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Review
. 2024 Dec;67(9):2127-2136.
doi: 10.1007/s10840-024-01835-6. Epub 2024 May 30.

National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety

Antonio Bisignani #  1 , Marco Schiavone #  2 , Francesco Solimene  3   4 , Antonio Dello Russo  4   5 , Pasquale Filannino  6 , Michele Magnocavallo  7 , Claudio Tondo  2 , Vincenzo Schillaci  3 , Michela Casella  5   8 , Andrea Petretta  6 , Pietro Rossi  7 , Gaetano Fassini  2 , Antonio Rossillo  9 , Ruggero Maggio  10 , Sakis Themistoclakis  11 , Claudio Pandozi  12 , Marco Polselli  7 , Fabrizio Tundo  2 , Alberto Arestia  3 , Paolo Compagnucci  4   5 , Annelisa Valente Perrone  13 , Maurizio Malacrida  13 , Saverio Iacopino #  6 , Stefano Bianchi #  7
Affiliations
Review

National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety

Antonio Bisignani et al. J Interv Card Electrophysiol. 2024 Dec.

Abstract

Background: Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes.

Methods: Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators' learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year.

Results: Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R2 0.92-0.68 across various procedural metrics). Current PFA skin-to-skin time was lower than the historical skin-to-skin one in 217 (62.4%) procedures; it was similar in 112 (32.2%) cases and higher than the historical skin-to-skin one in 19 (5.5%). No major complications were reported.

Conclusions: In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures.

Clinical trial registration: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.

Keywords: Atrial fibrillation; Clinical practice; Electroporation; Learning curve; Pulsed-field ablation.

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Conflict of interest statement

Declarations. Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. The locally appointed Ethics Committee approved the research protocol. Consent to participate: Informed consent was obtained from all individual participants included in the study. Consent for publication: Patients signed informed consent regarding publishing their data. Competing interests: M.M and A.V.P. are employees of Boston Scientific. S.B. and P.R. received teaching and proctor’s fees and honoraria from Boston Scientific and Medtronic. A.B. and M.P. received teaching and proctor’s fees and honoraria from Boston Scientific. G.F. is a clinical proctor for Boston Scientific. C.T. received speaker’s and proctor’s fees from Boston Scientific, Medtronic, Abbott, and Biosense Webster. He serves in the Advisory Board of Medtronic, Boston Scientific. S.B. and P.R. received speaker’s and proctor’s fees from Boston Scientific and Medtronic. The other authors have no conflicts of interest to declare. The other authors have no conflicts of interest to declare.

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