Pulsed Field Ablation for Persistent Atrial Fibrillation
Vivek Y. Reddy, Edward P. Gerstenfeld, Boris Schmidt, Devi Nair, Andrea Natale, Walid I. Saliba, Atul Verma, Philipp Sommer, Andreas Metzner, Mohit K. Turagam, Stanislav Weiner, Jean Champagne, Ignacio Garcio-Bolao, Hugh Calkins, Jeffrey L. Olson, Ziad F. Issa, Marshall Winner, Wilber Su, Gery Tomassoni, Jamie Kim, Bruce G. Hook, David B. DeLurgio, Douglas Gibson, Marcos Daccarett, Chinmay Patel, Karan Bhalla, Michael Shehata, John D. Harding, Jim W. Cheung, Jonathan D. Raybuck, Stephanie Roelke, Torri Schwartz, Brad Sutton, Moussa Mansour, William Whang, Vivek Reddy, Jacob Koruth, Srinivas Dukkipati, David DeLurgio, Anshul Patel, Jose Osorio, Anil Rajendra, Gustavo Morales, Jean Champagne, Isabelle Nault, Jean-François Sarrazin, Benjamin D'Souza, John Bullinga, Frank Cuoco, Darren Sidney, Marcos Daccarett, John Harding, Robert Sangrigoli, Robert Pickett, Daniel Kaiser, Andrea Natale, Joseph Gallinghouse, Sanjaya Gupta, Daniel Steinhaus, Moussa Mansour, Kevin Heist, Nathan Van Houzen, Jeffrey Winterfield, Michael Field, Tom McElderry, William Maddox, Larry Chinitz, Douglas Holmes, Hugh Calkins, David Spragg, Zayd Eldadah, Sung Lee, Athanasios Thomaides, Michael Mangrum, Douglas Gibson, Nicholas Olson, Christopher Woods, Amir Schricker, Christopher Ellis, Gregory Michaud, Edward Gerstenfeld, Joshua David Moss, Thomas Dewland, Stavros Mountantonakis, Nicholas Skipitaris, Kabir Bhasin, Wilber Su, Michael Zawaneh, Jonathan P. Weiss, Pasquale Santangeli, David Lin, Jamie Kim, Connor Haugh, Matthew Latacha, Chinmay Patel, Michael Link, Kenneth Ellenbogen, Jayanthi Koneru, Blair Halperin, D. Randolph Jones
Abstract
BACKGROUND: Pulsed field ablation (PFA) has gained prominence for pulmonary vein isolation (PVI) to treat atrial fibrillation, but there are limited outcome data on PFA to treat persistent atrial fibrillation (PerAF). 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).