Bastijanic Jennifer M, Etscheidt Jordan, Sattiraju Mallika, Bonsignore Craig, Kopchok George, White Rodney, Sarac Timur P
1 PeriTec Biosciences, LTD., Cleveland, Ohio, USA.
J Endovasc Ther. 2014 Oct;21(5):735-46. doi: 10.1583/14-4762.1.
To assess the fatigue and in vivo performance of a new stent-graft incorporating bovine peritoneum lining that is designed for application in peripheral vascular occlusive disease.
Bovine peritoneum-lined stent-grafts were subjected to accelerated in vitro pulsatile fatigue and axial/torsional fatigue testing designed to simulate 10 years of physiological strain on the devices. At specified times the devices were evaluated for stent fracture, suture failure, or tissue tearing. Seven dogs underwent bilateral common iliac artery (CIA) balloon angioplasty injury with unilateral placement of the peritoneum-lined stent-graft. Angiography and intravascular ultrasound were performed prior to treatment, after treatment, and prior to sacrifice at 30 days. Vessels were perfusion fixed and histologically evaluated at 5 regions: above stent, proximal stent, mid stent, distal stent, and below stent.
No evidence of stent, suture, or tissue failure was present during or after pulsatile and axial/torsional fatigue testing. At 30±0.3 days after implantation, all vessels were patent. The average lumen area at explantation across stented vessels was 25.45 mm(2). Lumen areas tended to be reduced above (23.57 mm(2)) and below (24.17 mm(2)) the stent. Lumen areas were consistent across stented regions at explantation (proximal stent 27.80 mm(2), mid stent 25.88 mm(2), and distal stent 25.81 mm(2)). The mean neointimal area in peritoneum-lined stents was 2.02±1.52 mm(2), with a neointima:media ratio of 1.03±0.50. These values were significantly lower in the above and below stent areas than in the stented regions, but there was no difference in either measure within the proximal, mid, or distal stent.
The custom-designed peritoneum-lined stent-graft is promising for clinical peripheral applications due to its ability to resist relevant long-term physiological stresses and outstanding short-term patency rates in canine implantations.
评估一种新的带有牛腹膜内衬的支架移植物的疲劳性能和体内性能，该支架移植物设计用于外周血管闭塞性疾病。
对带有牛腹膜内衬的支架移植物进行加速体外脉动疲劳以及轴向/扭转疲劳测试，旨在模拟该装置10年的生理应变。在特定时间评估装置的支架断裂、缝线失效或组织撕裂情况。7只犬接受双侧髂总动脉（CIA）球囊血管成形术损伤，并单侧植入带有腹膜内衬的支架移植物。在治疗前、治疗后以及30天处死前进行血管造影和血管内超声检查。对血管进行灌注固定，并在5个区域进行组织学评估：支架上方、支架近端、支架中部、支架远端以及支架下方。
在脉动和轴向/扭转疲劳测试期间及之后，均未发现支架、缝线或组织失效的迹象。植入后30±0.3天，所有血管均保持通畅。植入支架的血管在取出时的平均管腔面积为25.45平方毫米。支架上方（23.57平方毫米）和下方（24.17平方毫米）的管腔面积趋于减小。取出时，支架各区域的管腔面积一致（支架近端27.80平方毫米，支架中部25.88平方毫米，支架远端25.81平方毫米）。带有腹膜内衬的支架内新生内膜的平均面积为2.02±1.52平方毫米，新生内膜与中膜的比值为1.03±0.50。这些值在支架上方和下方区域显著低于支架区域，但在支架近端、中部或远端，这两项指标均无差异。
定制设计的带有腹膜内衬的支架移植物有望用于临床外周应用，因为它能够抵抗相关的长期生理应力，并且在犬类植入实验中具有出色的短期通畅率。
