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Quebec, Canada. The Amplatzer Cardiac Plug (ACP) is used for left atrial appendage closure (LAAC) for patients with non-valvular atrial fibrillation (NVAF). Recent studies evaluated the efficacy of this device for LAAC. However, there is no data with respect to long term outcomes. This study assessed long term outcomes of LAAC using ACP in patients with contraindication for anticoagulation.
Fifty-two NVAF patients with estimated annual stroke risk of > 2% and contraindications for anticoagulation therapy were included in the study. Patients were followed for a mean duration of 20 months after implantation of the ACP. Absence of severe residual leak was considered as successful implantation. Death, stroke, systemic embolism, pericardial effusion, and major bleeding were considered as major adverse events (MAEs). As a part of follow up, trans-esophageal echocardiography (TEE) was performed to identify peri-device leaks.
The study demonstrated that the procedure was successful in 98.1% of the patients. Only one procedure failed, which was likely due to an undersized ACP. There was one case in which e emoblization of device occurred but the device was safely retrieved. During follow-up, four patients presented with MAEs. Three patients died during the follow up, yet none were caused or related to the device. Of the 37 patients who underwent TEE at 6 months, mild peri-device leak (a jet width ?1 and <3 mm) was observed in only 16.2% of the study population.
Overall, LAAC with ACP device was very successful, with a high rate of procedural success and a low rate of complications. Also, LAAC coupled with antiplatelet therapy was associated with a low incidence of thromboembolic events. The authors proposed that lower occurrence of residual leak with ACP compared to Watchman (32%) was due to the double disc structure of ACP which enables better sealing of the LAA. However, in study evaluating Watchman device, the peri-device leaks < 1 mm was defined as mild leak. In summary, LAAC with the ACP device and antiplatelet therapy was associated with a low rate of bleeding and decreased thrombo-embolic events over a mean follow up duration of 20 months in this high risk patient cohort. This study shows ACP device is efficacious for LAAC. However more studies are needed to demonstrate whether LAAC alone with no anti-coagulation would be safe for these high risk AF patients.
Reference: 1. Urena M, Rodés-Cabau J, Freixa X, Saw J, Webb JG, Freeman M, Horlick E, Osten M, Chan A, Marquis JF, Champagne J, Ibrahim R, Percutaneous Left Atrial Appendage Closure with the Amplatzer Cardiac Plug Device in Patients with Non-Valvular Atrial Fibrillation and Contraindications for Anticoagulation Therapy, Journal of the American College of Cardiology (2013), doi: 10.1016/j.jacc.2013.02.089
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