Novel small-sized ePTFE valves for neonatal RVOT reconstruction: an in-vitro investigation

Small-sized right ventricle to pulmonary artery conduits are hindered by calcification, degeneration, or infective endocarditis and face limited availability. Valved conduits of expanded polytetrafluoroethylene leaflets offer a promising path toward enhanced longevity and performance. This in-vitro study introduces innovative expanded polytetrafluoroethylene valve designs for small-sized conduits.Three bicuspid and three tricuspid expanded polytetrafluoroethylene leaflets designed for size 12 mm were tested using an in-vitro pediatric right-heart mock-up loop and compared with our baseline leaflet design. Polyvinylchloride was used to create a transparent tube for visual access. Regurgitation rates, pressure gradients, effective orifice area under 0.5-3 L/min cardiac outputs, and 100-150beats/min heart rates are measured. Mechanical differences between expanded polytetrafluoroethylene and polyvinylchloride are investigated through biaxial strain tests. In newborn hemodynamic conditions, 0.5-1 L/min cardiac output, bileaflet valves demonstrated regurgitation rates below 20%, and two tricuspid models maintained regurgitation rates below 15% with gradients below 25 mmHg. In infant conditions, 1-3 L/min output, the regurgitation rates of trileaflet models were below 20%, with gradients consistently below 35 mmHg. The fully coapting bileaflet model showed a regurgitation rate of less than 15% and a gradient below 30 mmHg across newborn and infant conditions. A circumferential difference of less than 0.12 mm was detected between expanded polytetrafluoroethylene and polyvinylchloride. Both the fully coapting bileaflet and redundant trileaflet configurations can be integrated in the small conduits. Polyvinylchloride can be an alternative to expanded polytetrafluoroethylene tube graft in in-vitro studies, allowing visual access to assess leaflet kinematics.