LAMax^(TM) plus左心耳封堵器封堵犬双叶宽开口左心耳的可行性和即刻有效性  

Preliminary study on effectiveness of the LAMax^(TM) plus left atrial appendage occluder specially designed for left atrial appendage with two lobes and a wider orifice in canine model

作　　者：孟越之 吴晓霞[2] 王喜福[3] 陈奕龙 黄伟[5,6] 马东星[1] 

机构地区：[1]安徽医科大学武警总医院临床学院心内科,合肥230032 [2]武警总医院超声科,北京100039 [3]首都医科大学附属安贞医院急诊危重症中心,北京100029 [4]深圳市科奕顿生物医疗科技有限公司,深圳518010 [5]北京大学深圳研究院,深圳518057 [6]香港科技大学机械及航空航天工程学系

出　　处：《武警医学》2016年第6期589-592,596,共5页Medical Journal of the Chinese People's Armed Police Force

基　　金：深圳市科技创新委员会创业资助项目(深发改【2015】1342号)

摘　　要：目的初步探究一种新型国产左心耳封堵器(LAMax^(TM) plus)经皮封堵犬双叶宽开口左心耳的可行性及即刻有效性。方法选取3只双叶型宽开口左心耳健康犬使用LAMax^(TM) plus封堵器行经皮左心耳封堵术,术后即刻复查左心耳造影及经食管超声心动图评价封堵效果,以彩色多普勒超声观测无残余分流或残余分流直径<3 mm为封堵成功。结果 3只犬中1例使用单叶型封堵器封堵不全,更换为双叶封堵器后封堵成功;其余2例均一次封堵成功,且均未见新发二尖瓣反流,封堵器未影响肺静脉开口,无心包穿孔等手术或器械相关的并发症。结论本研究初步证实了LAMax^(TM) plus左心耳封堵器用于封堵犬双叶左心耳的可行性和即刻有效性。目前LAMax^(TM) plus封堵器后续动物试验正在进行中,关于其安全性和有效性进一步研究结果值得期待。Objective To demonstrate the feasibility and effectiveness of a left atrial appendage （LAA） occluder （ LAMaTM plus, Keyidun, China） for the instant occlusion of LAA in canine model, which is specially designed for the occlusion of LAA with two lobes and a wider orifice. Methods Three healthy dogs were used for the implantation of LAMaxTM plus devices, which can be fully re- captured and repositioned during implantation procedure. Before the implantation, transthoracic echocardiography （TTE） was per- formed for anatomical evaluation of LAA with two lobes and then transesophageal echocardiography （TEE） followed by angiography. The devices were delivered by 9F or 10F delivery sheathes. The angiography of LAA was performed immediately after the implantation and then TEE examination followed to evaluate the device position, leakage around the device, pericardial effusion, mitral valve func- tion, and pulmonary vein obstruction. The effectiveness of LAA occlusion was assessed by an endpoint of leak around the device less than 3mm of flow by TEE. Results The LAMaxTM plus was successfully implanted in all three dogs. By observation of the post-implant TEE, all dogs reached the defined endpoint for the effectiveness of LAA occlusion. Conclusions This preliminary study confirms that LAMaxTM plus device is feasible and effective for the instant occlusion of LAA with two lobes in canines. More studies are needed be- fore it can be used in clinical applications.

关 键 词：心房颤动 卒中 左心耳封堵 LAMax 动物实验 

分 类 号：R540.46[医药卫生—心血管疾病]