Mid-German Heart Center, Department of Internal Medicine III (KIM-III), Division of Cardiology, Angiology and Intensive Medical Care, University Hospital Halle, Martin-Luther-University Halle, Ernst-Grube-Strasse 40, D-06120, Halle (Saale), Germany.
3rd Department of Cardiology, Ippokrateio Hospital, Aristotle University of Thessaloniki, Konstantinoupoleos 49, 54642, Thessaloniki, Greece.
BMC Cardiovasc Disord. 2020 Feb 12;20(1):78. doi: 10.1186/s12872-020-01349-9.
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™.
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.
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 CHADS-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.
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.
经皮左心耳（LAA）封堵术（LAAC）是一种有效的预防非瓣膜性心房颤动（NVAF）和大量出血风险患者的方法。我们旨在系统地回顾新型封堵器 LAmbre™ 的 LAAC 相关数据。
在这项系统评价中，3 位独立的审查员进行了文献检索，报告了使用 LAmbre™ 治疗的患者的 LAAC 的安全性和治疗成功率。纳入了 n>5 例患者使用 LAmbre™ 的 LAAC 安全性和治疗成功率的出版物。
文献检索共检索到 n=10 篇出版物，共纳入 n=403 例 NVAF 患者接受 LAmbre™ LAAC 治疗，提供了该手术安全性和治疗成功率的相关数据。平均 CHADS-VASc 评分为 4.0+0.9，平均 HAS-BLED 评分为 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，透视时间为 9.6±5.9 分钟，造影剂用量为 96.7±0.7ml。大多数患者（96.8%）术后将抗凝方案转为 DAPT。部分和完全捕获分别占 45.5%和 25.6%。报道了 2.9%的主要并发症，死亡率为 0.3%，心包填塞为 1.7%，卒中为 0.3%，大出血并发症为 0.6%；未观察到器械栓塞。在 6 或 12 个月的随访中，报告了 3.3%的主要不良心血管事件：卒中或 TIA 为 1.7%，器械上血栓形成 0.7%，残余血流>5mm 为 1.0%。在一些出版物中，描述了 LAmbre™ 在浅或多叶 LAA 解剖结构等困难解剖结构中的良好植入特性。
本系统评价纳入了 n=403 例 NVAF 患者的 LAmbre™ LAA 封堵器，结果显示植入成功率高，随访临床数据有希望，对具有挑战性的 LAA 解剖结构也有良好的特性。虽然其设计似乎有助于防止器械栓塞，但与其他已确立的 LAAC 器械相比，心包填塞可能不会显著减少。需要进一步的大型前瞻性多中心登记和随机试验来仔细研究 LAmbre™ 与已确立的 LAAC 器械相比的价值。
