BACKGROUND Percutaneous closure (LAAC) of the left atrial appendage (LAA) is an efficacious preventive procedure for patients with non-valvular atrial fibrillation (NVAF) and considerable bleeding risk. We sought to systematically review the available LAAC data on the novel occluder device LAmbre™. METHODS For this systematic review, a search of the literature was conducted by 3 independent reviewers, reporting the safety and therapeutic success of LAAC in patients being treated with a LAmbre™. Publications reporting the safety and therapeutic success of LAAC using LAmbre™ in n > 5 patients were included. RESULTS The literature search retrieved n = 10 publications, encompassing n = 403 NVAF patients treated with a LAmbre™ LAAC, with relevant data regarding safety and therapeutic success of the procedure. The mean CHA2DS2-VASc Score was 4.0 + 0.9, and the mean HAS-BLED score was 3.4 + 0.5. The implantation success was 99.7%, with a mean procedure time of 45.4 ± 18.7 min, and a fluoroscopy time of 9.6 ± 5.9 min, and a contrast agent volume of 96.7 ± 0.7 ml. The anticoagulation regimen was switched to DAPT post procedure in the majority of the patients (96.8%). Partial and full recapture were done in 45.5% and in 25.6%, respectively. Major complications were reported in 2.9%, with 0.3% mortality, 1.7% pericardial tamponade, 0.3% stroke, and 0.6% major bleeding complications; no device embolization was observed. During follow up at 6 or 12 months, major adverse cardiovascular events were reported in 3.3%: Stroke or TIA in 1.7%, thrombus formation on the device in 0.7%, and residual flow > 5 mm in 1.0%. In some publications, the favorable implantion properties of the LAmbre™ for difficult anatomies such as shallow or multilobular LAA anatomies were described. CONCLUSIONS This systematic review on the LAmbre™ LAA-occluder including n = 403 NVAF patients demonstrates an excellent implantion success rate, promising follow-up clinical data, and favorable properties for also challenging LAA anatomies,. While its design seems to be helpful in preventing device embolization, pericardial tamponade may not be substantially reduced by the LAmbre™ as compared with other established LAAC devices. Further larger prospective multicenter registries and randomized trials are needed to scrutinize the value of the LAmbre™ compared with established LAAC devices.

中文翻译：

---

非瓣膜性心房颤动患者使用LAmbre装置对左心耳附件进行系统评价。

背景技术对于患有非瓣膜性心房颤动（NVAF）且出血风险相当大的患者，左心耳（LAA）的经皮闭合术（LAAC）是一种有效的预防措施。我们试图系统地审查新型封堵器LAmbre™上可用的LAAC数据。方法对于该系统评价，由3名独立评价者进行了文献检索，报道了LAmbre™治疗的患者中LAAC的安全性和治疗成功。包括报告使用LAmbre™在n> 5位患者中LAAC的安全性和治疗成功的出版物。结果文献检索检索了n = 10的出版物，包括n = 403接受LAmbre™LAAC治疗的NVAF患者，以及有关该过程安全性和治疗成功的相关数据。CHA2DS2-VASc平均得分是4。0 + 0.9，而平均HAS-BLED分数为3.4 + 0.5。植入成功率为99.7％，平均手术时间为45.4±18.7分钟，透视检查时间为9.6±5.9分钟，造影剂体积为96.7±0.7 ml。大多数患者（96.8％）的抗凝治疗方案在术后转为DAPT。部分和全部重新捕获分别占45.5％和25.6％。报告的主要并发症为2.9％，死亡率为0.3％，心包填塞为1.7％，中风为0.3％，主要出血并发症为0.6％。没有观察到装置栓塞。在6或12个月的随访期间，报告的主要不良心血管事件为3.3％：中风或TIA为1.7％，装置上的血栓形成为0.7％，残余流量> 5 mm为1.0％。在某些出版物中 描述了LAmbre™对困难解剖结构（例如浅或多叶LAA解剖结构）的有利植入特性。结论对包括n = 403 NVAF患者在内的LAmbre™LAA封堵器的系统评价显示出极好的植入成功率，有希望的随访临床数据以及对挑战性LAA解剖学也有利的特性。尽管其设计似乎有助于防止设备栓塞，但与其他已建立的LAAC设备相比，LAmbre™可能不会显着减少心包填塞物。与成熟的LAAC设备相比，还需要更大的前瞻性多中心注册表和随机试验来检查LAmbre™的价值。结论对包括n = 403 NVAF患者在内的LAmbre™LAA封堵器的系统评价显示出极好的植入成功率，有希望的随访临床数据以及对挑战性LAA解剖学也有利的特性。尽管其设计似乎有助于防止设备栓塞，但与其他已建立的LAAC设备相比，LAmbre™可能不会显着减少心包填塞物。与已建立的LAAC设备相比，还需要更大的前瞻性多中心注册表和随机试验来检查LAmbre™的价值。结论对包括n = 403 NVAF患者在内的LAmbre™LAA封堵器的系统评价显示出极好的植入成功率，有希望的随访临床数据以及对挑战性LAA解剖学也有利的特性。尽管其设计似乎有助于防止设备栓塞，但与其他已建立的LAAC设备相比，LAmbre™可能不会显着减少心包填塞物。与成熟的LAAC设备相比，还需要更大的前瞻性多中心注册表和随机试验来检查LAmbre™的价值。尽管其设计似乎有助于防止设备栓塞，但与其他已建立的LAAC设备相比，LAmbre™可能不会显着减少心包填塞物。与已建立的LAAC设备相比，还需要更大的前瞻性多中心注册表和随机试验来检查LAmbre™的价值。尽管其设计似乎有助于防止设备栓塞，但与其他已建立的LAAC设备相比，LAmbre™可能不会显着减少心包填塞物。与已建立的LAAC设备相比，还需要更大的前瞻性多中心注册表和随机试验来检查LAmbre™的价值。