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

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, 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, MANIFEST-PF Cooperative

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.

Keywords: Atrial fibrillation; Catheter ablation; Pulsed field ablation; Survey.

Conflict of interest statement

Conflict of interest: V.Y.R. reports receiving consulting fees and equity (stock) from Farapulse Inc. and is a consultant for Boston Scientific Inc.; he also has additional disclosures unrelated to this manuscript that are listed in the Supplementary material online. B.S. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. T.R. reports research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund. Speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS. Support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. L.R. reports receiving speaker honoraria from Abbott/SJM and consulting honoraria from Medtronic. K.N. reports speaker’s Fees from Farapulse, Inc. A.M. reports research grant and fees from Farapulse. A.R. reports receiving research grant from Farapulse. J.H. reports receiving speaker fees and grant support from Biosense Webster and Medtronic. Y.B.: reports receiving Research grant from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. P.S. reports member of the advisory board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. C.S. reports receiving modest honoraria from Medtronic. A.A. reports receiving consultant fees from Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster, and performs contracted research for Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster. F.A. reports receiving consulting fees from Boston Scientific, Medtronic and Microport CRM. S.B. reports receiving consulting fees for Medtronic, Boston Scientific, Microport, Zoll, and BMS. T.D. reports receiving speaker honoraria from Galaxy Medical, Abbott and Biotronik, being a consultant to Farapulse, and serving on a Clinical Events Committee for Boston Scientific. S.W. reports receiving grants and personal fees from Abbott, Boston Scientific, Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, Farapulse Inc. M.G. reports grant from Farapulse Inc. and Abbott. R.T. reports receiving consulting fees from Boston Scientific, Abbot Medical, Biotronik, and speakers honorarium from Boston Scientific, Abbot Medical, Biotronik, Biosense Webster. B.K. reports receiving Travel and Congress Sponsoring from Biotronik, Abbott, Impulse Dynamics, DGK AG EP, EHRA, Pfizer; she also received fellowship sponsoring from Johnson & Johnson, Boston Scientific and Lecture Honorary from Biotronik, Impulse Dynamics, C.T.I. GmbH, Doctrina Med. D.S. reports receiving an educational grant from Farapulse Inc., and is a consultant For Boston Scientific Inc. R.W. reports receiving consultant fees and travel expenses from Boston Scientific and Biotronik; investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. D.S. reports receiving speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grant from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. A.S. reports receiving lecture and consulting honoraria from Medtronic, Abbott, and Bayer. J.K. reports personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards, and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. P.J. reports receiving equity from Farapulse and consulting fees and grant from Boston Scientific. N.D. reports receiving consulting fees from Boston scientific. J.C. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. P.N. reports receiving grant from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). All the remaining authors have declared no conflict of interest.

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

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
PFA catheter. (A) Pentaspline PFA catheter in basket (top) and flower (bottom) configurations. (B and C) Fluoroscopic images of pentaspline PFA catheter over a guidewire in the left superior (B) or right superior (C) pulmonary veins.
Figure 2
Figure 2
Complications timeline. Shown are the pericardial tamponades and strokes occurring at each centre as a sequence at the time of event. The horizontal lines represent the number of patients treated at each of the 24 centres.

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