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

2024; Nature Portfolio; Volume: 30; Issue: 7 Linguagem: Inglês

10.1038/s41591-024-03114-3

1546-170X

Emmanuel Ekanem, Petr Neužil, Tobias Reichlin, J Kautzner, Pepijn van der Voort, Pierre Jaı̈s, Gian‐Battista Chierchia, Alan Bulava, Yuri Blaauw, Tomáš Skála, Martin Fiala, Mattias Duytschaever, Gábor Széplaki, Boris Schmidt, Grégoire Massoullié, Kars Neven, Olivier Thomas, Johan Vijgen, Estelle Gandjbakhch, Douglas S. Scherr, Arne Johannessen, David Keane, Serge Bovéda, Philippe Maury, Ignacio García-Bolao, Ante Anić, Peter S. Hansen, Franck Raczka, Antoine Lepillier, Yves Guyomar, Dhiraj Gupta, Jurren M. van Opstal, Pascal Defaye, Christian Sticherling, Philipp Sommer, Pavel Kučera, Joaquín Osca, Fariborz Tabrizi, Antoine Roux, Michael W. Gramlich, Stefano Bianchi, Pedro Adragão, Francesco Solimene, Claudio Tondo, Antonio Dello Russo, Jürgen Schreieck, Armin Luik, Obaida R. Rana, Gerrit Frommeyer, Frédéric Anselme, Ingo Kreis, Raphaël Rosso, Andreas Metzner, László Gellér, Samuel H. Baldinger, Ángel Ferrero, Stephan Willems, Andreas Goette, Greg Mellor, Shibu Mathew, Łukasz Szumowski, Roland Richard Tilz, Saverio Iacopino, Peter Karl Jacobsen, Antony George, Pavel Osmančík, Stefan G. Spitzer, Richard Balasubramaniam, Abdul Shokor Parwani, Thomas Deneke, Andrzej Główniak, Antonio Rossillo, Helmut Pürerfellner, David Duncker, P Reil, Thomas Arentz, Daniel Steven, Juan J. Olalla, Jonas S.S.G. de Jong, Reza Wakili, Sélim Abbey, Gottschling Timo, Antonio Asso, Tom Wong, Bertrand Pierre, Niels Christian Ewertsen, Leonard Bergau, Cristina Lozano-Granero, Maximo Rivero, Alexander Breitenstein, J Inkovaara, Samir Fareh, Decebal Gabriel Lațcu, Dominik Linz, Patrick Müller, Javier Ramos‐Maqueda, Thomas Beiert, Sakis Themistoclakis, Dirk Große Meininghaus, G Stix, Stylianos Tzeis, Jakub Baran, Henrik Almroth, Daniel Muñoz, João de Sousa, Michalis Efremidis, Paweł Balsam, Jan Petrů, Thomas Küffer, Petr Peichl, Henk L. Dekker, Domenico G. Della Rocca, Ondřej Moravec, Moritoshi Funasako, Sébastien Knecht, Gael Jauvert, Julian Chun, Romain Eschalier, Anna Füting, Alexandre Zhao, Pieter Koopman, Mikaël Laredo, Martin Manninger, Jim Hansen, Daniel O’Hare, Anne Rollin, Zrinka Jurišić, Thomas Fink, Corentin Chaumont, Andreas Rillig, Melanie Gunawerdene, Claire Martin, Bettina Kirstein, Karin Nentwich, Heiko Lehrmann, Arian Sultan, Jan Bohnen, Mohit K. Turagam, Vivek Y. Reddy,

Cardiac electrophysiology and arrhythmias

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.