Department of Radiology, University of California Davis Medical Center, Sacramento, CA 95817, USA.
Cardiovasc Intervent Radiol. 2011 Apr;34(2):383-90. doi: 10.1007/s00270-010-0024-7. Epub 2010 Nov 12.
Thrombotic and embolic vascular occlusion represents a leading cause of morbidity and mortality. Currently available thrombectomy devices have limitations, including difficulty removing organized thrombus and clot fragmentation with distal embolization. A novel mechanical thrombectomy device (MTD), designed to remove both hard and soft thrombus without trauma to the blood vessel, was tested in preclinical porcine models evaluating efficacy, safety, and ease of use.
A total of 26 vessels in 14 pigs underwent mechanical thrombectomy with MTD. Thrombectomy was performed in nine superficial femoral arteries, eight subclavian arteries, five primary branches of the subclavian artery, lateral thoracic artery or the thyrocervical trunk, and four external carotids. Subacute organized fibrin-laden thrombus was injected into the arteries producing vascular occlusion. The MTD was then used for thrombectomy to restore patency and blood flow.
Intact thrombus was retrieved from 24 of 26 of the vessels with a single pass of the MTD, resulting in complete restoration of patency in 21 vessels and partial patency in 4 vessels. In 8 cases that used an early design, the embolic material fragmented during withdrawal from the access sheath. In 4 procedures that used an early design, the MTD failed to deploy fully and the embolus was not completely captured. No intraprocedural complications or vascular damage occurred.
The present pilot studies demonstrate basic safety and efficacy of a novel MTD with design attributes suitable for retrieval of intact acute and organized chronic thrombus. The device has potential intracranial and peripheral utility.
血栓栓塞性血管闭塞是发病率和死亡率的主要原因。目前可用的血栓切除术器械存在局限性，包括难以去除已形成的血栓和在远端发生血栓碎片栓塞。一种新型机械血栓切除术器械（MTD），旨在不损伤血管的情况下清除硬血栓和软血栓，在临床前猪模型中进行了评估其疗效、安全性和易用性的研究。
共对 14 头猪的 26 条血管进行了机械血栓切除术，使用 MTD。血栓切除术在 9 条股浅动脉、8 条锁骨下动脉、5 条锁骨下动脉、胸外侧动脉或颈总动脉的主要分支和 4 条颈外动脉中进行。将亚急性纤维蛋白负荷血栓注入动脉以造成血管闭塞。然后使用 MTD 进行血栓切除术以恢复通畅和血流。
在 26 条血管中有 24 条通过单次使用 MTD 成功取出完整的血栓，其中 21 条血管完全恢复通畅，4 条血管部分通畅。在 8 例早期设计中，在从血管鞘中取出时，栓塞材料发生了碎片。在 4 例早期设计中，MTD 未能完全展开，且未能完全捕获栓子。没有发生术中并发症或血管损伤。
本初步研究表明了一种新型 MTD 的基本安全性和有效性，该器械具有适合提取完整的急性和已形成的慢性血栓的设计属性。该器械具有潜在的颅内和外周用途。
