University of Miami Miller School of Medicine, Miami, Florida, USA.
Neurovascular, Medtronic plc, Irvine, California, USA.
J Neurointerv Surg. 2020 Oct;12(10):981-986. doi: 10.1136/neurintsurg-2020-016043. Epub 2020 Jun 2.
The Pipeline Vantage Embolization Device with Shield Technology is a next generation flow diverter developed to improve aneurysm occlusion and implant endothelialization in addition to lowering thrombogenicity. We report here the in vivo biocompatibility and in vitro hemocompatibility performance of the Pipeline Vantage Embolization Device with Shield Technology (Vantage) compared with the Pipeline Flex Embolization Device (Flex).
Biocompatibility (via histology), aneurysm occlusion and vessel patency (via angiography), and endothelial coverage (via scanning electron microscopy (SEM)) for the Vantage and Flex devices were assessed in the rabbit elastase aneurysm model at 90 days (n=29) and 180 days (n=27). In vitro thrombogenicity for Flex and Vantage (n=16) was assessed using a human blood flow loop model at low heparin concentration (0.6 U/mL) with thrombin generation, platelet activation and thrombus visualization as outputs.
Raymond Roy Occlusion Classification grade 1 was higher for Vantage (61%) compared with Flex (46%), but was not statistically significant (p>0.05). All branch vessels were patent. Histological measures for both devices were similar (p>0.05). Endothelial coverage of the implant was significantly better for Vantage compared with Flex (p<0.05). In vitro measurements of thrombin generation (thrombin-antithrombin complex (µg/mL): Vantage 0.49±0.45; Flex 10.57±9.84) and platelet activation (β-thromboglobulin (IU/µl): Vantage 0.41±0.19; Flex 4.14±2.38) were both statistically lower (p0.05) for Vantage compared with Flex. High resolution microscopy showed less accumulation of thrombus on Vantage as compared with Flex.
Vantage improved aneurysm occlusion and implant endothelialization and had significantly lower thrombogenicity as compared with Flex, while preserving the biocompatibility safety profile of Flex.
Pipeline Vantage 栓塞装置 Shield Technology 是一种新一代的血流转向装置，旨在提高动脉瘤闭塞率和植入物内皮化，并降低血栓形成性。我们在此报告 Pipeline Vantage 栓塞装置 Shield Technology（Vantage）与 Pipeline Flex 栓塞装置（Flex）的体内生物相容性和体外血液相容性性能。
在 90 天（n=29）和 180 天（n=27）的兔弹性蛋白酶动脉瘤模型中，通过组织学评估 Vantage 和 Flex 装置的生物相容性（通过组织学评估）、动脉瘤闭塞和血管通畅性（通过血管造影评估）以及内皮覆盖（通过扫描电子显微镜（SEM）评估）。在低肝素浓度（0.6 U/mL）下，使用人体血流回路模型评估 Flex 和 Vantage（n=16）的体外血栓形成性，以血栓生成、血小板活化和血栓可视化作为输出。
Vantage 的 Raymond Roy 闭塞分级 1 级（61%）高于 Flex（46%），但无统计学意义（p>0.05）。所有分支血管均通畅。两种装置的组织学测量值相似（p>0.05）。Vantage 对植入物的内皮覆盖明显优于 Flex（p<0.05）。体外测量的血栓生成（凝血酶-抗凝血酶复合物（µg/mL）：Vantage 0.49±0.45；Flex 10.57±9.84）和血小板活化（β-血栓球蛋白（IU/µl）：Vantage 0.41±0.19；Flex 4.14±2.38）均明显低于 Flex（p<0.05）。高分辨率显微镜显示，与 Flex 相比，Vantage 上血栓的积聚较少。
与 Flex 相比，Vantage 提高了动脉瘤闭塞率和植入物内皮化，血栓形成性显著降低，同时保持了 Flex 的生物相容性安全性。
