Passive performance evaluation and validation of a viscous impeller pump for subpulmonary fontan circulatory support.

Patients with single ventricle defects undergoing the Fontan procedure eventually face Fontan failure. Long-term cavopulmonary assist devices using rotary pump technologies are currently being developed as a subpulmonary power source to prevent and treat Fontan failure. Low hydraulic resistance is a critical safety requirement in the event of pump failure (0 RPM) as a modest 2 mmHg cavopulmonary pressure drop can compromise patient hemodynamics. The goal of this study is therefore to assess the passive performance of a viscous impeller pump (VIP) we are developing for Fontan patients, and validate flow simulations against in-vitro data. Two different blade heights (1.09 mm vs 1.62 mm) and a blank housing model were tested using a mock circulatory loop (MCL) with cardiac output ranging from 3 to 11 L/min. Three-dimensional flow simulations were performed and compared against MCL data. In-silico and MCL results demonstrated a pressure drop of < 2 mmHg at a cardiac output of 7 L/min for both blade heights. There was good agreement between simulation and MCL results for pressure loss (mean difference - 0.23 mmHg 95% CI [0.24-0.71]). Compared to the blank housing model, low wall shear stress area and oscillatory shear index on the pump surface were low, and mean washout times were within 2 s. This study demonstrated the low resistance characteristic of current VIP designs in the failed condition that results in clinically acceptable minimal pressure loss without increased washout time as compared to a blank housing model under normal cardiac output in Fontan patients.

Passive Performance Evaluation and Validation of a Viscous Impeller Pump for Subpulmonary Fontan Circulatory Support.

Patients with single ventricle defects undergoing the Fontan procedure eventually face Fontan failure. Long-term cavopulmonary assist devices using rotary pump technologies are currently being developed as a subpulmonary power source to prevent and treat Fontan failure. Low hydraulic resistance is a critical safety requirement in the event of pump failure (0 RPM) as a modest 2 mmHg cavopulmonary pressure drop can compromise patient hemodynamics. The goal of this study is therefore to assess the passive performance for a viscous impeller pump (VIP) we are developing for Fontan patients, and validate flow simulations against in-vitro data. Two different blade heights (1.09 mm vs 1.62 mm) and a blank housing model were tested using a mock circulatory loop (MCL) with cardiac output ranging from 3 to 11 L/min. Three-dimensional flow simulations were performed and compared against MCL data. In-silico and MCL results demonstrated a clinically insignificant pressure drop of $<$ 2 mmHg at a cardiac output of 7 L/min for both blade heights. There was good agreement between simulation and MCL results for pressure loss (mean difference -0.23 mmHg 95% CI [0.24 -0.71]). Compared to the blank housing model, low wall shear stress area and oscillatory shear index on the pump surface were low, and mean washout times were within 2 seconds. This study demonstrated the low resistance characteristic of current VIP designs in the failed condition that results in clinically acceptable minimal pressure loss with low risk of thrombosis.

In Vitro Assessment of the Assisted Bidirectional Glenn Procedure for Stage One Single Ventricle Repair.

This in vitro study compares the hemodynamic performance of the Norwood and the Glenn circulations to assess the performance of a novel assisted bidirectional Glenn (ABG) procedure for stage one single ventricle surgery. In the ABG, the flow in a bidirectional Glenn procedure is assisted by injection of a high-energy flow stream from the systemic circulation using an aorta-caval shunt with nozzle. The aim is to explore experimentally the potential of the ABG as a surgical alternative to current surgical practice. The experiments are directly compared against previously published numerical simulations. A multiscale mock circulatory system was used to measure the hemodynamic performance of the three circulations. For each circulation, the system was tested using both low and high values of pulmonary vascular resistance. Resulting parameters measured were: pressure and flow rate at left/right pulmonary artery and superior vena cava (SVC). Systemic oxygen delivery (OD) was calculated. A parametric study of the ratio of ABG nozzle to shunt diameter was done. We report time-based comparisons with numerical simulations for the three surgical variants tested. The ABG circulation demonstrated an increase of 30-38% in pulmonary flow with a 2-3.7 mmHg increase in SVC pressure compared to the Glenn and a 4-14% higher systemic OD than either the Norwood or the Glenn. The nozzle/shunt diameter ratio affected the local hemodynamics. These experimental results agreed with those of the numerical model: mean flow values were not significantly different (p > 0.05) while mean pressures were comparable within 1.2 mmHg. The results verify the approaches providing two tools to study this complicated circulation. Using a realistic experimental model we demonstrate the performance of a novel surgical procedure with potential to improve patient hemodynamics in early palliation of the univentricular circulation.