纳米膜单铆型室间隔缺损封堵器动物实验研究  

Nano material occluder of single rivet type used for percutaneous closure of ventricular septal defect:an experimental study in dogs

作　　者：高力明[1] 许旭东[1] 汤佳旎 谭红伟[1] 耿亮[1] 刘学波[1] 

机构地区：[1]同济大学附属东方医院心内科,上海200120

出　　处：《介入放射学杂志》2015年第6期509-514,共6页Journal of Interventional Radiology

摘　　要：目的在室间隔缺损(VSD)犬模型中评价新型纳米膜单铆型VSD封堵器经导管植入的可行性、安全性和有效性,为临床应用提供实验依据。方法取健康成年犬26只,在开胸X线导引下通过右心室游离壁穿刺室间隔方法制备VSD模型;分为实验组(n=13,植入纳米膜单铆型VSD封堵器)和对照组(n=13,植入镍钛合金双铆型VSD封堵器)。术后1、2、3、6个月分别通过心脏大体标本、光镜、电镜检测及血镍离子浓度测定等评价新型封堵器植入后内皮化过程,观察有无残余分流、血栓形成等并发症。结果对26只犬成功建立开胸小切口VSD模型。实验组纳米膜单铆型VSD封堵器植入成功率为100%,对照组镍钛合金双铆型VSD封堵器植入成功率为91.7%。术后1、2、3、6个月分别取出25只犬心脏大体标本,观察显示两组封堵器位置均无移位,无合金丝断裂,盘面未见血栓形成和赘生物附着。术后1个月实验组封堵器双侧盘面可见薄层透亮组织覆盖,病理和电镜检查证实为纤维组织和内皮细胞;至术后6个月,盘面组织逐渐增厚,封堵器边缘与周围心脏组织融合。结论纳米膜单铆型VSD封堵器设计科学,与镍钛合金双铆型VSD封堵器相比并发症少,完全内皮化时间缩短,可有效封堵VSD,具有良好的临床应用前景。Objective To evaluate the feasibility, efficacy and safety of new nano material occluder of single rivet type（left-disk with no-hub） in treating ventricular septal defect（VSD） in order to provide experimental basis for clinical application. Methods A total of 26 healthy adult dogs were selected for this study. Under thoracotomy, VSD model was established through fluoroscopically-guided percutaneous puncturing of the right ventricular free wall. The models were randomly and equally divided into the study group（n =13, using nano material VSD occluder） and the control group（n =13, using double-hub nitinol occluder）. Every two dogs from each group were sacrificed each time at one, 2, and 3 months after percutaneous closure of VSD with corresponding occluder, the tissue samples were collected and sent for gross examination as well as for the optical and electronic microscopy study; the blood concentration of nickel ion was also determined. The state of endothelialization after implantation of the new type occluder was evaluated, and the complications such as residual shunt and superficial thrombus formation were recorded.The results were analyzed. Results By open chest operation with small incision and percutaneous puncturing of the right ventricular free wall, VSD model was successfully established in all 26 dogs. The success rate of the implantation of the VSD occluder in the study group was 100%, while it was 91.7% in the control group.One, 2, 3 and 6 months after the implantation, the heart specimens of 25 dogs were removed and gross examination showed that neither occluder displacement nor alloy wire fracture occurred in both groups. No thrombus formation or vegetation attached on the disk surface was observed. One month after the procedure,in the study group the bilateral disk surfaces of the occluder were covered with thin layer transparent tissue,which were proved to be composed of the fibrous tissue and endothelial cells through pathologic and electronic microscopy study. Six months after impl

关 键 词：纳米材料 室间隔穿刺 室间隔缺损 内皮化 封堵器 

分 类 号：R541.1[医药卫生—心血管疾病]