Percutaneous left atrial appendage occlusion with the Amulet device: The impact of device disc position upon periprocedural and long-term outcomes.

OBJECTIVE: To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes.

BACKGROUND: The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain.

METHODS: Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n = 45) had complete LAA ostium coverage; group B (n = 42) had incomplete ostium coverage because of disc prolapse. Periprocedural major adverse events (MAE) (composite of all cause death, tamponade, device/air embolization, cerebrovascular events, myocardial infarction, and major bleeding not related to vascular access complications) and total device-related periprocedural adverse events (defined as MAE and pericardial effusion) were evaluated. All patients were followed up longitudinally with long-term events defined as a composite of: cardiovascular death, cerebrovascular events, systemic embolization, and major bleeding requiring transfusion or intervention.

RESULTS: Median follow-up was 234 days (IQR 150-436 days). There was a trend toward more periprocedural MAE in group B (P = 0.07) with deep implantation of the Amulet device associated with significantly more periprocedural adverse events (P = 0.03). There were no differences in reposition attempts (P = 0.9) or long-term events (P = 0.57).

CONCLUSIONS: Our data suggest that suboptimal device positioning may be associated with worse periprocedural outcomes but no difference in long-term clinical outcomes. The results of this relatively small cohort does not seem to be affected by repositioning attempts during the index procedure.