The PROMPT-AF randomized clinical trial evaluated whether pulmonary vein isolation combined with linear ablation and ethanol infusion via the vein of Marshall offers superior rhythm control compared with PVI alone in patients with persistent atrial fibrillation. This multicenter study enrolled 498 patients aged 18-80 years across 12 tertiary hospitals in China between August 27, 2021, and July 16, 2023, with 495 patients (99.4%) included in the primary analysis.
In the intervention group, patients first underwent ethanol infusion via the vein of Marshall (EIVOM), followed by pulmonary vein isolation (PVI) and linear ablation of the left atrial roof, mitral isthmus, and cavotricuspid isthmus. EIVOM was successfully performed in 209 patients (85%) of the intervention group.
At 12 months, 70.7% of patients in the intervention group achieved freedom from atrial arrhythmias without antiarrhythmic drugs compared with 61.5% in the PVI-alone group (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.54-0.99; P = .045). Complete linear block was achieved in 233 patients (94.3%) for cavotricuspid isthmus and 215 patients (87.4%) for both roofline and mitral isthmus.
The intervention was associated with longer procedure times (188.0 versus 140.8 minutes; P < .001) and fluoroscopy exposure (15.9 versus 5.1 minutes; P < .001). While adverse event rates were comparable between groups, pericarditis occurred in seven patients in the intervention group compared with none in the PVI-alone group.
Secondary endpoints, including atrial fibrillation (AF) burden and quality-of-life scores, showed no significant differences between groups.
Limitations include the use of single-lead ECG patches for weekly 24-hour monitoring instead of implantable loop recorders, which may have underestimated atrial arrhythmia recurrence. Additionally, the findings are specific to patients with persistent AF episodes lasting more than three months and may not apply to those with shorter episode durations.
The PROMPT-AF trial findings, published in JAMA, suggest that combining EIVOM and linear ablation with PVI was associated with improvements in freedom from atrial arrhythmias in patients with persistent AF.
Full disclosures can be found in the published trial.
