Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, California, USA.
Cardiovascular Associates of Los Robles Health System, Thousand Oaks, California, USA.
JACC Cardiovasc Interv. 2023 Jun 12;16(11):1347-1357. doi: 10.1016/j.jcin.2023.04.028. Epub 2023 Jun 7.
The Laminar device rotates and closes the left atrial appendage (LAA) using an integrated ball and lock that excludes and eliminates the LAA pouch. There is a low device surface area, minimizing the risk of peridevice leak (PDL) and device-related thrombus (DRT) formation.
This study evaluates the safety and efficacy of the Laminar LAA exclusion device in healthy animals and human subjects with nonvalvular atrial fibrillation at risk of ischemic stroke and systemic thromboembolism.
The preclinical study implanted the Laminar device into canine subjects that underwent transesophageal echocardiography (TEE) and fluoroscopic evaluation, followed by necropsy and histological assessment at 45 and 150-days post-implant. The early clinical study implanted the device in human subjects, followed to 12 months postimplantation. Procedural success was defined as device implantation in the intended location without residual LAA leak >5 mm as seen by TEE. Safety endpoints included freedom from stroke, systemic embolism, pericardial effusion, or tamponade, life-threatening/major bleeding, or death.
The Laminar device was successfully implanted in 10 canines. In all animals at 45 days and 150 days, no PDL or DRT was found, and histological examination showed fully closed LAAs covered with neo-endocardium. The device was successfully implanted in 15 human subjects with no safety events out to 12 months postimplantation. All subjects had successful protocol-defined LAA closure without DRT at 45 days by TEE and computed tomography, which remained stable through 12 months' follow-up.
The preclinical and early clinical results demonstrate a promising safety and efficacy profile for the Laminar LAA exclusion device.
Laminar 装置通过一个集成的球和锁旋转并关闭左心耳（LAA），从而排除和消除 LAA 袋。该装置的表面面积较小，最大限度地降低了器械相关漏（PDL）和器械相关血栓（DRT）形成的风险。
本研究评估了 Laminar LAA 排除装置在有缺血性卒中和全身性血栓栓塞风险的非瓣膜性心房颤动的健康动物和人类受试者中的安全性和疗效。
在临床前研究中，将 Laminar 装置植入犬科动物体内，然后进行经食管超声心动图（TEE）和荧光透视评估，之后在植入后 45 天和 150 天进行尸检和组织学评估。早期临床研究将装置植入人体受试者体内，随后进行 12 个月的植入后随访。程序成功定义为器械植入预期位置，TEE 未见残余 LAA 漏>5mm。安全性终点包括无中风、全身性栓塞、心包积液或心脏压塞、危及生命/大出血或死亡。
Laminar 装置在 10 只犬中成功植入。所有动物在 45 天和 150 天均未发现 PDL 或 DRT，组织学检查显示完全闭合的 LAA 覆盖着新生心内膜。在 12 个月的植入后随访中，该装置在 15 名人类受试者中成功植入，无安全性事件发生。所有患者均成功地按照方案定义关闭 LAA，在 45 天时通过 TEE 和计算机断层扫描未发现 DRT，且在 12 个月的随访中保持稳定。
临床前和早期临床结果表明，Laminar LAA 排除装置具有良好的安全性和疗效。
