Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

心房颤动医学烧蚀心脏病学内科学导管消融麻痹肺静脉卫生棉条外科病理替代医学

作者

Emmanuel Ekanem,NULL AUTHOR_ID,Tobias Reichlin,J Kautzner,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Yuri Blaauw,NULL AUTHOR_ID,Martin Fiala,NULL AUTHOR_ID,Gábor Széplaki,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Estelle Gandjbakhch,Douglas S. Scherr,NULL AUTHOR_ID,David Keane,Serge Bovéda,NULL AUTHOR_ID,Ignacio García-Bolao,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Antoine Lepillier,Yves Guyomar,NULL AUTHOR_ID,Jurren M. van Opstal,NULL AUTHOR_ID,NULL AUTHOR_ID,Philipp Sommer,NULL AUTHOR_ID,Joaquín Osca,NULL AUTHOR_ID,Antoine Roux,NULL AUTHOR_ID,Stefano Bianchi,NULL AUTHOR_ID,Francesco Solimene,NULL AUTHOR_ID,Antonio Dello Russo,NULL AUTHOR_ID,NULL AUTHOR_ID,Obaida R. Rana,Gerrit Frommeyer,NULL AUTHOR_ID,Ingo Kreis,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Samuel H. Baldinger,Ángel Ferrero,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Stefan G. Spitzer,NULL AUTHOR_ID,Abdul Shokor Parwani,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,P Reil,Thomas Arentz,NULL AUTHOR_ID,NULL AUTHOR_ID,Jonas S.S.G. de Jong,Reza Wakili,NULL AUTHOR_ID,Gottschling Timo,NULL AUTHOR_ID,NULL AUTHOR_ID,Bertrand Pierre,NULL AUTHOR_ID,NULL AUTHOR_ID,Cristina Lozano-Granero,Maximo Rivero,NULL AUTHOR_ID,J Inkovaara,Samir Fareh,Decebal Gabriel Laţcu,Dominik Linz,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Sakis Themistoclakis,NULL AUTHOR_ID,G Stix,NULL AUTHOR_ID,Jakub Baran,NULL AUTHOR_ID,NULL AUTHOR_ID,João de Sousa,Michalis Efremidis,Paweł Balsam,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Moritoshi Funasako,NULL AUTHOR_ID,NULL AUTHOR_ID,Julian Chun,Romain Eschalier,Anna Füting,NULL AUTHOR_ID,Pieter Koopman,NULL AUTHOR_ID,Martin Manninger,NULL AUTHOR_ID,Daniel O’Hare,Anne Rollin,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Andreas Rillig,NULL AUTHOR_ID,Claire Martin,NULL AUTHOR_ID,Karin Nentwich,NULL AUTHOR_ID,NULL AUTHOR_ID,NULL AUTHOR_ID,Mohit K. Turagam,NULL AUTHOR_ID

出处

期刊：Nature Medicine [Springer Nature]
日期：2024-07-01 卷期号：30 (7): 2020-2029 被引量：12

链接

nature.com nih.gov nih.govdoi.org

标识

DOI：10.1038/s41591-024-03114-3

摘要

Abstract Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

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Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

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