Validation Strategy for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation in Long-Term Maintaining Sinus Rhythm: A Randomized Controlled Study.

Background: Data comparing the outcomes of loose versus rigorous validation strategies for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF) are limited. We aimed to prospectively assess the effectiveness of loose versus rigorous validation for PVI in patients with PAF with a maintained sinus rhythm. Methods: Patients (n = 117) with PAF were randomized to receive either loose validation (n = 59) or rigorous validation (n = 58) after PVI. The presence of dormant conduction in loose validation was assessed only by adenosine administration followed by isoproterenol infusion. The complete absence of pulmonary vein (PV) potentials in rigorous validation was confirmed by the combination of the Lasso catheter with isoproterenol plus adenosine. Dormant conduction, revealed by validation after PVI, was ablated until all reconnections were eliminated. Results: The procedure time in the rigorous validation group was greater than that in the loose validation group (161.3 ± 52.7 min vs. 142.5 ± 37.6 min, p=0.03, respectively). After successful PVI, the detection of dormant PV reconnections in the rigorous validation group was significantly greater than that in the loose validation group (69.0% vs. 37.3%, p=0.001). However, after reisolation of the sites of dormant PV conduction, the postablation recurrence rates in 1.3 years were similar between the groups (79.2% vs. 83.6%, p=0.67). Conclusion: Rigorous validation can reveal dormant conduction in more than two-thirds of patients with PAF undergoing PVI. However, rigorous validation and additional ablation of the resulting connections do not improve long-term outcomes when a protocol that includes electrophysiological confirmation and pharmacological validation is used.