Biomaterial characterization of off-the-shelf decellularized porcine pericardial tissue for use in prosthetic valvular applications

Abstract

Fixed pericardial tissue is commonly used for commercially available xenograft valve implants, and has proven durability, but lacks the capability to remodel and grow. Decellularized porcine pericardial tissue has the promise to outperform fixed tissue and remodel, but the decellularization process has been shown to damage the collagen structure and reduce mechanical integrity of the tissue. Therefore, a comparison of uniaxial tensile properties was performed on decellularized, decellularized‐sterilized, fixed, and native porcine pericardial tissue, versus native valve leaflet cusps. The results of non‐parametric analysis showed statistically significant differences (p0.05). SEM confirmed that valvular endothelial and interstitial cells colonized the decellularized pericardial surface when seeded and grown for 30 days in static culture. Collagen assays and TEM analysis showed limited reductions in collagen with processing; yet, GAG assays showed great reductions in the processed pericardium relative to native cusps. Decellularized pericardium had comparatively lower mechanical properties amongst the groups studied; yet, the stiffness was comparatively similar to the native cusps and demonstrated a lack of cytotoxicity. Suture retention, accelerated wear, and hydrodynamic testing of prototype decellularized and decell‐sterilized valves showed positive functionality. Sterilized tissue could mimic valvular mechanical environment in vitro, therefore making it a viable potential candidate for off‐the‐shelf tissue engineered valvular applications. KEYTERMS Decellularization, Sterilization, Pericardial Tissue, Heart Valves, Tissue Engineering, Biomechanics