Maximum Euclidean Deflection: A Novel Metric For Safety Of Neurovascular Devices In An In-vitro Stroke Model
Shashvat Desai1, Joshua Catapano3, Neil Majmundar4, Angelina Cooper2, Roxanne Flynn2, Loren Jones2, Andrew Ducruet4, Ashutosh Jadhav4
1Neurology, HonorHealth Research Institute, 2HonorHealth Research Institute, 3Neurosurgery, Barrow Neurological Institute, 4Barrow Neurological Institute
Objective:
To enable effective comparative analyses, there is a need to develop an objective in-vitro safety metric for new endovascular thrombectomy devices. 
Background:

Endovascular thrombectomy (EVT) devices are evolving rapidly to improve safety and efficacy of EVT-mediated recanalization of large vessel occlusion strokes, and to access medium and distal vessel occlusions.  

Design/Methods:

We utilized three FDA-approved stent-retrievers (4mm diameter; variable lengths) and deployed them in an in-vitro ischemic stroke bench model (Sim Agility, Mentice Inc., Sweden). The stent-retrievers were deployed in the M1 segment of the middle cerebral artery of the model using a system comprised of an 0.014inch guide wire and 0.021inch microcatheter. After unsheathing in the M1 segment, in the absence of a blood clot, the microcatheter was withdrawn back into the petrous internal carotid artery, and the whole system was withdrawn at a rate of 5mm/second. Maximum deflection of the terminal internal carotid was measured in 3 axes using a specialized camera set-up.

Results:

A total of 3 passes were performed for each stent-retriever (stent-A, stent-B, and stent-C). Maximum deflection of the terminal internal carotid artery (from resting position to largest displacement during stent-retrieval withdrawal) was measured in 3 planes (Table)-

 

Maximum deflection of the internal carotid artery terminus from baseline (mm)

Coronal plane (Supero-inferior)

Coronal plane (Medio-lateral)

Sagittal plane (Antero-posterior)

Euclidean deflection

Stent-A

8mm

3mm

3mm

9.1mm

Stent-B

6mm

2mm

2mm

6.6mm

Stent-C

8mm

3mm

3mm

9.1mm

Maximum Euclidean Deflection (MED) ranged from 6.1 to 9.1mm. Deflection varied based on 3 stent-retriever designs and the plane of measurement. Figure demonstrates deflections as seen in Stent-A.

 
Conclusions:

Withdrawing an unsheathed stent-retriever from the middle cerebral artery leads to significant deflection of the internal carotid artery terminus in an in-vitro stroke model. The degree of deflection varies based on stent-retriever design. Further studies are required to examine predictors and impact of the deflection.

10.1212/WNL.0000000000203866