Key result
Pulsed field ablation yields ~14% higher 12-month arrhythmia freedom compared to cryoballoon ablation.
Why the study?
PVI modulates the cardiac autonomic nervous system, but PFA appears to have minimal autonomic effects, leaving the impact of autonomic modulation on arrhythmia recurrence incompletely understood.
Does pulsed field ablation improve arrhythmia-free outcome and affect autonomic nervous system modulation compared to cryoballoon ablation in patients with symptomatic paroxysmal atrial fibrillation?
RCT (n=210)
1:1
Yes
Does pulsed field ablation improve arrhythmia-free outcome and affect autonomic nervous system modulation compared to cryoballoon ablation in patients with symptomatic paroxysmal atrial fibrillation?
Absolute Event Rate: 63% vs 49%
p-value: p=0.046
Pulsed field ablation resulted in superior arrhythmia-free outcomes compared to cryoballoon ablation in paroxysmal AF, suggesting that cardiac autonomic nervous system modulation is not critical for successful ablation.
PFA may improve arrhythmia freedom versus CBA in AF; leaves open autonomic mediation of outcomes.
BACKGROUND: Pulmonary vein isolation (PVI) using radiofrequency and cryoballoon ablation (CBA) modulates the cardiac autonomic nervous system (ANS) by affecting epicardial ganglionated plexi. In contrast, pulsed field ablation (PFA) appears to exert minimal autonomic effects. The impact of cardiac ANS modulation on arrhythmia recurrence remains incompletely understood. METHODS: In this multicenter trial substudy, 210 patients with symptomatic paroxysmal atrial fibrillation (AF) were randomized 1:1 to PVI using PFA or CBA. All patients received an implantable cardiac monitor at the time of ablation. Daytime heart rate (DHR), nighttime heart rate (NHR), and heart rate variability (HRV) were continuously recorded over 12 months and analyzed at day 1-2, month 3, 6, 9, and 12 post-ablation, and related to arrhythmia-free outcome. RESULTS: PFA (n = 105) was associated with higher HRV at day 1-2 compared to CBA (n = 105; 100 [79-122] ms vs. 73 [59-93] ms, p < 0.001). This trend persisted throughout follow-up. DHR and NHR were also consistently lower in the PFA group. Freedom from arrhythmia recurrence at 12 months was higher with PFA than CBA (63% vs. 49%, p = 0.046). HRV did not differ between PFA patients with and without recurrence. A stronger initial HRV suppression predicted favorable outcomes in CBA patients (67 ms vs. 84 ms in patients without vs. with arrhythmia recurrence, p = 0.002). CONCLUSIONS: Despite reduced cardiac ANS modulation, PFA was associated with a superior arrhythmia-free outcome compared to CBA. These findings suggest that cardiac ANS modulation may not be critical for the successful ablation of paroxysmal AF.
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Roten et al. (2026) conducted an RCT in Symptomatic paroxysmal atrial fibrillation (n=210). Pulsed field ablation (PFA) vs. Cryoballoon ablation (CBA) was evaluated on Freedom from arrhythmia recurrence at 12 months (p=0.046). Pulsed field ablation resulted in a higher rate of freedom from arrhythmia recurrence at 12 months compared to cryoballoon ablation (63% vs. 49%, p=0.046).
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