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

期刊论文
发表日期：

2024年5月30日

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Antonio Bisignani,
Marco Schiavone,
Francesco Solimene,
Antonio Dello Russo,
Pasquale Filannino,
Michele Magnocavallo,
Claudio Tondo,
Vincenzo Schillaci,
Michela Casella,
Andrea Petretta,
Pietro Rossi,
Gaetano Fassini,
Antonio Rossillo,
Ruggero Maggio,
Sakis Themistoclakis,
Claudio Pandozi,
Marco Polselli,
Fabrizio Tundo,
Alberto Arestia,
Paolo Compagnucci,
Annelisa Valente Perrone,
Maurizio Malacrida,
Saverio Iacopino,
Stefano Bianchi

摘要

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