新型国产覆膜支架腔内修复肾下型腹主动脉瘤的临床对照研究：近-中期随访结果与单中心经验总结

A novel domestic-made stent-graft in endovascular abdominal aortic aneurysm repair: outcome of short- and medium-term follow-up and experience summary of a single-center controlled clinical trial

BACKGROUND: Limited by the high financial burden of stent-graft and proof of evident-based medicine, the popularization of endovascular abdominal aortic aneurysm repair, a mini-invasive method, is impeded in China. In order to reduce costs, development of domestic-made stents is imperative, but the relative research is still rare.OBJECTIVE: To compare the effect of domestic-made stent-graft (Percutek) and Gore Excluder in the endovascular abdominal aortic aneurysm repair. METHODS: From January to November 2014, there were 32 male patients with infrarenal abdominal aortic aneurysm, aged 56-79 years old with mean age of (70.2±6.9) years, admitted in the Vascular Surgery Department of the Affiliated Hospital of Qingdao University. Clinical data were collected and retrospectively analyzed. There were 11 cases undergoing domestic-made stent-graft repair and 21 undergoing Gore Excluder repair. Aortic CT angiography was performed at 1 and 6 months after surgery, and every 6 months thereafter to evaluate the effect of the two modalities.RESULTS AND CONCLUSION: Domestic-made stent-grafts were successfully implanted into the 11 patients, and there were 1 case of late type I endoleak, 1 of type II endoleak, 1 of iliac occlusion and 1 of death after surgery. Totally 11 stent-graft trunks, 18 iliac stent-grafts, 1 Cuff, and 1 bare metal stent were implanted in the domestic-made stent-graft group (2.8 stents/case). Totally 21 patients were subjected to Gore Excluder repair with the success rate of 90%, and 2 cases of intraoperative I type endoleak (10%), 2 of postoperative I type endoleak and 2 of postoperative II type endoleak were observed. Totally 21 stent-graft trunks, 28 iliac stent-grafts and 3 Cuff were implanted in the Gore Excluder group (2.47 stents/case). These results suggest that the novel domestic-made stent-graft has achieved a satisfactory outcome in endovascular abdominal aortic aneurysm repair, showing no significant differences in related indicators with the Gore Excluder; however, the long-term outcomes still need to be further studied.