Article
作者: Chun, Julian ; Jauvert, Gael ; Kreis, Ingo ; Willems, Stephan ; Sommer, Philipp ; Boveda, Serge ; Inkovaara, Jaakko ; Wong, Tom ; Gramlich, Michael ; Laredo, Mikael ; Baldinger, Samuel H ; Szeplaki, Gabor ; Rollin, Anne ; Arentz, Thomas ; Zhao, Alexandre ; Tondo, Claudio ; Luik, Armin ; Ramos-Maqueda, Javier ; Pürerfellner, Helmut ; Reil, Peter ; O'Hare, Daniel ; Scherr, Daniel ; Glowniak, Andrzej ; Koopman, Pieter ; Reichlin, Tobias ; Füting, Anna ; Breitenstein, Alexander ; Solimene, Francesco ; Steven, Daniel ; Fink, Thomas ; Duncker, David ; Almroth, Henrik ; Kautzner, Joseph ; Efremidis, Michalis ; Guyomar, Yves ; Balasubramaniam, Richard ; Geller, Laszlo ; Mellor, Greg ; Bergau, Leonard ; Goette, Andreas ; Vijgen, Johan ; Defaye, Pascal ; Munoz, Daniel Rodriguez ; Gandjbakhch, Estelle ; Gupta, Dhiraj ; Lozano-Granero, Cristina ; García-Bolao, Ignacio ; Stix, Günter ; Jais, Pierre ; Wakili, Reza ; Della Rocca, Domenico G ; Eschalier, Romain ; Martin, Claire ; Latcu, Decebal Gabriel ; Jacobsen, Peter Karl ; Raczka, Franck ; Blaauw, Yuri ; Tzeis, Stylianos ; Deneke, Thomas ; Gunawerdene, Melanie ; Lepillier, Antoine ; Osca, Joaquin ; Bohnen, Jan ; Moravec, Ondrej ; Knecht, Sebastien ; Balsam, Pawel ; de Jong, Jonas S S G ; Baran, Jakub ; Meininghaus, Dirk Grosse ; Schmidt, Boris ; Maury, Philippe ; Russo, Antonio Dello ; Schreieck, Jürgen ; van der Voort, Pepijn ; Fiala, Martin ; Küffer, Thomas ; Skala, Tomas ; Massoullie, Grégoire ; Kucera, Pavel ; Tilz, Roland ; Rivero, Maximo ; Beiert, Thomas ; Roux, Antoine ; Neuzil, Petr ; Bulava, Alan ; Lehrmann, Heiko ; Szumowski, Lukasz ; Timo, Gottschling ; Olalla, Juan José ; Chierchia, Gian-Battista ; Anselme, Frédéric ; Osmancik, Pavel ; Nentwich, Karin ; Duytschaever, Mattias ; Thomas, Olivier ; Funasako, Moritoshi ; Ekanem, Emmanuel ; Johannessen, Arne ; Hansen, Jim ; Rillig, Andreas ; Kirstein, Bettina ; Ewertsen, Niels Christian ; Dekker, Lukas ; Hansen, Peter Steen ; Themistoclakis, Sakis ; Neven, Kars ; Metzner, Andreas ; Van Opstal, Jurren ; Mathew, Shibu ; Iacopino, Saverio ; Rana, Obaida ; de Sousa, João ; Rossillo, Antonio ; Sultan, Arian ; Tabrizi, Fariborz ; Ferrero, Angel ; Sticherling, Christian ; Müller, Patrick ; Pierre, Bertrand ; Jurisic, Zrinka ; Adragão, Pedro ; Frommeyer, Gerrit ; George, Andrikopoulos ; Petru, Jan ; Bianchi, Stefano ; Anic, Ante ; Manninger, Martin ; Parwani, Abdul Shokor ; Peichl, Petr ; Chaumont, Corentin ; Abbey, Selim ; Fareh, Samir ; Asso, Antonio ; Turagam, Mohit K ; Spitzer, Stefan ; Keane, David ; Reddy, Vivek Y ; Rosso, Raphael ; Linz, Dominik
AbstractPulsed 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.