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

TY - JOUR

T1 - Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)

AU - Ekanem, Emmanuel

AU - Reddy, Vivek Y

AU - Schmidt, Boris

AU - Reichlin, Tobias

AU - Neven, Kars

AU - Metzner, Andreas

AU - Hansen, Jim

AU - Blaauw, Yuri

AU - Maury, Philippe

AU - Arentz, Thomas

AU - Sommer, Philipp

AU - Anic, Ante

AU - Anselme, Frederic

AU - Boveda, Serge

AU - Deneke, Tom

AU - Willems, Stephan

AU - van der Voort, Pepijn

AU - Tilz, Roland

AU - Funasako, Moritoshi

AU - Scherr, Daniel

AU - Wakili, Reza

AU - Steven, Daniel

AU - Kautzner, Josef

AU - Vijgen, Johan

AU - Jais, Pierre

AU - Petru, Jan

AU - Chun, Julian

AU - Roten, Laurent

AU - Füting, Anna

AU - Rillig, Andreas

AU - Mulder, Bart A

AU - Johannessen, Arne

AU - Rollin, Anne

AU - Lehrmann, Heiko

AU - Sohns, Christian

AU - Jurisic, Zrinka

AU - Savoure, Arnaud

AU - Combes, Stephanes

AU - Nentwich, Karin

AU - Gunawardene, Melanie

AU - Ouss, Alexandre

AU - Kirstein, Bettina

AU - Manninger, Martin

AU - Bohnen, Jan Eric

AU - Sultan, Arian

AU - Peichl, Petr

AU - Koopman, Pieter

AU - Derval, Nicolas

AU - Turagam, Mohit K

AU - Neuzil, Petr

AU - MANIFEST-PF Cooperative

N1 - © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2022/9/1

Y1 - 2022/9/1

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Atrial Fibrillation/diagnosis

KW - Catheter Ablation/methods

KW - Female

KW - Humans

KW - Middle Aged

KW - Pulmonary Veins/surgery

KW - Retrospective Studies

KW - Stroke/etiology

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1093/europace/euac050

DO - 10.1093/europace/euac050

M3 - SCORING: Journal article

C2 - 35647644

VL - 24

SP - 1256

EP - 1266

JO - EUROPACE

JF - EUROPACE

SN - 1099-5129

IS - 8

ER -