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

Fecha de publicación: 08/07/2024 Fecha Ahead of Print: 08/07/2024

Autores de IIS La Fe

Joaquín Osca Asensi

Autor

Participantes ajenos a IIS La Fe

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, Gregoire
Neven, Kars
Thomas, Olivier
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
Van Opstal, Jurren
Defaye, Pascal
Sticherling, Christian
Sommer, Philipp
Kucera, Pavel
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
Purerfellner, 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
Muller, Patrick
Ramos-Maqueda, Javier
Beiert, Thomas
Themistoclakis, Sakis
Meininghaus, Dirk Grosse
Stix, Guenter
Tzeis, Stylianos
Baran, Jakub
Almroth, Henrik
Munoz, Daniel Rodriguez
de Sousa, Joao
Efremidis, Michalis
Balsam, Pawel
Petru, Jan
Kuffer, Thomas
Peichl, Petr
Dekker, Lukas
Della Rocca, Domenico G.
Moravec, Ondrej
Funasako, Moritoshi
Knecht, Sebastien
Jauvert, Gael
Chun, Julian
Eschalier, Romain
Futing, 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.

Grupos

Grupo de Investigación Clínica y Traslacional en Cardiología

Investigador Principal

Esther Roselló Lletí

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.