CAI Tao 1LYU Jian 2FANG Gang3
作者信息
- 1. Department of Mechanical Engineering,Tsinghua University,Beijing 100084,China||CardioTek Medical(Beijing)CO.,LTD.,Beijing 101300,China
- 2. PharmaLegacy Laboratories,Shanghai 201401,China
- 3. Department of Mechanical Engineering,Tsinghua University,Beijing 100084,China
- 折叠
摘要
Abstract
Objective To evaluate the biocompatibility,anti-calcification,and long-term stability of a novel balloon-expandable transcatheter aortic valve in pigs in vivo.Methods Twenty-seven healthy white pigs weighing approximately 45 kg were selected as experimental animals.Preoperative physical examination and appropriate pre-treatment,including drug treatment and disinfection,were performed.Under aseptic surgical conditions,a valve loaded on the balloon catheter delivery system was implanted into the porcine aortic valve position via femoral artery vascular access.The animals'vital signs,diet,and activity were then observed and continuous drug treatment was administered.Echocardiography and digital subtraction angiography were performed immediately and at 30,90 and 180 d,to assess the hemodynamics and location of the valve,and the impact on the surrounding cardiac structures.Hearts and major organ tissues were sampled at the corresponding follow-up points,and the tissue inflammatory response,thrombus score,calcification degree,and endothelialization degree were analyzed by histopathology staining.The structural integrity of the valve stent and calcification of the valve leaflets were evaluated by X-ray and micro-computed tomography.Results Twenty-three animals were included in the final analysis.Pigs with successful valve implantation recovered well and had stable vital signs.Follow-up examination showed that the aortic valve blood flow velocity,transvalvular pressure difference,and leaflet motion were all normal or gradually improved,the stent position was stable,and the vessel remained unobstructed.Histological analysis showed that the tissue at the implantation site had mild inflammatory cell infiltration,no thrombosis,low calcification area,good stent integrity,and low calcification of the valve leaflets.All the result were in line with expectations,and the differences were statistically significant(P＜0.05).Conclusions The new balloon-expandable transcatheter aortic valve system shows good biocompatibility,anti-calcification,and implant stability in animal experiments,laying a solid foundation for subsequent clinical trials.This system is expected to improve the therapeutic effect of transcatheter aortic valve implantation(TAVI)and promote the technological progress of domestic TAVI devices,to bring new breakthroughs and development opportunities in the field of cardiovascular disease treatment.关键词
经导管主动脉瓣膜置入术/动物实验/生物相容性/抗钙化性Key words
transcatheter aortic valve implantation/animal experiment/biocompatibility/anti-calcification分类
生物科学
