全生物可降解型房间隔缺损封堵器封堵猪房间隔缺损的实验研究

Experimental ASD closure using a fully biodegradable ASD occluder in swine models

目的评估全生物可降解型房间隔缺损(ASD)封堵器封堵猪ASD的疗效、并发症、生物相容性等。方法房隔穿刺及Rashkind球囊房隔造口术构建猪ASD模型成功后,即刻在透视及经食管超声心动图引导下用所设计全生物可降解型ASD封堵器封堵所构建ASD。术后1周、1个月、3个月和6个月处死实验猪,并行大体标本肉眼观察研究。结果共对10只制备好ASD模型的实验猪进行了封堵,技术成功率100%;术中及术后均未出现残余分流、心律失常、感染等并发症;大体解剖标本见内膜组织从边缘逐渐完全覆盖装置表面,未见装置表面赘生物及血栓形成,装置均未发生移位。结论全生物可降解型ASD封堵器关闭猪ASD技术成功率高、动物实验结果与金属ASD封堵器相仿,是一种安全、有效、可行的方法。其远期及对中、大型ASD的封堵疗效还有待进一步研究。

Objective To evaluate the effectiveness,complications and biocompatibility of interventional atrial septal defect （ASD） closure in swine model using a fully biodegradable occluder.Methods After ASD was created in pigs by the brockenbrough needle and following Rashkind balloon atrial septostomy,the fully biodegradable occluders were implanted under fluoroscopy and transesophageal ultrasound guidance.Macroscopic examination were done on explanted occulders in sacrificed pigs after the occluders implanted 1 week,1 month,3 months and 6 months respectively.Results All occulders were successfully implanted in ASD models.Complications such as residual shunt,arrhythmias,infection did not occured during and after the procedure.Macroscopic examination showed no vegetation and thrombus formation on surface of all occluders,no migratation was observed on all occulders.The occulders were embedded into endogenous host tissure gradually at 6 month＇s follow up.Conclusions ASD can be closed feasibily,effectively and safely using the fully biodegradable ASD occluder,but long-term results and the effectiveness for middle and large ASD need further study.