Background: The Visually-Guided Laser Balloon System (LB) for pulmonary vein isolation (PVI) has been available for over a decade. A novel 3^rdgeneration LB (X3) has been developed to improve case times with the goal of comparable performance to the current LB, but shorter ablation times. Acute safety and PVI results have been previously reported. This is the first report of chronic results.
Objective: To assess whether PVI with X3 results in shorter ablation and fluoroscopy times than the current LB with comparable chronic efficacy.
Methods: Patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled at 2 centers. Enrollment criteria for the X3 study (NCT03470636) were comparable to the historical control study - LB US pivotal clinical study. Treatments were completed by 4 operators. Ablation time was reported as time from introduction of the LB/X3 to end of the 30-min wait period. Chronic effectiveness was reported as having all PVs isolated, no AF recurrence after a 90-day blanking period >= 1 minute, no new left atrial flutter, no intervention for AF and being off AADs for AF.
Results: Sixty patients were treated by the 4 operators. Average ablation times and fluoroscopy times of X3 (n=60) compared favorably to control / LB (n=170) at 77 vs 174, and 6.9 vs 35.6 min, respectively. The AF-free rate at 6 months was 86.0% (49/57) for X3 and 75.0% (126/168) for HL.
Conclusion: The 3rd gen X3 catheter performs PVI with comparable chronic efficacy but reduced ablation and fluoroscopy times compared to the current generation LB.