BACKGROUND: The Amplatzer Amulet is the evolution of the Amplatzer Cardiac Plug, a dedicated device for percutaneous left atrial appendage (LAA) occlusion. The new device has been designed to facilitate the implantation, improve the sealing performance and further reduce the risk of complications. Modifications include lengthening of the device lobe with an increase in disk diameter and inversion of the proximal attachment screw. The device was released for initial assessment in 250 cases in selected OUS centers. We aimed to assess the safety and feasibility of this novel occluder and impressions of longer-term efficacy.
METHODS: LAA occlusion was offered to patients with atrial fibrillation in accordance with the health basket with a CHADS2 score ≥3 and a contraindication to anticoagulants due to severe bleeding. All procedures were performed under general anesthesia and transesophageal echocardiography guidance. Transthoracic echocardiography (TTE) was performed 24-hours after the procedure in order to
rule out procedural complications before discharge. Further follow-up was done with a clinical visit and TTE at 1, 3 and 6 months.
RESULTS: Between March and July 2013, 7 patients with a mean CHADS2 score of 4.3±1.7 underwent LAA occlusion with the Amplatzer Amulet. The device was successfully implanted in all cases without procedural stroke, pericardial effusion or device embolization.
In all cases the disk was positioned outside the ostium (beyond the pulmonary vein ridge). Mean follow-up was 7.5±0.2 months. No clinical events occurred during the follow-up period. Follow-up echocardiography demonstrated no device embolization, thrombus formation or peridevice leak.
CONCLUSION: In this initial series of patients, the new Amulet device configuration for LAA occlusion appears to be safe and feasible with the added benefits of being extremely stable, with an improved ability to completely cover the LAA ostium with associated good, although limited, mid-term outcomes.
