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.
Originalsprog | Engelsk |
---|---|
Tidsskrift | Nature Medicine |
Vol/bind | 30 |
Sider (fra-til) | 2020–2029 |
ISSN | 1078-8956 |
DOI | |
Status | Udgivet - 2024 |
Bibliografisk note
Publisher Copyright:© The Author(s) 2024.
Citationsformater
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS
I: Nature Medicine, Bind 30, 2024, s. 2020–2029.
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
}
TY - JOUR
T1 - Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
AU - Ekanem, Emmanuel
AU - Neuzil, Petr
AU - Reichlin, Tobias
AU - Kautzner, Joseph
AU - van der Voort, Pepijn
AU - Jais, Pierre
AU - Chierchia, Gian Battista
AU - Bulava, Alan
AU - Blaauw, Yuri
AU - Skala, Tomas
AU - Fiala, Martin
AU - Duytschaever, Mattias
AU - Szeplaki, Gabor
AU - Schmidt, Boris
AU - Massoullie, Grégoire
AU - Neven, Kars
AU - Thomas, Olivier
AU - Vijgen, Johan
AU - Gandjbakhch, Estelle
AU - Scherr, Daniel
AU - Johannessen, Arne
AU - Keane, David
AU - Boveda, Serge
AU - Maury, Philippe
AU - García-Bolao, Ignacio
AU - Anic, Ante
AU - Hansen, Peter Steen
AU - Raczka, Franck
AU - Lepillier, Antoine
AU - Guyomar, Yves
AU - Gupta, Dhiraj
AU - Van Opstal, Jurren
AU - Defaye, Pascal
AU - Sticherling, Christian
AU - Sommer, Philipp
AU - Kucera, Pavel
AU - Osca, Joaquin
AU - Tabrizi, Fariborz
AU - Roux, Antoine
AU - Gramlich, Michael
AU - Bianchi, Stefano
AU - Adragão, Pedro
AU - Solimene, Francesco
AU - Tondo, Claudio
AU - Russo, Antonio Dello
AU - Schreieck, Jürgen
AU - Luik, Armin
AU - Rana, Obaida
AU - Frommeyer, Gerrit
AU - Anselme, Frédéric
AU - Kreis, Ingo
AU - Rosso, Raphael
AU - Metzner, Andreas
AU - Geller, Laszlo
AU - Baldinger, Samuel H.
AU - Ferrero, Angel
AU - Willems, Stephan
AU - Goette, Andreas
AU - Mellor, Greg
AU - Mathew, Shibu
AU - Szumowski, Lukasz
AU - Tilz, Roland
AU - Iacopino, Saverio
AU - Jacobsen, Peter Karl
AU - George, Andrikopoulos
AU - Osmancik, Pavel
AU - Spitzer, Stefan
AU - Balasubramaniam, Richard
AU - Parwani, Abdul Shokor
AU - Deneke, Thomas
AU - Glowniak, Andrzej
AU - Rossillo, Antonio
AU - Pürerfellner, Helmut
AU - Duncker, David
AU - Reil, Peter
AU - Arentz, Thomas
AU - Steven, Daniel
AU - Olalla, Juan José
AU - de Jong, Jonas S.S.G.
AU - Wakili, Reza
AU - Abbey, Selim
AU - Timo, Gottschling
AU - Asso, Antonio
AU - Wong, Tom
AU - Pierre, Bertrand
AU - Ewertsen, Niels Christian
AU - Bergau, Leonard
AU - Lozano-Granero, Cristina
AU - Rivero, Maximo
AU - Breitenstein, Alexander
AU - Inkovaara, Jaakko
AU - Fareh, Samir
AU - Latcu, Decebal Gabriel
AU - Linz, Dominik
AU - Müller, Patrick
AU - Ramos-Maqueda, Javier
AU - Beiert, Thomas
AU - Themistoclakis, Sakis
AU - Meininghaus, Dirk Grosse
AU - Stix, Günter
AU - Tzeis, Stylianos
AU - Baran, Jakub
AU - Almroth, Henrik
AU - Munoz, Daniel Rodriguez
AU - de Sousa, João
AU - Efremidis, Michalis
AU - Balsam, Pawel
AU - Petru, Jan
AU - Küffer, Thomas
AU - Peichl, Petr
AU - Dekker, Lukas
AU - Della Rocca, Domenico G.
AU - Moravec, Ondrej
AU - Funasako, Moritoshi
AU - Knecht, Sebastien
AU - Jauvert, Gael
AU - Chun, Julian
AU - Eschalier, Romain
AU - Füting, Anna
AU - Zhao, Alexandre
AU - Koopman, Pieter
AU - Laredo, Mikael
AU - Manninger, Martin
AU - Hansen, Jim
AU - O’Hare, Daniel
AU - Rollin, Anne
AU - Jurisic, Zrinka
AU - Fink, Thomas
AU - Chaumont, Corentin
AU - Rillig, Andreas
AU - Gunawerdene, Melanie
AU - Martin, Claire
AU - Kirstein, Bettina
AU - Nentwich, Karin
AU - Lehrmann, Heiko
AU - Sultan, Arian
AU - Bohnen, Jan
AU - Turagam, Mohit K.
AU - Reddy, Vivek Y.
N1 - Publisher Copyright: © The Author(s) 2024.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
U2 - 10.1038/s41591-024-03114-3
DO - 10.1038/s41591-024-03114-3
M3 - Journal article
C2 - 38977913
AN - SCOPUS:85197684308
SN - 1078-8956
VL - 30
SP - 2020
EP - 2029
JO - Nature Medicine
JF - Nature Medicine
ER -