Journal of cardiovascular electrophysiology · 2026
Comparative Analysis of Safety Profiles of Pulsed Field and Thermal Energy Atrial Fibrillation Ablation: Insight From the Multicenter Real-World Ablation Registry.
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Inaba Osamu, Miyazaki Shinsuke, Nitta Junichi, Takahashi Atsushi, Yamashita Shu, Nagata Yasutoshi, Iwai Shinsuke, Takahashi Yoshihide, Yamauchi Yasuteru, Mizukami Akira, Hachiya Hitoshi, Suzuki Atsushi, Hayashi Yosuke, Negishi Miho, Sasano Tetsuo
Аннотация
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.
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.