Abstract: AbstractObjectiveTo assess the biocompatibility and endothelialization of the homemade atrial septal defect occluder device. MethodsSix piglets were selected.Atrial septal defects with different diameters were created using the Brockenbrough needle and Rashkind balloon atrial septostomy.With the guidance of echocardiography and fluoroscopy,the propersized occluders were implanted corresponding to the stretched diameter of ASD measured by balloon.Two swine had been killed at 1 month,3 months and 6 months after transcatheter procedure.Macroscopic,microscopic assessment and scanning electron microscope (SEM) were done on the explanted devices. ResultsMacroscopic examination showed no excrescence,thrombus formation,arm fractures and corrosion.The devices were covered with collagen fibrosis and discrete endocardial cells,apparent inflammatory infiltration in the devices and around the devices 1 month after implantation.The implants were nearly endothelialized,while the inflammatory reaction relieved gradually,with myocardial cells ingrowth at the edges of the device 3 months after implantation.The devices were completely covered with endocardium and fibrous tissue.Moreover,endothelial cells could be found on the smooth microscrew adaptor.The inflammatory reaction diminished with a few chronic inflammatory cells existing.Neovascularization and lymphatic vessels ingrowth could be observed 6 months after implantation. ConclusionThe homemade atrial septal defect occluder device has good biocompatibility,nearly endothelialized at 3 months,completely by 6 months.

Key words: Endothelialization, Occlude device , Piglet , Biocompatibility

摘要： 目的评价国产房间隔缺损封堵器的相容性和内皮化程度。 方法选用乳猪6头，应用房隔穿刺和Rashkind球囊房隔造口术，建立可控大小房间隔缺损(ASD)动物模型；在X线引导下，用测量球囊测定ASD最大伸展直径，并结合超声心动图选择适当大小的国产房间隔缺损封堵器进行猪的房间隔缺损堵塞；术后1个月、3个月和6个月分别将小猪处死(每次2只)，对标本进行肉眼、光镜和扫描电镜检查。 结果所有封堵装置表面均没有发现赘生物、血栓形成、支架发生断裂及被腐蚀；术后1个月，封堵装置表面被胶原纤维和散在内皮细胞所覆盖，大量炎症细胞浸润，封堵装置边缘有小灶性炎症细胞浸润；术后3个月，封堵装置表面几乎被内皮细胞所覆盖，炎症细胞较1个月时明显减少，封堵装置内见纤维化，封堵装置边缘心肌细胞浸入；术后6个月，封堵装置表面完全被心内膜和纤维组织所覆盖，伞尖表面光滑并有内皮细胞上爬，炎症反应明显消散，但仍有少量慢性炎症细胞存在，装置内有新生的血管、淋巴管长入。 结论国产房间隔缺损封堵器具有良好的生物相容性，置入动物体内3个月几乎完全内皮化，6个月已完全内皮化。

关键词: 间隔缺损, 房, 猪, 相容性, 内皮化, 封堵装置