From the Department of Neurology (S.H., T.R., R.V.), Department of Cardiology (C.Z., U.K., N.G., S.H.), and Institute of Medical Biometry and Informatics (G.R.), University of Heidelberg, Germany.
Neurology. 2014 Jan 14;82(2):135-8. doi: 10.1212/WNL.0000000000000022. Epub 2013 Dec 6.
To evaluate the safety and feasibility of percutaneous left atrial appendage occlusion (LAAO) in patients with atrial fibrillation (AF) and previous intracranial hemorrhage (ICH).
In an explorative, prospective, single-center, observational study, LAAO was performed in patients with previous ICH and AF using the Amplatzer Cardiac Plug device. Risks of ischemic strokes and hemorrhagic complications were estimated using the CHA2DS2Vasc score and the HAS-BLED score. Before and 1, 6, 12, and 24 months after the procedure, clinical status and complications were recorded. Major complications were predefined as periprocedural stroke, death, pericardial effusion, and device embolism.
LAAO was performed in 20 patients. Based on CHA2DS2Vasc score (mean 4.5 ± 1.4) and HAS-BLED score (mean 4.7 ± 1.0), annual risks of stroke and hemorrhagic complications were 4.0%-6.7% and 8.7%-12.5%, respectively. No patient had a procedure-related complication. Minor postprocedural complications were observed in 4/20 patients (2 inguinal hematoma, 1 self-limiting asystole, and 1 thrombus formation on device). No ischemic or hemorrhagic stroke occurred during a mean follow-up of 13.6 ± 8.2 months.
In this first study of LAAO in patients with previous ICH, LAAO appears feasible and safe. A larger, controlled trial is needed to assess the efficacy and safety of the procedure compared to other preventive measures.
This study provides Class III evidence that in patients with a history of previous ICH and AF, percutaneous LAAO is safe and feasible.
评估经皮左心耳封堵术（LAAO）在合并心房颤动（AF）和既往颅内出血（ICH）患者中的安全性和可行性。
在一项探索性、前瞻性、单中心、观察性研究中，使用 Amplatzer 心脏封堵器对既往有 ICH 和 AF 的患者进行 LAAO。使用 CHA2DS2Vasc 评分和 HAS-BLED 评分来评估缺血性中风和出血性并发症的风险。在手术前和手术后 1、6、12 和 24 个月，记录临床状况和并发症。主要并发症定义为围手术期中风、死亡、心包积液和器械栓塞。
共对 20 例患者进行了 LAAO。基于 CHA2DS2Vasc 评分（平均 4.5±1.4）和 HAS-BLED 评分（平均 4.7±1.0），中风和出血性并发症的年风险分别为 4.0%-6.7%和 8.7%-12.5%。无患者发生与手术相关的并发症。20 例患者中有 4 例（2 例腹股沟血肿、1 例短暂性窦性停搏、1 例器械上血栓形成）出现轻微的术后并发症。在平均 13.6±8.2 个月的随访中，未发生缺血性或出血性中风。
在既往 ICH 患者中进行的首次 LAAO 研究中，LAAO 似乎是可行和安全的。需要更大规模的对照试验来评估该术式与其他预防措施相比的疗效和安全性。
这项研究提供了 III 级证据，表明在既往有 ICH 和 AF 的患者中，经皮 LAAO 是安全和可行的。
