国产膜周部室间隔缺损封堵器的研制及临床应用

The development of a new perimenbranous ventricular septal defect occluder

目的 评价我们研制的一种国产膜周部室间隔缺损 (VSD)封堵器的临床应用价值及安全性。方法 膜周部VSD封堵器的结构设计为“工”字形,有对称型及非对称型两种,金属材料选用镍钛形状记忆合金,阻流体选用聚四氟乙烯。通过动物实验及临床试验,对该装置的安全性、有效性和并发症进行评价,并与Amplatzer封堵器进行对比,对该装置进行综合评价。结果 封堵器检验合格并通过国家安全检测。成功建立VSD模型的 22头猪均成功置入封堵器,随诊除 1例伤口感染外无并发症发生。进行临床实验的 58例膜周部VSD病例全部成功置入封堵器, 1例出现Ⅱ度Ⅱ型房室传导阻滞,其余无并发症发生。新型膜周部VSD封堵器与Amplatzer封堵器相比成功率、并发症方面差异无统计学意义。但术后即刻封堵效果优于Amplatzer封堵器。结论 我们研制的封堵器结构设计合理,是一种疗效确切的膜周部VSD介入治疗装置,达到或优于进口Amplatzer装置的治疗效果。

Objective The aim of this study was to develop a new perimembranous VSD occluder and to evaluate it.Methods The shape of VSD occluder was designed as fabric frame “工” shape that comprised two types: symmetric and asymmetric. The safety, efficacy, feasibility and complication were tested in 22 animal models and in 58 VSD patients in clinical trial. The device were compared with Amplatzer occluder in this study.Results The new perimembranous VSD occluder was passed the national material test. In animal study, artificial VSD were all occluded by using the new devices with no complication in follow up except one pig expresented wound infection. In clinical trial, all 58 VSD cases were healing with the new device. One patient suffered with atria vebtricular block 5 days after procedure and was free from AV block with medicine therapy. Compared with Amplatzer perimenbranous VSD occluder, the new devices had lower frequence of residual shunt. Conclusion The new perimembranous VSD occluder is a safe and effective perimembranous VSD interventional apparatus, and the effect of the new occluders seems not worse than that of the Amplatzer ones.