新型经导管三尖瓣介入瓣膜的耐久性测试  

The durability test of a novel transcatheter tricuspid valve device

作　　者：王秋吉 肖硕 钟丽珊 华林斌 张朝龙 柯英杰 庞善文 黄焕雷 WANG Qiu-ji;XIAO Shuo;ZHONG Lishan;HUA Lin-bin;ZHANG Chao-long;KE Ying-jie;PANG Shan-wen;HUANG Huan-lei(Department of Cardiac Surgery,Guangdong Provincial People′s Hospital(Guangdong Academy of Medical Sciences),Southern Medical University,Guangzhou 510080,Guangdong,China)

机构地区：[1]南方医科大学附属广东省人民医院(广东省医学科学院)心外科,广东广州510080 [2]广东省心血管病研究所,广东广州510100

出　　处：《广东医学》2024年第10期1221-1225,共5页Guangdong Medical Journal

基　　金：国家自然科学基金项目(82270373);广东省基础与应用基础研究基金项目(2019B1515120071);广州市卫生健康委员会项目(FTJCZ0011)。

摘　　要：目的测试新型牛心包三尖瓣介入瓣膜的耐久性。方法以19 mm、23 mm和29 mm三个不同型号的牛心包瓣叶作为测试瓣叶;以Edwards Life Sciences生产的对应型号的牛心包瓣作为对照组(每个测试型号包括3个测试瓣和1个对照瓣)。在测试前对所有型号的测试瓣和对照瓣初步评估流体力学性能,在测试中期,分别在瓣叶完成5000万次、1亿次和1.5亿次循环时的时间点对瓣叶进行流体力学性能评估。在瓣叶完成2亿次循环后,对其进行最终的体外耐疲劳性能评估。在数字减影血管造影下从右侧颈静脉经导管完成介入三尖瓣的释放,在术后6个月时通过经胸超声心动图及病理解剖来检查新型介入瓣膜的体内耐久性能。结果经过2亿次疲劳试验,测试瓣叶和对照瓣叶均完好无损,能够完全开放与闭合且流体动力学性能未受影响。新型经导管三尖瓣介入瓣膜耐疲劳测试通过了《GB12279-2008心血管植入物人工心脏瓣膜》7疲劳测试的要求,且流体力学测试结果符合《GB12279-2008心血管植入物人工心脏瓣膜》6.5脉动流试验的要求。体内耐久性试验表明该介入瓣膜具有良好的开闭性能,术后6个月瓣叶无钙化,无破损。结论新型经导管三尖瓣介入瓣膜具有良好的耐久性及流体力学特性。Objective This study was designed to test the durability of a novel interventional bovine pericardial tricuspid valve.Methods Bovine pericardial leaflets of three different sizes(19 mm,23 mm,and 29 mm)were used as the test valves,with corresponding sizes of valves produced by Edwards Life Sciences serving as the control group(each size including three test valves and one control valve).The hydrodynamic performance of all test and control valves was preliminarily assessed before testing.Mid-term hydrodynamic assessments were conducted after the valves completed 50 million,100 million,and 150 million cycles.After completing 200 million cycles,final ex vivo fatigue performance assessments were conducted.Digital subtraction angiography was used to guide the transcatheter implantation of the tricuspid valves via the right internal jugular vein,and durability was evaluated at 6 months post-operation through transthoracic echocardiography and pathological examination.Results After 200 million fatigue cycles,both the test and control valve leaflets remained intact,with complete opening and closing,and their hydrodynamic performance remained unaffected.The novel transcatheter tricuspid valve passed the fatigue test requirements of the“GB12279-2008 Cardiovascular Implants-Artificial Heart Valves”standard,and the hydrodynamic testing met the requirements of the pulsatile flow test specified in the same standard.The in vivo durability test indicated that the valve exhibited good opening and closing functions,with no calcification or damage observed at 6 months post-implantation.Conclusion The novel transcatheter tricuspid valve demonstrates excellent durability and hydrodynamic properties.

关 键 词：三尖瓣关闭不全 介入瓣膜 耐久性试验 装置研制 

分 类 号：R61[医药卫生—外科学] R605[医药卫生—临床医学]