Abstract
BACKGROUND: Historically, single port valveless pneumatic blood pumps have had a high incidence of thrombus formation due to areas of blood stagnation and hemolysis due to areas of high shear stress. METHODS: To ensure minimal hemolysis and favorable blood washing characteristics, particle image velocimetry (PIV) and computational fluid dynamics (CFD) were used to evaluate the design of a new single port, valveless counterpulsation device (Symphony). The Symphony design was tested in 6-h acute (n=8), 5-day (n=8) and 30-day (n=2) chronic experiments in a calf model (Jersey, 76 kg). Venous blood samples were collected during acute (hourly) and chronic (weekly) time courses to analyze for temporal changes in biochemical markers and quantify plasma free hemoglobin. At the end of the study, animals were euthanized and the Symphony and end-organs (brain, liver, kidney, lungs, heart, and spleen) were examined for thrombus formations. RESULTS: Both the PIV and the CFD showed the development of a strong moving vortex during filling phase and that blood exited the Symphony uniformly from all areas during ejection phase. The laminar shear stresses estimated by CFD remained well below the hemolysis threshold of 400 Pa inside the Symphony throughout filling and ejection phases. No areas of persistent blood stagnation or flow separation were observed. The maximum plasma free hemoglobin (<10mg/dl), average platelet count (pre-implant = 473 ± 56 K/μl and post-implant = 331 ± 62 K/μl), and average hematocrit (pre-implant = 31 ± 2% and post-implant = 29 ± 2%) were normal at all measured time-points for each test animal in acute and chronic experiments. There were no changes in measures of hepatic function (ALP, ALT) or renal function (creatinine) from pre-Symphony implantation values. The necropsy examination showed no signs of thrombus formation in the Symphony or end organs. CONCLUSIONS: These data suggest that the designed Symphony has good washing characteristics without persistent areas of blood stagnation sites during the entire pump cycle, and has a low risk of hemolysis and thrombus formations.