Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
Authors: Emmanuel Ekanem, Petr Neuzil, Tobias Reichlin, Joseph Kautzner, Pepijn van der Voort, Pierre Jais, Gian-Battista Chierchia, Alan Bulava, Yuri Blaauw, Tomas Skala, Martin Fiala, Mattias Duytschaever, Gabor Szeplaki, Boris Schmidt, Grégoire Massoullie, Kars Neven, Olivier Thomas, Johan Vijgen, Estelle Gandjbakhch, Daniel Scherr, Arne Johannessen, David Keane, Serge Boveda, Philippe Maury, Ignacio García-Bolao, Ante Anic, Peter Steen Hansen, Franck Raczka, Antoine Lepillier, Yves Guyomar, Dhiraj Gupta, Jurren Van Opstal, Pascal Defaye, Christian Sticherling, Philipp Sommer, Pavel Kucera, Joaquin Osca, Fariborz Tabrizi, Antoine Roux, Michael Gramlich, Stefano Bianchi, Pedro Adragão, Francesco Solimene, Claudio Tondo, Antonio Dello Russo, Jürgen Schreieck, Armin Luik, Obaida Rana, Gerrit Frommeyer, Frédéric Anselme, Ingo Kreis, Raphael Rosso, Andreas Metzner, Laszlo Geller, Samuel H. Baldinger, Angel Ferrero, Stephan Willems, Andreas Goette, Greg Mellor, Shibu Mathew, Lukasz Szumowski, Roland Tilz, Saverio Iacopino, Peter Karl Jacobsen, Andrikopoulos George, Pavel Osmancik, Stefan Spitzer, Richard Balasubramaniam, Abdul Shokor Parwani, Thomas Deneke, Andrzej Glowniak, Antonio Rossillo, Helmut Pürerfellner, David Duncker, Peter Reil, Thomas Arentz, Daniel Steven, Juan José Olalla, Jonas S. S. G. de Jong, Reza Wakili, Selim Abbey, Gottschling Timo, Antonio Asso, Tom Wong, Bertrand Pierre, Niels Christian Ewertsen, Leonard Bergau, Cristina Lozano-Granero, Maximo Rivero, Alexander Breitenstein, Jaakko Inkovaara, Samir Fareh, Decebal Gabriel Latcu, Dominik Linz, Patrick Müller, Javier Ramos-Maqueda, Thomas Beiert, Sakis Themistoclakis, Dirk Grosse Meininghaus, Günter Stix, Stylianos Tzeis, Jakub Baran, Henrik Almroth, Daniel Rodriguez Munoz, João de Sousa, Michalis Efremidis, Pawel Balsam, Jan Petru, Thomas Küffer, Petr Peichl, Lukas Dekker, Domenico G. Della Rocca, Ondrej Moravec, Moritoshi Funasako, Sebastien Knecht, Gael Jauvert, Julian Chun, Romain Eschalier, Anna Füting, Alexandre Zhao, Pieter Koopman, Mikael Laredo, Martin Manninger, Jim Hansen, Daniel O’Hare, Anne Rollin, Zrinka Jurisic, 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
Journal: Nature Medicine (2024)

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.