Pulsed field ablation for AF may reduce arrhythmia burden better than thermal ablation
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Key takeaways:
- Pulsed field ablation was linked to lower AF burden compared with thermal ablation at 1 year.
- Atrial arrhythmia burden less than 0.1% was linked to maximal quality of life and fewer returns to the hospital.
Pulsed field ablation lowered the odds of high residual atrial arrhythmia burden compared with thermal ablation for patients with atrial fibrillation at 1 year, according to a subanalysis of the ADVENT trial presented at Heart Rhythm 2024.
As Healio previously reported, in the main results of ADVENT, pulsed field ablation (Farapulse, Boston Scientific) was noninferior to thermal ablation (radiofrequency or cryoballoon ablation) for the primary efficacy endpoint of freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion or repeat ablation and for the primary safety endpoint of acute and chronic device- and procedure-related serious adverse events, but was associated with faster procedure times. The pulsed field ablation catheter was approved by the FDA in January.
The relevance of arrhythmia burden
“The problem with this ... is that the definition of success or failure is based on a 30-second cutoff for atrial fibrillation,” Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital and the Mount Sinai Health System and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn School of Medicine at Mount Sinai, who presented the results of the subanalysis, told Healio. “That 30 seconds is an arbitrary number, not based on any physiology or clinical outcomes. Given that there has been a lot of recent data indicating that AF burden may be a more relevant endpoint, we wanted to assess whether, with a burden cutoff using aggregate data, would we be able to find a cutoff value below which patients are not having symptoms, having the maximum quality of live, not going to the emergency room or getting cardioversions, etc? And then, if we could identify such a cutoff, to see whether, using that more clinically relevant definition of success or failure, would that success rate be different between the groups?”
The post hoc analysis, which was simultaneously published in the Journal of the American College of Cardiology, included 593 patients (mean age, 62 years; 34% women) with symptomatic paroxysmal AF enrolled in ADVENT who had failed at least one antiarrhythmic drug. Almost all were taking oral anticoagulation at baseline.
Reddy and colleagues determined than an atrial arrhythmia burden below 0.1% “was a good cutoff, below which there would be the maximum amount of quality of life and minimal utilization of resources,” he told Healio. “On the other hand, if it was above 0.1%, there was not as much of an increase in quality of life, and patients were utilizing health care resources more: more cardioversions, more redo procedures, more hospital visits, etc. A cutoff of 0.1% burden is a more robust and clinically relevant endpoint. This makes sense because the more you are in AF, the more negative the hemodynamic impact and other factors can affect the body. There are large studies indicating that burden correlates with mortality. For example, in patients with heart failure, burden correlates with mortality and heart failure hospitalization after AF ablation.”
Possible superiority
Patients assigned pulsed field ablation were more likely to achieve atrial arrhythmia burden less than 0.1% compared with those assigned thermal ablation (OR = 1.5; 95% CI, 1-2.3; P = .04), according to the researchers.
The between-group difference was most pronounced for patients who had failed class I or III antiarrhythmic drugs (OR = 2.5; 95% CI, 1.4-4.3; P = .002), and was not significant in patients who had failed class II or IV antiarrhythmic drugs (P for interaction = .012), according to the researchers.
The results “suggest that pulsed field ablation is superior, not just on safety, but even on effectiveness,” Reddy told Healio. “I hope this helps pave the road for even more studies like this, so we can move to a burden cutoff as the definition of success or failure in future AF trials.”
Reference:
For more information:
Vivek Y. Reddy, MD, can be reached at vivek.reddy@mountsinai.org.
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Reddy VY, et al. Late-breaking clinical trials and science – ablation. Presented at: Heart Rhythm 2024; May 16-19, 2024; Boston.
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