Outcomes of Adjunctive Left Atrial Appendage Ligation Utilizing the LARIAT Compared to Pulmonary Vein Antral Isolation Alone - aMAZE

Nov 14, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
AtriCure, Inc.
Date Presented:
11/14/2021
Date Published:
11/14/2021
Date Updated:
11/14/2021
Original Posted Date:
11/14/2021
References

Contribution To Literature:

The aMAZE trial showed that left atrial appendage ligation plus pulmonary vein isolation was not superior to pulmonary vein isolation alone at preventing recurrent atrial fibrillation.

Description:

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.

Study Design

  • Randomization
  • Parallel

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.

  • Total number of enrollees: 610
  • Duration of follow-up: 12 months
  • Mean patient age: 67 years
  • Percentage female: 27%
  • Percentage with diabetes: 20%

Inclusion criteria:

  • Symptomatic persistent and long-standing persistent atrial fibrillation
  • Failed antiarrhythmic drug therapy
  • Planned catheter ablation procedure

Principal 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).

Secondary outcomes:

  • 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 (p for interaction = 0.084).
  • 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 (p for interaction = 0.093).

Interpretation:

Among patients with persistent atrial fibrillation, left atrial appendage ligation/pulmonary vein antral isolation during the index procedure was feasible. Left atrial appendage ligation with the Lariat device met the criterion for safety versus an historical performance goal. 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. Exploratory analyses suggest possible benefit among those with early persistent atrial fibrillation and large left atrial volumes; however, further investigation would be needed to support these observations.

References:

Presented by Dr. David J. Wilber at the American Heart Association Virtual Annual Scientific Sessions (AHA 2021), November 14, 2021.

Clinical Topics: Arrhythmias and Clinical EP, Prevention, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: AHA Annual Scientific Sessions, AHA21, Anti-Arrhythmia Agents, Arrhythmias, Cardiac, Atrial Appendage, Atrial Fibrillation, Catheter Ablation, Ligation, Pulmonary Veins, Secondary Prevention


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