PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION : INITIAL EXPERIENCE WITH THE ARTICULATED ULTRASEPT LAA OCCLUDERTM

Abstract

We report the first series of left atrial appendage (LAA) occlusion with the (USLO) UltraSeptTM LAA Occluder (Cardia Inc, Eagen, MN), a novel device specifically designed to mitigate implantation challenges such as acute angulation and misizing. The USLO is a self-expanding device made of connecting nitinol wires creating a bulb and a sail. The bulb features 6 pairs of hooks and serves as the anchor in the LAA neck; the sail is made of several polypropylene-covered overlapping petals designed to occlude the LAA ostium and promote endothelialization. The bulb and sail are connected through a flexible dual articulating joint designed to allow a significant sail-to-bulb angulation, hence coaxial implantation of both these structures despite significant angulation between the LAA neck and ostium. The device is fully retrievable and repositionable up to final release. Bulb sizes vary from 16 to 32 mm with low radial force allowing implantation of a giving bulb in large range of anatomies. The bioptome-like delivery cable connects to the device in ball-and-socket fashion. Patients with atrial fibrillation and an indication for anticoagulation were considered for LAA closure if they had a long-term contraindication to anticoagulation. From January to April 2015, 5 patients underwent LAA occlusion with the USLO device in our center. All patients underwent pre-intervention TEE to rule-out thrombus. Procedures were performed under local anesthesia and conscious sedation using angiographic and intracardiac echocardiographic guidance (Figure 1). After measurements of the LAA neck diameter, USLO size was selected using 2-3mm oversizing. If position and sealing were satisfactory, device stability was tested with a pull test prior final release. Successful LAA occlusion was defined as the absence of peri-device leak larger than 3 mm. Baseline patient characteristics and procedural data are in Table 1. In one patient, the initial USLO was changed for a larger one. LAA occlusion was successful in all cases - 3 patients had no residual leak while the other two had leaks of 2 and 3 mm respectively. One patient suffered tamponade, successfully treated with pericardial drainage. There were no other complications. Adequate device position was generally easy to achieve, however the bulb is implanted in a deeper position than that of the similar Amplatzer Cardiac Plug (St.Jude Medical Inc.)View Large Image Figure ViewerDownload (PPT)