Computational design and experimental testing of a novel axial flow LVAD.

Thousands of cardiac failure patients per year in the United States could benefit from long-term mechanical circulatory support as destination therapy. To provide an improvement over currently available devices, we have designed a fully implantable axial-flow ventricular assist device with a magnetically levitated impeller (LEV-VAD). In contrast to currently available devices, the LEV-VAD has an unobstructed blood flow path and no secondary flow regions, generating substantially less retrograde and stagnant flow. The pump design included the extensive use of conventional pump design equations and computational fluid dynamics (CFD) modeling for predicting pressure-flow curves, hydraulic efficiencies, scalar fluid stress levels, exposure times to such stress, and axial fluid forces exerted on the impeller for the suspension design. Flow performance testing was completed on a plastic prototype of the LEV-VAD for comparison with the CFD predictions. Animal fit trials were completed to determine optimum pump location and cannulae configuration for future acute and long-term animal implantations, providing additional insight into the LEV-VAD configuration and implantability. Per the CFD results, the LEV-VAD produces 6 l/min and 100 mm Hg at a rotational speed of approximately 6300 rpm for steady flow conditions. The pressure-flow performance predictions demonstrated the VAD's ability to deliver adequate flow over physiologic pressures for reasonable rotational speeds with best efficiency points ranging from 25% to 30%. The CFD numerical estimations generally agree within 10% of the experimental measurements over the entire range of rotational speeds tested. Animal fit trials revealed that the LEV-VAD's size and configuration were adequate, requiring no alterations to cannulae configurations for future animal testing. These acceptable performance results for LEV-VAD design support proceeding with manufacturing of a prototype for extensive mock loop and initial acute animal testing.