Arrhythmias & EP

The probability of spontaneous conversion to sinus rhythm (SCV) was increased with the intravenous administration of magnesium and potassium in patients with nonpermanent atrial fibrillation presenting to the ER, a registry study shows.

Compared with no treatment, potassium and magnesium administration was associated with a 10% higher rate of SVC.

The finding suggests that giving intravenous potassium and magnesium might lessen the need for antiarrhythmic therapy and the associated potential adverse effects in patients with nonpermanent atrial fibrillation (AFib), the study authors say.

Still, they add, “The results of our study have no direct implications for clinical practice in the management of care for patients with AF [atrial fibrillation] or AFL [atrial flutter] in the ED. The findings are purely exploratory and hypothesis-generating but could potentially provide a rationale for an appropriate prospective trial.”

The study was published online in JAMA Network Open.

“Atrial fibrillation is becoming an increasing burden for health care systems worldwide owing to population aging,” write Filippo Cacioppo, MD, and colleagues from Medical University of Vienna (Austria).

“Pharmacologic and electrical conversion are common therapies in emergency departments, especially for highly symptomatic patients. Each intervention has specific risks, and neither is considered cost-effective owing to frequent recurrence of AF. In addition, AF often terminates spontaneously,” Dr. Cacioppo and colleagues write.

They add that evidence suggests hypokalemia and hypomagnesemia contribute to AFib development, and so the administration of potassium and magnesium could be a reasonable strategy to improve SCV rates.

To test their hypothesis, Dr. Cacioppo and associates conducted a registry-based cohort study in all patients with AFib or AFL presenting to their center’s ED between Feb. 6, 2009, and Feb. 16, 2020.

During this time, they observed a total of 2,546 episodes of nonpermanent AFib. The median patient age was 68 years (interquartile range, 58-75 years). Most were men (n = 1,411 patients, 55.4%).

In addition, there were 573 episodes of nonpermanent AFL. The median patient age was 68 years (IQR, 58-75 years), and 332 patients (57.9%) were men.

Intravenous potassium and magnesium were administered in just over half (n = 1,763; 56.5%) of the episodes.

The median amount of potassium and magnesium was delivered via one 250-mL infusion bag, which consisted of 24 mEq potassium and 145.8 mg magnesium combined with 500 mL of balanced crystalloid fluid containing 2.5 mEq potassium and 18.2 mg magnesium, administered for 90 minutes, the authors write.

If patients experienced pain at the injection site, the infusion rate was reduced until the pain subsided.

Conversion to sinus rhythm was considered spontaneous if no attempt at pharmacologic rhythm control was made until conversion occurred; if SCV occurred after an unsuccessful attempt at electrical cardioversion; or following rate control with beta-blockers, nondihydropyridine calcium channel blockers, or digitalis glycosides, the authors state.
 

IV treatment increased odds of SCV

The median duration of stay in the ED was 6.4 hours (IQR, 3.9-11.6 hours) for patients with AFib and 6.1 hours (IQR, 3.9-11.8 hours) for patients with AFL.

During the stay in the ED, SCV occurred in 15.4% (n = 393) of AFib episodes and 12.7% (n = 73) of AFL episodes.

Intravenous potassium and magnesium increased the possibility of SCV compared with no IV potassium and magnesium in AFib, but not in AFL.

In episodes of AFib, administration of intravenous potassium and magnesium was associated with 19.2% increased odds of SCV, compared with 10.4% with no administration (odds ratio, 1.98; 95% CI, 1.53-2.57).

In contrast, for AFL, no association was observed for the probability of SCV with potassium and magnesium administration when compared with no administration (13.0% vs. 12.5%; OR, 1.05; 95% CI, 0.65-1.69).
 

Not in the guidelines

“To date, it is unclear whether potassium and magnesium administration might be reasonable in the acute treatment of AF and AFL, and although this intervention may be common practice in some EDs, it is not part of the treatment recommendations in current guidelines,” Dr. Cacioppo and colleagues write.

“Our findings suggest that intravenous potassium and magnesium administration may increase the chance of SCV in patients with AF with either hypokalemia or with plasma potassium levels in the range of 3.50 to 3.99 mEq/L. In patients with AFL, however, potassium and magnesium administration may not be associated with SCV probability,” they write.

Dr. Cacioppo and associates add that in their study IV administration of potassium and magnesium was associated with SCV only in patients with symptom onset of less than 48 hours, suggesting a time-dependent outcome. However, they caution, “because only a limited number of patients with SCV had symptom onset greater than or equal to 48 hours, this finding warrants further investigation.”
 

A Band-Aid approach

“I’m a little skeptical about this study,” Georgios Syros, MD, director of arrhythmia services at Mount Sinai Queens and Mount Sinai Brooklyn, New York, said in an interview.

“Atrial fibrillation is a chronic disease. The natural history of this disease is that it is paroxysmal in the beginning, and at some point the episodes become more frequent and longer in duration. For some people, at some point, it becomes permanent,” Dr. Syros said.

“Suppose I cut my finger while slicing bread. I put a Band-Aid on the cut. That doesn’t mean I have fixed it, it means I’ve helped it temporarily. Atrial fibrillation in this paper is very analogous,” he said. “The patient may have episodes, goes to the emergency room, you give them medication, and temporarily alleviate the situation so that the patient does not have to be admitted. It’s simple, inexpensive, you make the heart rate go back to normal, not permanently, with few side effects, except perhaps for some pain at the injection site, but that doesn’t mean you have fixed the AFib permanently. But for someone who has had a first incidence, or doesn’t want to stay in the hospital because it’s the weekend, yes, you can use this as a Band-Aid,” he said.

Intravenous potassium and magnesium, as proposed in the current study, is similar to a medication currently in use in Europe, called vernakalant, Dr. Syros said.

“Vernakalant is not FDA approved in the U.S. It is not meant to treat atrial fibrillation permanently, so we have to inform the public about the limitations of what we are doing,” he said. “Vernakalant is similar to IV potassium and magnesium, as given in this study, but it is more expensive. It temporarily allows people to go back to sinus rhythm, but it’s not going to be there forever and you may go back to permanent AFib, so this is not magic, unfortunately.”

Dr. Syros emphasized that the current study results apply only to cases of paroxysmal atrial fibrillation of less than 48 hours duration. “This is a very important distinction,” he said.

“For example, a patient who drank a lot and the day after is in AFib, with what we call holiday heart, would be a good candidate for the treatment in this study. He’s young, without any heart damage, no diabetes, no hypertension, no prior stroke, so sure, help him out with potassium and magnesium, provided that he can prove to us that this started within 48 hours,” Dr. Syros said.

Dr. Cacioppo and colleagues and Dr. Syros report no relevant financial relationships. Study corresponding author Jan Niederdoeckl, MD, PhD, obtained funding for the study.

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

The probability of spontaneous conversion to sinus rhythm (SCV) was increased with the intravenous administration of magnesium and potassium in patients with nonpermanent atrial fibrillation presenting to the ER, a registry study shows.

Compared with no treatment, potassium and magnesium administration was associated with a 10% higher rate of SVC.

The finding suggests that giving intravenous potassium and magnesium might lessen the need for antiarrhythmic therapy and the associated potential adverse effects in patients with nonpermanent atrial fibrillation (AFib), the study authors say.

Still, they add, “The results of our study have no direct implications for clinical practice in the management of care for patients with AF [atrial fibrillation] or AFL [atrial flutter] in the ED. The findings are purely exploratory and hypothesis-generating but could potentially provide a rationale for an appropriate prospective trial.”

The study was published online in JAMA Network Open.

“Atrial fibrillation is becoming an increasing burden for health care systems worldwide owing to population aging,” write Filippo Cacioppo, MD, and colleagues from Medical University of Vienna (Austria).

“Pharmacologic and electrical conversion are common therapies in emergency departments, especially for highly symptomatic patients. Each intervention has specific risks, and neither is considered cost-effective owing to frequent recurrence of AF. In addition, AF often terminates spontaneously,” Dr. Cacioppo and colleagues write.

They add that evidence suggests hypokalemia and hypomagnesemia contribute to AFib development, and so the administration of potassium and magnesium could be a reasonable strategy to improve SCV rates.

To test their hypothesis, Dr. Cacioppo and associates conducted a registry-based cohort study in all patients with AFib or AFL presenting to their center’s ED between Feb. 6, 2009, and Feb. 16, 2020.

During this time, they observed a total of 2,546 episodes of nonpermanent AFib. The median patient age was 68 years (interquartile range, 58-75 years). Most were men (n = 1,411 patients, 55.4%).

In addition, there were 573 episodes of nonpermanent AFL. The median patient age was 68 years (IQR, 58-75 years), and 332 patients (57.9%) were men.

Intravenous potassium and magnesium were administered in just over half (n = 1,763; 56.5%) of the episodes.

The median amount of potassium and magnesium was delivered via one 250-mL infusion bag, which consisted of 24 mEq potassium and 145.8 mg magnesium combined with 500 mL of balanced crystalloid fluid containing 2.5 mEq potassium and 18.2 mg magnesium, administered for 90 minutes, the authors write.

If patients experienced pain at the injection site, the infusion rate was reduced until the pain subsided.

Conversion to sinus rhythm was considered spontaneous if no attempt at pharmacologic rhythm control was made until conversion occurred; if SCV occurred after an unsuccessful attempt at electrical cardioversion; or following rate control with beta-blockers, nondihydropyridine calcium channel blockers, or digitalis glycosides, the authors state.
 

IV treatment increased odds of SCV

The median duration of stay in the ED was 6.4 hours (IQR, 3.9-11.6 hours) for patients with AFib and 6.1 hours (IQR, 3.9-11.8 hours) for patients with AFL.

During the stay in the ED, SCV occurred in 15.4% (n = 393) of AFib episodes and 12.7% (n = 73) of AFL episodes.

Intravenous potassium and magnesium increased the possibility of SCV compared with no IV potassium and magnesium in AFib, but not in AFL.

In episodes of AFib, administration of intravenous potassium and magnesium was associated with 19.2% increased odds of SCV, compared with 10.4% with no administration (odds ratio, 1.98; 95% CI, 1.53-2.57).

In contrast, for AFL, no association was observed for the probability of SCV with potassium and magnesium administration when compared with no administration (13.0% vs. 12.5%; OR, 1.05; 95% CI, 0.65-1.69).
 

Not in the guidelines

“To date, it is unclear whether potassium and magnesium administration might be reasonable in the acute treatment of AF and AFL, and although this intervention may be common practice in some EDs, it is not part of the treatment recommendations in current guidelines,” Dr. Cacioppo and colleagues write.

“Our findings suggest that intravenous potassium and magnesium administration may increase the chance of SCV in patients with AF with either hypokalemia or with plasma potassium levels in the range of 3.50 to 3.99 mEq/L. In patients with AFL, however, potassium and magnesium administration may not be associated with SCV probability,” they write.

Dr. Cacioppo and associates add that in their study IV administration of potassium and magnesium was associated with SCV only in patients with symptom onset of less than 48 hours, suggesting a time-dependent outcome. However, they caution, “because only a limited number of patients with SCV had symptom onset greater than or equal to 48 hours, this finding warrants further investigation.”
 

A Band-Aid approach

“I’m a little skeptical about this study,” Georgios Syros, MD, director of arrhythmia services at Mount Sinai Queens and Mount Sinai Brooklyn, New York, said in an interview.

“Atrial fibrillation is a chronic disease. The natural history of this disease is that it is paroxysmal in the beginning, and at some point the episodes become more frequent and longer in duration. For some people, at some point, it becomes permanent,” Dr. Syros said.

“Suppose I cut my finger while slicing bread. I put a Band-Aid on the cut. That doesn’t mean I have fixed it, it means I’ve helped it temporarily. Atrial fibrillation in this paper is very analogous,” he said. “The patient may have episodes, goes to the emergency room, you give them medication, and temporarily alleviate the situation so that the patient does not have to be admitted. It’s simple, inexpensive, you make the heart rate go back to normal, not permanently, with few side effects, except perhaps for some pain at the injection site, but that doesn’t mean you have fixed the AFib permanently. But for someone who has had a first incidence, or doesn’t want to stay in the hospital because it’s the weekend, yes, you can use this as a Band-Aid,” he said.

Intravenous potassium and magnesium, as proposed in the current study, is similar to a medication currently in use in Europe, called vernakalant, Dr. Syros said.

“Vernakalant is not FDA approved in the U.S. It is not meant to treat atrial fibrillation permanently, so we have to inform the public about the limitations of what we are doing,” he said. “Vernakalant is similar to IV potassium and magnesium, as given in this study, but it is more expensive. It temporarily allows people to go back to sinus rhythm, but it’s not going to be there forever and you may go back to permanent AFib, so this is not magic, unfortunately.”

Dr. Syros emphasized that the current study results apply only to cases of paroxysmal atrial fibrillation of less than 48 hours duration. “This is a very important distinction,” he said.

“For example, a patient who drank a lot and the day after is in AFib, with what we call holiday heart, would be a good candidate for the treatment in this study. He’s young, without any heart damage, no diabetes, no hypertension, no prior stroke, so sure, help him out with potassium and magnesium, provided that he can prove to us that this started within 48 hours,” Dr. Syros said.

Dr. Cacioppo and colleagues and Dr. Syros report no relevant financial relationships. Study corresponding author Jan Niederdoeckl, MD, PhD, obtained funding for the study.

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

The probability of spontaneous conversion to sinus rhythm (SCV) was increased with the intravenous administration of magnesium and potassium in patients with nonpermanent atrial fibrillation presenting to the ER, a registry study shows.

Compared with no treatment, potassium and magnesium administration was associated with a 10% higher rate of SVC.

The finding suggests that giving intravenous potassium and magnesium might lessen the need for antiarrhythmic therapy and the associated potential adverse effects in patients with nonpermanent atrial fibrillation (AFib), the study authors say.

Still, they add, “The results of our study have no direct implications for clinical practice in the management of care for patients with AF [atrial fibrillation] or AFL [atrial flutter] in the ED. The findings are purely exploratory and hypothesis-generating but could potentially provide a rationale for an appropriate prospective trial.”

The study was published online in JAMA Network Open.

“Atrial fibrillation is becoming an increasing burden for health care systems worldwide owing to population aging,” write Filippo Cacioppo, MD, and colleagues from Medical University of Vienna (Austria).

“Pharmacologic and electrical conversion are common therapies in emergency departments, especially for highly symptomatic patients. Each intervention has specific risks, and neither is considered cost-effective owing to frequent recurrence of AF. In addition, AF often terminates spontaneously,” Dr. Cacioppo and colleagues write.

They add that evidence suggests hypokalemia and hypomagnesemia contribute to AFib development, and so the administration of potassium and magnesium could be a reasonable strategy to improve SCV rates.

To test their hypothesis, Dr. Cacioppo and associates conducted a registry-based cohort study in all patients with AFib or AFL presenting to their center’s ED between Feb. 6, 2009, and Feb. 16, 2020.

During this time, they observed a total of 2,546 episodes of nonpermanent AFib. The median patient age was 68 years (interquartile range, 58-75 years). Most were men (n = 1,411 patients, 55.4%).

In addition, there were 573 episodes of nonpermanent AFL. The median patient age was 68 years (IQR, 58-75 years), and 332 patients (57.9%) were men.

Intravenous potassium and magnesium were administered in just over half (n = 1,763; 56.5%) of the episodes.

The median amount of potassium and magnesium was delivered via one 250-mL infusion bag, which consisted of 24 mEq potassium and 145.8 mg magnesium combined with 500 mL of balanced crystalloid fluid containing 2.5 mEq potassium and 18.2 mg magnesium, administered for 90 minutes, the authors write.

If patients experienced pain at the injection site, the infusion rate was reduced until the pain subsided.

Conversion to sinus rhythm was considered spontaneous if no attempt at pharmacologic rhythm control was made until conversion occurred; if SCV occurred after an unsuccessful attempt at electrical cardioversion; or following rate control with beta-blockers, nondihydropyridine calcium channel blockers, or digitalis glycosides, the authors state.
 

IV treatment increased odds of SCV

The median duration of stay in the ED was 6.4 hours (IQR, 3.9-11.6 hours) for patients with AFib and 6.1 hours (IQR, 3.9-11.8 hours) for patients with AFL.

During the stay in the ED, SCV occurred in 15.4% (n = 393) of AFib episodes and 12.7% (n = 73) of AFL episodes.

Intravenous potassium and magnesium increased the possibility of SCV compared with no IV potassium and magnesium in AFib, but not in AFL.

In episodes of AFib, administration of intravenous potassium and magnesium was associated with 19.2% increased odds of SCV, compared with 10.4% with no administration (odds ratio, 1.98; 95% CI, 1.53-2.57).

In contrast, for AFL, no association was observed for the probability of SCV with potassium and magnesium administration when compared with no administration (13.0% vs. 12.5%; OR, 1.05; 95% CI, 0.65-1.69).
 

Not in the guidelines

“To date, it is unclear whether potassium and magnesium administration might be reasonable in the acute treatment of AF and AFL, and although this intervention may be common practice in some EDs, it is not part of the treatment recommendations in current guidelines,” Dr. Cacioppo and colleagues write.

“Our findings suggest that intravenous potassium and magnesium administration may increase the chance of SCV in patients with AF with either hypokalemia or with plasma potassium levels in the range of 3.50 to 3.99 mEq/L. In patients with AFL, however, potassium and magnesium administration may not be associated with SCV probability,” they write.

Dr. Cacioppo and associates add that in their study IV administration of potassium and magnesium was associated with SCV only in patients with symptom onset of less than 48 hours, suggesting a time-dependent outcome. However, they caution, “because only a limited number of patients with SCV had symptom onset greater than or equal to 48 hours, this finding warrants further investigation.”
 

A Band-Aid approach

“I’m a little skeptical about this study,” Georgios Syros, MD, director of arrhythmia services at Mount Sinai Queens and Mount Sinai Brooklyn, New York, said in an interview.

“Atrial fibrillation is a chronic disease. The natural history of this disease is that it is paroxysmal in the beginning, and at some point the episodes become more frequent and longer in duration. For some people, at some point, it becomes permanent,” Dr. Syros said.

“Suppose I cut my finger while slicing bread. I put a Band-Aid on the cut. That doesn’t mean I have fixed it, it means I’ve helped it temporarily. Atrial fibrillation in this paper is very analogous,” he said. “The patient may have episodes, goes to the emergency room, you give them medication, and temporarily alleviate the situation so that the patient does not have to be admitted. It’s simple, inexpensive, you make the heart rate go back to normal, not permanently, with few side effects, except perhaps for some pain at the injection site, but that doesn’t mean you have fixed the AFib permanently. But for someone who has had a first incidence, or doesn’t want to stay in the hospital because it’s the weekend, yes, you can use this as a Band-Aid,” he said.

Intravenous potassium and magnesium, as proposed in the current study, is similar to a medication currently in use in Europe, called vernakalant, Dr. Syros said.

“Vernakalant is not FDA approved in the U.S. It is not meant to treat atrial fibrillation permanently, so we have to inform the public about the limitations of what we are doing,” he said. “Vernakalant is similar to IV potassium and magnesium, as given in this study, but it is more expensive. It temporarily allows people to go back to sinus rhythm, but it’s not going to be there forever and you may go back to permanent AFib, so this is not magic, unfortunately.”

Dr. Syros emphasized that the current study results apply only to cases of paroxysmal atrial fibrillation of less than 48 hours duration. “This is a very important distinction,” he said.

“For example, a patient who drank a lot and the day after is in AFib, with what we call holiday heart, would be a good candidate for the treatment in this study. He’s young, without any heart damage, no diabetes, no hypertension, no prior stroke, so sure, help him out with potassium and magnesium, provided that he can prove to us that this started within 48 hours,” Dr. Syros said.

Dr. Cacioppo and colleagues and Dr. Syros report no relevant financial relationships. Study corresponding author Jan Niederdoeckl, MD, PhD, obtained funding for the study.

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

Cocaine, methamphetamine, opioids, and cannabis may independently increase risk of atrial fibrillation (AFib), based on data from almost 24 million people.

While more work is needed to uncover causal links, physicians should be aware that these commonly abused substances could be driving new cases of AFib, reported investigators from the University of California, San Francisco.

“Though alcohol and tobacco smoking have each been associated with a heightened risk of [AFib], relationships between other drug use and [AFib] are poorly understood,” they wrote in European Heart Journal.

Some previous studies have ventured into this terrain, but most focused on fatal arrhythmias, or offered anecdotal evidence. This knowledge gap is particularly concerning for cannabis, the researchers noted, as medical and recreational use are on the rise.

American Heart Association

The present analysis included data from 23.5 million adults in California who received care through a hospital, emergency department, or outpatient surgery center during 2005-2015. Based on ICD-9 diagnostic codes, 132,834 of these patients used cannabis, 98,271 used methamphetamines, 48,701 used cocaine, and 10,032 used opiates. Inclusion required lack of AFib at baseline.

Reliance on ICD-9 codes makes the data “quite specific,” but lacking sensitivity, according to principal author Gregory M. Marcus, MD, cardiologist and professor of medicine at UCSF.

“If they were designated as using these drugs, that is very likely true,” Dr. Marcus said in an interview. “But certainly, the absence of any mention of use of these drugs does not exclude the possibility that some people were still using them. That would not create spurious false-positive relationships; if anything, it attenuates existing relationships.”

In other words, using ICD-9 codes reduced the power to detect an association between each drug and AFib, meaning any relationship needed to be sufficiently strong enough to generate a significant result.

At the end of the decade-long study period, 998,747 patients (4.2%) had developed incident AFib. After adjusting for potential confounders and mediators, all four drugs showed significant, independent associations with AFib. Methamphetamines presented the greatest risk (hazard ratio, 1.86%), followed by opiates (HR, 1.74), cocaine (HR, 1.61), and cannabis (HR, 1.35).

“Our findings provide the first evidence utilizing a longitudinal cohort to demonstrate that cannabis use predicts the future onset of AFib,” Dr. Marcus and colleagues wrote.

Dose-response relationships were not detected for any of the substances; however, usage levels were also derived from ICD-9 codes, which may have been insufficient for this purpose, according to the investigators.
 

Causal mechanisms deserve a closer look

Causal links between AFib and each of the drugs remain unclear. Citing prior research, Dr. Marcus and colleagues explained how methamphetamines are capable of “significant cardiac electrical remodeling,” while cocaine may cause sodium channel dysregulation, and opioids can render atrial myocytes more susceptible to oxidative damage. Although cannabis has previously been linked with hospitalization for arrhythmia, a pharmacologic driver of this phenomenon remains largely unexamined.

“We don’t know for sure precisely what the constituents are that are responsible for our findings,” Dr. Marcus said. “It’s possible that there are some effects that are much more generic, such as inhaling a burned substance. There is good evidence that if you inhale pretty much any sort of particulate matter, that increases inflammation in the body. Inflammation is known to be a trigger for atrial fibrillation.”

Alternatively, all four drugs – whether stimulants or depressants – cause “quite dramatic and often rapid effects on the autonomic nervous system,” Dr. Marcus said, noting that these rapid swings are a known trigger for AFib.

Brian Olshansky, MD, emeritus professor of internal medicine-cardiovascular medicine at the University of Iowa, Iowa City, suggested that nonpharmacologic factors are likely also playing a role.

“All these drugs have slightly different mechanisms of action, so there’s not one mechanism that would explain why all of them would cause atrial fibrillation,” Dr. Olshansky said in an interview. “That does suggest that there’s something else going on, besides just the drug itself. It would be potentially concerning if we were to lay the blame totally on these drugs.”

Dr. Olshansky, who recently coauthored a review of stimulant drugs and arrhythmias, suggested that lifestyle, comorbidities, and drug impurities may have added to the risk of AF.

“[The investigators] did try to correct for that kind of stuff, but it’s very hard to correct for a lot of the issues that may be ongoing with individuals who partake in these drugs,” Dr. Olshansky said in an interview. “They may not be a healthy lot, in general.”

Still, considering previous data linking drugs of abuse with arrhythmias, he said the detected risks were “intriguing,” and deserved a closer look.

“It’s a nice groundbreaking study, with regard to the fact that they showed unique relationships that we don’t completely understand,” Dr. Olshansky said. “It opens up a new opportunity for further investigation.”

The investigators disclosed relationships with InCarda, Baylis Medical, Johnson & Johnson, and others. Dr. Olshansky disclosed no relevant competing interests.

Cocaine, methamphetamine, opioids, and cannabis may independently increase risk of atrial fibrillation (AFib), based on data from almost 24 million people.

While more work is needed to uncover causal links, physicians should be aware that these commonly abused substances could be driving new cases of AFib, reported investigators from the University of California, San Francisco.

“Though alcohol and tobacco smoking have each been associated with a heightened risk of [AFib], relationships between other drug use and [AFib] are poorly understood,” they wrote in European Heart Journal.

Some previous studies have ventured into this terrain, but most focused on fatal arrhythmias, or offered anecdotal evidence. This knowledge gap is particularly concerning for cannabis, the researchers noted, as medical and recreational use are on the rise.

American Heart Association

The present analysis included data from 23.5 million adults in California who received care through a hospital, emergency department, or outpatient surgery center during 2005-2015. Based on ICD-9 diagnostic codes, 132,834 of these patients used cannabis, 98,271 used methamphetamines, 48,701 used cocaine, and 10,032 used opiates. Inclusion required lack of AFib at baseline.

Reliance on ICD-9 codes makes the data “quite specific,” but lacking sensitivity, according to principal author Gregory M. Marcus, MD, cardiologist and professor of medicine at UCSF.

“If they were designated as using these drugs, that is very likely true,” Dr. Marcus said in an interview. “But certainly, the absence of any mention of use of these drugs does not exclude the possibility that some people were still using them. That would not create spurious false-positive relationships; if anything, it attenuates existing relationships.”

In other words, using ICD-9 codes reduced the power to detect an association between each drug and AFib, meaning any relationship needed to be sufficiently strong enough to generate a significant result.

At the end of the decade-long study period, 998,747 patients (4.2%) had developed incident AFib. After adjusting for potential confounders and mediators, all four drugs showed significant, independent associations with AFib. Methamphetamines presented the greatest risk (hazard ratio, 1.86%), followed by opiates (HR, 1.74), cocaine (HR, 1.61), and cannabis (HR, 1.35).

“Our findings provide the first evidence utilizing a longitudinal cohort to demonstrate that cannabis use predicts the future onset of AFib,” Dr. Marcus and colleagues wrote.

Dose-response relationships were not detected for any of the substances; however, usage levels were also derived from ICD-9 codes, which may have been insufficient for this purpose, according to the investigators.
 

Causal mechanisms deserve a closer look

Causal links between AFib and each of the drugs remain unclear. Citing prior research, Dr. Marcus and colleagues explained how methamphetamines are capable of “significant cardiac electrical remodeling,” while cocaine may cause sodium channel dysregulation, and opioids can render atrial myocytes more susceptible to oxidative damage. Although cannabis has previously been linked with hospitalization for arrhythmia, a pharmacologic driver of this phenomenon remains largely unexamined.

“We don’t know for sure precisely what the constituents are that are responsible for our findings,” Dr. Marcus said. “It’s possible that there are some effects that are much more generic, such as inhaling a burned substance. There is good evidence that if you inhale pretty much any sort of particulate matter, that increases inflammation in the body. Inflammation is known to be a trigger for atrial fibrillation.”

Alternatively, all four drugs – whether stimulants or depressants – cause “quite dramatic and often rapid effects on the autonomic nervous system,” Dr. Marcus said, noting that these rapid swings are a known trigger for AFib.

Brian Olshansky, MD, emeritus professor of internal medicine-cardiovascular medicine at the University of Iowa, Iowa City, suggested that nonpharmacologic factors are likely also playing a role.

“All these drugs have slightly different mechanisms of action, so there’s not one mechanism that would explain why all of them would cause atrial fibrillation,” Dr. Olshansky said in an interview. “That does suggest that there’s something else going on, besides just the drug itself. It would be potentially concerning if we were to lay the blame totally on these drugs.”

Dr. Olshansky, who recently coauthored a review of stimulant drugs and arrhythmias, suggested that lifestyle, comorbidities, and drug impurities may have added to the risk of AF.

“[The investigators] did try to correct for that kind of stuff, but it’s very hard to correct for a lot of the issues that may be ongoing with individuals who partake in these drugs,” Dr. Olshansky said in an interview. “They may not be a healthy lot, in general.”

Still, considering previous data linking drugs of abuse with arrhythmias, he said the detected risks were “intriguing,” and deserved a closer look.

“It’s a nice groundbreaking study, with regard to the fact that they showed unique relationships that we don’t completely understand,” Dr. Olshansky said. “It opens up a new opportunity for further investigation.”

The investigators disclosed relationships with InCarda, Baylis Medical, Johnson & Johnson, and others. Dr. Olshansky disclosed no relevant competing interests.

Cocaine, methamphetamine, opioids, and cannabis may independently increase risk of atrial fibrillation (AFib), based on data from almost 24 million people.

While more work is needed to uncover causal links, physicians should be aware that these commonly abused substances could be driving new cases of AFib, reported investigators from the University of California, San Francisco.

“Though alcohol and tobacco smoking have each been associated with a heightened risk of [AFib], relationships between other drug use and [AFib] are poorly understood,” they wrote in European Heart Journal.

Some previous studies have ventured into this terrain, but most focused on fatal arrhythmias, or offered anecdotal evidence. This knowledge gap is particularly concerning for cannabis, the researchers noted, as medical and recreational use are on the rise.

American Heart Association

The present analysis included data from 23.5 million adults in California who received care through a hospital, emergency department, or outpatient surgery center during 2005-2015. Based on ICD-9 diagnostic codes, 132,834 of these patients used cannabis, 98,271 used methamphetamines, 48,701 used cocaine, and 10,032 used opiates. Inclusion required lack of AFib at baseline.

Reliance on ICD-9 codes makes the data “quite specific,” but lacking sensitivity, according to principal author Gregory M. Marcus, MD, cardiologist and professor of medicine at UCSF.

“If they were designated as using these drugs, that is very likely true,” Dr. Marcus said in an interview. “But certainly, the absence of any mention of use of these drugs does not exclude the possibility that some people were still using them. That would not create spurious false-positive relationships; if anything, it attenuates existing relationships.”

In other words, using ICD-9 codes reduced the power to detect an association between each drug and AFib, meaning any relationship needed to be sufficiently strong enough to generate a significant result.

At the end of the decade-long study period, 998,747 patients (4.2%) had developed incident AFib. After adjusting for potential confounders and mediators, all four drugs showed significant, independent associations with AFib. Methamphetamines presented the greatest risk (hazard ratio, 1.86%), followed by opiates (HR, 1.74), cocaine (HR, 1.61), and cannabis (HR, 1.35).

“Our findings provide the first evidence utilizing a longitudinal cohort to demonstrate that cannabis use predicts the future onset of AFib,” Dr. Marcus and colleagues wrote.

Dose-response relationships were not detected for any of the substances; however, usage levels were also derived from ICD-9 codes, which may have been insufficient for this purpose, according to the investigators.
 

Causal mechanisms deserve a closer look

Causal links between AFib and each of the drugs remain unclear. Citing prior research, Dr. Marcus and colleagues explained how methamphetamines are capable of “significant cardiac electrical remodeling,” while cocaine may cause sodium channel dysregulation, and opioids can render atrial myocytes more susceptible to oxidative damage. Although cannabis has previously been linked with hospitalization for arrhythmia, a pharmacologic driver of this phenomenon remains largely unexamined.

“We don’t know for sure precisely what the constituents are that are responsible for our findings,” Dr. Marcus said. “It’s possible that there are some effects that are much more generic, such as inhaling a burned substance. There is good evidence that if you inhale pretty much any sort of particulate matter, that increases inflammation in the body. Inflammation is known to be a trigger for atrial fibrillation.”

Alternatively, all four drugs – whether stimulants or depressants – cause “quite dramatic and often rapid effects on the autonomic nervous system,” Dr. Marcus said, noting that these rapid swings are a known trigger for AFib.

Brian Olshansky, MD, emeritus professor of internal medicine-cardiovascular medicine at the University of Iowa, Iowa City, suggested that nonpharmacologic factors are likely also playing a role.

“All these drugs have slightly different mechanisms of action, so there’s not one mechanism that would explain why all of them would cause atrial fibrillation,” Dr. Olshansky said in an interview. “That does suggest that there’s something else going on, besides just the drug itself. It would be potentially concerning if we were to lay the blame totally on these drugs.”

Dr. Olshansky, who recently coauthored a review of stimulant drugs and arrhythmias, suggested that lifestyle, comorbidities, and drug impurities may have added to the risk of AF.

“[The investigators] did try to correct for that kind of stuff, but it’s very hard to correct for a lot of the issues that may be ongoing with individuals who partake in these drugs,” Dr. Olshansky said in an interview. “They may not be a healthy lot, in general.”

Still, considering previous data linking drugs of abuse with arrhythmias, he said the detected risks were “intriguing,” and deserved a closer look.

“It’s a nice groundbreaking study, with regard to the fact that they showed unique relationships that we don’t completely understand,” Dr. Olshansky said. “It opens up a new opportunity for further investigation.”

The investigators disclosed relationships with InCarda, Baylis Medical, Johnson & Johnson, and others. Dr. Olshansky disclosed no relevant competing interests.

Labeling for a Medtronic pacing lead, already indicated for stimulation of the His bundle, has been expanded to include the left bundle branch (LBB), the company announced on Oct. 17.

The U.S. Food and Drug Administration previously expanded the Medtronic SelectSecure MRI SureScan Model 3830 lead’s approval in 2018 to include His-bundle pacing. “Now this cardiac lead is approved for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to apical pacing in the right ventricle in a single- or dual-chamber pacing system,” Medtronic states in a press release.

Olivier Le Moal/Getty Images

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

Labeling for a Medtronic pacing lead, already indicated for stimulation of the His bundle, has been expanded to include the left bundle branch (LBB), the company announced on Oct. 17.

The U.S. Food and Drug Administration previously expanded the Medtronic SelectSecure MRI SureScan Model 3830 lead’s approval in 2018 to include His-bundle pacing. “Now this cardiac lead is approved for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to apical pacing in the right ventricle in a single- or dual-chamber pacing system,” Medtronic states in a press release.

Olivier Le Moal/Getty Images

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

Labeling for a Medtronic pacing lead, already indicated for stimulation of the His bundle, has been expanded to include the left bundle branch (LBB), the company announced on Oct. 17.

The U.S. Food and Drug Administration previously expanded the Medtronic SelectSecure MRI SureScan Model 3830 lead’s approval in 2018 to include His-bundle pacing. “Now this cardiac lead is approved for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to apical pacing in the right ventricle in a single- or dual-chamber pacing system,” Medtronic states in a press release.

Olivier Le Moal/Getty Images

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

Diabetes persists as a risk factor for cardiovascular events, but where it once meant the same risk of heart attack or stroke as cardiovascular disease itself, a large Canadian population study reports that’s no longer the case. Thanks to advances in diabetes management over the past quarter century, diabetes is no longer considered equivalent to CVD as a risk factor for cardiovascular events, researchers from the University of Toronto reported.

The retrospective, population-based study used administrative data from Ontario’s provincial universal health care system. The researchers created five population-based cohorts of adults at 5-year intervals from 1994 to 2014, consisting of 1.87 million adults in the first cohort and 1.5 million in the last. In that 20-year span, the prevalence of diabetes in this population tripled, from 3.1% to 9%.

“In the last 25 years we’ve seen wholesale changes in the way people approach diabetes,” lead study author Calvin Ke, MD, PhD, an endocrinologist and assistant professor at the University of Toronto, said in an interview. “Part of the findings show that diabetes and cardiovascular disease were equivalent for risk of cardiovascular events in 1994, but by 2014 that was not the case.”

However, Dr. Ke added, “Diabetes is still a very strong cardiovascular risk factor.”

The investigators for the study, reported as a research letter in JAMA, analyzed the risk of cardiovascular events in four subgroups: those who had both diabetes and CVD, CVD only, diabetes only, and no CVD or diabetes.

Between 1994 and 2014, the cardiovascular event rates declined significantly among people with diabetes alone, compared with people with no disease: from 28.4 to 12.7 per 1,000 person-years, or an absolute risk increase (ARI) of 4.4% and a relative risk (RR) more than double (2.06), in 1994 to 14 vs. 8 per 1,000 person-years, and an ARI of 2% and RR less than double (1.58) 20 years later.

Among people with CVD only, those values shifted from 36.1 per 1,000 person-years, ARI of 5.1% and RR of 2.16 in 1994 to 23.9, ARI of 3.7% and RR still more than double (2.06) in 2014.

People with both CVD and diabetes had the highest CVD event rates across all 5-year cohorts: 74 per 1,000 person-years, ARI of 12% and RR almost four times greater (3.81) in 1994 than people with no disease. By 2014, the ARI in this group was 7.6% and the RR 3.10.

The investigators calculated that event rates from 1994 to 2014 declined across all four subgroups, with rate ratios of 0.49 for diabetes only, 0.66 for CVD only, 0.60 for both diabetes and CVD, and 0.63 for neither disease.

Shift in practice

The study noted that the shift in diabetes as a risk factor for heart attack and stroke is “a change that likely reflects the use of modern, multifactorial approaches to diabetes.”

“A number of changes have occurred in practice that really focus on this idea of a multifactorial approach to diabetes: more aggressive management of blood sugar, blood pressure, and lipids,” Dr. Ke said. “We know from the statin trials that statins can reduce the risk of heart disease significantly, and the use of statins increased from 28.4% in 1999 to 56.3% in 2018 in the United States,” Dr. Ke said. He added that statin use in Canada in adults ages 40 and older went from 1.2% in 1994 to 58.4% in 2010-2015. Use of ACE inhibitors and angiotensin receptor blockers for hypertension followed similar trends, contributing further to reducing risks for heart attack and stroke, Dr. Ke said.

Dr. Ke also noted that the evolution of guidelines and advances in treatments for both CVD and diabetes since 1994 have contributed to improving risks for people with diabetes. SGLT2 inhibitors have been linked to a 2%-6% reduction in hemoglobin A1c, he said. “All of these factors combined have had a major effect on the reduced risk of cardiovascular events.”

Prakash Deedwania, MD, professor at the University of California, San Francisco, Fresno, said that this study confirms a trend that others have reported regarding the risk of CVD in diabetes. The large database covering millions of adults is a study strength, he said.

And the findings, Dr. Deedwania added, underscore what’s been published in clinical guidelines, notably the American Heart Association scientific statement for managing CVD risk in patients with diabetes. “This means that, from observations made 20-plus years ago, when most people were not being treated for diabetes or heart disease, the pendulum has swung,” he said.

However, he added, “The authors state clearly that it does not mean that diabetes is not associated with a higher risk of cardiovascular events; it just means it is no longer equivalent to CVD.”

Managing diabetes continues to be “particularly important,” Dr. Deedwania said, because the prevalence of diabetes continues to rise. “This is a phenomenal risk, and it emphasizes that, to really conquer or control diabetes, we should make every effort to prevent diabetes,” he said.

Dr. Ke and Dr. Deedwania have no relevant financial relationships to disclose.

Diabetes persists as a risk factor for cardiovascular events, but where it once meant the same risk of heart attack or stroke as cardiovascular disease itself, a large Canadian population study reports that’s no longer the case. Thanks to advances in diabetes management over the past quarter century, diabetes is no longer considered equivalent to CVD as a risk factor for cardiovascular events, researchers from the University of Toronto reported.

The retrospective, population-based study used administrative data from Ontario’s provincial universal health care system. The researchers created five population-based cohorts of adults at 5-year intervals from 1994 to 2014, consisting of 1.87 million adults in the first cohort and 1.5 million in the last. In that 20-year span, the prevalence of diabetes in this population tripled, from 3.1% to 9%.

“In the last 25 years we’ve seen wholesale changes in the way people approach diabetes,” lead study author Calvin Ke, MD, PhD, an endocrinologist and assistant professor at the University of Toronto, said in an interview. “Part of the findings show that diabetes and cardiovascular disease were equivalent for risk of cardiovascular events in 1994, but by 2014 that was not the case.”

However, Dr. Ke added, “Diabetes is still a very strong cardiovascular risk factor.”

The investigators for the study, reported as a research letter in JAMA, analyzed the risk of cardiovascular events in four subgroups: those who had both diabetes and CVD, CVD only, diabetes only, and no CVD or diabetes.

Between 1994 and 2014, the cardiovascular event rates declined significantly among people with diabetes alone, compared with people with no disease: from 28.4 to 12.7 per 1,000 person-years, or an absolute risk increase (ARI) of 4.4% and a relative risk (RR) more than double (2.06), in 1994 to 14 vs. 8 per 1,000 person-years, and an ARI of 2% and RR less than double (1.58) 20 years later.

Among people with CVD only, those values shifted from 36.1 per 1,000 person-years, ARI of 5.1% and RR of 2.16 in 1994 to 23.9, ARI of 3.7% and RR still more than double (2.06) in 2014.

People with both CVD and diabetes had the highest CVD event rates across all 5-year cohorts: 74 per 1,000 person-years, ARI of 12% and RR almost four times greater (3.81) in 1994 than people with no disease. By 2014, the ARI in this group was 7.6% and the RR 3.10.

The investigators calculated that event rates from 1994 to 2014 declined across all four subgroups, with rate ratios of 0.49 for diabetes only, 0.66 for CVD only, 0.60 for both diabetes and CVD, and 0.63 for neither disease.

Shift in practice

The study noted that the shift in diabetes as a risk factor for heart attack and stroke is “a change that likely reflects the use of modern, multifactorial approaches to diabetes.”

“A number of changes have occurred in practice that really focus on this idea of a multifactorial approach to diabetes: more aggressive management of blood sugar, blood pressure, and lipids,” Dr. Ke said. “We know from the statin trials that statins can reduce the risk of heart disease significantly, and the use of statins increased from 28.4% in 1999 to 56.3% in 2018 in the United States,” Dr. Ke said. He added that statin use in Canada in adults ages 40 and older went from 1.2% in 1994 to 58.4% in 2010-2015. Use of ACE inhibitors and angiotensin receptor blockers for hypertension followed similar trends, contributing further to reducing risks for heart attack and stroke, Dr. Ke said.

Dr. Ke also noted that the evolution of guidelines and advances in treatments for both CVD and diabetes since 1994 have contributed to improving risks for people with diabetes. SGLT2 inhibitors have been linked to a 2%-6% reduction in hemoglobin A1c, he said. “All of these factors combined have had a major effect on the reduced risk of cardiovascular events.”

Prakash Deedwania, MD, professor at the University of California, San Francisco, Fresno, said that this study confirms a trend that others have reported regarding the risk of CVD in diabetes. The large database covering millions of adults is a study strength, he said.

And the findings, Dr. Deedwania added, underscore what’s been published in clinical guidelines, notably the American Heart Association scientific statement for managing CVD risk in patients with diabetes. “This means that, from observations made 20-plus years ago, when most people were not being treated for diabetes or heart disease, the pendulum has swung,” he said.

However, he added, “The authors state clearly that it does not mean that diabetes is not associated with a higher risk of cardiovascular events; it just means it is no longer equivalent to CVD.”

Managing diabetes continues to be “particularly important,” Dr. Deedwania said, because the prevalence of diabetes continues to rise. “This is a phenomenal risk, and it emphasizes that, to really conquer or control diabetes, we should make every effort to prevent diabetes,” he said.

Dr. Ke and Dr. Deedwania have no relevant financial relationships to disclose.

Diabetes persists as a risk factor for cardiovascular events, but where it once meant the same risk of heart attack or stroke as cardiovascular disease itself, a large Canadian population study reports that’s no longer the case. Thanks to advances in diabetes management over the past quarter century, diabetes is no longer considered equivalent to CVD as a risk factor for cardiovascular events, researchers from the University of Toronto reported.

The retrospective, population-based study used administrative data from Ontario’s provincial universal health care system. The researchers created five population-based cohorts of adults at 5-year intervals from 1994 to 2014, consisting of 1.87 million adults in the first cohort and 1.5 million in the last. In that 20-year span, the prevalence of diabetes in this population tripled, from 3.1% to 9%.

“In the last 25 years we’ve seen wholesale changes in the way people approach diabetes,” lead study author Calvin Ke, MD, PhD, an endocrinologist and assistant professor at the University of Toronto, said in an interview. “Part of the findings show that diabetes and cardiovascular disease were equivalent for risk of cardiovascular events in 1994, but by 2014 that was not the case.”

However, Dr. Ke added, “Diabetes is still a very strong cardiovascular risk factor.”

The investigators for the study, reported as a research letter in JAMA, analyzed the risk of cardiovascular events in four subgroups: those who had both diabetes and CVD, CVD only, diabetes only, and no CVD or diabetes.

Between 1994 and 2014, the cardiovascular event rates declined significantly among people with diabetes alone, compared with people with no disease: from 28.4 to 12.7 per 1,000 person-years, or an absolute risk increase (ARI) of 4.4% and a relative risk (RR) more than double (2.06), in 1994 to 14 vs. 8 per 1,000 person-years, and an ARI of 2% and RR less than double (1.58) 20 years later.

Among people with CVD only, those values shifted from 36.1 per 1,000 person-years, ARI of 5.1% and RR of 2.16 in 1994 to 23.9, ARI of 3.7% and RR still more than double (2.06) in 2014.

People with both CVD and diabetes had the highest CVD event rates across all 5-year cohorts: 74 per 1,000 person-years, ARI of 12% and RR almost four times greater (3.81) in 1994 than people with no disease. By 2014, the ARI in this group was 7.6% and the RR 3.10.

The investigators calculated that event rates from 1994 to 2014 declined across all four subgroups, with rate ratios of 0.49 for diabetes only, 0.66 for CVD only, 0.60 for both diabetes and CVD, and 0.63 for neither disease.

Shift in practice

The study noted that the shift in diabetes as a risk factor for heart attack and stroke is “a change that likely reflects the use of modern, multifactorial approaches to diabetes.”

“A number of changes have occurred in practice that really focus on this idea of a multifactorial approach to diabetes: more aggressive management of blood sugar, blood pressure, and lipids,” Dr. Ke said. “We know from the statin trials that statins can reduce the risk of heart disease significantly, and the use of statins increased from 28.4% in 1999 to 56.3% in 2018 in the United States,” Dr. Ke said. He added that statin use in Canada in adults ages 40 and older went from 1.2% in 1994 to 58.4% in 2010-2015. Use of ACE inhibitors and angiotensin receptor blockers for hypertension followed similar trends, contributing further to reducing risks for heart attack and stroke, Dr. Ke said.

Dr. Ke also noted that the evolution of guidelines and advances in treatments for both CVD and diabetes since 1994 have contributed to improving risks for people with diabetes. SGLT2 inhibitors have been linked to a 2%-6% reduction in hemoglobin A1c, he said. “All of these factors combined have had a major effect on the reduced risk of cardiovascular events.”

Prakash Deedwania, MD, professor at the University of California, San Francisco, Fresno, said that this study confirms a trend that others have reported regarding the risk of CVD in diabetes. The large database covering millions of adults is a study strength, he said.

And the findings, Dr. Deedwania added, underscore what’s been published in clinical guidelines, notably the American Heart Association scientific statement for managing CVD risk in patients with diabetes. “This means that, from observations made 20-plus years ago, when most people were not being treated for diabetes or heart disease, the pendulum has swung,” he said.

However, he added, “The authors state clearly that it does not mean that diabetes is not associated with a higher risk of cardiovascular events; it just means it is no longer equivalent to CVD.”

Managing diabetes continues to be “particularly important,” Dr. Deedwania said, because the prevalence of diabetes continues to rise. “This is a phenomenal risk, and it emphasizes that, to really conquer or control diabetes, we should make every effort to prevent diabetes,” he said.

Dr. Ke and Dr. Deedwania have no relevant financial relationships to disclose.

Apixaban offers greater protection than rivaroxaban against ischemic stroke, systemic embolism, and bleeding in patients with both atrial fibrillation (AFib) and valvular heart disease (VHD), a new study finds.

Compared with rivaroxaban, apixaban cut risks nearly in half, suggesting that clinicians should consider these new data when choosing an anticoagulant, reported lead author Ghadeer K. Dawwas, PhD, of the University of Pennsylvania, Philadelphia, and colleagues.

In the new retrospective study involving almost 20,000 patients, Dr. Dawwas and her colleagues “emulated a target trial” using private insurance claims from Optum’s deidentified Clinformatics Data Mart Database. The cohort was narrowed from a screened population of 58,210 patients with concurrent AFib and VHD to 9,947 new apixaban users who could be closely matched with 9,947 new rivaroxaban users. Covariates included provider specialty, type of VHD, demographic characteristics, measures of health care use, baseline use of medications, and baseline comorbidities.

The primary effectiveness outcome was a composite of systemic embolism and ischemic stroke, while the primary safety outcome was a composite of intracranial or gastrointestinal bleeding.

“Although several ongoing trials aim to compare apixaban with warfarin in patients with AFib and VHD, none of these trials will directly compare apixaban and rivaroxaban,” the investigators wrote. Their report is in Annals of Internal Medicine.

Dr. Dawwas and colleagues previously showed that direct oral anticoagulants (DOACs) were safer and more effective than warfarin in the same patient population. Comparing apixaban and rivaroxaban – the two most common DOACs – was the next logical step, Dr. Dawwas said in an interview.
 

Study results

Compared with rivaroxaban, patients who received apixaban had a 43% reduced risk of stroke or embolism (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.40-0.80). Apixaban’s ability to protect against bleeding appeared even more pronounced, with a 49% reduced risk over rivaroxaban (HR, 0.51; 95% CI, 0.41-0.62).

Comparing the two agents on an absolute basis, apixaban reduced risk of embolism or stroke by 0.2% within the first 6 months of treatment initiation, and 1.1% within the first year of initiation. At the same time points, absolute risk reductions for bleeding were 1.2% and 1.9%, respectively.

The investigators noted that their results held consistent in an alternative analysis that considered separate types of VHD.

“Based on the results from our analysis, we showed that apixaban is effective and safe in patients with atrial fibrillation and valvular heart diseases,” Dr. Dawwas said.
 

Head-to-head trial needed to change practice

Christopher M. Bianco, DO, associate professor of medicine at West Virginia University Heart and Vascular Institute, Morgantown, said the findings “add to the growing body of literature,” but “a head-to-head trial would be necessary to make a definitive change to clinical practice.”

Dr. Bianco, who recently conducted a retrospective analysis of apixaban and rivaroxaban that found no difference in safety and efficacy among a different patient population, said these kinds of studies are helpful in generating hypotheses, but they can’t account for all relevant clinical factors.

“There are just so many things that go into the decision-making process of [prescribing] apixaban and rivaroxaban,” he said. “Even though [Dr. Dawwas and colleagues] used propensity matching, you’re never going to be able to sort that out with a retrospective analysis.”

Specifically, Dr. Bianco noted that the findings did not include dose data. This is a key gap, he said, considering how often real-world datasets have shown that providers underdose DOACs for a number of unaccountable reasons, and how frequently patients exhibit poor adherence.

The study also lacked detail concerning the degree of renal dysfunction, which can determine drug eligibility, Dr. Bianco said. Furthermore, attempts to stratify patients based on thrombosis and bleeding risk were likely “insufficient,” he added.

Dr. Bianco also cautioned that the investigators defined valvular heart disease as any valve-related disease of any severity. In contrast, previous studies have generally restricted valvular heart disease to patients with mitral stenosis or prosthetic valves.

“This is definitely not the traditional definition of valvular heart disease, so the title is a little bit misleading in that sense, although they certainly do disclose that in the methods,” Dr. Bianco said.

On a more positive note, he highlighted the size of the patient population, and the real-world data, which included many patients who would be excluded from clinical trials.

More broadly, the study helps drive research forward, Dr. Bianco concluded; namely, by attracting financial support for a more powerful head-to-head trial that drug makers are unlikely to fund due to inherent market risk.

This study was supported by the National Institutes of Health. The investigators disclosed additional relationships with Takeda, Spark, Sanofi, and others. Dr. Bianco disclosed no conflicts of interest.

Apixaban offers greater protection than rivaroxaban against ischemic stroke, systemic embolism, and bleeding in patients with both atrial fibrillation (AFib) and valvular heart disease (VHD), a new study finds.

Compared with rivaroxaban, apixaban cut risks nearly in half, suggesting that clinicians should consider these new data when choosing an anticoagulant, reported lead author Ghadeer K. Dawwas, PhD, of the University of Pennsylvania, Philadelphia, and colleagues.

In the new retrospective study involving almost 20,000 patients, Dr. Dawwas and her colleagues “emulated a target trial” using private insurance claims from Optum’s deidentified Clinformatics Data Mart Database. The cohort was narrowed from a screened population of 58,210 patients with concurrent AFib and VHD to 9,947 new apixaban users who could be closely matched with 9,947 new rivaroxaban users. Covariates included provider specialty, type of VHD, demographic characteristics, measures of health care use, baseline use of medications, and baseline comorbidities.

The primary effectiveness outcome was a composite of systemic embolism and ischemic stroke, while the primary safety outcome was a composite of intracranial or gastrointestinal bleeding.

“Although several ongoing trials aim to compare apixaban with warfarin in patients with AFib and VHD, none of these trials will directly compare apixaban and rivaroxaban,” the investigators wrote. Their report is in Annals of Internal Medicine.

Dr. Dawwas and colleagues previously showed that direct oral anticoagulants (DOACs) were safer and more effective than warfarin in the same patient population. Comparing apixaban and rivaroxaban – the two most common DOACs – was the next logical step, Dr. Dawwas said in an interview.
 

Study results

Compared with rivaroxaban, patients who received apixaban had a 43% reduced risk of stroke or embolism (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.40-0.80). Apixaban’s ability to protect against bleeding appeared even more pronounced, with a 49% reduced risk over rivaroxaban (HR, 0.51; 95% CI, 0.41-0.62).

Comparing the two agents on an absolute basis, apixaban reduced risk of embolism or stroke by 0.2% within the first 6 months of treatment initiation, and 1.1% within the first year of initiation. At the same time points, absolute risk reductions for bleeding were 1.2% and 1.9%, respectively.

The investigators noted that their results held consistent in an alternative analysis that considered separate types of VHD.

“Based on the results from our analysis, we showed that apixaban is effective and safe in patients with atrial fibrillation and valvular heart diseases,” Dr. Dawwas said.
 

Head-to-head trial needed to change practice

Christopher M. Bianco, DO, associate professor of medicine at West Virginia University Heart and Vascular Institute, Morgantown, said the findings “add to the growing body of literature,” but “a head-to-head trial would be necessary to make a definitive change to clinical practice.”

Dr. Bianco, who recently conducted a retrospective analysis of apixaban and rivaroxaban that found no difference in safety and efficacy among a different patient population, said these kinds of studies are helpful in generating hypotheses, but they can’t account for all relevant clinical factors.

“There are just so many things that go into the decision-making process of [prescribing] apixaban and rivaroxaban,” he said. “Even though [Dr. Dawwas and colleagues] used propensity matching, you’re never going to be able to sort that out with a retrospective analysis.”

Specifically, Dr. Bianco noted that the findings did not include dose data. This is a key gap, he said, considering how often real-world datasets have shown that providers underdose DOACs for a number of unaccountable reasons, and how frequently patients exhibit poor adherence.

The study also lacked detail concerning the degree of renal dysfunction, which can determine drug eligibility, Dr. Bianco said. Furthermore, attempts to stratify patients based on thrombosis and bleeding risk were likely “insufficient,” he added.

Dr. Bianco also cautioned that the investigators defined valvular heart disease as any valve-related disease of any severity. In contrast, previous studies have generally restricted valvular heart disease to patients with mitral stenosis or prosthetic valves.

“This is definitely not the traditional definition of valvular heart disease, so the title is a little bit misleading in that sense, although they certainly do disclose that in the methods,” Dr. Bianco said.

On a more positive note, he highlighted the size of the patient population, and the real-world data, which included many patients who would be excluded from clinical trials.

More broadly, the study helps drive research forward, Dr. Bianco concluded; namely, by attracting financial support for a more powerful head-to-head trial that drug makers are unlikely to fund due to inherent market risk.

This study was supported by the National Institutes of Health. The investigators disclosed additional relationships with Takeda, Spark, Sanofi, and others. Dr. Bianco disclosed no conflicts of interest.

Apixaban offers greater protection than rivaroxaban against ischemic stroke, systemic embolism, and bleeding in patients with both atrial fibrillation (AFib) and valvular heart disease (VHD), a new study finds.

Compared with rivaroxaban, apixaban cut risks nearly in half, suggesting that clinicians should consider these new data when choosing an anticoagulant, reported lead author Ghadeer K. Dawwas, PhD, of the University of Pennsylvania, Philadelphia, and colleagues.

In the new retrospective study involving almost 20,000 patients, Dr. Dawwas and her colleagues “emulated a target trial” using private insurance claims from Optum’s deidentified Clinformatics Data Mart Database. The cohort was narrowed from a screened population of 58,210 patients with concurrent AFib and VHD to 9,947 new apixaban users who could be closely matched with 9,947 new rivaroxaban users. Covariates included provider specialty, type of VHD, demographic characteristics, measures of health care use, baseline use of medications, and baseline comorbidities.

The primary effectiveness outcome was a composite of systemic embolism and ischemic stroke, while the primary safety outcome was a composite of intracranial or gastrointestinal bleeding.

“Although several ongoing trials aim to compare apixaban with warfarin in patients with AFib and VHD, none of these trials will directly compare apixaban and rivaroxaban,” the investigators wrote. Their report is in Annals of Internal Medicine.

Dr. Dawwas and colleagues previously showed that direct oral anticoagulants (DOACs) were safer and more effective than warfarin in the same patient population. Comparing apixaban and rivaroxaban – the two most common DOACs – was the next logical step, Dr. Dawwas said in an interview.
 

Study results

Compared with rivaroxaban, patients who received apixaban had a 43% reduced risk of stroke or embolism (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.40-0.80). Apixaban’s ability to protect against bleeding appeared even more pronounced, with a 49% reduced risk over rivaroxaban (HR, 0.51; 95% CI, 0.41-0.62).

Comparing the two agents on an absolute basis, apixaban reduced risk of embolism or stroke by 0.2% within the first 6 months of treatment initiation, and 1.1% within the first year of initiation. At the same time points, absolute risk reductions for bleeding were 1.2% and 1.9%, respectively.

The investigators noted that their results held consistent in an alternative analysis that considered separate types of VHD.

“Based on the results from our analysis, we showed that apixaban is effective and safe in patients with atrial fibrillation and valvular heart diseases,” Dr. Dawwas said.
 

Head-to-head trial needed to change practice

Christopher M. Bianco, DO, associate professor of medicine at West Virginia University Heart and Vascular Institute, Morgantown, said the findings “add to the growing body of literature,” but “a head-to-head trial would be necessary to make a definitive change to clinical practice.”

Dr. Bianco, who recently conducted a retrospective analysis of apixaban and rivaroxaban that found no difference in safety and efficacy among a different patient population, said these kinds of studies are helpful in generating hypotheses, but they can’t account for all relevant clinical factors.

“There are just so many things that go into the decision-making process of [prescribing] apixaban and rivaroxaban,” he said. “Even though [Dr. Dawwas and colleagues] used propensity matching, you’re never going to be able to sort that out with a retrospective analysis.”

Specifically, Dr. Bianco noted that the findings did not include dose data. This is a key gap, he said, considering how often real-world datasets have shown that providers underdose DOACs for a number of unaccountable reasons, and how frequently patients exhibit poor adherence.

The study also lacked detail concerning the degree of renal dysfunction, which can determine drug eligibility, Dr. Bianco said. Furthermore, attempts to stratify patients based on thrombosis and bleeding risk were likely “insufficient,” he added.

Dr. Bianco also cautioned that the investigators defined valvular heart disease as any valve-related disease of any severity. In contrast, previous studies have generally restricted valvular heart disease to patients with mitral stenosis or prosthetic valves.

“This is definitely not the traditional definition of valvular heart disease, so the title is a little bit misleading in that sense, although they certainly do disclose that in the methods,” Dr. Bianco said.

On a more positive note, he highlighted the size of the patient population, and the real-world data, which included many patients who would be excluded from clinical trials.

More broadly, the study helps drive research forward, Dr. Bianco concluded; namely, by attracting financial support for a more powerful head-to-head trial that drug makers are unlikely to fund due to inherent market risk.

This study was supported by the National Institutes of Health. The investigators disclosed additional relationships with Takeda, Spark, Sanofi, and others. Dr. Bianco disclosed no conflicts of interest.

The ability of an Apple Watch to detect atrial fibrillation (AFib) is significantly affected by underlying ECG abnormalities such as sinus node dysfunction, atrioventricular (AV) block, or intraventricular conduction delay (IVCD), a single-center study suggests.

LDProd/Getty Images

“We were surprised to find that in one in every five patients, the smartwatch ECG failed to produce an automatic diagnosis,” study author Marc Strik, MD, PhD, a clinician at Bordeaux University Hospital in Pessac, France, told this news organization. “This [failure] was mostly due to insufficient quality of the tracing [60%], but in a third of cases, [34%], it was due to bradycardia, and in some cases, tachycardia [6%].

“We were also surprised to find that the existence of ventricular conduction disease was associated with a higher likelihood of missing AFib,” he said.

The study was published in the Canadian Journal of Cardiology.
 

Abnormalities affected detection

The investigators tested the accuracy of the Apple Watch (Apple, Cupertino, California) in detecting AFib in patients with various ECG anomalies. All participants underwent 12-lead ECG, followed by a 30-second ECG tracing with an Apple Watch Series 5. The smartwatch’s automated AFib detection algorithm gave a result of “no signs of AFib,” “AFib,” or “not checked for AFib (unclassified).”

Unclassified recordings resulted from “low heart rate” (below 50 beats/min), “high heart rate” (above 150 beats/min), “poor recording,” or “inconclusive recording.”

The smartwatch recordings were reviewed by a blinded electrophysiologist who interpreted each tracing and assigned a diagnosis of “AFib,” “absence of AFib,” or “diagnosis unclear.” To assess interobserver agreement, a second blinded electrophysiologist interpreted 100 randomly selected tracings.

Among the 734 patients (mean age, 66; 58% men) enrolled, 539 (73%) were in normal sinus rhythm (SR), 154 (21%) in AFib, 33 in atrial flutter or atrial tachycardia, 3 in ventricular tachycardia, and 5 in junctional tachycardia.

Furthermore, 65 (8.9%) had sinus node dysfunction, 21 (2.9%) had second- or third-degree AV block, 39 (5.3%) had a ventricular paced rhythm, 54 (7.4%) had premature ventricular contractions (PVCs), and 132 (18%) had IVCD (right or left bundle branch block or nonspecific IVCD).

Of the 539 patients in normal SR, 437 recordings were correctly diagnosed by the smartwatch, 7 were diagnosed incorrectly as AFib, and 95 were not classified.

Of the 187 patients in AFib, 129 were correctly diagnosed, 17 were incorrectly diagnosed as SR, and 41 were not classified.

When unclassified ECGs were considered false results, the smartwatch had a sensitivity of 69% and specificity of 81% for AFib detection. When unclassified ECGs were excluded from the analysis, sensitivity was 88%, and specificity was 98%.

Compared with patients without the abnormality, the relative risk of having false positive tracings was higher for patients with premature atrial contractions (PACs) or PVCs (risk ratio, 2.9), sinus node dysfunction (RR, 3.71), and AV block (RR, 7.8).

Fifty-eight patients with AFib were classified as SR or inconclusive by the smartwatch. Among them, 21 (36%) had an IVCD, 7 (12%) had a ventricular paced rhythm, and 5 (9%) had PACs or PVCs.

The risk of having false negative tracings (missed AF) was higher for patients with IVCD (RR, 2.6) and pacing (RR, 2.47), compared with those without the abnormality.
 

‘A powerful tool’

Overall, cardiac electrophysiologists showed high agreement in differentiating between AFib and non-AFib, with high interobserver reproducibility. A manual diagnosis was not possible for 10% of tracings because of either poor ECG quality (3%) or unclear P-waves (7%).

Fifty-nine of the 580 patients in SR were misclassified as AFib by the experts, and 5 of the 154 patients in AFib were misclassified as SR.

“Our results show that the presence of sinus node dysfunction, second- or third-degree AV block, ventricular paced rhythm, PVCs, and IVCD were more frequently represented in smartwatch misdiagnoses,” wrote the authors. “Patients with PVCs were three times as likely to have false positive AFib diagnoses.”

Study limitations included the single-center nature of the study and the fact that patients were recruited in a cardiology office. The latter factor may have influenced the incidence of ECG abnormalities, which was much higher than for the average smartwatch user.

“Even with its limitations, the smartwatch remains a powerful tool that is able to detect AFib and multiple other abnormalities,” said Dr. Strik. “Missed diagnosis of AFib may be less important in real life because of repeated measurements, and algorithms will continue to improve.”
 

Technology improving

Richard C. Becker, MD, director and physician in chief of the University of Cincinnati Heart, Lung, and Vascular Institute, said, “This is exactly the kind of investigation required to improve upon existing detection algorithms that will someday facilitate routine use in patient care. An ability to detect AFib in a large proportion of those with the heart rhythm abnormality is encouraging.”

The findings should not detract from well-conducted studies in otherwise healthy individuals of varied age in whom AFib was accurately detected, he added. “Similarly, an automatic diagnosis algorithm for AF, pending optimization and validation in a large and diverse cohort, should be viewed as a communication tool between patients and health care providers.”

Patients at risk for developing AFib could benefit from continuous monitoring using a smartwatch, said Dr. Becker. “Pre-existing heart rhythm abnormalities must be taken into consideration. Optimal utilization of emerging technology to include wearables requires an understanding of performance and limitations. It is best undertaken in coordination with a health care provider.”

Andrés F. Miranda-Arboleda, MD, and Adrian Baranchuk, MD, of Kingston Health Sciences Center, Canada, conclude in an accompanying editorial, “In a certain manner, the smartwatch algorithms for the detection of AFib in patients with cardiovascular conditions are not yet smart enough ... but they may soon be.”

The study was supported by the French government. Dr. Strik, Dr. Miranda-Arboleda, Dr. Baranchuk, and Dr. Becker reported no conflicts of interest.

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

The ability of an Apple Watch to detect atrial fibrillation (AFib) is significantly affected by underlying ECG abnormalities such as sinus node dysfunction, atrioventricular (AV) block, or intraventricular conduction delay (IVCD), a single-center study suggests.

LDProd/Getty Images

“We were surprised to find that in one in every five patients, the smartwatch ECG failed to produce an automatic diagnosis,” study author Marc Strik, MD, PhD, a clinician at Bordeaux University Hospital in Pessac, France, told this news organization. “This [failure] was mostly due to insufficient quality of the tracing [60%], but in a third of cases, [34%], it was due to bradycardia, and in some cases, tachycardia [6%].

“We were also surprised to find that the existence of ventricular conduction disease was associated with a higher likelihood of missing AFib,” he said.

The study was published in the Canadian Journal of Cardiology.
 

Abnormalities affected detection

The investigators tested the accuracy of the Apple Watch (Apple, Cupertino, California) in detecting AFib in patients with various ECG anomalies. All participants underwent 12-lead ECG, followed by a 30-second ECG tracing with an Apple Watch Series 5. The smartwatch’s automated AFib detection algorithm gave a result of “no signs of AFib,” “AFib,” or “not checked for AFib (unclassified).”

Unclassified recordings resulted from “low heart rate” (below 50 beats/min), “high heart rate” (above 150 beats/min), “poor recording,” or “inconclusive recording.”

The smartwatch recordings were reviewed by a blinded electrophysiologist who interpreted each tracing and assigned a diagnosis of “AFib,” “absence of AFib,” or “diagnosis unclear.” To assess interobserver agreement, a second blinded electrophysiologist interpreted 100 randomly selected tracings.

Among the 734 patients (mean age, 66; 58% men) enrolled, 539 (73%) were in normal sinus rhythm (SR), 154 (21%) in AFib, 33 in atrial flutter or atrial tachycardia, 3 in ventricular tachycardia, and 5 in junctional tachycardia.

Furthermore, 65 (8.9%) had sinus node dysfunction, 21 (2.9%) had second- or third-degree AV block, 39 (5.3%) had a ventricular paced rhythm, 54 (7.4%) had premature ventricular contractions (PVCs), and 132 (18%) had IVCD (right or left bundle branch block or nonspecific IVCD).

Of the 539 patients in normal SR, 437 recordings were correctly diagnosed by the smartwatch, 7 were diagnosed incorrectly as AFib, and 95 were not classified.

Of the 187 patients in AFib, 129 were correctly diagnosed, 17 were incorrectly diagnosed as SR, and 41 were not classified.

When unclassified ECGs were considered false results, the smartwatch had a sensitivity of 69% and specificity of 81% for AFib detection. When unclassified ECGs were excluded from the analysis, sensitivity was 88%, and specificity was 98%.

Compared with patients without the abnormality, the relative risk of having false positive tracings was higher for patients with premature atrial contractions (PACs) or PVCs (risk ratio, 2.9), sinus node dysfunction (RR, 3.71), and AV block (RR, 7.8).

Fifty-eight patients with AFib were classified as SR or inconclusive by the smartwatch. Among them, 21 (36%) had an IVCD, 7 (12%) had a ventricular paced rhythm, and 5 (9%) had PACs or PVCs.

The risk of having false negative tracings (missed AF) was higher for patients with IVCD (RR, 2.6) and pacing (RR, 2.47), compared with those without the abnormality.
 

‘A powerful tool’

Overall, cardiac electrophysiologists showed high agreement in differentiating between AFib and non-AFib, with high interobserver reproducibility. A manual diagnosis was not possible for 10% of tracings because of either poor ECG quality (3%) or unclear P-waves (7%).

Fifty-nine of the 580 patients in SR were misclassified as AFib by the experts, and 5 of the 154 patients in AFib were misclassified as SR.

“Our results show that the presence of sinus node dysfunction, second- or third-degree AV block, ventricular paced rhythm, PVCs, and IVCD were more frequently represented in smartwatch misdiagnoses,” wrote the authors. “Patients with PVCs were three times as likely to have false positive AFib diagnoses.”

Study limitations included the single-center nature of the study and the fact that patients were recruited in a cardiology office. The latter factor may have influenced the incidence of ECG abnormalities, which was much higher than for the average smartwatch user.

“Even with its limitations, the smartwatch remains a powerful tool that is able to detect AFib and multiple other abnormalities,” said Dr. Strik. “Missed diagnosis of AFib may be less important in real life because of repeated measurements, and algorithms will continue to improve.”
 

Technology improving

Richard C. Becker, MD, director and physician in chief of the University of Cincinnati Heart, Lung, and Vascular Institute, said, “This is exactly the kind of investigation required to improve upon existing detection algorithms that will someday facilitate routine use in patient care. An ability to detect AFib in a large proportion of those with the heart rhythm abnormality is encouraging.”

The findings should not detract from well-conducted studies in otherwise healthy individuals of varied age in whom AFib was accurately detected, he added. “Similarly, an automatic diagnosis algorithm for AF, pending optimization and validation in a large and diverse cohort, should be viewed as a communication tool between patients and health care providers.”

Patients at risk for developing AFib could benefit from continuous monitoring using a smartwatch, said Dr. Becker. “Pre-existing heart rhythm abnormalities must be taken into consideration. Optimal utilization of emerging technology to include wearables requires an understanding of performance and limitations. It is best undertaken in coordination with a health care provider.”

Andrés F. Miranda-Arboleda, MD, and Adrian Baranchuk, MD, of Kingston Health Sciences Center, Canada, conclude in an accompanying editorial, “In a certain manner, the smartwatch algorithms for the detection of AFib in patients with cardiovascular conditions are not yet smart enough ... but they may soon be.”

The study was supported by the French government. Dr. Strik, Dr. Miranda-Arboleda, Dr. Baranchuk, and Dr. Becker reported no conflicts of interest.

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

The ability of an Apple Watch to detect atrial fibrillation (AFib) is significantly affected by underlying ECG abnormalities such as sinus node dysfunction, atrioventricular (AV) block, or intraventricular conduction delay (IVCD), a single-center study suggests.

LDProd/Getty Images

“We were surprised to find that in one in every five patients, the smartwatch ECG failed to produce an automatic diagnosis,” study author Marc Strik, MD, PhD, a clinician at Bordeaux University Hospital in Pessac, France, told this news organization. “This [failure] was mostly due to insufficient quality of the tracing [60%], but in a third of cases, [34%], it was due to bradycardia, and in some cases, tachycardia [6%].

“We were also surprised to find that the existence of ventricular conduction disease was associated with a higher likelihood of missing AFib,” he said.

The study was published in the Canadian Journal of Cardiology.
 

Abnormalities affected detection

The investigators tested the accuracy of the Apple Watch (Apple, Cupertino, California) in detecting AFib in patients with various ECG anomalies. All participants underwent 12-lead ECG, followed by a 30-second ECG tracing with an Apple Watch Series 5. The smartwatch’s automated AFib detection algorithm gave a result of “no signs of AFib,” “AFib,” or “not checked for AFib (unclassified).”

Unclassified recordings resulted from “low heart rate” (below 50 beats/min), “high heart rate” (above 150 beats/min), “poor recording,” or “inconclusive recording.”

The smartwatch recordings were reviewed by a blinded electrophysiologist who interpreted each tracing and assigned a diagnosis of “AFib,” “absence of AFib,” or “diagnosis unclear.” To assess interobserver agreement, a second blinded electrophysiologist interpreted 100 randomly selected tracings.

Among the 734 patients (mean age, 66; 58% men) enrolled, 539 (73%) were in normal sinus rhythm (SR), 154 (21%) in AFib, 33 in atrial flutter or atrial tachycardia, 3 in ventricular tachycardia, and 5 in junctional tachycardia.

Furthermore, 65 (8.9%) had sinus node dysfunction, 21 (2.9%) had second- or third-degree AV block, 39 (5.3%) had a ventricular paced rhythm, 54 (7.4%) had premature ventricular contractions (PVCs), and 132 (18%) had IVCD (right or left bundle branch block or nonspecific IVCD).

Of the 539 patients in normal SR, 437 recordings were correctly diagnosed by the smartwatch, 7 were diagnosed incorrectly as AFib, and 95 were not classified.

Of the 187 patients in AFib, 129 were correctly diagnosed, 17 were incorrectly diagnosed as SR, and 41 were not classified.

When unclassified ECGs were considered false results, the smartwatch had a sensitivity of 69% and specificity of 81% for AFib detection. When unclassified ECGs were excluded from the analysis, sensitivity was 88%, and specificity was 98%.

Compared with patients without the abnormality, the relative risk of having false positive tracings was higher for patients with premature atrial contractions (PACs) or PVCs (risk ratio, 2.9), sinus node dysfunction (RR, 3.71), and AV block (RR, 7.8).

Fifty-eight patients with AFib were classified as SR or inconclusive by the smartwatch. Among them, 21 (36%) had an IVCD, 7 (12%) had a ventricular paced rhythm, and 5 (9%) had PACs or PVCs.

The risk of having false negative tracings (missed AF) was higher for patients with IVCD (RR, 2.6) and pacing (RR, 2.47), compared with those without the abnormality.
 

‘A powerful tool’

Overall, cardiac electrophysiologists showed high agreement in differentiating between AFib and non-AFib, with high interobserver reproducibility. A manual diagnosis was not possible for 10% of tracings because of either poor ECG quality (3%) or unclear P-waves (7%).

Fifty-nine of the 580 patients in SR were misclassified as AFib by the experts, and 5 of the 154 patients in AFib were misclassified as SR.

“Our results show that the presence of sinus node dysfunction, second- or third-degree AV block, ventricular paced rhythm, PVCs, and IVCD were more frequently represented in smartwatch misdiagnoses,” wrote the authors. “Patients with PVCs were three times as likely to have false positive AFib diagnoses.”

Study limitations included the single-center nature of the study and the fact that patients were recruited in a cardiology office. The latter factor may have influenced the incidence of ECG abnormalities, which was much higher than for the average smartwatch user.

“Even with its limitations, the smartwatch remains a powerful tool that is able to detect AFib and multiple other abnormalities,” said Dr. Strik. “Missed diagnosis of AFib may be less important in real life because of repeated measurements, and algorithms will continue to improve.”
 

Technology improving

Richard C. Becker, MD, director and physician in chief of the University of Cincinnati Heart, Lung, and Vascular Institute, said, “This is exactly the kind of investigation required to improve upon existing detection algorithms that will someday facilitate routine use in patient care. An ability to detect AFib in a large proportion of those with the heart rhythm abnormality is encouraging.”

The findings should not detract from well-conducted studies in otherwise healthy individuals of varied age in whom AFib was accurately detected, he added. “Similarly, an automatic diagnosis algorithm for AF, pending optimization and validation in a large and diverse cohort, should be viewed as a communication tool between patients and health care providers.”

Patients at risk for developing AFib could benefit from continuous monitoring using a smartwatch, said Dr. Becker. “Pre-existing heart rhythm abnormalities must be taken into consideration. Optimal utilization of emerging technology to include wearables requires an understanding of performance and limitations. It is best undertaken in coordination with a health care provider.”

Andrés F. Miranda-Arboleda, MD, and Adrian Baranchuk, MD, of Kingston Health Sciences Center, Canada, conclude in an accompanying editorial, “In a certain manner, the smartwatch algorithms for the detection of AFib in patients with cardiovascular conditions are not yet smart enough ... but they may soon be.”

The study was supported by the French government. Dr. Strik, Dr. Miranda-Arboleda, Dr. Baranchuk, and Dr. Becker reported no conflicts of interest.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

A new statement from the American College of Cardiology is calling for a greater degree of career flexibility in the specialty to promote cardiologists’ personal and professional well-being and preserve excellence in patient care.

The statement recommends that cardiologists, from trainees to those contemplating retirement, be granted more leeway in their careers to allow them to take time for common life events, such as child-rearing, taking care of aged parents, or reducing their workload in case of poor health or physical disabilities, without jeopardizing their careers.

The “2022 ACC Health Policy Statement on Career Flexibility in Cardiology: A Report of the American College of Cardiology Solution Set Oversight Committee” was published online in the Journal of the American College of Cardiology.
 

‘Hard-driving profession’

The well-being of the cardiovascular workforce is critical to the achievement of the mission of the ACC, which is to transform cardiovascular care and improve heart health, the Health Policy writing committee stated. Career flexibility is an important component of ensuring that well-being, the authors wrote.

“The ACC has critically looked at the factors that contribute to the lack of diversity and inclusion in cardiovascular practice, and one of the issues is the lack of flexibility in our profession,” writing committee chair, Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs, Ascension St. Vincent Heart Center, Indianapolis, Ind., told this news organization.

The notion of work-life balance has become increasingly important but cardiology as a profession has traditionally not been open to the idea of its value, Dr. Walsh said.

“We have a very hard-driving profession. It takes many years to train to do the work we do. The need for on-call services is very significant, and we go along because we have always done it this way, but if you don’t reexamine the way that you are structuring your work, you’ll never change it,” she said.

“For example, the ‘full time, full call, come to work after you’ve been up all night’ work ethic, which is no longer allowed for trainees, is still in effect once you get into university practice or clinical practice. We have interventional cardiologists up all night doing STEMI care for patients and then having a full clinic the next day,” Dr. Walsh said. “The changes that came about for trainees have not trickled up to the faculty or clinical practice level. It’s really a patient safety issue.”

She emphasized that the new policy statement is not focused solely on women. “The need for time away or flexible time around family planning, childbirth, and parental leave is increasingly important to our younger colleagues, both men and women.”

Dr. Walsh pointed out that the writing committee was carefully composed to include representation from all stakeholders.

“We have representation from very young cardiologists, one of whom was in training at the time we began our work. We have two systems CEOs who are cardiologists, we have a chair of medicine, we have two very senior cardiologists, and someone who works in industry,” she said.

The ACC also believes that cardiologists with physically demanding roles should have pathways to transition into other opportunities in patient care, research, or education.

“Right now, there are many cardiology practices that have traditional policies, where you are either all in, or you are all out. They do not allow for what we term a ‘step down’ policy, where you perhaps stop going into the cath lab, but you still do clinic and see patients,” Dr. Walsh noted.

“One of the goals of this policy statement is to allow for such practices to look at their compensation and structure, and to realize that their most senior cardiologists may be willing to stay on for several more years and be contributing members to the practice, but they may no longer wish to stay in the cath lab or be in the night call pool,” she said.

Transparency around compensation is also very important because cardiologists contemplating a reduced work schedule need to know how this will affect the amount of money they will be earning, she added.

“Transparency about policies around compensation are crucial because if an individual cardiologist wishes to pursue a flexible scheduling at any time in their career, it’s clear that they won’t have the same compensation as someone who is a full-time employee. All of this has to be very transparent and clear on both sides, so that the person deciding toward some flexibility understands what the implications are from a financial and compensation standpoint,” Dr. Walsh said.

As an example, a senior career cardiologist who no longer wants to take night calls should know what this may cost financially.

“The practice should set a valuation of night calls, so that the individual who makes the choice to step out of the call pool understands what the impact on their compensation will be. That type of transparency is necessary for all to ensure that individuals who seek flexibility will not be blindsided by the resulting decrease in financial compensation,” she said.
 

A growing need

“In its new health policy statement, the American College of Cardiology addresses the growing need for career flexibility as an important component of ensuring the well-being of the cardiovascular care workforce,” Harlan M. Krumholz, MD, SM, Harold H. Hines Jr. Professor of Medicine and professor in the Institute for Social and Policy Studies at Yale University, New Haven, Conn., told this news organization.

Courtesy Yale University

“The writing committee reviews opportunities for offering flexibility at all career levels to combat burnout and increase retention in the field, as well as proposes system, policy, and practice solutions to allow both men and women to emphasize and embrace work-life balance,” Dr. Krumholz said.

“The document provides pathways for cardiologists looking to pursue other interests or career transitions while maintaining excellence in clinical care,” he added. “Chief among these recommendations are flexible/part-time hours, leave and reentry policies, changes in job descriptions to support overarching cultural change, and equitable compensation and opportunities. The document is intended to be used as a guide for innovation in the cardiology workforce.”
 

‘Thoughtful and long overdue’

“This policy statement is thoughtful and long overdue,” Steven E. Nissen, MD, Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine at Cleveland Clinic, told this news organization.

“Career flexibility will allow cardiologists to fulfill family responsibilities while continuing to advance their careers. Successfully contributing to patient care and research does not require physicians to isolate themselves from all their other responsibilities,” Dr. Nissen added.

“I am pleased that the ACC has articulated the value of a balanced approach to career and family.”

Dr. Walsh, Dr. Krumholz, and Dr. Nissen report no relevant financial relationships.

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

A new statement from the American College of Cardiology is calling for a greater degree of career flexibility in the specialty to promote cardiologists’ personal and professional well-being and preserve excellence in patient care.

The statement recommends that cardiologists, from trainees to those contemplating retirement, be granted more leeway in their careers to allow them to take time for common life events, such as child-rearing, taking care of aged parents, or reducing their workload in case of poor health or physical disabilities, without jeopardizing their careers.

The “2022 ACC Health Policy Statement on Career Flexibility in Cardiology: A Report of the American College of Cardiology Solution Set Oversight Committee” was published online in the Journal of the American College of Cardiology.
 

‘Hard-driving profession’

The well-being of the cardiovascular workforce is critical to the achievement of the mission of the ACC, which is to transform cardiovascular care and improve heart health, the Health Policy writing committee stated. Career flexibility is an important component of ensuring that well-being, the authors wrote.

“The ACC has critically looked at the factors that contribute to the lack of diversity and inclusion in cardiovascular practice, and one of the issues is the lack of flexibility in our profession,” writing committee chair, Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs, Ascension St. Vincent Heart Center, Indianapolis, Ind., told this news organization.

The notion of work-life balance has become increasingly important but cardiology as a profession has traditionally not been open to the idea of its value, Dr. Walsh said.

“We have a very hard-driving profession. It takes many years to train to do the work we do. The need for on-call services is very significant, and we go along because we have always done it this way, but if you don’t reexamine the way that you are structuring your work, you’ll never change it,” she said.

“For example, the ‘full time, full call, come to work after you’ve been up all night’ work ethic, which is no longer allowed for trainees, is still in effect once you get into university practice or clinical practice. We have interventional cardiologists up all night doing STEMI care for patients and then having a full clinic the next day,” Dr. Walsh said. “The changes that came about for trainees have not trickled up to the faculty or clinical practice level. It’s really a patient safety issue.”

She emphasized that the new policy statement is not focused solely on women. “The need for time away or flexible time around family planning, childbirth, and parental leave is increasingly important to our younger colleagues, both men and women.”

Dr. Walsh pointed out that the writing committee was carefully composed to include representation from all stakeholders.

“We have representation from very young cardiologists, one of whom was in training at the time we began our work. We have two systems CEOs who are cardiologists, we have a chair of medicine, we have two very senior cardiologists, and someone who works in industry,” she said.

The ACC also believes that cardiologists with physically demanding roles should have pathways to transition into other opportunities in patient care, research, or education.

“Right now, there are many cardiology practices that have traditional policies, where you are either all in, or you are all out. They do not allow for what we term a ‘step down’ policy, where you perhaps stop going into the cath lab, but you still do clinic and see patients,” Dr. Walsh noted.

“One of the goals of this policy statement is to allow for such practices to look at their compensation and structure, and to realize that their most senior cardiologists may be willing to stay on for several more years and be contributing members to the practice, but they may no longer wish to stay in the cath lab or be in the night call pool,” she said.

Transparency around compensation is also very important because cardiologists contemplating a reduced work schedule need to know how this will affect the amount of money they will be earning, she added.

“Transparency about policies around compensation are crucial because if an individual cardiologist wishes to pursue a flexible scheduling at any time in their career, it’s clear that they won’t have the same compensation as someone who is a full-time employee. All of this has to be very transparent and clear on both sides, so that the person deciding toward some flexibility understands what the implications are from a financial and compensation standpoint,” Dr. Walsh said.

As an example, a senior career cardiologist who no longer wants to take night calls should know what this may cost financially.

“The practice should set a valuation of night calls, so that the individual who makes the choice to step out of the call pool understands what the impact on their compensation will be. That type of transparency is necessary for all to ensure that individuals who seek flexibility will not be blindsided by the resulting decrease in financial compensation,” she said.
 

A growing need

“In its new health policy statement, the American College of Cardiology addresses the growing need for career flexibility as an important component of ensuring the well-being of the cardiovascular care workforce,” Harlan M. Krumholz, MD, SM, Harold H. Hines Jr. Professor of Medicine and professor in the Institute for Social and Policy Studies at Yale University, New Haven, Conn., told this news organization.

Courtesy Yale University

“The writing committee reviews opportunities for offering flexibility at all career levels to combat burnout and increase retention in the field, as well as proposes system, policy, and practice solutions to allow both men and women to emphasize and embrace work-life balance,” Dr. Krumholz said.

“The document provides pathways for cardiologists looking to pursue other interests or career transitions while maintaining excellence in clinical care,” he added. “Chief among these recommendations are flexible/part-time hours, leave and reentry policies, changes in job descriptions to support overarching cultural change, and equitable compensation and opportunities. The document is intended to be used as a guide for innovation in the cardiology workforce.”
 

‘Thoughtful and long overdue’

“This policy statement is thoughtful and long overdue,” Steven E. Nissen, MD, Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine at Cleveland Clinic, told this news organization.

“Career flexibility will allow cardiologists to fulfill family responsibilities while continuing to advance their careers. Successfully contributing to patient care and research does not require physicians to isolate themselves from all their other responsibilities,” Dr. Nissen added.

“I am pleased that the ACC has articulated the value of a balanced approach to career and family.”

Dr. Walsh, Dr. Krumholz, and Dr. Nissen report no relevant financial relationships.

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

A new statement from the American College of Cardiology is calling for a greater degree of career flexibility in the specialty to promote cardiologists’ personal and professional well-being and preserve excellence in patient care.

The statement recommends that cardiologists, from trainees to those contemplating retirement, be granted more leeway in their careers to allow them to take time for common life events, such as child-rearing, taking care of aged parents, or reducing their workload in case of poor health or physical disabilities, without jeopardizing their careers.

The “2022 ACC Health Policy Statement on Career Flexibility in Cardiology: A Report of the American College of Cardiology Solution Set Oversight Committee” was published online in the Journal of the American College of Cardiology.
 

‘Hard-driving profession’

The well-being of the cardiovascular workforce is critical to the achievement of the mission of the ACC, which is to transform cardiovascular care and improve heart health, the Health Policy writing committee stated. Career flexibility is an important component of ensuring that well-being, the authors wrote.

“The ACC has critically looked at the factors that contribute to the lack of diversity and inclusion in cardiovascular practice, and one of the issues is the lack of flexibility in our profession,” writing committee chair, Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs, Ascension St. Vincent Heart Center, Indianapolis, Ind., told this news organization.

The notion of work-life balance has become increasingly important but cardiology as a profession has traditionally not been open to the idea of its value, Dr. Walsh said.

“We have a very hard-driving profession. It takes many years to train to do the work we do. The need for on-call services is very significant, and we go along because we have always done it this way, but if you don’t reexamine the way that you are structuring your work, you’ll never change it,” she said.

“For example, the ‘full time, full call, come to work after you’ve been up all night’ work ethic, which is no longer allowed for trainees, is still in effect once you get into university practice or clinical practice. We have interventional cardiologists up all night doing STEMI care for patients and then having a full clinic the next day,” Dr. Walsh said. “The changes that came about for trainees have not trickled up to the faculty or clinical practice level. It’s really a patient safety issue.”

She emphasized that the new policy statement is not focused solely on women. “The need for time away or flexible time around family planning, childbirth, and parental leave is increasingly important to our younger colleagues, both men and women.”

Dr. Walsh pointed out that the writing committee was carefully composed to include representation from all stakeholders.

“We have representation from very young cardiologists, one of whom was in training at the time we began our work. We have two systems CEOs who are cardiologists, we have a chair of medicine, we have two very senior cardiologists, and someone who works in industry,” she said.

The ACC also believes that cardiologists with physically demanding roles should have pathways to transition into other opportunities in patient care, research, or education.

“Right now, there are many cardiology practices that have traditional policies, where you are either all in, or you are all out. They do not allow for what we term a ‘step down’ policy, where you perhaps stop going into the cath lab, but you still do clinic and see patients,” Dr. Walsh noted.

“One of the goals of this policy statement is to allow for such practices to look at their compensation and structure, and to realize that their most senior cardiologists may be willing to stay on for several more years and be contributing members to the practice, but they may no longer wish to stay in the cath lab or be in the night call pool,” she said.

Transparency around compensation is also very important because cardiologists contemplating a reduced work schedule need to know how this will affect the amount of money they will be earning, she added.

“Transparency about policies around compensation are crucial because if an individual cardiologist wishes to pursue a flexible scheduling at any time in their career, it’s clear that they won’t have the same compensation as someone who is a full-time employee. All of this has to be very transparent and clear on both sides, so that the person deciding toward some flexibility understands what the implications are from a financial and compensation standpoint,” Dr. Walsh said.

As an example, a senior career cardiologist who no longer wants to take night calls should know what this may cost financially.

“The practice should set a valuation of night calls, so that the individual who makes the choice to step out of the call pool understands what the impact on their compensation will be. That type of transparency is necessary for all to ensure that individuals who seek flexibility will not be blindsided by the resulting decrease in financial compensation,” she said.
 

A growing need

“In its new health policy statement, the American College of Cardiology addresses the growing need for career flexibility as an important component of ensuring the well-being of the cardiovascular care workforce,” Harlan M. Krumholz, MD, SM, Harold H. Hines Jr. Professor of Medicine and professor in the Institute for Social and Policy Studies at Yale University, New Haven, Conn., told this news organization.

Courtesy Yale University

“The writing committee reviews opportunities for offering flexibility at all career levels to combat burnout and increase retention in the field, as well as proposes system, policy, and practice solutions to allow both men and women to emphasize and embrace work-life balance,” Dr. Krumholz said.

“The document provides pathways for cardiologists looking to pursue other interests or career transitions while maintaining excellence in clinical care,” he added. “Chief among these recommendations are flexible/part-time hours, leave and reentry policies, changes in job descriptions to support overarching cultural change, and equitable compensation and opportunities. The document is intended to be used as a guide for innovation in the cardiology workforce.”
 

‘Thoughtful and long overdue’

“This policy statement is thoughtful and long overdue,” Steven E. Nissen, MD, Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine at Cleveland Clinic, told this news organization.

“Career flexibility will allow cardiologists to fulfill family responsibilities while continuing to advance their careers. Successfully contributing to patient care and research does not require physicians to isolate themselves from all their other responsibilities,” Dr. Nissen added.

“I am pleased that the ACC has articulated the value of a balanced approach to career and family.”

Dr. Walsh, Dr. Krumholz, and Dr. Nissen report no relevant financial relationships.

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

Athletes with mild hypertrophic cardiomyopathy (HCM) at low risk of sudden cardiac death (SCD) can safely continue to exercise at competitive levels, a retrospective study suggests.

During a mean follow-up of 4.5 years, athletes who continued to engage in high-intensity competitive sports after a mild HCM diagnosis were free of cardiac symptoms, and there were no deaths, incidents of sustained ventricular tachycardia or syncope, or changes in cardiac electrical, structural, or functional phenotypes.

Pavel1964/iStock/Getty Images

“This study supports emerging evidence that HCM individuals with a low-risk profile and mild hypertrophy may engage in vigorous exercise and competitive sport,” Sanjay Sharma, MD, of St. George’s University of London, said in an interview. Current guidelines from the European Society of Cardiology and the American College of Cardiology support a more liberal approach to exercise for these individuals.

That said, he added, “it is important to emphasize that our cohort consisted of a group of adult competitive athletes who had probably been competing for several years before the diagnosis was made and therefore represented a self-selected, low-risk cohort. It is difficult to extrapolate this data to adolescent athletes, who appear to be more vulnerable to exercise-related SCD from HCM.”

The study was published online in the Journal of the American College of Cardiology.
 

Vigorous exercise OK for some

Dr. Sharma and colleagues analyzed data from 53 athletes with HCM who continued to participate in competitive sports. The mean age was 39 years, 98% were men, and 72% were White. About half (53%) competed as professionals, and were most commonly engaged in cycling, football, running, and rugby.

Participants underwent 6-12 monthly assessments that included electrocardiograms, echocardiograms, cardiopulmonary exercise testing, Holter monitoring (≥ 24 hours), and cardiac magnetic resonance imaging. A majority (64.2%) were evaluated because of an abnormal electrocardiograms, and one presented with an incidental abnormal echocardiogram.

About a quarter (24.5%) were symptomatic and 5 (9.4%) were identified on family screening. Eight (15%) had a family history of HCM, and six (11.3%) of SCD.

At the baseline evaluation, all athletes had a “low” ESC 5-year SCD risk score for HCM (1.9% ± 0.9%). None had syncope. Mean peak VO₂ was 40.7 ± 6.8 mL/kg per minute.

The mean left ventricular wall thickness was 14.6 ± 2.3 mm; all had normal LV systolic and diastolic function and no LV outflow tract obstruction at rest or on provocation testing. In addition, none had an LV apical aneurysm.

Twenty-two (41%) showed late gadolinium enhancement on baseline cardiac magnetic resonance imaging.

A total of 19 participants underwent genotyping; 4 (21.1%) had a pathogenic/likely pathogenic sarcomeric variant. None took cardiovascular medication or had an implantable cardioverter defibrillator (ICD).

During a mean follow-up of 4.5 years, all participants continued to exercise at the same level as before their diagnosis; none underwent detraining. All stayed free of cardiac symptoms, and there were no deaths, sustained ventricular tachycardia episodes, or syncope.

Four demonstrated new, nonsustained ventricular tachycardia (NSVT) during follow-up, one of whom underwent ICD implantation because of an increased risk score and subsequently moderated exercise levels.

One participant had a 30-second atrial fibrillation (AFib) episode lasting longer than 30 seconds, started on a beta-blocker and oral anticoagulation, and also moderated exercise levels.

The event rate was 2.1% per year for asymptomatic arrhythmias (NSVT and AFib). No changes were observed in the cardiac electrical, structural, or functional phenotype during follow-up.

Dr. Sharma and colleagues stated: “Our sample size is small; however, it is nearly double the size of a previously studied Italian athletic cohort, and one-half were professional athletes. Furthermore, 17% of our cohort comprised Black athletes who are perceived to be at higher risk of SCD than White athletes.”

Daniele Massera, MD, assistant professor in the HCM program, department of medicine, Charney Division of Cardiology, New York University Langone Health, said in an interview: “Of note, these were athletes/patients at the very low end of phenotypic severity of HCM. ... It is also notable that diastolic function was normal in all of them, an uncommon finding in patients with HCM.”

Like Dr. Sharma, he said the findings are in line with recent guidelines, and cautioned: “This small study applies only to a very small subset of patients who are being evaluated at specialized HCM programs: asymptomatic male individuals who have mild, low-risk HCM and are on no medicines.

“The findings cannot be generalized to the population of symptomatic individuals with (or without) outflow obstruction, more severe hypertrophy, and who have ICDs and/or take medication for symptoms, nor to younger patients or adolescents, who may be at higher risk for adverse outcomes,” he concluded.
 

Individualized approach urged

Dr. Sharma was a coauthor of the recent article challenging the traditional restrictive approach to exercise for athletes diagnosed with HCM and other inherited cardiovascular diseases. The article suggested that individualized recommendations, taking risks into consideration, can help guide those who want to exercise or participate in competitive sports.

Dr. Sharma also is a coauthor of a 6-month follow-up to the SAFE-HCM study, which compared the effects of a supervised 12-week high-intensity exercise program to usual care in low-risk individuals with HCM (mean age, 45.7). 

In the 6-month follow-up study, published as an abstract in the European Journal of Preventive Cardiology 2021 supplement, “exercising individuals had improved functional capacity and atherosclerotic risk profile and there were no differences in the composite safety outcomes [cardiovascular death, cardiac arrest, device therapy, exercise-induced syncope, sustained VT, NSVT, or sustained atrial arrhythmias] between exercising individuals and usual care individuals,” Dr. Sharma said.

The full study will soon be ready to submit for publication, he added.

No commercial funding or relevant conflicts of interest were disclosed.

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

Athletes with mild hypertrophic cardiomyopathy (HCM) at low risk of sudden cardiac death (SCD) can safely continue to exercise at competitive levels, a retrospective study suggests.

During a mean follow-up of 4.5 years, athletes who continued to engage in high-intensity competitive sports after a mild HCM diagnosis were free of cardiac symptoms, and there were no deaths, incidents of sustained ventricular tachycardia or syncope, or changes in cardiac electrical, structural, or functional phenotypes.

Pavel1964/iStock/Getty Images

“This study supports emerging evidence that HCM individuals with a low-risk profile and mild hypertrophy may engage in vigorous exercise and competitive sport,” Sanjay Sharma, MD, of St. George’s University of London, said in an interview. Current guidelines from the European Society of Cardiology and the American College of Cardiology support a more liberal approach to exercise for these individuals.

That said, he added, “it is important to emphasize that our cohort consisted of a group of adult competitive athletes who had probably been competing for several years before the diagnosis was made and therefore represented a self-selected, low-risk cohort. It is difficult to extrapolate this data to adolescent athletes, who appear to be more vulnerable to exercise-related SCD from HCM.”

The study was published online in the Journal of the American College of Cardiology.
 

Vigorous exercise OK for some

Dr. Sharma and colleagues analyzed data from 53 athletes with HCM who continued to participate in competitive sports. The mean age was 39 years, 98% were men, and 72% were White. About half (53%) competed as professionals, and were most commonly engaged in cycling, football, running, and rugby.

Participants underwent 6-12 monthly assessments that included electrocardiograms, echocardiograms, cardiopulmonary exercise testing, Holter monitoring (≥ 24 hours), and cardiac magnetic resonance imaging. A majority (64.2%) were evaluated because of an abnormal electrocardiograms, and one presented with an incidental abnormal echocardiogram.

About a quarter (24.5%) were symptomatic and 5 (9.4%) were identified on family screening. Eight (15%) had a family history of HCM, and six (11.3%) of SCD.

At the baseline evaluation, all athletes had a “low” ESC 5-year SCD risk score for HCM (1.9% ± 0.9%). None had syncope. Mean peak VO₂ was 40.7 ± 6.8 mL/kg per minute.

The mean left ventricular wall thickness was 14.6 ± 2.3 mm; all had normal LV systolic and diastolic function and no LV outflow tract obstruction at rest or on provocation testing. In addition, none had an LV apical aneurysm.

Twenty-two (41%) showed late gadolinium enhancement on baseline cardiac magnetic resonance imaging.

A total of 19 participants underwent genotyping; 4 (21.1%) had a pathogenic/likely pathogenic sarcomeric variant. None took cardiovascular medication or had an implantable cardioverter defibrillator (ICD).

During a mean follow-up of 4.5 years, all participants continued to exercise at the same level as before their diagnosis; none underwent detraining. All stayed free of cardiac symptoms, and there were no deaths, sustained ventricular tachycardia episodes, or syncope.

Four demonstrated new, nonsustained ventricular tachycardia (NSVT) during follow-up, one of whom underwent ICD implantation because of an increased risk score and subsequently moderated exercise levels.

One participant had a 30-second atrial fibrillation (AFib) episode lasting longer than 30 seconds, started on a beta-blocker and oral anticoagulation, and also moderated exercise levels.

The event rate was 2.1% per year for asymptomatic arrhythmias (NSVT and AFib). No changes were observed in the cardiac electrical, structural, or functional phenotype during follow-up.

Dr. Sharma and colleagues stated: “Our sample size is small; however, it is nearly double the size of a previously studied Italian athletic cohort, and one-half were professional athletes. Furthermore, 17% of our cohort comprised Black athletes who are perceived to be at higher risk of SCD than White athletes.”

Daniele Massera, MD, assistant professor in the HCM program, department of medicine, Charney Division of Cardiology, New York University Langone Health, said in an interview: “Of note, these were athletes/patients at the very low end of phenotypic severity of HCM. ... It is also notable that diastolic function was normal in all of them, an uncommon finding in patients with HCM.”

Like Dr. Sharma, he said the findings are in line with recent guidelines, and cautioned: “This small study applies only to a very small subset of patients who are being evaluated at specialized HCM programs: asymptomatic male individuals who have mild, low-risk HCM and are on no medicines.

“The findings cannot be generalized to the population of symptomatic individuals with (or without) outflow obstruction, more severe hypertrophy, and who have ICDs and/or take medication for symptoms, nor to younger patients or adolescents, who may be at higher risk for adverse outcomes,” he concluded.
 

Individualized approach urged

Dr. Sharma was a coauthor of the recent article challenging the traditional restrictive approach to exercise for athletes diagnosed with HCM and other inherited cardiovascular diseases. The article suggested that individualized recommendations, taking risks into consideration, can help guide those who want to exercise or participate in competitive sports.

Dr. Sharma also is a coauthor of a 6-month follow-up to the SAFE-HCM study, which compared the effects of a supervised 12-week high-intensity exercise program to usual care in low-risk individuals with HCM (mean age, 45.7). 

In the 6-month follow-up study, published as an abstract in the European Journal of Preventive Cardiology 2021 supplement, “exercising individuals had improved functional capacity and atherosclerotic risk profile and there were no differences in the composite safety outcomes [cardiovascular death, cardiac arrest, device therapy, exercise-induced syncope, sustained VT, NSVT, or sustained atrial arrhythmias] between exercising individuals and usual care individuals,” Dr. Sharma said.

The full study will soon be ready to submit for publication, he added.

No commercial funding or relevant conflicts of interest were disclosed.

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

Athletes with mild hypertrophic cardiomyopathy (HCM) at low risk of sudden cardiac death (SCD) can safely continue to exercise at competitive levels, a retrospective study suggests.

During a mean follow-up of 4.5 years, athletes who continued to engage in high-intensity competitive sports after a mild HCM diagnosis were free of cardiac symptoms, and there were no deaths, incidents of sustained ventricular tachycardia or syncope, or changes in cardiac electrical, structural, or functional phenotypes.

Pavel1964/iStock/Getty Images

“This study supports emerging evidence that HCM individuals with a low-risk profile and mild hypertrophy may engage in vigorous exercise and competitive sport,” Sanjay Sharma, MD, of St. George’s University of London, said in an interview. Current guidelines from the European Society of Cardiology and the American College of Cardiology support a more liberal approach to exercise for these individuals.

That said, he added, “it is important to emphasize that our cohort consisted of a group of adult competitive athletes who had probably been competing for several years before the diagnosis was made and therefore represented a self-selected, low-risk cohort. It is difficult to extrapolate this data to adolescent athletes, who appear to be more vulnerable to exercise-related SCD from HCM.”

The study was published online in the Journal of the American College of Cardiology.
 

Vigorous exercise OK for some

Dr. Sharma and colleagues analyzed data from 53 athletes with HCM who continued to participate in competitive sports. The mean age was 39 years, 98% were men, and 72% were White. About half (53%) competed as professionals, and were most commonly engaged in cycling, football, running, and rugby.

Participants underwent 6-12 monthly assessments that included electrocardiograms, echocardiograms, cardiopulmonary exercise testing, Holter monitoring (≥ 24 hours), and cardiac magnetic resonance imaging. A majority (64.2%) were evaluated because of an abnormal electrocardiograms, and one presented with an incidental abnormal echocardiogram.

About a quarter (24.5%) were symptomatic and 5 (9.4%) were identified on family screening. Eight (15%) had a family history of HCM, and six (11.3%) of SCD.

At the baseline evaluation, all athletes had a “low” ESC 5-year SCD risk score for HCM (1.9% ± 0.9%). None had syncope. Mean peak VO₂ was 40.7 ± 6.8 mL/kg per minute.

The mean left ventricular wall thickness was 14.6 ± 2.3 mm; all had normal LV systolic and diastolic function and no LV outflow tract obstruction at rest or on provocation testing. In addition, none had an LV apical aneurysm.

Twenty-two (41%) showed late gadolinium enhancement on baseline cardiac magnetic resonance imaging.

A total of 19 participants underwent genotyping; 4 (21.1%) had a pathogenic/likely pathogenic sarcomeric variant. None took cardiovascular medication or had an implantable cardioverter defibrillator (ICD).

During a mean follow-up of 4.5 years, all participants continued to exercise at the same level as before their diagnosis; none underwent detraining. All stayed free of cardiac symptoms, and there were no deaths, sustained ventricular tachycardia episodes, or syncope.

Four demonstrated new, nonsustained ventricular tachycardia (NSVT) during follow-up, one of whom underwent ICD implantation because of an increased risk score and subsequently moderated exercise levels.

One participant had a 30-second atrial fibrillation (AFib) episode lasting longer than 30 seconds, started on a beta-blocker and oral anticoagulation, and also moderated exercise levels.

The event rate was 2.1% per year for asymptomatic arrhythmias (NSVT and AFib). No changes were observed in the cardiac electrical, structural, or functional phenotype during follow-up.

Dr. Sharma and colleagues stated: “Our sample size is small; however, it is nearly double the size of a previously studied Italian athletic cohort, and one-half were professional athletes. Furthermore, 17% of our cohort comprised Black athletes who are perceived to be at higher risk of SCD than White athletes.”

Daniele Massera, MD, assistant professor in the HCM program, department of medicine, Charney Division of Cardiology, New York University Langone Health, said in an interview: “Of note, these were athletes/patients at the very low end of phenotypic severity of HCM. ... It is also notable that diastolic function was normal in all of them, an uncommon finding in patients with HCM.”

Like Dr. Sharma, he said the findings are in line with recent guidelines, and cautioned: “This small study applies only to a very small subset of patients who are being evaluated at specialized HCM programs: asymptomatic male individuals who have mild, low-risk HCM and are on no medicines.

“The findings cannot be generalized to the population of symptomatic individuals with (or without) outflow obstruction, more severe hypertrophy, and who have ICDs and/or take medication for symptoms, nor to younger patients or adolescents, who may be at higher risk for adverse outcomes,” he concluded.
 

Individualized approach urged

Dr. Sharma was a coauthor of the recent article challenging the traditional restrictive approach to exercise for athletes diagnosed with HCM and other inherited cardiovascular diseases. The article suggested that individualized recommendations, taking risks into consideration, can help guide those who want to exercise or participate in competitive sports.

Dr. Sharma also is a coauthor of a 6-month follow-up to the SAFE-HCM study, which compared the effects of a supervised 12-week high-intensity exercise program to usual care in low-risk individuals with HCM (mean age, 45.7). 

In the 6-month follow-up study, published as an abstract in the European Journal of Preventive Cardiology 2021 supplement, “exercising individuals had improved functional capacity and atherosclerotic risk profile and there were no differences in the composite safety outcomes [cardiovascular death, cardiac arrest, device therapy, exercise-induced syncope, sustained VT, NSVT, or sustained atrial arrhythmias] between exercising individuals and usual care individuals,” Dr. Sharma said.

The full study will soon be ready to submit for publication, he added.

No commercial funding or relevant conflicts of interest were disclosed.

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

Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.

In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).

The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).

Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.

For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.

The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.

The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.

In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.

In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.

The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.

The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.

“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”

Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.

The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.

A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.

One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.

Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.

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

Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.

In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).

The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).

Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.

For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.

The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.

The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.

In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.

In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.

The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.

The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.

“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”

Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.

The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.

A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.

One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.

Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.

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

Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.

In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).

The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).

Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.

For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.

The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.

The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.

In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.

In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.

The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.

The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.

“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”

Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.

The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.

A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.

One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.

Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.

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