Treatment of atrial fibrillation (AF) with catheter ablation using pulsed field energy appears to be beneficial in more than three-fourths of patients, as shown in a study.
The study used data from MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation), which included 1,568 patients who underwent postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat AF between 2021 and 2022.
The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds, assessed using electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety endpoint was the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events.
The mean age of the cohort was 64.5 years, with 35 percent of the participants being women and 65 percent/32 percent having paroxysmal/persistent AF. The mean CHA2DS2-VASc was 2.2, median left ventricular ejection fraction was 60 percent, and left atrial diameter was 42 mm.
Treatment led to the achievement of pulmonary vein isolation in 99.2 percent of patients. The median follow-up was 367 days.
The Kaplan-Meier estimate for freedom from atrial arrhythmia at 1 year was 78.1 percent (95 percent confidence interval, 76.0–80.0). Of note, significantly more patients with paroxysmal AF achieved clinical effectiveness than those with persistent AF (81.6 percent vs 71.5 percent; p=0.001).
In terms of safety, acute major adverse events occurred in 1.9 percent of patients.