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In Vitro Evaluation Of A Novel Prosthetic Vein Valve

Laura-Lee Farrell¹, Deepak Nair², Ross Milner², David Ku¹ ∙
¹Georgia Institute of Technology, Atlanta, GA; ²Emory University, Atlanta, GA

Objectives: Over seven million Americans suffer from chronic venous insufficiency, secondary to valvular dysfunction, with few effective clinical therapies. A biocompatible prosthetic vein valve has been designed that is anatomic and flexible. Previous bench top studies have shown that the valves perform well after long-term hemodynamic cycles. We evaluated the competency and thrombotic potential of the artificial venous valve. Methods: Prosthetic venous valves were constructed from a novel PVA hydrogel biomaterial at our institution. The valves had flexible cusps similar to normal, anatomic venous valves. Whole blood was perfused through the valves to mimic the pulsatile physiologic conditions. A manometer quantified the pressure for valve opening and competency. The flow rate was quantified by timed collections. Cessation of flow indicated thrombotic obstruction. A group of valves were lined with Dacron to serve as a positive control. Histological analysis was performed using H&E staining and Carstair’s stain (specific for platelets). Results: All valves exhibited good competency of over 100 mm Hg of backpressure. Whole blood perfused through each of five PVA prosthetic valves exhibited no thrombosis or platelet adherence. All PVA valves were patent and competent after blood perfusion. The valves produced an average flow rate of 11.8 ± 0.4 mL/min for greater than 20 minutes (Figure 1). H&E staining revealed no thrombus deposition on the PVA vein valves. In contrast, all the valves lined with Dacron occluded within 6 ± 3.6 min of perfusion (p<0.02). The Dacron valves were occluded by thrombus connecting the polymer fibers with adherent platelets identified by Carstair’s staining (Figure 2). Conclusions: A novel vein valve has been developed that demonstrates excellent patency, low thrombogenicity, and long-term competency with pre-clinical bench testing.