Left atrial appendage occlusion: pilot study of a fourth-generation, minimally invasive device.

Abstract

OBJECTIVE: Exclusion of the left atrial appendage is proposed to reduce the risk of stroke in patients with atrial fibrillation. The aim of this study was to evaluate the feasibility and efficacy of a fourth-generation atrial exclusion device developed for minimally invasive applications. METHODS: The novel atrial exclusion device consists of two polymer beams and two elastomeric bands that connect the two beams at either end. Fifteen mongrel dogs were implanted with the device at the base of the left atrial appendage through a median sternotomy and were evaluated at 30 (n = 7), 90 (n = 6), and 180 (n = 2) days after implantation by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histology. RESULTS: Left atrial appendage exclusion was completed without hemodynamic instability. Coronary angiography revealed that the left circumflex artery was patent in all cases. A new endothelial tissue layer developed, as expected, on the occluded orifice of the left atrium. CONCLUSIONS: This novel atrial exclusion device achieved easy, reliable, and safe exclusion of the left atrial appendage, with favorable histological results in a canine model for up to 6 months. Clinical application could provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.