Key result
Biphasic asymmetric PFA achieves 100% acute PVI in AF without recurrences or serious adverse events.
Why the study?
Small-scale clinical trials were needed to test whether pulsed field ablation using biphasic asymmetric pulses is safe and feasible in patients with AF before extensive clinical trials.
Is pulsed field ablation using biphasic asymmetric pulses safe and feasible for achieving pulmonary vein isolation in patients with atrial fibrillation?
Is pulsed field ablation using biphasic asymmetric pulses safe and feasible for achieving pulmonary vein isolation in patients with atrial fibrillation?
A pilot study of 10 patients demonstrated that pulsed field ablation using biphasic asymmetric waveforms is safe and feasible for achieving pulmonary vein isolation in atrial fibrillation.
Answers are grounded in this paper and cite their sources.
Should not change ablation practice; hypothesis-generating for biphasic asymmetric PFA and requires larger randomized confirmation.
Pulsed field ablation (PFA) is a new treatment for atrial fibrillation (AF), and its selective ablation characteristics give it a significant advantage in treatment. In previous cellular and animal experiments, we have demonstrated that biphasic asymmetric pulses can be used to ablate myocardial tissue. However, small-scale clinical trials are needed to test whether this approach is safe and feasible before extensive clinical trials can be performed. Therefore, the purpose of this experiment is to determine the safety and feasibility of biphasic asymmetric pulses in patients with AF and is to lay the foundation for a larger clinical trial. Ablation was performed in 10 patients with AF using biphasic asymmetric pulses. Voltage mapping was performed before and after PFA operation to help us detect the change in the electrical voltage of the pulmonary veins (PV). 3-Dimensional mapping system showed continuous low potential in the ablation site, and pulmonary vein isolation (PVI) was achieved in all four PV of the patients. There were no recurrences, PV stenosis, or other serious adverse events during the 12 months follow-up. The results suggest that PFA using biphasic asymmetric waveforms for patients with AF is safe, durable, and effective and that a larger clinical trial could begin. Clinical Trial Registration: https://www.chictr.org.cn/, identifier, ChiCTR2100051894.
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Chen et al. (2024) studied Atrial fibrillation (n=10). Biphasic asymmetric pulsed field ablation (PFA) was evaluated on Acute success rate of pulmonary vein isolation (PVI). Biphasic asymmetric pulsed field ablation achieved acute pulmonary vein isolation in 100% of patients with atrial fibrillation, with no recurrences or serious adverse events over 12 months.
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