Background: Beyond pulmonary vein (PV) isolation, the optimal ablation strategy for persistent atrial fibrillation (AF) remains poorly defined. The purpose of this study was to compare 2 ablation strategies in the treatment of patients with persistent AF: a comprehensive ablation strategy based on anatomic considerations versus PV isolation alone.
Methods: The Marshall-Plan trial is a prospective, randomized, parallel-group, controlled clinical trial of superiority conducted at the Bordeaux University Hospital. Consecutive patients with symptomatic, documented persistent AF were included and randomized into 2 arms: Marshall-Plan consisting of PV isolation with additional ablation including vein of Marshall ethanol infusion, and lines of block at the mitral, dome, and cavotricuspid isthmuses versus PV isolation alone. The main outcome was the 1-year freedom from any arrhythmia (atrial fibrillation/atrial tachycardia >30 seconds) after a single ablation procedure with or without any antiarrhythmic medication at 12 months.
Results: A total of 120 patients were included (age 65±8 years; 21 women). Two patients were excluded from analysis. All PVs were successfully isolated in both groups. In the Marshall-Plan group, vein of Marshall ethanol infusion was completed in 57 (97%) patients. Conduction block across linear lesions was obtained in 93%, 92%, and 93% of the mitral, dome, and cavotricuspid isthmuses, respectively. The full lesion set was successfully completed in 52 (88%) patients in the Marshall-Plan group and 59 (100%) patients in the PV isolation group. At 12 months, freedom from recurrence of atrial arrhythmia >30 seconds after 1 ablation procedure, with or without antiarrhythmic medication, had occurred in 51 of the 59 (86.4%) patients assigned to the Marshall-Plan approach, and 39 of the 59 (66.1%) patients assigned to PV isolation only (P=0.012).
Conclusions: In this prospective randomized controlled trial, the Marshall-Plan strategy was significantly superior to a PV isolation strategy at 12 months.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04206982.
Keywords: cardiac arrhythmia; ethanol; heart; human; pulmonary veins; tachycardia; therapeutics.