Adjunctive LAA ligation does not significantly reduce atrial arrhythmia recurrence in AF: aMAZE Trial
USA: Results from the randomized aMAZE trial showed that left atrial appendage ligation plus pulmonary vein isolation is not superior to pulmonary vein isolation alone at preventing recurrent atrial fibrillation. The findings of the study were presented at the virtual American Heart Association (AHA) 2021 Scientific Sessions.
To elaborate, the addition of left atrial appendage (LAA) ligation with the Lariat system (AtriCure) did not improve arrhythmic outcomes over pulmonary vein antral isolation alone in patients with persistent atrial fibrillation (AF) undergoing initial catheter ablation. In 85% of patients, left atrial appendage ligation was associated with residual communication ≤1 mm 12 months after the procedure.
"The Lariat system appears to be safe and successfully excludes the left atrial appendage in this first prospective, rigorous, and independently monitored clinical trial evaluating the [system]," reported David Wilber (Loyola University Chicago, IL).
The goal of the trial was to evaluate left atrial appendage ligation/pulmonary vein antral isolation compared with pulmonary vein antral isolation alone among patients with persistent atrial fibrillation.
Participants with persistent atrial fibrillation were randomized to left atrial appendage ligation/pulmonary vein antral isolation (n = 404) versus pulmonary vein antral isolation alone (n = 206). Left atrial appendage ligation was performed with the Lariat device.
The study enrolled 610 patients who were followed for a median of 12 months. Mean patient age was 67 years; percentage female -- 27%; and percentage with diabetes -- 20%.
Patients with symptomatic persistent and long-standing persistent atrial fibrillation, failed antiarrhythmic drug therapy and planned catheter ablation procedure were included.
Following were the study's key findings:
- The primary safety endpoint occurred in 3.4% of the left atrial appendage ligation/pulmonary vein antral isolation group (primary safety endpoint was met).
- Residual communication ≤1 mm 12 months after procedure: 85%.
- The primary effectiveness endpoint (freedom from antiarrhythmic drug therapy at 12 months) was 64.3% in the left atrial appendage ligation/pulmonary vein antral isolation group versus 59.9% in the pulmonary vein antral isolation alone group (criterion for superiority not met).
- Among those with early persistent atrial fibrillation, there was weak evidence for treatment interaction favoring left atrial appendage ligation/pulmonary vein antral isolation versus pulmonary vein antral isolation alone.
- Among those with left atrial volume ≥133 cm3, there was weak evidence for treatment interaction favoring left atrial appendage ligation/pulmonary vein antral isolation versus pulmonary vein antral isolation alone.
"Left atrial appendage ligation/pulmonary vein antral isolation during the index procedure was feasible among patients with persistent atrial fibrillation. Left atrial appendage ligation with the Lariat device met the criterion for safety versus a historical performance goal," wrote the authors. "In 85% of patients, left atrial appendage ligation was associated with residual communication ≤1 mm 12 months after the procedure."
Left atrial appendage ligation/pulmonary vein antral isolation failed to meet the criterion for effectiveness since recurrent atrial arrhythmias were similar between treatment groups, they noted.
"Exploratory analyses suggest possible benefits among those with early persistent atrial fibrillation and large left atrial volumes; however, further investigation would be needed to support these observations."
Reference:
Wilber DJ. Outcomes of adjunctive left atrial appendage ligation utilizing the Lariat compared to pulmonary vein antral isolation alone: the aMAZE trial. Presented at: AHA 2021. November 14, 2021.
