Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term outcome of occluder implantation in the LAARGE Registry.

Background: Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE).

Methods: LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively.

Results: A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%).

Conclusions: LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients.