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

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

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.

© 2024. The Author(s).