Controversy - Pulsed Field Ablation Is the Standard Technique for All the Candidates for Atrial Fibrillation Ablation

Sep 28, 2026

Pulsed field ablation (PFA) is highlighted as a major technological advance for atrial fibrillation therapy, using irreversible electroporation to create rapid myocardial lesions and enabling pulmonary vein isolation within milliseconds. Early IDE trial data and large real-world MANIFEST-17 K registry results report non-inferior arrhythmia-free outcomes and very low major complication rates, supporting wider adoption. The controversy examines emerging evidence gaps on lesion durability, non-pulmonary targets, and PFA-specific risks such as transient atrial dysfunction, hemolysis, and coronary spasm, questioning whether PFA is already the universal standard for all candidates.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages15

Reading Time38 min

AccessFree to download

Introduction

Pulsed Field Ablation and Emerging Evidence

Clinical Outcomes and Registry Data

Mechanistic Factors Affecting Lesion Formation

Complications and Safety Vigilance

The Central Controversy: Standard Technique or Refinement Needed

Europace (2025) 27, euaf326 [https://doi.org/10.1093/europace/euaf326](https://doi.org/10.1093/europace/euaf326) CONTROVERSY Controversy: pulsed field ablation is the standard technique for all the candidates for atrial fibrillation ablation Luigi Di Biase 1*, Fengwei Zou 1, Waël Zaher 2,3, Jalaj Garg 4, Serge Boveda 2,3*, and Dhanunjaya Lakkireddy 5* 1Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, 111 E 210th street, Bronx, NY 10467, USA; 2Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Heart Rhythm Research Brussels, Postgraduate Program in Cardiac Electrophysiology and Pacing, Vrije Universiteit Brussel, Brussels, Belgium; 3Heart Rhythm Management Department, Clinique Pasteur, 45 Avenue de Lombez, Toulouse 31076, France; 4Division of Cardiology, Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA 92354, USA; and 5Kansas City Heart Rhythm Institute, University of Missouri-Columbia, HCA Midwest Health, 10500, West 105th Street, Suite 200, Overland Park, KS 661215, USA Received 27 October 2025; accepted after revision 10 December 2025; online publish-ahead-of-print 24 December 2025 Pulsed field ablation (PFA) represents one of the most significant technological advances in atrial fibrillation (AF) therapy in recent decades. By harnessing irreversible electroporation, PFA produces myocardial lesions within milliseconds, enabling rapid and efficient pulmonary vein (PV) isolation. Early clinical experience from pivotal investigational device exemption (IDE) trials has shown acute and one-year arrhythmia-free outcomes that are non-inferior to conventional radiofrequency (RF) and cryothermal ablation. The large MANIFEST-17 K registry, encompassing over 17 000 patients treated with the Farawave system, reported an exceptionally low 0.98% major complication rate with no atrio-oesophageal fistula, phrenic nerve injury, or PV stenosis. These findings have accelerated PFA adoption across many centres. However, as experience broadens, nuances in lesion formation and durability are becoming evident. Factors such as contact force, catheter rotation, pulse train configuration, and target tissue geometry influence lesion depth and transmurality. While PV isolation appears consistently durable, data remain limited for non-PV targets such as the posterior wall, mitral isthmus, and cavotricuspid isthmus. Moreover, novel PFA-specific complications including transient left atrial dysfunction, haemolysis, and coronary artery spasm warrant ongoing vigilance. PFA has undoubtedly transformed expectations for procedural safety and efficiency. Yet whether it should already be considered the standard technique for all AF ablation candidates remains an open question. This Controversy piece explores the balance between innovation and evidence, examining whether PFA’s rapid rise represents the inevitable new standard or a technology still undergoing critical refinement. * Corresponding author. Tel: +1 718-920-4321. E-mail address: [dibbia@gmail.com](dibbia@gmail.com) (L.D.); E-mail address: [sboveda@clinique-pasteur.com](sboveda@clinique-pasteur.com) (S.B.); Tel: +1 913-588-9681. E-mail address: [dhanunjaya.lakkireddy@hcahealthcare.com](dhanunjaya.lakkireddy@hcahealthcare.com) (D.L.) © The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ([https://creativecommons.org/licenses/by/4.0/](https://creativecommons.org/licenses/by/4.0/)), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. Graphical Abstract Pulsed field ablation is the standard technique for all candidates of atrial fibrillation ablation? Effective in achieving PVI compared to thermal ablation without catastrophic complications e.g. atrio-esophageal fistula or PV s

FAQs

What is pulsed field ablation (PFA) and why is it considered a significant advance in AF therapy?

PFA uses irreversible electroporation to create myocardial lesions within milliseconds, enabling rapid pulmonary vein isolation and aiming for procedural safety and efficiency improvements.

What do early trials and the MANIFEST-17 K registry indicate about outcomes and major complications?

IDE trial experience and the MANIFEST-17 K registry report acute and one-year arrhythmia-free outcomes that are non-inferior to conventional radiofrequency and cryothermal ablation, alongside an exceptionally low major complication rate without atrio-oesophageal fistula, phrenic nerve injury, or PV stenosis.

What evidence gaps and PFA-specific complications are emphasized in the controversy?

Durability data remain limited for non-PV targets such as the posterior wall, mitral isthmus, and cavotricuspid isthmus, and PFA-specific complications including transient left atrial dysfunction, hemolysis, and coronary artery spasm are highlighted for ongoing vigilance.

Sep 28, 2026

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