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.
Keywords: left atrial appendage closure; new device; structural heart intervention.
© 2014 Wiley Periodicals, Inc.