Scientific publications

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

Jul 8, 2024 | Magazine: Nature Medicine

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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