| Objective : To evaluate the safety , efficacy, feasibility and biocompatibility of new-type ASD occluder in an experimental canine ASD model(in vivo).Material and Method: ASD models were established by transseptal pucture and balloon dilatation, who were undergone catheterization and implanted the new-type occluder.The behavior of the dogs were observed and situations of the devices were followed up by UCG and MRI. They were raised until 1, 2 , 3 and 6 months respectively after the procedure, then sacrificed and autopsy were conducted. At equal pace nickel serum concentrations levels were measured.Result: The ASD model had been created in nine dogs successfully without complication, eight of whom were implanted successfully with the new device without shunts. Occluders were clearly shown under Cardiac MRI and no dislocation occurred. Echocardiography shows no dislocation and having no affect on valves . Gross examination manifested there was no thrombus formation, wire breakage or fracture of the device. Endothelial cell fully covered the surface without inflammation reaction after 3 month. Light microscopic examination of liver, kidney, lung and spleen showed no evidence of inflammation and embolization. Nickel serum concentrations were measured ( <2 ng/mL of nickel was considered to be normal) . A rise in mean nickel serum levels was observed, from 0.646ug/L before implantation to 1. 775ug/L 1 month after implantation. During follow-up, the values gradually decreased to preoperative one.Conclusion: The method of transseptal puncture and balloon dilatation is reliable, easy to manipulate and with good repeatable .Transcatheter ASD occlusion with new type ASD occluder is safe, feasible and effective. Retrievability and good biocompatibility give the occluder a good prospect in future clinical use.
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