responding better to treatment.

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

In a head-to-head comparison of fractional flow reserve (FFR) and intravenous ultrasound (IVUS) for guiding revascularization during percutaneous intervention (PCI), outcomes were noninferior at 2 years, but the approaches appear to have different strengths, according to results of the FLAVOUR trial.

For the primary composite outcome of death from any cause, myocardial infarction, or revascularization at 24 months, the approaches performed comparatively, but there were substantial differences in the number of revascularization procedures performed, reported Bon-Kwon Koo, MD, at the annual scientific sessions of the American College of Cardiology.

At 24 months, 8.1% of the FFR group and 8.5% of the IVUS group had a primary event. The 0.4% difference was not significantly different and fulfilled the definition of noninferiority (P = .015). When the components of the primary endpoint were compared along with rates of stroke, the rates were also similar and not significantly different.

However, the proportion of patients who received a stent (44.4% vs. 65.3%), the total number of stents per patient (0.6 vs. 0.9), and the total stent length per patient (16.5 vs. 25.2) were significantly lower (all P < .001) in the FFR group.

FLAVOUR (Fractional Flow Reserve And IVUS for Clinical Outcomes in Patients With Intermediate Stenosis) confirmed the investigators’ hypothesis that an FFR-guided strategy for intermediate coronary stenosis is noninferior to IVUS for outcomes. In addition, patient-reported angina outcomes on the Seattle Angina Questionnaire were nearly identical across domains, including angina frequency, physical limitations, and treatment satisfaction.
 

FFR vs. IVUS differences revealed

However, the more important value of this study might its role in showing how the two approaches differ in ways unrelated to the primary outcome, according to Dr. Koo, chair of cardiology at Seoul (South Korea) National University Hospital, as well as several experts that commented on the results.

Most notably, the fact that FFR-guided PCI provides similar outcomes at 2 years even though it was associated with a substantially reduced rate of revascularizations is telling about its role relative to IVUS.

“These data confirm how a lot of us are already approaching this,” said an ACC-invited expert, Frederick G. Welt, MD, director of the cardiac catheterization at the University of Utah, Salt Lake City. “FFR should be used to decide who should get an intervention, and IVUS should be use to optimize the intervention.”

Dr. Koo explained that FFR is an invasive tool that provides a physiological assessment of the degree to which a stenosis is causing ischemia. IVUS is a tool that permits visualization and measurement of plaque severity and characteristics to better optimize PCI. They can both help guide PCI, but they are not necessarily competing strategies. Often, the information they provide is complementary.

In this multicenter trial conducted at 18 centers in Korea and China, 1,682 candidates with de novo stenoses of intermediate severity, defined as 40%-70%, were randomized to FFR- or IVUS-guided PCI. At 24 months, outcomes could be assessed in 832 of the FFR patients and 836 of the IVUS patients, which represented more than 99% of both groups.

In the study, the indications for stent placement were predefined for the FFR-guided and IVUS-guided approaches. The criteria to define optimal outcomes post PCI were also predefined. For FFR, this included a postprocedure value of at least 0.88. For IVUS, the definition of optimal outcome included a plaque burden of 55% or less at the stent edge and a minimal stent area of at least 5.5 mm².

The primary outcome for those with optimal versus suboptimal FFR-guided PCI were similar at all time points. For those with an optimal post-PCI result, the event rate was only slightly higher for those with an optimal relative to a suboptimal result (12.3% vs. 11.8%).
 

Suboptimal IVUS differs from suboptimal FFR

In contrast, the event rates over the course of follow-up were consistently higher among those with a suboptimal relative to an optimal IVUS-guided PCI. At the end of 2 years, the numerically greater rate of events among those with a suboptimal IVUS-guided PCI was not significant (9.8% vs. 8.5%; P = .212), but the gap was larger than that seen with FFR-guided PCI.

FFR-guided and IVUS-guided PCI performed similarly for the primary outcome across numerous stratifications. These included age older or younger than 65 years, male or female sex, presence or absence of multivessel disease, and presence of diabetes. They were also similar for those with acute coronary syndrome (ACS) as an indication for PCI, which accounted for about 30% of patients, relative to those without ACS.

“I would say that at least some interventionalists in the U.S. would be uncomfortable using FFR in ACS patients,” said Dr. Welt, pointing out a potential difference between how these tools are used to guide PCI. Still, because “there are not a lot of data to compare these technologies,” he expressed appreciation for a study looking at these tools side-by-side.

A similar point was made by Ajay Kirtane, MD, director of Cardiac Catheterization Laboratories at New York–Presbyterian/Columbia University Irving Medical Center. With the slightly lower rates of primary events in those treated optimally according to IVUS relative to those treated optimally by FFR (8.5% vs. 12.3%), he suggested IVUS appears better for evaluating the physiology of the stenosis.

Dr. Kirtane pointed out that two-thirds of the lesions were left behind in those guided by FFR versus only about half of the lesions when PCI was guided by IVUS, yet outcomes were similar. He indicated that the data support current practice in which FFR is most commonly used to select PCI patients with intermediate disease for stent placement.

Dr. Koo has financial relationships with Abbott, Boston Scientific, and Philips Volcano. Dr. Welt has financial relationships with Medtronic and Xenter. Dr. Kirtane has financial relationships with Abbott, Amgen, Boston Scientific, Chiesi, Cardiovascular Systems Incorporate, Medtronic, Philips/Spectranetics, Recor Medical, and Regeneron. The study received a research grant from Boston Scientific.

In a head-to-head comparison of fractional flow reserve (FFR) and intravenous ultrasound (IVUS) for guiding revascularization during percutaneous intervention (PCI), outcomes were noninferior at 2 years, but the approaches appear to have different strengths, according to results of the FLAVOUR trial.

For the primary composite outcome of death from any cause, myocardial infarction, or revascularization at 24 months, the approaches performed comparatively, but there were substantial differences in the number of revascularization procedures performed, reported Bon-Kwon Koo, MD, at the annual scientific sessions of the American College of Cardiology.

At 24 months, 8.1% of the FFR group and 8.5% of the IVUS group had a primary event. The 0.4% difference was not significantly different and fulfilled the definition of noninferiority (P = .015). When the components of the primary endpoint were compared along with rates of stroke, the rates were also similar and not significantly different.

However, the proportion of patients who received a stent (44.4% vs. 65.3%), the total number of stents per patient (0.6 vs. 0.9), and the total stent length per patient (16.5 vs. 25.2) were significantly lower (all P < .001) in the FFR group.

FLAVOUR (Fractional Flow Reserve And IVUS for Clinical Outcomes in Patients With Intermediate Stenosis) confirmed the investigators’ hypothesis that an FFR-guided strategy for intermediate coronary stenosis is noninferior to IVUS for outcomes. In addition, patient-reported angina outcomes on the Seattle Angina Questionnaire were nearly identical across domains, including angina frequency, physical limitations, and treatment satisfaction.
 

FFR vs. IVUS differences revealed

However, the more important value of this study might its role in showing how the two approaches differ in ways unrelated to the primary outcome, according to Dr. Koo, chair of cardiology at Seoul (South Korea) National University Hospital, as well as several experts that commented on the results.

Most notably, the fact that FFR-guided PCI provides similar outcomes at 2 years even though it was associated with a substantially reduced rate of revascularizations is telling about its role relative to IVUS.

“These data confirm how a lot of us are already approaching this,” said an ACC-invited expert, Frederick G. Welt, MD, director of the cardiac catheterization at the University of Utah, Salt Lake City. “FFR should be used to decide who should get an intervention, and IVUS should be use to optimize the intervention.”

Dr. Koo explained that FFR is an invasive tool that provides a physiological assessment of the degree to which a stenosis is causing ischemia. IVUS is a tool that permits visualization and measurement of plaque severity and characteristics to better optimize PCI. They can both help guide PCI, but they are not necessarily competing strategies. Often, the information they provide is complementary.

In this multicenter trial conducted at 18 centers in Korea and China, 1,682 candidates with de novo stenoses of intermediate severity, defined as 40%-70%, were randomized to FFR- or IVUS-guided PCI. At 24 months, outcomes could be assessed in 832 of the FFR patients and 836 of the IVUS patients, which represented more than 99% of both groups.

In the study, the indications for stent placement were predefined for the FFR-guided and IVUS-guided approaches. The criteria to define optimal outcomes post PCI were also predefined. For FFR, this included a postprocedure value of at least 0.88. For IVUS, the definition of optimal outcome included a plaque burden of 55% or less at the stent edge and a minimal stent area of at least 5.5 mm².

The primary outcome for those with optimal versus suboptimal FFR-guided PCI were similar at all time points. For those with an optimal post-PCI result, the event rate was only slightly higher for those with an optimal relative to a suboptimal result (12.3% vs. 11.8%).
 

Suboptimal IVUS differs from suboptimal FFR

In contrast, the event rates over the course of follow-up were consistently higher among those with a suboptimal relative to an optimal IVUS-guided PCI. At the end of 2 years, the numerically greater rate of events among those with a suboptimal IVUS-guided PCI was not significant (9.8% vs. 8.5%; P = .212), but the gap was larger than that seen with FFR-guided PCI.

FFR-guided and IVUS-guided PCI performed similarly for the primary outcome across numerous stratifications. These included age older or younger than 65 years, male or female sex, presence or absence of multivessel disease, and presence of diabetes. They were also similar for those with acute coronary syndrome (ACS) as an indication for PCI, which accounted for about 30% of patients, relative to those without ACS.

“I would say that at least some interventionalists in the U.S. would be uncomfortable using FFR in ACS patients,” said Dr. Welt, pointing out a potential difference between how these tools are used to guide PCI. Still, because “there are not a lot of data to compare these technologies,” he expressed appreciation for a study looking at these tools side-by-side.

A similar point was made by Ajay Kirtane, MD, director of Cardiac Catheterization Laboratories at New York–Presbyterian/Columbia University Irving Medical Center. With the slightly lower rates of primary events in those treated optimally according to IVUS relative to those treated optimally by FFR (8.5% vs. 12.3%), he suggested IVUS appears better for evaluating the physiology of the stenosis.

Dr. Kirtane pointed out that two-thirds of the lesions were left behind in those guided by FFR versus only about half of the lesions when PCI was guided by IVUS, yet outcomes were similar. He indicated that the data support current practice in which FFR is most commonly used to select PCI patients with intermediate disease for stent placement.

Dr. Koo has financial relationships with Abbott, Boston Scientific, and Philips Volcano. Dr. Welt has financial relationships with Medtronic and Xenter. Dr. Kirtane has financial relationships with Abbott, Amgen, Boston Scientific, Chiesi, Cardiovascular Systems Incorporate, Medtronic, Philips/Spectranetics, Recor Medical, and Regeneron. The study received a research grant from Boston Scientific.

In a head-to-head comparison of fractional flow reserve (FFR) and intravenous ultrasound (IVUS) for guiding revascularization during percutaneous intervention (PCI), outcomes were noninferior at 2 years, but the approaches appear to have different strengths, according to results of the FLAVOUR trial.

For the primary composite outcome of death from any cause, myocardial infarction, or revascularization at 24 months, the approaches performed comparatively, but there were substantial differences in the number of revascularization procedures performed, reported Bon-Kwon Koo, MD, at the annual scientific sessions of the American College of Cardiology.

At 24 months, 8.1% of the FFR group and 8.5% of the IVUS group had a primary event. The 0.4% difference was not significantly different and fulfilled the definition of noninferiority (P = .015). When the components of the primary endpoint were compared along with rates of stroke, the rates were also similar and not significantly different.

However, the proportion of patients who received a stent (44.4% vs. 65.3%), the total number of stents per patient (0.6 vs. 0.9), and the total stent length per patient (16.5 vs. 25.2) were significantly lower (all P < .001) in the FFR group.

FLAVOUR (Fractional Flow Reserve And IVUS for Clinical Outcomes in Patients With Intermediate Stenosis) confirmed the investigators’ hypothesis that an FFR-guided strategy for intermediate coronary stenosis is noninferior to IVUS for outcomes. In addition, patient-reported angina outcomes on the Seattle Angina Questionnaire were nearly identical across domains, including angina frequency, physical limitations, and treatment satisfaction.
 

FFR vs. IVUS differences revealed

However, the more important value of this study might its role in showing how the two approaches differ in ways unrelated to the primary outcome, according to Dr. Koo, chair of cardiology at Seoul (South Korea) National University Hospital, as well as several experts that commented on the results.

Most notably, the fact that FFR-guided PCI provides similar outcomes at 2 years even though it was associated with a substantially reduced rate of revascularizations is telling about its role relative to IVUS.

“These data confirm how a lot of us are already approaching this,” said an ACC-invited expert, Frederick G. Welt, MD, director of the cardiac catheterization at the University of Utah, Salt Lake City. “FFR should be used to decide who should get an intervention, and IVUS should be use to optimize the intervention.”

Dr. Koo explained that FFR is an invasive tool that provides a physiological assessment of the degree to which a stenosis is causing ischemia. IVUS is a tool that permits visualization and measurement of plaque severity and characteristics to better optimize PCI. They can both help guide PCI, but they are not necessarily competing strategies. Often, the information they provide is complementary.

In this multicenter trial conducted at 18 centers in Korea and China, 1,682 candidates with de novo stenoses of intermediate severity, defined as 40%-70%, were randomized to FFR- or IVUS-guided PCI. At 24 months, outcomes could be assessed in 832 of the FFR patients and 836 of the IVUS patients, which represented more than 99% of both groups.

In the study, the indications for stent placement were predefined for the FFR-guided and IVUS-guided approaches. The criteria to define optimal outcomes post PCI were also predefined. For FFR, this included a postprocedure value of at least 0.88. For IVUS, the definition of optimal outcome included a plaque burden of 55% or less at the stent edge and a minimal stent area of at least 5.5 mm².

The primary outcome for those with optimal versus suboptimal FFR-guided PCI were similar at all time points. For those with an optimal post-PCI result, the event rate was only slightly higher for those with an optimal relative to a suboptimal result (12.3% vs. 11.8%).
 

Suboptimal IVUS differs from suboptimal FFR

In contrast, the event rates over the course of follow-up were consistently higher among those with a suboptimal relative to an optimal IVUS-guided PCI. At the end of 2 years, the numerically greater rate of events among those with a suboptimal IVUS-guided PCI was not significant (9.8% vs. 8.5%; P = .212), but the gap was larger than that seen with FFR-guided PCI.

FFR-guided and IVUS-guided PCI performed similarly for the primary outcome across numerous stratifications. These included age older or younger than 65 years, male or female sex, presence or absence of multivessel disease, and presence of diabetes. They were also similar for those with acute coronary syndrome (ACS) as an indication for PCI, which accounted for about 30% of patients, relative to those without ACS.

“I would say that at least some interventionalists in the U.S. would be uncomfortable using FFR in ACS patients,” said Dr. Welt, pointing out a potential difference between how these tools are used to guide PCI. Still, because “there are not a lot of data to compare these technologies,” he expressed appreciation for a study looking at these tools side-by-side.

A similar point was made by Ajay Kirtane, MD, director of Cardiac Catheterization Laboratories at New York–Presbyterian/Columbia University Irving Medical Center. With the slightly lower rates of primary events in those treated optimally according to IVUS relative to those treated optimally by FFR (8.5% vs. 12.3%), he suggested IVUS appears better for evaluating the physiology of the stenosis.

Dr. Kirtane pointed out that two-thirds of the lesions were left behind in those guided by FFR versus only about half of the lesions when PCI was guided by IVUS, yet outcomes were similar. He indicated that the data support current practice in which FFR is most commonly used to select PCI patients with intermediate disease for stent placement.

Dr. Koo has financial relationships with Abbott, Boston Scientific, and Philips Volcano. Dr. Welt has financial relationships with Medtronic and Xenter. Dr. Kirtane has financial relationships with Abbott, Amgen, Boston Scientific, Chiesi, Cardiovascular Systems Incorporate, Medtronic, Philips/Spectranetics, Recor Medical, and Regeneron. The study received a research grant from Boston Scientific.

At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.

The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.

“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”

Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.

This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.

Key take-homes

The AHA statement on NAFLD is sweeping. Among its key take-home messages:

• Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
• Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
• Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
• Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.

The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.

The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”

Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.” 

Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.

“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.

“NAFLD has not been at the forefront of  cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.

“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.

Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.


 

At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.

The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.

“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”

Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.

This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.

Key take-homes

The AHA statement on NAFLD is sweeping. Among its key take-home messages:

• Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
• Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
• Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
• Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.

The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.

The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”

Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.” 

Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.

“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.

“NAFLD has not been at the forefront of  cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.

“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.

Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.


 

At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.

The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.

“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”

Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.

This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.

Key take-homes

The AHA statement on NAFLD is sweeping. Among its key take-home messages:

• Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
• Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
• Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
• Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.

The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.

The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”

Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.” 

Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.

“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.

“NAFLD has not been at the forefront of  cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.

“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.

Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.


 

New data from two different sources on cardiac complications linked to COVID-19 have shown that such issues are low overall but are higher after infection than after vaccination.

The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
 

CDC data

The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.

It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.

Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.  

Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.

“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
 

International study

The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.

The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.

“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.

“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy. 

The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”

The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.

The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021. 

Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).

The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).

Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.

The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.

They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.

The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.

With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.

They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.

“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.

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

New data from two different sources on cardiac complications linked to COVID-19 have shown that such issues are low overall but are higher after infection than after vaccination.

The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
 

CDC data

The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.

It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.

Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.  

Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.

“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
 

International study

The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.

The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.

“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.

“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy. 

The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”

The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.

The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021. 

Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).

The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).

Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.

The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.

They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.

The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.

With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.

They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.

“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.

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

New data from two different sources on cardiac complications linked to COVID-19 have shown that such issues are low overall but are higher after infection than after vaccination.

The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
 

CDC data

The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.

It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.

Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.  

Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.

“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
 

International study

The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.

The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.

“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.

“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy. 

The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”

The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.

The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021. 

Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).

The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).

Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.

The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.

They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.

The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.

With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.

They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.

“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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