Flexible mechanoprosthesis made from woven ultra-high-molecular-weight polyethylene fibres: proof of concept in a chronic sheep model

Abstract

OBJECTIVES: Ultra-high-molecular-weight polyethylene (UHMWPE) fibres are flexible, have high tensile strength, and platelet and bacterial adhesion is low. Therefore, UHMWPE may overcome limitations of current mechanical valves and bioprostheses. In this study, the biocompatibility and functionality of prototype handmade stented valves from woven UHMWPE (U-valve) was assessed in a chronic sheep model with acetylsalicylic acid monotherapy. METHODS: Native pulmonary valves of 23 sheep were replaced by U-valves (n = 18) or Perimount bovine bioprostheses (reference group, n = 5). Sheep received 80 mg of acetylsalicylic acid daily. Follow-up was conducted at 1 week (n = 4), 1 month (n = 5), 3 months (n = 5) and 6 months (n = 4) in the U-valve group and at 3 months (n = 2) and 6 months (n = 3) in the reference group. Epicardial echocardiography and histology were used to assess valve function and tissue deposition, respectively. RESULTS: Seventeen U-valve sheep (94%) and 3 reference sheep (60%) survived the perioperative period. One reference valve sheep was sacrificed after 4 months because of congestive heart failure. At explantation, all U-valves were intact without leaflet tearing. Up to 3 months, U-valves were flexible and free of stenosis. Regurgitation was mostly mild though gradually increasing; histology showed minimal connective tissue near the leaflet base and sparse calcification. At 6 months, connective tissue was diffusely observed on the leaflets with retraction and consecutive regurgitation and leaflet thickening. CONCLUSIONS: Valves made from UHMWPE fibres demonstrated early feasibility in the pulmonary valve position with reasonably good haemodynamics and intact valve materials up to 6 months. Gradual leaflet thickening and retraction were observed after 3 months due to connective tissue overgrowth.