Left atrial appendage closure using the Amulet device: an initial experience with the second generation amplatzer cardiac plug.

OBJECTIVES

Aim of this study was to demonstrate the feasibility, safety, and short-term outcome of left atrial appendage (LAA) closure with a new generation LAA closure device.

BACKGROUND

The Amulet device (AGA, St Jude Medical, Minneapolis, MN) is a new generation of the amplatzer cardiac plug (ACP), specifically designed for LAA closure. This new version is designed to facilitate the implantation process and minimize procedural or device-related complications.

METHODS

The device was implanted in 17 patients with nonvalvular atrial fibrillation (AF). Clinical data were obtained at baseline, during the procedure, at discharge, at 30 and 90 days.

RESULTS

All devices were implanted successfully. Device sizes ranged from 20 mm to 31 mm. A 12 French (Fr) or 14 Fr delivery sheath was used depending on the selected device size. Full and partial recapture was performed in 1 case and 3 cases, respectively. There was 1 procedure-related pericardial effusion successfully managed with pericardiocentesis. There was no device embolization. The mean length of stay was 2.1 ± 0.3 days. At 90 days, there were no deaths, strokes, systemic thromboembolism, or bleeding complications. There was no device-related thrombus or pericardial effusion at 90-day TEE. In 2 of the 17 patients minimal peridevice flow (smaller than 2 mm) was present.

CONCLUSIONS

The Amulet device, which has new novel features as compared with the first generation ACP, is a feasible option for LAA closure. From our initial experience, implantation of the Amulet is associated with high success rate and good short-term outcome.