Publication details

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 PEPIJN van der Voort JAIS Pierre CHIERCHIA Gian-Battista BULAVA Alan BLAAUW Yuri SKALA Tomas FIALA Martin DUYTSCHAEVER Mattias SZEPLAKI Gabor SCHMIDT Boris MASSOULLIE Gregoire NEVEN Kars OLIVIER Thomas VIJGEN Johan GANDJBAKHCH Estelle SCHERR Daniel JOHANNESSEN Arne KEANE David BOVEDA Serge MAURY Philippe GARCIA-BOLAO Ignacio ANIC Ante HANSEN Peter Steen RACZKA Franck LEPILLIER Antoine GUYOMAR Yves GUPTA Dhiraj JURREN Van Opstal DEFAYE Pascal STICHERLING Christian SOMMER Philipp KUCERA Pavel OSCA Joaquin TABRIZI Fariborz ROUX Antoine GRAMLICH Michael BIANCHI Stefano ADRAGAO Pedro SOLIMENE Francesco TONDO Claudio RUSSO Antonio Dello SCHREIECK Juergen LUIK Armin RANA Obaida FROMMEYER Gerrit ANSELME Frederic 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 PUERERFELLNER Helmut DUNCKER David REIL Peter ARENTZ Thomas STEVEN Daniel OLALLA Juan Jose 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 MUELLER Patrick RAMOS-MAQUEDA Javier BEIERT Thomas THEMISTOCLAKIS Sakis MEININGHAUS Dirk Grosse STIX Guenter TZEIS Stylianos BARAN Jakub ALMROTH Henrik MUNOZ Daniel Rodriguez JOAO de Sousa EFREMIDIS Michalis BALSAM Pawel PETRU Jan KUEFFER Thomas PEICHL Petr DEKKER Lukas DELLA ROCCA Domenico G MORAVEC Ondrej FUNASAKO Moritoshi KNECHT Sebastien JAUVERT Gael CHUN Julian ESCHALIER Romain FUETING Anna ZHAO Alexandre KOOPMAN Pieter LAREDO Mikael MANNINGER Martin HANSEN Jim 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
Year of publication	2024
Type	Article in Periodical
Magazine / Source	Nature Medicine
MU Faculty or unit	Faculty of Medicine
Citation
Web	https://www.nature.com/articles/s41591-024-03114-3
Doi	http://dx.doi.org/10.1038/s41591-024-03114-3
Keywords	atrial fibrillation; pulsed field ablation
Description	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 similar to 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.