双侧无铆型房间隔缺损封堵器的实验研究

目的在犬房间隔缺损(ASD)模型上评价双侧无铆型ASD封堵器的疗效、安全性和生物相容性。方法自行设计封堵器是由镍钛合金丝编织成的网状结构,外形呈双盘状,其左房面平整,右房面中间凹陷,中央有与推送杆相接的连接袢,内衬有三层聚酯膜。犬ASD模型建立采用房间隔穿刺结合球囊扩张方法,模拟临床经导管封堵ASD过程,闭合人工制备的ASD。用心脏超声观察封堵器位置及封堵器对右、左房室瓣功能的影响。术后1、2、3、6个月分别处死动物行组织学检查,观察封堵器周围及表面的组织学反应。结果8条犬成功制作ASD模型并封堵,超声显示封堵器位置固定良好,不影响右、左房室瓣功能。各观察时间点肉眼见所有封堵器表面光滑均覆有薄层的新生内膜。3个月后封堵器表面完全内皮化,光镜和电镜检查显示封堵器置入部位周围组织无明显的炎症反应。6个月扫描电镜观察金属丝无腐蚀。HE染色显示肺、肝、脾、肾、胰等组织无血栓栓塞、炎症表现。结论双侧无铆型ASD封堵器操作简便、使用安全及有良好的生物相容性,提示自制的ASD封堵器将可安全地应用于临床。

Study on transcatheter ASD occlusion using modified atrial septal defect occluder with no stainless steel screw in canine model

Objective To evaluate the safety,biocompatibility and efficacy of transcatheter closure of atrial septal defect(ASD)with no stainless-steel-screw occluder in canine model.Methods The device was constructed from superelastic Nitinol wires tightly woven into two flat disks and sewed with polyester fibers inside,with a pliable loop on the right-atrial-disk of the device,connecting to the delivery cable.ASD was created by transcatheter puncture and balloon dilatation and then closed by occluder under fluoroscopy in the catheterization laboratory.The location and the influence of the implanted device on function of tricuspid valve and mitral valve were evaluated by echocardiography.At 1,2,3 and 6 months after the operation,the animals were killed and autopsy was conducted.Results Eight dogs with puncture-produced ASD underwent ASD closing procedure successfully.The occluder showed no influence on the function of MV and AV demonstrated by echocardiogram.The two disks of the implanted device were covered with a smooth intact neogenesis layer in all dogs.Endocardial cells fully covered the surface of the two disk without inflammating reaction 3 months later. There was no evidence of corrosion on the surface of the nitinol wire removed from the dog after 6 months.Light microscopic examination of the liver,kidney,lung and spleen showed no evidence of embolization and inflammation.Conclusion Transcatheter ASD occlusion with new-type occluder is safe,feasible,effective and good biocompatibility with a good prospective clinical application.