Does Electrogram Guided Substrate Ablation Add to the Success of Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation? A Prospective, Randomized Study

Abstract

Pulmonary vein isolation (PVI) is an established treatment for paroxysmal atrial fibrillation (AF). The ablation of complex fractionated atrial electrograms (CFAE) has emerged as a novel treatment approach. We sought to evaluate the additional effect of CFAE ablation to PVI in paroxysmal AF. Ninety-eight patients with paroxysmal AF (57 +/- 10 years, 74 male) were randomized to the PVI (n = 48) or PVI + CFAE group (n = 50). After PVI, CFAE ablation was performed in patients with inducible AF in the PVI + CFAE group. The primary endpoint was combined objective (7-day Holter ECG) and subjective (symptoms) freedom of atrial tachyarrhythmia 3 months after ablation. Long-term follow-up (19 +/- 8 months) was available in 94 of 98 patients. CFAE ablation was performed in 30 of 50 patients of the PVI + CFAE group. After 3 months, 36 of 48 patients (75%) in the PVI group and 38 of 50 patients (76%) in the PVI + CFAE group were in stable sinus rhythm (P = NS). During long-term follow-up (19 +/- 8 months), 34 of 46 patients (74%) in the PVI group and 40 of 48 patients (83%) in the PVI + CFAE group were in sinus rhythm (P = 0.08). In a subgroup analysis, a significantly better long-term outcome was achieved if inducible AF after PVI had been treated by additional CFAE ablation as compared with PVI only (sinus rhythm in 25/28 patients; 89% vs 22/30 patients 73%; P = 0.003). In the intention-to-treat analysis, additional CFAE ablation did not improve the success rate of PVI in patients with paroxysmal AF. However, during long-term follow-up, patients with still inducible AF after PVI seemed to profit from additional CFAE ablation.