University of Minnesota, Amplatz Children's Hospital, Minneapolis, Minnesota 55455, USA.
Catheter Cardiovasc Interv. 2012 Jun 1;79(7):1153-60. doi: 10.1002/ccd.23367. Epub 2011 Dec 12.
This study assessed the feasibility and efficacy of implanting a new nitinol device for closure of perimembranous ventricular septal defects in a swine model.
Perimembranous ventricular septal defect occurs in 80% of patients requiring treatment for congenital heart disease.
The Amplatzer perimembranous ventricular septal occluder device (pmVSO2 device, AGA Medical Company, Plymouth MN) is a new transcatheter Nitinol device containing polyester fabric designed to close the perimembranous ventricular septal defect (VSD). The device has 75% reduction in radial force, 45% reduction in clamping force, and increased stability as compared to the previous version. The device was implanted in six swine with naturally occurring perimembranous VSD with immediate, 1, 7, ∼30, and ∼90 day followup by echocardiography, angiography, and final pathological examination.
The device was successfully implanted in all animals and was retrievable and repositionable. There was complete occlusion of the VSD in five of six cases without embolization. There was no thrombus formation on the device or occurrence of complete heart block. A single instance of a tiny residual shunt was attributed to capture of tricuspid valve apparatus.
The success of this animal study confirms safety and feasibility of the Amplatzer pmVSO2 device. Human trials are planned.
本研究旨在评估在猪模型中植入新型 Nitinol 装置闭合膜周部室间隔缺损的可行性和疗效。
膜周部室间隔缺损发生于 80%需要治疗的先天性心脏病患者。
Amplatzer 膜周部室间隔缺损封堵器（pmVSO2 装置，AGA Medical Company，明尼苏达州普利茅斯）是一种新型经导管 Nitinol 装置，含有聚酯纤维，旨在闭合膜周部室间隔缺损（VSD）。与前代产品相比，该装置的径向力减少了 75%，夹持力减少了 45%，稳定性增加。该装置在 6 只存在自然发生的膜周部 VSD 的猪中进行了植入，通过即时、1 天、7 天、约 30 天和约 90 天的超声心动图、血管造影和最终的病理检查进行了随访。
该装置在所有动物中均成功植入，且可回收和重新定位。在 6 例中，有 5 例完全闭合了 VSD，没有发生栓塞。装置上没有血栓形成，也没有发生完全性心脏传导阻滞。仅有 1 例微小残余分流归因于三尖瓣装置的捕获。
这项动物研究的成功证实了 Amplatzer pmVSO2 装置的安全性和可行性。计划进行人体试验。
