Comparative Analysis of Safety Profiles of Pulsed Field and Thermal Energy Atrial Fibrillation Ablation: Insight From the Multicenter Real‐World Ablation Registry
Osamu Inaba, Shinsuke Miyazaki, Junichi Nitta, Atsushi Takahashi, Shu Yamashita, Yasutoshi Nagata, Shinsuke Iwai, Yoshihide Takahashi, Yasuteru Yamauchi, Akira Mizukami, Hitoshi Hachiya, Atsushi Suzuki, Yosuke Hayashi, Miho Negishi, Tetsuo SasanoABSTRACT
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.