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Multicenter Study
. 2025 May 6;85(17):1664-1678.
doi: 10.1016/j.jacc.2025.03.515.

Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF

Vivek Y Reddy  1 , Edward P Gerstenfeld  2 , Boris Schmidt  3 , Devi Nair  4 , Andrea Natale  5 , Walid Saliba  6 , Atul Verma  7 , Philipp Sommer  8 , Andreas Metzner  9 , Mohit Turagam  10 , Stanislav Weiner  11 , Jean Champagne  12 , Ignacio Garcio-Bolao  13 , Hugh Calkins  14 , Jeffrey Olson  15 , Ziad Issa  16 , Marshall Winner  17 , Wilber Su  18 , Gery Tomassoni  19 , Jamie Kim  20 , Bruce Hook  21 , David B Delurgio  22 , Douglas N Gibson  23 , Marcos Daccarett  24 , Chinmay Patel  25 , Karan Bhalla  26 , Michael Shehata  27 , John D Harding  28 , Jim W Cheung  29 , Jonathan D Raybuck  30 , Stephanie Roelke  30 , Torri Schwartz  30 , Brad S Sutton  30 , Moussa Mansour  31 ; ADVANTAGE-AF Investigators
Collaborators, Affiliations
Free article
Multicenter Study

Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF

Vivek Y Reddy et al. J Am Coll Cardiol. .
Free article

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).

Keywords: arrhythmia burden; persistent atrial fibrillation; posterior wall ablation; pulsed field ablation.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by Boston Scientific. Dr Reddy owns equity in Farapulse (now divested); has received grant support from and served as an unpaid consultant for Boston Scientific; unrelated to this manuscript, has served as a consultant for and owns equity in Ablacon-Cortex, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Append Medical, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Laminar Medical, LuxMed, Medlumics, Nuvera-Biosense Webster, Oracle Health, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath, and Volta Medical; unrelated to this work, has served as a consultant for Abbott, Adagio Medical, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, and Philips; and unrelated to this work, owns equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Soundcath, Surecor, and Vizaramed. Dr Gerstenfeld has served as a consultant for Boston Scientific, Biosense Webster, and Adagio Medical; has received lecture honoraria from Boston Scientific, Medtronic, Biosense Webster, Adagio Medical, and Abbott; and has received research grants from Abbott, Biosense Webster, and Adagio Medical. Dr Schmidt has served as a consultant for and received honoraria and research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. Dr Nair has served as a consultant for and has received research grants from Boston Scientific, Abbott, Medtronic, J&J MedTech, Atraverse, Siemens, and Volta. Dr Natale has served as a consultant for Abbott, Biosense Webster, Biotronik, Boston Scientific, iRhythm, Field Medicine, Medtronic, and Pulse Bioselect. Dr Saliba has served as a consultant for Boston Scientific, Biosense Webster, Volta, Siemens, and Philips. Dr Verma has served as a consultant for and has received grants from Johnson & Johnson, Medtronic, Abbott, and Medlumics. Dr Sommer has served as a consultant for Abbott, Boston Scientific, J&J MedTech, and Medtronic. Dr Metzner has served as a consultant for Medtronic, Boston Scientific, and Biosense Webster. Dr Turagam has served as a consultant for Biosense Webster, Boston Scientific, Medtronic, Abbott, and Sanofi. Dr Weiner has served as a consultant/advisor for Boston Scientific and Medtronic. Dr Garcio-Bolao has received speaker and proctor fees from Abbott and BSCI. Dr Calkins has served as a consultant for Johnson & Johnson, Abbott, Medtronic, and Boston Scientific. Dr Tomassoni has served as a speaker or consultant for BSC, Atricure, Haemonitics, S4, Impulse Dynamics, and Zoll. Dr Kim has served as a consultant for Boston Scientific and Biosense Webster. Dr Harding has served as a consultant for Medtronic. Dr Cheung has served as a consultant for Abbott, Biosense Webster, and Medtronic; has received research support from Boston Scientific; and has received fellowship grant support from Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Raybuck, Ms Roelke, Ms Schwartz, and Dr Sutton are employees of Boston Scientific. Dr Mansour has served as a consultant for Boston Scientific, Biosense Webster, Abbott, Medtronic, Siemens, and SentreHeart/Atricure; and owns equity in EPD-Philips (divested) and NewPace Ltd. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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