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

AbstractPulsed 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.