Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

Emmanuel Ekanem; Petr Neuzil; Tobias Reichlin; Joseph Kautzner; Pepijn van der Voort; Pierre Jais; Gian Battista Chierchia; Alan Bulava; Yuri Blaauw; Tomas Skala; Martin Fiala; Mattias Duytschaever; Gabor Szeplaki; Boris Schmidt; Grégoire Massoullie; Kars Neven; Olivier Thomas; Johan Vijgen; Estelle Gandjbakhch; Daniel Scherr; Arne Johannessen; David Keane; Serge Boveda; Philippe Maury; Ignacio García-Bolao; Ante Anic; Peter Steen Hansen; Franck Raczka; Antoine Lepillier; Yves Guyomar; Dhiraj Gupta; Jurren Van Opstal; Pascal Defaye; Christian Sticherling; Philipp Sommer; Pavel Kucera; Joaquin Osca; Fariborz Tabrizi; Antoine Roux; Michael Gramlich; Stefano Bianchi; Pedro Adragão; Francesco Solimene; Claudio Tondo; Antonio Dello Russo; Jürgen Schreieck; Armin Luik; Obaida Rana; Gerrit Frommeyer; Dominik Linz; Vivek Reddy; Et al.

doi:10.1038/s41591-024-03114-3

Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

Emmanuel Ekanem, Petr Neuzil, Tobias Reichlin, Joseph Kautzner, Pepijn van der Voort, Pierre Jais, Gian Battista Chierchia, Alan Bulava, Yuri Blaauw, Tomas Skala, Martin Fiala, Mattias Duytschaever, Gabor Szeplaki, Boris Schmidt, Grégoire Massoullie, Kars Neven, Olivier Thomas, Johan Vijgen, Estelle Gandjbakhch, Daniel ScherrArne Johannessen, David Keane, Serge Boveda, Philippe Maury, Ignacio García-Bolao, Ante Anic, Peter Steen Hansen, Franck Raczka, Antoine Lepillier, Yves Guyomar, Dhiraj Gupta, Jurren Van Opstal, Pascal Defaye, Christian Sticherling, Philipp Sommer, Pavel Kucera, Joaquin Osca, Fariborz Tabrizi, Antoine Roux, Michael Gramlich, Stefano Bianchi, Pedro Adragão, Francesco Solimene, Claudio Tondo, Antonio Dello Russo, Jürgen Schreieck, Armin Luik, Obaida Rana, Gerrit Frommeyer, Dominik Linz, Vivek Reddy^*, Et al.

^*Corresponding author for this work

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

Abstract

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

Original language	English
Pages (from-to)	2020-2029
Number of pages	10
Journal	Nature Medicine
Volume	30
Issue number	7
Early online date	1 Jan 2024
DOIs	https://doi.org/10.1038/s41591-024-03114-3
Publication status	Published - Jul 2024

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Ekanem, E., Neuzil, P., Reichlin, T., Kautzner, J., van der Voort, P., Jais, P., Chierchia, G. B., Bulava, A., Blaauw, Y., Skala, T., Fiala, M., Duytschaever, M., Szeplaki, G., Schmidt, B., Massoullie, G., Neven, K., Thomas, O., Vijgen, J., Gandjbakhch, E., ... Et al. (2024). Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nature Medicine, 30(7), 2020-2029. https://doi.org/10.1038/s41591-024-03114-3

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title = "Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study",

abstract = "Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.",

author = "Emmanuel Ekanem and Petr Neuzil and Tobias Reichlin and Joseph Kautzner and {van der Voort}, Pepijn and Pierre Jais and Chierchia, {Gian Battista} and Alan Bulava and Yuri Blaauw and Tomas Skala and Martin Fiala and Mattias Duytschaever and Gabor Szeplaki and Boris Schmidt and Gr{\'e}goire Massoullie and Kars Neven and Olivier Thomas and Johan Vijgen and Estelle Gandjbakhch and Daniel Scherr and Arne Johannessen and David Keane and Serge Boveda and Philippe Maury and Ignacio Garc{\'i}a-Bolao and Ante Anic and Hansen, {Peter Steen} and Franck Raczka and Antoine Lepillier and Yves Guyomar and Dhiraj Gupta and {Van Opstal}, Jurren and Pascal Defaye and Christian Sticherling and Philipp Sommer and Pavel Kucera and Joaquin Osca and Fariborz Tabrizi and Antoine Roux and Michael Gramlich and Stefano Bianchi and Pedro Adrag{\~a}o and Francesco Solimene and Claudio Tondo and Russo, {Antonio Dello} and J{\"u}rgen Schreieck and Armin Luik and Obaida Rana and Gerrit Frommeyer and Dominik Linz and Vivek Reddy and {Et al.}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = jul,

doi = "10.1038/s41591-024-03114-3",

language = "English",

volume = "30",

pages = "2020--2029",

journal = "Nature Medicine",

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Ekanem, E, Neuzil, P, Reichlin, T, Kautzner, J, van der Voort, P, Jais, P, Chierchia, GB, Bulava, A, Blaauw, Y, Skala, T, Fiala, M, Duytschaever, M, Szeplaki, G, Schmidt, B, Massoullie, G, Neven, K, Thomas, O, Vijgen, J, Gandjbakhch, E, Scherr, D, Johannessen, A, Keane, D, Boveda, S, Maury, P, García-Bolao, I, Anic, A, Hansen, PS, Raczka, F, Lepillier, A, Guyomar, Y, Gupta, D, Van Opstal, J, Defaye, P, Sticherling, C, Sommer, P, Kucera, P, Osca, J, Tabrizi, F, Roux, A, Gramlich, M, Bianchi, S, Adragão, P, Solimene, F, Tondo, C, Russo, AD, Schreieck, J, Luik, A, Rana, O, Frommeyer, G, Linz, D, Reddy, V & Et al. 2024, 'Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study', Nature Medicine, vol. 30, no. 7, pp. 2020-2029. https://doi.org/10.1038/s41591-024-03114-3

TY - JOUR

T1 - Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

AU - Ekanem, Emmanuel

AU - Neuzil, Petr

AU - Reichlin, Tobias

AU - Kautzner, Joseph

AU - van der Voort, Pepijn

AU - Jais, Pierre

AU - Chierchia, Gian Battista

AU - Bulava, Alan

AU - Blaauw, Yuri

AU - Skala, Tomas

AU - Fiala, Martin

AU - Duytschaever, Mattias

AU - Szeplaki, Gabor

AU - Schmidt, Boris

AU - Massoullie, Grégoire

AU - Neven, Kars

AU - Thomas, Olivier

AU - Vijgen, Johan

AU - Gandjbakhch, Estelle

AU - Scherr, Daniel

AU - Johannessen, Arne

AU - Keane, David

AU - Boveda, Serge

AU - Maury, Philippe

AU - García-Bolao, Ignacio

AU - Anic, Ante

AU - Hansen, Peter Steen

AU - Raczka, Franck

AU - Lepillier, Antoine

AU - Guyomar, Yves

AU - Gupta, Dhiraj

AU - Van Opstal, Jurren

AU - Defaye, Pascal

AU - Sticherling, Christian

AU - Sommer, Philipp

AU - Kucera, Pavel

AU - Osca, Joaquin

AU - Tabrizi, Fariborz

AU - Roux, Antoine

AU - Gramlich, Michael

AU - Bianchi, Stefano

AU - Adragão, Pedro

AU - Solimene, Francesco

AU - Tondo, Claudio

AU - Russo, Antonio Dello

AU - Schreieck, Jürgen

AU - Luik, Armin

AU - Rana, Obaida

AU - Frommeyer, Gerrit

AU - Linz, Dominik

AU - Reddy, Vivek

AU - Et al.

PY - 2024/7

Y1 - 2024/7

N2 - Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

AB - Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

U2 - 10.1038/s41591-024-03114-3

DO - 10.1038/s41591-024-03114-3

M3 - Article

SN - 1078-8956

VL - 30

SP - 2020

EP - 2029

JO - Nature Medicine

JF - Nature Medicine

IS - 7

ER -

Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

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