Huang Yi-gao, Zhang Cao-jin, Huang Tao, Huang Wen-hui, Huang Xin-sheng
Department of Cardiology, Guangdong General Hospital, Guangdong Cardiovascular Institute, Guangzhou 510100, China.
Zhonghua Xin Xue Guan Bing Za Zhi. 2009 Oct;37(10):936-8.
To evaluate the efficacy and safety of domestic left-disk-coated atrial septal occluder on treating patent foramen ovale in a miniswine model.
Foramen ovale was punctured in 12 Guangxi BA-MA miniswine and occluded by domestic left-disk-coated atrial septal occluder (Spider(TM) PFO closure system) under the guidance of fluoroscopy. After occlusion, miniswine were executed after transthoracic echocardiography examination with color Doppler at month 1, 2, 3 and 6 respectively for gross inspection and microscopic examinations.
There were no vegetation, thrombosis, broken stent, or erosion on the surface of all devices. The PFOs were completed occluded as evidenced by transthoracic echocardiography at 1 to 6 months after operation. The surface of the device was fully covered by collagen tissue and endothelial tissue at 1 month after operation and the thickened gradually thereafter.
The domestic left-disk-coated atrial septal occluder can efficiently occlude patent foramen ovale. Satisfactory biocompatibility, rapid and complete endothelium covering and low incidence of complication are also evidenced for this closure system in our experiment.
在小型猪模型中评估国产左盘覆膜房间隔封堵器治疗卵圆孔未闭的有效性和安全性。
对12只广西巴马小型猪的卵圆孔进行穿刺，并在荧光透视引导下用国产左盘覆膜房间隔封堵器（Spider™ PFO封堵系统）进行封堵。封堵后，分别在第1、2、3和6个月经胸超声心动图彩色多普勒检查后处死小型猪，进行大体检查和显微镜检查。
所有装置表面均无赘生物、血栓形成、支架断裂或侵蚀。术后1至6个月经胸超声心动图显示卵圆孔未闭完全封堵。术后1个月时装置表面完全被胶原组织和内皮组织覆盖，此后逐渐增厚。
国产左盘覆膜房间隔封堵器可有效封堵卵圆孔未闭。本实验中该封堵系统还显示出令人满意的生物相容性、快速且完全的内皮覆盖以及低并发症发生率。
