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E-080 Preclinical Evaluation of Mechanical Thrombectomy Devices in a Swine Clot Model
  1. L Bailey1,
  2. M Gilvarry2,
  3. M Holian2,
  4. A Tzafriri1,
  5. J Stanley3,
  6. E Edelman4
  1. 1Applied Sciences, CBSET, Lexington, MA
  2. 2Neuravi Ltd., Galway, Ireland
  3. 3Pathology, CBSET, Lexington, MA
  4. 4IMES MIT, Cambridge, MA

Abstract

Background Successful recanalization (TICI ≥ 2b) using mechanical thrombectomy (MT) with stent retriever devices is associated with good outcomes in the treatment of ischemic stroke. Preclinical TICI flow assessement is challenging due to the difficulty of consistently occluding selected blood vessels in vivo using lab-created thrombus. We describe the development of a discrete occlusive porcine clot model for predictable and repeatable assessment of TICI flow restoration and treatment effects on the vessels at the 3 day and 28 day timepoints and following MT.

Methods Firm and soft thrombus were aged for 24–48 hours prior to injection into the peripheral arteries of eight Yorkshire pigs. Oversized clots were introduced to the target region through a guide catheter via a customized luer to minimize shear/fragmentation. Clots were allowed to stabilize in the vessel prior to treatment. Clot retrieval was performed with a novel Revascularization Device (Neuravi Ltd.) or Trevo® ProVue Retriever (Stryker Inc.) as a control. TICI flow was assessed following clot administration and after thrombectomy. Vascular response to the treatment was assessed histologically at 3 and 28 days.

Results Complete occlusion was achieved in 92% (22/24) of the targeted arteries by insertion of one (20/22) or two (2/22) pre-measured clots. Of the occluded arteries treated, TICI 3 flow restoration was achieved in all cases (100%) with the Neuravi device and 90% cases with Trevo; single pass recanalization (TICI ≥ 2b) rates were 92% and 80% respectively. All vessels were patent at 3 and 28 days post treatment, and histologically the prototype Neuravi revascularization device was associated with favorable local and end organ tissue responses, and was comparable to the Trevo ProVue.

Conclusions Novel methods were developed to provide consistent thrombus morphology enabling controlled delivery and adherence and facilitating comparative analysis of thrombectomy devices using angiographic (TICI) flow assessment in the preclinical swine model. Angiographic assessments and vessel response to treatment by Mechanical Thrombectomy were successfully completed following occlusion with firm and soft thrombus administration.

Disclosures L. Bailey: 1; C; Neuravi Ltd. M. Gilvarry: 5; C; Neuravi Ltd. M. Holian: 5; C; Neuravi Ltd. A. Tzafriri: 1; C; Neuravi Ltd. J. Stanley: 1; C; Neuravi Ltd. E. Edelman: None.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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