Evaluation of prosthetic venous valves, fabricated by electrospinning, for percutaneous treatment of chronic venous insufficiency

Chronic venous insufficiency (CVI) remains a major health problem worldwide. Direct venous valve surgical repair and venous segment transplantation are clinical options; however, they are highly invasive procedures. The objectives of this study were to fabricate prosthetic venous valves (PVVs) by electrospinning, for percutaneous treatment of CVI, and evaluate their hydrodynamic characteristics in vitro at the same locations and under the same flow conditions. The PVVs consisted of polyurethane fiber scaffolds attached to a cobalt–chromium stent. PVVs with two different valve-leaflet configurations were compared: biomimetic PVV (bPVV) and open PVV (oPVV). A balloon catheter was used to implant the devices in a poly(vinyl chloride) tube and the column outlet was set at a height of 100 cm above the test valve to simulate the elevation of the heart above a distal vein valve while standing; 50 wt% glycerin solution was used as the test fluid. The devices were evaluated for antegrade flow, effect of ankle flexion, and stagnation zones around the valve leaflets. During sudden hydrostatic backpressure, little leakage and constant peripheral pressure were observed for the devices; under forward pulsatile pressure of 0–4 mmHg, to simulate the effect of breathing, the oPVV had a higher flow rate than the bPVV. With regard to the effect of ankle flexion, the oPVV was functionless. Moreover, the stagnation zone around the oPVV valve leaflets was larger than that around the bPVV valve leaflets. These results suggest that the bPVV would be clinically suitable for percutaneous treatment of CVI.