First results of the Brazilian Registry of Percutaneous Left Atrial Appendage Closure

BACKGROUND: Left atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). OBJECTIVE: To present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure. METHODS: 91 patients with NVAF, high stroke risk (CHA(2)DS(2)VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016. RESULTS: Ninety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%). CONCLUSIONS: In this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA(2)DS(2)VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.