Single-shot pulsed field ablation yielded similar 12-month arrhythmia-free survival compared to single-tip pulsed field ablation (76% vs 82%; P=0.46) for paroxysmal atrial fibrillation.
RCT (n=100)
1:1
Does single-shot pulsed field ablation improve arrhythmia-free survival compared to single-tip pulsed field ablation in patients with paroxysmal atrial fibrillation?
Both single-shot and single-tip PFA systems achieved high acute PVI rates and comparable 1-year arrhythmia-free survival, with differing procedural profiles.
Absolute Event Rate: 76% vs 82%
p-value: p=.46
BACKGROUND: Pulsed field ablation (PFA) is an emerging technology to perform pulmonary vein isolation (PVI) in atrial fibrillation. Comparative data between different PFA systems are scarce. OBJECTIVE: This study aimed to provide the first head-to-head evaluation of 2 PFA technologies for index PVI. METHODS: Patients with paroxysmal atrial fibrillation were 1:1 randomized to single-shot (pentaspline catheter) or single-tip PFA (focal contact force-sensing ablation catheter). The primary endpoint was arrhythmia-free survival at 12 months; secondary endpoints included procedural characteristics, safety, and biomarker assessments. RESULTS: 100 patients were assigned to the single-shot or the single-tip PFA group. Baseline characteristics were comparable. Acute PVI was achieved in 100%. Single-shot PFA reduced total procedure time (44 ± 11 minutes vs 119 ± 30 minutes; P < .001) but required longer fluoroscopy time (14 ± 5 minutes vs 4 ± 2 minutes; P < .001). New-onset arrhythmias (6%) could only be treated in the single-tip PFA group. Major complications included 1 non-PFA-related stroke (single-shot group) and 1 pericardial tamponade during single-tip PFA. No permanent sequelae occurred. Troponin levels were higher with single-tip PFA. At 12 months, arrhythmia-free survival was 76% (single-shot group) and 82% (single-tip group), respectively (P = .46). CONCLUSION: Both PFA systems achieved high acute PVI rates with favorable 1-year clinical outcomes. Single-shot PFA was associated with shorter procedure times and longer fluoroscopy times, whereas single-tip PFA allowed adjunctive ablation when required and was associated with higher postprocedural troponin T levels.
Hartl et al. (Fri,) conducted a rct in paroxysmal atrial fibrillation (n=100). Single-shot pulsed field ablation (pentaspline catheter) vs. Single-tip pulsed field ablation (focal contact force-sensing ablation catheter) was evaluated on arrhythmia-free survival at 12 months (p=.46). Single-shot pulsed field ablation yielded similar 12-month arrhythmia-free survival compared to single-tip pulsed field ablation (76% vs 82%; P=0.46) for paroxysmal atrial fibrillation.