Feasibility of a circulation model for the assessment of endovascular recanalization procedures and periprocedural thromboembolism in-vitro

Sci Rep. 2019 Nov 22;9(1):17356. doi: 10.1038/s41598-019-53607-2.

Abstract

Aim of this study was to establish a simple and highly reproducible physiological circulation model to investigate endovascular device performance. The developed circulation model included a pneumatically driven pulsatile pump to generate a flow rate of 2.7 L/min at 70 beats per minute. Sections from the superficial femoral arteries were used in order to simulate device/tissue interaction and a filter was integrated to analyze periinterventional thromboembolism of white, red and mixed thrombi. The working fluid (3 L) was a crystalloid solution constantly tempered at 36.5 °C. To evaluate the model, aspiration thrombectomy, stent-implantation and thrombectomy with the Fogarty catheter were performed. Usability of the model was measured by the System Usability Scale (SUS) - Score. Histological specimens were prepared and analyzed postinterventional to quantify tissue/device interaction. Moreover, micro- and macroembolism were evaluated for each thrombus entity and each device. Results were tested for normality using the D'Agostino-Pearson test. Statistical comparisons of two groups were performed using the Student's t-test. All devices were able to remove the occlusions after a maximum of 2 attempts. First-pass-recanalization was not fully achieved for aspiration thrombectomy of mixed thrombi (90.6%), aspiration thrombectomy of red thrombi (84.4%) and stent-implantation in occlusions of red thrombi (92.2%). Most micro- and macroembolism were observed using the Fogarty catheter and after stent-implantation in occlusions of white thrombi. Histological examinations revealed a significant reduction of the vascular layers suggesting vascular damage after use of the Fogarty catheter (327.3 ± 3.5 μm vs. 440.6 ± 3.9 μm; p = 0.026). Analysis of SUS rendered a mean SUS-Score of 80.4 which corresponds to an excellent user acceptability of the model. In conclusion, we describe a stable, easy to handle and reproducible physiological circulation model for the simulation of endovascular thrombectomy including device performance and thromboembolism.

Publication types

  • Evaluation Study

MeSH terms

  • Blood Circulation / physiology*
  • Catheterization* / adverse effects
  • Catheterization* / instrumentation
  • Catheterization* / methods
  • Endovascular Procedures* / adverse effects
  • Endovascular Procedures* / instrumentation
  • Endovascular Procedures* / methods
  • Feasibility Studies
  • Femoral Artery
  • Humans
  • In Vitro Techniques
  • Models, Cardiovascular*
  • Postoperative Complications / etiology
  • Postoperative Complications / pathology
  • Stents
  • Thrombectomy / adverse effects
  • Thrombectomy / instrumentation
  • Thrombectomy / methods
  • Thromboembolism / etiology
  • Thromboembolism / pathology
  • Thromboembolism / physiopathology
  • Thromboembolism / surgery
  • Thrombosis / etiology
  • Thrombosis / pathology*
  • Thrombosis / physiopathology
  • Thrombosis / surgery*