Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, European Center for AngioScience (ECAS), and German Center for Cardiovascular Research (DZHK) Partner Site Heidelberg/Mannheim, Mannheim, Germany.
REGIOMED-Kliniken, Coburg, Germany.
Catheter Cardiovasc Interv. 2022 Jun;99(7):2064-2070. doi: 10.1002/ccd.30165. Epub 2022 Apr 6.
Interventional left atrial appendage occlusion (LAAO) is routinely performed in patients with nonvalvular atrial fibrillation and contraindications to standard anticoagulation.
We investigated its role in patients at low stroke risk, and compared the effectiveness and safety in patients with low versus high risk.
LAARGE is a prospective registry depicting the clinical reality of LAAO. LAAO was conducted with different standard commercial devices, and follow-up period was 1 year. Patients with started procedure and documented CHA DS -VASc score were selected from the whole database.
A total of 638 patients from 38 centers were divided into CHA DS -VASc score ≤2, i.e., low-risk group (10.2%), and >2, i.e., high-risk group (89.8%). The latter had a pronounced cardiovascular risk profile and preceding strokes (0% vs. 23.9%; p < 0.001). Implantation success was consistently high (97.6%), frequencies of intrahospital major adverse cardiac and cerebrovascular events (0% vs. 0.5%) and other major complications (4.6% vs. 4.0%) were low (each p = not significant [NS]). Numerous moderate complications were also observed in the low-risk patients (12.3% vs. 9.4%; p = NS). Frequencies of nonfatal strokes (0% vs. 0.7%) and severe bleedings (0% vs. 0.7%) were low (each p = NS). In a specific analysis, patients at very high risk of stroke (i.e., CHA DS -VASc score >4) did not have increased rates of complications or nonfatal strokes in the first year after the procedure.
Low-risk patients had no nonfatal strokes and major bleedings within 1 year after hospital discharge but had unexpectedly high rates of moderate procedural complications. The indication in these patients should be strictly defined based on an individual benefit-risk assessment.
介入性左心耳封堵术（LAAO）常用于非瓣膜性心房颤动且存在标准抗凝禁忌的患者。
我们研究了 LAAO 在低卒中风险患者中的作用，并比较了低危和高危患者的有效性和安全性。
LAARGE 是一项描述 LAAO 临床实际情况的前瞻性登记研究。使用不同的标准商业设备进行 LAAO，随访时间为 1 年。从整个数据库中选择开始手术且记录有 CHA DS -VASc 评分的患者。
来自 38 个中心的 638 名患者被分为 CHA DS -VASc 评分≤2，即低危组（10.2%）和>2，即高危组（89.8%）。后者具有明显的心血管风险特征和既往卒中（0%比 23.9%；p<0.001）。植入成功率始终很高（97.6%），院内主要不良心脑血管事件（0%比 0.5%）和其他主要并发症（4.6%比 4.0%）的发生率较低（均为 p>0.05）。在低危患者中也观察到大量中度并发症（12.3%比 9.4%；p>0.05）。非致死性卒中（0%比 0.7%）和严重出血（0%比 0.7%）的发生率较低（均为 p>0.05）。在一项专门分析中，卒中风险极高（即 CHA DS -VASc 评分>4）的患者在术后 1 年内并未增加并发症或非致死性卒中的发生率。
低危患者在出院后 1 年内无非致死性卒中或大出血，但有意外高比例的中度手术并发症。这些患者的适应证应根据个体获益风险评估进行严格定义。
