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

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.
Nature Medicine SCOPUS WOS

ТИП ПУБЛИКАЦИИ статья в журнале - научная статья

ГОД 2024

ЯЗЫК EN

ЦИТИРОВАНИЙ 35

DOI 10.1038/s41591-024-03114-3

АННОТАЦИЯ

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.

ЦИТАТА

Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study / E. Ekanem, P. Neuzil, T. Reichlin, J. Kautzner, P. van der Voort, P. Jais, G. Chierchia, A. Bulava, Y. Blaauw, T. Skala, M. Fiala, M. Duytschaever, G. Szeplaki, B. Schmidt, G. Massoullie, K. Neven, O. Thomas, 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. Kreis, R. Rosso, A. Metzner, L. Geller, S.H. Baldinger, A. Ferrero, S. Willems, 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. Themistoclakis, D.G. Meininghaus, G. Stix, S. Tzeis, J. Baran, H. Almroth, D.R. Munoz, J. de Sousa, M. Efremidis, P. Balsam, J. Petru, T. Küffer, P. Peichl, L. Dekker, D.G. Della Rocca, O. Moravec, M. Funasako, S. Knecht, G. Jauvert, J. Chun, R. Eschalier, A. Füting, A. Zhao, P. Koopman, M. Laredo, M. Manninger, J. Hansen, D. O’Hare, A. Rollin, Z. Jurisic, T. Fink, C. Chaumont, A. Rillig, M. Gunawerdene, C. Martin, B. Kirstein, K. Nentwich, H. Lehrmann, A. Sultan, J. Bohnen, M.K. Turagam, V.Y. Reddy // Nature Medicine. – 2024. – Т. 30. – № 7. – P. 2020-2029

АВТОРЫ

Булава Александра Игоревна

ЛАБОРАТОРИЯ ПСИХОФИЗИОЛОГИИ имени В. Б. Швыркова
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