Ekanem, Emmanuel ORCID: 0000-0002-4128-8800, 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 ORCID: 0000-0002-0827-1329, 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 ORCID: 0000-0002-0545-4373, Bohnen, Jan-Eric, Sultan, Arian ORCID: 0000-0003-1807-4860, Peichl, Petr, Koopman, Pieter ORCID: 0000-0002-6373-180X, Derval, Nicolas, Turagam, Mohit K. and Neuzil, Petr . Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. OXFORD: OXFORD UNIV PRESS. ISSN 1532-2092

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Ekanem, EmmanuelUNSPECIFIEDorcid.org/0000-0002-4128-8800UNSPECIFIED
Reddy, Vivek Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, BorisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reichlin, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Neven, KarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Metzner, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hansen, JimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blaauw, YuriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maury, PhilippeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arentz, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sommer, PhilippUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Anic, AnteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Anselme, FredericUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boveda, SergeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deneke, TomUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Willems, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van der Voort, PepijnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tilz, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Funasako, MoritoshiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scherr, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wakili, RezaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Steven, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kautzner, JosefUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vijgen, JohanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jais, PierreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Petru, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chun, JulianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roten, LaurentUNSPECIFIEDorcid.org/0000-0002-0827-1329UNSPECIFIED
Fueting, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rillig, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mulder, Bart A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Johannessen, ArneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rollin, AnneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lehrmann, HeikoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sohns, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jurisic, ZrinkaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Savoure, ArnaudUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Combes, StephanesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nentwich, KarinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gunawardene, MelanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ouss, AlexandreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kirstein, BettinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Manninger, MartinUNSPECIFIEDorcid.org/0000-0002-0545-4373UNSPECIFIED
Bohnen, Jan-EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sultan, ArianUNSPECIFIEDorcid.org/0000-0003-1807-4860UNSPECIFIED
Peichl, PetrUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koopman, PieterUNSPECIFIEDorcid.org/0000-0002-6373-180XUNSPECIFIED
Derval, NicolasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Turagam, Mohit K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Neuzil, PetrUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-697832
DOI: 10.1093/europace/euac050
Journal or Publication Title: Europace
Publisher: OXFORD UNIV PRESS
Place of Publication: OXFORD
ISSN: 1532-2092
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PULMONARY VEIN ISOLATION; ATRIAL-FIBRILLATION; CATHETER ABLATION; ELECTROPORATION; INJURYMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69783

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