| Title: |
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; 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; 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; de Sousa, Joao; 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; 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. |
| Contributors: |
Ekanem, Emmanuel/0000-0002-4128-8800; 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; 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 |
| Publisher Information: |
NATURE PORTFOLIO |
| Publication Year: |
2024 |
| Collection: |
Document Server@UHasselt (Universiteit Hasselt) |
| Subject Terms: |
Humans; Female; Male; Middle Aged; Aged; Treatment Outcome; Postoperative Complications; Atrial Fibrillation; Catheter 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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://hdl.handle.net/1942/43453; 2029; 2020; 30; 001287307000001 |
| DOI: |
10.1038/s41591-024-03114-3 |
| Availability: |
https://hdl.handle.net/1942/43453; https://doi.org/10.1038/s41591-024-03114-3 |
| Rights: |
The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons. org/licenses/by/4.0/. ; info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.5B6CEC4 |
| Database: |
BASE |