国产室间隔缺损封堵器的动物实验研究

The experimental study of domestic nitinol ventricular septal defect occluder

目的观察国产室间隔缺损封堵器通过导管经心室植入动物体内后的封堵效果及组织学反应,评价其可行性、安全性及疗效。方法选用犬12只,在经心外膜超声的指引,非体外循环下建立室间隔缺损动物模型,直视下经导管植入国产室间隔缺损封堵器。术后15d、1、3、6个月分别处死动物,进行大体解剖、光镜及电镜观察。结果8只犬成功建立了室间隔缺损的动物模型并进行了封堵,均存活至观察终点,超声心动图随访无残余分流,生长发育无异常,无严重并发症发生,1～6个月的大体解剖可见封堵器表面被厚度不等的半透明、光滑的新生组织所覆盖,封堵器与室间隔组织结合紧密,光镜及扫描电镜检查证实为内皮细胞、纤维组织。各重要脏器无血栓栓塞及其它异常表现。结论国产的室间隔缺损封堵器具有良好的组织相容性,用外科方法修补室间隔缺损以及在超声心动图的指引下经心室植入室间隔缺损封堵器是可行的、安全的。

AIM: To evaluate the feasibility, safety and efficiency of a domestic nitinol occluder for perventricular closure of ventricular septal defect. METHODS: Twelve dogs are prepared for the experiment, after the chest and pericardium are opened, a complete, epicardial echocardiographic assessment of the ventricular septum is performed. A ventricular septal defect animal model was established under echocardiography guidance without exreacorpotreal circulation, the animals were killed for observation at various intervals after successful closure. RESULTS: Successful closure was achieved in 8 dogs. Postmortem gross and microscopic examination revealed no dislogement of the device. Gross inspection showed that the devices were covered with a different glistening, smooth, thin layer of endocardium. There was continuity between the endocardium over the device and the surrounding septal wall. Through light microscopy and electron microscopy, fibrous tissue and endothelia cell were seen. The heart, lungs, and great vessels show no evidence of embolization or any other abnormality. CONCLUSION: This observation showed the satisfactory biocompatibility, feasibility and safety of the domestic nitinol ventricular septal defect occluder by perventricular closure.