Arrhythmias & EP

Being obese and pregnant raises the risk for cardiac complications in women with preexisting heart disease, new research suggests, highlighting the need for earlier interventions in this high-risk population.

The analysis of 790 pregnancies revealed that 23% of women with obesity, defined as body mass index greater than 30 kg/m2, had a cardiac event during pregnancy versus 14% of women with normal body weight (P = .006).

The difference was driven largely by an increase in heart failure (8% vs. 3%; P = .02), although arrhythmias also trended higher in obese women (14% vs. 10%; P = .19).

Nearly half of the women with obesity and a cardiac event presented in the postpartum period (47%).

In multivariate analysis, both obesity and Canadian Cardiac Disease in Pregnancy Study (CARPREG) II risk score were independent predictors of cardiac events (odds ratios for both, 1.7), the investigators, led by Birgit Pfaller, MD, University of Toronto, reported in the Journal of the American College of Cardiology.

Although obesity has been linked to worse pregnancy outcomes and higher cardiovascular risk after delivery in the general population, the authors noted that this is the first study to examine its effect on outcomes in women with heart disease.

“We wanted to look at this high-risk group of women that had preexisting heart disease, but in addition had obesity, to try and find out if there was a kind of double hit for these women – and that, in the end, is what we found. It’s not just simply having heart disease, not simply having obesity, but the combination that’s problematic,” senior author and cardiologist Candice Silversides, MD, University of Toronto, said in an interview.

The findings are concerning given the rising prevalence of obesity worldwide. National data from 2018 show that slightly more than half of women who gave birth in the United States were significantly overweight or obese before becoming pregnant.

Similarly, in the present analysis of 600 women in the CARPREG study who gave birth from 2004 to 2014, nearly 1 in 5 pregnancies (19%) occurred in women with obesity and 25% were in overweight women.

Obese women were significantly more likely than those without obesity to have coronary artery disease (6% vs. 2%), cardiomyopathies (19% vs. 8%) and left ventricular dysfunction (19% vs. 12%) and to be hypertensive or have a hypertensive disorder of pregnancy (13% vs. 3%).

Preeclampsia developed in 32 women during the index pregnancy and 69% of these women were obese or overweight. Cardiac event rates were similar in women with or without preeclampsia but trended higher in women with preeclampsia with versus without obesity (36% vs. 14%; P = .20).

The ill effects of obesity were also reflected in fetal and neonatal events. Overall, 43% of women with obesity and 33% of normal-weight women had at least one fetal event (P = .02), with higher rates of preterm birth (19% vs. 10%; P = .005) and respiratory distress syndrome (8% vs. 3%; P = .02) in women with obesity. Congenital cardiac malformations were present in 6% of women in both groups.

Taken together, the composite of cardiac events, preeclampsia, or fetal events was significantly more common in women with obesity than in normal-weight women (56% vs. 41%; P = .002).

“We’ve spent the last number of years trying to research and understand what the drivers of these adverse outcomes are in this high-risk pregnant cohort, but on a bigger picture the real issue is how do we start intervening in a meaningful way,” Dr. Silversides said.

Like many in the burgeoning field of cardio-obstetrics, the team proposed a multidisciplinary approach that stresses preconception counseling, educating pregnant women with heart disease and obesity about their risks, ensuring that dietary advice, weight-gain recommendations, and comorbidities are addressed as part of routine care, and providing postpartum surveillance.

Preconception screening “has been the recommendation for a long, long time; it’s just that it doesn’t always happen in reality,” she said. “Many pregnancies aren’t planned and not all women are filtered into preconception counseling. So sometimes you’ll do it at the first antenatal visit and try to ensure women are educated but optimally you want to do it well in advance of pregnancy.”

Part of that preconception counseling “should also include giving them appropriate advice for contraception, if what they want to do is avoid pregnancy,” added Dr. Silversides.

Garima Sharma, MD, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, and colleagues wrote in an accompanying editorial that the adverse events observed in this high-risk cohort have “important implications for cardio-obstetricians and should be incorporated in routine prepregnancy and antenatal counseling, monitoring, and risk stratification for women with existing cardiovascular disease.”

They pointed to a paucity of data incorporating maternal prepregnancy obesity and gestational weight gain in risk prediction and called for larger population-based studies on the additive impact of obesity severity on predicting adverse cardiac events in women with existing cardiovascular disease.

Randomized trials are also urgently needed to evaluate the effect of nutritional and behavioral interventions in pregnancy on short- and long-term outcomes in mother and child.

“As the obesity epidemic continues to grow and public health interventions promoting lifestyle changes for obesity management remain a major challenge, maternal obesity may prove to be the ‘Achilles’ heel’ of sustainable national efforts to reduce maternal mortality and improve health equity. This is a call to action,” Dr. Sharma and colleagues concluded.

The investigators noted that the study was conducted at a single center and used self-reported pregnancy weight collected at the first antenatal visit, which may have underestimated obesity rates. Other limitations are that weight changes over the course of pregnancy were not studied and there was a limited number of women with a body mass index of 40 or higher.

The study was supported by a grant from the Allan E. Tiffin Trust, Toronto General and Western Hospital Foundation, and by a donation from Mrs. Josephine Rogers, Toronto General Hospital. Dr. Silversides is supported by the Miles Nadal Chair in Pregnancy and Heart Disease. Dr. Sharma and colleagues disclosed no relevant financial relationships.

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

Being obese and pregnant raises the risk for cardiac complications in women with preexisting heart disease, new research suggests, highlighting the need for earlier interventions in this high-risk population.

The analysis of 790 pregnancies revealed that 23% of women with obesity, defined as body mass index greater than 30 kg/m2, had a cardiac event during pregnancy versus 14% of women with normal body weight (P = .006).

The difference was driven largely by an increase in heart failure (8% vs. 3%; P = .02), although arrhythmias also trended higher in obese women (14% vs. 10%; P = .19).

Nearly half of the women with obesity and a cardiac event presented in the postpartum period (47%).

In multivariate analysis, both obesity and Canadian Cardiac Disease in Pregnancy Study (CARPREG) II risk score were independent predictors of cardiac events (odds ratios for both, 1.7), the investigators, led by Birgit Pfaller, MD, University of Toronto, reported in the Journal of the American College of Cardiology.

Although obesity has been linked to worse pregnancy outcomes and higher cardiovascular risk after delivery in the general population, the authors noted that this is the first study to examine its effect on outcomes in women with heart disease.

“We wanted to look at this high-risk group of women that had preexisting heart disease, but in addition had obesity, to try and find out if there was a kind of double hit for these women – and that, in the end, is what we found. It’s not just simply having heart disease, not simply having obesity, but the combination that’s problematic,” senior author and cardiologist Candice Silversides, MD, University of Toronto, said in an interview.

The findings are concerning given the rising prevalence of obesity worldwide. National data from 2018 show that slightly more than half of women who gave birth in the United States were significantly overweight or obese before becoming pregnant.

Similarly, in the present analysis of 600 women in the CARPREG study who gave birth from 2004 to 2014, nearly 1 in 5 pregnancies (19%) occurred in women with obesity and 25% were in overweight women.

Obese women were significantly more likely than those without obesity to have coronary artery disease (6% vs. 2%), cardiomyopathies (19% vs. 8%) and left ventricular dysfunction (19% vs. 12%) and to be hypertensive or have a hypertensive disorder of pregnancy (13% vs. 3%).

Preeclampsia developed in 32 women during the index pregnancy and 69% of these women were obese or overweight. Cardiac event rates were similar in women with or without preeclampsia but trended higher in women with preeclampsia with versus without obesity (36% vs. 14%; P = .20).

The ill effects of obesity were also reflected in fetal and neonatal events. Overall, 43% of women with obesity and 33% of normal-weight women had at least one fetal event (P = .02), with higher rates of preterm birth (19% vs. 10%; P = .005) and respiratory distress syndrome (8% vs. 3%; P = .02) in women with obesity. Congenital cardiac malformations were present in 6% of women in both groups.

Taken together, the composite of cardiac events, preeclampsia, or fetal events was significantly more common in women with obesity than in normal-weight women (56% vs. 41%; P = .002).

“We’ve spent the last number of years trying to research and understand what the drivers of these adverse outcomes are in this high-risk pregnant cohort, but on a bigger picture the real issue is how do we start intervening in a meaningful way,” Dr. Silversides said.

Like many in the burgeoning field of cardio-obstetrics, the team proposed a multidisciplinary approach that stresses preconception counseling, educating pregnant women with heart disease and obesity about their risks, ensuring that dietary advice, weight-gain recommendations, and comorbidities are addressed as part of routine care, and providing postpartum surveillance.

Preconception screening “has been the recommendation for a long, long time; it’s just that it doesn’t always happen in reality,” she said. “Many pregnancies aren’t planned and not all women are filtered into preconception counseling. So sometimes you’ll do it at the first antenatal visit and try to ensure women are educated but optimally you want to do it well in advance of pregnancy.”

Part of that preconception counseling “should also include giving them appropriate advice for contraception, if what they want to do is avoid pregnancy,” added Dr. Silversides.

Garima Sharma, MD, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, and colleagues wrote in an accompanying editorial that the adverse events observed in this high-risk cohort have “important implications for cardio-obstetricians and should be incorporated in routine prepregnancy and antenatal counseling, monitoring, and risk stratification for women with existing cardiovascular disease.”

They pointed to a paucity of data incorporating maternal prepregnancy obesity and gestational weight gain in risk prediction and called for larger population-based studies on the additive impact of obesity severity on predicting adverse cardiac events in women with existing cardiovascular disease.

Randomized trials are also urgently needed to evaluate the effect of nutritional and behavioral interventions in pregnancy on short- and long-term outcomes in mother and child.

“As the obesity epidemic continues to grow and public health interventions promoting lifestyle changes for obesity management remain a major challenge, maternal obesity may prove to be the ‘Achilles’ heel’ of sustainable national efforts to reduce maternal mortality and improve health equity. This is a call to action,” Dr. Sharma and colleagues concluded.

The investigators noted that the study was conducted at a single center and used self-reported pregnancy weight collected at the first antenatal visit, which may have underestimated obesity rates. Other limitations are that weight changes over the course of pregnancy were not studied and there was a limited number of women with a body mass index of 40 or higher.

The study was supported by a grant from the Allan E. Tiffin Trust, Toronto General and Western Hospital Foundation, and by a donation from Mrs. Josephine Rogers, Toronto General Hospital. Dr. Silversides is supported by the Miles Nadal Chair in Pregnancy and Heart Disease. Dr. Sharma and colleagues disclosed no relevant financial relationships.

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

Being obese and pregnant raises the risk for cardiac complications in women with preexisting heart disease, new research suggests, highlighting the need for earlier interventions in this high-risk population.

The analysis of 790 pregnancies revealed that 23% of women with obesity, defined as body mass index greater than 30 kg/m2, had a cardiac event during pregnancy versus 14% of women with normal body weight (P = .006).

The difference was driven largely by an increase in heart failure (8% vs. 3%; P = .02), although arrhythmias also trended higher in obese women (14% vs. 10%; P = .19).

Nearly half of the women with obesity and a cardiac event presented in the postpartum period (47%).

In multivariate analysis, both obesity and Canadian Cardiac Disease in Pregnancy Study (CARPREG) II risk score were independent predictors of cardiac events (odds ratios for both, 1.7), the investigators, led by Birgit Pfaller, MD, University of Toronto, reported in the Journal of the American College of Cardiology.

Although obesity has been linked to worse pregnancy outcomes and higher cardiovascular risk after delivery in the general population, the authors noted that this is the first study to examine its effect on outcomes in women with heart disease.

“We wanted to look at this high-risk group of women that had preexisting heart disease, but in addition had obesity, to try and find out if there was a kind of double hit for these women – and that, in the end, is what we found. It’s not just simply having heart disease, not simply having obesity, but the combination that’s problematic,” senior author and cardiologist Candice Silversides, MD, University of Toronto, said in an interview.

The findings are concerning given the rising prevalence of obesity worldwide. National data from 2018 show that slightly more than half of women who gave birth in the United States were significantly overweight or obese before becoming pregnant.

Similarly, in the present analysis of 600 women in the CARPREG study who gave birth from 2004 to 2014, nearly 1 in 5 pregnancies (19%) occurred in women with obesity and 25% were in overweight women.

Obese women were significantly more likely than those without obesity to have coronary artery disease (6% vs. 2%), cardiomyopathies (19% vs. 8%) and left ventricular dysfunction (19% vs. 12%) and to be hypertensive or have a hypertensive disorder of pregnancy (13% vs. 3%).

Preeclampsia developed in 32 women during the index pregnancy and 69% of these women were obese or overweight. Cardiac event rates were similar in women with or without preeclampsia but trended higher in women with preeclampsia with versus without obesity (36% vs. 14%; P = .20).

The ill effects of obesity were also reflected in fetal and neonatal events. Overall, 43% of women with obesity and 33% of normal-weight women had at least one fetal event (P = .02), with higher rates of preterm birth (19% vs. 10%; P = .005) and respiratory distress syndrome (8% vs. 3%; P = .02) in women with obesity. Congenital cardiac malformations were present in 6% of women in both groups.

Taken together, the composite of cardiac events, preeclampsia, or fetal events was significantly more common in women with obesity than in normal-weight women (56% vs. 41%; P = .002).

“We’ve spent the last number of years trying to research and understand what the drivers of these adverse outcomes are in this high-risk pregnant cohort, but on a bigger picture the real issue is how do we start intervening in a meaningful way,” Dr. Silversides said.

Like many in the burgeoning field of cardio-obstetrics, the team proposed a multidisciplinary approach that stresses preconception counseling, educating pregnant women with heart disease and obesity about their risks, ensuring that dietary advice, weight-gain recommendations, and comorbidities are addressed as part of routine care, and providing postpartum surveillance.

Preconception screening “has been the recommendation for a long, long time; it’s just that it doesn’t always happen in reality,” she said. “Many pregnancies aren’t planned and not all women are filtered into preconception counseling. So sometimes you’ll do it at the first antenatal visit and try to ensure women are educated but optimally you want to do it well in advance of pregnancy.”

Part of that preconception counseling “should also include giving them appropriate advice for contraception, if what they want to do is avoid pregnancy,” added Dr. Silversides.

Garima Sharma, MD, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, and colleagues wrote in an accompanying editorial that the adverse events observed in this high-risk cohort have “important implications for cardio-obstetricians and should be incorporated in routine prepregnancy and antenatal counseling, monitoring, and risk stratification for women with existing cardiovascular disease.”

They pointed to a paucity of data incorporating maternal prepregnancy obesity and gestational weight gain in risk prediction and called for larger population-based studies on the additive impact of obesity severity on predicting adverse cardiac events in women with existing cardiovascular disease.

Randomized trials are also urgently needed to evaluate the effect of nutritional and behavioral interventions in pregnancy on short- and long-term outcomes in mother and child.

“As the obesity epidemic continues to grow and public health interventions promoting lifestyle changes for obesity management remain a major challenge, maternal obesity may prove to be the ‘Achilles’ heel’ of sustainable national efforts to reduce maternal mortality and improve health equity. This is a call to action,” Dr. Sharma and colleagues concluded.

The investigators noted that the study was conducted at a single center and used self-reported pregnancy weight collected at the first antenatal visit, which may have underestimated obesity rates. Other limitations are that weight changes over the course of pregnancy were not studied and there was a limited number of women with a body mass index of 40 or higher.

The study was supported by a grant from the Allan E. Tiffin Trust, Toronto General and Western Hospital Foundation, and by a donation from Mrs. Josephine Rogers, Toronto General Hospital. Dr. Silversides is supported by the Miles Nadal Chair in Pregnancy and Heart Disease. Dr. Sharma and colleagues disclosed no relevant financial relationships.

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

Major ECG abnormalities were found in 13% of more than 8,000 unselected patients with type 2 diabetes, including a 9% prevalence in the subgroup of these patients without identified cardiovascular disease (CVD) in a community-based Dutch cohort. Minor ECG abnormalities were even more prevalent.

enot-poloskun/Getty Images

These prevalence rates were consistent with prior findings from patients with type 2 diabetes, but the current report is notable because “it provides the most thorough description of the prevalence of ECG abnormalities in people with type 2 diabetes,” and used an “unselected and large population with comprehensive measurements,” including many without a history of CVD, said Peter P. Harms, MSc, and associates noted in a recent report in the Journal of Diabetes and Its Complications.

The analysis also identified several parameters that significantly linked with the presence of a major ECG abnormality including hypertension, male sex, older age, and higher levels of hemoglobin A1c.

“Resting ECG abnormalities might be a useful tool for CVD screening in people with type 2 diabetes,” concluded Mr. Harms, a researcher at the Amsterdam University Medical Center, and coauthors.
 

Findings “not unexpected”

Patients with diabetes have a higher prevalence of ECG abnormalities “because of their higher likelihood of having hypertension and other CVD risk factors,” as well as potentially having subclinical CVD, said Fred M. Kusumoto, MD, so these findings are “not unexpected. The more risk factors a patient has for structural heart disease, atrial fibrillation (AFib), or stroke from AFib, the more a physician must consider whether a baseline ECG and future surveillance is appropriate,” Dr. Kusumoto said in an interview.

But he cautioned against seeing these findings as a rationale to routinely run a resting ECG examination on every adult with diabetes.

“Patients with diabetes are very heterogeneous,” which makes it “difficult to come up with a ‘one size fits all’ recommendation” for ECG screening of patients with diabetes, he said.

While a task force of the European Society of Cardiology and the European Association for the Study of Diabetes set a class I level C guideline for resting ECG screening of patients with diabetes if they also have either hypertension or suspected CVD, the American Diabetes Association has no specific recommendations on which patients with diabetes should receive ECG screening.

“The current absence of U.S. recommendations is reasonable, as it allows patients and physicians to discuss the issues and decide on the utility of an ECG in their specific situation,” said Dr. Kusumoto, director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. But he also suggested that “the more risk factors that a patient with diabetes has for structural heart disease, AFib, or stroke from AFib the more a physician must consider whether a baseline ECG and future surveillance is appropriate.”

Data from a Dutch prospective cohort

The new study used data collected from 8,068 patients with type 2 diabetes and enrolled in the prospective Hoorn Diabetes Care System cohort, which enrolled patients newly diagnosed with type 2 diabetes in the West Friesland region of the Netherlands starting in 1996. The study includes most of these patients in the region who are under regular care of a general practitioner, and the study protocol calls for an annual resting ECG examination.

The investigators used standard, 12-lead ECG readings taken for each patient during 2018, and classified abnormalities by the Minnesota Code criteria. They divided the abnormalities into major or minor groups “in accordance with consensus between previous studies who categorised abnormalities according to perceived importance and/or severity.” The major subgroup included major QS pattern abnormalities, major ST-segment abnormalities, complete left bundle branch block or intraventricular block, or atrial fibrillation or flutter. Minor abnormalities included minor QS pattern abnormalities, minor ST-segment abnormalities, complete right bundle branch block, or premature atrial or ventricular contractions.

The prevalence of a major abnormality in the entire cohort examined was 13%, and another 16% had a minor abnormality. The most common types of abnormalities were ventricular conduction defects, in 14%; and arrhythmias, in 11%. In the subgroup of 6,494 of these patients with no history of CVD, 9% had a major abnormality and 15% a minor abnormality. Within this subgroup, 23% also had no hypertension, and their prevalence of a major abnormality was 4%, while 9% had a minor abnormality.

A multivariable analysis of potential risk factors among the entire study cohort showed that patients with hypertension had nearly triple the prevalence of a major ECG abnormality as those without hypertension, and men had double the prevalence of a major abnormality compared with women. Other markers that significantly linked with a higher rate of a major abnormality were older age, higher body mass index, higher A1c levels, and moderately depressed renal function.

“While the criteria the authors used for differentiating major and minor criteria are reasonable, in an asymptomatic patient even the presence of frequent premature atrial contractions on a baseline ECG has been associated with the development of AFib and a higher risk for stroke. The presence of left or right bundle branch block could spur additional evaluation with an echocardiogram,” said Dr. Kusumoto, president-elect of the Heart Rhythm Society.

“Generally an ECG abnormality is supplemental to clinical data in deciding the choice and timing of next therapeutic steps or additional testing. Physicians should have a fairly low threshold for obtaining ECG in patients with diabetes since it is inexpensive and can provide supplemental and potentially actionable information,” he said. “The presence of ECG abnormalities increases the possibility of underlying cardiovascular disease. When taking care of patients with diabetes at initial evaluation or without prior cardiac history or symptoms referable to the heart, two main issues are identifying the likelihood of coronary artery disease and atrial fibrillation.”

Mr. Harms and coauthors, and Dr. Kusumoto, had no disclosures.

[email protected]

Major ECG abnormalities were found in 13% of more than 8,000 unselected patients with type 2 diabetes, including a 9% prevalence in the subgroup of these patients without identified cardiovascular disease (CVD) in a community-based Dutch cohort. Minor ECG abnormalities were even more prevalent.

enot-poloskun/Getty Images

These prevalence rates were consistent with prior findings from patients with type 2 diabetes, but the current report is notable because “it provides the most thorough description of the prevalence of ECG abnormalities in people with type 2 diabetes,” and used an “unselected and large population with comprehensive measurements,” including many without a history of CVD, said Peter P. Harms, MSc, and associates noted in a recent report in the Journal of Diabetes and Its Complications.

The analysis also identified several parameters that significantly linked with the presence of a major ECG abnormality including hypertension, male sex, older age, and higher levels of hemoglobin A1c.

“Resting ECG abnormalities might be a useful tool for CVD screening in people with type 2 diabetes,” concluded Mr. Harms, a researcher at the Amsterdam University Medical Center, and coauthors.
 

Findings “not unexpected”

Patients with diabetes have a higher prevalence of ECG abnormalities “because of their higher likelihood of having hypertension and other CVD risk factors,” as well as potentially having subclinical CVD, said Fred M. Kusumoto, MD, so these findings are “not unexpected. The more risk factors a patient has for structural heart disease, atrial fibrillation (AFib), or stroke from AFib, the more a physician must consider whether a baseline ECG and future surveillance is appropriate,” Dr. Kusumoto said in an interview.

But he cautioned against seeing these findings as a rationale to routinely run a resting ECG examination on every adult with diabetes.

“Patients with diabetes are very heterogeneous,” which makes it “difficult to come up with a ‘one size fits all’ recommendation” for ECG screening of patients with diabetes, he said.

While a task force of the European Society of Cardiology and the European Association for the Study of Diabetes set a class I level C guideline for resting ECG screening of patients with diabetes if they also have either hypertension or suspected CVD, the American Diabetes Association has no specific recommendations on which patients with diabetes should receive ECG screening.

“The current absence of U.S. recommendations is reasonable, as it allows patients and physicians to discuss the issues and decide on the utility of an ECG in their specific situation,” said Dr. Kusumoto, director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. But he also suggested that “the more risk factors that a patient with diabetes has for structural heart disease, AFib, or stroke from AFib the more a physician must consider whether a baseline ECG and future surveillance is appropriate.”

Data from a Dutch prospective cohort

The new study used data collected from 8,068 patients with type 2 diabetes and enrolled in the prospective Hoorn Diabetes Care System cohort, which enrolled patients newly diagnosed with type 2 diabetes in the West Friesland region of the Netherlands starting in 1996. The study includes most of these patients in the region who are under regular care of a general practitioner, and the study protocol calls for an annual resting ECG examination.

The investigators used standard, 12-lead ECG readings taken for each patient during 2018, and classified abnormalities by the Minnesota Code criteria. They divided the abnormalities into major or minor groups “in accordance with consensus between previous studies who categorised abnormalities according to perceived importance and/or severity.” The major subgroup included major QS pattern abnormalities, major ST-segment abnormalities, complete left bundle branch block or intraventricular block, or atrial fibrillation or flutter. Minor abnormalities included minor QS pattern abnormalities, minor ST-segment abnormalities, complete right bundle branch block, or premature atrial or ventricular contractions.

The prevalence of a major abnormality in the entire cohort examined was 13%, and another 16% had a minor abnormality. The most common types of abnormalities were ventricular conduction defects, in 14%; and arrhythmias, in 11%. In the subgroup of 6,494 of these patients with no history of CVD, 9% had a major abnormality and 15% a minor abnormality. Within this subgroup, 23% also had no hypertension, and their prevalence of a major abnormality was 4%, while 9% had a minor abnormality.

A multivariable analysis of potential risk factors among the entire study cohort showed that patients with hypertension had nearly triple the prevalence of a major ECG abnormality as those without hypertension, and men had double the prevalence of a major abnormality compared with women. Other markers that significantly linked with a higher rate of a major abnormality were older age, higher body mass index, higher A1c levels, and moderately depressed renal function.

“While the criteria the authors used for differentiating major and minor criteria are reasonable, in an asymptomatic patient even the presence of frequent premature atrial contractions on a baseline ECG has been associated with the development of AFib and a higher risk for stroke. The presence of left or right bundle branch block could spur additional evaluation with an echocardiogram,” said Dr. Kusumoto, president-elect of the Heart Rhythm Society.

“Generally an ECG abnormality is supplemental to clinical data in deciding the choice and timing of next therapeutic steps or additional testing. Physicians should have a fairly low threshold for obtaining ECG in patients with diabetes since it is inexpensive and can provide supplemental and potentially actionable information,” he said. “The presence of ECG abnormalities increases the possibility of underlying cardiovascular disease. When taking care of patients with diabetes at initial evaluation or without prior cardiac history or symptoms referable to the heart, two main issues are identifying the likelihood of coronary artery disease and atrial fibrillation.”

Mr. Harms and coauthors, and Dr. Kusumoto, had no disclosures.

[email protected]

Major ECG abnormalities were found in 13% of more than 8,000 unselected patients with type 2 diabetes, including a 9% prevalence in the subgroup of these patients without identified cardiovascular disease (CVD) in a community-based Dutch cohort. Minor ECG abnormalities were even more prevalent.

enot-poloskun/Getty Images

These prevalence rates were consistent with prior findings from patients with type 2 diabetes, but the current report is notable because “it provides the most thorough description of the prevalence of ECG abnormalities in people with type 2 diabetes,” and used an “unselected and large population with comprehensive measurements,” including many without a history of CVD, said Peter P. Harms, MSc, and associates noted in a recent report in the Journal of Diabetes and Its Complications.

The analysis also identified several parameters that significantly linked with the presence of a major ECG abnormality including hypertension, male sex, older age, and higher levels of hemoglobin A1c.

“Resting ECG abnormalities might be a useful tool for CVD screening in people with type 2 diabetes,” concluded Mr. Harms, a researcher at the Amsterdam University Medical Center, and coauthors.
 

Findings “not unexpected”

Patients with diabetes have a higher prevalence of ECG abnormalities “because of their higher likelihood of having hypertension and other CVD risk factors,” as well as potentially having subclinical CVD, said Fred M. Kusumoto, MD, so these findings are “not unexpected. The more risk factors a patient has for structural heart disease, atrial fibrillation (AFib), or stroke from AFib, the more a physician must consider whether a baseline ECG and future surveillance is appropriate,” Dr. Kusumoto said in an interview.

But he cautioned against seeing these findings as a rationale to routinely run a resting ECG examination on every adult with diabetes.

“Patients with diabetes are very heterogeneous,” which makes it “difficult to come up with a ‘one size fits all’ recommendation” for ECG screening of patients with diabetes, he said.

While a task force of the European Society of Cardiology and the European Association for the Study of Diabetes set a class I level C guideline for resting ECG screening of patients with diabetes if they also have either hypertension or suspected CVD, the American Diabetes Association has no specific recommendations on which patients with diabetes should receive ECG screening.

“The current absence of U.S. recommendations is reasonable, as it allows patients and physicians to discuss the issues and decide on the utility of an ECG in their specific situation,” said Dr. Kusumoto, director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. But he also suggested that “the more risk factors that a patient with diabetes has for structural heart disease, AFib, or stroke from AFib the more a physician must consider whether a baseline ECG and future surveillance is appropriate.”

Data from a Dutch prospective cohort

The new study used data collected from 8,068 patients with type 2 diabetes and enrolled in the prospective Hoorn Diabetes Care System cohort, which enrolled patients newly diagnosed with type 2 diabetes in the West Friesland region of the Netherlands starting in 1996. The study includes most of these patients in the region who are under regular care of a general practitioner, and the study protocol calls for an annual resting ECG examination.

The investigators used standard, 12-lead ECG readings taken for each patient during 2018, and classified abnormalities by the Minnesota Code criteria. They divided the abnormalities into major or minor groups “in accordance with consensus between previous studies who categorised abnormalities according to perceived importance and/or severity.” The major subgroup included major QS pattern abnormalities, major ST-segment abnormalities, complete left bundle branch block or intraventricular block, or atrial fibrillation or flutter. Minor abnormalities included minor QS pattern abnormalities, minor ST-segment abnormalities, complete right bundle branch block, or premature atrial or ventricular contractions.

The prevalence of a major abnormality in the entire cohort examined was 13%, and another 16% had a minor abnormality. The most common types of abnormalities were ventricular conduction defects, in 14%; and arrhythmias, in 11%. In the subgroup of 6,494 of these patients with no history of CVD, 9% had a major abnormality and 15% a minor abnormality. Within this subgroup, 23% also had no hypertension, and their prevalence of a major abnormality was 4%, while 9% had a minor abnormality.

A multivariable analysis of potential risk factors among the entire study cohort showed that patients with hypertension had nearly triple the prevalence of a major ECG abnormality as those without hypertension, and men had double the prevalence of a major abnormality compared with women. Other markers that significantly linked with a higher rate of a major abnormality were older age, higher body mass index, higher A1c levels, and moderately depressed renal function.

“While the criteria the authors used for differentiating major and minor criteria are reasonable, in an asymptomatic patient even the presence of frequent premature atrial contractions on a baseline ECG has been associated with the development of AFib and a higher risk for stroke. The presence of left or right bundle branch block could spur additional evaluation with an echocardiogram,” said Dr. Kusumoto, president-elect of the Heart Rhythm Society.

“Generally an ECG abnormality is supplemental to clinical data in deciding the choice and timing of next therapeutic steps or additional testing. Physicians should have a fairly low threshold for obtaining ECG in patients with diabetes since it is inexpensive and can provide supplemental and potentially actionable information,” he said. “The presence of ECG abnormalities increases the possibility of underlying cardiovascular disease. When taking care of patients with diabetes at initial evaluation or without prior cardiac history or symptoms referable to the heart, two main issues are identifying the likelihood of coronary artery disease and atrial fibrillation.”

Mr. Harms and coauthors, and Dr. Kusumoto, had no disclosures.

[email protected]

New onset atrial fibrillation or flutter (AF/AFL) is uncommon in patients hospitalized with COVID-19 and occurs at a rate similar to that seen in patients hospitalized with influenza.

Mitchel L. Zoler/MDedge News

Among 3,970 patients treated during the early months of the pandemic, new onset AF/AFL was seen in 4%, matching the 4% incidence found in a historic cohort of patients hospitalized with influenza.

On the other hand, mortality was similarly high in both groups of patients studied with AF/AFL, showing a 77% increased risk of death in COVID-19 and a 78% increased risk in influenza, a team from Icahn School of Medicine at Mount Sinai in New York reported.

“We saw new onset Afib and flutter in a minority of patients and it was associated with much higher mortality, but the point is that this increase is basically the same as what you see in influenza, which we feel is an indication that this is more of a generalized response to the inflammatory milieu of such a severe viral illness, as opposed to something specific to COVID,” Vivek Y. Reddy, MD, said in the report, published online Feb. 25 in JACC: Clinical Electrophysiology.

“Here we see, with a similar respiratory virus used as controls, that the results are exactly what I would have expected to see, which is that where there is a lot of inflammation, we see Afib,” said John Mandrola, MD, of Baptist Medical Associates, Louisville, Ky., who was not involved with the study.

“We need more studies like this one because we know SARS-CoV-2 is a bad virus that may have important effects on the heart, but all the of research done so far has been problematic because it didn’t include controls.”
 

Atrial arrhythmias in COVID and flu

Dr. Reddy and coinvestigators performed a retrospective analysis of a large cohort of patients admitted with laboratory-confirmed COVID-19 during Feb. 4-April 22, 2020, to one of five hospitals within the Mount Sinai Health System.

Their comparator arm included 1,420 patients with confirmed influenza A or B hospitalized between Jan. 1, 2017, and Jan. 1, 2020. For both cohorts, automated electronic record abstraction was used and all patient data were de-identified prior to analysis. In the COVID-19 cohort, a manual review of 1,110 charts was also performed.

Compared with those who did not develop AF/AFL, COVID-19 patients with newly detected AF/AFL and COVID-19 were older (74 vs. 66 years; P < .01) and had higher levels of inflammatory markers, including C-reactive protein and interleukin-6, and higher troponin and D-dimer levels (all P < .01).

Overall, including those with a history of atrial arrhythmias, 10% of patients with hospitalized COVID-19 (13% in the manual review) and 12% of those with influenza had AF/AFL detected during their hospitalization.

Mortality at 30 days was higher in COVID-19 patients with AF/AFL compared to those without (46% vs. 26%; P < .01), as were the rates of intubation (27% vs. 15%; relative risk, 1.8; P < .01), and stroke (1.6% vs. 0.6%, RR, 2.7; P = .05).

Despite having more comorbidities, in-hospital mortality was significantly lower in the influenza cohort overall, compared to the COVID-19 cohort (9% vs. 29%; P < .01), reflecting the higher case fatality rate in COVID-19, Dr. Reddy, director of cardiac arrhythmia services at Mount Sinai Hospital, said in an interview.

But as with COVID-19, those influenza patients who had in-hospital AF/AFL were more likely to require intubation (14% vs. 7%; P = .004) or die (16% vs. 10%; P = .003).

“The data are not perfect and there are always limitations when doing an observational study using historic controls, but my guess would be that if we looked at other databases and other populations hospitalized for severe illness, we’d likely see something similar because when the body is inflamed, you’re more likely to see Afib,” said Dr. Mandrola.

Dr. Reddy concurred, noting that they considered comparing other populations to COVID-19 patients, including those with “just generalized severe illness,” but in the end felt there were many similarities between influenza and COVID-19, even though mortality in the latter is higher.

“It would be interesting for people to look at other illnesses and see if they find the same thing,” he said.

Dr. Reddy reported having no disclosures relevant to COVID-19. Dr. Mandrola is chief cardiology correspondent for Medscape.com. He reported having no relevant disclosures. MDedge is a member of the Medscape Professional Network.

New onset atrial fibrillation or flutter (AF/AFL) is uncommon in patients hospitalized with COVID-19 and occurs at a rate similar to that seen in patients hospitalized with influenza.

Mitchel L. Zoler/MDedge News

Among 3,970 patients treated during the early months of the pandemic, new onset AF/AFL was seen in 4%, matching the 4% incidence found in a historic cohort of patients hospitalized with influenza.

On the other hand, mortality was similarly high in both groups of patients studied with AF/AFL, showing a 77% increased risk of death in COVID-19 and a 78% increased risk in influenza, a team from Icahn School of Medicine at Mount Sinai in New York reported.

“We saw new onset Afib and flutter in a minority of patients and it was associated with much higher mortality, but the point is that this increase is basically the same as what you see in influenza, which we feel is an indication that this is more of a generalized response to the inflammatory milieu of such a severe viral illness, as opposed to something specific to COVID,” Vivek Y. Reddy, MD, said in the report, published online Feb. 25 in JACC: Clinical Electrophysiology.

“Here we see, with a similar respiratory virus used as controls, that the results are exactly what I would have expected to see, which is that where there is a lot of inflammation, we see Afib,” said John Mandrola, MD, of Baptist Medical Associates, Louisville, Ky., who was not involved with the study.

“We need more studies like this one because we know SARS-CoV-2 is a bad virus that may have important effects on the heart, but all the of research done so far has been problematic because it didn’t include controls.”
 

Atrial arrhythmias in COVID and flu

Dr. Reddy and coinvestigators performed a retrospective analysis of a large cohort of patients admitted with laboratory-confirmed COVID-19 during Feb. 4-April 22, 2020, to one of five hospitals within the Mount Sinai Health System.

Their comparator arm included 1,420 patients with confirmed influenza A or B hospitalized between Jan. 1, 2017, and Jan. 1, 2020. For both cohorts, automated electronic record abstraction was used and all patient data were de-identified prior to analysis. In the COVID-19 cohort, a manual review of 1,110 charts was also performed.

Compared with those who did not develop AF/AFL, COVID-19 patients with newly detected AF/AFL and COVID-19 were older (74 vs. 66 years; P < .01) and had higher levels of inflammatory markers, including C-reactive protein and interleukin-6, and higher troponin and D-dimer levels (all P < .01).

Overall, including those with a history of atrial arrhythmias, 10% of patients with hospitalized COVID-19 (13% in the manual review) and 12% of those with influenza had AF/AFL detected during their hospitalization.

Mortality at 30 days was higher in COVID-19 patients with AF/AFL compared to those without (46% vs. 26%; P < .01), as were the rates of intubation (27% vs. 15%; relative risk, 1.8; P < .01), and stroke (1.6% vs. 0.6%, RR, 2.7; P = .05).

Despite having more comorbidities, in-hospital mortality was significantly lower in the influenza cohort overall, compared to the COVID-19 cohort (9% vs. 29%; P < .01), reflecting the higher case fatality rate in COVID-19, Dr. Reddy, director of cardiac arrhythmia services at Mount Sinai Hospital, said in an interview.

But as with COVID-19, those influenza patients who had in-hospital AF/AFL were more likely to require intubation (14% vs. 7%; P = .004) or die (16% vs. 10%; P = .003).

“The data are not perfect and there are always limitations when doing an observational study using historic controls, but my guess would be that if we looked at other databases and other populations hospitalized for severe illness, we’d likely see something similar because when the body is inflamed, you’re more likely to see Afib,” said Dr. Mandrola.

Dr. Reddy concurred, noting that they considered comparing other populations to COVID-19 patients, including those with “just generalized severe illness,” but in the end felt there were many similarities between influenza and COVID-19, even though mortality in the latter is higher.

“It would be interesting for people to look at other illnesses and see if they find the same thing,” he said.

Dr. Reddy reported having no disclosures relevant to COVID-19. Dr. Mandrola is chief cardiology correspondent for Medscape.com. He reported having no relevant disclosures. MDedge is a member of the Medscape Professional Network.

New onset atrial fibrillation or flutter (AF/AFL) is uncommon in patients hospitalized with COVID-19 and occurs at a rate similar to that seen in patients hospitalized with influenza.

Mitchel L. Zoler/MDedge News

Among 3,970 patients treated during the early months of the pandemic, new onset AF/AFL was seen in 4%, matching the 4% incidence found in a historic cohort of patients hospitalized with influenza.

On the other hand, mortality was similarly high in both groups of patients studied with AF/AFL, showing a 77% increased risk of death in COVID-19 and a 78% increased risk in influenza, a team from Icahn School of Medicine at Mount Sinai in New York reported.

“We saw new onset Afib and flutter in a minority of patients and it was associated with much higher mortality, but the point is that this increase is basically the same as what you see in influenza, which we feel is an indication that this is more of a generalized response to the inflammatory milieu of such a severe viral illness, as opposed to something specific to COVID,” Vivek Y. Reddy, MD, said in the report, published online Feb. 25 in JACC: Clinical Electrophysiology.

“Here we see, with a similar respiratory virus used as controls, that the results are exactly what I would have expected to see, which is that where there is a lot of inflammation, we see Afib,” said John Mandrola, MD, of Baptist Medical Associates, Louisville, Ky., who was not involved with the study.

“We need more studies like this one because we know SARS-CoV-2 is a bad virus that may have important effects on the heart, but all the of research done so far has been problematic because it didn’t include controls.”
 

Atrial arrhythmias in COVID and flu

Dr. Reddy and coinvestigators performed a retrospective analysis of a large cohort of patients admitted with laboratory-confirmed COVID-19 during Feb. 4-April 22, 2020, to one of five hospitals within the Mount Sinai Health System.

Their comparator arm included 1,420 patients with confirmed influenza A or B hospitalized between Jan. 1, 2017, and Jan. 1, 2020. For both cohorts, automated electronic record abstraction was used and all patient data were de-identified prior to analysis. In the COVID-19 cohort, a manual review of 1,110 charts was also performed.

Compared with those who did not develop AF/AFL, COVID-19 patients with newly detected AF/AFL and COVID-19 were older (74 vs. 66 years; P < .01) and had higher levels of inflammatory markers, including C-reactive protein and interleukin-6, and higher troponin and D-dimer levels (all P < .01).

Overall, including those with a history of atrial arrhythmias, 10% of patients with hospitalized COVID-19 (13% in the manual review) and 12% of those with influenza had AF/AFL detected during their hospitalization.

Mortality at 30 days was higher in COVID-19 patients with AF/AFL compared to those without (46% vs. 26%; P < .01), as were the rates of intubation (27% vs. 15%; relative risk, 1.8; P < .01), and stroke (1.6% vs. 0.6%, RR, 2.7; P = .05).

Despite having more comorbidities, in-hospital mortality was significantly lower in the influenza cohort overall, compared to the COVID-19 cohort (9% vs. 29%; P < .01), reflecting the higher case fatality rate in COVID-19, Dr. Reddy, director of cardiac arrhythmia services at Mount Sinai Hospital, said in an interview.

But as with COVID-19, those influenza patients who had in-hospital AF/AFL were more likely to require intubation (14% vs. 7%; P = .004) or die (16% vs. 10%; P = .003).

“The data are not perfect and there are always limitations when doing an observational study using historic controls, but my guess would be that if we looked at other databases and other populations hospitalized for severe illness, we’d likely see something similar because when the body is inflamed, you’re more likely to see Afib,” said Dr. Mandrola.

Dr. Reddy concurred, noting that they considered comparing other populations to COVID-19 patients, including those with “just generalized severe illness,” but in the end felt there were many similarities between influenza and COVID-19, even though mortality in the latter is higher.

“It would be interesting for people to look at other illnesses and see if they find the same thing,” he said.

Dr. Reddy reported having no disclosures relevant to COVID-19. Dr. Mandrola is chief cardiology correspondent for Medscape.com. He reported having no relevant disclosures. MDedge is a member of the Medscape Professional Network.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

Among critically ill patients pulseless after planned withdrawal of life-sustaining therapies, cardiac activity restarted in 14% of cases, research shows.

Reassuringly, most resumption of heart activity happened in the first 1-2 minutes and most lasted 1 or 2 seconds.

“The reason we wanted to look at death determination specifically is we know that the stories persist about people coming back to life following death, and that’s not just in the public, it’s in the medical community as well,” lead author Sonny Dhanani, MD, of Children’s Hospital of Eastern Ontario, Ottawa, said in an interview.

“We thought that if we provided scientific evidence of whether this happened or not, we might dispel some myths and misunderstanding, which would hopefully promote organ donation.”

About 70% of organ donations occur after brain death, but an increasing number follow circulatory determination of death, he noted. Most protocols recommend 5 minutes of apnea and pulselessness by arterial catheter monitor before declaring death. But practices vary from 10 minutes in some European countries to 75 seconds in infant heart donors at one Colorado hospital.

Reports of patients recovering 10 minutes after pulselessness have raised concerns about the Lazarus phenomenon, or autoresuscitation, but are based in patients after cardiopulmonary resuscitation was terminated.

The present study, known as Death Prediction and Physiology after Removal of Therapy (DePParRT), enrolled patients at 20 intensive care sites in Canada, the Czech Republic, and the Netherlands, only if surrogate decision-makers agreed on withdrawal of life-sustaining measures without CPR and imminent death was anticipated.

As reported Jan. 28 in the New England Journal of Medicine, physicians observed resumption of circulation or cardiac activity prospectively in 1% of 631 patients based on bedside ECG, arterial pressure catheter monitors, palpated arterial pulse, breaths, or physical movements.

A retrospective review of data from 480 patients with complete ECG and arterial waveforms and at least 5 minutes of continuous waveform monitoring after pulselessness showed resumption of cardiac activity in 14% of patients.

The longest period of pulselessness before the heart showed signs of activity again was 4 minutes and 20 seconds. “So that was a reassuring number, because that’s within our 5-minute window that we currently use,” Dr. Dhanani said.

Importantly, “nobody woke up, nobody ended up being resuscitated, and all of these individuals died. And I think that’s going to be very helpful in this context,” he added.

In all, there were 77 cessations and resumptions in 67 of the 480 patients. The median duration of resumed cardiac activity was 3.9 seconds but, notably, ranged from 1 second to 13 minutes and 14 seconds.

“Though surprising, I think maybe not unreasonable,” observed Dr. Dhanani. “The heart is a very robust organ, and we maybe should anticipate these things happening, where at the end of life the heart may restart for minutes.”

In this situation, it’s important to wait the 13 minutes for the heart to stop again and then “wait another 5 minutes to make sure it doesn’t restart before determining death,” he said. “I think that’s where this study is going to now inform policy makers and guidelines, especially in the context of donations.”

The findings will be taken as strong support for the 5-minute window, said Robert Truog, MD, director of the Harvard Medical School Center for Bioethics and the Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics, Boston.

“I think it’s a safe point, I think people will refer to it, and it will be used to support the 5-minute window, and that’s probably reasonable,” he told this news organization. “Certainly, if it’s read in Europe it will cut the time from 10 minutes to 5 minutes, and that’s a good thing because 10 minutes is a very long time to wait.”

He noted that the 5-minute window provides reasonable assurance to the public and, with new technologies, permits most organs to be usable for donation after cardiac death. That said, there’s nothing magical about the number.

“In some ways I see this paper as providing interesting data but not actually providing an answer, because from the patient’s perspective and from the recipient’s perspective, waiting until the heart has made its last squeeze may not be the most relevant ethical question,” Dr. Truog said. “It may be, once we know this patient is not going to have return of cardiorespiratory function, is not going to wake up, that’s the point at which we ought to focus on organ preservation and organ retrieval, and that can be much sooner than 5 minutes.”

Dr. Dhanani and colleagues note that the generalizability of the results might be limited because patients without arterial pressure catheters were excluded, and 24% of enrolled patients could not be included in the retrospective waveform analysis owing to incomplete data.

“Our study definition of cardiac activity used an arbitrary threshold of pulse pressure (less than 5 mm Hg) that does not imply meaningful circulation,” they add. “This conservative consensus definition may have been partially responsible for the ostensibly high incidence (14%) of transient resumptions of cardiac activity identified through waveform adjudication.”

The study was supported by the Canadian Institutes for Health Research as part of the Canadian Donation and Transplantation Research Program, CHEO Research Institute, and Karel Pavlík Foundation. Dr. Dhanani has consulted for Canadian Blood Services. Dr. Truog reports no relevant conflicts of interest.

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

Among critically ill patients pulseless after planned withdrawal of life-sustaining therapies, cardiac activity restarted in 14% of cases, research shows.

Reassuringly, most resumption of heart activity happened in the first 1-2 minutes and most lasted 1 or 2 seconds.

“The reason we wanted to look at death determination specifically is we know that the stories persist about people coming back to life following death, and that’s not just in the public, it’s in the medical community as well,” lead author Sonny Dhanani, MD, of Children’s Hospital of Eastern Ontario, Ottawa, said in an interview.

“We thought that if we provided scientific evidence of whether this happened or not, we might dispel some myths and misunderstanding, which would hopefully promote organ donation.”

About 70% of organ donations occur after brain death, but an increasing number follow circulatory determination of death, he noted. Most protocols recommend 5 minutes of apnea and pulselessness by arterial catheter monitor before declaring death. But practices vary from 10 minutes in some European countries to 75 seconds in infant heart donors at one Colorado hospital.

Reports of patients recovering 10 minutes after pulselessness have raised concerns about the Lazarus phenomenon, or autoresuscitation, but are based in patients after cardiopulmonary resuscitation was terminated.

The present study, known as Death Prediction and Physiology after Removal of Therapy (DePParRT), enrolled patients at 20 intensive care sites in Canada, the Czech Republic, and the Netherlands, only if surrogate decision-makers agreed on withdrawal of life-sustaining measures without CPR and imminent death was anticipated.

As reported Jan. 28 in the New England Journal of Medicine, physicians observed resumption of circulation or cardiac activity prospectively in 1% of 631 patients based on bedside ECG, arterial pressure catheter monitors, palpated arterial pulse, breaths, or physical movements.

A retrospective review of data from 480 patients with complete ECG and arterial waveforms and at least 5 minutes of continuous waveform monitoring after pulselessness showed resumption of cardiac activity in 14% of patients.

The longest period of pulselessness before the heart showed signs of activity again was 4 minutes and 20 seconds. “So that was a reassuring number, because that’s within our 5-minute window that we currently use,” Dr. Dhanani said.

Importantly, “nobody woke up, nobody ended up being resuscitated, and all of these individuals died. And I think that’s going to be very helpful in this context,” he added.

In all, there were 77 cessations and resumptions in 67 of the 480 patients. The median duration of resumed cardiac activity was 3.9 seconds but, notably, ranged from 1 second to 13 minutes and 14 seconds.

“Though surprising, I think maybe not unreasonable,” observed Dr. Dhanani. “The heart is a very robust organ, and we maybe should anticipate these things happening, where at the end of life the heart may restart for minutes.”

In this situation, it’s important to wait the 13 minutes for the heart to stop again and then “wait another 5 minutes to make sure it doesn’t restart before determining death,” he said. “I think that’s where this study is going to now inform policy makers and guidelines, especially in the context of donations.”

The findings will be taken as strong support for the 5-minute window, said Robert Truog, MD, director of the Harvard Medical School Center for Bioethics and the Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics, Boston.

“I think it’s a safe point, I think people will refer to it, and it will be used to support the 5-minute window, and that’s probably reasonable,” he told this news organization. “Certainly, if it’s read in Europe it will cut the time from 10 minutes to 5 minutes, and that’s a good thing because 10 minutes is a very long time to wait.”

He noted that the 5-minute window provides reasonable assurance to the public and, with new technologies, permits most organs to be usable for donation after cardiac death. That said, there’s nothing magical about the number.

“In some ways I see this paper as providing interesting data but not actually providing an answer, because from the patient’s perspective and from the recipient’s perspective, waiting until the heart has made its last squeeze may not be the most relevant ethical question,” Dr. Truog said. “It may be, once we know this patient is not going to have return of cardiorespiratory function, is not going to wake up, that’s the point at which we ought to focus on organ preservation and organ retrieval, and that can be much sooner than 5 minutes.”

Dr. Dhanani and colleagues note that the generalizability of the results might be limited because patients without arterial pressure catheters were excluded, and 24% of enrolled patients could not be included in the retrospective waveform analysis owing to incomplete data.

“Our study definition of cardiac activity used an arbitrary threshold of pulse pressure (less than 5 mm Hg) that does not imply meaningful circulation,” they add. “This conservative consensus definition may have been partially responsible for the ostensibly high incidence (14%) of transient resumptions of cardiac activity identified through waveform adjudication.”

The study was supported by the Canadian Institutes for Health Research as part of the Canadian Donation and Transplantation Research Program, CHEO Research Institute, and Karel Pavlík Foundation. Dr. Dhanani has consulted for Canadian Blood Services. Dr. Truog reports no relevant conflicts of interest.

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

Among critically ill patients pulseless after planned withdrawal of life-sustaining therapies, cardiac activity restarted in 14% of cases, research shows.

Reassuringly, most resumption of heart activity happened in the first 1-2 minutes and most lasted 1 or 2 seconds.

“The reason we wanted to look at death determination specifically is we know that the stories persist about people coming back to life following death, and that’s not just in the public, it’s in the medical community as well,” lead author Sonny Dhanani, MD, of Children’s Hospital of Eastern Ontario, Ottawa, said in an interview.

“We thought that if we provided scientific evidence of whether this happened or not, we might dispel some myths and misunderstanding, which would hopefully promote organ donation.”

About 70% of organ donations occur after brain death, but an increasing number follow circulatory determination of death, he noted. Most protocols recommend 5 minutes of apnea and pulselessness by arterial catheter monitor before declaring death. But practices vary from 10 minutes in some European countries to 75 seconds in infant heart donors at one Colorado hospital.

Reports of patients recovering 10 minutes after pulselessness have raised concerns about the Lazarus phenomenon, or autoresuscitation, but are based in patients after cardiopulmonary resuscitation was terminated.

The present study, known as Death Prediction and Physiology after Removal of Therapy (DePParRT), enrolled patients at 20 intensive care sites in Canada, the Czech Republic, and the Netherlands, only if surrogate decision-makers agreed on withdrawal of life-sustaining measures without CPR and imminent death was anticipated.

As reported Jan. 28 in the New England Journal of Medicine, physicians observed resumption of circulation or cardiac activity prospectively in 1% of 631 patients based on bedside ECG, arterial pressure catheter monitors, palpated arterial pulse, breaths, or physical movements.

A retrospective review of data from 480 patients with complete ECG and arterial waveforms and at least 5 minutes of continuous waveform monitoring after pulselessness showed resumption of cardiac activity in 14% of patients.

The longest period of pulselessness before the heart showed signs of activity again was 4 minutes and 20 seconds. “So that was a reassuring number, because that’s within our 5-minute window that we currently use,” Dr. Dhanani said.

Importantly, “nobody woke up, nobody ended up being resuscitated, and all of these individuals died. And I think that’s going to be very helpful in this context,” he added.

In all, there were 77 cessations and resumptions in 67 of the 480 patients. The median duration of resumed cardiac activity was 3.9 seconds but, notably, ranged from 1 second to 13 minutes and 14 seconds.

“Though surprising, I think maybe not unreasonable,” observed Dr. Dhanani. “The heart is a very robust organ, and we maybe should anticipate these things happening, where at the end of life the heart may restart for minutes.”

In this situation, it’s important to wait the 13 minutes for the heart to stop again and then “wait another 5 minutes to make sure it doesn’t restart before determining death,” he said. “I think that’s where this study is going to now inform policy makers and guidelines, especially in the context of donations.”

The findings will be taken as strong support for the 5-minute window, said Robert Truog, MD, director of the Harvard Medical School Center for Bioethics and the Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics, Boston.

“I think it’s a safe point, I think people will refer to it, and it will be used to support the 5-minute window, and that’s probably reasonable,” he told this news organization. “Certainly, if it’s read in Europe it will cut the time from 10 minutes to 5 minutes, and that’s a good thing because 10 minutes is a very long time to wait.”

He noted that the 5-minute window provides reasonable assurance to the public and, with new technologies, permits most organs to be usable for donation after cardiac death. That said, there’s nothing magical about the number.

“In some ways I see this paper as providing interesting data but not actually providing an answer, because from the patient’s perspective and from the recipient’s perspective, waiting until the heart has made its last squeeze may not be the most relevant ethical question,” Dr. Truog said. “It may be, once we know this patient is not going to have return of cardiorespiratory function, is not going to wake up, that’s the point at which we ought to focus on organ preservation and organ retrieval, and that can be much sooner than 5 minutes.”

Dr. Dhanani and colleagues note that the generalizability of the results might be limited because patients without arterial pressure catheters were excluded, and 24% of enrolled patients could not be included in the retrospective waveform analysis owing to incomplete data.

“Our study definition of cardiac activity used an arbitrary threshold of pulse pressure (less than 5 mm Hg) that does not imply meaningful circulation,” they add. “This conservative consensus definition may have been partially responsible for the ostensibly high incidence (14%) of transient resumptions of cardiac activity identified through waveform adjudication.”

The study was supported by the Canadian Institutes for Health Research as part of the Canadian Donation and Transplantation Research Program, CHEO Research Institute, and Karel Pavlík Foundation. Dr. Dhanani has consulted for Canadian Blood Services. Dr. Truog reports no relevant conflicts of interest.

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

Patients with an implantable cardioverter defibrillator (ICD) should be warned that some newer models of smartphones equipped with magnets, such as the iPhone 12, can disable their device, inhibiting its lifesaving functions, according to investigators who tested and confirmed this effect.

SL/Getty Images

“Once the iPhone was brought close to the ICD over the left chest area, immediate suspension of ICD therapies was noted which persisted for the duration of the test,” reported the investigating team led by Joshua C. Greenberg, MD, who is an electrophysiology fellow at Henry Ford Hospital, Detroit. The results were published in Heart Rhythm.

The American Heart Association has already cautioned that magnetic fields can inhibit the pulse generators for ICDs and pacemakers. On the AHA website, there is a list of devices and their potential for functional interference, but cell phones and other common devices are identified as posing a low risk.

The most recent iPhone and perhaps other advanced smartphones appear to be different. According to the authors of a study that tested the iPhone 12, this model has a circular array of magnets around a central charging coil. This array interacts with Apple’s proprietary MagSafe technology, which accelerates charging. The magnets also serve to orient the phone on the charger and enable other MagSafe accessories.

The authors of the new study were concerned that this array of magnets might be sufficiently strong to interfere with ICDs or other devices at risk. In a previously published study, the strength of a magnetic field sufficient to interfere with implantable cardiac devices was estimated to be at least 10 gauss.

Tests were performed on a patient wearing a Medtronic ICD.

“Once the iPhone was brought close to the ICD over the left chest area, immediate suspension of ICD therapies was noted,” according to the authors of the study. The functional loss of the ICS persisted for the duration of proximity. It was reproduced multiple times and with multiple phone positions.

Previous studies have provided evidence that earlier models do not share this risk. In a study testing the iPhone 6 and an Apple Watch in 148 patients with various types of implantable electronic devices, including pacemakers, cardioverter defibrillators, resynchronization defibrillators, and resynchronization pacemakers, only one instance of interference was observed in 1,352 tests.

With wand telemetry, iPhone-induced interferences could be detected with the iPhone 6 in 14% of the patients, but these did not appear to be clinically meaningful, and this type of interference could not be detected with the Apple Watch, according to the report. The single observed interaction, which was between an iPhone 6 and a dual-chamber pacemaker, suggested device-device interactions are uncommon.

More recently, a woman with a single-chamber Medtronic ICD who went to sleep wearing an Apple Watch was awoken by warning beeps from her cardiac device, according to a case report published online. The Apple watch became the prime suspect in causing the ICD warning when proximity of the watch reproduced the warning during clinical examination. However, the magnetic interference was ultimately found to be emanating from the wristband, not the watch.

This case prompted additional studies with Fitbit and other Apple Watch wristbands. Both wristbands contain magnets used to track heart rate. Both were found capable of deactivating ICDs at distances of approximately 2 cm. On the basis of these results, the authors concluded that patients should be counseled about the risk posed by wristbands used in fitness tracking, concluding that they should be kept at least 6 inches away from ICDs and not worn while sleeping.

On their website, Apple maintains a page that specifically warns about the potential for interactions between iPhone 12s and medical devices . Although there is an acknowledgment that the iPhone12 contains more magnets than prior iPhone models, it is stated that iPhone 12 models are “not expected to pose a greater risk of magnetic interference to medical devices than prior iPhone models.” Nevertheless, the Apple instructions advise keeping the iPhone and MagSafe accessories more than 6 inches away from medical devices.

Dr. Greenberg and coinvestigators concluded that the iPhone 12 does pose a greater risk to the dysfunction of ICDs and other medical devices because of the more powerful magnets. As a result, the study brings forward “an important public health issue concerning the newer generation iPhone 12.”

Well aware of this issue and this study, Bruce L. Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices, Cleveland Clinic, agreed. He said the focus should not be restricted to the iPhone 12 series but other wearable devices as alluded to in the study.

“Pacemakers and implantable defibrillators are designed to respond to magnets for important reasons, but magnets have many common uses,” he said. These can change the function of the implantable cardiac devise, but “it is temporary and only when placed in close proximity.”

The solution is simple. “Patients should be careful to avoid locating these objects near these devices,” Dr. Wilkoff said.

However, the first step is awareness. According to the study authors, devices with magnets powerful enough to impair function of implantable devices, such as the iPhone 12 “can potentially inhibit lifesaving therapy.”

Patients should be counseled and provided with practical steps, according to the authors. This includes keeping these devices out of pockets near implantable devices. They called for more noise from makers of smartphones and other devices with strong enough magnets to alter pacemaker and ICD function, and they advised physicians to draw awareness to this issue.

Dr. Greenberg reported no potential conflicts of interest.

Patients with an implantable cardioverter defibrillator (ICD) should be warned that some newer models of smartphones equipped with magnets, such as the iPhone 12, can disable their device, inhibiting its lifesaving functions, according to investigators who tested and confirmed this effect.

SL/Getty Images

“Once the iPhone was brought close to the ICD over the left chest area, immediate suspension of ICD therapies was noted which persisted for the duration of the test,” reported the investigating team led by Joshua C. Greenberg, MD, who is an electrophysiology fellow at Henry Ford Hospital, Detroit. The results were published in Heart Rhythm.

The American Heart Association has already cautioned that magnetic fields can inhibit the pulse generators for ICDs and pacemakers. On the AHA website, there is a list of devices and their potential for functional interference, but cell phones and other common devices are identified as posing a low risk.

The most recent iPhone and perhaps other advanced smartphones appear to be different. According to the authors of a study that tested the iPhone 12, this model has a circular array of magnets around a central charging coil. This array interacts with Apple’s proprietary MagSafe technology, which accelerates charging. The magnets also serve to orient the phone on the charger and enable other MagSafe accessories.

The authors of the new study were concerned that this array of magnets might be sufficiently strong to interfere with ICDs or other devices at risk. In a previously published study, the strength of a magnetic field sufficient to interfere with implantable cardiac devices was estimated to be at least 10 gauss.

Tests were performed on a patient wearing a Medtronic ICD.

“Once the iPhone was brought close to the ICD over the left chest area, immediate suspension of ICD therapies was noted,” according to the authors of the study. The functional loss of the ICS persisted for the duration of proximity. It was reproduced multiple times and with multiple phone positions.

Previous studies have provided evidence that earlier models do not share this risk. In a study testing the iPhone 6 and an Apple Watch in 148 patients with various types of implantable electronic devices, including pacemakers, cardioverter defibrillators, resynchronization defibrillators, and resynchronization pacemakers, only one instance of interference was observed in 1,352 tests.

With wand telemetry, iPhone-induced interferences could be detected with the iPhone 6 in 14% of the patients, but these did not appear to be clinically meaningful, and this type of interference could not be detected with the Apple Watch, according to the report. The single observed interaction, which was between an iPhone 6 and a dual-chamber pacemaker, suggested device-device interactions are uncommon.

More recently, a woman with a single-chamber Medtronic ICD who went to sleep wearing an Apple Watch was awoken by warning beeps from her cardiac device, according to a case report published online. The Apple watch became the prime suspect in causing the ICD warning when proximity of the watch reproduced the warning during clinical examination. However, the magnetic interference was ultimately found to be emanating from the wristband, not the watch.

This case prompted additional studies with Fitbit and other Apple Watch wristbands. Both wristbands contain magnets used to track heart rate. Both were found capable of deactivating ICDs at distances of approximately 2 cm. On the basis of these results, the authors concluded that patients should be counseled about the risk posed by wristbands used in fitness tracking, concluding that they should be kept at least 6 inches away from ICDs and not worn while sleeping.

On their website, Apple maintains a page that specifically warns about the potential for interactions between iPhone 12s and medical devices . Although there is an acknowledgment that the iPhone12 contains more magnets than prior iPhone models, it is stated that iPhone 12 models are “not expected to pose a greater risk of magnetic interference to medical devices than prior iPhone models.” Nevertheless, the Apple instructions advise keeping the iPhone and MagSafe accessories more than 6 inches away from medical devices.

Dr. Greenberg and coinvestigators concluded that the iPhone 12 does pose a greater risk to the dysfunction of ICDs and other medical devices because of the more powerful magnets. As a result, the study brings forward “an important public health issue concerning the newer generation iPhone 12.”

Well aware of this issue and this study, Bruce L. Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices, Cleveland Clinic, agreed. He said the focus should not be restricted to the iPhone 12 series but other wearable devices as alluded to in the study.

“Pacemakers and implantable defibrillators are designed to respond to magnets for important reasons, but magnets have many common uses,” he said. These can change the function of the implantable cardiac devise, but “it is temporary and only when placed in close proximity.”

The solution is simple. “Patients should be careful to avoid locating these objects near these devices,” Dr. Wilkoff said.

However, the first step is awareness. According to the study authors, devices with magnets powerful enough to impair function of implantable devices, such as the iPhone 12 “can potentially inhibit lifesaving therapy.”

Patients should be counseled and provided with practical steps, according to the authors. This includes keeping these devices out of pockets near implantable devices. They called for more noise from makers of smartphones and other devices with strong enough magnets to alter pacemaker and ICD function, and they advised physicians to draw awareness to this issue.

Dr. Greenberg reported no potential conflicts of interest.

Patients with an implantable cardioverter defibrillator (ICD) should be warned that some newer models of smartphones equipped with magnets, such as the iPhone 12, can disable their device, inhibiting its lifesaving functions, according to investigators who tested and confirmed this effect.

SL/Getty Images

“Once the iPhone was brought close to the ICD over the left chest area, immediate suspension of ICD therapies was noted which persisted for the duration of the test,” reported the investigating team led by Joshua C. Greenberg, MD, who is an electrophysiology fellow at Henry Ford Hospital, Detroit. The results were published in Heart Rhythm.

The American Heart Association has already cautioned that magnetic fields can inhibit the pulse generators for ICDs and pacemakers. On the AHA website, there is a list of devices and their potential for functional interference, but cell phones and other common devices are identified as posing a low risk.

The most recent iPhone and perhaps other advanced smartphones appear to be different. According to the authors of a study that tested the iPhone 12, this model has a circular array of magnets around a central charging coil. This array interacts with Apple’s proprietary MagSafe technology, which accelerates charging. The magnets also serve to orient the phone on the charger and enable other MagSafe accessories.

The authors of the new study were concerned that this array of magnets might be sufficiently strong to interfere with ICDs or other devices at risk. In a previously published study, the strength of a magnetic field sufficient to interfere with implantable cardiac devices was estimated to be at least 10 gauss.

Tests were performed on a patient wearing a Medtronic ICD.

“Once the iPhone was brought close to the ICD over the left chest area, immediate suspension of ICD therapies was noted,” according to the authors of the study. The functional loss of the ICS persisted for the duration of proximity. It was reproduced multiple times and with multiple phone positions.

Previous studies have provided evidence that earlier models do not share this risk. In a study testing the iPhone 6 and an Apple Watch in 148 patients with various types of implantable electronic devices, including pacemakers, cardioverter defibrillators, resynchronization defibrillators, and resynchronization pacemakers, only one instance of interference was observed in 1,352 tests.

With wand telemetry, iPhone-induced interferences could be detected with the iPhone 6 in 14% of the patients, but these did not appear to be clinically meaningful, and this type of interference could not be detected with the Apple Watch, according to the report. The single observed interaction, which was between an iPhone 6 and a dual-chamber pacemaker, suggested device-device interactions are uncommon.

More recently, a woman with a single-chamber Medtronic ICD who went to sleep wearing an Apple Watch was awoken by warning beeps from her cardiac device, according to a case report published online. The Apple watch became the prime suspect in causing the ICD warning when proximity of the watch reproduced the warning during clinical examination. However, the magnetic interference was ultimately found to be emanating from the wristband, not the watch.

This case prompted additional studies with Fitbit and other Apple Watch wristbands. Both wristbands contain magnets used to track heart rate. Both were found capable of deactivating ICDs at distances of approximately 2 cm. On the basis of these results, the authors concluded that patients should be counseled about the risk posed by wristbands used in fitness tracking, concluding that they should be kept at least 6 inches away from ICDs and not worn while sleeping.

On their website, Apple maintains a page that specifically warns about the potential for interactions between iPhone 12s and medical devices . Although there is an acknowledgment that the iPhone12 contains more magnets than prior iPhone models, it is stated that iPhone 12 models are “not expected to pose a greater risk of magnetic interference to medical devices than prior iPhone models.” Nevertheless, the Apple instructions advise keeping the iPhone and MagSafe accessories more than 6 inches away from medical devices.

Dr. Greenberg and coinvestigators concluded that the iPhone 12 does pose a greater risk to the dysfunction of ICDs and other medical devices because of the more powerful magnets. As a result, the study brings forward “an important public health issue concerning the newer generation iPhone 12.”

Well aware of this issue and this study, Bruce L. Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices, Cleveland Clinic, agreed. He said the focus should not be restricted to the iPhone 12 series but other wearable devices as alluded to in the study.

“Pacemakers and implantable defibrillators are designed to respond to magnets for important reasons, but magnets have many common uses,” he said. These can change the function of the implantable cardiac devise, but “it is temporary and only when placed in close proximity.”

The solution is simple. “Patients should be careful to avoid locating these objects near these devices,” Dr. Wilkoff said.

However, the first step is awareness. According to the study authors, devices with magnets powerful enough to impair function of implantable devices, such as the iPhone 12 “can potentially inhibit lifesaving therapy.”

Patients should be counseled and provided with practical steps, according to the authors. This includes keeping these devices out of pockets near implantable devices. They called for more noise from makers of smartphones and other devices with strong enough magnets to alter pacemaker and ICD function, and they advised physicians to draw awareness to this issue.

Dr. Greenberg reported no potential conflicts of interest.

While the direct toll of the COVID-19 pandemic is being tallied and shared on the nightly news, the indirect effects will undoubtedly take years to fully measure.

Floaria Bicher/iStock/Getty Images Plus

In two papers published online Jan. 11 in the Journal of the American College of Cardiology, researchers have started the process of quantifying the impact of the pandemic on the care of patients with cardiovascular disease (CVD).

In the first study, Rishi Wadhera, MD, MPP, MPhil, and colleagues from the Beth Israel Deaconess Medical Center and Harvard Medical School in Boston examined population-level data to determine how deaths from cardiovascular causes changed in the United States in the early months of the pandemic relative to the same periods in 2019.

In a second paper, Andrew J. Einstein, MD, PhD, from Columbia University Irving Medical Center/New York–Presbyterian Hospital and colleagues looked at the pandemic’s international impact on the diagnosis of heart disease.

Using data from the National Center for Health Statistics, Dr. Wadhera and colleagues compared death rates from cardiovascular causes in the United States from March 18, 2020, to June 2, 2020, (the first wave of the pandemic) and from Jan. 1, 2020, to March 17, 2020, (the period just before the pandemic started) and compared them to the same periods in 2019. ICD codes were used to identify underlying causes of death.

Relative to 2019, they found a significant increase in deaths from ischemic heart disease nationally (1.11; 95% confidence interval, 1.04-1.18), as well as an increase in deaths caused by hypertensive disease (1.17; 95% CI, 1.09-1.26). There was no apparent increase in deaths from heart failure, cerebrovascular disease, or other diseases of the circulatory system.

When they looked just at New York City, the area hit hardest during the early part of the pandemic, the relative increases in deaths from ischemic heart disease were more pronounced.

Deaths from ischemic heart disease or hypertensive diseases jumped 139% and 164%, respectively, between March 18, 2020, and June 2, 2020.

More modest increases in deaths were seen in the remainder of New York state, New Jersey, Michigan and Illinois, while Massachusetts and Louisiana did not see a change in cardiovascular deaths.

Several studies from different parts of the world have indicated a 40%-50% drop in hospitalization for myocardial infarction in the initial months of the pandemic, said Dr. Wadhera in an interview.

“We wanted to understand where did all the heart attacks go? And we worried that patients with urgent heart conditions were not seeking the medical care they needed. I think our data suggest that this may have been the case,” reported Dr. Wadhera.  

“This very much reflects the reality of what we’re seeing on the ground,” he told this news organization. “After the initial surge ended, when hospital volumes began to return to normal, we saw patients come into the hospital who clearly had a heart attack during the surge months – and were now experiencing complications of that event – because they had initially not come into the hospital due to concerns about exposure to the virus.”

A limitation of their data, he stressed, is whether some deaths coded as CVD deaths were really deaths from undiagnosed COVID-19. “It’s possible that some portion of the increased deaths we observed really reflect the cardiovascular complications of undiagnosed COVID-19, because we know that testing was quite limited during the early first surge of cases.”

“I think that basically three factors – patients avoiding the health care system because of fear of getting COVID, health care systems being strained and overwhelmed leading to the deferral of cardiovascular care and semi-elective procedures, and the cardiovascular complications of COVID-19 itself – all probably collectively contributed to the rise in cardiovascular deaths that we observed,” said Dr. Wadhera.

In an accompanying editorial, Michael N. Young, MD, Geisel School of Medicine at Dartmouth, Lebanon, N.H., and colleagues write that these data, taken together with an earlier study showing an increase in out-of-hospital cardiac arrests at the pandemic peak in New York City, “support the notion of excess fatalities due to unattended comorbid illnesses.” That said, attribution of death in the COVID era “remains problematic.”

In the second article, Andrew Einstein, MD, PhD, and the INCAPS COVID Investigators Group took a broader approach and looked at the impact of COVID-19 on cardiac diagnostic procedures in over 100 countries.

The INCAPS (International Atomic Energy Agency Noninvasive Cardiology Protocols Study) group has for the past decade conducted numerous studies addressing the use of best practices and worldwide practice variation in CVD diagnosis.

For this effort, they sent a survey link to INCAPS participants worldwide, ultimately including 909 survey responses from 108 countries in the final analysis.

Compared with March 2019, overall procedure volume decreased 42% in March 2020 and 64% in April 2020.

The greatest decreases were seen in stress testing (78%) and transesophageal echocardiography (76%), both procedures, noted Dr. Einstein, associated with a greater risk of aerosolization.

“Whether as we reset after COVID we return to the same place in terms of the use of cardiovascular diagnostic testing remains to be seen, but it certainly poses an opportunity to improve our utilization of various modes of testing,” said Dr. Einstein.

Using regression analysis, Dr. Einstein and colleagues were able to see that sites located in low-income and lower-middle-income countries saw an additional 22% reduction in cardiac procedures and less availability of personal protective equipment (PPE) and telehealth.

Fifty-two percent of survey respondents reported significant shortages of N95 masks early in the pandemic, with fewer issues in supplies of gloves, gowns, and face shields. Lower-income countries were more likely to face significant PPE shortages and less likely to be able to implement telehealth strategies to make up for reduced in-person care. PPE shortage itself, however, was not related to lower procedural volume on multivariable regression.

“It all really begs the question of whether there is more that the world can do to help out the developing world in terms of managing the pandemic in all its facets,” said Dr. Einstein in an interview, adding he was “shocked” to learn how difficult it was for some lower-income countries to get sufficient PPE.
 

Did shutdowns go too far?

Calling this a “remarkable study,” an editorial written by Darryl P. Leong, MBBS, PhD, John W. Eikelboom, MBBS, and Salim Yusuf, MBBS, DPhil, all from McMaster University, Hamilton, Ont., suggests that perhaps health systems in some places went too far in closing down during the first wave of the pandemic, naming specifically Canada, Eastern Europe, and Saudi Arabia as examples.

“Although these measures were taken to prepare for the worst, overwhelming numbers of patients with COVID-19 did not materialize during the first wave of the pandemic in these countries. It is possible that delaying so-called nonessential services may have been unnecessary and potentially harmful, because it likely led to delays in providing care for the treatment of serious non–COVID-19 illnesses.”

Since then, more experience and more data have largely allowed hospital systems to “tackle the ebb and flow” of COVID-19 cases in ways that limit shutdowns of important health services, they said.

Given the more pronounced effect in low- and middle-income countries, they stressed the need to focus resources on ways to promote prevention and treatment that do not rely on diagnostic procedures.

“This calls for more emphasis on developing efficient systems of telehealth, especially in poorer countries or in remote settings in all countries,” Dr. Leong and colleagues conclude.

Dr. Wadhera has reported research support from the National Heart, Lung, and Blood Institute, along with fellow senior author Robert W. Yeh, MD, MBA, who has also received personal fees and grants from several companies not related to the submitted work. Dr. Einstein, Dr. Leong, Dr. Eikelboom, and Dr. Yusuf have reported no relevant financial relationships.

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

While the direct toll of the COVID-19 pandemic is being tallied and shared on the nightly news, the indirect effects will undoubtedly take years to fully measure.

Floaria Bicher/iStock/Getty Images Plus

In two papers published online Jan. 11 in the Journal of the American College of Cardiology, researchers have started the process of quantifying the impact of the pandemic on the care of patients with cardiovascular disease (CVD).

In the first study, Rishi Wadhera, MD, MPP, MPhil, and colleagues from the Beth Israel Deaconess Medical Center and Harvard Medical School in Boston examined population-level data to determine how deaths from cardiovascular causes changed in the United States in the early months of the pandemic relative to the same periods in 2019.

In a second paper, Andrew J. Einstein, MD, PhD, from Columbia University Irving Medical Center/New York–Presbyterian Hospital and colleagues looked at the pandemic’s international impact on the diagnosis of heart disease.

Using data from the National Center for Health Statistics, Dr. Wadhera and colleagues compared death rates from cardiovascular causes in the United States from March 18, 2020, to June 2, 2020, (the first wave of the pandemic) and from Jan. 1, 2020, to March 17, 2020, (the period just before the pandemic started) and compared them to the same periods in 2019. ICD codes were used to identify underlying causes of death.

Relative to 2019, they found a significant increase in deaths from ischemic heart disease nationally (1.11; 95% confidence interval, 1.04-1.18), as well as an increase in deaths caused by hypertensive disease (1.17; 95% CI, 1.09-1.26). There was no apparent increase in deaths from heart failure, cerebrovascular disease, or other diseases of the circulatory system.

When they looked just at New York City, the area hit hardest during the early part of the pandemic, the relative increases in deaths from ischemic heart disease were more pronounced.

Deaths from ischemic heart disease or hypertensive diseases jumped 139% and 164%, respectively, between March 18, 2020, and June 2, 2020.

More modest increases in deaths were seen in the remainder of New York state, New Jersey, Michigan and Illinois, while Massachusetts and Louisiana did not see a change in cardiovascular deaths.

Several studies from different parts of the world have indicated a 40%-50% drop in hospitalization for myocardial infarction in the initial months of the pandemic, said Dr. Wadhera in an interview.

“We wanted to understand where did all the heart attacks go? And we worried that patients with urgent heart conditions were not seeking the medical care they needed. I think our data suggest that this may have been the case,” reported Dr. Wadhera.  

“This very much reflects the reality of what we’re seeing on the ground,” he told this news organization. “After the initial surge ended, when hospital volumes began to return to normal, we saw patients come into the hospital who clearly had a heart attack during the surge months – and were now experiencing complications of that event – because they had initially not come into the hospital due to concerns about exposure to the virus.”

A limitation of their data, he stressed, is whether some deaths coded as CVD deaths were really deaths from undiagnosed COVID-19. “It’s possible that some portion of the increased deaths we observed really reflect the cardiovascular complications of undiagnosed COVID-19, because we know that testing was quite limited during the early first surge of cases.”

“I think that basically three factors – patients avoiding the health care system because of fear of getting COVID, health care systems being strained and overwhelmed leading to the deferral of cardiovascular care and semi-elective procedures, and the cardiovascular complications of COVID-19 itself – all probably collectively contributed to the rise in cardiovascular deaths that we observed,” said Dr. Wadhera.

In an accompanying editorial, Michael N. Young, MD, Geisel School of Medicine at Dartmouth, Lebanon, N.H., and colleagues write that these data, taken together with an earlier study showing an increase in out-of-hospital cardiac arrests at the pandemic peak in New York City, “support the notion of excess fatalities due to unattended comorbid illnesses.” That said, attribution of death in the COVID era “remains problematic.”

In the second article, Andrew Einstein, MD, PhD, and the INCAPS COVID Investigators Group took a broader approach and looked at the impact of COVID-19 on cardiac diagnostic procedures in over 100 countries.

The INCAPS (International Atomic Energy Agency Noninvasive Cardiology Protocols Study) group has for the past decade conducted numerous studies addressing the use of best practices and worldwide practice variation in CVD diagnosis.

For this effort, they sent a survey link to INCAPS participants worldwide, ultimately including 909 survey responses from 108 countries in the final analysis.

Compared with March 2019, overall procedure volume decreased 42% in March 2020 and 64% in April 2020.

The greatest decreases were seen in stress testing (78%) and transesophageal echocardiography (76%), both procedures, noted Dr. Einstein, associated with a greater risk of aerosolization.

“Whether as we reset after COVID we return to the same place in terms of the use of cardiovascular diagnostic testing remains to be seen, but it certainly poses an opportunity to improve our utilization of various modes of testing,” said Dr. Einstein.

Using regression analysis, Dr. Einstein and colleagues were able to see that sites located in low-income and lower-middle-income countries saw an additional 22% reduction in cardiac procedures and less availability of personal protective equipment (PPE) and telehealth.

Fifty-two percent of survey respondents reported significant shortages of N95 masks early in the pandemic, with fewer issues in supplies of gloves, gowns, and face shields. Lower-income countries were more likely to face significant PPE shortages and less likely to be able to implement telehealth strategies to make up for reduced in-person care. PPE shortage itself, however, was not related to lower procedural volume on multivariable regression.

“It all really begs the question of whether there is more that the world can do to help out the developing world in terms of managing the pandemic in all its facets,” said Dr. Einstein in an interview, adding he was “shocked” to learn how difficult it was for some lower-income countries to get sufficient PPE.
 

Did shutdowns go too far?

Calling this a “remarkable study,” an editorial written by Darryl P. Leong, MBBS, PhD, John W. Eikelboom, MBBS, and Salim Yusuf, MBBS, DPhil, all from McMaster University, Hamilton, Ont., suggests that perhaps health systems in some places went too far in closing down during the first wave of the pandemic, naming specifically Canada, Eastern Europe, and Saudi Arabia as examples.

“Although these measures were taken to prepare for the worst, overwhelming numbers of patients with COVID-19 did not materialize during the first wave of the pandemic in these countries. It is possible that delaying so-called nonessential services may have been unnecessary and potentially harmful, because it likely led to delays in providing care for the treatment of serious non–COVID-19 illnesses.”

Since then, more experience and more data have largely allowed hospital systems to “tackle the ebb and flow” of COVID-19 cases in ways that limit shutdowns of important health services, they said.

Given the more pronounced effect in low- and middle-income countries, they stressed the need to focus resources on ways to promote prevention and treatment that do not rely on diagnostic procedures.

“This calls for more emphasis on developing efficient systems of telehealth, especially in poorer countries or in remote settings in all countries,” Dr. Leong and colleagues conclude.

Dr. Wadhera has reported research support from the National Heart, Lung, and Blood Institute, along with fellow senior author Robert W. Yeh, MD, MBA, who has also received personal fees and grants from several companies not related to the submitted work. Dr. Einstein, Dr. Leong, Dr. Eikelboom, and Dr. Yusuf have reported no relevant financial relationships.

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

While the direct toll of the COVID-19 pandemic is being tallied and shared on the nightly news, the indirect effects will undoubtedly take years to fully measure.

Floaria Bicher/iStock/Getty Images Plus

In two papers published online Jan. 11 in the Journal of the American College of Cardiology, researchers have started the process of quantifying the impact of the pandemic on the care of patients with cardiovascular disease (CVD).

In the first study, Rishi Wadhera, MD, MPP, MPhil, and colleagues from the Beth Israel Deaconess Medical Center and Harvard Medical School in Boston examined population-level data to determine how deaths from cardiovascular causes changed in the United States in the early months of the pandemic relative to the same periods in 2019.

In a second paper, Andrew J. Einstein, MD, PhD, from Columbia University Irving Medical Center/New York–Presbyterian Hospital and colleagues looked at the pandemic’s international impact on the diagnosis of heart disease.

Using data from the National Center for Health Statistics, Dr. Wadhera and colleagues compared death rates from cardiovascular causes in the United States from March 18, 2020, to June 2, 2020, (the first wave of the pandemic) and from Jan. 1, 2020, to March 17, 2020, (the period just before the pandemic started) and compared them to the same periods in 2019. ICD codes were used to identify underlying causes of death.

Relative to 2019, they found a significant increase in deaths from ischemic heart disease nationally (1.11; 95% confidence interval, 1.04-1.18), as well as an increase in deaths caused by hypertensive disease (1.17; 95% CI, 1.09-1.26). There was no apparent increase in deaths from heart failure, cerebrovascular disease, or other diseases of the circulatory system.

When they looked just at New York City, the area hit hardest during the early part of the pandemic, the relative increases in deaths from ischemic heart disease were more pronounced.

Deaths from ischemic heart disease or hypertensive diseases jumped 139% and 164%, respectively, between March 18, 2020, and June 2, 2020.

More modest increases in deaths were seen in the remainder of New York state, New Jersey, Michigan and Illinois, while Massachusetts and Louisiana did not see a change in cardiovascular deaths.

Several studies from different parts of the world have indicated a 40%-50% drop in hospitalization for myocardial infarction in the initial months of the pandemic, said Dr. Wadhera in an interview.

“We wanted to understand where did all the heart attacks go? And we worried that patients with urgent heart conditions were not seeking the medical care they needed. I think our data suggest that this may have been the case,” reported Dr. Wadhera.  

“This very much reflects the reality of what we’re seeing on the ground,” he told this news organization. “After the initial surge ended, when hospital volumes began to return to normal, we saw patients come into the hospital who clearly had a heart attack during the surge months – and were now experiencing complications of that event – because they had initially not come into the hospital due to concerns about exposure to the virus.”

A limitation of their data, he stressed, is whether some deaths coded as CVD deaths were really deaths from undiagnosed COVID-19. “It’s possible that some portion of the increased deaths we observed really reflect the cardiovascular complications of undiagnosed COVID-19, because we know that testing was quite limited during the early first surge of cases.”

“I think that basically three factors – patients avoiding the health care system because of fear of getting COVID, health care systems being strained and overwhelmed leading to the deferral of cardiovascular care and semi-elective procedures, and the cardiovascular complications of COVID-19 itself – all probably collectively contributed to the rise in cardiovascular deaths that we observed,” said Dr. Wadhera.

In an accompanying editorial, Michael N. Young, MD, Geisel School of Medicine at Dartmouth, Lebanon, N.H., and colleagues write that these data, taken together with an earlier study showing an increase in out-of-hospital cardiac arrests at the pandemic peak in New York City, “support the notion of excess fatalities due to unattended comorbid illnesses.” That said, attribution of death in the COVID era “remains problematic.”

In the second article, Andrew Einstein, MD, PhD, and the INCAPS COVID Investigators Group took a broader approach and looked at the impact of COVID-19 on cardiac diagnostic procedures in over 100 countries.

The INCAPS (International Atomic Energy Agency Noninvasive Cardiology Protocols Study) group has for the past decade conducted numerous studies addressing the use of best practices and worldwide practice variation in CVD diagnosis.

For this effort, they sent a survey link to INCAPS participants worldwide, ultimately including 909 survey responses from 108 countries in the final analysis.

Compared with March 2019, overall procedure volume decreased 42% in March 2020 and 64% in April 2020.

The greatest decreases were seen in stress testing (78%) and transesophageal echocardiography (76%), both procedures, noted Dr. Einstein, associated with a greater risk of aerosolization.

“Whether as we reset after COVID we return to the same place in terms of the use of cardiovascular diagnostic testing remains to be seen, but it certainly poses an opportunity to improve our utilization of various modes of testing,” said Dr. Einstein.

Using regression analysis, Dr. Einstein and colleagues were able to see that sites located in low-income and lower-middle-income countries saw an additional 22% reduction in cardiac procedures and less availability of personal protective equipment (PPE) and telehealth.

Fifty-two percent of survey respondents reported significant shortages of N95 masks early in the pandemic, with fewer issues in supplies of gloves, gowns, and face shields. Lower-income countries were more likely to face significant PPE shortages and less likely to be able to implement telehealth strategies to make up for reduced in-person care. PPE shortage itself, however, was not related to lower procedural volume on multivariable regression.

“It all really begs the question of whether there is more that the world can do to help out the developing world in terms of managing the pandemic in all its facets,” said Dr. Einstein in an interview, adding he was “shocked” to learn how difficult it was for some lower-income countries to get sufficient PPE.
 

Did shutdowns go too far?

Calling this a “remarkable study,” an editorial written by Darryl P. Leong, MBBS, PhD, John W. Eikelboom, MBBS, and Salim Yusuf, MBBS, DPhil, all from McMaster University, Hamilton, Ont., suggests that perhaps health systems in some places went too far in closing down during the first wave of the pandemic, naming specifically Canada, Eastern Europe, and Saudi Arabia as examples.

“Although these measures were taken to prepare for the worst, overwhelming numbers of patients with COVID-19 did not materialize during the first wave of the pandemic in these countries. It is possible that delaying so-called nonessential services may have been unnecessary and potentially harmful, because it likely led to delays in providing care for the treatment of serious non–COVID-19 illnesses.”

Since then, more experience and more data have largely allowed hospital systems to “tackle the ebb and flow” of COVID-19 cases in ways that limit shutdowns of important health services, they said.

Given the more pronounced effect in low- and middle-income countries, they stressed the need to focus resources on ways to promote prevention and treatment that do not rely on diagnostic procedures.

“This calls for more emphasis on developing efficient systems of telehealth, especially in poorer countries or in remote settings in all countries,” Dr. Leong and colleagues conclude.

Dr. Wadhera has reported research support from the National Heart, Lung, and Blood Institute, along with fellow senior author Robert W. Yeh, MD, MBA, who has also received personal fees and grants from several companies not related to the submitted work. Dr. Einstein, Dr. Leong, Dr. Eikelboom, and Dr. Yusuf have reported no relevant financial relationships.

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

Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.

About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.

“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.

“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.

The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.

Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.

“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.

“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.

Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.

“South-paw” cardiology trainees face their first challenge in the examination room.

Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.

“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.

In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.

“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.

In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.

“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.

A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.

“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.

For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.

“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.

There are also some advantages to being left-handed, Dr. Prashant Patel said.

This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”

“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
 

An insightful paper

“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.

“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.

“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”

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

Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.

About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.

“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.

“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.

The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.

Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.

“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.

“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.

Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.

“South-paw” cardiology trainees face their first challenge in the examination room.

Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.

“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.

In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.

“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.

In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.

“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.

A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.

“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.

For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.

“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.

There are also some advantages to being left-handed, Dr. Prashant Patel said.

This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”

“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
 

An insightful paper

“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.

“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.

“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”

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

Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.

About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.

“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.

“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.

The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.

Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.

“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.

“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.

Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.

“South-paw” cardiology trainees face their first challenge in the examination room.

Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.

“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.

In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.

“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.

In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.

“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.

A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.

“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.

For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.

“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.

There are also some advantages to being left-handed, Dr. Prashant Patel said.

This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”

“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
 

An insightful paper

“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.

“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.

“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”

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

Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.

“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.

The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.

Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.

After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.

The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.

“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
 

Is ‘nuisance’ arrhythmia worth targeting?

In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.

MDedge News

“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.

“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”

Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.

“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.

The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.

Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.

“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.

The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.

Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.

After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.

The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.

“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
 

Is ‘nuisance’ arrhythmia worth targeting?

In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.

MDedge News

“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.

“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”

Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.

“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.

The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.

Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.

“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.

The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.

Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.

After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.

The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.

“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
 

Is ‘nuisance’ arrhythmia worth targeting?

In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.

MDedge News

“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.

“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”

Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.

“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.

The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.

Left atrial appendage occlusion (LAAO) for high-risk atrial fibrillation seems to prevent stroke as well as direct oral anticoagulation (DOAC) with a lower risk of major bleeding, according to results of a European study.

And although some experts question the strength of the conclusions, a lead researcher contends the study may provide enough support for interventional cardiologists to consider LAAO in selected patients until randomized clinical trials yield stronger evidence.

“The results suggest LAAO to be superior to DOAC in AF patients who have a predicted high risk of stroke and bleeding and adds to the evidence that LAAO is a promising stroke prevention strategy in selected AF patients,” said lead investigator Jens Erik Nielsen-Kudsk, MD, DMSc, a cardiologist at Aarhus University Hospital in Denmark.

Dr. Nielsen-Kudsk and colleagues wrote in JACC: Cardiovascular Interventions that this is the largest comparative study of LAAO vs. DOAC to date, but they also acknowledged the study limitations: its observational design, unaccounted confounders, potential selection bias, and disparities in the nature of the comparative datasets (a multination cohort vs. a single national registry).

Observational registry study shows 43% reduction in primary outcome

The study compared outcomes of 1,078 patients from the Amulet Observational Study who had LAAO during June 2015–September 2016 with 1,184 patients on DOAC therapy selected by propensity score matching from two Danish national registries. The LAAO population was prospectively enrolled at 61 centers in 17 countries. The study population had a high risk of stroke and bleeding; about one-third had a previous stroke and about three-quarters had a prior bleeding episode. The average age was 75 years.

The LAAO group had almost half the rate of the primary outcome – either stroke, major bleeding, or all-cause death – 256 vs. 461 events in the DOAC group with median follow-up of 2 years. The annualized event rate was significantly lower for the LAAO group: 14.5 vs. 25.7 per 100 patient years in the DOAC group. The researchers calculated the LAAO group had a relative 43% reduction risk.

Of the LAAO group, 155 patients (14.5%) died in the follow-up period, 35% of them from a cardiovascular cause, whereas 308 (26%) of patients in the DOAC group died, with a similar percentage, 36%, from a cardiovascular cause.

Using data from the Danish Cause of Death Registry, the study determined cause of death in the DOAC patients on a more granular level: 9.5% of the deaths were from vascular disease and 4.5% from stroke (the remainder in both groups were from noncardiovascular events).

Stroke incidence was similar between the two groups: 39 in the LAAO group vs. 37 in DOAC patients, conferring an 11% greater risk in the former. The risk of major bleeding and all-cause mortality were significantly lower in LAAO patients, 37% and 47%, respectively. However, 50% of DOAC patients had discontinued therapy after a year of follow-up, and 58% had done so after 2 years.

Dr. Nielsen-Kudsk noted that the findings line up with those from the smaller PRAQUE-17 study comparing LAAO and DOAC. He added that his group is participating in two larger RCTs, CATALYST and CHAMPION-AF, evaluating LAAO and medical therapy in about 6,000 patients combined.

“It will take at least 2 to 5 years before we have data from these randomized LAAO trials,” Dr. Nielsen-Kudsk said. “Meanwhile, based on data from three prior randomized clinical trials, propensity-score matched studies and data from large registries, LAAO should be considered in clinical practice for patients who have a high risk of bleeding or who for any other reason are unsuitable for long-term DOAC treatment.”

Noncompliance to DOAC therapy a concern

In an invited commentary, Mohamad Alkhouli, MD, of the Mayo Medical School, Rochester, Minn., wrote, “These findings provide reassuring evidence supporting the efficacy of LAAO despite the remaining challenges with this therapy.”

However, Dr. Alkhouli pointed out that the high rate of noncompliance among AF patients on DOAC can be a confounding factor for interpreting the efficacy of therapy. “This highlights the challenges of comparing LAAO to DOAC, considering that many patients are actually not on effective anticoagulation, but also suggests a possible real important role for LAAO in addressing the unmet need in stroke prevention in nonvalvular atrial fibrillation,” he said in an interview.

“The study showed a very good safety profile for LAAO,” Dr. Alkhouli added. “However, we should remember that this was an observational study without routine temporal imaging and a relatively short-term follow- up.”

Methods ‘severely flawed’

John Mandrola, MD, an electrophysiologist at Baptist Health in Louisville, Ky., said the study methodology was “severely flawed,” citing its nonrandomized nature and enrollment of only patients with successful implants in the LAAO group. “You have to take all patients who had attempted implants,” he said. Further, the study may be subject to selection bias based on how patients were recruited for the Ampulet Observational Study.

“Comparing LAAO to DOAC is a vital clinical question,” said Dr. Mandrola. “It simply cannot be answered with observational methods like this. It requires a properly powered RCT.”

Dr. Alkhouli said he’s looking forward to results from five large RCTS evaluating LAAO due in 3-5 years. “Until the results of those trials are out, careful patient selection and shared decision-making should continue to govern the rational dissipation of LAAO as a stroke prevention strategy,” he said.

Novo Nordisk Research Foundation supported the study and Abbott provided a grant. Dr. Nielsen-Kudsk disclosed financial relationships with Abbott and Boston Scientific. Coauthors disclosed relationships with Abbott, Boston Scientific, Bayer Vital, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portolo, and Sanofi.

Dr. Alkhouli disclosed a relationship with Boston Scientific. Dr. Mandrola has no relevant disclosures. He is chief cardiology correspondent for Medscape.com. MDedge is a member of the Medscape Professional Network.

Left atrial appendage occlusion (LAAO) for high-risk atrial fibrillation seems to prevent stroke as well as direct oral anticoagulation (DOAC) with a lower risk of major bleeding, according to results of a European study.

And although some experts question the strength of the conclusions, a lead researcher contends the study may provide enough support for interventional cardiologists to consider LAAO in selected patients until randomized clinical trials yield stronger evidence.

“The results suggest LAAO to be superior to DOAC in AF patients who have a predicted high risk of stroke and bleeding and adds to the evidence that LAAO is a promising stroke prevention strategy in selected AF patients,” said lead investigator Jens Erik Nielsen-Kudsk, MD, DMSc, a cardiologist at Aarhus University Hospital in Denmark.

Dr. Nielsen-Kudsk and colleagues wrote in JACC: Cardiovascular Interventions that this is the largest comparative study of LAAO vs. DOAC to date, but they also acknowledged the study limitations: its observational design, unaccounted confounders, potential selection bias, and disparities in the nature of the comparative datasets (a multination cohort vs. a single national registry).

Observational registry study shows 43% reduction in primary outcome

The study compared outcomes of 1,078 patients from the Amulet Observational Study who had LAAO during June 2015–September 2016 with 1,184 patients on DOAC therapy selected by propensity score matching from two Danish national registries. The LAAO population was prospectively enrolled at 61 centers in 17 countries. The study population had a high risk of stroke and bleeding; about one-third had a previous stroke and about three-quarters had a prior bleeding episode. The average age was 75 years.

The LAAO group had almost half the rate of the primary outcome – either stroke, major bleeding, or all-cause death – 256 vs. 461 events in the DOAC group with median follow-up of 2 years. The annualized event rate was significantly lower for the LAAO group: 14.5 vs. 25.7 per 100 patient years in the DOAC group. The researchers calculated the LAAO group had a relative 43% reduction risk.

Of the LAAO group, 155 patients (14.5%) died in the follow-up period, 35% of them from a cardiovascular cause, whereas 308 (26%) of patients in the DOAC group died, with a similar percentage, 36%, from a cardiovascular cause.

Using data from the Danish Cause of Death Registry, the study determined cause of death in the DOAC patients on a more granular level: 9.5% of the deaths were from vascular disease and 4.5% from stroke (the remainder in both groups were from noncardiovascular events).

Stroke incidence was similar between the two groups: 39 in the LAAO group vs. 37 in DOAC patients, conferring an 11% greater risk in the former. The risk of major bleeding and all-cause mortality were significantly lower in LAAO patients, 37% and 47%, respectively. However, 50% of DOAC patients had discontinued therapy after a year of follow-up, and 58% had done so after 2 years.

Dr. Nielsen-Kudsk noted that the findings line up with those from the smaller PRAQUE-17 study comparing LAAO and DOAC. He added that his group is participating in two larger RCTs, CATALYST and CHAMPION-AF, evaluating LAAO and medical therapy in about 6,000 patients combined.

“It will take at least 2 to 5 years before we have data from these randomized LAAO trials,” Dr. Nielsen-Kudsk said. “Meanwhile, based on data from three prior randomized clinical trials, propensity-score matched studies and data from large registries, LAAO should be considered in clinical practice for patients who have a high risk of bleeding or who for any other reason are unsuitable for long-term DOAC treatment.”

Noncompliance to DOAC therapy a concern

In an invited commentary, Mohamad Alkhouli, MD, of the Mayo Medical School, Rochester, Minn., wrote, “These findings provide reassuring evidence supporting the efficacy of LAAO despite the remaining challenges with this therapy.”

However, Dr. Alkhouli pointed out that the high rate of noncompliance among AF patients on DOAC can be a confounding factor for interpreting the efficacy of therapy. “This highlights the challenges of comparing LAAO to DOAC, considering that many patients are actually not on effective anticoagulation, but also suggests a possible real important role for LAAO in addressing the unmet need in stroke prevention in nonvalvular atrial fibrillation,” he said in an interview.

“The study showed a very good safety profile for LAAO,” Dr. Alkhouli added. “However, we should remember that this was an observational study without routine temporal imaging and a relatively short-term follow- up.”

Methods ‘severely flawed’

John Mandrola, MD, an electrophysiologist at Baptist Health in Louisville, Ky., said the study methodology was “severely flawed,” citing its nonrandomized nature and enrollment of only patients with successful implants in the LAAO group. “You have to take all patients who had attempted implants,” he said. Further, the study may be subject to selection bias based on how patients were recruited for the Ampulet Observational Study.

“Comparing LAAO to DOAC is a vital clinical question,” said Dr. Mandrola. “It simply cannot be answered with observational methods like this. It requires a properly powered RCT.”

Dr. Alkhouli said he’s looking forward to results from five large RCTS evaluating LAAO due in 3-5 years. “Until the results of those trials are out, careful patient selection and shared decision-making should continue to govern the rational dissipation of LAAO as a stroke prevention strategy,” he said.

Novo Nordisk Research Foundation supported the study and Abbott provided a grant. Dr. Nielsen-Kudsk disclosed financial relationships with Abbott and Boston Scientific. Coauthors disclosed relationships with Abbott, Boston Scientific, Bayer Vital, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portolo, and Sanofi.

Dr. Alkhouli disclosed a relationship with Boston Scientific. Dr. Mandrola has no relevant disclosures. He is chief cardiology correspondent for Medscape.com. MDedge is a member of the Medscape Professional Network.

Left atrial appendage occlusion (LAAO) for high-risk atrial fibrillation seems to prevent stroke as well as direct oral anticoagulation (DOAC) with a lower risk of major bleeding, according to results of a European study.

And although some experts question the strength of the conclusions, a lead researcher contends the study may provide enough support for interventional cardiologists to consider LAAO in selected patients until randomized clinical trials yield stronger evidence.

“The results suggest LAAO to be superior to DOAC in AF patients who have a predicted high risk of stroke and bleeding and adds to the evidence that LAAO is a promising stroke prevention strategy in selected AF patients,” said lead investigator Jens Erik Nielsen-Kudsk, MD, DMSc, a cardiologist at Aarhus University Hospital in Denmark.

Dr. Nielsen-Kudsk and colleagues wrote in JACC: Cardiovascular Interventions that this is the largest comparative study of LAAO vs. DOAC to date, but they also acknowledged the study limitations: its observational design, unaccounted confounders, potential selection bias, and disparities in the nature of the comparative datasets (a multination cohort vs. a single national registry).

Observational registry study shows 43% reduction in primary outcome

The study compared outcomes of 1,078 patients from the Amulet Observational Study who had LAAO during June 2015–September 2016 with 1,184 patients on DOAC therapy selected by propensity score matching from two Danish national registries. The LAAO population was prospectively enrolled at 61 centers in 17 countries. The study population had a high risk of stroke and bleeding; about one-third had a previous stroke and about three-quarters had a prior bleeding episode. The average age was 75 years.

The LAAO group had almost half the rate of the primary outcome – either stroke, major bleeding, or all-cause death – 256 vs. 461 events in the DOAC group with median follow-up of 2 years. The annualized event rate was significantly lower for the LAAO group: 14.5 vs. 25.7 per 100 patient years in the DOAC group. The researchers calculated the LAAO group had a relative 43% reduction risk.

Of the LAAO group, 155 patients (14.5%) died in the follow-up period, 35% of them from a cardiovascular cause, whereas 308 (26%) of patients in the DOAC group died, with a similar percentage, 36%, from a cardiovascular cause.

Using data from the Danish Cause of Death Registry, the study determined cause of death in the DOAC patients on a more granular level: 9.5% of the deaths were from vascular disease and 4.5% from stroke (the remainder in both groups were from noncardiovascular events).

Stroke incidence was similar between the two groups: 39 in the LAAO group vs. 37 in DOAC patients, conferring an 11% greater risk in the former. The risk of major bleeding and all-cause mortality were significantly lower in LAAO patients, 37% and 47%, respectively. However, 50% of DOAC patients had discontinued therapy after a year of follow-up, and 58% had done so after 2 years.

Dr. Nielsen-Kudsk noted that the findings line up with those from the smaller PRAQUE-17 study comparing LAAO and DOAC. He added that his group is participating in two larger RCTs, CATALYST and CHAMPION-AF, evaluating LAAO and medical therapy in about 6,000 patients combined.

“It will take at least 2 to 5 years before we have data from these randomized LAAO trials,” Dr. Nielsen-Kudsk said. “Meanwhile, based on data from three prior randomized clinical trials, propensity-score matched studies and data from large registries, LAAO should be considered in clinical practice for patients who have a high risk of bleeding or who for any other reason are unsuitable for long-term DOAC treatment.”

Noncompliance to DOAC therapy a concern

In an invited commentary, Mohamad Alkhouli, MD, of the Mayo Medical School, Rochester, Minn., wrote, “These findings provide reassuring evidence supporting the efficacy of LAAO despite the remaining challenges with this therapy.”

However, Dr. Alkhouli pointed out that the high rate of noncompliance among AF patients on DOAC can be a confounding factor for interpreting the efficacy of therapy. “This highlights the challenges of comparing LAAO to DOAC, considering that many patients are actually not on effective anticoagulation, but also suggests a possible real important role for LAAO in addressing the unmet need in stroke prevention in nonvalvular atrial fibrillation,” he said in an interview.

“The study showed a very good safety profile for LAAO,” Dr. Alkhouli added. “However, we should remember that this was an observational study without routine temporal imaging and a relatively short-term follow- up.”

Methods ‘severely flawed’

John Mandrola, MD, an electrophysiologist at Baptist Health in Louisville, Ky., said the study methodology was “severely flawed,” citing its nonrandomized nature and enrollment of only patients with successful implants in the LAAO group. “You have to take all patients who had attempted implants,” he said. Further, the study may be subject to selection bias based on how patients were recruited for the Ampulet Observational Study.

“Comparing LAAO to DOAC is a vital clinical question,” said Dr. Mandrola. “It simply cannot be answered with observational methods like this. It requires a properly powered RCT.”

Dr. Alkhouli said he’s looking forward to results from five large RCTS evaluating LAAO due in 3-5 years. “Until the results of those trials are out, careful patient selection and shared decision-making should continue to govern the rational dissipation of LAAO as a stroke prevention strategy,” he said.

Novo Nordisk Research Foundation supported the study and Abbott provided a grant. Dr. Nielsen-Kudsk disclosed financial relationships with Abbott and Boston Scientific. Coauthors disclosed relationships with Abbott, Boston Scientific, Bayer Vital, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portolo, and Sanofi.

Dr. Alkhouli disclosed a relationship with Boston Scientific. Dr. Mandrola has no relevant disclosures. He is chief cardiology correspondent for Medscape.com. MDedge is a member of the Medscape Professional Network.