Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry

医学 心房颤动 烧蚀 心脏病学 内科学 导管消融 肺静脉 房性心动过速 心房扑动 四分位间距 射血分数 心力衰竭
作者
Mohit K. Turagam,Petr Neužil,Boris Schmidt,Tobias Reichlin,Kars Neven,Andreas Metzner,Jim Hansen,Yuri Blaauw,Philippe Maury,Thomas Arentz,Philipp Sommer,Ante Anić,Frédéric Anselme,Serge Boveda,Tom Deneke,Stephan Willems,Pepijn van der Voort,Roland Richard Tilz,Moritoshi Funasako,Daniel Scherr
出处
期刊:Circulation [Lippincott Williams & Wilkins]
卷期号:148 (1): 35-46 被引量:326
标识
DOI:10.1161/circulationaha.123.064959
摘要

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: =0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.
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