Introduction Endovascular thrombectomies have proven to be standard of care for treating acute ischemic strokes. However, nearly one-fifth of thrombectomies fail due to tortuous vasculature and altered anatomy. Direct carotid access has been rarely adopted due to the lack of a vascular closure device (VCD) designed specifically for the carotid artery. Here, we detail the shortcomings of current VCDs and propose the requirements necessary to design and develop a percutaneous carotid closure device (CCD).
Methods An engineering design analysis was conducted following a process of defining a clinical problem, identifying user needs, and creating design inputs. A PubMed literature search on current VCDs was conducted from inception to January 2023 to understand shortcomings associated with VCDs. We interviewed 30 clinical specialists including 23 neuro-interventionalists, 4 interventional cardiologists, and 3 interventional radiologists from 8 institutions within the US to determine the user needs for addressing the shortcomings of current VCDs. These user needs were divided into four distinct categories: 1) critical engineering requirements, 2) device characteristics, 3) materials, and 4) human factors. The results from the literature review and user interviews were analyzed and classified according to these 4 categories of user needs.
Results Critical engineering requirements included the ability to achieve rapid hemostasis while avoiding punctures in the carotid wall and reducing the risk of thromboembolic complications. Device characteristics included limiting the distal length of the device to prevent crossing the carotid bifurcation, maintaining compatibility with existing 6-8F sheaths, and maintenance of vascular access through 0.014-inch microwire. The materials included intra- and extravascular components. Intravascularly, components must be rigid, low-profile, and non-thrombogenic, such as poly-lactic-acid (PLA). The main requirement for extravascular components was thrombogenicity to promote rapid hemostasis; collagen was noted as the most widely used material. Additionally, a rigid PLA component with ability to couple the extravascular collagen was deemed necessary to prevent displacement to the intravascular space. Lastly, human factors are needed to incorporate tactile and visual feedback mechanisms for the user.
Conclusion A thorough engineering design analysis of the current VCDs is necessary for development of a safe and effective CCD. Based on this study, an ideal percutaneous CCD should have: 1) a rigid, low-profile, non-thrombogenic intravascular anchor; 2) a thrombogenic, extravascular plug to promote rapid hemostasis; and 3) a rigid extravascular component to secure the extravascular plug in place. Further studies are needed to evaluate the efficacy of these requirements through the development of a safe and effective CCD.
Disclosures S. Bhatia: None. J. Cruz: None. N. Lima: None. D. Prusener: None. G. Riccobono: None. R. Tawk: 4; C; Medtronic.
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