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

E. Ekanem, VY. Reddy, B. Schmidt, T. Reichlin, K. Neven, A. Metzner, J. Hansen, Y. Blaauw, P. Maury, T. Arentz, P. Sommer, A. Anic, F. Anselme, S. Boveda, T. Deneke, S. Willems, P. van der Voort, R. Tilz, M. Funasako, D. Scherr, R. Wakili, D....

. 2022 ; 24 (8) : 1256-1266. [pub] 2022Sep01

Language English Country England, Great Britain

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc22024572

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.

Asklepios Hospital St Georg Hamburg Germany

Cardiology Department Na Homolce Hospital Homolka Hospital Roentgenova 37 2 15030 Praha 5 Prague Czech Republic

Clinic for Electrophysiology Herz und Diabeteszentrum NRW Ruhr University Bochum Bad Oeynhausen Germany

Copenhagen University Hospital Copenhagen Denmark

Department for Cardiovascular Diseases University Hospital Center Split Split Croatia

Department of Cardiology and Vascular Medicine West German Heart and Vascular Center Essen University Duisburg Essen Duisburg Germany

Department of Cardiology Catharina Ziekenhuis Eindhoven Eindhoven The Netherlands

Department of Cardiology Jessa Hospitals Hasselt Belgium

Department of Cardiology Rouen Hospital Rouen France

Department of Cardiology University Hospital Rangueil Toulouse France

Department of Electrophysiology Alfried Krupp Hospital Essen Germany

Department of Medicine Witten Herdecke University Witten Germany

Department of Rhythmology University Heart Center Lubeck Germany

German Center for Cardiovascular Research Partner Site Hamburg Kiel Lübeck Lübeck Germany

Heart Center Bad Neustadt Rhoen Clinic Campus Bad Neustadt Bad Neustadt an der Saale Germany

Heart Rhythm Department Clinique Pasteur Toulouse France

I2MC INSERM UMR 1297 Toulouse France

Icahn School of Medicine at Mount Sinai New York NY USA

IHU LIRYC CHU Bordeaux University of Bordeaux Bordeaux France

IKEM Institute for Clinical and Experimental Medicine Prague Czech Republic

Inselspital Bern University Hospital University of Bern Bern Switzerland

LANS Cardio Hamburg Germany

Medical University of Graz Graz Austria

MVZ CCB Frankfurt und Main Taunus GbR Frankfurt Germany

Neuron Medical Brno Czech Republic

Universitair Medish Groningen Groningen The Netherlands

Universitair Ziekenhuis VUB Brussels Belgium

Universitätsklinikum Freiburg Breisgau Germany

Universitätsklinikum Köln AöR Köln Germany

University Heart and Vascular Center University of Hamburg Hamburg Germany

References provided by Crossref.org

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