This study explores a quantitative evaluation of blood damage that occurs in a continuous flow left ventricular assist device due to fluid stress. Computational fluid dynamics (CFD) analysis is used to track the shear stress history of 388 particle streaklines. The accumulation of shear and exposure time is integrated along the streaklines to evaluate the levels of blood trauma. This analysis, which includes viscous and turbulent stresses, provides a statistical estimate of possible damage to cells flowing through the pump. In vitro normalized index of hemolysis values for clinically available ventricular assist devices were compared to our damage indices. This allowed for an order of magnitude comparison between our estimations and experimentally measured hemolysis levels, which resulted in a reasonable correlation. This work ultimately demonstrates that CFD is a convenient and effective approach to analyze the Lagranian behavior of blood in a heart assist device.
This study explores a quantitative evaluation of blood damage that occurs in a continuous flow left ventricular assist device (LVAD) due to fluid stress. Computational fluid dynamics (CFD) analysis is used to track the shear stress history of 388 particle streaklines. The accumulation of shear and exposure time is integrated along the streaklines to evaluate the levels of blood trauma. This analysis, which includes viscous and turbulent stresses, provides a statistical estimate of possible damage to cells flowing through the pump. Since experimental data for hemolysis levels in our LVAD are not available, in vitro normalized index of hemolysis values for clinically available ventricular assist devices were compared to our damage indices. This approach allowed for an order of magnitude comparison between our estimations and experimentally measured hemolysis levels, which resulted in a reasonable correlation. This work ultimately demonstrates that CFD is a convenient and effective approach to analyze the Lagrangian behavior of blood in a heart assist device.
Mechanical circulatory support is gaining increased recognition as a viable treatment option for pediatric patients who suffer from congenital or acquired heart disease. Historically, the treatment options have been very limited for pediatric patients, but recent technological advances, combined with new research into circulatory support devices, are seeking alternative therapeutics options for infants and children. We present a review of the technological advances of mechanical circulatory support in the pediatric population, including the recent emergence of a new class of circulatory support devices for pediatric patients with single ventricle physiology. The National Heart, Lung, and Blood Institute pediatric circulatory support program is discussed, in addition to the use of adult devices in pediatric applications, the Berlin Heart Excor, and several other blood pumps in development for bridge-to-transplant and bridge-to-recovery support. These devices have the potential to generate a paradigm shift in the treatment of the pediatric patients with heart failure--a shift is likely already be underway.
The use of mechanical circulatory support (MCS) devices is a viable therapeutic treatment option for patients with congestive heart failure. Ventricular assist devices, cavopulmonary assist devices, and total artificial heart pumps continue to gain acceptance as viable treatment strategies for both adults and pediatric patients as bridge-to-transplant, bridge-to-recovery, and longer-term circulatory support alternatives. We present a review of the current and future MCS devices for patients having congenital heart disease (CHD) with biventricular or univentricular circulations. Several devices that are specifically designed for patients with complex CHD are in the development pipeline undergoing rigorous animal testing as readiness experiments in preparation for future clinical trials. These advances in the development of new blood pumps for patients with CHD will address a significant unmet clinical need, as well as generally improve innovation of the current state of the art in MCS technology.
Mechanical circulatory support options for infants and children are very limited in the United States. Existing circulatory support systems have proven successful for short-term pediatric assist, but are not completely successful as a bridge-to-transplant or bridge-to-recovery. To address this substantial need for alternative pediatric mechanical assist, we are developing a novel, magnetically levitated, axial flow pediatric ventricular assist device (PVAD) intended for longer-term ventricular support. Three major numerical design and optimization phases have been completed. A prototype was built based on the latest numerical design (PVAD3) and hydraulically tested in a flow loop. The plastic PVAD prototype delivered 0.5-4 lpm, generating pressure rises of 50-115 mm Hg for operating speeds of 6,000-9,000 rpm. The experimental testing data and the numerical predictions correlated well. The error between these sets of data was found to be generally 7.8% with a maximum deviation of 24% at higher flow rates. The axial fluid forces for the numerical simulations ranged from 0.5 to 1 N and deviated from the experimental results by generally 8.5% with a maximum deviation of 12% at higher flow rates. These hydraulic results demonstrate the excellent performance of the PVAD3 and illustrate the achievement of the design objectives.
Clinical studies using total artificial hearts (TAHs) have demonstrated that pediatric and adult patients derive quality-of-life benefits from this form of therapy. Two clinically-approved TAHs and other pumps under development, however, have design challenges and limitations, including thromboembolic events, neurologic impairment, infection risk due to large size and percutaneous drivelines, and lack of ambulation, to name a few. To address these limitations, we are developing a hybrid-design, continuous-flow, implantable or extracorporeal, magnetically-levitated TAH for pediatric and adult patients with heart failure. This TAH has only two moving parts: an axial impeller for the pulmonary circulation and a centrifugal impeller for the systemic circulation. This device will utilize the latest generation of magnetic bearing technology. Initial geometries were established using pump design equations, and computational modeling provided insight into pump performance. The designs were the basis for prototype manufacturing and hydraulic testing. The study results demonstrate that the TAH is capable of delivering target blood flow rates of 1-6.5 L/min with pressure rises of 1-92 mm Hg for the pulmonary circulation and 24-150 mm Hg for the systemic circulation at 1500-10 000 rpm. This initial design of the TAH was successful and serves as the foundation to continue its development as a novel, more compact, nonthrombogenic, and effective therapeutic alternative for infants, children, adolescents, and adults with heart failure.
This study investigated the performance of a magnetically levitated, intravascular axial flow blood pump for mechanical circulatory support of the thousands of Fontan patients in desperate need of a therapeutic alternative. Four models of the extracardiac, total cavopulmonary connection (TCPC) Fontan configuration were evaluated to formulate numerical predictions: an idealized TCPC, a patient-specific TCPC per magnetic resonance imaging data, and each of these two models having a blood pump in the inferior vena cava (IVC). A lumped parameter model of the Fontan physiology was used to specify boundary conditions. Pressure-flow characteristics, energy gain calculations, scalar stress levels, and blood damage estimations were executed for each model. Suction limitation experiments using the Sylgard elastomer tubing were also conducted. The pump produced pressures of 1-16 mm Hg for 2000-6000 rpm and flow rates of 0.5-4.5 L/min. The pump inlet or IVC pressure was found to decrease at higher rotational speeds. Maximum scalar stress estimations were 3 Pa for the nonpump models and 290 Pa for the pump-supported cases. The blood residence times for the pump-supported cases were shorter (0.9 s) as compared with the nonsupported configurations (2.5 s). However, the blood damage indices were higher (1.5%) for the anatomic model with pump support. The pump successfully augmented pressure in the TCPC junction and increased the hydraulic energy of the TCPC as a function of flow rate and rotational speed. The suction experiments revealed minimal deformation (<3%) at 9000 rpm. The findings of this study support the continued design and development of this blood pump.
Currently available mechanical circulatory support systems are limited for adolescent and adult patients with a Fontan physiology. To address this growing need, we are developing a collapsible, percutaneously-inserted, axial flow blood pump to support the cavopulmonary circulation in Fontan patients. During the first phase of development, the design and experimental evaluation of an axial flow blood pump was performed. We completed numerical modeling of the pump using computational fluid dynamics analysis, hydraulic testing of a plastic pump prototype, and blood bag experiments (n=7) to measure the levels of hemolysis produced by the pump. Statistical analyses using regression were performed. The prototype with a 4-bladed impeller generated a pressure rise of 2-30 mmHg with a flow rate of 0.5-4 L/min for 3000-6000 RPM. A comparison of the experimental performance data to the numerical predictions demonstrated an excellent agreement with a maximum deviation being less than 6%. A linear increase in the plasma-free hemoglobin (pfHb) levels during the 6-h experiments was found, as desired. The maximum pfHb level was measured to be 21 mg/dL, and the average normalized index of hemolysis was determined to be 0.0097 g/100 L for all experiments. The hydraulic performance of the prototype and level of hemolysis are indicative of significant progress in the design of this blood pump. These results support the continued development of this intravascular pump as a bridge-to-transplant, bridge-to-recovery, bridge-to-hemodynamic stability, or bridge-to-surgical reconstruction for Fontan patients.
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