Two-day control of pulmonary blood flow with an adjustable systemic-pulmonary artery shunt.

Our laboratory has developed an adjustable systemic-pulmonary artery shunt (AS) to provide improved control of pulmonary blood flow (PBF) after neonatal palliation of hypoplastic left heart syndrome (HLHS). Six piglets of 6-10 kg underwent left thoracotomy and placement of a 3.5 mm polytetrafluoroethylene (PTFE) shunt from the left subclavian artery to the left pulmonary artery (LPA). The LPA was ligated at its origin. An AS was placed on the PTFE graft after both anastomoses had been performed. A flow probe was placed on the LPA distal to the shunt insertion. The AS was adjusted every 2 hours (0.1 mm increments over 18 minutes) from fully open to an estimated 60% flow reduction throughout the 44-hour test period, similar to delayed sternal closure (DSC). At any shunt setting, standard deviations of normalized blood flow in each piglet were ranged from 1.34% to 8.05% indicating consistent and stable relationship between shunt setting and flow over the DSC. These data lend strong evidence that the device would perform successfully in a human infant during the DSC. Clinical trials are necessary to determine whether mechanical control of PBF results in improved clinical outcomes.