Key result
Pulsed field ablation yields ~75% 1-year arrhythmia-free survival in paroxysmal AF with minimal thermal injury.
Why the study?
Pulsed field ablation has rapidly advanced from an experimental modality to a front-line therapy for AF, with recent FDA approvals expanding platforms from single-shot systems toward focal and hybrid ablation strategies.
Does pulsed field ablation using FDA-approved single-shot, focal, and hybrid platforms improve arrhythmia-free survival and procedural safety compared to thermal ablation in patients with atrial fibrillation?
Does pulsed field ablation using FDA-approved single-shot, focal, and hybrid platforms improve arrhythmia-free survival and procedural safety compared to thermal ablation in patients with atrial fibrillation?
This review highlights the rapid evolution of FDA-approved pulsed field ablation platforms from single-shot pulmonary vein isolation tools to versatile focal and hybrid RF-PFA systems that offer high acute efficacy and superior tissue-selective safety compared to traditional thermal ablation.
PFA platforms may enhance safety in paroxysmal AF procedures; extends RCT and registry data to focal/hybrid systems but leaves comparative durability open.
Pulsed field ablation (PFA) has rapidly advanced from an experimental modality to a front-line therapy for catheter ablation of atrial fibrillation (AF). Unlike thermal approaches such as radiofrequency (RF) or cryoablation, PFA relies on irreversible electroporation, producing rapid and selective myocardial lesions with minimal risk of collateral injury. This review examines the contemporary landscape of PFA technology, with emphasis on recent United States Food and Drug Administration (FDA) approvals that have expanded PFA from single-energy, single-shot systems toward focal and hybrid ablation strategies. Particular focus is placed on FDA-approved platforms, including PulseSelect™ (Medtronic, Minneapolis, MN, USA), FARAPULSE™ (Boston Scientific, Marlborough, MA, USA), and VARIPULSE™ (Biosense Webster, Diamond Bar, CA, USA), as well as next-generation systems such as the Affera Sphere-9™ dual-energy RF-PFA platform (Medtronic) and the Volt™ focal PFA system (Abbott, Chicago, IL, USA). Differences in catheter design, energy delivery, workflow, mapping integration, regulatory labeling, and clinical outcomes are reviewed. By contextualizing these platforms within evolving ablation strategies, this review highlights a second evolutionary phase of PFA focused on procedural flexibility, lesion durability, and integration with established electrophysiology (EP) workflows, with implications for future AF management and EP lab practice.
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AMAR et al. (2026) conducted a review in Atrial fibrillation. Pulsed field ablation (PulseSelect, FARAPULSE, VARIPULSE, Affera Sphere-9, Volt) vs. Thermal ablation (radiofrequency or cryoablation) was evaluated on 12-month arrhythmia-free survival following pulmonary vein isolation for paroxysmal atrial fibrillation. Pulsed field ablation platforms achieve >95% acute pulmonary vein isolation and 70%–80% 12-month arrhythmia-free survival in paroxysmal atrial fibrillation with minimal collateral thermal injury.
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