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Published on: August 25, 2022
Comparative Analysis of Safety Profiles of Pulsed Field and Thermal Energy Atrial Fibrillation Ablation: Insight From
Osamu Inaba1, Shinsuke Miyazaki2, Junichi Nitta3
1Department of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.
Background:
Beginning in September 2024, three large-footprint pulsed-field ablation (PFA) systems were introduced in Japan for atrial fibrillation (AF) ablation.
Objective:
To compare acute procedural outcomes and safety profiles between PFA and thermal ablation.
Methods:
This multi-center observational study included 4969 consecutive index AF ablation procedures (69 ± 11 years, 1495 women, 2705 paroxysmal) performed between January 2024 and July 2025. Among them, 2817 and 2152 procedures were performed with thermal ablation and PFA (FARAPULSE 53.3%, PulseSelect 41.3%, and VARIPULSE 5.5%), respectively.
Results:
PFA procedures were performed under deeper sedation (70.5% deep sedation) compared with thermal ablation. The total PFA application numbers were 50 ± 13 for FARAPULSE, 49 ± 13 for PulseSelect, and 24 ± 8.5 for VARIPULSE. Touch-up ablation for pulmonary veins was more frequently required with balloon-based thermal ablation than with PFA (7.2% vs. 1.5%, p < 0.01). Adjunctive posterior wall isolation was more common in the PFA-group than Thermal-group (30.3% vs. 11.4%, p < 0.01). Fluoroscopy time was significantly longer (27.8 ± 17.1 vs. 24.9 ± 17.6 min, p < 0.01) and total procedure time significantly shorter in the PFA-group than Thermal-group (106 ± 48.5 vs. 131 ± 54.4 min, p < 0.01). The overall complication rate (2.4% vs. 4.4%, p < 0.01) and phrenic nerve palsy rate (0.1% vs. 1.5%, p < 0.01) were significantly lower, while coronary spasms tended to be more frequent in the PFA-group. No gastric hypomotility or pericarditis occurred in the PFA-group despite much lower use of esophageal temperature monitoring (3.2% vs. 83.1%, p < 0.01).
Conclusions:
This large real-world registry demonstrated a significantly lower incidence of procedure-related complications with large-footprint PFA devices compared with thermal ablation systems, despite early-phase adoption.
