Small patients – Big needs: A material-based approach to develop miniaturised valves for congenital heart diseases

This study presents the development of a miniaturized polymer–protein hybrid valve specifically designed for the mechanical and anatomical requirements of infants with congenital heart diseases such as hypoplastic left heart syndrome (HLHS). The authors engineered a thin electrospun thermoplastic polyurethane (TPU) scaffold coated with an elastin-like recombinamer (ELR) to enhance hemocompatibility, reduce inflammatory activation, and improve endothelialization potential. The coated scaffold was mounted into a nitinol stent and formed into a three-leaflet construct optimized for small-diameter hydrodynamics. Mechanical tensile tests, suture retention analyses, cyclic fatigue testing, hydrodynamic performance assessment, platelet adhesion assays, and burst-pressure characterization demonstrated that the ELR-coated TPU scaffold achieved the strength, durability, and compliance needed for short-term implantation in pediatric circulatory environments. The results highlight a promising materials-driven pathway for the production of catheter-deliverable pediatric valves using scalable manufacturing techniques.