Key result
Pulsed-field ablation linked to ~45% fewer complications versus thermal ablation for AF.
Why the study?
Following the introduction of three large-footprint pulsed-field ablation systems in Japan, acute procedural outcomes and safety profiles needed to be compared against thermal ablation.
Does pulsed-field ablation improve acute procedural outcomes and safety compared to thermal ablation in patients undergoing index atrial fibrillation ablation?
Observational (n=4,969)
Yes
Does pulsed-field ablation improve acute procedural outcomes and safety compared to thermal ablation in patients undergoing index atrial fibrillation ablation?
Absolute Event Rate: 2.4% vs 4.4%
p-value: p=<0.01
Pulsed-field ablation is associated with a significantly lower incidence of procedure-related complications and shorter procedure times compared to thermal ablation in real-world practice.
PFA shows comparable acute safety to thermal ablation in real-world Japanese practice; leaves open long-term efficacy for randomized trials.
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.
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Inaba et al. (2026) conducted an observational in Atrial fibrillation (n=4,969). Pulsed-field ablation vs. Thermal ablation was evaluated on Overall complication rate (p=<0.01). Pulsed-field ablation was associated with a significantly lower overall complication rate compared with thermal ablation (2.4% vs. 4.4%, p<0.01) for atrial fibrillation.
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