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Biomaterial-Based Approaches to Address Vein Graft and Hemodialysis Access Failures
Timothy C Boire1, Daniel A Balikov1, Yunki Lee1
1Department of Biomedical Engineering, Vanderbilt University, 37235, Nashville, TN, USA.
Insights
External stents show promise in preventing vein graft and hemodialysis access failures caused by neointimal hyperplasia. Further research into biomaterial and drug-eluting approaches is crucial for clinical translation.
Area of Science:
- Biomaterials Science
- Vascular Surgery
- Medical Device Engineering
Background:
- Vein grafts and hemodialysis access points have high failure rates due to neointimal hyperplasia, leading to significant patient morbidity and mortality.
- Current surgical and systemic treatments for vein graft failure are often unsuccessful and costly.
- External stents have shown potential in preclinical models to reduce neointimal hyperplasia, but clinical translation remains a challenge.
Purpose of the Study:
- To review the current progress, design considerations, and future perspectives of biomaterial-based external stents for preventing vein graft and hemodialysis access failures.
- To highlight the need for more research to bridge the gap between animal model success and clinical application.
- To identify critical areas for future investigation, including biomaterial and drug-eluting approaches.
Main Methods:
- This review synthesizes findings from numerous studies on external stents and neointimal hyperplasia.
- It discusses design considerations for biomaterial-based external stents.
- It explores future perspectives and research needs in the field.
Main Results:
- External stents have demonstrated an ability to reduce neointimal hyperplasia in various studies.
- Despite promising results in animal models, no external stent is currently approved in the US for preventing vein graft or hemodialysis access failures.
- Significant knowledge gaps remain regarding the mechanistic understanding of external stent application in the arteriovenous environment.
Conclusions:
- Biomaterial-based external stents represent a promising localized solution for preventing vein graft and hemodialysis access failures.
- Iterative comparative studies modulating biomaterial and drug-eluting approaches are essential.
- Addressing mechanistic knowledge gaps is critical for developing viable clinical solutions and improving patient outcomes.
Abstract:
Veins used as grafts in heart bypass or as access points in hemodialysis exhibit high failure rates, thereby causing significant morbidity and mortality for patients. Interventional or revisional surgeries required to correct these failures have been met with limited success and exorbitant costs, particularly for the US Centers for Medicare & Medicaid Services. Vein stenosis or occlusion leading to failure is primarily the result of neointimal hyperplasia. Systemic therapies have achieved little long-term success, indicating the need for more localized, sustained, biomaterial-based solutions. Numerous studies have demonstrated the ability of external stents to reduce neointimal hyperplasia. However, successful results from animal models have failed to translate to the clinic thus far, and no external stent is currently approved for use in the US to prevent vein graft or hemodialysis access failures. This review discusses current progress in the field, design considerations, and future perspectives for biomaterial-based external stents. More comparative studies iteratively modulating biomaterial and biomaterial-drug approaches are critical in addressing mechanistic knowledge gaps associated with external stent application to the arteriovenous environment. Addressing these gaps will ultimately lead to more viable solutions that prevent vein graft and hemodialysis access failures.
