Torsello Giovanni Federico, Herten Monika, Müller Markus, Frank André-, Torsello Giovanni B, Austermann Martin
1 Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Charité Campus Virchow-Klinikum, Charité University Medicine Berlin, Germany.
2 Department of Vascular Surgery, St Franziskus Hospital Münster, Germany.
J Endovasc Ther. 2019 Jun;26(3):361-368. doi: 10.1177/1526602819842569. Epub 2019 Apr 11.
To evaluate the safety and integrity of a new stent-graft as a potential bridging device in fenestrated stent-grafts using an in vitro fenestrated model.
Polyester test sheets with ten 6-mm- or 8-mm-diameter fenestrations were used to simulate a fenestrated main body endoprosthesis. In total, 50 Viabahn balloon-expandable (VBX) stent-grafts of varying lengths (29 and 39 mm) and diameters (6, 7, and 8 mm) were implanted in the fitting fenestrations. After release, the 6- and 7-mm-diameter stent-grafts were flared with a 10×20-mm angioplasty balloon; a 12×20-mm balloon was used in the 8-mm-diameter devices. Safety of the devices was defined as absence of fractures detected on radiography or computed tomography (CT), as well as material failure detected by microscopy and water permeability testing. The forces (in Newtons, N) needed for perpendicular dislocation (pullout force) and axial dislocation (shear stress force) were also evaluated.
Forty VBX stent-grafts were subjected to digital radiographic imaging and multiplanar CT. None showed any stent fracture. Subsequent microscopy indicated no damage to the fabric or separation of the graft after flaring. Ten VBX stent-grafts underwent water permeability testing after flaring; no water passed through the graft wall during a 10-minute period under an intraluminal pressure at 120 mm Hg. Testing of 25 VBX stent-grafts revealed initial pullout forces between 11.3 and 31 N. Shear stress tests showed that the average force needed to dislocate the stent-grafts by 50% of their diameter ranged between 5.75 and 6.91 N (mean 6.1±0.5 N) for the 6-mm stents and between 3.31 and 5.4 N (mean 4.4±0.8) for the 8-mm stents.
This preliminary study demonstrated the applicability of the VBX as a bridging stent-graft in a simulated fenestration model. A comparison with other stent-grafts and clinical assessment are required.
使用体外开窗模型评估一种新型支架型人工血管作为开窗支架型人工血管潜在桥接装置的安全性和完整性。
使用带有10个直径为6毫米或8毫米开窗的聚酯测试片来模拟开窗的主体内支架。总共将50个不同长度（29毫米和39毫米）和直径（6毫米、7毫米和8毫米）的Viabahn球囊扩张式（VBX）支架型人工血管植入合适的开窗处。释放后，直径为6毫米和7毫米的支架型人工血管用10×20毫米的血管成形球囊进行扩张；直径为8毫米的装置使用12×20毫米的球囊。装置的安全性定义为在X线摄影或计算机断层扫描（CT）上未检测到骨折，以及通过显微镜检查和水渗透性测试未检测到材料故障。还评估了垂直脱位（拔出力）和轴向脱位（剪切应力力）所需的力（以牛顿，N为单位）。
40个VBX支架型人工血管接受了数字X线摄影成像和多平面CT检查。均未显示任何支架骨折。随后的显微镜检查表明，扩张后织物未受损，人工血管也未分离。10个VBX支架型人工血管在扩张后进行了水渗透性测试；在120毫米汞柱的腔内压力下，10分钟内没有水通过人工血管壁。对25个VBX支架型人工血管的测试显示初始拔出力在11.3至31 N之间。剪切应力测试表明，对于6毫米的支架，将支架型人工血管脱位其直径的50%所需的平均力在5.75至6.91 N之间（平均6.1±0.5 N），对于8毫米的支架，在3.31至5.4 N之间（平均4.4±0.8）。
这项初步研究证明了VBX作为模拟开窗模型中的桥接支架型人工血管的适用性。需要与其他支架型人工血管进行比较并进行临床评估。
