Design and Preliminary Testing of a Quadleaflet ePTFE Pediatric Prosthetic Heart Valve

In the United States, congenital heart defects affect nearly 40,000 births each year and often will require heart valve replacement [1]. Viable prosthetic heart valve options are limited for pediatric patients that need a valve smaller than 16mm in diameter. When commercially available valve sizes are not available, surgeons often handcraft a valve using expanded polytetrafluoroethylene (ePTFE) to fabricate a valve that is small enough to meet the size constraints of young pediatric patients. There is limited published hemodynamic data for ePTFE valves. A comparison between the two ePTFE handmade valves (trileaflet and quadleaflet) demonstrated hemodynamic differences in regurgitation due to leaflet number. The handmade valves both showed increased regurgitation compared to a Carbomedics valve (commercially available design). Regurgitation had varying effects on pressure gradients and cardiac output. The aim of this paper is to: 1) showcase the design process of a quadleaflet ePTFE valved conduit with a diameter of 16mm or less and 2) offer a hemodynamic performance comparison.