Initial Worldwide Experience With the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Atrial Fibrillation

Abstract

OBJECTIVES This study assessed the feasibility of implanting a device in the left atrial appendage (LAA) in patients with atrial fibrillation (AF) to prevent thromboembolic stroke. BACKGROUND Meta-analyses confirmed that in cases of left atrial thrombus in nonrheumatic AF patients approximately 90% of them are in the LAA. METHODS The WATCHMAN Left Atrial Appendage System (Atritech Inc., Plymouth, Minnesota) is a nitinol device implanted percutaneously to seal the LAA. Patients were followed by clinical and transesophageal echocardiography at 45 days and 6 months with annual clinical follow-up thereafter. RESULTS Sixty-six patients underwent device implantation. Mean follow-up was 740 +/- 341 days. At 45 days, 93% (54 of 58) devices showed successful sealing of LAA according to protocol. Two patients experienced device embolization, both successfully retrieved percutaneously. No embolizations occurred in 53 patients enrolled after modification of fixation barbs. There were 2 cardiac tamponades, 1 air embolism, and 1 delivery wire fracture (first generation) with surgical explantation but no long-term sequelae for the patient. Four patients developed a flat thrombus layer on the device at 6 months that resolved with additional anticoagulation. Two patients experienced transient ischemic attack, 1 without visible thrombus. There were 2 deaths, neither device related. Autopsy documented a stable, fully endothelialized device 9 months after implantation. No strokes occurred during follow-up despite >90% of patients with discontinuation of anticoagulation. CONCLUSIONS Preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible. A randomized study is ongoing comparing oral anticoagulation with percutaneous closure.