国产房间隔缺损封堵器的实验研究

目的　通过外科手术创建的房间隔缺损动物模型评价国产心健TM 房间隔缺损封堵器介入治疗的可行性、安全性、有效性。方法　体外循环下 ,在幼猪的房间隔剪一个缺损口形成房间隔缺损 (ASD)动物模型 ,7d后行房间隔缺损封堵术。术后进行超声心动图、大体解剖、扫描电镜和透射电镜检查。结果　共 8只猪建立了房间隔缺损模型并进行封堵术 ,封堵器放置的成功率为 10 0 % ,超声心动图随访无残余分流 ,动物生长发育正常 ,无严重并发症出现。 1～ 6个月大体解剖可见封堵器与房间隔组织紧密嵌合 ,表面被一层白色半透明组织覆盖 ,电镜证实为内皮组织。结论　国产心健TM 房间隔缺损封堵器关闭外科手术创建的ASD模型可行、安全、有效

A new homemade secundum atrial septal defect closure device

Objective To evaluate the feasibility, safety and efficacy of a new homemade device for percutaneous closure of secundum atrial septal defects (ASDs) Methods Percutaneous closure of surgically created fossa ovalis ASD was attempted in 8 piglets The device was braided from Nitinol wires in the shape of two flat discs with a short connecting waist with a diameter corresponding to that of the defect to be closed Polyethylene filling was implanted to enhance thrombogenicity Pulmonary arteriography with levo phase was obtained before closure and immediately after closure Transthoracic echocardiography with color Doppler was used in all animals during closure and in follow up examinations The animals were killed at various intervals up to 6 months after occlusion for microscopic examination Results Successful placement of the device was achieved in all the 8 animals All ASDs were completely occluded in 1 month, observed by transthoracic echocardiography Postmortem gross and microscopic examination of the 8 specimens 1 to 6 months after placement showed complete or near complete fibrous neoendocardium coverage of both the right and left atrial discs Conclusion These observations show the feasibility of occlusion of secundum ASDs by the homemade device with the advantages of easy placement and repositionability in piglets