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Title: | Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF) | Authors: | Ekanem, Emmanuel Reddy, Vivek Y. Schmidt , Boris Reichlin, Tobias NEVEN, Kars Metzner, Andreas Hansen , Jim Blaauw, Yuri Maury, Philippe Arentz, Thomas Sommer, Philipp Anic, Ante Anselme, Frederic Boveda, Serge Deneke, Tom Willems , Stephan van der Voort, Pepijn Tilz, Roland Funasako, Moritoshi Scherr, Daniel Wakili, Reza Steven, Daniel Kautzner, Josef VIJGEN, Johan Jais, Pierre Petru, Jan Chun, Julian Roten, Laurent Fueting, Anna Rillig, Andreas Mulder, Bart A. Johannessen, Arne Rollin, Anne Lehrmann, Heiko Sohns, Christian Jurisic, Zrinka Savoure, Arnaud Combes, Stephanes Nentwich, Karin Gunawardene, Melanie Ouss, Alexandre Kirstein, Bettina Manninger, Martin Bohnen, Jan-Eric Sultan, Arian Peichl, Petr KOOPMAN, Pieter Derval, Nicolas Turagam, Mohit K. Neuzil, Petr |
Issue Date: | 2022 | Publisher: | OXFORD UNIV PRESS | Source: | Europace (London, England), | Status: | Early view | Abstract: | Aims Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. Methods and results This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). Conclusion In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement. | Notes: | Neuzil, P (corresponding author), Homolka Hosp, Cardiol Dept, Roentgenova 37-2, Prague 15030 5, Czech Republic. pneuzil@seznam.cz |
Keywords: | Atrial fibrillation;Pulsed field ablation;Survey;Catheter ablation | Document URI: | http://hdl.handle.net/1942/37605 | ISSN: | 1099-5129 | e-ISSN: | 1532-2092 | DOI: | 10.1093/europace/euac050 | ISI #: | WOS:000804174500001 | Rights: | The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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