Efficacy and Safety of Left Atrial Appendage Occlusion Device Implantation (Watchman) for High Risk Patients

Background: Left atrial appendage occlusion (LAAO) Device implantation is an alternative to anticoagulation therapy for prevention of stroke in patients with atrial fibrillations. However, the efficacy and the safety of this device in high risk patient is undetermined yet.

Methods and Results: Forty-seven consecutive high-risk patients with atrial fibrillation which had relative high contraindication for anticoagulant therapy underwent LAAO device implantation (Watchman device). Sixty-six percent were male, the average age, CHADS₂ score and CHA₂DS₂VASC score were 76± 8 years, 3.4±1.01 and 4.7±1.3, respectively. The indication for the LAACD implantation was GI bleeding, intracranial hemorrhage and other (64%, 20.5% and 9%, respectively). Acute success rate of implantation was 93.6% (44/47). The unsuccessful three patients were due to failed trans-septal, LAA thrombus and large-oversized LAA. Thirty-one (70%) patients discharged on aspirin and plavix and 27% on a NOAC for an average of 100.7±69.9 days.

Watchman implantation was safe with no acute complications. At 45 day-TEE follow up all devices were well positioned with full closure of the LAA. In one patient, device-related thrombus was observed which resolved with oral anticoagulation. One patient suffered intra cranial bleeding on dual anti-platelets therapy 20 days post-implantation. At an average follow-up of 37.9±15.4 there were two patients with thromboembolic event (one TIA and one CVA at one year). In addition, 10/47 (21%) had died (13±5.9 month post procedure), none of deaths wese related to the procedure.

Conclusions: LAAO device implantation for prevention of thromboembolic events in patients with atrial fibrillation is an effective and safe for high risk patients.