| 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, Grégoire; Neven, Kars; Thomas, Olivier; Vijgen, Johan; Gandjbakhch, Estelle; Scherr, Daniel; Johannessen, Arne; Keane, David; Boveda, Serge; Maury, Philippe; García-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; Adragão, Pedro; Solimene, Francesco; Tondo, Claudio; Russo, Antonio Dello; Schreieck, Jürgen; Luik, Armin; Rana, Obaida; Frommeyer, Gerrit; Anselme, Frédéric; 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; Pürerfellner, Helmut; Duncker, David; Reil, Peter; Arentz, Thomas; Steven, Daniel; Olalla, Juan José; 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; Müller, Patrick; Ramos-Maqueda, Javier; Beiert, Thomas; Themistoclakis, Sakis; Meininghaus, Dirk Grosse; Stix, Günter; Tzeis, Stylianos; Baran, Jakub; Almroth, Henrik; Munoz, Daniel Rodriguez; de Sousa, João; Efremidis, Michalis; Balsam, Pawel; Petru, Jan; Küffer, Thomas; Peichl, Petr; Dekker, Lukas; Della Rocca, Domenico G; Moravec, Ondrej; Funasako, Moritoshi; Knecht, Sebastien; Jauvert, Gael; Chun, Julian; Eschalier, Romain; Füting, 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: |
E. Ekanem; P. Neuzil; T. Reichlin; J. Kautzner; P. van der Voort; P. Jai; G. Chierchia; A. Bulava; Y. Blaauw; T. Skala; M. Fiala; M. Duytschaever; G. Szeplaki; B. Schmidt; G. Massoullie; K. Neven; O. Thoma; J. Vijgen; E. Gandjbakhch; D. Scherr; A. Johannessen; D. Keane; S. Boveda; P. Maury; I. García-Bolao; A. Anic; P.S. Hansen; F. Raczka; A. Lepillier; Y. Guyomar; D. Gupta; J. Van Opstal; P. Defaye; C. Sticherling; P. Sommer; P. Kucera; J. Osca; F. Tabrizi; A. Roux; M. Gramlich; S. Bianchi; P. Adragão; F. Solimene; C. Tondo; A.D. Russo; J. Schreieck; A. Luik; O. Rana; G. Frommeyer; F. Anselme; I. Krei; R. Rosso; A. Metzner; L. Geller; S.H. Baldinger; A. Ferrero; S. Willem; A. Goette; G. Mellor; S. Mathew; L. Szumowski; R. Tilz; S. Iacopino; P.K. Jacobsen; A. George; P. Osmancik; S. Spitzer; R. Balasubramaniam; A.S. Parwani; T. Deneke; A. Glowniak; A. Rossillo; H. Pürerfellner; D. Duncker; P. Reil; T. Arentz; D. Steven; J.J. Olalla; J.S.S.G. de Jong; R. Wakili; S. Abbey; G. Timo; A. Asso; T. Wong; B. Pierre; N.C. Ewertsen; L. Bergau; C. Lozano-Granero; M. Rivero; A. Breitenstein; J. Inkovaara; S. Fareh; D.G. Latcu; D. Linz; P. Müller; J. Ramos-Maqueda; T. Beiert; S. Themistoclaki; D.G. Meininghau; G. Stix |
| Publisher Information: |
Nature Publishing Group |
| Publication Year: |
2024 |
| Collection: |
The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| Subject Terms: |
Settore MED/11 - Malattie dell'Apparato Cardiovascolare |
| 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 ~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 |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/38977913; info:eu-repo/semantics/altIdentifier/wos/WOS:001264739500001; volume:30; issue:7; firstpage:2020; lastpage:2029; numberofpages:10; journal:NATURE MEDICINE; https://hdl.handle.net/2434/1078608 |
| DOI: |
10.1038/s41591-024-03114-3 |
| Availability: |
https://hdl.handle.net/2434/1078608; https://doi.org/10.1038/s41591-024-03114-3 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.76C85B58 |
| Database: |
BASE |