Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Charité Campus Virchow-Klinikum, Charité University Medicine, Berlin, Germany.
Department of Vascular Surgery, St Franziskus Hospital, Münster, Germany.
J Endovasc Ther. 2020 Apr;27(2):258-265. doi: 10.1177/1526602820908602. Epub 2020 Feb 25.
To compare experimentally the biomechanical properties of the Viabahn Balloon-Expandable Stent Graft (VBX) with the widely used Advanta V12/iCast in the role of bridging stent-grafts for fenestrated endovascular aortic repair. Test sheets made of polyester having 2 rows of 5 fenestrations in 6-mm and 8-mm diameters were used to simulate a commercially made fenestrated aortic endograft. In total, 40 stent-grafts measuring 6×39 mm and 8×39 mm (10 of each size for each stent-graft) were implanted in fenestration sheets immersed in a 37°C water bath. After flaring, all stent-grafts were evaluated using microscopy and radiography. Biomechanical evaluation included pullout and the shear stress force testing; results are reported in Newtons (N) as the median (minimum-maximum). After flaring, no damage or fracture to the stent-graft structures were detected. Pullout forces for the 6-mm stent-grafts were 27.1 N (20.0-28.9) for the VBX and 16.6 N (14.7-19.2) for the Advanta (p=0.008). Pullout forces for the 8-mm stent-grafts were 20.1 N (14.8-21.5) for the VBX and 15.8 N (12.4-17.5) for the Advanta (p=0.095). The shear stress forces necessary to dislocate the device at 150% stent diameter displacement was 12.5 N (VBX) vs 14.7 N (Advanta) for the 6-mm devices and 23.3 N (VBX) vs 20.2 N (Advanta) for the 8-mm stents (p>0.99 and p=0.222, respectively). In vitro tests simulating external pull and shear forces on bridging stent-grafts implanted in fenestrations showed that the VBX had resistance to dislocation equivalent to a well-known control device.
为了比较 Viabahn 球囊扩张支架(VBX)和广泛使用的 Advanta V12/iCast 在充当 fenestrated 血管内主动脉修复的桥接支架中的生物力学性能,我们在 37°C 水浴中的 fenestrated 人造主动脉内移植物中进行了体外测试。总共植入了 40 个 6×39mm 和 8×39mm 的支架(每种尺寸各 10 个)。在扩张后,所有的支架都进行了显微镜和射线照相评估。生物力学评估包括拔出和剪切力测试;结果以牛顿(N)为单位报告,中位数(最小值-最大值)。在扩张后,没有发现支架结构的损坏或断裂。6mm 支架的拔出力为 VBX 的 27.1N(20.0-28.9)和 Advanta 的 16.6N(14.7-19.2)(p=0.008)。8mm 支架的拔出力为 VBX 的 20.1N(14.8-21.5)和 Advanta 的 15.8N(12.4-17.5)(p=0.095)。在 150%支架直径位移下,使装置脱位所需的剪切力为 VBX 的 12.5N(6mm 装置)和 Advanta 的 14.7N(6mm 装置);VBX 的 23.3N(8mm 支架)和 Advanta 的 20.2N(8mm 支架)(p>0.99 和 p=0.222,分别)。在模拟 fenestrated 中植入的桥接支架外部拉力和剪切力的体外测试中,VBX 具有与知名对照装置相当的抗脱位能力。