Vivek Reddy, MD
Patients with atrial fibrillation (AF) undergoing a first ablation using the pentaspline pulsed-field ablation (PFA) catheter had a “1 year of freedom from an AF” recurrence rate of 78%, according to results from the MANIFEST-PF registry. Vivek Reddy, MD, presented these findings at the 2023 European Heart Rhythm Association (EHRA) in Barcelona, Spain1.
The study included 1,568 patients who underwent first-time PFA for AF. The primary effectiveness outcome was freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence of 30 seconds or more, with a median follow-up time of 367 days.
The primary outcome showed a success rate of 78.1% after 12 months of follow-up. Dr. Reddy noted that the success rate was higher in patients with paroxysmal AF than in patients with persistent AF (81.6% vs 71.5%; logrank, P=0.001). Additionally, he pointed out that patient age greater than 65, a left atrial diameter greater than 45 mm, a left ventricular ejection fraction of 50% or less, a procedure time greater than 60 minutes, and persistent AF were independent risk factors for primary efficacy failure (P<0.001 for all).
For the secondary endpoint of freedom from AF/AFL/AT or antiarrhythmic drugs or redo ablation, the success rate was 70.8% after 12 months. The safety profile of the PFA catheter was satisfactory, according to Dr. Reddy, with no reported cases of esophageal damage or pulmonary vein stenosis. Major adverse events occurred in 1.9% of patients.
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