Left atrial appendage closure using AMPLATZER (TM) devices: A large, multicenter, Italian registry

Background: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER (TM) devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding.Methods: From December 2008 to April 2015 613 NVAF patients (75.1 +/- 8.0 years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER (TM) devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset.Results: AMPLATZER (TM) devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20 months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6 months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively.Conclusions: In this large, multicenter, single-nation study, LAAO with the AMPLATZER (TM) devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism. (C) 2017 Elsevier B.V. All rights reserved