Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)

MANIFEST-PF Cooperative, Emmanuel Ekanem, Vivek Y Reddy, Boris Schmidt, Tobias Reichlin, Kars Neven, Andreas Metzner, Jim Hansen, Yuri Blaauw, Philippe Maury, Thomas Arentz, Philipp Sommer, Ante Anic, Frederic Anselme, Serge Boveda, Tom Deneke, Stephan Willems, Pepijn van der Voort, Roland Tilz, Moritoshi FunasakoDaniel Scherr, Reza Wakili, Daniel Steven, Josef Kautzner, Johan Vijgen, Pierre Jais, Jan Petru, Julian Chun, Laurent Roten, Anna Füting, Andreas Rillig, Bart A Mulder, Arne Johannessen, Anne Rollin, Heiko Lehrmann, Christian Sohns, Zrinka Jurisic, Arnaud Savoure, Stephanes Combes, Karin Nentwich, Melanie Gunawardene, Alexandre Ouss, Bettina Kirstein, Martin Manninger, Jan-Eric Bohnen, Arian Sultan, Petr Peichl, Pieter Koopman, Nicolas Derval, Mohit K Turagam, Petr Neuzil

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    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.

    Original languageEnglish
    Article numbereuac050
    Pages (from-to)1256–1266
    Number of pages11
    Issue number8
    Early online date1-Jun-2022
    Publication statusPublished - 1-Sept-2022

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