Department of Vascular Surgery, St Franziskus Hospital, Münster, Germany.
Clinic for Diagnostic and Interventional Radiology, Klinikum Esslingen, Esslingen, Germany.
J Endovasc Ther. 2019 Dec;26(6):865-870. doi: 10.1177/1526602819872498. Epub 2019 Aug 28.
To compare balloon-expandable covered stents (BECS) available for use as renal chimney grafts to the Advanta V12 approved for use with the Endurant endograft. A silicone model was manufactured based on preoperative computed tomography angiography (CTA) scans of a patient with a 7-cm juxtarenal aneurysm treated with an Endurant bifurcated endograft and an Advanta V12 covered stent for the 6-mm-diameter right renal artery. The model was placed in a flow box filled with a 37°C blood-mimicking solution equipped with a pulsatile pumping system (140/60 mm Hg). The tested BECS were the Advanta V12, the VBX, and the BeGraft+. A 36-mm-diameter Endurant II endograft with a 16-mm-diameter contralateral limb and a 6×59-mm BECS chimney graft were used in 9 consecutive tests (3 for each combination). After each implantation, the model was placed in the CT scanner, and 2 radiologists blinded to the test device independently measured the gutter areas and the patent chimney graft lumen at the level of the Endurant's suprarenal stent, at the level of the chimney's maximum curvature, and 10 mm inside the renal artery. The intraclass correlation coefficients (ICC) were calculated to assess interreader reliability. The mean gutter areas were 19.3±7, 20.2±8, and 22.3±8 mm for the Advanta, VBX, and BeGraft+, respectively (all p>0.05). At the level of the aortic endograft's suprarenal stent struts, the mean diameter of the Advanta V12, VBX, and BeGraft+ were 4.46±0.3, 4.12±0.4, and 4.12±0.3 mm, respectively (all p>0.05). At the level of the maximum chimney graft angulation, the mean diameters were 3.77±0.3, 4.16±0.1, and 3.74±0.3 mm, respectively (all p>0.05). In the right renal artery, the mean diameters were 3.91±0.2, 4.05±0.9, and 4.3±0.4 mm, respectively (all p>0.05). The ICCs varied between 0.7 and 0.9, indicating good agreement between readers. These in vitro findings showed comparable results between the Advanta V12 and the available BECS used in conjunction with the Endurant endograft according to the instructions for use. Further clinical evaluation is needed to confirm these results.
比较可用于作为肾烟囱移植物的球囊扩张覆膜支架（BECS）与 Advanta V12，后者被批准与 Endurant 分叉型覆膜支架联合使用。根据一名接受 Endurant 分叉型覆膜支架和 Advanta V12 覆膜支架治疗的 7cm 肾周动脉瘤患者的术前 CT 血管造影（CTA）扫描，制造了一个硅胶模型，用于治疗 6mm 直径的右肾动脉。模型被放置在一个充满 37°C 血液模拟溶液的流动盒中，配备有脉动泵系统（140/60mmHg）。测试的 BECS 是 Advanta V12、VBX 和 BeGraft+。连续 9 次测试（每次测试 3 次）使用了一个 36mm 直径的 Endurant II 覆膜支架，其对侧肢有 16mm 直径，6×59mm 的 BECS 烟囱移植物。每次植入后，模型都被放置在 CT 扫描仪中，两名对测试设备不知情的放射科医生独立测量了 Endurant 肾上支架水平、烟囱最大弯曲处水平和肾动脉内 10mm 处的烟囱移植物腔的 gutter 区域和通畅的烟囱移植物腔。计算了组内相关系数（ICC）来评估读者间的可靠性。Advanta、VBX 和 BeGraft+的 gutter 区域平均值分别为 19.3±7、20.2±8 和 22.3±8mm（均 p>0.05）。在主动脉覆膜支架肾上支架支柱水平，Advanta V12、VBX 和 BeGraft+的平均直径分别为 4.46±0.3、4.12±0.4 和 4.12±0.3mm（均 p>0.05）。在烟囱移植物最大弯曲处水平，平均直径分别为 3.77±0.3、4.16±0.1 和 3.74±0.3mm（均 p>0.05）。在右肾动脉中，平均直径分别为 3.91±0.2、4.05±0.9 和 4.3±0.4mm（均 p>0.05）。ICC 介于 0.7 至 0.9 之间，表明读者之间具有良好的一致性。这些体外发现表明，根据使用说明，Advanta V12 与与 Endurant 覆膜支架联合使用的现有 BECS 之间的结果具有可比性。需要进一步的临床评估来确认这些结果。
