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

This study assessed the safety of pulsed field ablation (PFA) in 17,642 patients with atrial fibrillation. No esophageal complications, pulmonary vein stenosis, or persistent phrenic palsy were reported. Major complications (0.98%) included pericardial tamponade (0.36%) and vascular events (0.30%). Stroke was rare (0.12%), and death was even rarer (0.03%). Unexpected complications included coronary arterial spasm (0.14%) and hemolysis-related acute renal failure (0.03%). The data suggest PFA has a favorable safety profile compared to conventional thermal ablation.

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 Szeplak, Boris Schmidt, Grégoire Massoullie, Kars Neven, Oliver 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, Jürgen Schreieck, Armin Luik, Obaida Rana, Francesco Solimene, Claudio Tondo, Antonio Dello Russo, Stefano Bianchi, Pedro Adragão, 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 lacopino, Peter Karl Jacobsen, Andrikopoulos George, Pavel Osmancik, Stefan Spitzer, Richard Balasubramaniam, Abdul Shokor Parwani, Thomas Deneke, Andrzej Glowniak, Antonio Rossi, 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