新型人工介入心脏瓣膜系统SinoCrown^(TM)的动物实验研究  

Experimental Evaluation on the Effectiveness and Safety of SinoCrown^(TM) Valve in Pigs

作　　者：刘庆荣[1] 邱克劲 张洪亮[1] 陈阳[1] 赵轩铖 鲁炳呈 昌仁操 张昱昕 高润霖[1] 吴永健[1] LIU Qingrong;QIU Kejin;ZHANG Hongliang;CHEN Yang;ZHAO Xuancheng;LU Bingcheng;CHANG Rencao;ZHANG Yuxin;GAO Runlin;WU Yongjian(Coronary Heart Disease Center,National Center for Cardiovascualr Diseases and Fuwai Hospital,CAMS and PUMC,Beijing(100037,)China)

机构地区：[1]中国医学科学院北京协和医学院国家心血管病中心阜外医院冠心病中心,北京市100037 [2]乐普(北京)医疗器械股份有限公司结构产品器械部

出　　处：《中国循环杂志》2022年第4期405-412,共8页Chinese Circulation Journal

基　　金：国家重点研发计划(2020YFC2008103);北京市科技计划医药协同科技创新研究(Z181100001918029);中国医学科学院医学与健康科技创新工(程2017-I2M-3-002)。

摘　　要：目的:通过动物实验评价新型人工介入心脏瓣膜系统SinoCrown^(TM)(北京乐普医疗)的有效性和安全性。方法:14头4~5月龄健康实验用白猪,平均体重为(44.39±2.56)kg,通过经导管主动脉瓣置换术(TAVR)置入SinoCrown^(TM)瓣膜,分为急性组(n=5,术后即刻处死)、慢性组(n=3,术后饲养3个月)、长期组(n=6,术后饲养6个月)。三组动物分别于术后即刻、3个月、6个月行经胸超声心动图、血液、数字减影血管造影、病理学等检查,评估SinoCrown^(TM)瓣膜置换效果。结果:SinoCrown^(TM)在14头白猪中均成功释放,即刻器械成功率100%。急性组3头(2头因术前评估不足而死亡)、慢性组3头、长期组6头白猪均按照研究方案完成主动脉瓣膜置换和随访,无不良事件和异常死亡发生。6个月随访时,超声心动图检查显示:SinoCrown^(TM)瓣膜开闭自如,形态位置良好,有效瓣口面积、跨瓣压差等指标良好,未见明显钙化、增生、狭窄和赘生物等;实验室检查未见异常;病理学检查示:白猪的心脏、脑、肝、脾、肾脏标本未见明显病理改变,SinoCrown^(TM)瓣叶未发现炎症和钙盐沉积,未见病理性排斥。结论:动物实验表明,SinoCrown^(TM)瓣膜的安全性和有效性较好,可有效替代原生主动脉瓣正常工作。Objectives:To evaluate the efficacy and safety of SinoCrown^(TM) valve(Lepu Medical Technology,Beijing)in pigs.Methods:Transcatheter aortic valve replacement(TAVR)using the SinoCrown^(TM) valve was performed in 14 healthy white pigs aged 4 to 5 months(mean body weight:[44.39±2.56]kg).The pigs were divided into immediate group(n=5,immediately sacrificed after TAVR),chronic group(n=3,postoperative feeding for 3 months),long-term group(n=6,postoperative feeding for 6 months).Transthoracic echocardiography,laboratory examination,digital subtraction angiography and pathological examination were performed immediately,3 months and 6 months after TAVR to evaluate the impact of SinoCrown^(TM) valve replacement.Results:SinoCrown^(TM) was released successfully in all 14 animals,and the instrument success rate was 100%.TAVR and follow-up were performed in 3 pigs in the immediate group(2 died due to inadequate preoperative evaluation),3 pigs in the chronic group and 6 pigs in the long-term group according to the trial protocol,and no adverse events or abnormal animal death occurred.At 6 months follow-up,echocardiography examination showed that the valve opened and closed freely,shape and position of implanted valve were optimal,and valve opening indicators such as effective orifice area and mean gradient were satisfactory.No obvious calcification,hyperplasia,stenosis and neoplasm were observed.No abnormality was found in laboratory examination.Pathological examination results revealed that there were no obvious pathological changes in the samples of heart,brain,liver,spleen and kidney,there was no inflammation and calcium deposit in the leaflets,and no evidence of pathological rejection was found.Conclusions:Our animal experiments confirm that SinoCrown^(TM) valve is safe and effective,and can effectively replace the native aortic valve.

关 键 词：经导管主动脉瓣置换术 人工心脏瓣膜 SinoCrown^(TM) 动物实验 

分 类 号：R54[医药卫生—心血管疾病]