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

MANIFEST-PF Cooperative; Emmanuel Ekanem; Vivek Y Reddy; Boris Schmidt; Tobias Reichlin; Kars Neven; Andreas Metzner; Jim Hansen; Yuri Blaauw; Philippe Maury; Thomas Arentz; Philipp Sommer; Ante Anic; Frederic Anselme; Serge Boveda; Tom Deneke; Stephan Willems; Pepijn van der Voort; Roland Tilz; Moritoshi Funasako; Daniel Scherr; Reza Wakili; Daniel Steven; Josef Kautzner; Johan Vijgen; Pierre Jais; Jan Petru; Julian Chun; Laurent Roten; Anna Füting; Andreas Rillig; Bart A Mulder; Arne Johannessen; Anne Rollin; Heiko Lehrmann; Christian Sohns; Zrinka Jurisic; Arnaud Savoure; Stephanes Combes; Karin Nentwich; Melanie Gunawardene; Alexandre Ouss; Bettina Kirstein; Martin Manninger; Jan-Eric Bohnen; Arian Sultan; Petr Peichl; Pieter Koopman; Nicolas Derval; Mohit K Turagam; Petr Neuzil

doi:10.1093/europace/euac050

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

MANIFEST-PF Cooperative, Emmanuel Ekanem, Vivek Y Reddy, Boris Schmidt, Tobias Reichlin, Kars Neven, Andreas Metzner, Jim Hansen, Yuri Blaauw, Philippe Maury, Thomas Arentz, Philipp Sommer, Ante Anic, Frederic Anselme, Serge Boveda, Tom Deneke, Stephan Willems, Pepijn van der Voort, Roland Tilz, Moritoshi FunasakoDaniel Scherr, Reza Wakili, Daniel Steven, Josef Kautzner, Johan Vijgen, Pierre Jais, Jan Petru, Julian Chun, Laurent Roten, Anna Füting, Andreas Rillig, Bart A Mulder, Arne Johannessen, Anne Rollin, Heiko Lehrmann, Christian Sohns, Zrinka Jurisic, Arnaud Savoure, Stephanes Combes, Karin Nentwich, Melanie Gunawardene, Alexandre Ouss, Bettina Kirstein, Martin Manninger, Jan-Eric Bohnen, Arian Sultan, Petr Peichl, Pieter Koopman, Nicolas Derval, Mohit K Turagam, Petr Neuzil

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Article number	euac050
Pages (from-to)	1256–1266
Number of pages	11
Journal	Europace
Volume	24
Issue number	8
Early online date	1-Jun-2022
DOIs	https://doi.org/10.1093/europace/euac050
Publication status	Published - 1-Sept-2022

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MANIFEST-PF Cooperative, Ekanem, E., Reddy, V. Y., 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., ... Neuzil, P. (2022). Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace, 24(8), 1256–1266. [euac050]. https://doi.org/10.1093/europace/euac050

@article{50fb4030e8da480ebc78e74d48c44962,

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

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.",

author = "{MANIFEST-PF Cooperative} and Emmanuel Ekanem and Reddy, {Vivek Y} and Boris Schmidt and Tobias Reichlin and Kars Neven and Andreas Metzner and Jim Hansen and Yuri Blaauw and Philippe Maury and Thomas Arentz and Philipp Sommer and Ante Anic and Frederic Anselme and Serge Boveda and Tom Deneke and Stephan Willems and {van der Voort}, Pepijn and Roland Tilz and Moritoshi Funasako and Daniel Scherr and Reza Wakili and Daniel Steven and Josef Kautzner and Johan Vijgen and Pierre Jais and Jan Petru and Julian Chun and Laurent Roten and Anna F{\"u}ting and Andreas Rillig and Mulder, {Bart A} and Arne Johannessen and Anne Rollin and Heiko Lehrmann and Christian Sohns and Zrinka Jurisic and Arnaud Savoure and Stephanes Combes and Karin Nentwich and Melanie Gunawardene and Alexandre Ouss and Bettina Kirstein and Martin Manninger and Jan-Eric Bohnen and Arian Sultan and Petr Peichl and Pieter Koopman and Nicolas Derval and Turagam, {Mohit K} and Petr Neuzil",

note = "{\textcopyright} The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.",

year = "2022",

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day = "1",

doi = "10.1093/europace/euac050",

language = "English",

volume = "24",

pages = "1256–1266",

journal = "Europace",

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MANIFEST-PF Cooperative, 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, J-E, Sultan, A, Peichl, P, Koopman, P, Derval, N, Turagam, MK & Neuzil, P 2022, 'Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)', Europace, vol. 24, no. 8, euac050, pp. 1256–1266. https://doi.org/10.1093/europace/euac050

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 - MANIFEST-PF Cooperative

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

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.

U2 - 10.1093/europace/euac050

DO - 10.1093/europace/euac050

M3 - Article

C2 - 35647644

SN - 1099-5129

VL - 24

SP - 1256

EP - 1266

JO - Europace

JF - Europace

IS - 8

M1 - euac050

ER -