Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation.

BACKGROUND: Clinically effective ablation approaches for patients with persistent atrial fibrillation (AF) are still being debated. So far, ablation targets and strategies beyond pulmonary vein isolation (PVI) have failed to show systematic outcome improvement in randomized controlled clinical trials. METHODS: We conducted a multicenter, randomized trial to determine whether PVI plus individualized substrate ablation of atrial low-voltage myocardium improves outcome in patients with persistent AF. We randomly assigned 324 patients in a 1:1 ratio to receive PVI alone (163 patients; PVI only) or PVI plus substrate modification (161 patients; PVI+SM). The primary study end point was the first recurrence of an atrial arrhythmia longer than 30 seconds after single ablation, with 3 months blanking, using serial 7-day electrocardiogram recordings over 12 months of observation. Patients were also encouraged to receive implantable cardiac monitors. RESULTS: The primary study end point occurred in 75 PVI-only patients (50%) and in 54 PVI+SM patients (35%) (Kaplan­Meier event rate estimates: hazard ratio=0.62, 95% confidence interval [CI]=0.43 to 0.88, log rank P=0.006). Adverse events occurred in three PVI-only patients (1.8%) and in six PVI+SM patients (3.7%) (difference: −1.9 percentage points, 95% CI=−5.5 to 1.7 percentage points). Implant monitoring was used in 242 patients. Among them, 65 PVI-only patients (55%) versus 47 PVI+SM patients (39%) experienced recurrences (difference: 15 percentage points, 95% CI=3 to 28 percentage points). CONCLUSIONS: In this randomized trial, PVI plus individualized ablation of atrial low-voltage myocardium significantly improved outcomes in patients with persistent AF. (ClinicalTrials.gov number, NCT02732626.)