国产全热解碳双叶瓣的动物实验

Experimental Study of Home-made Solid Pyrolytic Carbon Bileaflet Valve Prosthesis in Sheep

目的 :探讨人造瓣膜动物实验的方法 ,并对国产瓣的性能作动物体内评价。方法 :体外循环下行羊的二尖瓣替换术 ,先作预实验以确定实验方法 ,后作正式实验。用心导管和超声 ,并用多巴酚丁胺负荷法模拟运动条件 ,分别测定人造瓣的血流动力学参数 ;根据动物存活情况及有无血栓形成和血栓栓塞等评价其生物相容性。结果 :预实验 10只羊均死亡 ,主要与瓣环撕裂有关 ;正式实验 5只羊均存活。术中和术后 2 .5年用导管法测得平均跨瓣压差分别为 0 .69± 0 .2 3k Pa、0 .81± 0 .0 4k Pa;动物尸检未见血栓形成和血栓栓塞。结论 :瓣环撕裂是本组手术主要死亡原因 ,选择适当体重的动物和保留瓣叶的折叠缝补 ,及术后合理的呼吸支持等是实验的关键 ;

Objective:To investigate the methods for animal experiments of home made prosthetic valve,and to assess the performance of the prosthesis in vivo.Methods:Fifteen sheep underwent mitral replacement with 21 mm valve prostheses under cardiopulmonary bypass.The first 10 sheep underwent preliminary experiment.The hemodynamic parameters of the prosthesis were determined by means of catheterization and echocardiography respectively.The biocompatibility of prosthesis was evaluated by observing animal survival and valve related thrombosis or thromboembolism.Results:The 10 sheep undergoing preliminary experiment all died,while the other 5 sheep survived well.The transvalvular gradients measured by catheterization intraoperatively and 2.5 years after operation were 0.69±0.23 kPa and 0.81±0.04 kPa,respectively.Thrombosis or thromboembolic phenomenon was not found in postmortem.Conclusion:Annulus tearing is the major cause of operative death.Approp riate weight of animals,rational respiration support and mitral valve leaflets preserving by reflective suture are key points of test.The home made valve has good biocompatibility and excellent hemodyna mic performance in vivo.