Department of Cardiology, Klinikum Coburg, Coburg, Germany.
Department of Cardiology and Intensive Care, Peter Osypka Heart Center Munich, Hospital for Internal Medicine Munich South, Am Isarkanal 36, 81379, Munich, Germany.
J Interv Card Electrophysiol. 2020 Sep;58(3):273-280. doi: 10.1007/s10840-019-00635-7. Epub 2019 Nov 9.
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).
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.
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%).
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.
左心耳封堵（LAAO）植入术是一种替代方法，可用于因不能长期接受口服抗凝而不适合接受抗凝治疗的房颤（AF）患者预防卒中。本文介绍了前瞻性、多中心德国左心耳封堵注册研究（LAARGE）的急性和 1 年随访结果数据。
LAARGE 纳入了 641 例拟行 LAAO 植入术的患者。收集的数据包括人口统计学、临床特征、适应证、植入术细节和结果；患者在植入术后 1 年进行随访。通过发生血栓栓塞和出血事件来评估随访期间的疗效和安全性。
2014 年 7 月至 2016 年 1 月，德国 38 家医院共连续纳入 641 例患者（平均年龄：75.9±8.0 岁）。患者的人口统计学特征代表了一个重症患者群体，计算出的 CHA2DS2-VASc 评分和 HASBLED 评分分别为 4.5 和 3.9，其中出血事件是 LAAO 植入术的主要适应证（79.4%）。术后 1 年全因死亡率为 11.5%，非致死性卒中和 TIA 发生率为 1.3%（8 例），大出血发生率为 1.6%（10 例）。术后 1 年的抗凝方案包括：5.5%的患者接受口服抗凝治疗，84.1%的患者（多数采用单一抗血小板治疗，即阿司匹林（ASS），占 74.5%，少数采用双联抗血小板治疗，占 6.7%）接受抗血小板治疗。
LAARGE 是一项前瞻性、多中心、真实世界、所有患者纳入的注册研究，其概念独特，非制造商赞助，包括所有市售器械。LAAO 植入术主要用于老年、重症、有出血史的患者。LAARGE 在 1 年随访中显示出良好的疗效和安全性，卒中和 TIA 发生率为 1.3%，大出血发生率为 1.6%，大多数患者采用单一抗血小板治疗。
