Clinical Research Assistant University of Miami Department of Neurosurgery Coral Gables, Florida, United States
Introduction: Endovascular mechanical thrombectomy represents the gold standard for treatment of large vessel occlusion and acute ischemic stroke. However, nearly one-fifth of thrombectomies fail due to tortuous vasculature and atherosclerotic arteries. Direct carotid access has been rarely utilized due to the lack of a vascular closure device (VCD) designed specifically for endovascular carotid closure.
Methods: In an attempt to develop a VCD for the carotid artery, we interviewed 30 endovascular neurosurgeons, vascular surgeons, interventional radiologists, and interventional cardiologists to develop a comprehensive list of design inputs. The inputs drove the development of 100 concepts, which were narrowed down using a comprehensive decision matrix. The prevailing design was developed into a high-fidelity prototype. Experiments were conducted on a bovine carotid artery, comparing our device to AngioSeal, evaluating the maximum pressure each device can withstand before leaking and the amount of volume each device leaked in 2 minutes. Mann-Whitney tests were conducted to evaluate differences between devices (IBM SPSS 28.0).
Results: The prototype design of the device consisted of a three-layer arrangement: a low-profile intravascular anchor, a self-guiding intravascular component, an extravascular collagen layer to mitigate any residual leakage, and a cap to create a tight seal. The prototype and AngioSeal were able to withstand pressures up to 131.8mmHg and 124.9mmHg, respectively, before leaking (p < 0.01) and leaked 0.29mL and 0.10mL in 2 minutes, respectively (p=0.22).
Conclusion : This study presents a design concept specific for endovascular closure of the carotid artery. Further work is needed to advance the design concept and to evaluate the safety and efficacy of the device in clinical practice.
