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

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Fältnamn	Indikatorer	Metadata
000		12896naa a2201945 4500
001		oai:DiVA.org:liu-206384
003		SwePub
008		240816s2024 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-2063842 URI
024	7	a https://doi.org/10.1038/s41591-024-03114-32 DOI
040		a (SwePub)liu
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Ekanem, Emmanuelu Icahn Sch Med Mt Sinai, NY 10029 USA; Valley Hlth Winchester Med Ctr, VA USA4 aut
245	1 0	a Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
264		c 2024
264	1	b NATURE PORTFOLIO,c 2024
338		a print2 rdacarrier
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kardiologi0 (SwePub)302062 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cardiac and Cardiovascular Systems0 (SwePub)302062 hsv//eng
700	1	a Neuzil, Petru Homolka Hosp, Czech Republic4 aut
700	1	a Reichlin, Tobiasu Bern Univ Hosp, Switzerland4 aut
700	1	a Kautzner, Josephu IKEM, Czech Republic4 aut
700	1	a van der Voort, Pepijnu Catharina Ziekenhuis Eindhoven, Netherlands4 aut
700	1	a Jais, Pierreu Univ Bordeaux, France4 aut
700	1	a Chierchia, Gian-Battistau Univ Ziekenhuis Brussel, Belgium4 aut
700	1	a Bulava, Alanu Univ South Bohemia Ceske Budejovice, Czech Republic4 aut
700	1	a Blaauw, Yuriu Groningen Inst Archaeol, Netherlands4 aut
700	1	a Skala, Tomasu Univ Hosp Olomouc, Czech Republic4 aut
700	1	a Fiala, Martinu Masaryk Univ, Czech Republic4 aut
700	1	a Duytschaever, Mattiasu AZ Sint Jan Hosp Bruges, Belgium4 aut
700	1	a Szeplaki, Gaboru Mater Private Hosp, Ireland; Royal Coll Surg Ireland RCSI, Ireland4 aut
700	1	a Schmidt, Borisu Cardioangiol Ctr Bethanien, Germany4 aut
700	1	a Massoullie, Gregoireu Clermont Ferrand Univ Hosp, France4 aut
700	1	a Neven, Karsu Alfried Krupp Hosp, Germany; Witten Herdecke Univ, Germany4 aut
700	1	a Thomas, Olivieru GHP Ambroise Pare Hartmann, France4 aut
700	1	a Vijgen, Johanu Jessa Hosp, Belgium4 aut
700	1	a Gandjbakhch, Estelleu Sorbonne Univ, France4 aut
700	1	a Scherr, Danielu Med Univ Graz, Austria4 aut
700	1	a Johannessen, Arneu Copenhagen Univ Hosp, Denmark4 aut
700	1	a Keane, Davidu Adaptemy, Ireland4 aut
700	1	a Boveda, Sergeu Clin Pasteur, France; Free Univ Brussels, Belgium4 aut
700	1	a Maury, Philippeu Univ Hosp Rangueil, France4 aut
700	1	a Garcia-Bolao, Ignaciou Univ Navarra, Spain; Inst Invest Sanitaria Navarra, Spain4 aut
700	1	a Anic, Anteu Univ Hosp Ctr Split, Croatia4 aut
700	1	a Hansen, Peter Steenu Sygehus Lillebaelt Rontgen Vejle, Denmark4 aut
700	1	a Raczka, Francku Clin Millenaire, France4 aut
700	1	a Lepillier, Antoineu Ctr Cardiol Nord, France4 aut
700	1	a Guyomar, Yvesu Hop St Philibert, France4 aut
700	1	a Gupta, Dhiraju Liverpool Heart & Chest Hosp, England4 aut
700	1	a Van Opstal, Jurrenu Med Spectrum Twente, Netherlands4 aut
700	1	a Defaye, Pascalu Grenoble Alpes Univ Hosp, France4 aut
700	1	a Sticherling, Christianu Univ Hosp Basel, Switzerland4 aut
700	1	a Sommer, Philippu Ruhr Univ Bochum, Germany4 aut
700	1	a Kucera, Pavelu Reg Hosp Liberec, Czech Republic4 aut
700	1	a Osca, Joaquinu La Fe Univ & Polytech Hosp, Spain4 aut
700	1	a Tabrizi, Fariborzu Stockholm Ctr Org Res Score, Sweden4 aut
700	1	a Roux, Antoineu Pole Sante Republ ELSAN, France4 aut
700	1	a Gramlich, Michaelu Uniklinikum RWTH Aachen, Germany4 aut
700	1	a Bianchi, Stefanou Osped Isola Tiberina Gemelli Isola, Italy4 aut
700	1	a Adragao, Pedrou CHLO, Portugal4 aut
700	1	a Solimene, Francescou Clin Montevergine, Italy4 aut
700	1	a Tondo, Claudiou Univ Milan, Italy4 aut
700	1	a Russo, Antonio Dellou Dept Biomed Sci & Publ Hlth, Italy; Univ Hosp, Italy4 aut
700	1	a Schreieck, Juergenu Univ Tubingen, Germany4 aut
700	1	a Luik, Arminu Stadt Klinikum Karlsruhe, Germany4 aut
700	1	a Rana, Obaidau Universitatsklinikum Dusseldorf, Germany4 aut
700	1	a Frommeyer, Gerritu Univ Hosp Munster, Germany4 aut
700	1	a Anselme, Fredericu Univ Hosp Rouen, France4 aut
700	1	a Kreis, Ingou St Johannes Hosp Dortmund, Germany4 aut
700	1	a Rosso, Raphaelu Tel Aviv Sourasky Med Ctr, Israel4 aut
700	1	a Metzner, Andreasu Univ Heart Vasc Ctr, Germany4 aut
700	1	a Geller, Laszlou Semmelweis Univ, Hungary4 aut
700	1	a Baldinger, Samuel H.u Hirslanden Klin Beau Site, Switzerland4 aut
700	1	a Ferrero, Angelu Hosp Clin Univ Valencia, Spain4 aut
700	1	a Willems, Stephanu Asklepios Hosp St Georg, Germany4 aut
700	1	a Goette, Andreasu St Vincenz Hosp, Germany; AFNET, Germany; Otto Von Guericke Univ, Germany4 aut
700	1	a Mellor, Gregu Royal Papworth Hosp, England4 aut
700	1	a Mathew, Shibuu Universitatsklinikum Essen, Germany4 aut
700	1	a Szumowski, Lukaszu Natl Inst Cardiol, Poland4 aut
700	1	a Tilz, Rolandu Univ Hosp Schleswig Holstein, Germany; German Ctr Cardiovasc Res DZHK, Germany4 aut
700	1	a Iacopino, Saveriou Maria Cecilia Hosp, Italy4 aut
700	1	a Jacobsen, Peter Karlu Copenhagen Univ Hosp, Denmark4 aut
700	1	a George, Andrikopoulosu Henry Dunant Hosp, Greece4 aut
700	1	a Osmancik, Pavelu FNKV, Czech Republic4 aut
700	1	a Spitzer, Stefanu Praxisklin Herz & Gefasse, Germany4 aut
700	1	a Balasubramaniam, Richardu Royal Bournemouth Hosp, England4 aut
700	1	a Parwani, Abdul Shokoru Campus Virchow Klinikum, Germany4 aut
700	1	a Deneke, Thomasu Heart Ctr Bad Neustadt, Germany4 aut
700	1	a Glowniak, Andrzeju Med Univ Lublin, Poland4 aut
700	1	a Rossillo, Antoniou San Bortolo Hosp, Italy4 aut
700	1	a Puererfellner, Helmutu Ordensklinikum Linz Elisabethinen, Austria4 aut
700	1	a Duncker, Davidu Hannover Heart Rhythm Ctr, Germany4 aut
700	1	a Reil, Peteru Klinikum Ingolstadt, Germany4 aut
700	1	a Arentz, Thomasu Universitatsklinikum Freiburg, Germany4 aut
700	1	a Steven, Danielu Univ Cologne, Germany; Univ Cologne, Germany4 aut
700	1	a Olalla, Juan Joseu Hosp Univ Marques Valdecilla, Spain4 aut
700	1	a de Jong, Jonas S. S. G.u OLVG, Netherlands4 aut
700	1	a Wakili, Rezau Univ Duisburg Essen, Germany; Goethe Univ Frankfurt Frankfurt, Germany4 aut
700	1	a Abbey, Selimu CRENAU UMR, France4 aut
700	1	a Timo, Gottschlingu Christliches Klinikum Unna, Germany4 aut
700	1	a Asso, Antoniou Hosp Quironsalud, Spain4 aut
700	1	a Wong, Tomu Royal Brompton & Harefield Hosp, England4 aut
700	1	a Pierre, Bertrandu Hop Trousseau, France4 aut
700	1	a Ewertsen, Niels Christianu Vivantes Klinikum Friedrichshain & Urban, Germany4 aut
700	1	a Bergau, Leonardu Univ Med Ctr Gottingen, Germany4 aut
700	1	a Lozano-Granero, Cristinau Univ Hosp Ramon y Cajal, Spain4 aut
700	1	a Rivero, Maximou Ziekenhuis Oost Limburg, Belgium4 aut
700	1	a Breitenstein, Alexanderu Kantonsspital Baden AG, Switzerland4 aut
700	1	a Inkovaara, Jaakkou Tampere Univ, Finland4 aut
700	1	a Fareh, Samiru Hop Croix Rousse, France4 aut
700	1	a Latcu, Decebal Gabrielu Ctr Hospitalier Princesse Grace, Monaco4 aut
700	1	a Linz, Dominiku Maastricht Univ, Netherlands; Univ Copenhagen, Denmark4 aut
700	1	a Mueller, Patricku Knappschaftskrankenhaus Recklinghausen, Germany4 aut
700	1	a Ramos-Maqueda, Javieru Univ Hosp Clin Lozano Blesa, Spain; Aragon Hlth Res Inst, Spain4 aut
700	1	a Beiert, Thomasu Univ Hosp Bonn, Germany4 aut
700	1	a Themistoclakis, Sakisu Osped Angelo, Italy4 aut
700	1	a Meininghaus, Dirk Grosseu Carl Thiem Klinikum Cottbus, Germany4 aut
700	1	a Stix, Guenteru TIERARZLICHE HSCH WIEN, Austria4 aut
700	1	a Tzeis, Stylianosu Mitera Hosp, Greece4 aut
700	1	a Baran, Jakubu Med Univ Warsaw, Poland4 aut
700	1	a Almroth, Henriku Region Östergötland4 aut0 (Swepub:liu)n/a
700	1	a Munoz, Daniel Rodriguezu Hosp Doce Octubre, Spain4 aut
700	1	a de Sousa, Joaou St Maria Univ Hosp, Portugal4 aut
700	1	a Efremidis, Michalisu Onassis Cardiac Surg Ctr, Greece4 aut
700	1	a Balsam, Pawelu Med Univ Warsaw, Poland4 aut
700	1	a Petru, Janu Homolka Hosp, Czech Republic4 aut
700	1	a Kueffer, Thomasu Bern Univ Hosp, Switzerland4 aut
700	1	a Peichl, Petru IKEM, Czech Republic4 aut
700	1	a Dekker, Lukasu Catharina Ziekenhuis Eindhoven, Netherlands4 aut
700	1	a Della Rocca, Domenico G.u Univ Ziekenhuis Brussel, Belgium4 aut
700	1	a Moravec, Ondreju Univ Hosp Olomouc, Czech Republic4 aut
700	1	a Funasako, Moritoshiu Masaryk Univ, Czech Republic4 aut
700	1	a Knecht, Sebastienu AZ Sint Jan Hosp Bruges, Belgium4 aut
700	1	a Jauvert, Gaelu Mater Private Hosp, Ireland4 aut
700	1	a Chun, Julianu Cardioangiol Ctr Bethanien, Germany4 aut
700	1	a Eschalier, Romainu Clermont Ferrand Univ Hosp, France4 aut
700	1	a Fueting, Annau Alfried Krupp Hosp, Germany; Witten Herdecke Univ, Germany4 aut
700	1	a Zhao, Alexandreu GHP Ambroise Pare Hartmann, France4 aut
700	1	a Koopman, Pieteru Jessa Hosp, Belgium4 aut
700	1	a Laredo, Mikaelu Sorbonne Univ, France4 aut
700	1	a Manninger, Martinu Med Univ Graz, Austria4 aut
700	1	a Hansen, Jimu Copenhagen Univ Hosp, Denmark4 aut
700	1	a O'Hare, Danielu Adaptemy, Ireland4 aut
700	1	a Rollin, Anneu Univ Hosp Rangueil, France4 aut
700	1	a Jurisic, Zrinkau Univ Hosp Ctr Split, Croatia4 aut
700	1	a Fink, Thomasu Ruhr Univ Bochum, Germany4 aut
700	1	a Chaumont, Corentinu Univ Hosp Rouen, France4 aut
700	1	a Rillig, Andreasu Univ Heart Vasc Ctr, Germany4 aut
700	1	a Gunawerdene, Melanieu Asklepios Hosp St Georg, Germany4 aut
700	1	a Martin, Claireu Royal Papworth Hosp, England4 aut
700	1	a Kirstein, Bettinau Univ Hosp Schleswig Holstein, Germany; German Ctr Cardiovasc Res DZHK, Germany4 aut
700	1	a Nentwich, Karinu Heart Ctr Bad Neustadt, Germany4 aut
700	1	a Lehrmann, Heikou Universitatsklinikum Freiburg, Germany4 aut
700	1	a Sultan, Arianu Univ Cologne, Germany; Univ Cologne, Germany4 aut
700	1	a Bohnen, Janu Univ Duisburg Essen, Germany; Goethe Univ Frankfurt Frankfurt, Germany4 aut
700	1	a Turagam, Mohit K.u Icahn Sch Med Mt Sinai, NY 10029 USA4 aut
700	1	a Reddy, Vivek Y.u Icahn Sch Med Mt Sinai, NY 10029 USA; Homolka Hosp, Czech Republic4 aut
710	2	a Icahn Sch Med Mt Sinai, NY 10029 USA; Valley Hlth Winchester Med Ctr, VA USAb Homolka Hosp, Czech Republic4 org
773	0	t Nature Medicined : NATURE PORTFOLIOx 1078-8956x 1546-170X
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-206384
856	4 8	u https://doi.org/10.1038/s41591-024-03114-3

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