Cardioangiologisches Centrum Bethanien Frankfurt Am Main, Medizinische Klinik III, Markuskrankenhaus, Frankfurt Am Main, Germany.
J Cardiovasc Electrophysiol. 2018 Feb;29(2):291-297. doi: 10.1111/jce.13385. Epub 2017 Dec 7.
The LAmbre™ occluder is a novel device for percutaneous left atrial appendage closure (LAAC). The presented study aimed to report the initial experience in implantation of the novel LAmbre for LAAC in patients with nonvalvular AF.
We conducted a prospective, observational, cohort registry study to evaluate the feasibility of percutaneous LAAC using the LAmbre system.
Thirty patients (15 female, mean age 77.6 ± 8.9 years) who had high risks of stroke and contraindications for oral anticoagulation were prospectively enrolled in this registry study. The mean CHA2DS2-VaSc was 3.9 ± 1.5, and the mean HAS-BLED score was 4.1 ± 1.0. Twenty (66.7%) patients had chicken-wing LAA morphology. The implant success rate was 100%. The mean fluoroscopic time and procedure time were 3.5 ± 1.9 and 29.0 ± 10.1 minutes, respectively. No significant procedure-related complications were observed during in-hospital and acute clinical follow-up.
In this preliminary study, the LAmbre occluder showed an excellent implant success rate, favorable implant property, and very low incidence of complications. Larger sample, randomized studies are further warranted.
LAmbre™封堵器是一种用于经皮左心耳封堵术(LAAC)的新型装置。本研究旨在报告使用新型 LAmbre 装置进行 LAAC 的初步经验,适用于非瓣膜性房颤患者。
我们进行了一项前瞻性、观察性、队列注册研究,以评估使用 LAmbre 系统进行经皮 LAAC 的可行性。
30 名(15 名女性,平均年龄 77.6 ± 8.9 岁)存在高卒中风险且存在口服抗凝禁忌证的患者前瞻性纳入本注册研究。平均 CHA2DS2-VaSc 评分为 3.9 ± 1.5,平均 HAS-BLED 评分为 4.1 ± 1.0。20 名(66.7%)患者的左心耳呈“鸡翅”样形态。植入成功率为 100%。平均透视时间和手术时间分别为 3.5 ± 1.9 分钟和 29.0 ± 10.1 分钟。在住院期间和急性临床随访期间未观察到与手术相关的严重并发症。
在这项初步研究中,LAmbre 封堵器显示出了出色的植入成功率、良好的植入特性和极低的并发症发生率。需要进一步开展更大样本量、随机研究。