从内皮化进程评价LAMaxTM左心耳封堵器的有效性  

Feasibility of Assessing the Efficacy of LAMaxTM Left Atrial Appendage Occluder by Observing the Intimal Coverage in a Canine Model

作　　者：吴晓霞 马东星 孟越之 黄伟[2] 陈奕龙 沈叶佳 WU Xiaoxia;MA Dongxing;MENG Yuezhi;HUANG Wei;CHEN Yilong;SHEN Yejia(Department of Cardiology,The Third Medical Center,Chinese PLA(People’s Liberation Army)General Hospital,Beijing(100039),China)

机构地区：[1]中国人民解放军总医院第三医学中心心内科,北京市100039 [2]香港科技大学机械和航空航天工程系,中国香港特别行政区 [3]深圳市科奕顿生物医疗科技有限公司深圳心血管药物与器械开发工程实验室

出　　处：《中国循环杂志》2019年第11期1117-1122,共6页Chinese Circulation Journal

基　　金：深圳市战略新兴产业项目[深发改(2018)965号]

摘　　要：目的:探讨从封堵器内皮化进程评价LAMax^TM左心耳(LAA)封堵器的有效性。方法:30只健康犬,体重为(27.8±3.7)kg,行左心耳封堵术并随机分为即刻组7只、1个月组6只、2个月组5只、3个月组7只、6个月组5只,分别于相应时间节点行解剖术,观察封堵器置入及其表面愈合情况,评价封堵效果。结果:30只健康犬完成左心耳造影并成功封堵,即刻封堵成功率100%,解剖可见封堵盘均覆盖于左心耳开口,表面无血栓。封堵盘完全拉入左心耳开口呈新月型者,其愈合反应较快,在1个月时即可以完全覆盖封堵盘表面;封堵盘未完全拉入左心耳开口的封堵盘表面愈合反应差异显著。有残余分流的2只至术后3个月仍可见缝隙与左心房交通。结论:LAMax^TM左心耳封堵器安全、有效,特别是按照“COVER”原则置入者愈合反应较良好。Objectives:To evaluate the feasibility of assessing the efficacy of LAMax^TM left atrial appendage(LAA)occluder(ShenZhen KYD BioMedical Technology Co.Ltd.,Shenzhen,China)by observing the intimal coverage at the 1-,2-,3-,and 6-months postimplantation in a canine model.Methods:Thirty healthy dogs(body weight:[27.8±3.7]kg)underwent LAMax^TM devices implantation were sacrificed at<24 hours(n=7),1-(n=6),2-(n=5),3-(n=7),and 6-months(n=5)for gross anatomical examinations to observe the implants and tissue healing response.Results:The LAMax^TM device was successfully implanted in all 30 dogs,success rate of instant occlusion measured by angiography was 100%.Gross examinations showed that all devices were placed within LAA,and all LAA ostia were satisfactorily occluded by the cover-plates,and no thrombus was found on the atrial-surface of the cover-plate.It was found that better healing response was related to the achievement of concavity of the implanted cover-plate;when achieving the concavity,the complete intimal coverage was found on the atrial-surface of the cover-plate;if the cover-plate was over the LAA orifice,the healing was poor.In 2 animals,the communication between LAA and left atrium and the residual flow were evidenced at 3 months post-implantation.Conclusions:Our result suggest that the LAMaxTM device is safe and feasible with high success occlude rate in dogs,and the healing response is optimal when the COVER principles are applied.

关 键 词：左心耳 封堵器 内皮化 愈合反应 

分 类 号：R54[医药卫生—心血管疾病]