Department of Neurology, Grady Memorial Hospital, Emory University School of Medicine, Atlanta, Georgia, USA.
J Neurointerv Surg. 2012 Jul;4(4):295-300. doi: 10.1136/neurintsurg-2011-010053. Epub 2011 Aug 20.
The currently available mechanical devices fail to achieve recanalization in as many as 20-40% of proximal arterial occlusion strokes.
The preclinical evaluation of the safety and efficacy of a novel thrombectomy device designed to achieve immediate flow restoration by quickly removing clot is reported.
Four confirmatory animal studies were performed with the Trevo device (Concentric Medical Inc, Mountain View, California, USA) in the swine (n=2) and canine (n=1) models of arterial thrombo-occlusive disease employing autologous thrombin generated thrombi. The angiographic response and the degree of device-clot incorporation were evaluated. High resolution flat panel three-dimensional CT was performed to further define the in vivo device-thrombus-vessel interaction. Finally, samples of three swine vessels treated with six passes of the device were explanted for histopathological analysis.
A total of 16 clots of variable hardness and consistency were implanted in a variety of vascular settings, including the swine internal maxillary, lingual and forelimb arteries as well as the canine external carotid and vertebral arteries. Thrombolysis in Myocardial Infarction (TIMI) 2-3 reperfusion was achieved in all cases immediately after device deployment. All 16 clots were retrieved after one (n=15) or two (n=1) passes with the device. Histopathological analysis demonstrated severe disruption of the intima but no hemorrhage of media or adventitia.
The experimental data suggest that the Trevo device is highly effective at achieving immediate reperfusion of occluded arteries without causing any clinically significant disruption of vascular integrity.
目前可用的机械装置未能实现多达 20-40%的近端动脉闭塞性中风再通。
报告一种新型取栓装置的临床前安全性和有效性评估，该装置旨在通过快速清除血栓来实现即时血流恢复。
在猪（n=2）和犬（n=1）动脉血栓闭塞性疾病模型中，使用自体凝血酶生成的血栓进行了四项确证性动物研究，采用了 Trevo 装置（Concentric Medical Inc，美国加利福尼亚州山景城）。评估了血管造影反应和装置-血栓结合程度。进行高分辨率平板三维 CT 以进一步定义体内装置-血栓-血管相互作用。最后，对用该装置处理过的三只猪的血管样本进行了六次处理，以进行组织病理学分析。
总共植入了 16 个不同硬度和一致性的血栓，这些血栓植入了各种血管环境中，包括猪的内上颌、舌和前肢动脉以及犬的颈外和椎动脉。在所有情况下，装置部署后立即实现了血栓溶解（心肌梗死）（TIMI）2-3 再灌注。在 16 个血栓中，有 15 个在一次通过装置后被取出，1 个在两次通过装置后被取出。组织病理学分析表明，内膜严重破裂，但中膜或外膜无出血。
实验数据表明，Trevo 装置在不引起任何血管完整性临床显著破坏的情况下，可高效实现闭塞动脉的即时再通。
