Background: Myocardial fibrosis is key for atrial fibrillation maintenance. We aimed to test the efficacy of ablating cardiac magnetic resonance (CMR)-detected atrial fibrosis plus pulmonary vein isolation (PVI).
Methods: This was an open-label, parallel-group, randomized, controlled trial. Patients with symptomatic drug-refractory atrial fibrillation (paroxysmal and persistent) undergoing first or repeat ablation were randomized in a 1:1 basis to receive PVI plus CMR-guided fibrosis ablation (CMR group) or PVI alone (PVI-alone group). The primary end point was the rate of recurrence (>30 seconds) at 12 months of follow-up using a 12-lead ECG and Holter monitoring at 3, 6, and 12 months. The analysis was conducted by intention-to-treat.
Results: In total, 155 patients (71% male, age 59±10, CHA2DS2-VASc 1.3±1.1, 54% paroxysmal atrial fibrillation) were allocated to the PVI-alone group (N=76) or CMR group (N=79). First ablation was performed in 80% and 71% of patients in the PVI-alone and CMR groups, respectively. The mean atrial fibrosis burden was 12% (only ≈50% of patients had fibrosis outside the pulmonary vein area). One hundred percent and 99% of patients received the assigned intervention in the PVI-alone and CMR group, respectively. The primary outcome was achieved in 21 patients (27.6%) in the PVI-alone group and 22 patients (27.8%) in the CMR group (odds ratio: 1.01 [95% CI, 0.50-2.04]; P=0.976). There were no differences in the rate of adverse events (3 in the CMR group and 2 in the PVI-alone group; P=0.68).
Conclusions: A pragmatic ablation approach targeting CMR-detected atrial fibrosis plus PVI was not more effective than PVI alone in an unselected population undergoing atrial fibrillation ablation with low fibrosis burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02698631.
Keywords: atrial fibrillation; fibrosis; magnetic resonance imaging; pulmonary veins; treatment outcome.