Key Points:
- It is unknown if linear ablation with ethanol infusion of the vein of Marshall (EIVOM) in addition to pulmonary vein isolation (PVI) improves outcomes as compared to PVI alone in patients with persistent atrial fibrillation.
- In this investigator-initiated, open-label randomized clinical trial, 498 patients with persistent atrial fibrillation without a history of ablation were randomized in a 1:1 fashion.
- Linear ablation with EIVOM plus PVI was associated with freedom from atrial arrhythmia recurrence at 12 months compared to PVI alone.
Pulmonary vein isolation (PVI) is the ablation strategy of choice for individuals with atrial fibrillation (AF). It has been demonstrated that patients with paroxysmal AF have greater response to PVI than those with persistent AF. In those with persistent AF, linear ablations (such as roof lines or mitral isthmus lines) have been studied without significant improvement to PVI alone. Ethanol infusion via the vein of Marshall (EIVOM) has been shown to improve outcomes in those with persistent AF. It is unknown whether the addition of EIVOM to linear ablations with PVI is superior to PVI alone in individuals with persistent AF.
The Comparison of Linear Ablation Plus Pulmonary Vein Isolation vs. Pulmonary Vein Isolation Alone for Persistent Atrial Fibrillation (PROMPT-AF) trial was an investigator-initiated, multicenter, open-label, randomized clinical trial performed at 12 sites in China. The study randomized adults <80 years old with persistent atrial fibrillation that was refractory to at least one antiarrhytmic drug and no prior history of AF ablation to undergo linear ablation with EIVOM and PVI (246 participants) or pulmonary vein isolation alone (249 participants). The primary outcome was freedom from any documented atrial arrhythmias for 12 months.
The results of the trial were presented as a late breaking clinical trial at the American Heart Association on November 18, 2024, with a simultaneous publication in JAMA. Among the 498 patients who underwent randomization, the average age was 61 years, 27% were women, and the median duration of persistent AF diagnosis at the time of ablation was 12 months. At 12 months, 70.7% of the linear ablation with EIVOM and PVI group were free from arrhythmias compared to 61.5%of the PVI group alone (hazard ratio 0.73; 95% confidence interval [CI] 0.54 to 0.99, P < 0.045). There was no significant difference in procedure-related adverse events between the two groups (P = 0.15). However, 7 patients in the linear ablation with EIVOM and PVI group experienced pericarditis or pericardial effusion not requiring drainage compared to none in the PVI alone group.
Limitations of the trial include open-label design, the lack of continuous electrical monitoring with implantable loop recorders thus underestimating atrial arrhythmia recurrence, and the exclusion of patients with persistent AF lasting longer than 3 months.
In the simultaneous publication, Dr. Caihua Sang and colleagues concluded that “among patients with persistent AF, linear ablation combined with EIVOM in addition to PVI significantly improved freedom from atrial arrhythmias within 12 months compared with PVI alone.”
- Sang C, Liu Q, Lai Y, et al. Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial. Published online November 18, 2024. doi:10.1001/jama.2024.24438