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SHR Neuro Cancer Cardio Lipid Metab Microb
Ekanem, E; Reddy, VY; Schmidt, B; Reichlin, T; Neven, K; Metzner, A; Hansen, J; Blaauw, Y; Maury, P; Arentz, T; Sommer, P; Anic, A; Anselme, F; Boveda, S; Deneke, T; Willems, S; van, der, Voort, P; Tilz, R; Funasako, M; Scherr, D; Wakili, R; Steven, D; Kautzner, J; Vijgen, J; Jais, P; Petru, J; Chun, J; Roten, L; Füting, A; Rillig, A; Mulder, BA; Johannessen, A; Rollin, A; Lehrmann, H; Sohns, C; Jurisic, Z; Savoure, A; Combes, S; Nentwich, K; Gunawardene, M; Ouss, A; Kirstein, B; Manninger, M; Bohnen, JE; Sultan, A; Peichl, P; Koopman, P; Derval, N; Turagam, MK; Neuzil, P, , MANIFEST-PF, Cooperative.
Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).
Europace. 2022; 24(8):1256-1266
Doi: 10.1093/europace/euac050
[OPEN ACCESS]
Web of Science
PubMed
FullText
FullText_MUG
- Co-authors Med Uni Graz
- Manninger-Wünscher Martin
- Scherr Daniel
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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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult - administration & dosage
- Aged - administration & dosage
- Aged, 80 and over - administration & dosage
- Atrial Fibrillation - diagnosis, etiology, surgery
- Catheter Ablation - methods
- Female - administration & dosage
- Humans - administration & dosage
- Middle Aged - administration & dosage
- Pulmonary Veins - surgery
- Retrospective Studies - administration & dosage
- Stroke - etiology
- Treatment Outcome - administration & dosage
- Young Adult - administration & dosage
- Find related publications in this database (Keywords)
- Atrial fibrillation
- Pulsed field ablation
- Survey
- Catheter ablation