Evaluation of hemolysis in the VentrAssist implantable rotary blood pump

The VentrAssist implantable rotary blood pump (IRBP) is an implantable centrifugal blood pump with a hydrodynamically suspended impeller; optimal efficiency requires small running clearances (70-300 microm). The effect of running clearance and polish on hemolysis was evaluated in vitro. Three different human blood suspensions were compared: phosphate buffered saline (PBS), plasma volume expander (Hemaccel), and whole blood. The test conditions were: blood hematocrit 30%, flow rate 5 L/min, pressure across pump 100 mm Hg, 6 h flow period, and 37 degrees C. Normalized Index of Hemolysis (NIH) for the Biomedicus BP-80, used as a control, was: 0.0040 +/- 0.0023 (n = 9; x +/- SD) and 0.00014 +/- 0.00009 (n = 5) for pooled blood suspensions in PBS and Hemaccel respectively, and 0.00053 +/- 0.0002 (n = 3) in whole blood. Hemolysis was reduced by improved surface finish and unaffected by running clearance. NIH for the VentrAssist IRBP with 0.2 microm Ra surface finish was 0.000167 +/- 0.00007 (n = 4) g/100 L in whole human blood, demonstrating minimal hemolysis.