Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF.
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Reddy Vivek Y, Gerstenfeld Edward P, Schmidt Boris, Nair Devi, Natale Andrea, Saliba Walid, Verma Atul, Sommer Philipp, Metzner Andreas, Turagam Mohit, Weiner Stanislav, Champagne Jean, Garcio-Bolao Ignacio, Calkins Hugh, Olson Jeffrey, Issa Ziad, Winner Marshall, Su Wilber, Tomassoni Gery, Kim Jamie, Hook Bruce, Delurgio David B, Gibson Douglas N, Daccarett Marcos, Patel Chinmay, Bhalla Karan, Shehata Michael, Harding John D, Cheung Jim W, Raybuck Jonathan D, Roelke Stephanie, Schwartz Torri, Sutton Brad S, Mansour Moussa, ADVANTAGE-AF Investigators
Аннотация
OBJECTIVES: This study sought to determine the safety and efficacy of PVI + posterior wall ablation (PWA) with PFA in PerAF.
METHODS: ADVANTAGE AF (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation) is a prospective, single-arm, multicenter pivotal investigational device exemption study of PerAF patients undergoing PVI+PWA with the pentaspline PFA catheter. One-year follow-up included 24-hour Holter monitoring at 6 and 12 months and twice monthly and symptomatic transtelephonic monitoring. The primary safety endpoint was incidence of predefined adverse events. The primary effectiveness endpoint included acute success and postblanking 1-year freedom from atrial tachyarrhythmia recurrence (>30 seconds), redo ablation, cardioversion, or antiarrhythmic drug escalation. Endpoint analysis used Kaplan-Meier methodology with 97.5% 1-sided confidence limits compared with a 12% safety and 40% effectiveness goals, with 85% power.
RESULTS: PFA in 339 patients (260 treatment and 79 roll-in) resulted in 99.7% success for both PVI and PWA. The primary safety endpoint was 2.3% (5.1% upper confidence limit), including 1 with pericarditis, 1 with myocardial infarction, and 4 with pulmonary edema; no tamponade, stroke, pulmonary vein stenosis, or esophageal fistula occurred. Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation recurrence. Freedom from symptomatic atrial fibrillation was 85.3%; efficacy varied by operator experience.
CONCLUSIONS: ADVANTAGE AF, the first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness outcomes. (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation [ADVANTAGE AF]; NCT05443594).