BACKGROUND: The primary objective was to modify the external geometry of a small blood pump that had previously underwent significant chronic animal testing via traditional invasive surgical deployment to a geometry with the same flow path that could be inserted into the vasculature with an intake in the inferior vena cava and an output at the pulmonary artery.
METHODS: A prototype delivery system was developed to deploy the pump system in an acute porcine study. The pump was inserted into the right heart through the caudal vena cava (CVC) after the vessel was surgically exposed through a right retroperitoneal approach. Fluoroscopy imaging was employed to position the pump in the vena cava with an outflow conduit extending across the tricuspid and pulmonic valves. The animals were euthanized and underwent necropsy and pump positioning was assessed.
RESULTS: The right heart mechanical circulatory support system was successfully deployed and fully functional in an acute porcine model. Average pump flow was 3.6 L/min. Necropsy confirmed pump and outflow conduit positioning, albeit the outflow conduit was inserted up to the branching of right and left pulmonary arteries.
CONCLUSIONS: The pump that was designed for chronic circulatory support was successfully transformed to an 8 mm OD device without compromising device performance, and shown to be deployable in the right heart support configuration in an acute porcine model.
