We propose the development of a novel compliant-silicone impeller-based rotating thrombectomy tool for improving the safety and efficacy of dialysis access. Hemodialysis requires functional vascular access facilitated by hemodialysis fistulas, which are a surgically created communication between the native artery and vein in an extremity. The creation and maintenance of a well-functioning dialysis vascular access remains a major contributor to morbidity and mortality in patients with end stage renal disease. The cost of vascular access care is high among patients with arteriovenous fistula (AVF) thrombosis and highest for patients selected for central venous catheterization. In a retrospective study, it was observed that salvaging thrombosed AVFs by percutaneous thrombectomy is a safe and cost-effective policy; and therefore, recommended that intensive efforts should be undertaken to universalize these procedures. There exists great enthusiasm for percutaneous dialysis access interventions to resolve thrombosis symptoms. Thrombectomy devices on the market have high costs and are not optimized for fistula and graft treatment. The proposed project explores a novel tool to remove thrombotic material that we hypothesize will result in safer and more effective dialysis access interventional procedures and improved long-term patient outcomes. A prototype device will be developed and evaluated.
The proposed project relates to the development of tools to maintain vascular access for dialysis. The creation and maintenance of a well-functioning dialysis vascular access remains a major contributor to the morbidity and mortality seen in patients with end stage renal disease (ESRD). In 2012, the USRDS data documents that there were 368,000 Medicare dependents on dialysis in the US. From Medicare data, it has also been estimated that vascular access dysfunction is responsible for 20% of all hospitalizations in the hemodialysis population. Expenditures on dialysis on dialysis vascular access contribute $2.5 billion annually to the ESRD patient costs.
