J 2024

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

EKANEM, Emmanuel, Petr NEUZIL, Tobias REICHLIN, Joseph KAUTZNER, van der Voort PEPIJN et. al.

Basic information

Original name

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

Authors

EKANEM, Emmanuel, Petr NEUZIL, Tobias REICHLIN, Joseph KAUTZNER, van der Voort PEPIJN, Pierre JAIS, Gian-Battista CHIERCHIA, Alan BULAVA, Yuri BLAAUW, Tomas SKALA (203 Czech Republic), Martin FIALA (203 Czech Republic, belonging to the institution), Mattias DUYTSCHAEVER, Gabor SZEPLAKI, Boris SCHMIDT, Gregoire MASSOULLIE, Kars NEVEN, Thomas OLIVIER, Johan VIJGEN, Estelle GANDJBAKHCH, Daniel SCHERR, Arne JOHANNESSEN, David KEANE, Serge BOVEDA, Philippe MAURY, Ignacio GARCIA-BOLAO, Ante ANIC, Peter Steen HANSEN, Franck RACZKA, Antoine LEPILLIER, Yves GUYOMAR, Dhiraj GUPTA, Van Opstal JURREN, Pascal DEFAYE, Christian STICHERLING, Philipp SOMMER, Pavel KUCERA (203 Czech Republic), Joaquin OSCA, Fariborz TABRIZI, Antoine ROUX, Michael GRAMLICH, Stefano BIANCHI, Pedro ADRAGAO, Francesco SOLIMENE, Claudio TONDO, Antonio Dello RUSSO, Juergen SCHREIECK, Armin LUIK, Obaida RANA, Gerrit FROMMEYER, Frederic 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 IACOPINO, Peter Karl JACOBSEN, Andrikopoulos GEORGE, Pavel OSMANCIK, Stefan SPITZER, Richard BALASUBRAMANIAM, Abdul Shokor PARWANI, Thomas DENEKE, Andrzej GLOWNIAK, Antonio ROSSILLO, Helmut PUERERFELLNER, David DUNCKER, Peter REIL, Thomas ARENTZ, Daniel STEVEN, Juan Jose 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 MUELLER, Javier RAMOS-MAQUEDA, Thomas BEIERT, Sakis THEMISTOCLAKIS, Dirk Grosse MEININGHAUS, Guenter STIX, Stylianos TZEIS, Jakub BARAN, Henrik ALMROTH, Daniel Rodriguez MUNOZ, de Sousa JOAO, Michalis EFREMIDIS, Pawel BALSAM, Jan PETRU (203 Czech Republic), Thomas KUEFFER, Petr PEICHL (203 Czech Republic), Lukas DEKKER, Domenico G DELLA ROCCA, Ondrej MORAVEC (203 Czech Republic), Moritoshi FUNASAKO, Sebastien KNECHT, Gael JAUVERT, Julian CHUN, Romain ESCHALIER, Anna FUETING, Alexandre ZHAO, Pieter KOOPMAN, Mikael LAREDO, Martin MANNINGER, Jim HANSEN, Daniel 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 and Vivek Y REDDY

Edition

Nature Medicine, BERLIN, Nature Research, 2024, 1078-8956

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

Germany

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 82.900 in 2022

Organization unit

Faculty of Medicine

UT WoS

001264739500001

Keywords in English

atrial fibrillation; pulsed field ablation

Tags

Tags

International impact, Reviewed
Změněno: 5/8/2024 11:18, Mgr. Tereza Miškechová

Abstract

V originále

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.