Cardiology

Patients who do not receive care for non–ST-segment elevation myocardial infarction (NSTEMI) within 24 hours have a substantially increased risk of mortality 3 years later when compared with those receiving earlier intervention, according to a population-based study evaluating more than 6,000 patients.

The characteristics of patients receiving NSTEMI care more than 24 hours after symptom onset were different from those treated earlier, but understanding these differences might provide clues for improved pathways to care, according to the investigators of this study, published in the Journal of the American College of Cardiology.

In a study of 6,544 NSTEMI patients in the Korea Acute Myocardial Infarction Registry, 1,827 (27%) were evaluated and treated 24 hours or more after symptom onset. When compared with the group with a shorter symptom-to-door time, outcomes at a median follow-up of 1,098 days were substantially worse.

Most importantly, this included a more than 50% absolute unadjusted increase in death from any cause (17.0% vs. 10.5%). On a 3-year adjusted multivariate hazard ratio, the increase was 35% (HR, 1.35; 95% confidence interval, 1.17-1.56; P < .001)

The absolute relative increase in cardiac death was similar in the delayed treatment group (10.8% vs. 6.4%) with a 37% increase in the 3-year multivariate adjustment (HR, 1.37; 95% CI 1.14-1.65; P < .001).
 

Delay raises composite adverse outcome >50%

On a composite of events that included mortality, recurrent MI, or hospitalization for heart failure, the rates climbed from 15.7% in the group treated within 24 hours to 23.3% (P < .001) when treatment was delayed. Heart failure, which was not significantly increased when evaluated separately, was not a major contributor to adverse outcomes, but those with delayed treatment did have more recurrent MIs (5.3% vs. 3.7%; P = .02).

Among a long list of differences between groups, those with delayed care had higher rates of atypical chest pain (25.1% vs. 14.8%; P < .001) and dyspnea (32.6% vs. 23.4%; P < .001). Expressed in odds ratios, they were also significantly more likely to be female (OR, 1.23), be aged 75 years or older (OR, 1.44), have diabetes (OR, 1.31), and to arrive at the hospital without aid from emergency medical services (OR, 3.44).

NSTEMI patients with delayed symptom-to-door time were also less likely to have hypertension (54.8% vs. 59.1%; P < .001), chronic kidney disease (20.8% vs. 25.5%), or a family history of cardiovascular disease (4.7% vs. 7.4%; P < .001). They were more likely to have left main and multivessel disease (57.1% vs. 50.5%; P < .001).

The value of early treatment has already been demonstrated for STEMI, which is reflected in guidelines, most of which now emphasize minimizing the door-to-balloon angioplasty time in order to more rapidly restore perfusion, thereby preserving more functional cardiac tissue. This study suggests that benefit from early intervention is also true of NSTEMI.

Reducing prehospital delay in care “should be emphasized as a crucial factor that increases the risk of all-cause mortality in NSTEMI patients,” reported the authors, led by Jung-Joon Cha, MD, PhD, division of cardiology, Korea University Anam Hospital, Seoul.
 

Public health campaigns needed

When asked about the take-home message, Dr. Cha, along with the senior author, Tae Hoon Ahn, MD, PhD, contend that delays can be addressed by educating both the public and clinicians.

“We would like to emphasize the need for public health campaigns to make patients more aware of atypical symptoms,” Dr. Cha said in an interview.

Dr. Ahn also believes that there is not enough current emphasis within medical systems to recognize and urgently treat NSTEMI patients with a nontraditional profile.

“Atypical symptoms in NSTEMI patients may lead physicians to underestimate the disease severity,” according to Dr. Ahn, who participated in an interview on the significance of these results. He said that atypical symptoms should induce clinicians to exercise “more caution rather than to neglect them.”

For understanding the value of prompt care in NSTEMI patients, this is important information. However, the importance of the 24-hour threshold as a discriminator of long-term risk was questioned by José A. Barrabés, MD, PhD, head of the acute cardiac care unit, University Hospital Vall d’Hebron, Barcelona.

The cutoff in this study was 24 hours, but Dr. Barrabés in an accompanying editorial pointed out that the median delay in those with a symptom-to-door time of at least 24 hours was in fact 72.0 hours.
 

Intermediate delay effect unknown

“This time lag is unusual and reduces the generalizability of the results,” according to Dr. Barrabés. He suggested that the exceptional delay increases the likelihood that the characteristics of the patients, such as more comorbidities or lower socioeconomic status, might have played a role in the differences in outcomes.

Asked to elaborate, Dr. Barrabés explained that delays in treatment, such as antithrombotic therapy, are plausible explanations for the worse outcomes at 3 years, but it is unclear from this data whether the risk starts at a delay of 24 hours.

“It is certainly plausible that intermediate delays are also associated with a worse prognosis,” Dr. Barrabés said in an interview, but “the risk associated with an intermediate delay in symptom-to-door time cannot be quantified with the data collected in this study.”

Dr. Cha and coinvestigators reported no potential conflicts of interest for this study. Dr. Barrabés has financial relationship with AstraZeneca, Novo Nordisk, and Rovi.

Patients who do not receive care for non–ST-segment elevation myocardial infarction (NSTEMI) within 24 hours have a substantially increased risk of mortality 3 years later when compared with those receiving earlier intervention, according to a population-based study evaluating more than 6,000 patients.

The characteristics of patients receiving NSTEMI care more than 24 hours after symptom onset were different from those treated earlier, but understanding these differences might provide clues for improved pathways to care, according to the investigators of this study, published in the Journal of the American College of Cardiology.

In a study of 6,544 NSTEMI patients in the Korea Acute Myocardial Infarction Registry, 1,827 (27%) were evaluated and treated 24 hours or more after symptom onset. When compared with the group with a shorter symptom-to-door time, outcomes at a median follow-up of 1,098 days were substantially worse.

Most importantly, this included a more than 50% absolute unadjusted increase in death from any cause (17.0% vs. 10.5%). On a 3-year adjusted multivariate hazard ratio, the increase was 35% (HR, 1.35; 95% confidence interval, 1.17-1.56; P < .001)

The absolute relative increase in cardiac death was similar in the delayed treatment group (10.8% vs. 6.4%) with a 37% increase in the 3-year multivariate adjustment (HR, 1.37; 95% CI 1.14-1.65; P < .001).
 

Delay raises composite adverse outcome >50%

On a composite of events that included mortality, recurrent MI, or hospitalization for heart failure, the rates climbed from 15.7% in the group treated within 24 hours to 23.3% (P < .001) when treatment was delayed. Heart failure, which was not significantly increased when evaluated separately, was not a major contributor to adverse outcomes, but those with delayed treatment did have more recurrent MIs (5.3% vs. 3.7%; P = .02).

Among a long list of differences between groups, those with delayed care had higher rates of atypical chest pain (25.1% vs. 14.8%; P < .001) and dyspnea (32.6% vs. 23.4%; P < .001). Expressed in odds ratios, they were also significantly more likely to be female (OR, 1.23), be aged 75 years or older (OR, 1.44), have diabetes (OR, 1.31), and to arrive at the hospital without aid from emergency medical services (OR, 3.44).

NSTEMI patients with delayed symptom-to-door time were also less likely to have hypertension (54.8% vs. 59.1%; P < .001), chronic kidney disease (20.8% vs. 25.5%), or a family history of cardiovascular disease (4.7% vs. 7.4%; P < .001). They were more likely to have left main and multivessel disease (57.1% vs. 50.5%; P < .001).

The value of early treatment has already been demonstrated for STEMI, which is reflected in guidelines, most of which now emphasize minimizing the door-to-balloon angioplasty time in order to more rapidly restore perfusion, thereby preserving more functional cardiac tissue. This study suggests that benefit from early intervention is also true of NSTEMI.

Reducing prehospital delay in care “should be emphasized as a crucial factor that increases the risk of all-cause mortality in NSTEMI patients,” reported the authors, led by Jung-Joon Cha, MD, PhD, division of cardiology, Korea University Anam Hospital, Seoul.
 

Public health campaigns needed

When asked about the take-home message, Dr. Cha, along with the senior author, Tae Hoon Ahn, MD, PhD, contend that delays can be addressed by educating both the public and clinicians.

“We would like to emphasize the need for public health campaigns to make patients more aware of atypical symptoms,” Dr. Cha said in an interview.

Dr. Ahn also believes that there is not enough current emphasis within medical systems to recognize and urgently treat NSTEMI patients with a nontraditional profile.

“Atypical symptoms in NSTEMI patients may lead physicians to underestimate the disease severity,” according to Dr. Ahn, who participated in an interview on the significance of these results. He said that atypical symptoms should induce clinicians to exercise “more caution rather than to neglect them.”

For understanding the value of prompt care in NSTEMI patients, this is important information. However, the importance of the 24-hour threshold as a discriminator of long-term risk was questioned by José A. Barrabés, MD, PhD, head of the acute cardiac care unit, University Hospital Vall d’Hebron, Barcelona.

The cutoff in this study was 24 hours, but Dr. Barrabés in an accompanying editorial pointed out that the median delay in those with a symptom-to-door time of at least 24 hours was in fact 72.0 hours.
 

Intermediate delay effect unknown

“This time lag is unusual and reduces the generalizability of the results,” according to Dr. Barrabés. He suggested that the exceptional delay increases the likelihood that the characteristics of the patients, such as more comorbidities or lower socioeconomic status, might have played a role in the differences in outcomes.

Asked to elaborate, Dr. Barrabés explained that delays in treatment, such as antithrombotic therapy, are plausible explanations for the worse outcomes at 3 years, but it is unclear from this data whether the risk starts at a delay of 24 hours.

“It is certainly plausible that intermediate delays are also associated with a worse prognosis,” Dr. Barrabés said in an interview, but “the risk associated with an intermediate delay in symptom-to-door time cannot be quantified with the data collected in this study.”

Dr. Cha and coinvestigators reported no potential conflicts of interest for this study. Dr. Barrabés has financial relationship with AstraZeneca, Novo Nordisk, and Rovi.

Patients who do not receive care for non–ST-segment elevation myocardial infarction (NSTEMI) within 24 hours have a substantially increased risk of mortality 3 years later when compared with those receiving earlier intervention, according to a population-based study evaluating more than 6,000 patients.

The characteristics of patients receiving NSTEMI care more than 24 hours after symptom onset were different from those treated earlier, but understanding these differences might provide clues for improved pathways to care, according to the investigators of this study, published in the Journal of the American College of Cardiology.

In a study of 6,544 NSTEMI patients in the Korea Acute Myocardial Infarction Registry, 1,827 (27%) were evaluated and treated 24 hours or more after symptom onset. When compared with the group with a shorter symptom-to-door time, outcomes at a median follow-up of 1,098 days were substantially worse.

Most importantly, this included a more than 50% absolute unadjusted increase in death from any cause (17.0% vs. 10.5%). On a 3-year adjusted multivariate hazard ratio, the increase was 35% (HR, 1.35; 95% confidence interval, 1.17-1.56; P < .001)

The absolute relative increase in cardiac death was similar in the delayed treatment group (10.8% vs. 6.4%) with a 37% increase in the 3-year multivariate adjustment (HR, 1.37; 95% CI 1.14-1.65; P < .001).
 

Delay raises composite adverse outcome >50%

On a composite of events that included mortality, recurrent MI, or hospitalization for heart failure, the rates climbed from 15.7% in the group treated within 24 hours to 23.3% (P < .001) when treatment was delayed. Heart failure, which was not significantly increased when evaluated separately, was not a major contributor to adverse outcomes, but those with delayed treatment did have more recurrent MIs (5.3% vs. 3.7%; P = .02).

Among a long list of differences between groups, those with delayed care had higher rates of atypical chest pain (25.1% vs. 14.8%; P < .001) and dyspnea (32.6% vs. 23.4%; P < .001). Expressed in odds ratios, they were also significantly more likely to be female (OR, 1.23), be aged 75 years or older (OR, 1.44), have diabetes (OR, 1.31), and to arrive at the hospital without aid from emergency medical services (OR, 3.44).

NSTEMI patients with delayed symptom-to-door time were also less likely to have hypertension (54.8% vs. 59.1%; P < .001), chronic kidney disease (20.8% vs. 25.5%), or a family history of cardiovascular disease (4.7% vs. 7.4%; P < .001). They were more likely to have left main and multivessel disease (57.1% vs. 50.5%; P < .001).

The value of early treatment has already been demonstrated for STEMI, which is reflected in guidelines, most of which now emphasize minimizing the door-to-balloon angioplasty time in order to more rapidly restore perfusion, thereby preserving more functional cardiac tissue. This study suggests that benefit from early intervention is also true of NSTEMI.

Reducing prehospital delay in care “should be emphasized as a crucial factor that increases the risk of all-cause mortality in NSTEMI patients,” reported the authors, led by Jung-Joon Cha, MD, PhD, division of cardiology, Korea University Anam Hospital, Seoul.
 

Public health campaigns needed

When asked about the take-home message, Dr. Cha, along with the senior author, Tae Hoon Ahn, MD, PhD, contend that delays can be addressed by educating both the public and clinicians.

“We would like to emphasize the need for public health campaigns to make patients more aware of atypical symptoms,” Dr. Cha said in an interview.

Dr. Ahn also believes that there is not enough current emphasis within medical systems to recognize and urgently treat NSTEMI patients with a nontraditional profile.

“Atypical symptoms in NSTEMI patients may lead physicians to underestimate the disease severity,” according to Dr. Ahn, who participated in an interview on the significance of these results. He said that atypical symptoms should induce clinicians to exercise “more caution rather than to neglect them.”

For understanding the value of prompt care in NSTEMI patients, this is important information. However, the importance of the 24-hour threshold as a discriminator of long-term risk was questioned by José A. Barrabés, MD, PhD, head of the acute cardiac care unit, University Hospital Vall d’Hebron, Barcelona.

The cutoff in this study was 24 hours, but Dr. Barrabés in an accompanying editorial pointed out that the median delay in those with a symptom-to-door time of at least 24 hours was in fact 72.0 hours.
 

Intermediate delay effect unknown

“This time lag is unusual and reduces the generalizability of the results,” according to Dr. Barrabés. He suggested that the exceptional delay increases the likelihood that the characteristics of the patients, such as more comorbidities or lower socioeconomic status, might have played a role in the differences in outcomes.

Asked to elaborate, Dr. Barrabés explained that delays in treatment, such as antithrombotic therapy, are plausible explanations for the worse outcomes at 3 years, but it is unclear from this data whether the risk starts at a delay of 24 hours.

“It is certainly plausible that intermediate delays are also associated with a worse prognosis,” Dr. Barrabés said in an interview, but “the risk associated with an intermediate delay in symptom-to-door time cannot be quantified with the data collected in this study.”

Dr. Cha and coinvestigators reported no potential conflicts of interest for this study. Dr. Barrabés has financial relationship with AstraZeneca, Novo Nordisk, and Rovi.

Emergency department visits for atrial fibrillation (AFib) appear to go up on days around some annual events in the United States that many people commemorate by consuming alcohol in excess – think Christmas, New Year’s Day, and Super Bowl Sunday.

The novel finding seemed especially true for people without a previous AFib diagnosis, suggesting that alcohol intake, and especially binge drinking, “may acutely enhance the risk” of new-onset AFib, propose researchers in their Jan. 12 report for the inaugural issue of Nature Cardiovascular Research.

Leveraging an international database of breathalyzer test results, the group saw jumps in alcohol intake across several days surrounding eight “recurrent, nationally recognized events,” which also included U.S. Independence Day and the FIFA World Cup.

They then compared the timing of those events to ED visits linked to acute alcohol ingestion and, separately, to ED visits coded for AFib in 10 years of data that cover all of California.

Collectively, the eight annual occasions for heavy alcohol use corresponded to spikes in both kinds of ED visit. Their relationship to AFib-related visits overall grew in strength when the analysis was restricted to new AFib diagnoses.

The researchers acknowledge the limitations of their observational study. Still, the findings represent “the first evidence that acute exposure to alcohol can lead to a given atrial fib episode in a short period of time, even among those without an established AFib diagnosis,” senior author Gregory M. Marcus, MD, MAS, University of California, San Francisco, told this news organization.

“The observation that this was detectable in the general population is a warning to those who drink heavily that any one episode of excessive alcohol consumption could land them in the ED with atrial fibrillation,” he said.

It’s “definitely speculation,” but such ED visits could represent an opportunity for individuals to link their new arrhythmia with a specific episode of excessive drinking, strengthening the message that the two are likely connected, Dr. Marcus observed. The experience could potentially inspire some to “reduce or eliminate” their alcohol intake in an effort to avoid future AFib.

The group obtained data from 2014 to 2016 on more than 1.2 million breath alcohol measurements from about 36,000 people in 59 countries, half residing in the United States, who used commercially available breathalyzer devices from one manufacturer (BACtrack).  

The 8 days marking recurrent nationally recognized events, and the days before and after them, were associated with mean blood-alcohol concentrations in the top fifth percentile for the year.

The same eight occasions marked significant bumps in ED visits related to acute alcohol ingestion in records from the California Office of Statewide Health Planning and Development (OSHPD), which documented almost 1.2 million such visits from 2005 to 2015.

Collectively in adjusted analysis, the eight nationally recognized events, compared with other days of the year, accounted for 2,640 excess alcohol-related ED visits per 100,000 person-years across all of California (P < .001).

Separately, ED visits coded for a diagnosis of AFib concentrated significantly around those same 8 days, on which there was an excess of 719 such AFib-related visits per 100,000 person-years (P = .008).

The analysis was replicated after exclusion of OSHPD records from anyone with a previous AFib-related ED visit or hospitalization, or previous outpatient procedure related to AFib, such as ablation or cardioversion. It saw 1,757 excess ED visits per 100,000 person-years (P < .001) for what was considered new-onset AFib in association with the eight nationally recognized events, compared with the rest of the year.  

The implication, that a bout of alcohol use leading to an ED visit can acutely raise the risk for a first episode of AFib, was subjected to a “negative control analysis” that focused on ED visits for supraventricular tachycardia. It showed no significant relationships with the eight nationally recognized events.

“We think that helps demonstrate that it’s not just more ED visits, more palpitations, or more heart-related visits per se” associated with acute alcohol use, Dr. Marcus said, “but that it’s something fairly specific to AFib.”

The authors declare no competing interests. Dr. Marcus has previously reported research with Medtronic, Eight Sleep, and Baylis; consulting for InCarda Therapeutics and Johnson & Johnson; and equity in InCarda Therapeutics as cofounder.

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

Emergency department visits for atrial fibrillation (AFib) appear to go up on days around some annual events in the United States that many people commemorate by consuming alcohol in excess – think Christmas, New Year’s Day, and Super Bowl Sunday.

The novel finding seemed especially true for people without a previous AFib diagnosis, suggesting that alcohol intake, and especially binge drinking, “may acutely enhance the risk” of new-onset AFib, propose researchers in their Jan. 12 report for the inaugural issue of Nature Cardiovascular Research.

Leveraging an international database of breathalyzer test results, the group saw jumps in alcohol intake across several days surrounding eight “recurrent, nationally recognized events,” which also included U.S. Independence Day and the FIFA World Cup.

They then compared the timing of those events to ED visits linked to acute alcohol ingestion and, separately, to ED visits coded for AFib in 10 years of data that cover all of California.

Collectively, the eight annual occasions for heavy alcohol use corresponded to spikes in both kinds of ED visit. Their relationship to AFib-related visits overall grew in strength when the analysis was restricted to new AFib diagnoses.

The researchers acknowledge the limitations of their observational study. Still, the findings represent “the first evidence that acute exposure to alcohol can lead to a given atrial fib episode in a short period of time, even among those without an established AFib diagnosis,” senior author Gregory M. Marcus, MD, MAS, University of California, San Francisco, told this news organization.

“The observation that this was detectable in the general population is a warning to those who drink heavily that any one episode of excessive alcohol consumption could land them in the ED with atrial fibrillation,” he said.

It’s “definitely speculation,” but such ED visits could represent an opportunity for individuals to link their new arrhythmia with a specific episode of excessive drinking, strengthening the message that the two are likely connected, Dr. Marcus observed. The experience could potentially inspire some to “reduce or eliminate” their alcohol intake in an effort to avoid future AFib.

The group obtained data from 2014 to 2016 on more than 1.2 million breath alcohol measurements from about 36,000 people in 59 countries, half residing in the United States, who used commercially available breathalyzer devices from one manufacturer (BACtrack).  

The 8 days marking recurrent nationally recognized events, and the days before and after them, were associated with mean blood-alcohol concentrations in the top fifth percentile for the year.

The same eight occasions marked significant bumps in ED visits related to acute alcohol ingestion in records from the California Office of Statewide Health Planning and Development (OSHPD), which documented almost 1.2 million such visits from 2005 to 2015.

Collectively in adjusted analysis, the eight nationally recognized events, compared with other days of the year, accounted for 2,640 excess alcohol-related ED visits per 100,000 person-years across all of California (P < .001).

Separately, ED visits coded for a diagnosis of AFib concentrated significantly around those same 8 days, on which there was an excess of 719 such AFib-related visits per 100,000 person-years (P = .008).

The analysis was replicated after exclusion of OSHPD records from anyone with a previous AFib-related ED visit or hospitalization, or previous outpatient procedure related to AFib, such as ablation or cardioversion. It saw 1,757 excess ED visits per 100,000 person-years (P < .001) for what was considered new-onset AFib in association with the eight nationally recognized events, compared with the rest of the year.  

The implication, that a bout of alcohol use leading to an ED visit can acutely raise the risk for a first episode of AFib, was subjected to a “negative control analysis” that focused on ED visits for supraventricular tachycardia. It showed no significant relationships with the eight nationally recognized events.

“We think that helps demonstrate that it’s not just more ED visits, more palpitations, or more heart-related visits per se” associated with acute alcohol use, Dr. Marcus said, “but that it’s something fairly specific to AFib.”

The authors declare no competing interests. Dr. Marcus has previously reported research with Medtronic, Eight Sleep, and Baylis; consulting for InCarda Therapeutics and Johnson & Johnson; and equity in InCarda Therapeutics as cofounder.

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

Emergency department visits for atrial fibrillation (AFib) appear to go up on days around some annual events in the United States that many people commemorate by consuming alcohol in excess – think Christmas, New Year’s Day, and Super Bowl Sunday.

The novel finding seemed especially true for people without a previous AFib diagnosis, suggesting that alcohol intake, and especially binge drinking, “may acutely enhance the risk” of new-onset AFib, propose researchers in their Jan. 12 report for the inaugural issue of Nature Cardiovascular Research.

Leveraging an international database of breathalyzer test results, the group saw jumps in alcohol intake across several days surrounding eight “recurrent, nationally recognized events,” which also included U.S. Independence Day and the FIFA World Cup.

They then compared the timing of those events to ED visits linked to acute alcohol ingestion and, separately, to ED visits coded for AFib in 10 years of data that cover all of California.

Collectively, the eight annual occasions for heavy alcohol use corresponded to spikes in both kinds of ED visit. Their relationship to AFib-related visits overall grew in strength when the analysis was restricted to new AFib diagnoses.

The researchers acknowledge the limitations of their observational study. Still, the findings represent “the first evidence that acute exposure to alcohol can lead to a given atrial fib episode in a short period of time, even among those without an established AFib diagnosis,” senior author Gregory M. Marcus, MD, MAS, University of California, San Francisco, told this news organization.

“The observation that this was detectable in the general population is a warning to those who drink heavily that any one episode of excessive alcohol consumption could land them in the ED with atrial fibrillation,” he said.

It’s “definitely speculation,” but such ED visits could represent an opportunity for individuals to link their new arrhythmia with a specific episode of excessive drinking, strengthening the message that the two are likely connected, Dr. Marcus observed. The experience could potentially inspire some to “reduce or eliminate” their alcohol intake in an effort to avoid future AFib.

The group obtained data from 2014 to 2016 on more than 1.2 million breath alcohol measurements from about 36,000 people in 59 countries, half residing in the United States, who used commercially available breathalyzer devices from one manufacturer (BACtrack).  

The 8 days marking recurrent nationally recognized events, and the days before and after them, were associated with mean blood-alcohol concentrations in the top fifth percentile for the year.

The same eight occasions marked significant bumps in ED visits related to acute alcohol ingestion in records from the California Office of Statewide Health Planning and Development (OSHPD), which documented almost 1.2 million such visits from 2005 to 2015.

Collectively in adjusted analysis, the eight nationally recognized events, compared with other days of the year, accounted for 2,640 excess alcohol-related ED visits per 100,000 person-years across all of California (P < .001).

Separately, ED visits coded for a diagnosis of AFib concentrated significantly around those same 8 days, on which there was an excess of 719 such AFib-related visits per 100,000 person-years (P = .008).

The analysis was replicated after exclusion of OSHPD records from anyone with a previous AFib-related ED visit or hospitalization, or previous outpatient procedure related to AFib, such as ablation or cardioversion. It saw 1,757 excess ED visits per 100,000 person-years (P < .001) for what was considered new-onset AFib in association with the eight nationally recognized events, compared with the rest of the year.  

The implication, that a bout of alcohol use leading to an ED visit can acutely raise the risk for a first episode of AFib, was subjected to a “negative control analysis” that focused on ED visits for supraventricular tachycardia. It showed no significant relationships with the eight nationally recognized events.

“We think that helps demonstrate that it’s not just more ED visits, more palpitations, or more heart-related visits per se” associated with acute alcohol use, Dr. Marcus said, “but that it’s something fairly specific to AFib.”

The authors declare no competing interests. Dr. Marcus has previously reported research with Medtronic, Eight Sleep, and Baylis; consulting for InCarda Therapeutics and Johnson & Johnson; and equity in InCarda Therapeutics as cofounder.

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

BUENOS AIRES – The Latin American Association of Cardiac and Endovascular Surgery (LACES) has demanded “urgent reconsideration” of the decision to downgrade the strength of the recommendation for revascularization or coronary artery bypass graft (CABG) surgery for multivessel disease in the new guideline on coronary artery revascularization, putting it in the same class as the recommendation for percutaneous coronary intervention, which has no apparent advantage over optimal medical therapy.

With the prevalence of stable ischemic heart disease in patients with multivessel disease, the contradiction between the evidence and the new recommendation “may affect the lives and survival of millions of patients worldwide and have a major socio-economic impact,” the association warned in a public letter.

In the 2011 guideline, CABG for patients with multivessel coronary artery disease was given a class I recommendation, which means that it is considered useful and effective and should be performed in the majority of patients in most circumstances. But the new, much weaker class IIb recommendation suggests that the benefit only marginally exceeds the risk and that it should be used selectively and only after careful consideration.

“It is an incomprehensible rollercoaster drop in the recommendation level. We totally disagree. In the absence of evidence, a IIb level provides equal freedom to send a patient to surgery or not. And in patients who are not being sent to surgery, it could take years of survival before we can be sure that we are doing the right thing,” said LACES president Víctor Dayan, MD, PhD, from the cardiovascular center at the Hospital de Clínicas “Dr. Manuel Quintela”, which is part of the School of Medicine at the University of the Republic, Montevideo, Uruguay.

The change in the recommendation for this indication “reflects new evidence showing no advantage of coronary artery bypass grafting over medical therapy alone to improve survival in patients with three-vessel coronary disease with preserved left ventricular function and no left main disease,” according to the authors of the guideline, issued jointly by the American College of Cardiology (ACC), the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI). In particular, they cite the 2019 ISCHEMIA clinical study that failed to show that an early invasive strategy reduces major adverse cardiovascular events, compared with optimal medical therapy and a handful of meta-analyses.

However, ISCHEMIA did not discriminate between the two types of invasive strategy – CABG and percutaneous coronary intervention (PCI) – so cannot be considered as a basis to downgrade the CABG recommendation, Dr. Dayan explained.

“Furthermore, the authors neglected previous RCTs that have shown the survival benefit of CABG in these patients and decided to put PCI in the same [class of recommendation], although no RCT has been able to show any survival advantage of PCI compared to optimal medical treatment,” the LACES letter states.

Basis should be evidence, ‘not inferences’

Three large randomized clinical trials and a 1994 meta-analysis with individual patient data from seven studies firmly established that survival is better with CABG than with medical treatment, the letter continues. However, the guideline authors did not provide any additional randomized clinical trials that refute this evidence.

“Furthermore, the committee disregarded data from the Ten-Year Follow-up Survival of the Medicine, Angioplasty, or Surgery Study (MASS II) randomized control[led] trial, which showed a lower incidence of cardiac mortality (as part of its secondary outcomes) following CABG compared to optimal medical therapy and PCI,” the letter explains.

The guideline authors might have judged current optimal medical therapy to be better than what existed 10, 15, or 30 years ago, diluting the relative benefits of surgery, but the “recommendation in a guideline must act on evidence, not inferences. And there is no evidence to support this drop in recommendation class,” Dr. Dayan said.

Other experts have drawn attention to the fact that two surgical societies – the American Association for Thoracic Surgery (AAST) and the Society of Thoracic Surgeons (STS) – did not endorse the final document, despite having participated in its review, reported this news organization.

“This is a very disappointing update that will negatively affect the lives of many people,” tweeted Marc Pelletier, MD, head of cardiac surgery at University Hospitals, Case Western Reserve University, Cleveland.

Contradictions in the text that examines the evidence and the final recommendations, are “unclear” and “open to various interpretations, when they should be a pillar for decisionmaking,” said Javier Ferrari Ayarragaray, MD, president of the Argentine College of Cardiovascular Surgeons (CACCV) and vice president of LACES.

The new guidelines “show no additional randomized controlled trial to support this downgrade in the level of evidence,” according to a recent CACCV statement. “The inclusion, approval and endorsement of this type of [recommendation,] including [other] international surgical scientific societies, such as STS, AATS, EACTS, LACES[,] is necessary to obtain a better understanding and agreement on the current evidence.”

In a Dec. 17, 2021 response to LACES, Patrick O’Gara, MD, who was chair of the ACC/AHA Joint Committee on Clinical Practice Guidelines at the time, and his successor, Joshua Beckman, MD, explained that both organizations approved the guideline for publication and support its authors “in their interpretation of the published evidence and findings.”

The pair pointed out that the drafting committee members, who have extensive clinical judgment and experience, deliberated extensively on the issue and that the change from a class I to a class IIb recommendation was “carefully considered after a review of the entire available and relevant evidence.”

“When we bring together multiple organizations to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of published and peer-reviewed literature and create clinical practice recommendations,” said Thomas Getchius, director of guideline strategy and operations at the AHA.

“The final guideline reflects the latest evidence-based recommendations for coronary artery revascularization, as agreed upon by the ACC, AHA, SCAI, and the full drafting committee,” Mr. Getchius said.

Dr. Dayan and Dr. Ferrari Ayarragaray have disclosed no relevant financial relationships. Mr. Getchius is an employee of the American Heart Association.

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

BUENOS AIRES – The Latin American Association of Cardiac and Endovascular Surgery (LACES) has demanded “urgent reconsideration” of the decision to downgrade the strength of the recommendation for revascularization or coronary artery bypass graft (CABG) surgery for multivessel disease in the new guideline on coronary artery revascularization, putting it in the same class as the recommendation for percutaneous coronary intervention, which has no apparent advantage over optimal medical therapy.

With the prevalence of stable ischemic heart disease in patients with multivessel disease, the contradiction between the evidence and the new recommendation “may affect the lives and survival of millions of patients worldwide and have a major socio-economic impact,” the association warned in a public letter.

In the 2011 guideline, CABG for patients with multivessel coronary artery disease was given a class I recommendation, which means that it is considered useful and effective and should be performed in the majority of patients in most circumstances. But the new, much weaker class IIb recommendation suggests that the benefit only marginally exceeds the risk and that it should be used selectively and only after careful consideration.

“It is an incomprehensible rollercoaster drop in the recommendation level. We totally disagree. In the absence of evidence, a IIb level provides equal freedom to send a patient to surgery or not. And in patients who are not being sent to surgery, it could take years of survival before we can be sure that we are doing the right thing,” said LACES president Víctor Dayan, MD, PhD, from the cardiovascular center at the Hospital de Clínicas “Dr. Manuel Quintela”, which is part of the School of Medicine at the University of the Republic, Montevideo, Uruguay.

The change in the recommendation for this indication “reflects new evidence showing no advantage of coronary artery bypass grafting over medical therapy alone to improve survival in patients with three-vessel coronary disease with preserved left ventricular function and no left main disease,” according to the authors of the guideline, issued jointly by the American College of Cardiology (ACC), the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI). In particular, they cite the 2019 ISCHEMIA clinical study that failed to show that an early invasive strategy reduces major adverse cardiovascular events, compared with optimal medical therapy and a handful of meta-analyses.

However, ISCHEMIA did not discriminate between the two types of invasive strategy – CABG and percutaneous coronary intervention (PCI) – so cannot be considered as a basis to downgrade the CABG recommendation, Dr. Dayan explained.

“Furthermore, the authors neglected previous RCTs that have shown the survival benefit of CABG in these patients and decided to put PCI in the same [class of recommendation], although no RCT has been able to show any survival advantage of PCI compared to optimal medical treatment,” the LACES letter states.

Basis should be evidence, ‘not inferences’

Three large randomized clinical trials and a 1994 meta-analysis with individual patient data from seven studies firmly established that survival is better with CABG than with medical treatment, the letter continues. However, the guideline authors did not provide any additional randomized clinical trials that refute this evidence.

“Furthermore, the committee disregarded data from the Ten-Year Follow-up Survival of the Medicine, Angioplasty, or Surgery Study (MASS II) randomized control[led] trial, which showed a lower incidence of cardiac mortality (as part of its secondary outcomes) following CABG compared to optimal medical therapy and PCI,” the letter explains.

The guideline authors might have judged current optimal medical therapy to be better than what existed 10, 15, or 30 years ago, diluting the relative benefits of surgery, but the “recommendation in a guideline must act on evidence, not inferences. And there is no evidence to support this drop in recommendation class,” Dr. Dayan said.

Other experts have drawn attention to the fact that two surgical societies – the American Association for Thoracic Surgery (AAST) and the Society of Thoracic Surgeons (STS) – did not endorse the final document, despite having participated in its review, reported this news organization.

“This is a very disappointing update that will negatively affect the lives of many people,” tweeted Marc Pelletier, MD, head of cardiac surgery at University Hospitals, Case Western Reserve University, Cleveland.

Contradictions in the text that examines the evidence and the final recommendations, are “unclear” and “open to various interpretations, when they should be a pillar for decisionmaking,” said Javier Ferrari Ayarragaray, MD, president of the Argentine College of Cardiovascular Surgeons (CACCV) and vice president of LACES.

The new guidelines “show no additional randomized controlled trial to support this downgrade in the level of evidence,” according to a recent CACCV statement. “The inclusion, approval and endorsement of this type of [recommendation,] including [other] international surgical scientific societies, such as STS, AATS, EACTS, LACES[,] is necessary to obtain a better understanding and agreement on the current evidence.”

In a Dec. 17, 2021 response to LACES, Patrick O’Gara, MD, who was chair of the ACC/AHA Joint Committee on Clinical Practice Guidelines at the time, and his successor, Joshua Beckman, MD, explained that both organizations approved the guideline for publication and support its authors “in their interpretation of the published evidence and findings.”

The pair pointed out that the drafting committee members, who have extensive clinical judgment and experience, deliberated extensively on the issue and that the change from a class I to a class IIb recommendation was “carefully considered after a review of the entire available and relevant evidence.”

“When we bring together multiple organizations to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of published and peer-reviewed literature and create clinical practice recommendations,” said Thomas Getchius, director of guideline strategy and operations at the AHA.

“The final guideline reflects the latest evidence-based recommendations for coronary artery revascularization, as agreed upon by the ACC, AHA, SCAI, and the full drafting committee,” Mr. Getchius said.

Dr. Dayan and Dr. Ferrari Ayarragaray have disclosed no relevant financial relationships. Mr. Getchius is an employee of the American Heart Association.

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

BUENOS AIRES – The Latin American Association of Cardiac and Endovascular Surgery (LACES) has demanded “urgent reconsideration” of the decision to downgrade the strength of the recommendation for revascularization or coronary artery bypass graft (CABG) surgery for multivessel disease in the new guideline on coronary artery revascularization, putting it in the same class as the recommendation for percutaneous coronary intervention, which has no apparent advantage over optimal medical therapy.

With the prevalence of stable ischemic heart disease in patients with multivessel disease, the contradiction between the evidence and the new recommendation “may affect the lives and survival of millions of patients worldwide and have a major socio-economic impact,” the association warned in a public letter.

In the 2011 guideline, CABG for patients with multivessel coronary artery disease was given a class I recommendation, which means that it is considered useful and effective and should be performed in the majority of patients in most circumstances. But the new, much weaker class IIb recommendation suggests that the benefit only marginally exceeds the risk and that it should be used selectively and only after careful consideration.

“It is an incomprehensible rollercoaster drop in the recommendation level. We totally disagree. In the absence of evidence, a IIb level provides equal freedom to send a patient to surgery or not. And in patients who are not being sent to surgery, it could take years of survival before we can be sure that we are doing the right thing,” said LACES president Víctor Dayan, MD, PhD, from the cardiovascular center at the Hospital de Clínicas “Dr. Manuel Quintela”, which is part of the School of Medicine at the University of the Republic, Montevideo, Uruguay.

The change in the recommendation for this indication “reflects new evidence showing no advantage of coronary artery bypass grafting over medical therapy alone to improve survival in patients with three-vessel coronary disease with preserved left ventricular function and no left main disease,” according to the authors of the guideline, issued jointly by the American College of Cardiology (ACC), the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI). In particular, they cite the 2019 ISCHEMIA clinical study that failed to show that an early invasive strategy reduces major adverse cardiovascular events, compared with optimal medical therapy and a handful of meta-analyses.

However, ISCHEMIA did not discriminate between the two types of invasive strategy – CABG and percutaneous coronary intervention (PCI) – so cannot be considered as a basis to downgrade the CABG recommendation, Dr. Dayan explained.

“Furthermore, the authors neglected previous RCTs that have shown the survival benefit of CABG in these patients and decided to put PCI in the same [class of recommendation], although no RCT has been able to show any survival advantage of PCI compared to optimal medical treatment,” the LACES letter states.

Basis should be evidence, ‘not inferences’

Three large randomized clinical trials and a 1994 meta-analysis with individual patient data from seven studies firmly established that survival is better with CABG than with medical treatment, the letter continues. However, the guideline authors did not provide any additional randomized clinical trials that refute this evidence.

“Furthermore, the committee disregarded data from the Ten-Year Follow-up Survival of the Medicine, Angioplasty, or Surgery Study (MASS II) randomized control[led] trial, which showed a lower incidence of cardiac mortality (as part of its secondary outcomes) following CABG compared to optimal medical therapy and PCI,” the letter explains.

The guideline authors might have judged current optimal medical therapy to be better than what existed 10, 15, or 30 years ago, diluting the relative benefits of surgery, but the “recommendation in a guideline must act on evidence, not inferences. And there is no evidence to support this drop in recommendation class,” Dr. Dayan said.

Other experts have drawn attention to the fact that two surgical societies – the American Association for Thoracic Surgery (AAST) and the Society of Thoracic Surgeons (STS) – did not endorse the final document, despite having participated in its review, reported this news organization.

“This is a very disappointing update that will negatively affect the lives of many people,” tweeted Marc Pelletier, MD, head of cardiac surgery at University Hospitals, Case Western Reserve University, Cleveland.

Contradictions in the text that examines the evidence and the final recommendations, are “unclear” and “open to various interpretations, when they should be a pillar for decisionmaking,” said Javier Ferrari Ayarragaray, MD, president of the Argentine College of Cardiovascular Surgeons (CACCV) and vice president of LACES.

The new guidelines “show no additional randomized controlled trial to support this downgrade in the level of evidence,” according to a recent CACCV statement. “The inclusion, approval and endorsement of this type of [recommendation,] including [other] international surgical scientific societies, such as STS, AATS, EACTS, LACES[,] is necessary to obtain a better understanding and agreement on the current evidence.”

In a Dec. 17, 2021 response to LACES, Patrick O’Gara, MD, who was chair of the ACC/AHA Joint Committee on Clinical Practice Guidelines at the time, and his successor, Joshua Beckman, MD, explained that both organizations approved the guideline for publication and support its authors “in their interpretation of the published evidence and findings.”

The pair pointed out that the drafting committee members, who have extensive clinical judgment and experience, deliberated extensively on the issue and that the change from a class I to a class IIb recommendation was “carefully considered after a review of the entire available and relevant evidence.”

“When we bring together multiple organizations to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of published and peer-reviewed literature and create clinical practice recommendations,” said Thomas Getchius, director of guideline strategy and operations at the AHA.

“The final guideline reflects the latest evidence-based recommendations for coronary artery revascularization, as agreed upon by the ACC, AHA, SCAI, and the full drafting committee,” Mr. Getchius said.

Dr. Dayan and Dr. Ferrari Ayarragaray have disclosed no relevant financial relationships. Mr. Getchius is an employee of the American Heart Association.

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

THE CASE

A 52-year-old man with a history of hypertension and gastroesophageal reflux disease (GERD) presented to the emergency department (ED) after an episode of syncope. He reported that the syncope occurred soon after he stood up to go to the kitchen to make dinner but was without prodrome or associated symptoms. He recalled little of the event, and the episode was unwitnessed. He had a few bruises on his arms but no significant injuries.

On questioning, he reported occasional palpitations but no changes in his normal exercise tolerance. His only medication was lisinopril 10 mg/d.

In the ED, his vital signs, physical exam (including orthostatic vital signs), basic labs (including troponin I), and a 12-lead EKG were normal. After a cardiology consultation, he was discharged home with a 30-day ambulatory rhythm monitor.

A few days later, while walking up and down some hills, he experienced about 15 seconds of chest pain accompanied by mild lightheadedness. Thinking it might be related to his GERD, he took some over-the-counter antacids when he returned home, since these had been effective for him in the past.

However, the rhythm monitoring company contacted the EKG lab to transmit a concerning strip (FIGURE). They also reported that the patient had been contacted and reported no further symptoms.

IMAGES COURTESY OF HARBORVIEW MEDICAL CENTER EKG LABORATORY

THE DIAGNOSIS

Most notable on the patient’s rhythm strip was a continuously varying QRS complex, which was indicative of polymorphic ventricular tachycardia and consistent with the patient’s syncope and other symptoms. Less obvious at first glance was an ST-segment elevation in the preceding beats. Comparison to a post-episode tracing (FIGURE) highlights the abnormality. Polymorphic ventricular tachycardia resolves in 1 of 2 ways: It will either stop on its own (causing syncope if it lasts more than a few seconds) or it will devolve into ventricular fibrillation, causing cardiac arrest.¹

The combination of these findings and the clinical scenario prompted a recommendation that the patient report to the ED for admission (his wife drove him). He was admitted to the intensive care unit (ICU) for continuous telemetry monitoring, and a cardiac catheterization was ordered. The procedure revealed a 99% thrombotic mid-right coronary artery lesion, for which aspiration thrombectomy and uncomplicated stenting were performed.

Continue to: DISCUSSION

 

 

DISCUSSION

Guidelines from the American College of Cardiology/American Heart Association/Heart Rhythm Society recommend a detailed history and physical exam, as well as an EKG, for the initial evaluation of syncope.² If this does not point to a diagnosis (and depending on the presentation and other factors), an ambulatory rhythm monitor can be considered. Other possible testing modalities include stress testing, resting transthoracic echocardiography, electrophysiologic testing, and cardiac magnetic resonance imaging or computed tomography.

Is the cause cardiac? The guidelines suggest that a cardiac cause of syncope is more likely if several of the following factors are present: age > 60 years; male sex; presence of known heart disease (acquired or congenital); brief prodrome (eg, palpitations) or no prodrome; exertional or supine syncope; 1 to 2 episodes; an abnormal cardiac exam; and a family history of premature sudden death.² A noncardiac cause is suggested by other factors: younger age; no known cardiac disease; standing or a position change from supine to sitting/standing; prodrome; specific triggers (eg, dehydration, pain); and frequent and prolonged stereotypic episodes.²

Our patient experienced syncope upon standing, which suggested a noncardiac cause. However, his history of palpitations increased our suspicion for a cardiac cause.

While the guidelines do not specify the number of factors or endorse a specific scoring system, such tools have been developed. For example, the EGSYS (Evaluation of Guidelines in Syncope Study) Score assigns 1 point for each of 6 factors: palpitations; heart disease and/or abnormal EKG; effort syncope; supine syncope; precipitating or predisposing factors; and autonomic prodromes. A score ≥ 3 identified cardiac syncope with a sensitivity of 95%, but with a specificity of only 61%. In the derivation study, patients with a score ≥ 3 had higher mortality than those with a lower score (17 vs 3%; P < .001).³

Myocardial ischemia can trigger ventricular arrhythmias. In the GUSTO-1 trial of fibrinolytic therapy in patients with acute ST-segment elevation myocardial infarction (n = 40,895), the incidence of ventricular tachycardia or ventricular fibrillation was 10.2%.⁴ In a pooled analysis (4 trials; n = 26,416) of patients who were treated for non–ST-segment elevation or unstable ­angina-type acute coronary syndromes, the rate of these arrhythmias was markedly lower (2.1%).⁵ The risk of ventricular arrhythmia is one reason close monitoring (eg, continuous telemetry, ICU admission) is the standard of care for patients with acute coronary syndromes.

Our patient experienced syncope upon standing, which suggested a noncardiac cause (usually orthostatic hypotension). However, the history of palpitations increased the suspicion for a cardiac cause, and thus the rhythm monitor was ordered.

THE TAKEAWAY

This case was unusual in that ambulatory monitoring captured electrocardiographic evidence of myocardial ischemia leading directly to a ventricular arrhythmia. In the evaluation of syncope, a detailed history, physical exam, and a baseline 12-lead EKG can sometimes give clues to an arrhythmic cause of syncope (eg, Brugada syndrome, prior infarct pattern, prolonged QTc, bradycardia, heart block, arrhythmogenic right ventricular cardiomyopathy)—but prolonged rhythm monitoring is sometimes needed to identify a cause.

CORRESPONDENCE
Michael A. Chen, MD, PhD, Harborview Medical Center, University of Washington School of Medicine, 325 9th Avenue, Box 359748 (Cardiology), Seattle, WA 98104; michen@u.washington.edu

THE CASE

A 52-year-old man with a history of hypertension and gastroesophageal reflux disease (GERD) presented to the emergency department (ED) after an episode of syncope. He reported that the syncope occurred soon after he stood up to go to the kitchen to make dinner but was without prodrome or associated symptoms. He recalled little of the event, and the episode was unwitnessed. He had a few bruises on his arms but no significant injuries.

On questioning, he reported occasional palpitations but no changes in his normal exercise tolerance. His only medication was lisinopril 10 mg/d.

In the ED, his vital signs, physical exam (including orthostatic vital signs), basic labs (including troponin I), and a 12-lead EKG were normal. After a cardiology consultation, he was discharged home with a 30-day ambulatory rhythm monitor.

A few days later, while walking up and down some hills, he experienced about 15 seconds of chest pain accompanied by mild lightheadedness. Thinking it might be related to his GERD, he took some over-the-counter antacids when he returned home, since these had been effective for him in the past.

However, the rhythm monitoring company contacted the EKG lab to transmit a concerning strip (FIGURE). They also reported that the patient had been contacted and reported no further symptoms.

IMAGES COURTESY OF HARBORVIEW MEDICAL CENTER EKG LABORATORY

THE DIAGNOSIS

Most notable on the patient’s rhythm strip was a continuously varying QRS complex, which was indicative of polymorphic ventricular tachycardia and consistent with the patient’s syncope and other symptoms. Less obvious at first glance was an ST-segment elevation in the preceding beats. Comparison to a post-episode tracing (FIGURE) highlights the abnormality. Polymorphic ventricular tachycardia resolves in 1 of 2 ways: It will either stop on its own (causing syncope if it lasts more than a few seconds) or it will devolve into ventricular fibrillation, causing cardiac arrest.¹

The combination of these findings and the clinical scenario prompted a recommendation that the patient report to the ED for admission (his wife drove him). He was admitted to the intensive care unit (ICU) for continuous telemetry monitoring, and a cardiac catheterization was ordered. The procedure revealed a 99% thrombotic mid-right coronary artery lesion, for which aspiration thrombectomy and uncomplicated stenting were performed.

Continue to: DISCUSSION

 

 

DISCUSSION

Guidelines from the American College of Cardiology/American Heart Association/Heart Rhythm Society recommend a detailed history and physical exam, as well as an EKG, for the initial evaluation of syncope.² If this does not point to a diagnosis (and depending on the presentation and other factors), an ambulatory rhythm monitor can be considered. Other possible testing modalities include stress testing, resting transthoracic echocardiography, electrophysiologic testing, and cardiac magnetic resonance imaging or computed tomography.

Is the cause cardiac? The guidelines suggest that a cardiac cause of syncope is more likely if several of the following factors are present: age > 60 years; male sex; presence of known heart disease (acquired or congenital); brief prodrome (eg, palpitations) or no prodrome; exertional or supine syncope; 1 to 2 episodes; an abnormal cardiac exam; and a family history of premature sudden death.² A noncardiac cause is suggested by other factors: younger age; no known cardiac disease; standing or a position change from supine to sitting/standing; prodrome; specific triggers (eg, dehydration, pain); and frequent and prolonged stereotypic episodes.²

Our patient experienced syncope upon standing, which suggested a noncardiac cause. However, his history of palpitations increased our suspicion for a cardiac cause.

While the guidelines do not specify the number of factors or endorse a specific scoring system, such tools have been developed. For example, the EGSYS (Evaluation of Guidelines in Syncope Study) Score assigns 1 point for each of 6 factors: palpitations; heart disease and/or abnormal EKG; effort syncope; supine syncope; precipitating or predisposing factors; and autonomic prodromes. A score ≥ 3 identified cardiac syncope with a sensitivity of 95%, but with a specificity of only 61%. In the derivation study, patients with a score ≥ 3 had higher mortality than those with a lower score (17 vs 3%; P < .001).³

Myocardial ischemia can trigger ventricular arrhythmias. In the GUSTO-1 trial of fibrinolytic therapy in patients with acute ST-segment elevation myocardial infarction (n = 40,895), the incidence of ventricular tachycardia or ventricular fibrillation was 10.2%.⁴ In a pooled analysis (4 trials; n = 26,416) of patients who were treated for non–ST-segment elevation or unstable ­angina-type acute coronary syndromes, the rate of these arrhythmias was markedly lower (2.1%).⁵ The risk of ventricular arrhythmia is one reason close monitoring (eg, continuous telemetry, ICU admission) is the standard of care for patients with acute coronary syndromes.

Our patient experienced syncope upon standing, which suggested a noncardiac cause (usually orthostatic hypotension). However, the history of palpitations increased the suspicion for a cardiac cause, and thus the rhythm monitor was ordered.

THE TAKEAWAY

This case was unusual in that ambulatory monitoring captured electrocardiographic evidence of myocardial ischemia leading directly to a ventricular arrhythmia. In the evaluation of syncope, a detailed history, physical exam, and a baseline 12-lead EKG can sometimes give clues to an arrhythmic cause of syncope (eg, Brugada syndrome, prior infarct pattern, prolonged QTc, bradycardia, heart block, arrhythmogenic right ventricular cardiomyopathy)—but prolonged rhythm monitoring is sometimes needed to identify a cause.

CORRESPONDENCE
Michael A. Chen, MD, PhD, Harborview Medical Center, University of Washington School of Medicine, 325 9th Avenue, Box 359748 (Cardiology), Seattle, WA 98104; michen@u.washington.edu

THE CASE

A 52-year-old man with a history of hypertension and gastroesophageal reflux disease (GERD) presented to the emergency department (ED) after an episode of syncope. He reported that the syncope occurred soon after he stood up to go to the kitchen to make dinner but was without prodrome or associated symptoms. He recalled little of the event, and the episode was unwitnessed. He had a few bruises on his arms but no significant injuries.

On questioning, he reported occasional palpitations but no changes in his normal exercise tolerance. His only medication was lisinopril 10 mg/d.

In the ED, his vital signs, physical exam (including orthostatic vital signs), basic labs (including troponin I), and a 12-lead EKG were normal. After a cardiology consultation, he was discharged home with a 30-day ambulatory rhythm monitor.

A few days later, while walking up and down some hills, he experienced about 15 seconds of chest pain accompanied by mild lightheadedness. Thinking it might be related to his GERD, he took some over-the-counter antacids when he returned home, since these had been effective for him in the past.

However, the rhythm monitoring company contacted the EKG lab to transmit a concerning strip (FIGURE). They also reported that the patient had been contacted and reported no further symptoms.

IMAGES COURTESY OF HARBORVIEW MEDICAL CENTER EKG LABORATORY

THE DIAGNOSIS

Most notable on the patient’s rhythm strip was a continuously varying QRS complex, which was indicative of polymorphic ventricular tachycardia and consistent with the patient’s syncope and other symptoms. Less obvious at first glance was an ST-segment elevation in the preceding beats. Comparison to a post-episode tracing (FIGURE) highlights the abnormality. Polymorphic ventricular tachycardia resolves in 1 of 2 ways: It will either stop on its own (causing syncope if it lasts more than a few seconds) or it will devolve into ventricular fibrillation, causing cardiac arrest.¹

The combination of these findings and the clinical scenario prompted a recommendation that the patient report to the ED for admission (his wife drove him). He was admitted to the intensive care unit (ICU) for continuous telemetry monitoring, and a cardiac catheterization was ordered. The procedure revealed a 99% thrombotic mid-right coronary artery lesion, for which aspiration thrombectomy and uncomplicated stenting were performed.

Continue to: DISCUSSION

 

 

DISCUSSION

Guidelines from the American College of Cardiology/American Heart Association/Heart Rhythm Society recommend a detailed history and physical exam, as well as an EKG, for the initial evaluation of syncope.² If this does not point to a diagnosis (and depending on the presentation and other factors), an ambulatory rhythm monitor can be considered. Other possible testing modalities include stress testing, resting transthoracic echocardiography, electrophysiologic testing, and cardiac magnetic resonance imaging or computed tomography.

Is the cause cardiac? The guidelines suggest that a cardiac cause of syncope is more likely if several of the following factors are present: age > 60 years; male sex; presence of known heart disease (acquired or congenital); brief prodrome (eg, palpitations) or no prodrome; exertional or supine syncope; 1 to 2 episodes; an abnormal cardiac exam; and a family history of premature sudden death.² A noncardiac cause is suggested by other factors: younger age; no known cardiac disease; standing or a position change from supine to sitting/standing; prodrome; specific triggers (eg, dehydration, pain); and frequent and prolonged stereotypic episodes.²

Our patient experienced syncope upon standing, which suggested a noncardiac cause. However, his history of palpitations increased our suspicion for a cardiac cause.

While the guidelines do not specify the number of factors or endorse a specific scoring system, such tools have been developed. For example, the EGSYS (Evaluation of Guidelines in Syncope Study) Score assigns 1 point for each of 6 factors: palpitations; heart disease and/or abnormal EKG; effort syncope; supine syncope; precipitating or predisposing factors; and autonomic prodromes. A score ≥ 3 identified cardiac syncope with a sensitivity of 95%, but with a specificity of only 61%. In the derivation study, patients with a score ≥ 3 had higher mortality than those with a lower score (17 vs 3%; P < .001).³

Myocardial ischemia can trigger ventricular arrhythmias. In the GUSTO-1 trial of fibrinolytic therapy in patients with acute ST-segment elevation myocardial infarction (n = 40,895), the incidence of ventricular tachycardia or ventricular fibrillation was 10.2%.⁴ In a pooled analysis (4 trials; n = 26,416) of patients who were treated for non–ST-segment elevation or unstable ­angina-type acute coronary syndromes, the rate of these arrhythmias was markedly lower (2.1%).⁵ The risk of ventricular arrhythmia is one reason close monitoring (eg, continuous telemetry, ICU admission) is the standard of care for patients with acute coronary syndromes.

Our patient experienced syncope upon standing, which suggested a noncardiac cause (usually orthostatic hypotension). However, the history of palpitations increased the suspicion for a cardiac cause, and thus the rhythm monitor was ordered.

THE TAKEAWAY

This case was unusual in that ambulatory monitoring captured electrocardiographic evidence of myocardial ischemia leading directly to a ventricular arrhythmia. In the evaluation of syncope, a detailed history, physical exam, and a baseline 12-lead EKG can sometimes give clues to an arrhythmic cause of syncope (eg, Brugada syndrome, prior infarct pattern, prolonged QTc, bradycardia, heart block, arrhythmogenic right ventricular cardiomyopathy)—but prolonged rhythm monitoring is sometimes needed to identify a cause.

CORRESPONDENCE
Michael A. Chen, MD, PhD, Harborview Medical Center, University of Washington School of Medicine, 325 9th Avenue, Box 359748 (Cardiology), Seattle, WA 98104; michen@u.washington.edu

New research suggests serial coronary CT angiography (CCTA) can provide novel insights into the association between lipoprotein(a) and plaque progression over time in patients with advanced coronary artery disease.

Researchers examined data from 191 individuals with multivessel coronary disease receiving preventive statin (95%) and antiplatelet (100%) therapy in the single-center Scottish DIAMOND trial and compared CCTA at baseline and 12 months available for 160 patients.

As reported in the Journal of the American College of Cardiology, patients with high Lp(a), defined as at least 70 mg/dL, had higher baseline high-density lipoprotein cholesterol and ASSIGN scores than those with low Lp(a) but had comparable coronary artery calcium (CAC) scores and total, calcific, noncalcific, and low-attenuation plaque (LAP) volumes.

At 1 year, however, LAP volume – a marker for necrotic core – increased by 26.2 mm3 in the high-Lp(a) group and decreased by –0.7 mm3 in the low-Lp(a) group (P = .020).

There was no significant difference in change in total, calcific, and noncalcific plaque volumes between groups.

In multivariate linear regression analysis adjusting for body mass index, ASSIGN score, and segment involvement score, LAP volume increased by 10.5% for each 50 mg/dL increment in Lp(a) (P = .034).

“It’s an exciting observation, because we’ve done previous studies where we’ve demonstrated the association of that particular plaque type with future myocardial infarction,” senior author Marc R. Dweck, MD, PhD, University of Amsterdam, told this news organization. “So, you’ve potentially got an explanation for the adverse prognosis associated with high lipoprotein(a) and its link to cardiovascular events and, in particular, myocardial infarction.”

The team’s recent SCOT-HEART analysis found that LAP burden was a stronger predictor of myocardial infarction (MI) than cardiovascular risk scores, stenosis severity, and CAC scoring, with MI risk nearly five-fold higher if LAP was above 4%.

As to why total, calcific, and noncalcific plaque volumes didn’t change significantly on repeat CCTA in the present study, Dr. Dweck said it’s possible that the sample was too small and follow-up too short but also that “total plaque volume is really dominated by the fibrous plaque, which doesn’t appear affected by Lp(a).” Nevertheless, Lp(a)’s effect on low-attenuation plaque was clearly present and supported by the change in fibro-fatty plaque, the next-most unstable plaque type.

At 1 year, fibro-fatty plaque volume was 55.0 mm3 in the high-Lp(a) group versus –25.0 mm3 in the low-Lp(a) group (P = .020).

Lp(a) was associated with fibro-fatty plaque progression in univariate analysis (β = 6.7%; P = .034) and showed a trend in multivariable analysis (β = 6.0%; P = .062).

“This study shows you can track changes in plaque over time and highlight important disease mechanisms and use them to understand the pathology of the disease,” Dr. Dweck said. “I’m very encouraged by this.”

What’s novel in the present study is that “it represents the beginning of our understanding of the role of Lp(a) in plaque progression,” Sotirios Tsimikas, MD, University of California, San Diego, and Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, say in an accompanying commentary.

They note that prior studies, including the Dallas Heart Study, have struggled to find a strong association between Lp(a) with the extent or progression of CAC, despite elevated Lp(a) and CAC identifying higher-risk patients.

Similarly, a meta-analysis of intravascular ultrasound trials turned up only a 1.2% absolute difference in atheroma volume in patients with elevated Lp(a), and a recent optical coherence tomography study found an association of Lp(a) with thin-cap fibroatheromas but not lipid core.

With just 36 patients with elevated Lp(a), however, the current findings need validation in a larger data set, Dr. Tsimikas and Dr. Narula say.

Although Lp(a) is genetically elevated in about one in five individuals and measurement is recommended in European dyslipidemia guidelines, testing rates are low, in part because the argument has been that there are no Lp(a)-lowering therapies available, Dr. Dweck observed. That may change with the phase 3 cardiovascular outcomes Lp(a)HORIZON trial, which follows strong phase 2 results with the antisense agent AKCEA-APO(a)-LRx and is enrolling patients similar to the current cohort.

“Ultimately it comes down to that fundamental thing, that you need an action once you’ve done the test and then insurers will be happy to pay for it and clinicians will ask for it. That’s why that trial is so important,” Dr. Dweck said.

Dr. Tsimikas and Dr. Narula also point to the eagerly awaited results of that trial, expected in 2025. “A positive trial is likely to lead to additional trials and new drugs that may reinvigorate the use of imaging modalities that could go beyond plaque volume and atherosclerosis to also predict clinically relevant inflammation and atherothrombosis,” they conclude.

Dr. Dweck is supported by the British Heart Foundation and is the recipient of the Sir Jules Thorn Award for Biomedical Research 2015; has received speaker fees from Pfizer and Novartis; and has received consultancy fees from Novartis, Jupiter Bioventures, and Silence Therapeutics. Coauthor disclosures are listed in the paper. Dr. Tsimikas has a dual appointment at the University of California, San Diego, (UCSD) and Ionis Pharmaceuticals; is a coinventor and receives royalties from patents owned by UCSD; and is a cofounder and has an equity interest in Oxitope and its affiliates, Kleanthi Diagnostics, and Covicept Therapeutics. Dr. Narula reports having no relevant financial relationships.

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

New research suggests serial coronary CT angiography (CCTA) can provide novel insights into the association between lipoprotein(a) and plaque progression over time in patients with advanced coronary artery disease.

Researchers examined data from 191 individuals with multivessel coronary disease receiving preventive statin (95%) and antiplatelet (100%) therapy in the single-center Scottish DIAMOND trial and compared CCTA at baseline and 12 months available for 160 patients.

As reported in the Journal of the American College of Cardiology, patients with high Lp(a), defined as at least 70 mg/dL, had higher baseline high-density lipoprotein cholesterol and ASSIGN scores than those with low Lp(a) but had comparable coronary artery calcium (CAC) scores and total, calcific, noncalcific, and low-attenuation plaque (LAP) volumes.

At 1 year, however, LAP volume – a marker for necrotic core – increased by 26.2 mm3 in the high-Lp(a) group and decreased by –0.7 mm3 in the low-Lp(a) group (P = .020).

There was no significant difference in change in total, calcific, and noncalcific plaque volumes between groups.

In multivariate linear regression analysis adjusting for body mass index, ASSIGN score, and segment involvement score, LAP volume increased by 10.5% for each 50 mg/dL increment in Lp(a) (P = .034).

“It’s an exciting observation, because we’ve done previous studies where we’ve demonstrated the association of that particular plaque type with future myocardial infarction,” senior author Marc R. Dweck, MD, PhD, University of Amsterdam, told this news organization. “So, you’ve potentially got an explanation for the adverse prognosis associated with high lipoprotein(a) and its link to cardiovascular events and, in particular, myocardial infarction.”

The team’s recent SCOT-HEART analysis found that LAP burden was a stronger predictor of myocardial infarction (MI) than cardiovascular risk scores, stenosis severity, and CAC scoring, with MI risk nearly five-fold higher if LAP was above 4%.

As to why total, calcific, and noncalcific plaque volumes didn’t change significantly on repeat CCTA in the present study, Dr. Dweck said it’s possible that the sample was too small and follow-up too short but also that “total plaque volume is really dominated by the fibrous plaque, which doesn’t appear affected by Lp(a).” Nevertheless, Lp(a)’s effect on low-attenuation plaque was clearly present and supported by the change in fibro-fatty plaque, the next-most unstable plaque type.

At 1 year, fibro-fatty plaque volume was 55.0 mm3 in the high-Lp(a) group versus –25.0 mm3 in the low-Lp(a) group (P = .020).

Lp(a) was associated with fibro-fatty plaque progression in univariate analysis (β = 6.7%; P = .034) and showed a trend in multivariable analysis (β = 6.0%; P = .062).

“This study shows you can track changes in plaque over time and highlight important disease mechanisms and use them to understand the pathology of the disease,” Dr. Dweck said. “I’m very encouraged by this.”

What’s novel in the present study is that “it represents the beginning of our understanding of the role of Lp(a) in plaque progression,” Sotirios Tsimikas, MD, University of California, San Diego, and Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, say in an accompanying commentary.

They note that prior studies, including the Dallas Heart Study, have struggled to find a strong association between Lp(a) with the extent or progression of CAC, despite elevated Lp(a) and CAC identifying higher-risk patients.

Similarly, a meta-analysis of intravascular ultrasound trials turned up only a 1.2% absolute difference in atheroma volume in patients with elevated Lp(a), and a recent optical coherence tomography study found an association of Lp(a) with thin-cap fibroatheromas but not lipid core.

With just 36 patients with elevated Lp(a), however, the current findings need validation in a larger data set, Dr. Tsimikas and Dr. Narula say.

Although Lp(a) is genetically elevated in about one in five individuals and measurement is recommended in European dyslipidemia guidelines, testing rates are low, in part because the argument has been that there are no Lp(a)-lowering therapies available, Dr. Dweck observed. That may change with the phase 3 cardiovascular outcomes Lp(a)HORIZON trial, which follows strong phase 2 results with the antisense agent AKCEA-APO(a)-LRx and is enrolling patients similar to the current cohort.

“Ultimately it comes down to that fundamental thing, that you need an action once you’ve done the test and then insurers will be happy to pay for it and clinicians will ask for it. That’s why that trial is so important,” Dr. Dweck said.

Dr. Tsimikas and Dr. Narula also point to the eagerly awaited results of that trial, expected in 2025. “A positive trial is likely to lead to additional trials and new drugs that may reinvigorate the use of imaging modalities that could go beyond plaque volume and atherosclerosis to also predict clinically relevant inflammation and atherothrombosis,” they conclude.

Dr. Dweck is supported by the British Heart Foundation and is the recipient of the Sir Jules Thorn Award for Biomedical Research 2015; has received speaker fees from Pfizer and Novartis; and has received consultancy fees from Novartis, Jupiter Bioventures, and Silence Therapeutics. Coauthor disclosures are listed in the paper. Dr. Tsimikas has a dual appointment at the University of California, San Diego, (UCSD) and Ionis Pharmaceuticals; is a coinventor and receives royalties from patents owned by UCSD; and is a cofounder and has an equity interest in Oxitope and its affiliates, Kleanthi Diagnostics, and Covicept Therapeutics. Dr. Narula reports having no relevant financial relationships.

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

New research suggests serial coronary CT angiography (CCTA) can provide novel insights into the association between lipoprotein(a) and plaque progression over time in patients with advanced coronary artery disease.

Researchers examined data from 191 individuals with multivessel coronary disease receiving preventive statin (95%) and antiplatelet (100%) therapy in the single-center Scottish DIAMOND trial and compared CCTA at baseline and 12 months available for 160 patients.

As reported in the Journal of the American College of Cardiology, patients with high Lp(a), defined as at least 70 mg/dL, had higher baseline high-density lipoprotein cholesterol and ASSIGN scores than those with low Lp(a) but had comparable coronary artery calcium (CAC) scores and total, calcific, noncalcific, and low-attenuation plaque (LAP) volumes.

At 1 year, however, LAP volume – a marker for necrotic core – increased by 26.2 mm3 in the high-Lp(a) group and decreased by –0.7 mm3 in the low-Lp(a) group (P = .020).

There was no significant difference in change in total, calcific, and noncalcific plaque volumes between groups.

In multivariate linear regression analysis adjusting for body mass index, ASSIGN score, and segment involvement score, LAP volume increased by 10.5% for each 50 mg/dL increment in Lp(a) (P = .034).

“It’s an exciting observation, because we’ve done previous studies where we’ve demonstrated the association of that particular plaque type with future myocardial infarction,” senior author Marc R. Dweck, MD, PhD, University of Amsterdam, told this news organization. “So, you’ve potentially got an explanation for the adverse prognosis associated with high lipoprotein(a) and its link to cardiovascular events and, in particular, myocardial infarction.”

The team’s recent SCOT-HEART analysis found that LAP burden was a stronger predictor of myocardial infarction (MI) than cardiovascular risk scores, stenosis severity, and CAC scoring, with MI risk nearly five-fold higher if LAP was above 4%.

As to why total, calcific, and noncalcific plaque volumes didn’t change significantly on repeat CCTA in the present study, Dr. Dweck said it’s possible that the sample was too small and follow-up too short but also that “total plaque volume is really dominated by the fibrous plaque, which doesn’t appear affected by Lp(a).” Nevertheless, Lp(a)’s effect on low-attenuation plaque was clearly present and supported by the change in fibro-fatty plaque, the next-most unstable plaque type.

At 1 year, fibro-fatty plaque volume was 55.0 mm3 in the high-Lp(a) group versus –25.0 mm3 in the low-Lp(a) group (P = .020).

Lp(a) was associated with fibro-fatty plaque progression in univariate analysis (β = 6.7%; P = .034) and showed a trend in multivariable analysis (β = 6.0%; P = .062).

“This study shows you can track changes in plaque over time and highlight important disease mechanisms and use them to understand the pathology of the disease,” Dr. Dweck said. “I’m very encouraged by this.”

What’s novel in the present study is that “it represents the beginning of our understanding of the role of Lp(a) in plaque progression,” Sotirios Tsimikas, MD, University of California, San Diego, and Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, say in an accompanying commentary.

They note that prior studies, including the Dallas Heart Study, have struggled to find a strong association between Lp(a) with the extent or progression of CAC, despite elevated Lp(a) and CAC identifying higher-risk patients.

Similarly, a meta-analysis of intravascular ultrasound trials turned up only a 1.2% absolute difference in atheroma volume in patients with elevated Lp(a), and a recent optical coherence tomography study found an association of Lp(a) with thin-cap fibroatheromas but not lipid core.

With just 36 patients with elevated Lp(a), however, the current findings need validation in a larger data set, Dr. Tsimikas and Dr. Narula say.

Although Lp(a) is genetically elevated in about one in five individuals and measurement is recommended in European dyslipidemia guidelines, testing rates are low, in part because the argument has been that there are no Lp(a)-lowering therapies available, Dr. Dweck observed. That may change with the phase 3 cardiovascular outcomes Lp(a)HORIZON trial, which follows strong phase 2 results with the antisense agent AKCEA-APO(a)-LRx and is enrolling patients similar to the current cohort.

“Ultimately it comes down to that fundamental thing, that you need an action once you’ve done the test and then insurers will be happy to pay for it and clinicians will ask for it. That’s why that trial is so important,” Dr. Dweck said.

Dr. Tsimikas and Dr. Narula also point to the eagerly awaited results of that trial, expected in 2025. “A positive trial is likely to lead to additional trials and new drugs that may reinvigorate the use of imaging modalities that could go beyond plaque volume and atherosclerosis to also predict clinically relevant inflammation and atherothrombosis,” they conclude.

Dr. Dweck is supported by the British Heart Foundation and is the recipient of the Sir Jules Thorn Award for Biomedical Research 2015; has received speaker fees from Pfizer and Novartis; and has received consultancy fees from Novartis, Jupiter Bioventures, and Silence Therapeutics. Coauthor disclosures are listed in the paper. Dr. Tsimikas has a dual appointment at the University of California, San Diego, (UCSD) and Ionis Pharmaceuticals; is a coinventor and receives royalties from patents owned by UCSD; and is a cofounder and has an equity interest in Oxitope and its affiliates, Kleanthi Diagnostics, and Covicept Therapeutics. Dr. Narula reports having no relevant financial relationships.

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

In a meta-analysis of more than 1 million mothers, those who breastfed their children had an 11% to 17% lower risk of developing cardiovascular disease (CVD), coronary heart disease (CHD), or stroke, and of dying from CVD, in later life than mothers who did not.

On average, the women had two children and had breastfed for 15.9 months in total. Longer breastfeeding was associated with greater CV health benefit.

This meta-analysis of eight studies from different countries was published online Jan. 11 in an issue of the Journal of the American Heart Association devoted to the impact of pregnancy on CV health in the mother and child.

Breastfeeding is known to be associated with a lower risk for death from infectious disease and with fewer respiratory infections in babies, the researchers write, but what is less well known is that it is also associated with a reduced risk for breast and ovarian cancer and type 2 diabetes in mothers.

The current study showed a clear association between breastfeeding and reduced risk for CVD in later life, lead author Lena Tschiderer, Dipl.-Ing., PhD, and senior author Peter Willeit, MD, MPhil, PhD, summarized in a joint email to this news organization.

Specifically, mothers who had breastfed their children at any time had an 11% lower risk for CVD, a 14% lower risk for CHD, a 12% lower risk for stroke, and a 17% lower risk of dying from CVD in later life, compared with other mothers.

On the basis of existing evidence, the researchers write, the World Health Organization recommends exclusive breastfeeding until a baby is 6 months old, followed by breastfeeding plus complementary feeding until the baby is 2 years or older.

“We believe that [breastfeeding] benefits for the mother are communicated poorly,” said Dr. Tschiderer and Dr. Willeit, from the University of Innsbruck, Austria.

“Positive effects of breastfeeding on mothers need to be communicated effectively, awareness for breastfeeding recommendations needs to be raised, and interventions to promote and facilitate breastfeeding need to be implemented and reinforced,” the researchers conclude.
 

‘Should not be ignored’

Two cardiologists invited to comment, who were not involved with the research, noted that this study provides insight into an important topic.

“This is yet another body of evidence [and the largest population to date] to show that breastfeeding is protective for women and may show important beneficial effects in terms of CV risk,” Roxana Mehran, MD, said in an email.

“The risk reductions were 11% for CVD events and 14% for CHD events; these are impressive numbers,” said Dr. Mehran, from Icahn School of Medicine at Mount Sinai, New York.

“The caveat,” she said, “is that these are data from several trials, but nonetheless, this is a very important observation that should not be ignored.”

The study did not address the definitive amount of time of breastfeeding and its correlation to the improvement of CVD risk, but it did show that for the lifetime duration, the longer the better.

“The beneficial effects,” she noted, “can be linked to hormones during breastfeeding, as well as weight loss associated with breastfeeding, and resetting the maternal metabolism, as the authors suggest.”

Clinicians and employers “must provide ways to educate women about breastfeeding and make it easy for women who are in the workplace to pump, and to provide them with resources” where possible, Dr. Mehran said.

Michelle O’Donoghue, MD, MPH, noted that over the past several years, there has been intense interest in the possible health benefits of breastfeeding for both mother and child.

There is biologic plausibility for some of the possible maternal benefits because the favorable CV effects of both prolactin and oxytocin are only now being better understood, said Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School, Boston.

“The current meta-analysis provides a large dataset that helps support the concept that breastfeeding may offer some cardiovascular benefit for the mother,” she agreed.

“However, ultimately more research will be necessary since this method of combining data across trials relies upon the robustness of the statistical method in each study,” Dr. O’Donoghue said. “I applaud the authors for shining a spotlight on this important topic.”

Although the benefits of breastfeeding appear to continue over time, “it is incredibly difficult for women to continue breastfeeding once they return to work,” she added. “Women in some countries outside the U.S. have an advantage due to longer durations of maternity leave.

“If we want to encourage breastfeeding,” Dr. O’Donoghue stressed, “we need to make sure that we put the right supports in place. Women need protected places to breastfeed in the workplace and places to store their milk. Most importantly, women need to be allowed dedicated time to make it happen.”
 

First large study of CVD in mothers

Emerging individual studies suggest that mothers who breastfeed may have a lower risk for CVD in later life, but studies have been inconsistent, and it is not clear if longer breastfeeding would strengthen this benefit, the authors note.

To examine this, they pooled data from the following eight studies (with study acronym, country, and baseline enrolment dates in brackets): 45&Up (Australia, 2006-2009), China Kadoorie Biobank (CKB, China, 2004-2008), European Prospective Investigation into Cancer and Nutrition (EPIC, multinational, 1992-2000), Gallagher et al. (China, 1989-1991), Nord-Trøndelag Health Survey 2 (HUNT2, Norway, 1995-1997), Japan Public Health Center-based Prospective Study (JPHC, Japan, 1990-1994), Nurses’ Health Study (NHS, U.S., 1986), and the Woman’s Health Initiative (WHI, U.S., 1993-1998).

On average, the women were 51.3 years old (range, 40-65 years) when they enrolled in the study, and they were followed for a median of 10.3 years (range, 7.9-20.9 years, in the individual studies).

On average, they had their first child at age 25 and had two to three children (mean, 2.3); 82% had breastfed at some point (ranging from 58% of women in the two U.S. studies to 97% in CKB and HUNT2).

The women had breastfed for a mean of 7.4 to 18.9 months during their lifetimes (except women in the CKB study, who had breastfed for a median of 24 months).

Among the 1,192,700 women, there were 54,226 incident CVD events, 26,913 incident CHD events, 30,843 incident strokes, and 10,766 deaths from CVD during follow-up.

The researchers acknowledge that study limitations include the fact that there could have been publication bias, since fewer than 10 studies were available for pooling. There was significant between-study heterogeneity for CVD, CHD, and stroke outcomes.

Participant-level data were also lacking, and breastfeeding was self-reported. There may have been unaccounted residual confounding, and the benefits of lifetime breastfeeding that is longer than 2 years are not clear, because few women in this population breastfed that long.

The research was funded by the Austrian Science Fund. The researchers and Dr. Mehran and Dr. O’Donoghue have no relevant financial disclosures.

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

In a meta-analysis of more than 1 million mothers, those who breastfed their children had an 11% to 17% lower risk of developing cardiovascular disease (CVD), coronary heart disease (CHD), or stroke, and of dying from CVD, in later life than mothers who did not.

On average, the women had two children and had breastfed for 15.9 months in total. Longer breastfeeding was associated with greater CV health benefit.

This meta-analysis of eight studies from different countries was published online Jan. 11 in an issue of the Journal of the American Heart Association devoted to the impact of pregnancy on CV health in the mother and child.

Breastfeeding is known to be associated with a lower risk for death from infectious disease and with fewer respiratory infections in babies, the researchers write, but what is less well known is that it is also associated with a reduced risk for breast and ovarian cancer and type 2 diabetes in mothers.

The current study showed a clear association between breastfeeding and reduced risk for CVD in later life, lead author Lena Tschiderer, Dipl.-Ing., PhD, and senior author Peter Willeit, MD, MPhil, PhD, summarized in a joint email to this news organization.

Specifically, mothers who had breastfed their children at any time had an 11% lower risk for CVD, a 14% lower risk for CHD, a 12% lower risk for stroke, and a 17% lower risk of dying from CVD in later life, compared with other mothers.

On the basis of existing evidence, the researchers write, the World Health Organization recommends exclusive breastfeeding until a baby is 6 months old, followed by breastfeeding plus complementary feeding until the baby is 2 years or older.

“We believe that [breastfeeding] benefits for the mother are communicated poorly,” said Dr. Tschiderer and Dr. Willeit, from the University of Innsbruck, Austria.

“Positive effects of breastfeeding on mothers need to be communicated effectively, awareness for breastfeeding recommendations needs to be raised, and interventions to promote and facilitate breastfeeding need to be implemented and reinforced,” the researchers conclude.
 

‘Should not be ignored’

Two cardiologists invited to comment, who were not involved with the research, noted that this study provides insight into an important topic.

“This is yet another body of evidence [and the largest population to date] to show that breastfeeding is protective for women and may show important beneficial effects in terms of CV risk,” Roxana Mehran, MD, said in an email.

“The risk reductions were 11% for CVD events and 14% for CHD events; these are impressive numbers,” said Dr. Mehran, from Icahn School of Medicine at Mount Sinai, New York.

“The caveat,” she said, “is that these are data from several trials, but nonetheless, this is a very important observation that should not be ignored.”

The study did not address the definitive amount of time of breastfeeding and its correlation to the improvement of CVD risk, but it did show that for the lifetime duration, the longer the better.

“The beneficial effects,” she noted, “can be linked to hormones during breastfeeding, as well as weight loss associated with breastfeeding, and resetting the maternal metabolism, as the authors suggest.”

Clinicians and employers “must provide ways to educate women about breastfeeding and make it easy for women who are in the workplace to pump, and to provide them with resources” where possible, Dr. Mehran said.

Michelle O’Donoghue, MD, MPH, noted that over the past several years, there has been intense interest in the possible health benefits of breastfeeding for both mother and child.

There is biologic plausibility for some of the possible maternal benefits because the favorable CV effects of both prolactin and oxytocin are only now being better understood, said Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School, Boston.

“The current meta-analysis provides a large dataset that helps support the concept that breastfeeding may offer some cardiovascular benefit for the mother,” she agreed.

“However, ultimately more research will be necessary since this method of combining data across trials relies upon the robustness of the statistical method in each study,” Dr. O’Donoghue said. “I applaud the authors for shining a spotlight on this important topic.”

Although the benefits of breastfeeding appear to continue over time, “it is incredibly difficult for women to continue breastfeeding once they return to work,” she added. “Women in some countries outside the U.S. have an advantage due to longer durations of maternity leave.

“If we want to encourage breastfeeding,” Dr. O’Donoghue stressed, “we need to make sure that we put the right supports in place. Women need protected places to breastfeed in the workplace and places to store their milk. Most importantly, women need to be allowed dedicated time to make it happen.”
 

First large study of CVD in mothers

Emerging individual studies suggest that mothers who breastfeed may have a lower risk for CVD in later life, but studies have been inconsistent, and it is not clear if longer breastfeeding would strengthen this benefit, the authors note.

To examine this, they pooled data from the following eight studies (with study acronym, country, and baseline enrolment dates in brackets): 45&Up (Australia, 2006-2009), China Kadoorie Biobank (CKB, China, 2004-2008), European Prospective Investigation into Cancer and Nutrition (EPIC, multinational, 1992-2000), Gallagher et al. (China, 1989-1991), Nord-Trøndelag Health Survey 2 (HUNT2, Norway, 1995-1997), Japan Public Health Center-based Prospective Study (JPHC, Japan, 1990-1994), Nurses’ Health Study (NHS, U.S., 1986), and the Woman’s Health Initiative (WHI, U.S., 1993-1998).

On average, the women were 51.3 years old (range, 40-65 years) when they enrolled in the study, and they were followed for a median of 10.3 years (range, 7.9-20.9 years, in the individual studies).

On average, they had their first child at age 25 and had two to three children (mean, 2.3); 82% had breastfed at some point (ranging from 58% of women in the two U.S. studies to 97% in CKB and HUNT2).

The women had breastfed for a mean of 7.4 to 18.9 months during their lifetimes (except women in the CKB study, who had breastfed for a median of 24 months).

Among the 1,192,700 women, there were 54,226 incident CVD events, 26,913 incident CHD events, 30,843 incident strokes, and 10,766 deaths from CVD during follow-up.

The researchers acknowledge that study limitations include the fact that there could have been publication bias, since fewer than 10 studies were available for pooling. There was significant between-study heterogeneity for CVD, CHD, and stroke outcomes.

Participant-level data were also lacking, and breastfeeding was self-reported. There may have been unaccounted residual confounding, and the benefits of lifetime breastfeeding that is longer than 2 years are not clear, because few women in this population breastfed that long.

The research was funded by the Austrian Science Fund. The researchers and Dr. Mehran and Dr. O’Donoghue have no relevant financial disclosures.

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

In a meta-analysis of more than 1 million mothers, those who breastfed their children had an 11% to 17% lower risk of developing cardiovascular disease (CVD), coronary heart disease (CHD), or stroke, and of dying from CVD, in later life than mothers who did not.

On average, the women had two children and had breastfed for 15.9 months in total. Longer breastfeeding was associated with greater CV health benefit.

This meta-analysis of eight studies from different countries was published online Jan. 11 in an issue of the Journal of the American Heart Association devoted to the impact of pregnancy on CV health in the mother and child.

Breastfeeding is known to be associated with a lower risk for death from infectious disease and with fewer respiratory infections in babies, the researchers write, but what is less well known is that it is also associated with a reduced risk for breast and ovarian cancer and type 2 diabetes in mothers.

The current study showed a clear association between breastfeeding and reduced risk for CVD in later life, lead author Lena Tschiderer, Dipl.-Ing., PhD, and senior author Peter Willeit, MD, MPhil, PhD, summarized in a joint email to this news organization.

Specifically, mothers who had breastfed their children at any time had an 11% lower risk for CVD, a 14% lower risk for CHD, a 12% lower risk for stroke, and a 17% lower risk of dying from CVD in later life, compared with other mothers.

On the basis of existing evidence, the researchers write, the World Health Organization recommends exclusive breastfeeding until a baby is 6 months old, followed by breastfeeding plus complementary feeding until the baby is 2 years or older.

“We believe that [breastfeeding] benefits for the mother are communicated poorly,” said Dr. Tschiderer and Dr. Willeit, from the University of Innsbruck, Austria.

“Positive effects of breastfeeding on mothers need to be communicated effectively, awareness for breastfeeding recommendations needs to be raised, and interventions to promote and facilitate breastfeeding need to be implemented and reinforced,” the researchers conclude.
 

‘Should not be ignored’

Two cardiologists invited to comment, who were not involved with the research, noted that this study provides insight into an important topic.

“This is yet another body of evidence [and the largest population to date] to show that breastfeeding is protective for women and may show important beneficial effects in terms of CV risk,” Roxana Mehran, MD, said in an email.

“The risk reductions were 11% for CVD events and 14% for CHD events; these are impressive numbers,” said Dr. Mehran, from Icahn School of Medicine at Mount Sinai, New York.

“The caveat,” she said, “is that these are data from several trials, but nonetheless, this is a very important observation that should not be ignored.”

The study did not address the definitive amount of time of breastfeeding and its correlation to the improvement of CVD risk, but it did show that for the lifetime duration, the longer the better.

“The beneficial effects,” she noted, “can be linked to hormones during breastfeeding, as well as weight loss associated with breastfeeding, and resetting the maternal metabolism, as the authors suggest.”

Clinicians and employers “must provide ways to educate women about breastfeeding and make it easy for women who are in the workplace to pump, and to provide them with resources” where possible, Dr. Mehran said.

Michelle O’Donoghue, MD, MPH, noted that over the past several years, there has been intense interest in the possible health benefits of breastfeeding for both mother and child.

There is biologic plausibility for some of the possible maternal benefits because the favorable CV effects of both prolactin and oxytocin are only now being better understood, said Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School, Boston.

“The current meta-analysis provides a large dataset that helps support the concept that breastfeeding may offer some cardiovascular benefit for the mother,” she agreed.

“However, ultimately more research will be necessary since this method of combining data across trials relies upon the robustness of the statistical method in each study,” Dr. O’Donoghue said. “I applaud the authors for shining a spotlight on this important topic.”

Although the benefits of breastfeeding appear to continue over time, “it is incredibly difficult for women to continue breastfeeding once they return to work,” she added. “Women in some countries outside the U.S. have an advantage due to longer durations of maternity leave.

“If we want to encourage breastfeeding,” Dr. O’Donoghue stressed, “we need to make sure that we put the right supports in place. Women need protected places to breastfeed in the workplace and places to store their milk. Most importantly, women need to be allowed dedicated time to make it happen.”
 

First large study of CVD in mothers

Emerging individual studies suggest that mothers who breastfeed may have a lower risk for CVD in later life, but studies have been inconsistent, and it is not clear if longer breastfeeding would strengthen this benefit, the authors note.

To examine this, they pooled data from the following eight studies (with study acronym, country, and baseline enrolment dates in brackets): 45&Up (Australia, 2006-2009), China Kadoorie Biobank (CKB, China, 2004-2008), European Prospective Investigation into Cancer and Nutrition (EPIC, multinational, 1992-2000), Gallagher et al. (China, 1989-1991), Nord-Trøndelag Health Survey 2 (HUNT2, Norway, 1995-1997), Japan Public Health Center-based Prospective Study (JPHC, Japan, 1990-1994), Nurses’ Health Study (NHS, U.S., 1986), and the Woman’s Health Initiative (WHI, U.S., 1993-1998).

On average, the women were 51.3 years old (range, 40-65 years) when they enrolled in the study, and they were followed for a median of 10.3 years (range, 7.9-20.9 years, in the individual studies).

On average, they had their first child at age 25 and had two to three children (mean, 2.3); 82% had breastfed at some point (ranging from 58% of women in the two U.S. studies to 97% in CKB and HUNT2).

The women had breastfed for a mean of 7.4 to 18.9 months during their lifetimes (except women in the CKB study, who had breastfed for a median of 24 months).

Among the 1,192,700 women, there were 54,226 incident CVD events, 26,913 incident CHD events, 30,843 incident strokes, and 10,766 deaths from CVD during follow-up.

The researchers acknowledge that study limitations include the fact that there could have been publication bias, since fewer than 10 studies were available for pooling. There was significant between-study heterogeneity for CVD, CHD, and stroke outcomes.

Participant-level data were also lacking, and breastfeeding was self-reported. There may have been unaccounted residual confounding, and the benefits of lifetime breastfeeding that is longer than 2 years are not clear, because few women in this population breastfed that long.

The research was funded by the Austrian Science Fund. The researchers and Dr. Mehran and Dr. O’Donoghue have no relevant financial disclosures.

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

Patients looking to refill a prescription for apixaban (Eliquis) through CVS Caremark may be in for a surprise following its decision to exclude the direct oral anticoagulant (DOAC) from its formulary starting Jan. 1.

The move leaves just one DOAC, rivaroxaban (Xarelto), on CVS’ commercial formulary and is being assailed as the latest example of “nonmedical switching” used by health insurers to control costs.

In a letter to CVS Caremark backed by 14 provider and patient organizations, the nonprofit Partnership to Advance Cardiovascular Health (PACH) calls on the pharmacy chain to reverse its “dangerously disruptive” decision to force stable patients at high risk of cardiovascular events to switch anticoagulation, without an apparent option to be grandfathered into the new plan.

PACH president Dharmesh Patel, MD, Stern Cardiovascular Center, Memphis, called the formulary change “reckless and irresponsible, especially because the decision is not based in science and evidence, but on budgets. Patients and their health care providers, not insurance companies, need to be trusted to determine what medication is best,” he said in a statement.

Craig Beavers, PharmD, vice president of Baptist Health Paducah, Kentucky, said that, as chair of the American College of Cardiology’s Cardiovascular Team Section, he and other organizations have met with CVS Caremark medical leadership to advocate for patients and to understand the company’s perspective.

“The underlying driver is cost,” he told this news organization.

Current guidelines recommend DOACs in general for a variety of indications, including to reduce the risk of stroke and embolism in nonvalvular atrial fibrillation and to prevent deep vein thrombosis, but there are select instances where a particular DOAC might be more appropriate, he observed.

“Apixaban may be better for a patient with a history of GI bleeding because there’s less GI bleeding, but the guidelines don’t necessarily spell those things out,” Dr. Beavers said. “That’s where the clinician should advocate for their patient and, unfortunately, they are making their decision strictly based off the guidelines.”

Requests to speak with medical officers at CVS Caremark went unanswered, but its executive director of communications, Christina Peaslee, told this news organization that the formulary decision “maintains clinically appropriate, cost-effective prescription coverage” for its clients and members.

“Both the American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend DOACs over warfarin for treatment of various cardiology conditions such as atrial fibrillation, but neither list a specific agent as preferred – showing that consensus clinical guidelines do not favor one over the other,” she said in an email. “Further, Xarelto has more FDA-approved indications than Eliquis (e.g., Xarelto is approved for a reduction in risk of major CV events in patients with CAD or PAD) in addition to all the same FDA indications as Eliquis.”

Ms. Peaslee pointed out that all formulary changes are evaluated by an external medical expert specializing in the disease state, followed by review and approval by an independent national Pharmacy & Therapeutics Committee.

The decision to exclude apixaban is also limited to a “subset of commercial drug lists,” she said, although specifics on which plans and the number of affected patients were not forthcoming.

The choice of DOAC is a timely question in cardiology, with recent studies suggesting an advantage for apixaban over rivaroxaban in reducing the risk of recurrent venous thromboembolism, as well as reducing the risk of major ischemic or hemorrhagic events in atrial fibrillation.

Ms. Peaslee said CVS Caremark closely monitors medical literature for relevant clinical trial data and that most clients allow reasonable formulary exceptions when justified. “This formulary exceptions process has been successfully used for changes of this type and allows patients to get a medication that is safe and effective, as determined by their prescriber.”

The company will also continue to provide “robust, personalized outreach to the small number of members who will need to switch to an alternative medication,” she added.

Dr. Beavers said negotiations with CVS are still in the early stages, but, in the meantime, the ACC is providing health care providers with tools, such as drug copay cards and electronic prior authorizations, to help ensure patients don’t have gaps in coverage.

In a Jan. 14 news release addressing the formulary change, ACC notes that a patient’s pharmacy can also request a one-time override when trying to fill a nonpreferred DOAC in January to buy time if switching medications with their clinician or requesting a formulary exception.

During discussions with CVS Caremark, it says the ACC and the American Society of Hematology “underscored the negative impacts of this decision on patients currently taking one of the nonpreferred DOACs and on those who have previously tried rivaroxaban and changed medications.”

The groups also highlighted difficulties with other prior authorization programs in terms of the need for dedicated staff and time away from direct patient care.

“The ACC and ASH will continue discussions with CVS Caremark regarding the burden on clinicians and the effect of the formulary decision on patient access,” the release says.

In its letter to CVS, PACH argues that the apixaban exclusion will disproportionately affect historically disadvantaged patients, leaving those who can least afford the change with limited options. Notably, no generic is available for either apixaban or rivaroxaban.

The group also highlights a 2019 national poll, in which nearly 40% of patients who had their medication switched were so frustrated that they stopped their medication altogether.

PACH has an online petition against nonmedical switching, which at press time had garnered 2,126 signatures.

One signee, Jan Griffin, who survived bilateral pulmonary embolisms, writes that she has been on Eliquis [apixaban] successfully since her hospital discharge. “Now, as of midnight, Caremark apparently knows better than my hematologist as to what blood thinner is better for me and will no longer cover my Eliquis prescription. This is criminal, immoral, and unethical. #StopTheSwitch.”

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

Patients looking to refill a prescription for apixaban (Eliquis) through CVS Caremark may be in for a surprise following its decision to exclude the direct oral anticoagulant (DOAC) from its formulary starting Jan. 1.

The move leaves just one DOAC, rivaroxaban (Xarelto), on CVS’ commercial formulary and is being assailed as the latest example of “nonmedical switching” used by health insurers to control costs.

In a letter to CVS Caremark backed by 14 provider and patient organizations, the nonprofit Partnership to Advance Cardiovascular Health (PACH) calls on the pharmacy chain to reverse its “dangerously disruptive” decision to force stable patients at high risk of cardiovascular events to switch anticoagulation, without an apparent option to be grandfathered into the new plan.

PACH president Dharmesh Patel, MD, Stern Cardiovascular Center, Memphis, called the formulary change “reckless and irresponsible, especially because the decision is not based in science and evidence, but on budgets. Patients and their health care providers, not insurance companies, need to be trusted to determine what medication is best,” he said in a statement.

Craig Beavers, PharmD, vice president of Baptist Health Paducah, Kentucky, said that, as chair of the American College of Cardiology’s Cardiovascular Team Section, he and other organizations have met with CVS Caremark medical leadership to advocate for patients and to understand the company’s perspective.

“The underlying driver is cost,” he told this news organization.

Current guidelines recommend DOACs in general for a variety of indications, including to reduce the risk of stroke and embolism in nonvalvular atrial fibrillation and to prevent deep vein thrombosis, but there are select instances where a particular DOAC might be more appropriate, he observed.

“Apixaban may be better for a patient with a history of GI bleeding because there’s less GI bleeding, but the guidelines don’t necessarily spell those things out,” Dr. Beavers said. “That’s where the clinician should advocate for their patient and, unfortunately, they are making their decision strictly based off the guidelines.”

Requests to speak with medical officers at CVS Caremark went unanswered, but its executive director of communications, Christina Peaslee, told this news organization that the formulary decision “maintains clinically appropriate, cost-effective prescription coverage” for its clients and members.

“Both the American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend DOACs over warfarin for treatment of various cardiology conditions such as atrial fibrillation, but neither list a specific agent as preferred – showing that consensus clinical guidelines do not favor one over the other,” she said in an email. “Further, Xarelto has more FDA-approved indications than Eliquis (e.g., Xarelto is approved for a reduction in risk of major CV events in patients with CAD or PAD) in addition to all the same FDA indications as Eliquis.”

Ms. Peaslee pointed out that all formulary changes are evaluated by an external medical expert specializing in the disease state, followed by review and approval by an independent national Pharmacy & Therapeutics Committee.

The decision to exclude apixaban is also limited to a “subset of commercial drug lists,” she said, although specifics on which plans and the number of affected patients were not forthcoming.

The choice of DOAC is a timely question in cardiology, with recent studies suggesting an advantage for apixaban over rivaroxaban in reducing the risk of recurrent venous thromboembolism, as well as reducing the risk of major ischemic or hemorrhagic events in atrial fibrillation.

Ms. Peaslee said CVS Caremark closely monitors medical literature for relevant clinical trial data and that most clients allow reasonable formulary exceptions when justified. “This formulary exceptions process has been successfully used for changes of this type and allows patients to get a medication that is safe and effective, as determined by their prescriber.”

The company will also continue to provide “robust, personalized outreach to the small number of members who will need to switch to an alternative medication,” she added.

Dr. Beavers said negotiations with CVS are still in the early stages, but, in the meantime, the ACC is providing health care providers with tools, such as drug copay cards and electronic prior authorizations, to help ensure patients don’t have gaps in coverage.

In a Jan. 14 news release addressing the formulary change, ACC notes that a patient’s pharmacy can also request a one-time override when trying to fill a nonpreferred DOAC in January to buy time if switching medications with their clinician or requesting a formulary exception.

During discussions with CVS Caremark, it says the ACC and the American Society of Hematology “underscored the negative impacts of this decision on patients currently taking one of the nonpreferred DOACs and on those who have previously tried rivaroxaban and changed medications.”

The groups also highlighted difficulties with other prior authorization programs in terms of the need for dedicated staff and time away from direct patient care.

“The ACC and ASH will continue discussions with CVS Caremark regarding the burden on clinicians and the effect of the formulary decision on patient access,” the release says.

In its letter to CVS, PACH argues that the apixaban exclusion will disproportionately affect historically disadvantaged patients, leaving those who can least afford the change with limited options. Notably, no generic is available for either apixaban or rivaroxaban.

The group also highlights a 2019 national poll, in which nearly 40% of patients who had their medication switched were so frustrated that they stopped their medication altogether.

PACH has an online petition against nonmedical switching, which at press time had garnered 2,126 signatures.

One signee, Jan Griffin, who survived bilateral pulmonary embolisms, writes that she has been on Eliquis [apixaban] successfully since her hospital discharge. “Now, as of midnight, Caremark apparently knows better than my hematologist as to what blood thinner is better for me and will no longer cover my Eliquis prescription. This is criminal, immoral, and unethical. #StopTheSwitch.”

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

Patients looking to refill a prescription for apixaban (Eliquis) through CVS Caremark may be in for a surprise following its decision to exclude the direct oral anticoagulant (DOAC) from its formulary starting Jan. 1.

The move leaves just one DOAC, rivaroxaban (Xarelto), on CVS’ commercial formulary and is being assailed as the latest example of “nonmedical switching” used by health insurers to control costs.

In a letter to CVS Caremark backed by 14 provider and patient organizations, the nonprofit Partnership to Advance Cardiovascular Health (PACH) calls on the pharmacy chain to reverse its “dangerously disruptive” decision to force stable patients at high risk of cardiovascular events to switch anticoagulation, without an apparent option to be grandfathered into the new plan.

PACH president Dharmesh Patel, MD, Stern Cardiovascular Center, Memphis, called the formulary change “reckless and irresponsible, especially because the decision is not based in science and evidence, but on budgets. Patients and their health care providers, not insurance companies, need to be trusted to determine what medication is best,” he said in a statement.

Craig Beavers, PharmD, vice president of Baptist Health Paducah, Kentucky, said that, as chair of the American College of Cardiology’s Cardiovascular Team Section, he and other organizations have met with CVS Caremark medical leadership to advocate for patients and to understand the company’s perspective.

“The underlying driver is cost,” he told this news organization.

Current guidelines recommend DOACs in general for a variety of indications, including to reduce the risk of stroke and embolism in nonvalvular atrial fibrillation and to prevent deep vein thrombosis, but there are select instances where a particular DOAC might be more appropriate, he observed.

“Apixaban may be better for a patient with a history of GI bleeding because there’s less GI bleeding, but the guidelines don’t necessarily spell those things out,” Dr. Beavers said. “That’s where the clinician should advocate for their patient and, unfortunately, they are making their decision strictly based off the guidelines.”

Requests to speak with medical officers at CVS Caremark went unanswered, but its executive director of communications, Christina Peaslee, told this news organization that the formulary decision “maintains clinically appropriate, cost-effective prescription coverage” for its clients and members.

“Both the American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend DOACs over warfarin for treatment of various cardiology conditions such as atrial fibrillation, but neither list a specific agent as preferred – showing that consensus clinical guidelines do not favor one over the other,” she said in an email. “Further, Xarelto has more FDA-approved indications than Eliquis (e.g., Xarelto is approved for a reduction in risk of major CV events in patients with CAD or PAD) in addition to all the same FDA indications as Eliquis.”

Ms. Peaslee pointed out that all formulary changes are evaluated by an external medical expert specializing in the disease state, followed by review and approval by an independent national Pharmacy & Therapeutics Committee.

The decision to exclude apixaban is also limited to a “subset of commercial drug lists,” she said, although specifics on which plans and the number of affected patients were not forthcoming.

The choice of DOAC is a timely question in cardiology, with recent studies suggesting an advantage for apixaban over rivaroxaban in reducing the risk of recurrent venous thromboembolism, as well as reducing the risk of major ischemic or hemorrhagic events in atrial fibrillation.

Ms. Peaslee said CVS Caremark closely monitors medical literature for relevant clinical trial data and that most clients allow reasonable formulary exceptions when justified. “This formulary exceptions process has been successfully used for changes of this type and allows patients to get a medication that is safe and effective, as determined by their prescriber.”

The company will also continue to provide “robust, personalized outreach to the small number of members who will need to switch to an alternative medication,” she added.

Dr. Beavers said negotiations with CVS are still in the early stages, but, in the meantime, the ACC is providing health care providers with tools, such as drug copay cards and electronic prior authorizations, to help ensure patients don’t have gaps in coverage.

In a Jan. 14 news release addressing the formulary change, ACC notes that a patient’s pharmacy can also request a one-time override when trying to fill a nonpreferred DOAC in January to buy time if switching medications with their clinician or requesting a formulary exception.

During discussions with CVS Caremark, it says the ACC and the American Society of Hematology “underscored the negative impacts of this decision on patients currently taking one of the nonpreferred DOACs and on those who have previously tried rivaroxaban and changed medications.”

The groups also highlighted difficulties with other prior authorization programs in terms of the need for dedicated staff and time away from direct patient care.

“The ACC and ASH will continue discussions with CVS Caremark regarding the burden on clinicians and the effect of the formulary decision on patient access,” the release says.

In its letter to CVS, PACH argues that the apixaban exclusion will disproportionately affect historically disadvantaged patients, leaving those who can least afford the change with limited options. Notably, no generic is available for either apixaban or rivaroxaban.

The group also highlights a 2019 national poll, in which nearly 40% of patients who had their medication switched were so frustrated that they stopped their medication altogether.

PACH has an online petition against nonmedical switching, which at press time had garnered 2,126 signatures.

One signee, Jan Griffin, who survived bilateral pulmonary embolisms, writes that she has been on Eliquis [apixaban] successfully since her hospital discharge. “Now, as of midnight, Caremark apparently knows better than my hematologist as to what blood thinner is better for me and will no longer cover my Eliquis prescription. This is criminal, immoral, and unethical. #StopTheSwitch.”

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

Most children with multisystem inflammatory syndrome related to COVID-19 infection show recovery of cardiac function by 3 months, but longer term follow-up is still needed, suggests a new retrospective longitudinal cohort study.

While 80%-85% of children with multisystem inflammatory syndrome have cardiovascular involvement, “lack of knowledge about the short-term consequences of MIS-C has led to uncertainty among physicians in making recommendations about follow-up,” Daisuke Matsubara, MD, PhD, and colleagues wrote in their paper, which was published in the Journal of the American Heart Association.

Dr. Matsubara, of the department of pediatrics at the Children’s Hospital of Philadelphia, and colleagues examined cardiac outcomes among 60 patients aged 18 years or under admitted to two Philadelphia hospitals with MIS-C between April 2020 and January 2021. They compared those with outcomes in 60 age-matched healthy children who had undergone echocardiography for a range of non–COVID-related conditions such as chest pain or syncope.

The study used echocardiography, MRI, biochemistry, and functional and clinical parameters to assess the degree of change and damage to the heart at 3 months after admission.

When the patients first presented to a hospital, 42 had biochemical signs of myocardial injury, such as elevated brain-type natriuretic peptide and troponin levels. However, most patients’ symptoms were no longer present by the time they were discharged from hospital.

The researchers found that 81% of patients who presented with myocardial injury had lost the left atrial contraction phase. This dropped to 51% during the subacute phase, then 30% at 1 month. By 3-4 months, all patients achieved normal left atrial contraction phase.

At 1 month after admission, all MIS-C patients had significant signs of cardiac strain, compared with controls, including changes to global longitudinal strain, global circumferential strain, circumferential early diastolic strain rate, and right ventricular free wall longitudinal strain.
 

Parameters of strain normalized by 3 months

All parameters of strain had normalized, compared with controls, by 3 months. In the case of global longitudinal strain and left atrial strain, the median time to normalization was 6 days. For left ventricular ejection fraction the median time to normalization was 8 days and for right ventricular free wall longitudinal strain it was 9 days.

A small difference persisted with global longitudinal strain, but the authors said the difference was within the range of normal published values and not clinically relevant. The dysfunction appeared to be spread evenly across the heart rather than varying between segments, they noted.

“Deformation analysis could detect subtle myocardial changes; therefore, our study suggests the absence of persistent subclinical myocardial dysfunction after 3-4 months,” Dr. Matsubara said in an interview.

Four patients experienced small coronary aneurysms during the acute phase of MIS-C, but all had resolved within 2 months and none experienced any further lesions.

Among the 14 patients who underwent cardiac MRI at presentation, 2 had evidence of myocardial edema and fibrosis during the subacute phase of illness, despite having normal left ventricular systolic function and conventional echocardiography.

At follow-up, only one patient had residual edema; this individual had no evidence of fibrosis and had normal systolic function.
 

Study provides reassurance, but longer follow-up needed

Commenting on the study, pediatric cardiologist Devyani Chowdhury, MD, director of Cardiology Care for Children in Lancaster, Pa., said that overall it provided reassurance that most children do recover from MIS-C – and fits with her own clinical experience of the condition – but cautioned that longer-term follow-up was still needed.

“Three months is really not long term for a child,” Dr. Chowdhury said in an interview. “I’ve had a couple of patients whose MRIs have not normalized even after 1 year.”

Dr. Chowdhury also noted that it was a relatively small sample size, and it was also not yet possible to work out what host factors might play a role in increasing the risk of longer-term effects of MIS-C.

“I think it is a disease in evolution and we have to give it time, but in the very short term at least these kids are not dying, they are recovering, going home, and returning to activity and the heart is getting better,” she said.

The study authors suggested their findings could provide an evidence base for recommendations on when children with MIS-C can return to sports and physical activity, given that current consensus statements on the issue treat MIS-C as being equivalent to myocarditis in adults.

Dr. Matsubara noted that the cardiac outcomes of MIS-C were very different from those in COVID-19–affected adults, where echocardiography and MRI show longer-term evidence of myocardial impairments.

“This finding is also different from that of adult COVID-19, where the high troponin is reported to be the prognostic factor,” he said, suggesting this could explain different mechanisms of myocardial injury between MIS-C and COVID-19 myocarditis.

One author was supported by the National Institutes of Health. No conflicts of interest were declared.

Most children with multisystem inflammatory syndrome related to COVID-19 infection show recovery of cardiac function by 3 months, but longer term follow-up is still needed, suggests a new retrospective longitudinal cohort study.

While 80%-85% of children with multisystem inflammatory syndrome have cardiovascular involvement, “lack of knowledge about the short-term consequences of MIS-C has led to uncertainty among physicians in making recommendations about follow-up,” Daisuke Matsubara, MD, PhD, and colleagues wrote in their paper, which was published in the Journal of the American Heart Association.

Dr. Matsubara, of the department of pediatrics at the Children’s Hospital of Philadelphia, and colleagues examined cardiac outcomes among 60 patients aged 18 years or under admitted to two Philadelphia hospitals with MIS-C between April 2020 and January 2021. They compared those with outcomes in 60 age-matched healthy children who had undergone echocardiography for a range of non–COVID-related conditions such as chest pain or syncope.

The study used echocardiography, MRI, biochemistry, and functional and clinical parameters to assess the degree of change and damage to the heart at 3 months after admission.

When the patients first presented to a hospital, 42 had biochemical signs of myocardial injury, such as elevated brain-type natriuretic peptide and troponin levels. However, most patients’ symptoms were no longer present by the time they were discharged from hospital.

The researchers found that 81% of patients who presented with myocardial injury had lost the left atrial contraction phase. This dropped to 51% during the subacute phase, then 30% at 1 month. By 3-4 months, all patients achieved normal left atrial contraction phase.

At 1 month after admission, all MIS-C patients had significant signs of cardiac strain, compared with controls, including changes to global longitudinal strain, global circumferential strain, circumferential early diastolic strain rate, and right ventricular free wall longitudinal strain.
 

Parameters of strain normalized by 3 months

All parameters of strain had normalized, compared with controls, by 3 months. In the case of global longitudinal strain and left atrial strain, the median time to normalization was 6 days. For left ventricular ejection fraction the median time to normalization was 8 days and for right ventricular free wall longitudinal strain it was 9 days.

A small difference persisted with global longitudinal strain, but the authors said the difference was within the range of normal published values and not clinically relevant. The dysfunction appeared to be spread evenly across the heart rather than varying between segments, they noted.

“Deformation analysis could detect subtle myocardial changes; therefore, our study suggests the absence of persistent subclinical myocardial dysfunction after 3-4 months,” Dr. Matsubara said in an interview.

Four patients experienced small coronary aneurysms during the acute phase of MIS-C, but all had resolved within 2 months and none experienced any further lesions.

Among the 14 patients who underwent cardiac MRI at presentation, 2 had evidence of myocardial edema and fibrosis during the subacute phase of illness, despite having normal left ventricular systolic function and conventional echocardiography.

At follow-up, only one patient had residual edema; this individual had no evidence of fibrosis and had normal systolic function.
 

Study provides reassurance, but longer follow-up needed

Commenting on the study, pediatric cardiologist Devyani Chowdhury, MD, director of Cardiology Care for Children in Lancaster, Pa., said that overall it provided reassurance that most children do recover from MIS-C – and fits with her own clinical experience of the condition – but cautioned that longer-term follow-up was still needed.

“Three months is really not long term for a child,” Dr. Chowdhury said in an interview. “I’ve had a couple of patients whose MRIs have not normalized even after 1 year.”

Dr. Chowdhury also noted that it was a relatively small sample size, and it was also not yet possible to work out what host factors might play a role in increasing the risk of longer-term effects of MIS-C.

“I think it is a disease in evolution and we have to give it time, but in the very short term at least these kids are not dying, they are recovering, going home, and returning to activity and the heart is getting better,” she said.

The study authors suggested their findings could provide an evidence base for recommendations on when children with MIS-C can return to sports and physical activity, given that current consensus statements on the issue treat MIS-C as being equivalent to myocarditis in adults.

Dr. Matsubara noted that the cardiac outcomes of MIS-C were very different from those in COVID-19–affected adults, where echocardiography and MRI show longer-term evidence of myocardial impairments.

“This finding is also different from that of adult COVID-19, where the high troponin is reported to be the prognostic factor,” he said, suggesting this could explain different mechanisms of myocardial injury between MIS-C and COVID-19 myocarditis.

One author was supported by the National Institutes of Health. No conflicts of interest were declared.

Most children with multisystem inflammatory syndrome related to COVID-19 infection show recovery of cardiac function by 3 months, but longer term follow-up is still needed, suggests a new retrospective longitudinal cohort study.

While 80%-85% of children with multisystem inflammatory syndrome have cardiovascular involvement, “lack of knowledge about the short-term consequences of MIS-C has led to uncertainty among physicians in making recommendations about follow-up,” Daisuke Matsubara, MD, PhD, and colleagues wrote in their paper, which was published in the Journal of the American Heart Association.

Dr. Matsubara, of the department of pediatrics at the Children’s Hospital of Philadelphia, and colleagues examined cardiac outcomes among 60 patients aged 18 years or under admitted to two Philadelphia hospitals with MIS-C between April 2020 and January 2021. They compared those with outcomes in 60 age-matched healthy children who had undergone echocardiography for a range of non–COVID-related conditions such as chest pain or syncope.

The study used echocardiography, MRI, biochemistry, and functional and clinical parameters to assess the degree of change and damage to the heart at 3 months after admission.

When the patients first presented to a hospital, 42 had biochemical signs of myocardial injury, such as elevated brain-type natriuretic peptide and troponin levels. However, most patients’ symptoms were no longer present by the time they were discharged from hospital.

The researchers found that 81% of patients who presented with myocardial injury had lost the left atrial contraction phase. This dropped to 51% during the subacute phase, then 30% at 1 month. By 3-4 months, all patients achieved normal left atrial contraction phase.

At 1 month after admission, all MIS-C patients had significant signs of cardiac strain, compared with controls, including changes to global longitudinal strain, global circumferential strain, circumferential early diastolic strain rate, and right ventricular free wall longitudinal strain.
 

Parameters of strain normalized by 3 months

All parameters of strain had normalized, compared with controls, by 3 months. In the case of global longitudinal strain and left atrial strain, the median time to normalization was 6 days. For left ventricular ejection fraction the median time to normalization was 8 days and for right ventricular free wall longitudinal strain it was 9 days.

A small difference persisted with global longitudinal strain, but the authors said the difference was within the range of normal published values and not clinically relevant. The dysfunction appeared to be spread evenly across the heart rather than varying between segments, they noted.

“Deformation analysis could detect subtle myocardial changes; therefore, our study suggests the absence of persistent subclinical myocardial dysfunction after 3-4 months,” Dr. Matsubara said in an interview.

Four patients experienced small coronary aneurysms during the acute phase of MIS-C, but all had resolved within 2 months and none experienced any further lesions.

Among the 14 patients who underwent cardiac MRI at presentation, 2 had evidence of myocardial edema and fibrosis during the subacute phase of illness, despite having normal left ventricular systolic function and conventional echocardiography.

At follow-up, only one patient had residual edema; this individual had no evidence of fibrosis and had normal systolic function.
 

Study provides reassurance, but longer follow-up needed

Commenting on the study, pediatric cardiologist Devyani Chowdhury, MD, director of Cardiology Care for Children in Lancaster, Pa., said that overall it provided reassurance that most children do recover from MIS-C – and fits with her own clinical experience of the condition – but cautioned that longer-term follow-up was still needed.

“Three months is really not long term for a child,” Dr. Chowdhury said in an interview. “I’ve had a couple of patients whose MRIs have not normalized even after 1 year.”

Dr. Chowdhury also noted that it was a relatively small sample size, and it was also not yet possible to work out what host factors might play a role in increasing the risk of longer-term effects of MIS-C.

“I think it is a disease in evolution and we have to give it time, but in the very short term at least these kids are not dying, they are recovering, going home, and returning to activity and the heart is getting better,” she said.

The study authors suggested their findings could provide an evidence base for recommendations on when children with MIS-C can return to sports and physical activity, given that current consensus statements on the issue treat MIS-C as being equivalent to myocarditis in adults.

Dr. Matsubara noted that the cardiac outcomes of MIS-C were very different from those in COVID-19–affected adults, where echocardiography and MRI show longer-term evidence of myocardial impairments.

“This finding is also different from that of adult COVID-19, where the high troponin is reported to be the prognostic factor,” he said, suggesting this could explain different mechanisms of myocardial injury between MIS-C and COVID-19 myocarditis.

One author was supported by the National Institutes of Health. No conflicts of interest were declared.

Creators of a pilot program that educates preschoolers about good heart health have validated a template for successful early childhood intervention that, they claim, provides a pathway for translating scientific evidence into the community and classroom for educational purposes to encourage long-lasting lifestyle changes.

That validation supports the creators' plans to take the program into more schools.

They reported key lessons in crafting the program, known as the SI! Program (for Salud Integral-Comprehensive Health), online in the Journal of the American College of Cardiology.

Mount Sinai Hospital

“This is a research-based program that uses randomized clinical trial evidence with implementation strategies to design educational health promotion programs,” senior author Valentin Fuster, MD, PhD, founder and trustees chairman of the Foundation for Science, Health, and Education (SHE) based in Barcelona, under whose aegis the SI! Program was implemented, said in an interview. Dr. Fuster is also director of Mount Sinai Heart and physician-in-chief at Mount Sinai Hospital in New York, and general director of the National Center for Cardiovascular Investigation (CNIC) in Madrid, Spain’s equivalent of the National Heart, Lung, and Blood Institute.

“There are specific times in a child’s life when improvements can be made to enhance long-term cardiovascular health status,” said Rodrigo Fernández-Jiménez, MD, PhD, group leader of the cardiovascular health and imaging lab at CNIC and study coauthor. “Our review, and previous studies, suggest that 4-5 years of age is the most favorable time to start a school-based intervention focused on healthy habits.”

A key piece of the SI! Program used a Sesame Street character, known as Dr. Ruster, a Muppet based on Dr. Fuster, to introduce and convey most messages and activities to the preschool children. The program also used a heart-shaped mascot named “Cardio” to teach about healthy behaviors. Other components include video segments, a colorful storybook, an interactive board game, flash cards, and a teacher’s guide. The activities and messages were tailored based on the country in which the program was implemented.
 

A decade of experience

The review evaluated 10 years of experience with the preschool-based program, drawing upon cluster-randomized clinical trials of the program in three countries with different socioeconomic conditions: Colombia, Spain, and the United States. The studies randomized schools to receive the SI! Program for 4 months or to a control group and included more than 3,800 children from 50 schools, along with their parents or caregivers and teachers. The studies found significant increases in preschoolers’ knowledge, attitudes, and habits toward healthy eating and living an active lifestyle. Now, the SI! Program is expanding into more than 250 schools in Spain and more than 40 schools in all five boroughs of New York City.

“This is a multidimensional program,” Dr. Fuster said. The review identified five stages for implementing the program: dissemination; adoption; implementation; evaluation; and institutionalization.

Dissemination involves three substages for intervention: components, design, and strategy. With regard to the components, said Dr. Fuster, “We’re targeting children to educate them in four topics: how the body works; nutritional and dietary requirements; physical activity; and the need to control emotions – to say no in the future when they’re confronted with alcohol, drugs, and tobacco.”

Design involved a multidisciplinary team of experts to develop the intervention, Dr. Fuster said. The strategy itself enlists parents and teachers in the implementation, but goes beyond that. “This is a community,” Dr. Fuster said. Hence, the school environment and classroom itself are also engaged to support the message of the four topics.

Dr. Fuster said future research should look at knowledge, attitude, and habits and biological outcomes in children who’ve been in the SI! Program when they reach adolescence. “Our hypothesis is that we can do this in older children, but when they reach age 10 we want to reintervene in them,” Dr. Fuster said. “Humans need reintervention. Our findings don’t get into sustainability.” He added that further research should also identify socioeconomic factors that influence child health.

Expanding the program across the New York City’s five boroughs “offers a unique opportunity to explore which socioeconomic factors, at both the family and borough level, and may eventually affect children’s health, how they are implicated in the intervention’s effectiveness, and how they can be addressed to reduce the gap in health inequalities,” he said. 

Karalyn Kinsella, MD, a pediatrician affiliated with Yale New Haven (Conn.) Medical Center, noted the program’s multidimensional nature is an important element. “I think what is so important about this intervention is that it is not one single intervention but a curriculum that takes a significant amount of time (up to 50 hours) that allows for repetition of the information, which allows it to become remembered,” she said in an interview. “I also think incorporating families in the intervention is key as that is where change often has to happen.”

While she said the program may provide a template for a mental health curriculum, she added, “My concern is that teachers are already feeling overwhelmed and this may be viewed as another burden.”

The American Heart Association provided funding for the study in the United States. Dr Fernández-Jiménez has received funding from the Fondo de Investigación Sanitaria–Instituto de Salud Carlos III, which is cofunded by the European Regional Development Fund/European Social Fund. Dr. Fuster and Dr. Kinsella have no relevant disclosures.

Creators of a pilot program that educates preschoolers about good heart health have validated a template for successful early childhood intervention that, they claim, provides a pathway for translating scientific evidence into the community and classroom for educational purposes to encourage long-lasting lifestyle changes.

That validation supports the creators' plans to take the program into more schools.

They reported key lessons in crafting the program, known as the SI! Program (for Salud Integral-Comprehensive Health), online in the Journal of the American College of Cardiology.

Mount Sinai Hospital

“This is a research-based program that uses randomized clinical trial evidence with implementation strategies to design educational health promotion programs,” senior author Valentin Fuster, MD, PhD, founder and trustees chairman of the Foundation for Science, Health, and Education (SHE) based in Barcelona, under whose aegis the SI! Program was implemented, said in an interview. Dr. Fuster is also director of Mount Sinai Heart and physician-in-chief at Mount Sinai Hospital in New York, and general director of the National Center for Cardiovascular Investigation (CNIC) in Madrid, Spain’s equivalent of the National Heart, Lung, and Blood Institute.

“There are specific times in a child’s life when improvements can be made to enhance long-term cardiovascular health status,” said Rodrigo Fernández-Jiménez, MD, PhD, group leader of the cardiovascular health and imaging lab at CNIC and study coauthor. “Our review, and previous studies, suggest that 4-5 years of age is the most favorable time to start a school-based intervention focused on healthy habits.”

A key piece of the SI! Program used a Sesame Street character, known as Dr. Ruster, a Muppet based on Dr. Fuster, to introduce and convey most messages and activities to the preschool children. The program also used a heart-shaped mascot named “Cardio” to teach about healthy behaviors. Other components include video segments, a colorful storybook, an interactive board game, flash cards, and a teacher’s guide. The activities and messages were tailored based on the country in which the program was implemented.
 

A decade of experience

The review evaluated 10 years of experience with the preschool-based program, drawing upon cluster-randomized clinical trials of the program in three countries with different socioeconomic conditions: Colombia, Spain, and the United States. The studies randomized schools to receive the SI! Program for 4 months or to a control group and included more than 3,800 children from 50 schools, along with their parents or caregivers and teachers. The studies found significant increases in preschoolers’ knowledge, attitudes, and habits toward healthy eating and living an active lifestyle. Now, the SI! Program is expanding into more than 250 schools in Spain and more than 40 schools in all five boroughs of New York City.

“This is a multidimensional program,” Dr. Fuster said. The review identified five stages for implementing the program: dissemination; adoption; implementation; evaluation; and institutionalization.

Dissemination involves three substages for intervention: components, design, and strategy. With regard to the components, said Dr. Fuster, “We’re targeting children to educate them in four topics: how the body works; nutritional and dietary requirements; physical activity; and the need to control emotions – to say no in the future when they’re confronted with alcohol, drugs, and tobacco.”

Design involved a multidisciplinary team of experts to develop the intervention, Dr. Fuster said. The strategy itself enlists parents and teachers in the implementation, but goes beyond that. “This is a community,” Dr. Fuster said. Hence, the school environment and classroom itself are also engaged to support the message of the four topics.

Dr. Fuster said future research should look at knowledge, attitude, and habits and biological outcomes in children who’ve been in the SI! Program when they reach adolescence. “Our hypothesis is that we can do this in older children, but when they reach age 10 we want to reintervene in them,” Dr. Fuster said. “Humans need reintervention. Our findings don’t get into sustainability.” He added that further research should also identify socioeconomic factors that influence child health.

Expanding the program across the New York City’s five boroughs “offers a unique opportunity to explore which socioeconomic factors, at both the family and borough level, and may eventually affect children’s health, how they are implicated in the intervention’s effectiveness, and how they can be addressed to reduce the gap in health inequalities,” he said. 

Karalyn Kinsella, MD, a pediatrician affiliated with Yale New Haven (Conn.) Medical Center, noted the program’s multidimensional nature is an important element. “I think what is so important about this intervention is that it is not one single intervention but a curriculum that takes a significant amount of time (up to 50 hours) that allows for repetition of the information, which allows it to become remembered,” she said in an interview. “I also think incorporating families in the intervention is key as that is where change often has to happen.”

While she said the program may provide a template for a mental health curriculum, she added, “My concern is that teachers are already feeling overwhelmed and this may be viewed as another burden.”

The American Heart Association provided funding for the study in the United States. Dr Fernández-Jiménez has received funding from the Fondo de Investigación Sanitaria–Instituto de Salud Carlos III, which is cofunded by the European Regional Development Fund/European Social Fund. Dr. Fuster and Dr. Kinsella have no relevant disclosures.

Creators of a pilot program that educates preschoolers about good heart health have validated a template for successful early childhood intervention that, they claim, provides a pathway for translating scientific evidence into the community and classroom for educational purposes to encourage long-lasting lifestyle changes.

That validation supports the creators' plans to take the program into more schools.

They reported key lessons in crafting the program, known as the SI! Program (for Salud Integral-Comprehensive Health), online in the Journal of the American College of Cardiology.

Mount Sinai Hospital

“This is a research-based program that uses randomized clinical trial evidence with implementation strategies to design educational health promotion programs,” senior author Valentin Fuster, MD, PhD, founder and trustees chairman of the Foundation for Science, Health, and Education (SHE) based in Barcelona, under whose aegis the SI! Program was implemented, said in an interview. Dr. Fuster is also director of Mount Sinai Heart and physician-in-chief at Mount Sinai Hospital in New York, and general director of the National Center for Cardiovascular Investigation (CNIC) in Madrid, Spain’s equivalent of the National Heart, Lung, and Blood Institute.

“There are specific times in a child’s life when improvements can be made to enhance long-term cardiovascular health status,” said Rodrigo Fernández-Jiménez, MD, PhD, group leader of the cardiovascular health and imaging lab at CNIC and study coauthor. “Our review, and previous studies, suggest that 4-5 years of age is the most favorable time to start a school-based intervention focused on healthy habits.”

A key piece of the SI! Program used a Sesame Street character, known as Dr. Ruster, a Muppet based on Dr. Fuster, to introduce and convey most messages and activities to the preschool children. The program also used a heart-shaped mascot named “Cardio” to teach about healthy behaviors. Other components include video segments, a colorful storybook, an interactive board game, flash cards, and a teacher’s guide. The activities and messages were tailored based on the country in which the program was implemented.
 

A decade of experience

The review evaluated 10 years of experience with the preschool-based program, drawing upon cluster-randomized clinical trials of the program in three countries with different socioeconomic conditions: Colombia, Spain, and the United States. The studies randomized schools to receive the SI! Program for 4 months or to a control group and included more than 3,800 children from 50 schools, along with their parents or caregivers and teachers. The studies found significant increases in preschoolers’ knowledge, attitudes, and habits toward healthy eating and living an active lifestyle. Now, the SI! Program is expanding into more than 250 schools in Spain and more than 40 schools in all five boroughs of New York City.

“This is a multidimensional program,” Dr. Fuster said. The review identified five stages for implementing the program: dissemination; adoption; implementation; evaluation; and institutionalization.

Dissemination involves three substages for intervention: components, design, and strategy. With regard to the components, said Dr. Fuster, “We’re targeting children to educate them in four topics: how the body works; nutritional and dietary requirements; physical activity; and the need to control emotions – to say no in the future when they’re confronted with alcohol, drugs, and tobacco.”

Design involved a multidisciplinary team of experts to develop the intervention, Dr. Fuster said. The strategy itself enlists parents and teachers in the implementation, but goes beyond that. “This is a community,” Dr. Fuster said. Hence, the school environment and classroom itself are also engaged to support the message of the four topics.

Dr. Fuster said future research should look at knowledge, attitude, and habits and biological outcomes in children who’ve been in the SI! Program when they reach adolescence. “Our hypothesis is that we can do this in older children, but when they reach age 10 we want to reintervene in them,” Dr. Fuster said. “Humans need reintervention. Our findings don’t get into sustainability.” He added that further research should also identify socioeconomic factors that influence child health.

Expanding the program across the New York City’s five boroughs “offers a unique opportunity to explore which socioeconomic factors, at both the family and borough level, and may eventually affect children’s health, how they are implicated in the intervention’s effectiveness, and how they can be addressed to reduce the gap in health inequalities,” he said. 

Karalyn Kinsella, MD, a pediatrician affiliated with Yale New Haven (Conn.) Medical Center, noted the program’s multidimensional nature is an important element. “I think what is so important about this intervention is that it is not one single intervention but a curriculum that takes a significant amount of time (up to 50 hours) that allows for repetition of the information, which allows it to become remembered,” she said in an interview. “I also think incorporating families in the intervention is key as that is where change often has to happen.”

While she said the program may provide a template for a mental health curriculum, she added, “My concern is that teachers are already feeling overwhelmed and this may be viewed as another burden.”

The American Heart Association provided funding for the study in the United States. Dr Fernández-Jiménez has received funding from the Fondo de Investigación Sanitaria–Instituto de Salud Carlos III, which is cofunded by the European Regional Development Fund/European Social Fund. Dr. Fuster and Dr. Kinsella have no relevant disclosures.

Therapeutic inertia regarding intensification of blood pressure treatment has been shown to be more of an issue in Black patients, but this was not the case in the SPRINT trial, which involved a strict standardized approach to blood pressure management, a new analysis shows.

Ingram Publishing/ThinkStock

“Overall, we found that therapeutic inertia was similar in different races in the SPRINT trial. We did not see disparities that have been reported in previous observational studies,” lead author, Alexander Zheutlin, MD, University of Utah School of Medicine, Salt Lake City, told this news organization.

“These results show that a well-resourced approach in which a standardized approach to blood pressure measurement and treatment intensification is followed can overcome the racial disparity that is seen in therapeutic inertia and the treatment of blood pressure,” he added.

The study was published online in JAMA Network Open on Jan. 10.

The authors explain that hypertension remains a leading modifiable cause of racial disparities in cardiovascular disease. Despite similar treatment rates and increased availability of safe, effective, and affordable antihypertensive medications, blood pressure control rates among Black and Hispanic adults remain significantly lower than among White adults in the United States, and one of the factors contributing to this is thought to be therapeutic inertia – the phenomenon of clinicians not initiating or up-titrating clinically indicated therapy in the setting of unmet treatment goals.

The current analysis of the SPRINT trial was conducted to investigate whether racial and ethnic differences in therapeutic inertia in hypertension were present when blood pressure care was standardized and protocolized.

The landmark SPRINT trial compared intensive (<120 mm Hg) with standard (<140 mm Hg) systolic blood pressure treatment goals in adults 50 years and older at high risk for cardiovascular disease. The present analysis was restricted to participant visits with measured blood pressure above the target goal and included 4,141 patients in the standard group and 4,415 patients in the intensive group.

Results showed that the overall prevalence of therapeutic inertia – defined as no antihypertensive medication intensification at each study visit where the blood pressure was above target goal – was either similar or lower for Black and Hispanic participants than for White participants. This pattern was observed whether participants were randomized to the standard or intensive treatment group.

“These findings support the idea that a standardized approach to blood pressure management, as implemented in SPRINT, may help ensure equitable care is provided to all patients and could reduce the contribution of therapeutic inertia to disparities in uncontrolled blood pressure,” the authors say.

They point out that therapeutic inertia has been identified as a key clinician-level barrier to blood pressure control and is estimated to be present in more than 80% of clinic visits in community practice, whereas in the current analysis of the SPRINT trial, therapeutic inertia was present in 50% to 60% of participant visits with uncontrolled blood pressure.

“In SPRINT, blood pressure had to be measured at defined intervals with a specific method, and there were clear instructions on intensifying treatment if blood pressure was above a certain goal,” Dr. Zheutlin noted. “Our results show that within such strict confines, therapeutic inertia does not seem to be different between different racial groups. This suggests that we could make better gains in blood pressure control and more equitable treatment if we adopted a standardized approach to hypertension management.”

He added: “Many guidelines have been published on when to start treatment and the targets for blood pressure, but there is a lot of variation in how we turn these guidelines into protocols. We need to bring in more consistent protocols on blood pressure measurement and intensification and ensure they are followed. In practice, if the BP is 5 or 10 mm Hg above target, a clinician may defer a decision to intensify treatment and intensification never gets done. But if there was a strict protocol to follow, there would be less chance of this happening.”
 

Therapeutic inertia still high

In an accompanying commentary, Matthew Rivara, MD, Nisha Bansal, MD, and Bessie Young, MD, University of Washington, Seattle, say the current SPRINT analysis has broad implications for reducing racial and ethnic disparities in achievement of evidence-based treatment targets in the general population.

“In hypertension management, standardized protocols for medication adjustments may limit clinician practice heterogeneity to ultimately reduce differences in blood pressure control among racial and ethnic minority populations,” they write. But they add that such protocols must be implemented thoughtfully to incorporate individualized clinical assessment and clinician-patient shared decision-making.

Dr. Rivara et al. point out that the rates of therapeutic inertia in SPRINT, while lower than community-based estimates, were still very high. They suggest reasons for this could include clinician concerns about medication efficacy, adverse effects, and patient mistrust of medical professionals. Outside the clinical trial environment, additional considerations may include prescription drug and laboratory test costs, pharmacy access, and competing demands during busy clinic visits.

To address these challenges, they say that clinicians need education on current clinical practice guidelines, managing complications of intensified antihypertensive therapies, and shared decisionmaking, including culturally sensitive collaborative care. Similarly, care systems must support patients on how to address concerns about treatments.

Finally, further research is needed to better define the specific factors associated with therapeutic inertia to allow tailored interventions to overcome this inertia.

“In designing and performing such research, it is vital that investigators engage with racial and ethnic minority groups to better explore the intersection of race, ethnicity, therapeutic decision-making, trust, and shared decisionmaking,” they add.

The SPRINT trial was funded with federal funds from the National Institutes of Health. Dr. Zheutlin reported receiving grants from the NIH during the conduct of the study.

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

Therapeutic inertia regarding intensification of blood pressure treatment has been shown to be more of an issue in Black patients, but this was not the case in the SPRINT trial, which involved a strict standardized approach to blood pressure management, a new analysis shows.

Ingram Publishing/ThinkStock

“Overall, we found that therapeutic inertia was similar in different races in the SPRINT trial. We did not see disparities that have been reported in previous observational studies,” lead author, Alexander Zheutlin, MD, University of Utah School of Medicine, Salt Lake City, told this news organization.

“These results show that a well-resourced approach in which a standardized approach to blood pressure measurement and treatment intensification is followed can overcome the racial disparity that is seen in therapeutic inertia and the treatment of blood pressure,” he added.

The study was published online in JAMA Network Open on Jan. 10.

The authors explain that hypertension remains a leading modifiable cause of racial disparities in cardiovascular disease. Despite similar treatment rates and increased availability of safe, effective, and affordable antihypertensive medications, blood pressure control rates among Black and Hispanic adults remain significantly lower than among White adults in the United States, and one of the factors contributing to this is thought to be therapeutic inertia – the phenomenon of clinicians not initiating or up-titrating clinically indicated therapy in the setting of unmet treatment goals.

The current analysis of the SPRINT trial was conducted to investigate whether racial and ethnic differences in therapeutic inertia in hypertension were present when blood pressure care was standardized and protocolized.

The landmark SPRINT trial compared intensive (<120 mm Hg) with standard (<140 mm Hg) systolic blood pressure treatment goals in adults 50 years and older at high risk for cardiovascular disease. The present analysis was restricted to participant visits with measured blood pressure above the target goal and included 4,141 patients in the standard group and 4,415 patients in the intensive group.

Results showed that the overall prevalence of therapeutic inertia – defined as no antihypertensive medication intensification at each study visit where the blood pressure was above target goal – was either similar or lower for Black and Hispanic participants than for White participants. This pattern was observed whether participants were randomized to the standard or intensive treatment group.

“These findings support the idea that a standardized approach to blood pressure management, as implemented in SPRINT, may help ensure equitable care is provided to all patients and could reduce the contribution of therapeutic inertia to disparities in uncontrolled blood pressure,” the authors say.

They point out that therapeutic inertia has been identified as a key clinician-level barrier to blood pressure control and is estimated to be present in more than 80% of clinic visits in community practice, whereas in the current analysis of the SPRINT trial, therapeutic inertia was present in 50% to 60% of participant visits with uncontrolled blood pressure.

“In SPRINT, blood pressure had to be measured at defined intervals with a specific method, and there were clear instructions on intensifying treatment if blood pressure was above a certain goal,” Dr. Zheutlin noted. “Our results show that within such strict confines, therapeutic inertia does not seem to be different between different racial groups. This suggests that we could make better gains in blood pressure control and more equitable treatment if we adopted a standardized approach to hypertension management.”

He added: “Many guidelines have been published on when to start treatment and the targets for blood pressure, but there is a lot of variation in how we turn these guidelines into protocols. We need to bring in more consistent protocols on blood pressure measurement and intensification and ensure they are followed. In practice, if the BP is 5 or 10 mm Hg above target, a clinician may defer a decision to intensify treatment and intensification never gets done. But if there was a strict protocol to follow, there would be less chance of this happening.”
 

Therapeutic inertia still high

In an accompanying commentary, Matthew Rivara, MD, Nisha Bansal, MD, and Bessie Young, MD, University of Washington, Seattle, say the current SPRINT analysis has broad implications for reducing racial and ethnic disparities in achievement of evidence-based treatment targets in the general population.

“In hypertension management, standardized protocols for medication adjustments may limit clinician practice heterogeneity to ultimately reduce differences in blood pressure control among racial and ethnic minority populations,” they write. But they add that such protocols must be implemented thoughtfully to incorporate individualized clinical assessment and clinician-patient shared decision-making.

Dr. Rivara et al. point out that the rates of therapeutic inertia in SPRINT, while lower than community-based estimates, were still very high. They suggest reasons for this could include clinician concerns about medication efficacy, adverse effects, and patient mistrust of medical professionals. Outside the clinical trial environment, additional considerations may include prescription drug and laboratory test costs, pharmacy access, and competing demands during busy clinic visits.

To address these challenges, they say that clinicians need education on current clinical practice guidelines, managing complications of intensified antihypertensive therapies, and shared decisionmaking, including culturally sensitive collaborative care. Similarly, care systems must support patients on how to address concerns about treatments.

Finally, further research is needed to better define the specific factors associated with therapeutic inertia to allow tailored interventions to overcome this inertia.

“In designing and performing such research, it is vital that investigators engage with racial and ethnic minority groups to better explore the intersection of race, ethnicity, therapeutic decision-making, trust, and shared decisionmaking,” they add.

The SPRINT trial was funded with federal funds from the National Institutes of Health. Dr. Zheutlin reported receiving grants from the NIH during the conduct of the study.

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

Therapeutic inertia regarding intensification of blood pressure treatment has been shown to be more of an issue in Black patients, but this was not the case in the SPRINT trial, which involved a strict standardized approach to blood pressure management, a new analysis shows.

Ingram Publishing/ThinkStock

“Overall, we found that therapeutic inertia was similar in different races in the SPRINT trial. We did not see disparities that have been reported in previous observational studies,” lead author, Alexander Zheutlin, MD, University of Utah School of Medicine, Salt Lake City, told this news organization.

“These results show that a well-resourced approach in which a standardized approach to blood pressure measurement and treatment intensification is followed can overcome the racial disparity that is seen in therapeutic inertia and the treatment of blood pressure,” he added.

The study was published online in JAMA Network Open on Jan. 10.

The authors explain that hypertension remains a leading modifiable cause of racial disparities in cardiovascular disease. Despite similar treatment rates and increased availability of safe, effective, and affordable antihypertensive medications, blood pressure control rates among Black and Hispanic adults remain significantly lower than among White adults in the United States, and one of the factors contributing to this is thought to be therapeutic inertia – the phenomenon of clinicians not initiating or up-titrating clinically indicated therapy in the setting of unmet treatment goals.

The current analysis of the SPRINT trial was conducted to investigate whether racial and ethnic differences in therapeutic inertia in hypertension were present when blood pressure care was standardized and protocolized.

The landmark SPRINT trial compared intensive (<120 mm Hg) with standard (<140 mm Hg) systolic blood pressure treatment goals in adults 50 years and older at high risk for cardiovascular disease. The present analysis was restricted to participant visits with measured blood pressure above the target goal and included 4,141 patients in the standard group and 4,415 patients in the intensive group.

Results showed that the overall prevalence of therapeutic inertia – defined as no antihypertensive medication intensification at each study visit where the blood pressure was above target goal – was either similar or lower for Black and Hispanic participants than for White participants. This pattern was observed whether participants were randomized to the standard or intensive treatment group.

“These findings support the idea that a standardized approach to blood pressure management, as implemented in SPRINT, may help ensure equitable care is provided to all patients and could reduce the contribution of therapeutic inertia to disparities in uncontrolled blood pressure,” the authors say.

They point out that therapeutic inertia has been identified as a key clinician-level barrier to blood pressure control and is estimated to be present in more than 80% of clinic visits in community practice, whereas in the current analysis of the SPRINT trial, therapeutic inertia was present in 50% to 60% of participant visits with uncontrolled blood pressure.

“In SPRINT, blood pressure had to be measured at defined intervals with a specific method, and there were clear instructions on intensifying treatment if blood pressure was above a certain goal,” Dr. Zheutlin noted. “Our results show that within such strict confines, therapeutic inertia does not seem to be different between different racial groups. This suggests that we could make better gains in blood pressure control and more equitable treatment if we adopted a standardized approach to hypertension management.”

He added: “Many guidelines have been published on when to start treatment and the targets for blood pressure, but there is a lot of variation in how we turn these guidelines into protocols. We need to bring in more consistent protocols on blood pressure measurement and intensification and ensure they are followed. In practice, if the BP is 5 or 10 mm Hg above target, a clinician may defer a decision to intensify treatment and intensification never gets done. But if there was a strict protocol to follow, there would be less chance of this happening.”
 

Therapeutic inertia still high

In an accompanying commentary, Matthew Rivara, MD, Nisha Bansal, MD, and Bessie Young, MD, University of Washington, Seattle, say the current SPRINT analysis has broad implications for reducing racial and ethnic disparities in achievement of evidence-based treatment targets in the general population.

“In hypertension management, standardized protocols for medication adjustments may limit clinician practice heterogeneity to ultimately reduce differences in blood pressure control among racial and ethnic minority populations,” they write. But they add that such protocols must be implemented thoughtfully to incorporate individualized clinical assessment and clinician-patient shared decision-making.

Dr. Rivara et al. point out that the rates of therapeutic inertia in SPRINT, while lower than community-based estimates, were still very high. They suggest reasons for this could include clinician concerns about medication efficacy, adverse effects, and patient mistrust of medical professionals. Outside the clinical trial environment, additional considerations may include prescription drug and laboratory test costs, pharmacy access, and competing demands during busy clinic visits.

To address these challenges, they say that clinicians need education on current clinical practice guidelines, managing complications of intensified antihypertensive therapies, and shared decisionmaking, including culturally sensitive collaborative care. Similarly, care systems must support patients on how to address concerns about treatments.

Finally, further research is needed to better define the specific factors associated with therapeutic inertia to allow tailored interventions to overcome this inertia.

“In designing and performing such research, it is vital that investigators engage with racial and ethnic minority groups to better explore the intersection of race, ethnicity, therapeutic decision-making, trust, and shared decisionmaking,” they add.

The SPRINT trial was funded with federal funds from the National Institutes of Health. Dr. Zheutlin reported receiving grants from the NIH during the conduct of the study.

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