Asymmetric biphasic pulsed field ablation of paroxysmal atrial fibrillation: clinical assessment

Background Pulsed field ablation (PFA) is a non-thermal, tissue-selective therapy for atrial fibrillation. In this study, we evaluated the safety and efficacy of a novel asymmetric biphasic PFA system, which combines a unique pulse-parameter configuration with a dedicated, adjustable six-spline catheter. Methods This prospective, multicenter, single-arm study was conducted in China. Patients with drug-refractory paroxysmal AF underwent pulmonary vein isolation (PVI) using a 1,000 V asymmetric biphasic PFA system with a novel parameter configuration. The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence through 12 months post-blanking. The primary safety endpoint was predefined serious adverse events. The secondary safety endpoint was hemolysis and silent cerebral lesions (SCLs). Results Among 120 enrolled patients, 105 underwent ablation and completed the 12-month follow-up, while 15 patients withdrew before the PFA operation. Acute PVI was successfully achieved in all 420 targeted veins. At 12 months, the Kaplan–Meier estimate of freedom from atrial arrhythmia recurrence was 69.5% (95% CI, 60.1–77.5%). The observed 12-month effectiveness was within the range reported in previous studies of PFA technologies. Regarding safety, major procedural complications—including pulmonary vein stenosis, phrenic nerve injury, atrioesophageal fistula, stroke, and acute kidney injury (AKI)—were entirely absent. However, one patient (0.95%) experienced a transient coronary vasospasm that was successfully resolved with an intracoronary vasodilator. Additionally, SCLs were detected in two patients (1.9%). While laboratory hemolysis was a common finding, it did not lead to renal impairment. Conclusions This asymmetric biphasic PFA system achieved complete acute PVI and 12-month effectiveness was within the range reported in previous studies of PFA technologies. It showed a favorable safety profile, with few SCLs and no hemolysis-related AKI. Clinical Trial Registration https://www.chictr.org.cn/showproj.html?proj=134973 , identifier ChiCTR2200062157.