In vitro evaluation of right ventricular outflow tract reconstruction with bicuspid valved polytetrafluoroethylene conduit.

Conduits available for right ventricular outflow tract (RVOT) reconstruction eventually become stenotic and/or insufficient due to calcification. In order to reduce the incidence of reoperations we have developed and used a bicuspid valved polytetrafluoroethylene (PTFE) conduit for the RVOT reconstruction. The purpose of this study is to investigate the hemodynamic performance of the new design using a pediatric in vitro right heart mock loop. PTFE conduit has been used for the complete biventricular repair of 20 patients (age 1.7±6 years) with cyanotic congenital defects. To account for the large variability of conduit sizes, 14, 16, 22, and 24-mm conduit sizes were evaluated using an in vitro flow loop comprised of a pulsatile pump with cardiac output (CO) of 1.2-3.2L/min, bicuspid valved RVOT conduit, pulmonary artery, venous compartments, and the flow visualization setup. We recorded the diastolic valve leakage and pre- and post-conduit pressures in static and pulsatile settings. In vitro valve function and overall hemodynamic performance was evaluated using high-speed cameras and ultrasonic flow probes. Three-dimensional flow fields for different in vivo conduit curvatures and inflow regimes were calculated by computational fluid dynamics (CFD) analysis to further aid the conduit design process. The average pressure drop over the valved conduits was 0.8±1.7mm Hg for the CO range tested. Typical values for regurgitant fraction, peak-to-peak pressure gradient, and effective office area were 23±2.1%, 13±2.4mm Hg, and 1.56±0.2 cm(2) , respectively. High-speed videos captured the intact valve motion with asymmetrical valve opening during the systole. CFD simulations demonstrated the flow skewness toward the major curvature of the conduit based on the pulmonic curvature. In vitro evaluation of the bicuspid valved PTFE conduit coincides well with acceptable early clinical performance (mild insufficiency), with relatively low pressure drop, and intact valve motion independent from the conduit curvature, orientation or valve location, but at the expense of increased diastolic flow regurgitation. These findings benchmark the baseline performance of the bicuspid valved conduit and will be used for future designs to improve valve competency.