Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
- PMID: 38977913
- PMCID: PMC11271404
- DOI: 10.1038/s41591-024-03114-3
Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
Abstract
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.
© 2024. The Author(s).
Conflict of interest statement
E.E. received speaker honorarium from Boston Scientific and travel grants from Abbott and Biotronik. V.Y.R. has served as a consultant to Boston Scientific and formerly owned stock options in Farapulse (now divested); unrelated to this manuscript, he serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for Abbott, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore and Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor and Vizaramed. T.R. has received research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the sitem insel support funds, Boston-Scientific, Medtronic and Biotronik. He has received speaker/consulting honoraria or travel support from Abbott/SJM, Biosense Webster, Biotronik, Boston-Scientific and Medtronic, and support for the institution’s fellowship program from Abbott/SJM, Biosense Webster, Biotronik, Boston-Scientific and Medtronic. J.K. reports personal fees from Abbott, Biosense Webster, Biotronik, Boehringer Ingelheim, GE Healthcare, Medtronic, Pfizer, ProMed CS, and Viatris for lectures, advisory boards, and consultancy. P.J. has received grants by BSC and ANR grant IHU LIRYC ANR-10-IAHU-04. G.-B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific and Acutus Medical. A. Bulava received consultant and/or grant support from Abbott, Biotronik and Boston Scientific. Y.B. received research grants from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster and Boston Scientific. G.S. received personal fees from Abbott, Bayer, Boston Scientific, Biosense Webster Inc. and LumaVision outside the submitted work. G.J. received personal fees from Boston Scientific. B.S. received consulting fees from Boston Scientific, Biosense Webster and Medtronic. J.C. has received funding from Boston Scientific, Medtronic and Biosense Webster (Education). K.N. has received funding from Biosense Webster, Boston Scientific and Field Medical. A.F. has received funding from Boston Scientific. J.V. has received research grants from Medtronic, Boston Scientific, Abbott, Biotronik, Daiichi Sankyo, BMS and Pfizer. He received honoraria from Abbott and Daiichi Sankyo, and support for meeting attendance from Biosense and Boston Scientific. He serves on the advisory board for Boston Scientific and is the Chairman of the Belgian Heart Rhythm Association. E.G. reports consulting fees from Medtronic, Boston, Microport, Abbott and Biotronik. P.K. has received research grants from Medtronic, Boston Scientific, Abbott, Biotronik, Daiichi Sankyo, BMS and Pfizer. He received honoraria from Abbott and Daiichi Sankyo, and support for meeting attendance from Biosense and Boston Scientific. He serves on the advisory board for Boston Scientific and is the Chairman of the Belgian Heart Rhythm Association. D. Scherr reports speaker and consulting fees from Boston Scientific. M.M. reports receiving speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo and BMS/Pfizer and research grants from Biosense Webster and Abbott. J.H. reports receiving speaker fees and grant support from Biosense Webster and Medtronic. S.B. serves as a consultant for Medtronic, Boston Scientific, Microport and Zoll. I.G.-B. received speaker honoraria from Boston Scientific and proctorship fees from Abbott. A.A. has served as a consultant to Boston Scientific Inc., Farapulse Inc., Galaxy Medical Inc., Biosense and Webster and Arga Medtech, and has contracted research with Boston Scientific Inc., Farapulse Inc., Galaxy Medical Inc., Biosense and Webster, Arga Medtech, Future Cardia Inc. and Atacor Medical Inc. Z.J. served as consultant to Boston Scientific Inc and has contracted research with Atacor Medical Inc. D.G. has received research grants from Boston Scientific. P.D. has received research grants and honoraria from Boston Scientific. C.S. is a member of Medtronic Advisory Board Europe and Boston Scientitic Advisory Board Europe. He has received educational grants from Biosense Webster and Biotronik and a research grant from the European Union’s FP7 program and Biosense Webster. He reports lecture and consulting fees from Abbott, Medtronic, Biosense Webster, Boston Scientific, Microport and Biotronik, all outside the submitted work. P.S. is a member of the advisory board for Abbott, Biosense Webster, Boston Scientific and Medtronic. J.O. received speaking honoraria from Boston Scientific, Abbot, Biotronik and Medtronic. M. Gramlich received speaker honoraria and travel grants from Boston Scientific. C.T. served on the advisory board of and has received lecture/tutoring fees from Boston Scientific, Medtronic and Atricure. He has received lecture/tutoring fees from Abbott Medical. A.D.R. received speaker honoraria from Boston Scientific and Abbott. J.S. received speaker’s honoraria and travel grants from Boston Scientific, Biosense Webster, Medtronic, Bayer HealthCare and Bristol-Myers Squibb. A.L. received consulting fees from Boston Scientific, Biosense Webster, Pfizer, Bristol-Myers Squibb and Medtronic. G.F. received lecture honoraria and travel grants from Boston Scientific. F.A. received honoraria and served as a consultant for Boston Scientific, Medtronic and Microport CRM. A.M. received lecture honoraria and travel fees from Medtronic, Boston Scientific, Biosense Webster, Lifetech, BMS and Bayer. He also served as a consultant for Medtronic, Boston-Scientific and Biosense Webster. L.G. served as a consultant for Abbott, Medtronic, Boston, Biotronik and Johnson and Johnson. S.W. reports receiving grants and personal fees from Abbott, Boston Scientific and Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi and Farapulse Inc. M. Gunawardene reports grants from Farapulse Inc. and Abbott. A. Goette was supported by EU Grant Horizon 2020 MAESTRIA Consortium grant number 965286 and has received speaker fees from Abbott, AstraZeneca, Bayer Health Care, Berlin Chemie, Biotronik, Boehringer Ingelheim, BMS/Pfizer, Boston Scientific, Daiichi Sankyo, Medtronic, Viofor, Novartis and Sanofi. C.M. reports honoraria and speaker’s fees from Boston Scientific, Medtronic, Biosense Webster, Acutus and Adagio. She served as a consultant and on the advisory board for Boston Scientific and Medtronic. She received research grant from Boston Scientific. R.T. reports receiving consulting fees from Boston Scientific, Abbot Medical, Biotronik and speaker’s honoraria from Boston Scientific, Abbot Medical, Biotronik and Biosense Webster. A. George has served as a consultant to Boston Scientific and has received fees for lectures from Boston Scientific. He has also received fees for consultation and/or lecturing from Abbot, AstraZeneca, Bard, Bayer Healthcare, Boehringer Ingelheim, Bristol-Myers Squibb, ELPEN, Galenica, Lilly, Medtronic, Menarini, MSD, Pfizer, Sanofi, Servier, Unifarma and Vianex. S.S. received speaker’s honoraria from Medtronic and Abbott, and participation in clinical trials with Abbott, Ablacon, Boston and Medtronic. R.B. received honoraria from Boston Scientific. T.D. received consulting fees from Farapulse (<2,000 US$), speaker fees with Galaxy Medical (<1,000 US$) and speaker fees with Abbott (<3,000 US$). A. Glowniak received compensation for proctoring and speaking duties from Medtronic and for speaking duties from Abbott and Boston. A.R. served as a consultant for Boston Scientific. H.P. served as a consultant/advisory board for Abbott, Biosense Webster, Boston Scientific and Medtronic. D.D. received modest lecture honoraria, travel grants and/or a fellowship grant from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, CVRx, Medtronic, Microport, Pfizer and Zoll. D. Steven received research grant <50,000 € and speaker fees <10,000 € from Biosense Webster and Boston Scientific. A.S. reports receiving lecture and consulting honoraria from Medtronic, Abbott and Bayer. J.S.S.G.d.J. was a consultant for Medtronic. R.W. reports receiving honoraria for lectures from Adagio medical, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Boston Scientific, Biotronik, Daiichi Sankyo, Abiomed, Bayer, Novartis, Zoll. Honoraria for advisory board activities from Adagio medical, Boehringer Ingelheim, Bristol-Myers Squibb,Pfizer, Bayer. He reports participating in clinical trials with Daiichi Sankyo, Boehringer Ingelheim, Boston Scientific. He reports research funding from boston Scientific, BMS/Pfizer, Abiomed (all investigator-initiated trials). C.L.-G. received honoraria from Abbott and Biosense Webster. A. Breitenstein received consulting fees from Abbott, Bayer Health Care, Biosense Webster, Biotronik, BMS/Pfizer, Boston Scientific, Cook Medical, Daiichi Sankyo, Spectranetics/Philips and Medtronic. He received educational grants from Biosense Webster, Biotronik and Actelion. He received presenter fees from Abbott, Bayer Health Care, Biotronik, Cook Medical, BMS/Pfizer, Boston Scientific, Daiichi Sankyo, Medtronic and Spectranetics/Philips. J.I. received fees from Boston Scientific and an educational grant from Boston Scientific. D.L. has served as a consultant to Boston Scientific (now divested); and unrelated to this manuscript, he serves as a consultant for Ablacon, ATriAN, Bayer, Biosense Webster, Medtronic and Philips. J.R.-M. has received research funding and speaker/proctorship fees from Boston Scientific. D.R.M. has received speaker honoraria and research grants from Boston Scientific. All of the remaining authors have declared no conflicts of interest. There was no external funding support for this study.
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