Haage P, Tacke J, Bovelander J, Wildberger J E, Klosterhalfen B, Vorwerk D, Günther R W
Department of Diagnostic Radiology, University of Technology, Pauwelsstrasse 30, D-52057 Aachen, Germany.
Radiology. 2001 Jul;220(1):135-41. doi: 10.1148/radiology.220.1.r01jl28135.
To develop an animal model of subacute inferior vena caval (IVC) thrombosis and apply this model in evaluating the safety and efficacy of a prototype percutaneous thrombolytic device for restoring patency.
In 11 pigs, a stent with a ligature in the middle was placed in the IVC. Thrombin was injected to induce thrombosis. Hemostasis was achieved by using an occlusion balloon. The stent was ligated to prevent thrombus migration. Five to 8 days after thrombus induction, the ligature was broken and the stent fully deployed. In 10 animals, thrombectomy was performed by using the percutaneous thrombolytic device. A vena caval filter was inserted at the beginning of each declotting procedure. Thrombus removal percentage was estimated and pulmonary angiograms obtained to detect embolism before and after thrombectomy. The IVC was analyzed histologically. To determine thrombus composition, one animal was sacrificed without thrombectomy. Concerning procedural safety, failure of the stent delivery system, stent migration, and venous perforation due to balloon inflation and the stent placement or thrombectomy procedure were evaluated.
Thrombus creation was successful in all animals. Fragmentation led to 75%--100% thrombus removal with flow restoration in all cases. There were no episodes of stent delivery failure, stent migration, or venous perforation. No significant pulmonary embolism was observed. In one case, a vessel dissection was identified at histologic examination.
In this animal model of IVC thrombosis, the percutaneous thrombolytic device is effective and safe for clot removal.
建立亚急性下腔静脉（IVC）血栓形成的动物模型，并应用该模型评估一种用于恢复血管通畅的经皮溶栓装置原型的安全性和有效性。
在11头猪中，将一个中间带有结扎线的支架置入IVC。注射凝血酶以诱导血栓形成。使用阻塞球囊实现止血。结扎支架以防止血栓迁移。在诱导血栓形成后5至8天，剪断结扎线并完全展开支架。在10只动物中，使用经皮溶栓装置进行血栓切除术。在每次溶栓手术开始时插入下腔静脉滤器。估计血栓清除率，并在血栓切除术前和术后获取肺血管造影以检测栓塞情况。对IVC进行组织学分析。为确定血栓成分，处死1只未进行血栓切除术的动物。关于手术安全性，评估支架输送系统故障、支架迁移以及因球囊膨胀和支架置入或血栓切除手术导致的静脉穿孔情况。
所有动物均成功形成血栓。在所有病例中，血栓破碎导致75% - 100%的血栓清除且血流恢复。未发生支架输送失败、支架迁移或静脉穿孔事件。未观察到明显的肺栓塞。在1例组织学检查中发现血管夹层。
在这种IVC血栓形成的动物模型中，经皮溶栓装置在清除血栓方面有效且安全。
