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在尸体和体外血栓切除术模型中对 Millipede 088 颅内抽吸导管的临床前评估。

Preclinical evaluation of Millipede 088 intracranial aspiration catheter in cadaver and in vitro thrombectomy models.

机构信息

Department of Physiology, National University of Ireland Galway, Galway, Ireland

Department of Mechanical Engineering, National University of Ireland Galway, Galway, Ireland.

出版信息

J Neurointerv Surg. 2021 May;13(5):447-452. doi: 10.1136/neurintsurg-2020-016218. Epub 2020 Jun 30.

DOI:10.1136/neurintsurg-2020-016218
PMID:32606100
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8053321/
Abstract

BACKGROUND

Larger bore aspiration catheters are expected to significantly improve the speed and completeness of acute stroke revascularization.

OBJECTIVE

To evaluate the navigability and clot retrieval performance of a novel 8Fr aspiration catheter, Millipede 088 (Perfuze Ltd), using fresh-frozen cadavers and an in vitro thrombectomy model, respectively.

METHODS

Transfemoral catheterization of the intracranial arteries was performed in six cadavers, allowing evaluation of navigation to 12 middle cerebral arteries (MCAs) and six basilar arteries. Commercially available 6Fr aspiration catheters (SOFIA Plus, Microvention) were used as controls. Three human blood clot phenotypes were created; red blood cell-rich, mixed, and fibrin/platelets-rich. Two clot sizes, resulting in occlusion of the internal carotid artery (ICA) and MCA-M1 were investigated. Endpoints were first-pass effect (FPE), first-pass complete ingestion, and second-pass recanalization.

RESULTS

Both the Millipede 088 and SOFIA Plus devices reached the distal MCA-M1 and the basilar artery in 10/12 and 2/2 of the navigation attempts, respectively. In the two instances of unsuccessful navigation, neither device was able to cross the ophthalmic artery. In 10 mm long M1 occlusions, Millipede 088 achieved 100% FPE versus 40% for 6Fr devices (p>0.001). In 20 mm long ICA occlusions, Millipede 088 achieved 100% removal success within two passes in each clot phenotype compared with an average of 27% for 6Fr devices (p>0.001).

CONCLUSIONS

Navigation of the Millipede 088 catheter to the MCA-M1 and basilar artery is feasible in a cadaver model. Millipede 088 demonstrates superiority over 6Fr aspiration catheters for three representative clot phenotypes at the most common sites of occlusion in an in vitro vasculature model.

摘要

背景

较大口径的抽吸导管有望显著提高急性脑卒中血管再通的速度和完全性。

目的

分别使用新鲜冷冻尸体和体外血栓切除术模型评估新型 8Fr 抽吸导管(Perfuze Ltd 的 Millipede 088)的可导航性和血栓清除性能。

方法

对 6 具尸体进行经股动脉入颅动脉置管术,以评估对 12 条大脑中动脉(MCA)和 6 条基底动脉的导航能力。将商业上可获得的 6Fr 抽吸导管(SOFIA Plus,Microvention)用作对照。创建了三种人类血栓表型;富含红细胞、混合和富含纤维蛋白/血小板。研究了两种导致颈内动脉(ICA)和 MCA-M1 闭塞的血栓大小。终点为首次通过效应(FPE)、首次通过完全摄入和第二次通过再通。

结果

Millipede 088 和 SOFIA Plus 装置均成功到达 12 次导航尝试中的远端 MCA-M1 和基底动脉,成功率分别为 10/12 和 2/2。在 2 次不成功的导航尝试中,两种装置均无法穿过眼动脉。在 10mm 长的 M1 闭塞中,Millipede 088 实现了 100%的 FPE,而 6Fr 装置为 40%(p>0.001)。在 20mm 长的 ICA 闭塞中,Millipede 088 在每种血栓表型中均能在两次通过内实现 100%的清除成功,而 6Fr 装置的平均清除成功率为 27%(p>0.001)。

结论

在尸体模型中,Millipede 088 导管可到达 MCA-M1 和基底动脉,具有可导航性。在体外血管模型中,最常见的闭塞部位,Millipede 088 导管在三种代表性血栓表型上的表现优于 6Fr 抽吸导管。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e15/8053321/014a5bf2891a/neurintsurg-2020-016218f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e15/8053321/69841254a595/neurintsurg-2020-016218f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e15/8053321/014a5bf2891a/neurintsurg-2020-016218f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e15/8053321/69841254a595/neurintsurg-2020-016218f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e15/8053321/014a5bf2891a/neurintsurg-2020-016218f02.jpg

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