No inferiority of Tonbridge thrombectomy device for acute thrombus retrial compared with Solitaire device: an experimental evaluation with a canine distal external carotid-maxillary artery occlusion model
No inferiority of Tonbridge thrombectomy device for acute thrombus retrial compared with Solitaire device: an experimental evaluation with a canine distal external carotid-maxillary artery occlusion model
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与 Solitaire 装置相比，Tonbridge 血栓切除装置用于急性血栓再试验并不逊色：犬远端颈外动脉-上颌动脉闭塞模型的实验评估
DOI：
10.1136/neurintsurg-2017-013673
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发表时间：
2018-11-01
影响因子：
4.8
通讯作者：
Zhu, Yue-Qi
中科院分区：
文献类型：
--
作者：
Zhou, Geng;Li, Ming-Hua;Zhu, Yue-Qi
简介 机械血栓切除术 (MT) 已被广泛认为是治疗急性缺血性卒中 (AIS) 的安全有效的方法。在过去的二十年里，支架回收装置的开发得到了深入的发展。在这项研究中，我们比较了新型血栓切除装置与 Solitaire FR 治疗 AIS 模型的有效性和安全性。方法体外测试支架取回器的力学性能。将凝血酶诱导的血栓预先注射到18只狗的右远端颈外动脉-上颌动脉中，以建立急性血栓闭塞模型，并将这些动物分为Tonbridge组（n=9，使用Tonbridge医疗技术支架）和作为对照的Solitaire组（n=9，使用Solitaire支架，ev3神经血管）。记录并比较最终血流恢复、侧支、再通时间、远端血管栓塞和装置相关并发症。在血栓切除术后 30 天和 90 天进行术后血管造影。通过组织学评估与装置操作相关的动脉壁损伤。结果 体外测试显示，Tonbridge装置的微导管内最大摩擦力为0.763，Solitaire装置的微导管内最大摩擦力为0.784 n（P>0.05）。 Tonbridge 的径向力略有增加（0.035 N/mm 对比 Solitaire 的 0.031 N/mm，P>0.05）。汤布里奇组（平均 2.0 次尝试）和纸牌组（平均 1.8 次尝试）分别进行了 18 次和 16 次寻回犬尝试（P=0.74）。 Tonbridge 装置在所有九个模型 (100%) 中均实现了良好的血流恢复，而 Solitaire 组中只有八个模型 (88.9%) (P=0.30)。两组之间的侧枝影响（P=0.39）、远端血栓栓塞（P=0.60）和装置相关并发症（P=1.00）没有差异。标本的内弹性层破坏率（IEL）分别为8.3%（2/24）和4.2%（1/24）（P=0.683）。两组患者1个月（6/6 vs 6/6）和3个月（6/6 vs 6/6）随访时右侧CCA TICI 2b/3血流相似（P>0.05）。结论 我们的初步研究表明，这种新装置在犬模型中用于血栓切除术治疗急性血栓闭塞在技术上是可行且有效的。
Introduction Mechanical thrombectomy (MT) has been widely accepted as a safe and effective treatment for acute ischemic stroke (AIS). Development of stent retriever devices has been intensively developed over the past two decades. In this study, we compared the effectiveness and safety of a new thrombectomy device with Solitaire FR for the treatment of AIS models. Methods Mechanical performance of stent retrievers was tested in vitro. Thrombin-induced thrombus was pre-injected into the right distal external carotid-maxillary artery in 18 dogs to create an acute thrombus occlusion model, and these animals were divided into a Tonbridge group (n=9, with Tonbridge stent Tonbridge Medical Technology) and a Solitaire group as control (n=9, with Solitaire stent, ev3 Neurovascular). Final flow restoration, side branches, recanalization time, distal vessel embolism, and device-related complications were recorded and compared. A post-procedure angiogram was obtained at 30 and 90 days after thrombectomy. Device manipulation-related damage to the arterial walls was evaluated histologically. Results In vitro test showed that the maximum friction within the microcatheter was 0.763 for the Tonbridge device and 0.784 n for the Solitaire (P>0.05). Slight increase in radial force was noticed for the Tonbridge (0.035 N/mm vs 0.031 N/mm of Solitaire, P>0.05). Eighteen and 16 retriever attempts were done in the Tonbridge (mean 2.0 attempts) and the Solitaire (mean 1.8 attempts) groups (P=0.74). The Tonbridge device led to good flow restoration in all nine (100%) models compared with eight (88.9%) in the Solitaire group (P=0.30). Side branches' influence (P=0.39), distal thromboembolism (P=0.60), and device-related complications (P=1.00) found no difference between the two groups. The rates of disruption of the internal elastic lamina (IEL) were 8.3% (2/24) and 4.2% (1/24) of the specimens, respectively (P=0.683). TICI 2b/3 flow of the right CCA were similar between the two groups at 1 (6/6 vs 6/6) and 3 months (6/6 vs 6/6) follow-up (P>0.05). Conclusion Our preliminary study indicated this new device was technically feasible and effective to be used in thrombectomy for the treatment of acute thrombus occlusion in canine models.