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

doi:10.3969/j.issn.2095-4344.2016.47.015

Abstract

Abstract:

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.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Stents, Aortic Aneurysm, Abdominal, Postoperative Complications, Tissue Engineering

CLC Number:

R318

Liu Ming-yuan, Liu Bing, Wang Hao-fu. 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[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(47): 7097-7105.

Figures/Tables 7

References

[1]王豪夫,王曰伟,李君,等.腹主动脉瘤腔内修复术22例围手术期处理回顾性总结[J]. 介入放射学杂志, 2010, 19(11): 858-861.
[2]陈卓,丁文彬,袁瑞凡,等.国产一体式分叉型覆膜支架治疗腹主动脉瘤的临床评价[J]. 实用临床医药杂志, 2011, 15(3):88-90.
[3]蒋米尔,陆民,黄新天,等.国产覆膜支架腔内修复术治疗主动脉病变的疗效[J].上海第二医科大学学报, 2005, 25(11): 73-76.
[4]Chaikof EL, Blankensteijn JD, Harris PL, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35(5):1048-1060.
[5]Harris PL, Buth J, Mialhe C, et al. The need for clinical trials of endovascular abdominal aortic aneurysm stent-graft repair: The EUROSTAR Project. EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair. J Endovasc Surg. 1997; 4(1):72-77; discussion 78-79.
[6]Prinssen M, Buskens E, Blankensteijn JD. The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial. Background, design and methods. Cardiovasc Surg. 2002; 43(3):379-384.
[7]United Kingdom ET, Greenhalgh RM. Endovascular versus open repair of abdominal aortic aneurysm. N Eng J Med.2010;362(20):1863-1871.
[8]Lederle FA, Freischlag JA, Kyriakides TC, et al. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA. 2009; 302(14):1535-1542.
[9]Becquemin JP, Pillet JC, Lescalie F, et al. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg.2011; 53(5):1167-1173.
[10]Donas KP, Torsello G, Bisdas T. New EVAR devices: pros and cons. J Cardiovasc Surg.2012; 53(5): 559-569.
[11]符伟国,李永生,王玉琦.腹主动脉瘤腔内治疗的合理应用和技术要点[J]. 中国实用外科杂志, 2012,32(12): 991-994.
[12]Verhoeven EL, Katsargyris A, Bachoo P, et al. Real-world performance of the new C3 Gore Excluder stent-graft: 1-year results from the European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT). Eur J Vasc Endovasc Surg.2014; 48(2):131-137.
[13]Katsargyris A, Botos B, Oikonomou K, et al. The new C3 Gore Excluder stent-graft: single-center experience with 100 patients. Eur J Vasc Endovasc Surg.2014; 47(4):342-348.
[14]Pratesi C, Piffaretti G, Pratesi G, et al. ITalian Excluder Registry and results of Gore Excluder endograft for the treatment of elective infrarenal abdominal aortic aneurysms. J Vasc Surg.2014; 59(1):52-57.e51.
[15]丁锦辉,刘光,李维敏,等.低渗透设计GORE EXCLUDER覆膜支架在复杂腹主动脉瘤腔内治疗中的应用[J].上海交通大学学报(医学版), 2015,35(4): 563-567.
[16]Chen J, Stavropoulos SW. Management of Endoleaks. Semin Intervent Radiol.2015;32(3):259-264.
[17]Buckley CJ, Buckley SD. Limitations of current EVAR endografts and potential solutions for their deficiencies. Semin Vasc Surg.2012;25(3):136-137.
[18]Mantas GK, Antonopoulos CN, Sfyroeras GS, et al. Factors Predisposing to Endograft Limb Occlusion after Endovascular Aortic Repair. Eur J Vasc Endovasc Surg. 2015;49(1):39-44.
[19]Maleux G, Koolen M, Heye S, et al. Limb occlusion after endovascular repair of abdominal aortic aneurysms with supported endografts. J Vasc Int Radiol. 2008;19(10):1409-1412.
[20]唐骁,符伟国,郭大乔,等.腹主动脉瘤腔内修复术后常见问题分析[J]. 中华外科杂志,2011, 49(10):888-892.
[21]Delle M, Lonn L, Wingren U, et al. Preserved pelvic circulation after stent-graft treatment of complex aortoiliac artery aneurysms: a new approach. J Endovasc Ther. 2005;12(2):189-195.
[22]Koutouzi G, Henrikson O, Roos H, et al. EVAR Guided by 3D Image Fusion and CO2 DSA: A New Imaging Combination for Patients With Renal Insufficiency. J Endovasc Ther. 2015, 22(6): 912-917.
[23]McNally MM, Scali ST, Feezor RJ, et al. Three-dimensional fusion computed tomography decreases radiation exposure, procedure time, and contrast use during fenestrated endovascular aortic repair. J Vasc Surg. 2015;61(2):309-316.
[24]侯凯,饶圣祥,顾君英,等. CTA与DSA-DYNA-CT融合图像在腹主动脉瘤腔内修复术中的应用[J]. 中国临床医学, 2012,19(6):697-699.