Scientific publications
Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
Emmanuel Ekanem 1 2 , Petr Neuzil 3 , Tobias Reichlin 4 , Joseph Kautzner 5 , Pepijn van der Voort 6 , Pierre Jais 7 , Gian-Battista Chierchia 8 , Alan Bulava 9 , Yuri Blaauw 10 , Tomas Skala 11 , Martin Fiala 12 , Mattias Duytschaever 13 , Gabor Szeplaki 14 15 , Boris Schmidt 16 , Grégoire Massoullie 17 , Kars Neven 18 19 , Olivier Thomas 20 , Johan Vijgen 21 , Estelle Gandjbakhch 22 , Daniel Scherr 23 , Arne Johannessen 24 , David Keane 25 , Serge Boveda 26 27 , Philippe Maury 28 , Ignacio García-Bolao 29 30 , Ante Anic 31 , Peter Steen Hansen 32 , Franck Raczka 33 , Antoine Lepillier 34 , Yves Guyomar 35 , Dhiraj Gupta 36 , Jurren Van Opstal 37 , Pascal Defaye 38 , Christian Sticherling 39 , Philipp Sommer 40 , Pavel Kucera 41 , Joaquin Osca 42 , Fariborz Tabrizi 43 , Antoine Roux 44 , Michael Gramlich 45 , Stefano Bianchi 46 , Pedro Adragão 47 , Francesco Solimene 48 , Claudio Tondo 49 , Antonio Dello Russo 50 51 , Jürgen Schreieck 52 , Armin Luik 53 , Obaida Rana 54 , Gerrit Frommeyer 55 , Frédéric Anselme 56 , Ingo Kreis 57 , Raphael Rosso 58 , Andreas Metzner 59 , Laszlo Geller 60 , Samuel H Baldinger 61 , Angel Ferrero 62 , Stephan Willems 63 , Andreas Goette 64 65 66 , Greg Mellor 67 , Shibu Mathew 68 , Lukasz Szumowski 69 , Roland Tilz 70 71 , Saverio Iacopino 72 , Peter Karl Jacobsen 73 , Andrikopoulos George 74 , Pavel Osmancik 75 , Stefan Spitzer 76 , Richard Balasubramaniam 77 , Abdul Shokor Parwani 78 , Thomas Deneke 79 , Andrzej Glowniak 80 , Antonio Rossillo 81 , Helmut Pürerfellner 82 , David Duncker 83 , Peter Reil 84 , Thomas Arentz 85 , Daniel Steven 86 87 , Juan José Olalla 88 , Jonas S S G de Jong 89 , Reza Wakili 90 91 , Selim Abbey 92 , Gottschling Timo 93 , Antonio Asso 94 , Tom Wong 95 , Bertrand Pierre 96 , Niels Christian Ewertsen 97 , Leonard Bergau 98 , Cristina Lozano-Granero 99 , Maximo Rivero 100 , Alexander Breitenstein 101 , Jaakko Inkovaara 102 , Samir Fareh 103 , Decebal Gabriel Latcu 104 , Dominik Linz 105 106 , Patrick Müller 107 , Javier Ramos-Maqueda 108 109 , Thomas Beiert 110 , Sakis Themistoclakis 111 , Dirk Grosse Meininghaus 112 , Günter Stix 113 , Stylianos Tzeis 114 , Jakub Baran 115 , Henrik Almroth 116 , Daniel Rodriguez Munoz 117 , João de Sousa 118 , Michalis Efremidis 119 , Pawel Balsam 120 , Jan Petru 3 , Thomas Küffer 4 , Petr Peichl 5 , Lukas Dekker 6 , Domenico G Della Rocca 8 , Ondrej Moravec 11 , Moritoshi Funasako 12 , Sebastien Knecht 13 , Gael Jauvert 14 , Julian Chun 16 , Romain Eschalier 17 , Anna Füting 18 19 , Alexandre Zhao 20 , Pieter Koopman 21 , Mikael Laredo 22 , Martin Manninger 23 , Jim Hansen 24 , Daniel O'Hare 25 , Anne Rollin 28 , Zrinka Jurisic 31 , Thomas Fink 40 , Corentin Chaumont 56 , Andreas Rillig 59 , Melanie Gunawerdene 63 , Claire Martin 67 , Bettina Kirstein 70 71 , Karin Nentwich 79 , Heiko Lehrmann 85 , Arian Sultan 86 87 , Jan Bohnen 90 91 , Mohit K Turagam 1 , Vivek Y Reddy 121 122
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.
CITATION Nat Med. 2024 Jul 8. doi: 10.1038/s41591-024-03114-3
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