Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)
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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). / Ekanem, Emmanuel; 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; Füting, 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; Bohnen, Jan Eric; Sultan, Arian; Peichl, Petr; Koopman, Pieter; Derval, Nicolas; Turagam, Mohit K; Neuzil, Petr; MANIFEST-PF Cooperative.
in: EUROPACE, Jahrgang 24, Nr. 8, 01.09.2022, S. 1256-1266.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -