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Cognitive problems transient after AFib ablation
Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.
Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.
The study was published online in the July issue of JACC: Clinical Electrophysiology.
Important pillar
Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.
Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.
The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.
Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).
Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.
AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.
Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).
Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.
The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
More research needed
Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.
At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)
But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).
Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).
When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.
At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).
Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).
As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).
“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.
They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
‘Reassuring’ findings
In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.
Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.
Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.
Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”
Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”
The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.
A version of this article first appeared on Medscape.com.
Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.
Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.
The study was published online in the July issue of JACC: Clinical Electrophysiology.
Important pillar
Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.
Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.
The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.
Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).
Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.
AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.
Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).
Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.
The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
More research needed
Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.
At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)
But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).
Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).
When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.
At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).
Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).
As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).
“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.
They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
‘Reassuring’ findings
In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.
Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.
Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.
Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”
Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”
The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.
A version of this article first appeared on Medscape.com.
Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.
Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.
The study was published online in the July issue of JACC: Clinical Electrophysiology.
Important pillar
Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.
Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.
The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.
Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).
Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.
AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.
Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).
Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.
The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
More research needed
Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.
At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)
But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).
Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).
When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.
At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).
Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).
As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).
“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.
They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
‘Reassuring’ findings
In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.
Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.
Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.
Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”
Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”
The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.
A version of this article first appeared on Medscape.com.
FROM JACC: CLINICAL ELECTROPHYSIOLOGY
S-ICD shows virtues, limits in ‘real-world’ postmarket study
In the latest chapter in the U.S. saga of the subcutaneous implantable cardioverter-defibrillator (S-ICD) system (Boston Scientific) – a large postmarket, multicenter registry study – the device performed at least as well as it did in earlier trials, researchers say.
The device met all prespecified safety and efficacy endpoints in a study that enrolled more than 1,600 patients and followed them for about 5 years, they noted in their report on the S-ICD Post-Approval Study (S-ICD-PAS) published online in the Journal of the American College of Cardiology.
the group reported.
The team was “pleasantly surprised” that the device’s safety and efficacy performance “was as good if not better than previous studies,” despite a sicker group of patients, lead author Michael R. Gold, MD, PhD, Medical University of South Carolina, Charleston, said in an interview.
No predictors of initial-shock failure were identified, suggesting the S-ICD should be effective in a broad range of ICD candidates without indications for pacing, Dr. Gold said.
The S-ICD was approved in Europe in 2008 and by the Food and Drug Administration in 2012. Clinical trials have suggested its performance and risk for inappropriate shocks are in line with transvenous-lead systems for most patients with ICD indications who don’t need pacing, while avoiding the sometimes serious risks posed by transvenous leads.
The S-ICD doesn’t have antitachycardia pacing (ATP), an alternative way to stop some arrhythmias and a universal feature of transvenous-lead systems. Its lack of ATP may be partly responsible for the device’s weak uptake in practice, some observers noted.
The S-ICD-PAS study “laudably included centers with variable prior experience with the S-ICD; however, data were not analyzed by center experience,” Jonathan S. Steinberg, MD, and Valentina Kutyifa, MD, PhD, University of Rochester (N.Y.) Medical Center, New York, wrote in an accompanying editorial regarding the report’s potential limitations.
Also of concern, they wrote, is the large proportion of patients who were lost to follow-up; almost 42% left the study before its prospectively defined end.
Still, wrote Dr. Steinberg and Dr. Kutyifa, S-ICD-PAS “provides robust, long-term evidence in favor of S-ICD use in a diverse cohort of younger patients receiving implants for primary or secondary prevention of sudden arrhythmic death.” Further analyses are needed, however, to clarify its performance “in centers with low vs high volume as well as in important clinical subgroups.”
It’s “reassuring to see the phase 4 postapproval study results sort of corroborate what the initial clinical study shows,” Miguel Leal, MD, Emory University, Atlanta, said in an interview.
The study’s significant attrition rate “does not negate the results because the performance curves of the device remained approximately stable over the 5 years,” he said, “suggesting that the patients who were lost [and whose clinical outcomes were not included] may not have made a significant impact when it comes to the final results.”
Although the S-ICD seems unlikely to cause complications related to endovascular occlusions or infection, “it can still cause complications related to the implant technique, particularly a device site erosion or device dislodgement,” said Dr. Leal, who chairs the American Heart Association Council on Clinical Cardiology–Electrocardiography & Arrhythmia Committee.
The S-ICD’s biggest contribution has been “the ability to promote efficacious therapy without a need for penetrating the endovascular space,” he observed. “We need to continue to push the envelope towards developing device-based technologies that spare the endovascular space.”
The study enrolled 1,643 patients at 86 U.S. centers; their mean age was 53 and 32% were women. Of the total, 1637 were implanted with the device, 665 completed the study, 288 died, and 686 left the study before completing follow-up. Of the latter, 102 (6.2% of the total) underwent S-ICD explantation, often because of infection.
In addition to the overall shock efficacy rate of 98.4%, induced-arrhythmia shock efficacy was 98.7%, first-shock efficacy for spontaneous arrhythmias was 92.2%, and the rate for either induced or spontaneous arrhythmia was 94.7%. A mean of 1.1 shocks was needed to terminate the arrhythmias; time to shock delivery averaged 17.5 seconds.
The rate of inappropriate shocks was 6.7% at 1 year and 15.8% at 5 years, notably with no significant differences between patients who had and had not undergone defibrillation threshold testing at implantation.
Of 516 inappropriate-shock episodes in 224 patients, almost 86% resulted from inappropriate sensing. Inappropriate shocks became less frequent with longer implantation times and during the course of the study.
The rate of freedom from type 1 complications, the primary safety endpoint, was 93.4%, besting the 85% performance goal. The rate of freedom from electrode-related complications was 99.3%, compared with the performance goal of 92.5%.
The S-ICD was replaced by a transvenous system because of the need for pacing in 1.6% of the cohort.
Sana M. Al-Khatib, MD, MHS, who chaired a 2017 multisociety guideline for managing ventricular arrhythmias and prevention of sudden death, acknowledged the 5-year safety and effectiveness of the S-ICD but also highlighted the “very high dropout rate.”
Moreover, given the cohort’s average age, “these results cannot be generalized to much older patients, in their 70s and 80s [for example]. More data on the S-ICD in older patients are needed, especially because some of these patients will need pacing, which is not provided by the S-ICD,” Dr. Al-Khatib, Duke University, Durham, N.C., said in an interview.
Longer follow-up of patients with the S-ICD is also needed, she added, and “having an S-ICD that is smaller with longer battery life would be great for my patients.”
The study was sponsored by Boston Scientific. Dr. Gold reported receiving consulting fees from Boston Scientific and Medtronic and participating in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr. Steinberg, Dr. Kutyifa, Dr. Al-Khatib, and Dr. Leal reported no relevant relationships.
A version of this article first appeared on Medscape.com.
In the latest chapter in the U.S. saga of the subcutaneous implantable cardioverter-defibrillator (S-ICD) system (Boston Scientific) – a large postmarket, multicenter registry study – the device performed at least as well as it did in earlier trials, researchers say.
The device met all prespecified safety and efficacy endpoints in a study that enrolled more than 1,600 patients and followed them for about 5 years, they noted in their report on the S-ICD Post-Approval Study (S-ICD-PAS) published online in the Journal of the American College of Cardiology.
the group reported.
The team was “pleasantly surprised” that the device’s safety and efficacy performance “was as good if not better than previous studies,” despite a sicker group of patients, lead author Michael R. Gold, MD, PhD, Medical University of South Carolina, Charleston, said in an interview.
No predictors of initial-shock failure were identified, suggesting the S-ICD should be effective in a broad range of ICD candidates without indications for pacing, Dr. Gold said.
The S-ICD was approved in Europe in 2008 and by the Food and Drug Administration in 2012. Clinical trials have suggested its performance and risk for inappropriate shocks are in line with transvenous-lead systems for most patients with ICD indications who don’t need pacing, while avoiding the sometimes serious risks posed by transvenous leads.
The S-ICD doesn’t have antitachycardia pacing (ATP), an alternative way to stop some arrhythmias and a universal feature of transvenous-lead systems. Its lack of ATP may be partly responsible for the device’s weak uptake in practice, some observers noted.
The S-ICD-PAS study “laudably included centers with variable prior experience with the S-ICD; however, data were not analyzed by center experience,” Jonathan S. Steinberg, MD, and Valentina Kutyifa, MD, PhD, University of Rochester (N.Y.) Medical Center, New York, wrote in an accompanying editorial regarding the report’s potential limitations.
Also of concern, they wrote, is the large proportion of patients who were lost to follow-up; almost 42% left the study before its prospectively defined end.
Still, wrote Dr. Steinberg and Dr. Kutyifa, S-ICD-PAS “provides robust, long-term evidence in favor of S-ICD use in a diverse cohort of younger patients receiving implants for primary or secondary prevention of sudden arrhythmic death.” Further analyses are needed, however, to clarify its performance “in centers with low vs high volume as well as in important clinical subgroups.”
It’s “reassuring to see the phase 4 postapproval study results sort of corroborate what the initial clinical study shows,” Miguel Leal, MD, Emory University, Atlanta, said in an interview.
The study’s significant attrition rate “does not negate the results because the performance curves of the device remained approximately stable over the 5 years,” he said, “suggesting that the patients who were lost [and whose clinical outcomes were not included] may not have made a significant impact when it comes to the final results.”
Although the S-ICD seems unlikely to cause complications related to endovascular occlusions or infection, “it can still cause complications related to the implant technique, particularly a device site erosion or device dislodgement,” said Dr. Leal, who chairs the American Heart Association Council on Clinical Cardiology–Electrocardiography & Arrhythmia Committee.
The S-ICD’s biggest contribution has been “the ability to promote efficacious therapy without a need for penetrating the endovascular space,” he observed. “We need to continue to push the envelope towards developing device-based technologies that spare the endovascular space.”
The study enrolled 1,643 patients at 86 U.S. centers; their mean age was 53 and 32% were women. Of the total, 1637 were implanted with the device, 665 completed the study, 288 died, and 686 left the study before completing follow-up. Of the latter, 102 (6.2% of the total) underwent S-ICD explantation, often because of infection.
In addition to the overall shock efficacy rate of 98.4%, induced-arrhythmia shock efficacy was 98.7%, first-shock efficacy for spontaneous arrhythmias was 92.2%, and the rate for either induced or spontaneous arrhythmia was 94.7%. A mean of 1.1 shocks was needed to terminate the arrhythmias; time to shock delivery averaged 17.5 seconds.
The rate of inappropriate shocks was 6.7% at 1 year and 15.8% at 5 years, notably with no significant differences between patients who had and had not undergone defibrillation threshold testing at implantation.
Of 516 inappropriate-shock episodes in 224 patients, almost 86% resulted from inappropriate sensing. Inappropriate shocks became less frequent with longer implantation times and during the course of the study.
The rate of freedom from type 1 complications, the primary safety endpoint, was 93.4%, besting the 85% performance goal. The rate of freedom from electrode-related complications was 99.3%, compared with the performance goal of 92.5%.
The S-ICD was replaced by a transvenous system because of the need for pacing in 1.6% of the cohort.
Sana M. Al-Khatib, MD, MHS, who chaired a 2017 multisociety guideline for managing ventricular arrhythmias and prevention of sudden death, acknowledged the 5-year safety and effectiveness of the S-ICD but also highlighted the “very high dropout rate.”
Moreover, given the cohort’s average age, “these results cannot be generalized to much older patients, in their 70s and 80s [for example]. More data on the S-ICD in older patients are needed, especially because some of these patients will need pacing, which is not provided by the S-ICD,” Dr. Al-Khatib, Duke University, Durham, N.C., said in an interview.
Longer follow-up of patients with the S-ICD is also needed, she added, and “having an S-ICD that is smaller with longer battery life would be great for my patients.”
The study was sponsored by Boston Scientific. Dr. Gold reported receiving consulting fees from Boston Scientific and Medtronic and participating in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr. Steinberg, Dr. Kutyifa, Dr. Al-Khatib, and Dr. Leal reported no relevant relationships.
A version of this article first appeared on Medscape.com.
In the latest chapter in the U.S. saga of the subcutaneous implantable cardioverter-defibrillator (S-ICD) system (Boston Scientific) – a large postmarket, multicenter registry study – the device performed at least as well as it did in earlier trials, researchers say.
The device met all prespecified safety and efficacy endpoints in a study that enrolled more than 1,600 patients and followed them for about 5 years, they noted in their report on the S-ICD Post-Approval Study (S-ICD-PAS) published online in the Journal of the American College of Cardiology.
the group reported.
The team was “pleasantly surprised” that the device’s safety and efficacy performance “was as good if not better than previous studies,” despite a sicker group of patients, lead author Michael R. Gold, MD, PhD, Medical University of South Carolina, Charleston, said in an interview.
No predictors of initial-shock failure were identified, suggesting the S-ICD should be effective in a broad range of ICD candidates without indications for pacing, Dr. Gold said.
The S-ICD was approved in Europe in 2008 and by the Food and Drug Administration in 2012. Clinical trials have suggested its performance and risk for inappropriate shocks are in line with transvenous-lead systems for most patients with ICD indications who don’t need pacing, while avoiding the sometimes serious risks posed by transvenous leads.
The S-ICD doesn’t have antitachycardia pacing (ATP), an alternative way to stop some arrhythmias and a universal feature of transvenous-lead systems. Its lack of ATP may be partly responsible for the device’s weak uptake in practice, some observers noted.
The S-ICD-PAS study “laudably included centers with variable prior experience with the S-ICD; however, data were not analyzed by center experience,” Jonathan S. Steinberg, MD, and Valentina Kutyifa, MD, PhD, University of Rochester (N.Y.) Medical Center, New York, wrote in an accompanying editorial regarding the report’s potential limitations.
Also of concern, they wrote, is the large proportion of patients who were lost to follow-up; almost 42% left the study before its prospectively defined end.
Still, wrote Dr. Steinberg and Dr. Kutyifa, S-ICD-PAS “provides robust, long-term evidence in favor of S-ICD use in a diverse cohort of younger patients receiving implants for primary or secondary prevention of sudden arrhythmic death.” Further analyses are needed, however, to clarify its performance “in centers with low vs high volume as well as in important clinical subgroups.”
It’s “reassuring to see the phase 4 postapproval study results sort of corroborate what the initial clinical study shows,” Miguel Leal, MD, Emory University, Atlanta, said in an interview.
The study’s significant attrition rate “does not negate the results because the performance curves of the device remained approximately stable over the 5 years,” he said, “suggesting that the patients who were lost [and whose clinical outcomes were not included] may not have made a significant impact when it comes to the final results.”
Although the S-ICD seems unlikely to cause complications related to endovascular occlusions or infection, “it can still cause complications related to the implant technique, particularly a device site erosion or device dislodgement,” said Dr. Leal, who chairs the American Heart Association Council on Clinical Cardiology–Electrocardiography & Arrhythmia Committee.
The S-ICD’s biggest contribution has been “the ability to promote efficacious therapy without a need for penetrating the endovascular space,” he observed. “We need to continue to push the envelope towards developing device-based technologies that spare the endovascular space.”
The study enrolled 1,643 patients at 86 U.S. centers; their mean age was 53 and 32% were women. Of the total, 1637 were implanted with the device, 665 completed the study, 288 died, and 686 left the study before completing follow-up. Of the latter, 102 (6.2% of the total) underwent S-ICD explantation, often because of infection.
In addition to the overall shock efficacy rate of 98.4%, induced-arrhythmia shock efficacy was 98.7%, first-shock efficacy for spontaneous arrhythmias was 92.2%, and the rate for either induced or spontaneous arrhythmia was 94.7%. A mean of 1.1 shocks was needed to terminate the arrhythmias; time to shock delivery averaged 17.5 seconds.
The rate of inappropriate shocks was 6.7% at 1 year and 15.8% at 5 years, notably with no significant differences between patients who had and had not undergone defibrillation threshold testing at implantation.
Of 516 inappropriate-shock episodes in 224 patients, almost 86% resulted from inappropriate sensing. Inappropriate shocks became less frequent with longer implantation times and during the course of the study.
The rate of freedom from type 1 complications, the primary safety endpoint, was 93.4%, besting the 85% performance goal. The rate of freedom from electrode-related complications was 99.3%, compared with the performance goal of 92.5%.
The S-ICD was replaced by a transvenous system because of the need for pacing in 1.6% of the cohort.
Sana M. Al-Khatib, MD, MHS, who chaired a 2017 multisociety guideline for managing ventricular arrhythmias and prevention of sudden death, acknowledged the 5-year safety and effectiveness of the S-ICD but also highlighted the “very high dropout rate.”
Moreover, given the cohort’s average age, “these results cannot be generalized to much older patients, in their 70s and 80s [for example]. More data on the S-ICD in older patients are needed, especially because some of these patients will need pacing, which is not provided by the S-ICD,” Dr. Al-Khatib, Duke University, Durham, N.C., said in an interview.
Longer follow-up of patients with the S-ICD is also needed, she added, and “having an S-ICD that is smaller with longer battery life would be great for my patients.”
The study was sponsored by Boston Scientific. Dr. Gold reported receiving consulting fees from Boston Scientific and Medtronic and participating in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr. Steinberg, Dr. Kutyifa, Dr. Al-Khatib, and Dr. Leal reported no relevant relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Early or delayed AFib ablation after heart failure hospitalization?
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
FROM JACC: CLINICAL ELECTROPHYSIOLOGY
Omega-3s and AFib: No added risk from eating fish but high-dose supplement questions persist
Regular consumption of fish and other foods rich in omega-3 fatty acids (FA) won’t raise an individual’s risk for developing atrial fibrillation (AFib), suggests a meta-analysis of population-based studies.
The finding may alleviate recent concerns about higher-dose omega-3 FA supplement intake in clinical-trial patients at elevated cardiovascular (CV) risk, researchers say.
Indeed, across the 17 cohort studies in the meta-analysis, risk for incident AFib was unaffected by elevated circulating and adipose tissue levels of eicosapentaenoic acid (EPA) from dietary intake. Moreover, the risk appeared to drop significantly with such levels of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and EPA plus DHA.
The signals of AFib risk associated with high-dose omega-3 FA in supplements or prescription form in some clinical trials “may not necessarily be generalizable to lower-dose habitual dietary omega-3 intakes,” concludes the study’s report published in the Journal of the American College of Cardiology.
Other recent research suggests that any elevated AFib risk from omega-3 FA intake is dose-related and may be associated with omega-3 FA supplement or medication intake in high doses, such as 4 g/day.
“Coupled with the more consistent benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption should be maintained,” conclude the authors of the report, led by Frank Qian, MD, MPH, Harvard T.H. Chan School of Public Health and Beth Israel Deaconess Medical Center, Boston.
The current study is “important in showing that physiologic levels of omega-3s that would accumulate through diet don’t seem to increase the risk of arrhythmia,” preventive cardiologist Sean Heffron, MD, NYU Langone Health and Grossman School of Medicine, told this news organization.
“It also lends credence to the fact that the increased risk is specific to the high dose supplementation, because that’s the only instance in which we’ve seen increased atrial fibrillation in association with omega-3s,” said Dr. Heffron, who wasn’t involved in the meta-analysis.
An accompanying editorial agrees. “Based on present evidence, moderate dietary intake of fish and seafood is unlikely to achieve sufficiently high levels of omega-3-FAs in blood or tissue that would result in increased AFib risk as observed in clinical trials of fish oil supplements and high-dose prescriptions,” write Christie Ballantyne, MD, and Xiaoming Jia, MD, Baylor College of Medicine, Houston.
Therefore, they conclude, “fish should continue to be an important part of the menu of a heart-healthy diet.”
The meta-analysis comprised 54,799 participants from 21 countries worldwide in 17 prospective cohort studies that yielded data on incident AFib, in which there were 7,720 cases of the arrhythmia over a median follow-up of 13 years. It looked at associations between such cases and levels of omega-3 FA in blood and adipose tissue samples.
In multivariable analysis, EPA levels were not associated with incident AFib, with a hazard ratio of 1.00 (95% confidence interval, 0.95-1.05) per interquintile range, which the report describes as the difference between the 90th and 10th percentiles.
In contrast, levels of DPA, DHA, and EPA plus DHA were all associated with reduced AFib incidence at interquintile-range HRs of 0.89 (95% CI, 0.83-0.95) for DPA, 0.90 (95% CI, 0.85-0.96) for DHA and 0.93 (95% CI, 0.87-0.99) for EPA and DHA combined.
“We found little evidence that the associations significantly varied by age, sex, or global region, or across the various lipid compartments,” the report states. “Moreover, the relationship between omega-3 fatty acids and AFib did not significantly differ among individuals at higher CV risk.”
The authors observe that the prevalence of omega-3 FA supplement use in the cohorts was very low, suggesting that the omega-3 FA biomarker levels largely reflected habitual dietary intake.
Most of the meta-analysis population were free of CV disease or at relatively low CV risk, they write, and “it is conceivable that the effects of omega-3 fatty acids on atrial arrhythmias may differ in those with existing CV disease versus without.”
However, they note, in a prespecified subgroup analysis of participants mirroring the REDUCE-IT cohort of people with established CV disease or at elevated CV risk, no association with incident AFib was observed for EPA and inverse associations emerged for DPA, DHA, and EPA plus DHA.
In their editorial, Dr. Ballantyne and Dr. Jia say the meta-analysis “represents the largest epidemiological study assessing laboratory-measured omega-3 fatty acid concentrations and AFib risk in the general population.”
But significant heterogeneity across the studies and their populations is a major limitation of the analysis, they write, and made for differences in protocols, sample preparation, outcomes ascertainment, follow-up time, and other variables.
“Despite a rigorous approach to harmonize the data across cohorts and adjusting for multiple confounders,” note Dr. Ballantyne and Dr. Jia, “observational studies always have potential for residual confounders.”
The findings support fish consumption as heart-healthy, they write, but “clinicians should be aware of and discuss with patients the risks versus benefits when prescribing high-dose omega-3 FA therapies.”
The Fatty Acid Research Institute retrospectively provided a small honorarium to a subset of the analysts who participated in this study, but it had no role in its design, analysis, manuscript writing, or decision to submit for publication, the report states. Dr. Ballantyne received grant/research support through his institution from Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, Novartis, and Regeneron, as well as consulting fees from Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Esperion, Genentech, Gilead, Matinas BioPharma, Merck, New Amsterdam, Novartis, Pfizer, and Regeneron. Dr. Heffron and Dr. Jia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Regular consumption of fish and other foods rich in omega-3 fatty acids (FA) won’t raise an individual’s risk for developing atrial fibrillation (AFib), suggests a meta-analysis of population-based studies.
The finding may alleviate recent concerns about higher-dose omega-3 FA supplement intake in clinical-trial patients at elevated cardiovascular (CV) risk, researchers say.
Indeed, across the 17 cohort studies in the meta-analysis, risk for incident AFib was unaffected by elevated circulating and adipose tissue levels of eicosapentaenoic acid (EPA) from dietary intake. Moreover, the risk appeared to drop significantly with such levels of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and EPA plus DHA.
The signals of AFib risk associated with high-dose omega-3 FA in supplements or prescription form in some clinical trials “may not necessarily be generalizable to lower-dose habitual dietary omega-3 intakes,” concludes the study’s report published in the Journal of the American College of Cardiology.
Other recent research suggests that any elevated AFib risk from omega-3 FA intake is dose-related and may be associated with omega-3 FA supplement or medication intake in high doses, such as 4 g/day.
“Coupled with the more consistent benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption should be maintained,” conclude the authors of the report, led by Frank Qian, MD, MPH, Harvard T.H. Chan School of Public Health and Beth Israel Deaconess Medical Center, Boston.
The current study is “important in showing that physiologic levels of omega-3s that would accumulate through diet don’t seem to increase the risk of arrhythmia,” preventive cardiologist Sean Heffron, MD, NYU Langone Health and Grossman School of Medicine, told this news organization.
“It also lends credence to the fact that the increased risk is specific to the high dose supplementation, because that’s the only instance in which we’ve seen increased atrial fibrillation in association with omega-3s,” said Dr. Heffron, who wasn’t involved in the meta-analysis.
An accompanying editorial agrees. “Based on present evidence, moderate dietary intake of fish and seafood is unlikely to achieve sufficiently high levels of omega-3-FAs in blood or tissue that would result in increased AFib risk as observed in clinical trials of fish oil supplements and high-dose prescriptions,” write Christie Ballantyne, MD, and Xiaoming Jia, MD, Baylor College of Medicine, Houston.
Therefore, they conclude, “fish should continue to be an important part of the menu of a heart-healthy diet.”
The meta-analysis comprised 54,799 participants from 21 countries worldwide in 17 prospective cohort studies that yielded data on incident AFib, in which there were 7,720 cases of the arrhythmia over a median follow-up of 13 years. It looked at associations between such cases and levels of omega-3 FA in blood and adipose tissue samples.
In multivariable analysis, EPA levels were not associated with incident AFib, with a hazard ratio of 1.00 (95% confidence interval, 0.95-1.05) per interquintile range, which the report describes as the difference between the 90th and 10th percentiles.
In contrast, levels of DPA, DHA, and EPA plus DHA were all associated with reduced AFib incidence at interquintile-range HRs of 0.89 (95% CI, 0.83-0.95) for DPA, 0.90 (95% CI, 0.85-0.96) for DHA and 0.93 (95% CI, 0.87-0.99) for EPA and DHA combined.
“We found little evidence that the associations significantly varied by age, sex, or global region, or across the various lipid compartments,” the report states. “Moreover, the relationship between omega-3 fatty acids and AFib did not significantly differ among individuals at higher CV risk.”
The authors observe that the prevalence of omega-3 FA supplement use in the cohorts was very low, suggesting that the omega-3 FA biomarker levels largely reflected habitual dietary intake.
Most of the meta-analysis population were free of CV disease or at relatively low CV risk, they write, and “it is conceivable that the effects of omega-3 fatty acids on atrial arrhythmias may differ in those with existing CV disease versus without.”
However, they note, in a prespecified subgroup analysis of participants mirroring the REDUCE-IT cohort of people with established CV disease or at elevated CV risk, no association with incident AFib was observed for EPA and inverse associations emerged for DPA, DHA, and EPA plus DHA.
In their editorial, Dr. Ballantyne and Dr. Jia say the meta-analysis “represents the largest epidemiological study assessing laboratory-measured omega-3 fatty acid concentrations and AFib risk in the general population.”
But significant heterogeneity across the studies and their populations is a major limitation of the analysis, they write, and made for differences in protocols, sample preparation, outcomes ascertainment, follow-up time, and other variables.
“Despite a rigorous approach to harmonize the data across cohorts and adjusting for multiple confounders,” note Dr. Ballantyne and Dr. Jia, “observational studies always have potential for residual confounders.”
The findings support fish consumption as heart-healthy, they write, but “clinicians should be aware of and discuss with patients the risks versus benefits when prescribing high-dose omega-3 FA therapies.”
The Fatty Acid Research Institute retrospectively provided a small honorarium to a subset of the analysts who participated in this study, but it had no role in its design, analysis, manuscript writing, or decision to submit for publication, the report states. Dr. Ballantyne received grant/research support through his institution from Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, Novartis, and Regeneron, as well as consulting fees from Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Esperion, Genentech, Gilead, Matinas BioPharma, Merck, New Amsterdam, Novartis, Pfizer, and Regeneron. Dr. Heffron and Dr. Jia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Regular consumption of fish and other foods rich in omega-3 fatty acids (FA) won’t raise an individual’s risk for developing atrial fibrillation (AFib), suggests a meta-analysis of population-based studies.
The finding may alleviate recent concerns about higher-dose omega-3 FA supplement intake in clinical-trial patients at elevated cardiovascular (CV) risk, researchers say.
Indeed, across the 17 cohort studies in the meta-analysis, risk for incident AFib was unaffected by elevated circulating and adipose tissue levels of eicosapentaenoic acid (EPA) from dietary intake. Moreover, the risk appeared to drop significantly with such levels of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and EPA plus DHA.
The signals of AFib risk associated with high-dose omega-3 FA in supplements or prescription form in some clinical trials “may not necessarily be generalizable to lower-dose habitual dietary omega-3 intakes,” concludes the study’s report published in the Journal of the American College of Cardiology.
Other recent research suggests that any elevated AFib risk from omega-3 FA intake is dose-related and may be associated with omega-3 FA supplement or medication intake in high doses, such as 4 g/day.
“Coupled with the more consistent benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption should be maintained,” conclude the authors of the report, led by Frank Qian, MD, MPH, Harvard T.H. Chan School of Public Health and Beth Israel Deaconess Medical Center, Boston.
The current study is “important in showing that physiologic levels of omega-3s that would accumulate through diet don’t seem to increase the risk of arrhythmia,” preventive cardiologist Sean Heffron, MD, NYU Langone Health and Grossman School of Medicine, told this news organization.
“It also lends credence to the fact that the increased risk is specific to the high dose supplementation, because that’s the only instance in which we’ve seen increased atrial fibrillation in association with omega-3s,” said Dr. Heffron, who wasn’t involved in the meta-analysis.
An accompanying editorial agrees. “Based on present evidence, moderate dietary intake of fish and seafood is unlikely to achieve sufficiently high levels of omega-3-FAs in blood or tissue that would result in increased AFib risk as observed in clinical trials of fish oil supplements and high-dose prescriptions,” write Christie Ballantyne, MD, and Xiaoming Jia, MD, Baylor College of Medicine, Houston.
Therefore, they conclude, “fish should continue to be an important part of the menu of a heart-healthy diet.”
The meta-analysis comprised 54,799 participants from 21 countries worldwide in 17 prospective cohort studies that yielded data on incident AFib, in which there were 7,720 cases of the arrhythmia over a median follow-up of 13 years. It looked at associations between such cases and levels of omega-3 FA in blood and adipose tissue samples.
In multivariable analysis, EPA levels were not associated with incident AFib, with a hazard ratio of 1.00 (95% confidence interval, 0.95-1.05) per interquintile range, which the report describes as the difference between the 90th and 10th percentiles.
In contrast, levels of DPA, DHA, and EPA plus DHA were all associated with reduced AFib incidence at interquintile-range HRs of 0.89 (95% CI, 0.83-0.95) for DPA, 0.90 (95% CI, 0.85-0.96) for DHA and 0.93 (95% CI, 0.87-0.99) for EPA and DHA combined.
“We found little evidence that the associations significantly varied by age, sex, or global region, or across the various lipid compartments,” the report states. “Moreover, the relationship between omega-3 fatty acids and AFib did not significantly differ among individuals at higher CV risk.”
The authors observe that the prevalence of omega-3 FA supplement use in the cohorts was very low, suggesting that the omega-3 FA biomarker levels largely reflected habitual dietary intake.
Most of the meta-analysis population were free of CV disease or at relatively low CV risk, they write, and “it is conceivable that the effects of omega-3 fatty acids on atrial arrhythmias may differ in those with existing CV disease versus without.”
However, they note, in a prespecified subgroup analysis of participants mirroring the REDUCE-IT cohort of people with established CV disease or at elevated CV risk, no association with incident AFib was observed for EPA and inverse associations emerged for DPA, DHA, and EPA plus DHA.
In their editorial, Dr. Ballantyne and Dr. Jia say the meta-analysis “represents the largest epidemiological study assessing laboratory-measured omega-3 fatty acid concentrations and AFib risk in the general population.”
But significant heterogeneity across the studies and their populations is a major limitation of the analysis, they write, and made for differences in protocols, sample preparation, outcomes ascertainment, follow-up time, and other variables.
“Despite a rigorous approach to harmonize the data across cohorts and adjusting for multiple confounders,” note Dr. Ballantyne and Dr. Jia, “observational studies always have potential for residual confounders.”
The findings support fish consumption as heart-healthy, they write, but “clinicians should be aware of and discuss with patients the risks versus benefits when prescribing high-dose omega-3 FA therapies.”
The Fatty Acid Research Institute retrospectively provided a small honorarium to a subset of the analysts who participated in this study, but it had no role in its design, analysis, manuscript writing, or decision to submit for publication, the report states. Dr. Ballantyne received grant/research support through his institution from Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, Novartis, and Regeneron, as well as consulting fees from Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Esperion, Genentech, Gilead, Matinas BioPharma, Merck, New Amsterdam, Novartis, Pfizer, and Regeneron. Dr. Heffron and Dr. Jia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
High-dose vitamin D may cut risk for new atrial fibrillation
TOPLINE:
a post hoc analysis from a randomized trial conducted in Finland suggests.
METHODOLOGY:
- Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
- The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
- Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
- Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.
TAKEAWAY:
- Atrial fibrillation was diagnosed in 190 participants.
- Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
- The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
- After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.
IN PRACTICE:
High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.
STUDY DETAILS:
The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.
LIMITATIONS:
Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.
DISCLOSURES:
The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
a post hoc analysis from a randomized trial conducted in Finland suggests.
METHODOLOGY:
- Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
- The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
- Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
- Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.
TAKEAWAY:
- Atrial fibrillation was diagnosed in 190 participants.
- Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
- The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
- After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.
IN PRACTICE:
High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.
STUDY DETAILS:
The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.
LIMITATIONS:
Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.
DISCLOSURES:
The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
a post hoc analysis from a randomized trial conducted in Finland suggests.
METHODOLOGY:
- Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
- The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
- Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
- Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.
TAKEAWAY:
- Atrial fibrillation was diagnosed in 190 participants.
- Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
- The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
- After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.
IN PRACTICE:
High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.
STUDY DETAILS:
The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.
LIMITATIONS:
Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.
DISCLOSURES:
The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA approves first leadless dual-chamber pacing system
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
Women with atrial fibrillation more likely to develop dementia
New data suggest a significantly stronger link in women compared with men between atrial fibrillation (AF) and mild cognitive impairment (MCI) and dementia.
“Our findings imply that women with AF may be at higher risk for MCI and dementia with potentially more rapid disease progression from normal cognition to MCI or dementia than women without AF or men with and without AF,” wrote authors of a new study led by Kathryn A. Wood, PhD, RN, Neil Hodgson Woodruff School of Nursing at Emory University in Atlanta.
The findings were published online in Alzheimer’s & Dementia.
Researchers used the National Alzheimer’s Coordinating Center data with 43,630 patients and analyzed sex differences between men and women with AF and their performance on neuropsychological tests and cognitive disease progression.
Higher odds of dementia, MCI in women
According to the paper, AF is associated with higher odds of dementia (odds ratio [OR], 3.00; 95% confidence interval [CI], 1.22-7.37) in women and MCI in women (OR, 3.43; 95% CI, 1.55-7.55) compared with men.
Women with AF and normal cognition at baseline had a higher risk of disease progression (hazard ratio [HR], 1.26; 95% CI, 1.06-1.50) from normal to MCI and from MCI to vascular dementia (HR, 3.27; 95% CI, 1.89-5.65) than that of men with AF or men and women without AF.
AF is a major public health problem linked with stroke and heart failure, and is an independent risk factor of increased mortality. It is associated with higher risk of cognitive impairment and dementia independent of stroke history.
Cognitive screening for AF patients
The authors wrote that cognitive screening, especially in women, should be part of yearly cardiology visits for patients with AF to help identify early those at highest risk for cognitive disease.
T. Jared Bunch, MD, professor of medicine in the division of cardiovascular medicine at University of Utah in Salt Lake City, said in an interview, “We have learned that how we treat atrial fibrillation can influence risk.”
First, he said, outcomes, including brain health, are better when rhythm control approaches are used within the first year of diagnosis.
“Restoring a normal heart rhythm improves brain perfusion and cognitive function. Next, aggressive rhythm control – such as catheter ablation – is associated with much lower long-term risks of dementia in the [patients]. Finally, early and effective use of anticoagulation in patients with atrial fibrillation lowers risk of stroke, dementia, and cognitive decline.”
Several factors unknown
Dr. Bunch said there are some unknowns in the study, such as how long patients were in atrial fibrillation.
He said one way to address the inequities is to refer women earlier as women are often referred later in disease to specialty care, which can have consequences.
He said it is not known how many people underwent early and effective rhythm control.
“Women also are less likely to receive catheter ablation, a cardioversion, or be placed on antiarrhythmic drugs,” said Dr. Bunch, who was not part of the study. “These also represent potential opportunities to improve outcomes by treating the rhythm in a similar and aggressive manner in both men and women.”
Also unknown is how many people were on effective oral anticoagulation, Dr. Bunch noted.
The study importantly highlights a significant problem surrounding the care of women with AF, he said, but there are strategies to improve outcomes.
In addition to earlier screening and referral for women, providers should recognize that men and women may present differently with different AF symptoms. He added that physicians should offer catheter ablation, the most effective treatment, equally to men and women who are candidates.
In all people, he said, it’s important “to start anticoagulation very early in the disease to lower the risk of micro- and macrothrombotic events that lead to poor brain health and function.”
The study authors and Dr. Bunch declared no relevant financial relationships.
New data suggest a significantly stronger link in women compared with men between atrial fibrillation (AF) and mild cognitive impairment (MCI) and dementia.
“Our findings imply that women with AF may be at higher risk for MCI and dementia with potentially more rapid disease progression from normal cognition to MCI or dementia than women without AF or men with and without AF,” wrote authors of a new study led by Kathryn A. Wood, PhD, RN, Neil Hodgson Woodruff School of Nursing at Emory University in Atlanta.
The findings were published online in Alzheimer’s & Dementia.
Researchers used the National Alzheimer’s Coordinating Center data with 43,630 patients and analyzed sex differences between men and women with AF and their performance on neuropsychological tests and cognitive disease progression.
Higher odds of dementia, MCI in women
According to the paper, AF is associated with higher odds of dementia (odds ratio [OR], 3.00; 95% confidence interval [CI], 1.22-7.37) in women and MCI in women (OR, 3.43; 95% CI, 1.55-7.55) compared with men.
Women with AF and normal cognition at baseline had a higher risk of disease progression (hazard ratio [HR], 1.26; 95% CI, 1.06-1.50) from normal to MCI and from MCI to vascular dementia (HR, 3.27; 95% CI, 1.89-5.65) than that of men with AF or men and women without AF.
AF is a major public health problem linked with stroke and heart failure, and is an independent risk factor of increased mortality. It is associated with higher risk of cognitive impairment and dementia independent of stroke history.
Cognitive screening for AF patients
The authors wrote that cognitive screening, especially in women, should be part of yearly cardiology visits for patients with AF to help identify early those at highest risk for cognitive disease.
T. Jared Bunch, MD, professor of medicine in the division of cardiovascular medicine at University of Utah in Salt Lake City, said in an interview, “We have learned that how we treat atrial fibrillation can influence risk.”
First, he said, outcomes, including brain health, are better when rhythm control approaches are used within the first year of diagnosis.
“Restoring a normal heart rhythm improves brain perfusion and cognitive function. Next, aggressive rhythm control – such as catheter ablation – is associated with much lower long-term risks of dementia in the [patients]. Finally, early and effective use of anticoagulation in patients with atrial fibrillation lowers risk of stroke, dementia, and cognitive decline.”
Several factors unknown
Dr. Bunch said there are some unknowns in the study, such as how long patients were in atrial fibrillation.
He said one way to address the inequities is to refer women earlier as women are often referred later in disease to specialty care, which can have consequences.
He said it is not known how many people underwent early and effective rhythm control.
“Women also are less likely to receive catheter ablation, a cardioversion, or be placed on antiarrhythmic drugs,” said Dr. Bunch, who was not part of the study. “These also represent potential opportunities to improve outcomes by treating the rhythm in a similar and aggressive manner in both men and women.”
Also unknown is how many people were on effective oral anticoagulation, Dr. Bunch noted.
The study importantly highlights a significant problem surrounding the care of women with AF, he said, but there are strategies to improve outcomes.
In addition to earlier screening and referral for women, providers should recognize that men and women may present differently with different AF symptoms. He added that physicians should offer catheter ablation, the most effective treatment, equally to men and women who are candidates.
In all people, he said, it’s important “to start anticoagulation very early in the disease to lower the risk of micro- and macrothrombotic events that lead to poor brain health and function.”
The study authors and Dr. Bunch declared no relevant financial relationships.
New data suggest a significantly stronger link in women compared with men between atrial fibrillation (AF) and mild cognitive impairment (MCI) and dementia.
“Our findings imply that women with AF may be at higher risk for MCI and dementia with potentially more rapid disease progression from normal cognition to MCI or dementia than women without AF or men with and without AF,” wrote authors of a new study led by Kathryn A. Wood, PhD, RN, Neil Hodgson Woodruff School of Nursing at Emory University in Atlanta.
The findings were published online in Alzheimer’s & Dementia.
Researchers used the National Alzheimer’s Coordinating Center data with 43,630 patients and analyzed sex differences between men and women with AF and their performance on neuropsychological tests and cognitive disease progression.
Higher odds of dementia, MCI in women
According to the paper, AF is associated with higher odds of dementia (odds ratio [OR], 3.00; 95% confidence interval [CI], 1.22-7.37) in women and MCI in women (OR, 3.43; 95% CI, 1.55-7.55) compared with men.
Women with AF and normal cognition at baseline had a higher risk of disease progression (hazard ratio [HR], 1.26; 95% CI, 1.06-1.50) from normal to MCI and from MCI to vascular dementia (HR, 3.27; 95% CI, 1.89-5.65) than that of men with AF or men and women without AF.
AF is a major public health problem linked with stroke and heart failure, and is an independent risk factor of increased mortality. It is associated with higher risk of cognitive impairment and dementia independent of stroke history.
Cognitive screening for AF patients
The authors wrote that cognitive screening, especially in women, should be part of yearly cardiology visits for patients with AF to help identify early those at highest risk for cognitive disease.
T. Jared Bunch, MD, professor of medicine in the division of cardiovascular medicine at University of Utah in Salt Lake City, said in an interview, “We have learned that how we treat atrial fibrillation can influence risk.”
First, he said, outcomes, including brain health, are better when rhythm control approaches are used within the first year of diagnosis.
“Restoring a normal heart rhythm improves brain perfusion and cognitive function. Next, aggressive rhythm control – such as catheter ablation – is associated with much lower long-term risks of dementia in the [patients]. Finally, early and effective use of anticoagulation in patients with atrial fibrillation lowers risk of stroke, dementia, and cognitive decline.”
Several factors unknown
Dr. Bunch said there are some unknowns in the study, such as how long patients were in atrial fibrillation.
He said one way to address the inequities is to refer women earlier as women are often referred later in disease to specialty care, which can have consequences.
He said it is not known how many people underwent early and effective rhythm control.
“Women also are less likely to receive catheter ablation, a cardioversion, or be placed on antiarrhythmic drugs,” said Dr. Bunch, who was not part of the study. “These also represent potential opportunities to improve outcomes by treating the rhythm in a similar and aggressive manner in both men and women.”
Also unknown is how many people were on effective oral anticoagulation, Dr. Bunch noted.
The study importantly highlights a significant problem surrounding the care of women with AF, he said, but there are strategies to improve outcomes.
In addition to earlier screening and referral for women, providers should recognize that men and women may present differently with different AF symptoms. He added that physicians should offer catheter ablation, the most effective treatment, equally to men and women who are candidates.
In all people, he said, it’s important “to start anticoagulation very early in the disease to lower the risk of micro- and macrothrombotic events that lead to poor brain health and function.”
The study authors and Dr. Bunch declared no relevant financial relationships.
FROM ALZHEIMER’S & DEMENTIA
ECG implant tightens AFib management, improves outcomes in MONITOR-AF
Chronic conditions like diabetes or hypertension “often require long-term care through long-term monitoring,” observed a researcher, and “we know that continuous monitoring is superior to intermittent monitoring for long-term outcomes.”
So maybe practice should rely more on continuous ECG monitoring for patients with atrial fibrillation (AFib), also a chronic condition, proposed Dhanunjaya R. Lakkireddy, MD, of the Kansas City Heart Rhythm Institute, Overland Park, Kan., in presenting a new analysis at the annual scientific sessions of the Heart Rhythm Society.
(ILRs), compared with standard care. The latter could include intermittent 12-lead ECG, Holter, or other intermittent monitoring at physicians’ discretion.
Patients with AFib and the ECG implants in the MONITOR-AF study, which was not randomized and therefore only suggestive, were managed “more efficiently” with greater access to electrophysiologists (P < .01) and adherence to oral anticoagulants (P = .020) and other medications.
Followed for a mean of 2 years, patients with ILRs were more likely to undergo catheter ablation, and their time to a catheter ablation “was impressively shorter, 153 days versus 426 days” (P < .001), Dr. Lakkireddy said.
The ILR group also had fewer strokes and bleeding complications and were less likely to be hospitalized for AFib-related reasons, he said, because “a lot of these patients were caught ahead of time through the remote monitoring.”
For example, ILR patients had fewer heart failure (HF) hospitalizations, likely because “you’re not allowing these patients to remain with untreated rapid ventricular rates for a long period of time. You intervene early, thereby mitigating the onset of heart failure.”
Indeed, Dr. Lakkireddy said, their cumulative rate of any cardiovascular complication was “dramatically lower” – 3.4 versus 10.4 events per 100 person-years (P < .001).
Certainly, a routine recommendation to consider AFib patients for continuous monitoring would require randomized-trial evidence, he acknowledged. “This is an observation registry and proof of concept from a very heterogeneous cohort of patients. There were no obvious set criteria for ILR implantation.”
Nonetheless, “continuous and dynamic monitoring enabled quicker decision-making and patient management,” Dr. Lakkireddy said. “Especially in those patients who may have silent atrial fibrillation, an ILR could significantly mitigate the risk of complications from stroke and heart failure exacerbations.”
Several randomized trials have supported “earlier, more aggressive treatment” for AFib, including EAST-AFNET4, EARLY-AF, and CABANA, observed Daniel Morin, MD, MPH, of Ochsner Medical Center, New Orleans, as the invited discussant for Dr. Lakkireddy’s presentation.
So, he continued, if the goal is to “get every single AFib patient to ablation just as soon as possible,” then maybe MONITOR-AF supports the use of ILRs in such cases.
Indeed, it is “certainly possible” that the continuous stream of data from ILRs “allows faster progression of therapy and possibly even better outcomes” as MONITOR-AF suggests, said Dr. Morin, who is director of electrophysiology research at his center.
Moreover, ILR data could potentially “support shared decision-making perhaps by convincing the patient, and maybe their insurers, that we should move forward with ablation.”
But given the study’s observational, registry-based nature, the MONITOR-AF analysis is limited by potential confounders that complicate its interpretation.
For example, Dr. Morin continued, all ILR patients but only 60% of those on standard care˙ had access to an electrophysiologist (P = .001). That means “less access to some antiarrhythmic medications and certainly far less access to ablation therapy.”
Moreover, “during shared decision-making, a patient who sees the results of their ILR monitoring may be more prone to seek out or to accept earlier, more definitive therapy via ablation,” he said. “The presence of an ILR may then be a good way to move the needle toward ablation.”
Of note, an overwhelming majority of ILR patients received ablation, 93.5%, compared with 58.6% of standard-care patients. “It’s unclear how much of that association was caused by the ILR’s presence vs. other factors, such as physician availability, physician aggressiveness, or patient willingness for intervention,” Dr. Morin noted.
MONITOR-AF included 2,458 patients with paroxysmal or persistent AFib who either were implanted with or did not receive an ILR from 2018 to 2021 and were followed for at least 12 months.
The two groups were similar, Dr. Lakkireddy reported, with respect to demographics and baseline history AFib, hypertension, hyperlipidemia, diabetes, coronary disease, neurovascular events, peripheral artery disease, and obstructive sleep apnea.
Dr. Lakkireddy said a subgroup analysis is forthcoming, but that he’d “intuitively” think that the 15%-20% of AFib patients who are asymptomatic would gain the most from the ILR monitoring approach. There is already evidence that such patients tend to have the worst AFib outcomes, often receiving an AFib diagnosis only after presenting with consequences such as stroke or heart failure.
Dr. Lakkireddy disclosed receiving research grants, modest honoraria, or consulting fees from Abbott, Janssen, Boston Scientific, Johnson & Johnson, Biotronik, Bristol-Myers Squibb, Pfizer, Atricure, Northeast Scientific, and Acutus. Dr. Morin disclosed receiving research grants, honoraria, or consulting fees from Abbott and serving on a speakers’ bureau for Boston Scientific, Medtronic, and Zoll Medical.
A version of this article first appeared on Medscape.com.
Chronic conditions like diabetes or hypertension “often require long-term care through long-term monitoring,” observed a researcher, and “we know that continuous monitoring is superior to intermittent monitoring for long-term outcomes.”
So maybe practice should rely more on continuous ECG monitoring for patients with atrial fibrillation (AFib), also a chronic condition, proposed Dhanunjaya R. Lakkireddy, MD, of the Kansas City Heart Rhythm Institute, Overland Park, Kan., in presenting a new analysis at the annual scientific sessions of the Heart Rhythm Society.
(ILRs), compared with standard care. The latter could include intermittent 12-lead ECG, Holter, or other intermittent monitoring at physicians’ discretion.
Patients with AFib and the ECG implants in the MONITOR-AF study, which was not randomized and therefore only suggestive, were managed “more efficiently” with greater access to electrophysiologists (P < .01) and adherence to oral anticoagulants (P = .020) and other medications.
Followed for a mean of 2 years, patients with ILRs were more likely to undergo catheter ablation, and their time to a catheter ablation “was impressively shorter, 153 days versus 426 days” (P < .001), Dr. Lakkireddy said.
The ILR group also had fewer strokes and bleeding complications and were less likely to be hospitalized for AFib-related reasons, he said, because “a lot of these patients were caught ahead of time through the remote monitoring.”
For example, ILR patients had fewer heart failure (HF) hospitalizations, likely because “you’re not allowing these patients to remain with untreated rapid ventricular rates for a long period of time. You intervene early, thereby mitigating the onset of heart failure.”
Indeed, Dr. Lakkireddy said, their cumulative rate of any cardiovascular complication was “dramatically lower” – 3.4 versus 10.4 events per 100 person-years (P < .001).
Certainly, a routine recommendation to consider AFib patients for continuous monitoring would require randomized-trial evidence, he acknowledged. “This is an observation registry and proof of concept from a very heterogeneous cohort of patients. There were no obvious set criteria for ILR implantation.”
Nonetheless, “continuous and dynamic monitoring enabled quicker decision-making and patient management,” Dr. Lakkireddy said. “Especially in those patients who may have silent atrial fibrillation, an ILR could significantly mitigate the risk of complications from stroke and heart failure exacerbations.”
Several randomized trials have supported “earlier, more aggressive treatment” for AFib, including EAST-AFNET4, EARLY-AF, and CABANA, observed Daniel Morin, MD, MPH, of Ochsner Medical Center, New Orleans, as the invited discussant for Dr. Lakkireddy’s presentation.
So, he continued, if the goal is to “get every single AFib patient to ablation just as soon as possible,” then maybe MONITOR-AF supports the use of ILRs in such cases.
Indeed, it is “certainly possible” that the continuous stream of data from ILRs “allows faster progression of therapy and possibly even better outcomes” as MONITOR-AF suggests, said Dr. Morin, who is director of electrophysiology research at his center.
Moreover, ILR data could potentially “support shared decision-making perhaps by convincing the patient, and maybe their insurers, that we should move forward with ablation.”
But given the study’s observational, registry-based nature, the MONITOR-AF analysis is limited by potential confounders that complicate its interpretation.
For example, Dr. Morin continued, all ILR patients but only 60% of those on standard care˙ had access to an electrophysiologist (P = .001). That means “less access to some antiarrhythmic medications and certainly far less access to ablation therapy.”
Moreover, “during shared decision-making, a patient who sees the results of their ILR monitoring may be more prone to seek out or to accept earlier, more definitive therapy via ablation,” he said. “The presence of an ILR may then be a good way to move the needle toward ablation.”
Of note, an overwhelming majority of ILR patients received ablation, 93.5%, compared with 58.6% of standard-care patients. “It’s unclear how much of that association was caused by the ILR’s presence vs. other factors, such as physician availability, physician aggressiveness, or patient willingness for intervention,” Dr. Morin noted.
MONITOR-AF included 2,458 patients with paroxysmal or persistent AFib who either were implanted with or did not receive an ILR from 2018 to 2021 and were followed for at least 12 months.
The two groups were similar, Dr. Lakkireddy reported, with respect to demographics and baseline history AFib, hypertension, hyperlipidemia, diabetes, coronary disease, neurovascular events, peripheral artery disease, and obstructive sleep apnea.
Dr. Lakkireddy said a subgroup analysis is forthcoming, but that he’d “intuitively” think that the 15%-20% of AFib patients who are asymptomatic would gain the most from the ILR monitoring approach. There is already evidence that such patients tend to have the worst AFib outcomes, often receiving an AFib diagnosis only after presenting with consequences such as stroke or heart failure.
Dr. Lakkireddy disclosed receiving research grants, modest honoraria, or consulting fees from Abbott, Janssen, Boston Scientific, Johnson & Johnson, Biotronik, Bristol-Myers Squibb, Pfizer, Atricure, Northeast Scientific, and Acutus. Dr. Morin disclosed receiving research grants, honoraria, or consulting fees from Abbott and serving on a speakers’ bureau for Boston Scientific, Medtronic, and Zoll Medical.
A version of this article first appeared on Medscape.com.
Chronic conditions like diabetes or hypertension “often require long-term care through long-term monitoring,” observed a researcher, and “we know that continuous monitoring is superior to intermittent monitoring for long-term outcomes.”
So maybe practice should rely more on continuous ECG monitoring for patients with atrial fibrillation (AFib), also a chronic condition, proposed Dhanunjaya R. Lakkireddy, MD, of the Kansas City Heart Rhythm Institute, Overland Park, Kan., in presenting a new analysis at the annual scientific sessions of the Heart Rhythm Society.
(ILRs), compared with standard care. The latter could include intermittent 12-lead ECG, Holter, or other intermittent monitoring at physicians’ discretion.
Patients with AFib and the ECG implants in the MONITOR-AF study, which was not randomized and therefore only suggestive, were managed “more efficiently” with greater access to electrophysiologists (P < .01) and adherence to oral anticoagulants (P = .020) and other medications.
Followed for a mean of 2 years, patients with ILRs were more likely to undergo catheter ablation, and their time to a catheter ablation “was impressively shorter, 153 days versus 426 days” (P < .001), Dr. Lakkireddy said.
The ILR group also had fewer strokes and bleeding complications and were less likely to be hospitalized for AFib-related reasons, he said, because “a lot of these patients were caught ahead of time through the remote monitoring.”
For example, ILR patients had fewer heart failure (HF) hospitalizations, likely because “you’re not allowing these patients to remain with untreated rapid ventricular rates for a long period of time. You intervene early, thereby mitigating the onset of heart failure.”
Indeed, Dr. Lakkireddy said, their cumulative rate of any cardiovascular complication was “dramatically lower” – 3.4 versus 10.4 events per 100 person-years (P < .001).
Certainly, a routine recommendation to consider AFib patients for continuous monitoring would require randomized-trial evidence, he acknowledged. “This is an observation registry and proof of concept from a very heterogeneous cohort of patients. There were no obvious set criteria for ILR implantation.”
Nonetheless, “continuous and dynamic monitoring enabled quicker decision-making and patient management,” Dr. Lakkireddy said. “Especially in those patients who may have silent atrial fibrillation, an ILR could significantly mitigate the risk of complications from stroke and heart failure exacerbations.”
Several randomized trials have supported “earlier, more aggressive treatment” for AFib, including EAST-AFNET4, EARLY-AF, and CABANA, observed Daniel Morin, MD, MPH, of Ochsner Medical Center, New Orleans, as the invited discussant for Dr. Lakkireddy’s presentation.
So, he continued, if the goal is to “get every single AFib patient to ablation just as soon as possible,” then maybe MONITOR-AF supports the use of ILRs in such cases.
Indeed, it is “certainly possible” that the continuous stream of data from ILRs “allows faster progression of therapy and possibly even better outcomes” as MONITOR-AF suggests, said Dr. Morin, who is director of electrophysiology research at his center.
Moreover, ILR data could potentially “support shared decision-making perhaps by convincing the patient, and maybe their insurers, that we should move forward with ablation.”
But given the study’s observational, registry-based nature, the MONITOR-AF analysis is limited by potential confounders that complicate its interpretation.
For example, Dr. Morin continued, all ILR patients but only 60% of those on standard care˙ had access to an electrophysiologist (P = .001). That means “less access to some antiarrhythmic medications and certainly far less access to ablation therapy.”
Moreover, “during shared decision-making, a patient who sees the results of their ILR monitoring may be more prone to seek out or to accept earlier, more definitive therapy via ablation,” he said. “The presence of an ILR may then be a good way to move the needle toward ablation.”
Of note, an overwhelming majority of ILR patients received ablation, 93.5%, compared with 58.6% of standard-care patients. “It’s unclear how much of that association was caused by the ILR’s presence vs. other factors, such as physician availability, physician aggressiveness, or patient willingness for intervention,” Dr. Morin noted.
MONITOR-AF included 2,458 patients with paroxysmal or persistent AFib who either were implanted with or did not receive an ILR from 2018 to 2021 and were followed for at least 12 months.
The two groups were similar, Dr. Lakkireddy reported, with respect to demographics and baseline history AFib, hypertension, hyperlipidemia, diabetes, coronary disease, neurovascular events, peripheral artery disease, and obstructive sleep apnea.
Dr. Lakkireddy said a subgroup analysis is forthcoming, but that he’d “intuitively” think that the 15%-20% of AFib patients who are asymptomatic would gain the most from the ILR monitoring approach. There is already evidence that such patients tend to have the worst AFib outcomes, often receiving an AFib diagnosis only after presenting with consequences such as stroke or heart failure.
Dr. Lakkireddy disclosed receiving research grants, modest honoraria, or consulting fees from Abbott, Janssen, Boston Scientific, Johnson & Johnson, Biotronik, Bristol-Myers Squibb, Pfizer, Atricure, Northeast Scientific, and Acutus. Dr. Morin disclosed receiving research grants, honoraria, or consulting fees from Abbott and serving on a speakers’ bureau for Boston Scientific, Medtronic, and Zoll Medical.
A version of this article first appeared on Medscape.com.
FROM HEART RHYTHM 2023
Leadless dual-chamber pacemaker clears early safety, performance hurdles
Cardiology, well into the age of leadless pacemakers, could be headed for an age of leadless pacemaker systems in which various pacing functions are achieved by multiple implants that “talk” to each other.
Even now, a leadless two-part pacemaker system has shown it can safely achieve atrioventricular (AV) synchrony in patients with standard indications for a dual-chamber device, at least over the short term, suggests a prospective observational study. Currently available leadless pacemakers can stimulate only the right ventricle.
Experienced operators achieved a 98% implantation success rate in 300 patients who received an investigational dual-chamber leadless system, the AVEIR DR i2i (Abbott).
Its two separately implanted miniature pulse generators achieve AV synchrony via “beat-to-beat wireless bidirectional communication,” Daniel J. Cantillon, MD, said when presenting the study at the annual scientific sessions of the Heart Rhythm Societyin New Orleans.
The system seemed to work well regardless of the patient’s body orientation. “Sitting, supine, left lateral, right lateral, standing, normal walk, fast walk – we demonstrated robust AV synchrony in all of those positions and with movement,” said Dr. Cantillon, of the Cleveland Clinic.
Should the device be approved, it could “expand the use case for leadless cardiac pacing” to include atrial-only, ventricular-only, fully functional dual-chamber pacing scenarios.”
Dr. Cantillon is senior author on the study’s online publication in the New England Journal of Medicine, timed to coincide with his HRS presentation, with first author Reinoud E. Knops, MD, PhD, Amsterdam University Medical Center.
“The electrical performance of both the atrial and ventricular leadless pacemakers appears to be similar to that of transvenous dual-chamber pacemakers,” the published report states.
More data needed
The study is important and has “significant implications for our pacing field,” Jonathan P. Piccini, MD, MHS, said in an interview. It suggests that “dual-chamber pacing can be achieved with leadless technology” and “with a very high degree” of AV synchrony.
“Obviously, more data as the technology moves into clinical practice will be critical,” said Dr. Piccini, who directs cardiac electrophysiology at Duke University Medical Center, Durham, N.C. “We will also need to understand which patients are best served by leadless technology and which will be better served with traditional transvenous devices.”
The AVEIR DR i2i system consists of two leadless pulse generators for percutaneous implantation in the right atrium and right ventricle, respectively. They link like components of a wireless network to coordinate their separate sensing and rate-adaptive, AV-synchronous pacing functions.
The right ventricular implant “is physically identical to a commercially available single-chamber leadless pacemaker” from Abbott, the published report states.
Leadless pacemaker systems inherently avoid the two main sources of transvenous devices’ major complication – infection – by not requiring such leads or surgery for creating a pulse-generator subcutaneous pocket.
The first such systems consisted of one implant that could provide single-chamber ventricular pacing but not atrial pacing or AV synchronous pacing. The transcatheter single-chamber leadless Micra (Medtronic) for example, was approved in the United States in April 2016 for ventricular-only pacing.
A successor, the Micra AV, approved in 2020, was designed to simulate AV-synchronous pacing by stimulating the ventricle in sequence with mechanically sensed atrial contractions, as described by Dr. Cantillon and associates. But it could not directly pace the atrium, “rendering it inappropriate for patients with sinus-node dysfunction.”
The AVEIR DR i2i system doesn’t have those limitations. It was, however, associated with 35 device- or procedure-related complications in the study, of which the most common was procedural arrhythmia, “namely atrial fibrillation,” Dr. Cantillon said.
Atrial fibrillation can develop during implantation of pacemakers with transvenous leads but is generally terminated without being considered an important event. Yet the study classified it as a serious complication, inflating the complication rate, because “the patients had to be restored to sinus rhythm so we could assess the AV synchrony and also the atrial electrical performance,” he said.
Some of the devices dislodged from their implantation site within a month of the procedure, but “all of those patients were successfully managed percutaneously,” said Dr. Cantillon.
“The 1.7% dislodgement rate is something that we will need to keep an eye on, as embolization of devices is always a significant concern,” Dr. Piccini said. Still, the observed total complication rate “was certainly in line” with rates associated with conventional pacemaker implantation.
Reliable AV synchrony
Fred M. Kusumoto, MD, Mayo Clinic, Jacksonville, Fla., lauded what seems to be the system’s “incredibly reliable AV synchrony in different conditions, albeit in a very controlled environment.”
Of interest will be whether its performance, including maintenance of AV synchrony, holds up in “a more long-term evaluation in the outpatient setting,” said Dr. Kusumoto, speaking as the invited discussant for Dr. Cantillon’s presentation.
Also missing or in short supply from the study, he observed, are insights about long-term efficacy and complications, battery longevity, effectiveness of its rate-responsive capability, and any effect on clinical outcomes.
Local body network
Of the study’s 300 patients (mean age 69 years; 38% female) at 55 sites in Canada, Europe, and the United States, 63.3% had sinus-node dysfunction and 33.3% had AV block as their primary dual-chamber pacing indication; 298 were successfully implanted with both devices.
About 45% had a history of supraventricular arrhythmia, 4.3% had prior ventricular arrhythmia, and 20% had a history of arrhythmia ablation.
By 3 months, the group reported, the primary safety endpoint (freedom from device- or procedure-related serious adverse events) occurred in 90.3%, compared with the performance goal of 78% (P < .001).
The first of two primary performance endpoints (adequate atrial capture threshold and sensing amplitude by predefined criteria) was met in 90.2%, surpassing the 82.5% performance goal (P < .001).
The second primary performance goal (at least 70% AV synchrony with the patient sitting) was seen in 97.3% against the performance goal of 83% (P < .001).
What shouldn’t be “glossed over” from the study, Dr. Kusumoto offered, is that it’s possible to achieve a wireless connection “between two devices that are actually intracardiac.” That raises the prospect of a “local body network” that could be “expanded even more dramatically with other types of devices. I mean, think of the paradigm shift.”
The AVEIR DR i2i trial was funded by Abbott. Dr. Cantillon discloses receiving honoraria or fees for speaking or consulting from Abbott Laboratories, Boston Scientific, Biosense Webster, and Shockwave Medical, as well as holding royalty rights with AirStrip. Dr. Piccini has disclosed relationships with Abbott, Medtronic, Biotronik, Boston Scientific, and other drug and medical device companies. Dr. Kusumoto reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiology, well into the age of leadless pacemakers, could be headed for an age of leadless pacemaker systems in which various pacing functions are achieved by multiple implants that “talk” to each other.
Even now, a leadless two-part pacemaker system has shown it can safely achieve atrioventricular (AV) synchrony in patients with standard indications for a dual-chamber device, at least over the short term, suggests a prospective observational study. Currently available leadless pacemakers can stimulate only the right ventricle.
Experienced operators achieved a 98% implantation success rate in 300 patients who received an investigational dual-chamber leadless system, the AVEIR DR i2i (Abbott).
Its two separately implanted miniature pulse generators achieve AV synchrony via “beat-to-beat wireless bidirectional communication,” Daniel J. Cantillon, MD, said when presenting the study at the annual scientific sessions of the Heart Rhythm Societyin New Orleans.
The system seemed to work well regardless of the patient’s body orientation. “Sitting, supine, left lateral, right lateral, standing, normal walk, fast walk – we demonstrated robust AV synchrony in all of those positions and with movement,” said Dr. Cantillon, of the Cleveland Clinic.
Should the device be approved, it could “expand the use case for leadless cardiac pacing” to include atrial-only, ventricular-only, fully functional dual-chamber pacing scenarios.”
Dr. Cantillon is senior author on the study’s online publication in the New England Journal of Medicine, timed to coincide with his HRS presentation, with first author Reinoud E. Knops, MD, PhD, Amsterdam University Medical Center.
“The electrical performance of both the atrial and ventricular leadless pacemakers appears to be similar to that of transvenous dual-chamber pacemakers,” the published report states.
More data needed
The study is important and has “significant implications for our pacing field,” Jonathan P. Piccini, MD, MHS, said in an interview. It suggests that “dual-chamber pacing can be achieved with leadless technology” and “with a very high degree” of AV synchrony.
“Obviously, more data as the technology moves into clinical practice will be critical,” said Dr. Piccini, who directs cardiac electrophysiology at Duke University Medical Center, Durham, N.C. “We will also need to understand which patients are best served by leadless technology and which will be better served with traditional transvenous devices.”
The AVEIR DR i2i system consists of two leadless pulse generators for percutaneous implantation in the right atrium and right ventricle, respectively. They link like components of a wireless network to coordinate their separate sensing and rate-adaptive, AV-synchronous pacing functions.
The right ventricular implant “is physically identical to a commercially available single-chamber leadless pacemaker” from Abbott, the published report states.
Leadless pacemaker systems inherently avoid the two main sources of transvenous devices’ major complication – infection – by not requiring such leads or surgery for creating a pulse-generator subcutaneous pocket.
The first such systems consisted of one implant that could provide single-chamber ventricular pacing but not atrial pacing or AV synchronous pacing. The transcatheter single-chamber leadless Micra (Medtronic) for example, was approved in the United States in April 2016 for ventricular-only pacing.
A successor, the Micra AV, approved in 2020, was designed to simulate AV-synchronous pacing by stimulating the ventricle in sequence with mechanically sensed atrial contractions, as described by Dr. Cantillon and associates. But it could not directly pace the atrium, “rendering it inappropriate for patients with sinus-node dysfunction.”
The AVEIR DR i2i system doesn’t have those limitations. It was, however, associated with 35 device- or procedure-related complications in the study, of which the most common was procedural arrhythmia, “namely atrial fibrillation,” Dr. Cantillon said.
Atrial fibrillation can develop during implantation of pacemakers with transvenous leads but is generally terminated without being considered an important event. Yet the study classified it as a serious complication, inflating the complication rate, because “the patients had to be restored to sinus rhythm so we could assess the AV synchrony and also the atrial electrical performance,” he said.
Some of the devices dislodged from their implantation site within a month of the procedure, but “all of those patients were successfully managed percutaneously,” said Dr. Cantillon.
“The 1.7% dislodgement rate is something that we will need to keep an eye on, as embolization of devices is always a significant concern,” Dr. Piccini said. Still, the observed total complication rate “was certainly in line” with rates associated with conventional pacemaker implantation.
Reliable AV synchrony
Fred M. Kusumoto, MD, Mayo Clinic, Jacksonville, Fla., lauded what seems to be the system’s “incredibly reliable AV synchrony in different conditions, albeit in a very controlled environment.”
Of interest will be whether its performance, including maintenance of AV synchrony, holds up in “a more long-term evaluation in the outpatient setting,” said Dr. Kusumoto, speaking as the invited discussant for Dr. Cantillon’s presentation.
Also missing or in short supply from the study, he observed, are insights about long-term efficacy and complications, battery longevity, effectiveness of its rate-responsive capability, and any effect on clinical outcomes.
Local body network
Of the study’s 300 patients (mean age 69 years; 38% female) at 55 sites in Canada, Europe, and the United States, 63.3% had sinus-node dysfunction and 33.3% had AV block as their primary dual-chamber pacing indication; 298 were successfully implanted with both devices.
About 45% had a history of supraventricular arrhythmia, 4.3% had prior ventricular arrhythmia, and 20% had a history of arrhythmia ablation.
By 3 months, the group reported, the primary safety endpoint (freedom from device- or procedure-related serious adverse events) occurred in 90.3%, compared with the performance goal of 78% (P < .001).
The first of two primary performance endpoints (adequate atrial capture threshold and sensing amplitude by predefined criteria) was met in 90.2%, surpassing the 82.5% performance goal (P < .001).
The second primary performance goal (at least 70% AV synchrony with the patient sitting) was seen in 97.3% against the performance goal of 83% (P < .001).
What shouldn’t be “glossed over” from the study, Dr. Kusumoto offered, is that it’s possible to achieve a wireless connection “between two devices that are actually intracardiac.” That raises the prospect of a “local body network” that could be “expanded even more dramatically with other types of devices. I mean, think of the paradigm shift.”
The AVEIR DR i2i trial was funded by Abbott. Dr. Cantillon discloses receiving honoraria or fees for speaking or consulting from Abbott Laboratories, Boston Scientific, Biosense Webster, and Shockwave Medical, as well as holding royalty rights with AirStrip. Dr. Piccini has disclosed relationships with Abbott, Medtronic, Biotronik, Boston Scientific, and other drug and medical device companies. Dr. Kusumoto reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiology, well into the age of leadless pacemakers, could be headed for an age of leadless pacemaker systems in which various pacing functions are achieved by multiple implants that “talk” to each other.
Even now, a leadless two-part pacemaker system has shown it can safely achieve atrioventricular (AV) synchrony in patients with standard indications for a dual-chamber device, at least over the short term, suggests a prospective observational study. Currently available leadless pacemakers can stimulate only the right ventricle.
Experienced operators achieved a 98% implantation success rate in 300 patients who received an investigational dual-chamber leadless system, the AVEIR DR i2i (Abbott).
Its two separately implanted miniature pulse generators achieve AV synchrony via “beat-to-beat wireless bidirectional communication,” Daniel J. Cantillon, MD, said when presenting the study at the annual scientific sessions of the Heart Rhythm Societyin New Orleans.
The system seemed to work well regardless of the patient’s body orientation. “Sitting, supine, left lateral, right lateral, standing, normal walk, fast walk – we demonstrated robust AV synchrony in all of those positions and with movement,” said Dr. Cantillon, of the Cleveland Clinic.
Should the device be approved, it could “expand the use case for leadless cardiac pacing” to include atrial-only, ventricular-only, fully functional dual-chamber pacing scenarios.”
Dr. Cantillon is senior author on the study’s online publication in the New England Journal of Medicine, timed to coincide with his HRS presentation, with first author Reinoud E. Knops, MD, PhD, Amsterdam University Medical Center.
“The electrical performance of both the atrial and ventricular leadless pacemakers appears to be similar to that of transvenous dual-chamber pacemakers,” the published report states.
More data needed
The study is important and has “significant implications for our pacing field,” Jonathan P. Piccini, MD, MHS, said in an interview. It suggests that “dual-chamber pacing can be achieved with leadless technology” and “with a very high degree” of AV synchrony.
“Obviously, more data as the technology moves into clinical practice will be critical,” said Dr. Piccini, who directs cardiac electrophysiology at Duke University Medical Center, Durham, N.C. “We will also need to understand which patients are best served by leadless technology and which will be better served with traditional transvenous devices.”
The AVEIR DR i2i system consists of two leadless pulse generators for percutaneous implantation in the right atrium and right ventricle, respectively. They link like components of a wireless network to coordinate their separate sensing and rate-adaptive, AV-synchronous pacing functions.
The right ventricular implant “is physically identical to a commercially available single-chamber leadless pacemaker” from Abbott, the published report states.
Leadless pacemaker systems inherently avoid the two main sources of transvenous devices’ major complication – infection – by not requiring such leads or surgery for creating a pulse-generator subcutaneous pocket.
The first such systems consisted of one implant that could provide single-chamber ventricular pacing but not atrial pacing or AV synchronous pacing. The transcatheter single-chamber leadless Micra (Medtronic) for example, was approved in the United States in April 2016 for ventricular-only pacing.
A successor, the Micra AV, approved in 2020, was designed to simulate AV-synchronous pacing by stimulating the ventricle in sequence with mechanically sensed atrial contractions, as described by Dr. Cantillon and associates. But it could not directly pace the atrium, “rendering it inappropriate for patients with sinus-node dysfunction.”
The AVEIR DR i2i system doesn’t have those limitations. It was, however, associated with 35 device- or procedure-related complications in the study, of which the most common was procedural arrhythmia, “namely atrial fibrillation,” Dr. Cantillon said.
Atrial fibrillation can develop during implantation of pacemakers with transvenous leads but is generally terminated without being considered an important event. Yet the study classified it as a serious complication, inflating the complication rate, because “the patients had to be restored to sinus rhythm so we could assess the AV synchrony and also the atrial electrical performance,” he said.
Some of the devices dislodged from their implantation site within a month of the procedure, but “all of those patients were successfully managed percutaneously,” said Dr. Cantillon.
“The 1.7% dislodgement rate is something that we will need to keep an eye on, as embolization of devices is always a significant concern,” Dr. Piccini said. Still, the observed total complication rate “was certainly in line” with rates associated with conventional pacemaker implantation.
Reliable AV synchrony
Fred M. Kusumoto, MD, Mayo Clinic, Jacksonville, Fla., lauded what seems to be the system’s “incredibly reliable AV synchrony in different conditions, albeit in a very controlled environment.”
Of interest will be whether its performance, including maintenance of AV synchrony, holds up in “a more long-term evaluation in the outpatient setting,” said Dr. Kusumoto, speaking as the invited discussant for Dr. Cantillon’s presentation.
Also missing or in short supply from the study, he observed, are insights about long-term efficacy and complications, battery longevity, effectiveness of its rate-responsive capability, and any effect on clinical outcomes.
Local body network
Of the study’s 300 patients (mean age 69 years; 38% female) at 55 sites in Canada, Europe, and the United States, 63.3% had sinus-node dysfunction and 33.3% had AV block as their primary dual-chamber pacing indication; 298 were successfully implanted with both devices.
About 45% had a history of supraventricular arrhythmia, 4.3% had prior ventricular arrhythmia, and 20% had a history of arrhythmia ablation.
By 3 months, the group reported, the primary safety endpoint (freedom from device- or procedure-related serious adverse events) occurred in 90.3%, compared with the performance goal of 78% (P < .001).
The first of two primary performance endpoints (adequate atrial capture threshold and sensing amplitude by predefined criteria) was met in 90.2%, surpassing the 82.5% performance goal (P < .001).
The second primary performance goal (at least 70% AV synchrony with the patient sitting) was seen in 97.3% against the performance goal of 83% (P < .001).
What shouldn’t be “glossed over” from the study, Dr. Kusumoto offered, is that it’s possible to achieve a wireless connection “between two devices that are actually intracardiac.” That raises the prospect of a “local body network” that could be “expanded even more dramatically with other types of devices. I mean, think of the paradigm shift.”
The AVEIR DR i2i trial was funded by Abbott. Dr. Cantillon discloses receiving honoraria or fees for speaking or consulting from Abbott Laboratories, Boston Scientific, Biosense Webster, and Shockwave Medical, as well as holding royalty rights with AirStrip. Dr. Piccini has disclosed relationships with Abbott, Medtronic, Biotronik, Boston Scientific, and other drug and medical device companies. Dr. Kusumoto reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HRS 2023
Cut in AFib burden gains traction as gauge of ablation success: PULSED-AF
suggests a new analysis.
It’s the first study tying those outcomes to residual AFib burden after ablation achieved using the emerging pulsed-field ablation (PFA) technology, say researchers. These associations are already established for cath ablation using traditional radiofrequency energy or cryoablation.
The new findings come from a secondary analysis of the recently published PULSED-AF study, which highlighted the ablation efficacy of Medtronic’s investigational PulseSelect PFA system in patients with either paroxysmal AFib (PAF) or persistent AFib.
The trial had entered 300 adult candidates for catheter ablation of recurrent, symptomatic PAF or persistent AFib at 41 centers in Australia, Canada, Europe, Japan, and the United States.
After ablation, 69% of PAF patients and 62% of those who had persistent AFib showed no sign of atrial arrhythmia (AA) over 12 months, based on the trial’s method for estimating AA burden.
Residual AA burden less than 10% was seen in 87% and 82% of those initially with PAF and persistent AFib, respectively. Burdens in that lowest range, compared with greater AA burden, predicted a “clinically meaningful” improvement in QoL scores in PAF patients.
Those who entered the study with persistent AFib showed such improvement – defined as a more than 19-point gain on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire – regardless of postablation AA burden.
Moreover, patients initially with either type of AFib and residual burdens in the lowest range went on to have fewer cardioversions and repeat ablations (P < .01), Atul Verma, MD, McGill University Health Centre, Montreal, reported at the annual scientific sessions of the Heart Rhythm Society.
Dr. Verma, the trial’s principal investigator, is also lead author on the same-day publication of the secondary analysis in Heart Rhythm.
Binary endpoint lacks relevance
The PULSED-AF primary analysis defined ablation efficacy partly as freedom from AA recurrence lasting at least 30 seconds, with or without symptoms, a traditional AFib-ablation trial endpoint that is nonetheless considered clinically unhelpful.
The secondary analysis recasts that binary endpoint as degree of reduction in AFib burden, a continuous variable. That potentially allows AFib ablation efficacy to be assessed in a more nuanced way likely to be more meaningful to patients and the health care system, observed Dr. Verma and colleagues.
The “30-second endpoint” is limited in clinical usefulness and “doesn’t mean much to the patient,” he said at a press conference on the analysis before formally presenting it at the HRS sessions.
Recent AFib ablation trials have explored AA burden as possibly a superior way to assess the procedure’s success “but also to see if it’s better correlated with quality of life and health care outcomes,” Dr. Verma said. “So that’s exactly what we’ve tried to do here using the PULSED-AF data.”
In the secondary analysis, he said, patients’ rate of freedom from the 30-second endpoint was about 70%, but “more than 85% of them had an AFib burden of less than 10%.”
“This efficacy endpoint of 30 seconds of atrial arrhythmia has been challenged and has been seen clinically as insignificant,” agreed Rajeev Pathak, MBBS, PhD, of Australian National University and director of cardiac electrophysiology at Canberra (Australia) Hospital.
In AFib radiofrequency ablation and cryoablation studies “there is clear disconnect between these 30-second episodes of atrial arrhythmias we see and the clinical relevance of health care utilization and quality of life,” said Dr. Pathak, invited discussant for Dr. Verma’s presentation at the sessions.
Now an AFib ablation trial using PFA catheters has yielded similar results, finding AA burden to be “a more objective and relevant measure of success,” he said. “A 30-second endpoint is arbitrary, lacks significance, and is highly dependent on the monitoring strategy.”
The more you look, the more you see
The new secondary analysis included a demonstration that success rates based on the 30-second endpoint indeed vary depending on how subsequent arrhythmias are monitored.
As described by Dr. Verma, PULSED-AF data were assessed for the 30-second endpoint captured using three separate intermittent monitoring strategies that it and other recent ablation trials have used:
- Strategy A: Transtelephonic monitoring weekly and in the event of symptoms, plus 24-hour Holter monitoring at 6 and 12 months and 12-lead ECG at 3, 6, and 12 months
- Strategy B: Transtelephonic monitoring weekly and at symptoms for 3-6 months followed by monthly and at symptoms from 6 to 12 months, plus 24-hour Holter monitoring at 6 and 12 months, plus 12-lead ECG at 3, 6, and 12 months
- Strategy C: The median of two 24-hour Holter monitoring sessions per patient over 12 months
As Dr. Verma reported, rates of freedom from the 30-second endpoint climbed with successive monitoring strategies. The rates for PAF and persistent AFib patients, respectively, were: Strategy A – 70% and 62%, Strategy B – 71% and 68%, Strategy C – 91% and 86%.
“If you’re using the ‘freedom-from-30-seconds’ endpoint, the results that you are going to get are highly dependent on the monitoring strategy,” Dr. Verma said. “The more you look, the more you see.”
Valid estimation of burden
For the main PULSED-AF secondary analysis, the investigators defined AA burden according to findings on either Holter monitoring or the 12-lead ECG. “So as not to bias these results,” Dr. Verma said, “for every patient, we picked the method that gave us the highest atrial arrhythmia burden.”
Ideally, Dr. Verma said in an interview, arrhythmia burden would be determined using devices such as implantable loop recorders. “The problem is, this is expensive and not practical” in both clinical practice and many trials, so PULSED-AF investigators went with the intermittent monitoring strategy to estimate burdens.
Their method appears valid, he said, given that the study identified a statistically relevant 10% AA burden cut off for predicting quality of life improvement or less health care resource use.
“If their residual atrial arrhythmia burden was greater than 10%, they did not have a statistically significant improvement in quality of life,” Dr. Verma observed. And “very few” of them had cardioversions or repeat ablation.
“I couldn’t agree more” that residual AA burden is preferable to the 30-second endpoint for gauging AFib ablation success, Kenneth Ellenbogen, MD, Virginia Commonwealth University Medical Center, Richmond, said in an interview. Dr. Ellenbogen is also director of clinical cardiac electrophysiology and pacing at VCU Health Pauley Heart Center and not associated with PULSED-AF.
That AA burden was linked to health care resource use in the study “is absolutely brilliant,” he said, “because that’s what the bean counters really want at the end of the day. And as doctors we care about patients feeling better – improving quality of life.”
PULSED-AF was funded by Medtronic. Dr. Verma disclosed financial relationships with Bayer, Biosense Webster, Medtronic, Thermedical, Kardium, and Galaxy Medical, as well as and research grants from Adagio Medical. Dr. Ellenbogen disclosed financial relationships with Boston Scientific, Medtronic, Kestra, Hylomorph, Biotronik, MediLynx, Impulse Dynamics USA, Abbott, Biosense Webster, Milestone Pharmaceuticals, Sanofi, Medpace, and Elsevier. Dr. Pathak disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
suggests a new analysis.
It’s the first study tying those outcomes to residual AFib burden after ablation achieved using the emerging pulsed-field ablation (PFA) technology, say researchers. These associations are already established for cath ablation using traditional radiofrequency energy or cryoablation.
The new findings come from a secondary analysis of the recently published PULSED-AF study, which highlighted the ablation efficacy of Medtronic’s investigational PulseSelect PFA system in patients with either paroxysmal AFib (PAF) or persistent AFib.
The trial had entered 300 adult candidates for catheter ablation of recurrent, symptomatic PAF or persistent AFib at 41 centers in Australia, Canada, Europe, Japan, and the United States.
After ablation, 69% of PAF patients and 62% of those who had persistent AFib showed no sign of atrial arrhythmia (AA) over 12 months, based on the trial’s method for estimating AA burden.
Residual AA burden less than 10% was seen in 87% and 82% of those initially with PAF and persistent AFib, respectively. Burdens in that lowest range, compared with greater AA burden, predicted a “clinically meaningful” improvement in QoL scores in PAF patients.
Those who entered the study with persistent AFib showed such improvement – defined as a more than 19-point gain on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire – regardless of postablation AA burden.
Moreover, patients initially with either type of AFib and residual burdens in the lowest range went on to have fewer cardioversions and repeat ablations (P < .01), Atul Verma, MD, McGill University Health Centre, Montreal, reported at the annual scientific sessions of the Heart Rhythm Society.
Dr. Verma, the trial’s principal investigator, is also lead author on the same-day publication of the secondary analysis in Heart Rhythm.
Binary endpoint lacks relevance
The PULSED-AF primary analysis defined ablation efficacy partly as freedom from AA recurrence lasting at least 30 seconds, with or without symptoms, a traditional AFib-ablation trial endpoint that is nonetheless considered clinically unhelpful.
The secondary analysis recasts that binary endpoint as degree of reduction in AFib burden, a continuous variable. That potentially allows AFib ablation efficacy to be assessed in a more nuanced way likely to be more meaningful to patients and the health care system, observed Dr. Verma and colleagues.
The “30-second endpoint” is limited in clinical usefulness and “doesn’t mean much to the patient,” he said at a press conference on the analysis before formally presenting it at the HRS sessions.
Recent AFib ablation trials have explored AA burden as possibly a superior way to assess the procedure’s success “but also to see if it’s better correlated with quality of life and health care outcomes,” Dr. Verma said. “So that’s exactly what we’ve tried to do here using the PULSED-AF data.”
In the secondary analysis, he said, patients’ rate of freedom from the 30-second endpoint was about 70%, but “more than 85% of them had an AFib burden of less than 10%.”
“This efficacy endpoint of 30 seconds of atrial arrhythmia has been challenged and has been seen clinically as insignificant,” agreed Rajeev Pathak, MBBS, PhD, of Australian National University and director of cardiac electrophysiology at Canberra (Australia) Hospital.
In AFib radiofrequency ablation and cryoablation studies “there is clear disconnect between these 30-second episodes of atrial arrhythmias we see and the clinical relevance of health care utilization and quality of life,” said Dr. Pathak, invited discussant for Dr. Verma’s presentation at the sessions.
Now an AFib ablation trial using PFA catheters has yielded similar results, finding AA burden to be “a more objective and relevant measure of success,” he said. “A 30-second endpoint is arbitrary, lacks significance, and is highly dependent on the monitoring strategy.”
The more you look, the more you see
The new secondary analysis included a demonstration that success rates based on the 30-second endpoint indeed vary depending on how subsequent arrhythmias are monitored.
As described by Dr. Verma, PULSED-AF data were assessed for the 30-second endpoint captured using three separate intermittent monitoring strategies that it and other recent ablation trials have used:
- Strategy A: Transtelephonic monitoring weekly and in the event of symptoms, plus 24-hour Holter monitoring at 6 and 12 months and 12-lead ECG at 3, 6, and 12 months
- Strategy B: Transtelephonic monitoring weekly and at symptoms for 3-6 months followed by monthly and at symptoms from 6 to 12 months, plus 24-hour Holter monitoring at 6 and 12 months, plus 12-lead ECG at 3, 6, and 12 months
- Strategy C: The median of two 24-hour Holter monitoring sessions per patient over 12 months
As Dr. Verma reported, rates of freedom from the 30-second endpoint climbed with successive monitoring strategies. The rates for PAF and persistent AFib patients, respectively, were: Strategy A – 70% and 62%, Strategy B – 71% and 68%, Strategy C – 91% and 86%.
“If you’re using the ‘freedom-from-30-seconds’ endpoint, the results that you are going to get are highly dependent on the monitoring strategy,” Dr. Verma said. “The more you look, the more you see.”
Valid estimation of burden
For the main PULSED-AF secondary analysis, the investigators defined AA burden according to findings on either Holter monitoring or the 12-lead ECG. “So as not to bias these results,” Dr. Verma said, “for every patient, we picked the method that gave us the highest atrial arrhythmia burden.”
Ideally, Dr. Verma said in an interview, arrhythmia burden would be determined using devices such as implantable loop recorders. “The problem is, this is expensive and not practical” in both clinical practice and many trials, so PULSED-AF investigators went with the intermittent monitoring strategy to estimate burdens.
Their method appears valid, he said, given that the study identified a statistically relevant 10% AA burden cut off for predicting quality of life improvement or less health care resource use.
“If their residual atrial arrhythmia burden was greater than 10%, they did not have a statistically significant improvement in quality of life,” Dr. Verma observed. And “very few” of them had cardioversions or repeat ablation.
“I couldn’t agree more” that residual AA burden is preferable to the 30-second endpoint for gauging AFib ablation success, Kenneth Ellenbogen, MD, Virginia Commonwealth University Medical Center, Richmond, said in an interview. Dr. Ellenbogen is also director of clinical cardiac electrophysiology and pacing at VCU Health Pauley Heart Center and not associated with PULSED-AF.
That AA burden was linked to health care resource use in the study “is absolutely brilliant,” he said, “because that’s what the bean counters really want at the end of the day. And as doctors we care about patients feeling better – improving quality of life.”
PULSED-AF was funded by Medtronic. Dr. Verma disclosed financial relationships with Bayer, Biosense Webster, Medtronic, Thermedical, Kardium, and Galaxy Medical, as well as and research grants from Adagio Medical. Dr. Ellenbogen disclosed financial relationships with Boston Scientific, Medtronic, Kestra, Hylomorph, Biotronik, MediLynx, Impulse Dynamics USA, Abbott, Biosense Webster, Milestone Pharmaceuticals, Sanofi, Medpace, and Elsevier. Dr. Pathak disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
suggests a new analysis.
It’s the first study tying those outcomes to residual AFib burden after ablation achieved using the emerging pulsed-field ablation (PFA) technology, say researchers. These associations are already established for cath ablation using traditional radiofrequency energy or cryoablation.
The new findings come from a secondary analysis of the recently published PULSED-AF study, which highlighted the ablation efficacy of Medtronic’s investigational PulseSelect PFA system in patients with either paroxysmal AFib (PAF) or persistent AFib.
The trial had entered 300 adult candidates for catheter ablation of recurrent, symptomatic PAF or persistent AFib at 41 centers in Australia, Canada, Europe, Japan, and the United States.
After ablation, 69% of PAF patients and 62% of those who had persistent AFib showed no sign of atrial arrhythmia (AA) over 12 months, based on the trial’s method for estimating AA burden.
Residual AA burden less than 10% was seen in 87% and 82% of those initially with PAF and persistent AFib, respectively. Burdens in that lowest range, compared with greater AA burden, predicted a “clinically meaningful” improvement in QoL scores in PAF patients.
Those who entered the study with persistent AFib showed such improvement – defined as a more than 19-point gain on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire – regardless of postablation AA burden.
Moreover, patients initially with either type of AFib and residual burdens in the lowest range went on to have fewer cardioversions and repeat ablations (P < .01), Atul Verma, MD, McGill University Health Centre, Montreal, reported at the annual scientific sessions of the Heart Rhythm Society.
Dr. Verma, the trial’s principal investigator, is also lead author on the same-day publication of the secondary analysis in Heart Rhythm.
Binary endpoint lacks relevance
The PULSED-AF primary analysis defined ablation efficacy partly as freedom from AA recurrence lasting at least 30 seconds, with or without symptoms, a traditional AFib-ablation trial endpoint that is nonetheless considered clinically unhelpful.
The secondary analysis recasts that binary endpoint as degree of reduction in AFib burden, a continuous variable. That potentially allows AFib ablation efficacy to be assessed in a more nuanced way likely to be more meaningful to patients and the health care system, observed Dr. Verma and colleagues.
The “30-second endpoint” is limited in clinical usefulness and “doesn’t mean much to the patient,” he said at a press conference on the analysis before formally presenting it at the HRS sessions.
Recent AFib ablation trials have explored AA burden as possibly a superior way to assess the procedure’s success “but also to see if it’s better correlated with quality of life and health care outcomes,” Dr. Verma said. “So that’s exactly what we’ve tried to do here using the PULSED-AF data.”
In the secondary analysis, he said, patients’ rate of freedom from the 30-second endpoint was about 70%, but “more than 85% of them had an AFib burden of less than 10%.”
“This efficacy endpoint of 30 seconds of atrial arrhythmia has been challenged and has been seen clinically as insignificant,” agreed Rajeev Pathak, MBBS, PhD, of Australian National University and director of cardiac electrophysiology at Canberra (Australia) Hospital.
In AFib radiofrequency ablation and cryoablation studies “there is clear disconnect between these 30-second episodes of atrial arrhythmias we see and the clinical relevance of health care utilization and quality of life,” said Dr. Pathak, invited discussant for Dr. Verma’s presentation at the sessions.
Now an AFib ablation trial using PFA catheters has yielded similar results, finding AA burden to be “a more objective and relevant measure of success,” he said. “A 30-second endpoint is arbitrary, lacks significance, and is highly dependent on the monitoring strategy.”
The more you look, the more you see
The new secondary analysis included a demonstration that success rates based on the 30-second endpoint indeed vary depending on how subsequent arrhythmias are monitored.
As described by Dr. Verma, PULSED-AF data were assessed for the 30-second endpoint captured using three separate intermittent monitoring strategies that it and other recent ablation trials have used:
- Strategy A: Transtelephonic monitoring weekly and in the event of symptoms, plus 24-hour Holter monitoring at 6 and 12 months and 12-lead ECG at 3, 6, and 12 months
- Strategy B: Transtelephonic monitoring weekly and at symptoms for 3-6 months followed by monthly and at symptoms from 6 to 12 months, plus 24-hour Holter monitoring at 6 and 12 months, plus 12-lead ECG at 3, 6, and 12 months
- Strategy C: The median of two 24-hour Holter monitoring sessions per patient over 12 months
As Dr. Verma reported, rates of freedom from the 30-second endpoint climbed with successive monitoring strategies. The rates for PAF and persistent AFib patients, respectively, were: Strategy A – 70% and 62%, Strategy B – 71% and 68%, Strategy C – 91% and 86%.
“If you’re using the ‘freedom-from-30-seconds’ endpoint, the results that you are going to get are highly dependent on the monitoring strategy,” Dr. Verma said. “The more you look, the more you see.”
Valid estimation of burden
For the main PULSED-AF secondary analysis, the investigators defined AA burden according to findings on either Holter monitoring or the 12-lead ECG. “So as not to bias these results,” Dr. Verma said, “for every patient, we picked the method that gave us the highest atrial arrhythmia burden.”
Ideally, Dr. Verma said in an interview, arrhythmia burden would be determined using devices such as implantable loop recorders. “The problem is, this is expensive and not practical” in both clinical practice and many trials, so PULSED-AF investigators went with the intermittent monitoring strategy to estimate burdens.
Their method appears valid, he said, given that the study identified a statistically relevant 10% AA burden cut off for predicting quality of life improvement or less health care resource use.
“If their residual atrial arrhythmia burden was greater than 10%, they did not have a statistically significant improvement in quality of life,” Dr. Verma observed. And “very few” of them had cardioversions or repeat ablation.
“I couldn’t agree more” that residual AA burden is preferable to the 30-second endpoint for gauging AFib ablation success, Kenneth Ellenbogen, MD, Virginia Commonwealth University Medical Center, Richmond, said in an interview. Dr. Ellenbogen is also director of clinical cardiac electrophysiology and pacing at VCU Health Pauley Heart Center and not associated with PULSED-AF.
That AA burden was linked to health care resource use in the study “is absolutely brilliant,” he said, “because that’s what the bean counters really want at the end of the day. And as doctors we care about patients feeling better – improving quality of life.”
PULSED-AF was funded by Medtronic. Dr. Verma disclosed financial relationships with Bayer, Biosense Webster, Medtronic, Thermedical, Kardium, and Galaxy Medical, as well as and research grants from Adagio Medical. Dr. Ellenbogen disclosed financial relationships with Boston Scientific, Medtronic, Kestra, Hylomorph, Biotronik, MediLynx, Impulse Dynamics USA, Abbott, Biosense Webster, Milestone Pharmaceuticals, Sanofi, Medpace, and Elsevier. Dr. Pathak disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HRS 2023