Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Numerical modeling of anisotropic fiber bundle behavior in oxygenators.

Prediction of flow patterns through oxygenator fiber bundles can allow shape optimization so that efficient gas exchange occurs with minimal thrombus formation and hemolysis. Computational fluid dynamics (CFD) simulations can be used to predict three-dimensional flow velocities and flow distribution from spatially dependent variables and they allow estimations of erythrocyte residence time within the fiber bundle. This study builds upon previous work to develop an accurate numerical model for oxygenators, which would allow for accelerated iterations in oxygenator shape and diffuser plate design optimization. Hollow fiber flow channels were developed to permit experimental calculation of fluid permeability in two directions: main flow along the hollow fiber and perpendicular to the hollow fibers. Commercial software was used to develop three-dimensional CFD models of the experimental flow channels and an anisotropic porous media model for oxygenators from these experimental results. The oxygenator model was used to predict pressure loss throughout the device, visualize blood distribution within the fiber bundle, and estimate erythrocyte residence time within the bundle. Experimental flow channels measurements produced a streamwise permeability of 1.143e(-8) m(2) and transverse permeability of 2.385e(-9) m(2) . These permeabilities, coupled with previous work with volume porosity, were used to develop the numerical model of anisotropic behavior through porous fiber bundles, which indicated a more uniform flow field throughout the oxygenator. Incorporation of known anisotropic fiber bundle behavior in previous numerical models more accurately represents fluid behavior through an oxygenator fiber bundle. CFD coupled with experimental validation can produce a powerful tool for oxygenator design and development.

Mechanical cavopulmonary assistance of a patient-specific Fontan physiology: numerical simulations, lumped parameter modeling, and suction experiments.

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.

Interaction of an idealized cavopulmonary circulation with mechanical circulatory assist using an intravascular rotary blood pump.

This study evaluated the performance of an intravascular, percutaneously-inserted, axial flow blood pump in an idealized total cavopulmonary connection (TCPC) model of a Fontan physiology. This blood pump, intended for placement in the inferior vena cava (IVC), is designed to augment pressure and blood flow from the IVC to the pulmonary circulation. Three different computational models were examined: (i) an idealized TCPC without a pump; (ii) an idealized TCPC with an impeller pump; and (iii) an idealized TCPC with an impeller and diffuser pump. Computational fluid dynamics analyses of these models were performed to assess the hydraulic performance of each model under varying physiologic conditions. Pressure-flow characteristics, fluid streamlines, energy augmentation calculations, and blood damage analyses were evaluated. Numerical predictions indicate that the pump with an impeller and diffuser blade set produces pressure generations of 1 to 16 mm Hg for rotational speeds of 2000 to 6000 rpm and flow rates of 1 to 4 L/min. In contrast, for the same flow range, the model with the impeller only in the IVC demonstrated pressure generations of 1 to 9 mm Hg at rotational speeds of 10,000 to 12,000 rpm. Influence of blood viscosity was found to be insignificant at low rotational speeds with minimal performance deviation at higher rotational speeds. Results from the blood damage index analyses indicate a low probability for damage with maximum damage index levels less than 1% and maximum fluid residence times below 0.6 s. The numerical predictions further indicated successful energy augmentation of the TCPC with a pump in the IVC. These results support the continued design and development of this cavopulmonary assist device.

Filament support spindle for an intravascular cavopulmonary assist device.

We are developing an intravascular axial flow blood pump to support adolescent and adult Fontan patients. To protect the blood vessel, this pump has an outer cage with radially arranged filaments and a newly designed spindle at the pump outlet. The outlet spindle is included to limit the axial movement of the rotor and to house bearings that support the rotor. This study evaluates the impact of the outlet spindle on pump performance using computational fluid dynamics (CFD) and experimental testing of a prototype configuration. We measured the pressure-flow performance of the prototype with a protective cage using a blood analog fluid. The pump with the cage filaments and spindle generated 1 to 16mmHg of pressure rise for flow rates of 1 to 4L/min at 4000 to 7000rpm. The difference between the CFD predictions and experimental results was found to be approximately 9.8%. Scalar stress levels remained below 570Pa with exposure times on the order of 1.5s. These results are acceptable and support the continued development of this cavopulmonary assist device with an outlet spindle to reinforce the protective cage filament design.

Intravascular mechanical cavopulmonary assistance for patients with failing Fontan physiology.

To provide a viable bridge-to-transplant, bridge-to-recovery, or bridge-to-surgical reconstruction for patients with failing Fontan physiology, we are developing a collapsible, percutaneously inserted, magnetically levitated axial flow blood pump to support the cavopulmonary circulation in adolescent and adult patients. This unique blood pump will augment pressure and thus flow in the inferior vena cava through the lungs and ameliorate the poor hemodynamics associated with the univentricular circulation. Computational fluid dynamics analyses were performed to create the design of the impeller, the protective cage of filaments, and the set of diffuser blades for our axial flow blood pump. These analyses included the generation of pressure-flow characteristics, scalar stress estimations, and blood damage indexes. A quasi-steady analysis of the diffuser rotation was also completed and indicated an optimal diffuser rotational orientation of approximately 12 degrees. The numerical predictions of the pump performance demonstrated a pressure generation of 2-25 mm Hg for 1-7 L/min over 3000-8000 rpm. Scalar stress values were less than 200 Pa, and fluid residence times were found to be within acceptable ranges being less than 0.25 s. The maximum blood damage index was calculated to be 0.068%. These results support the continued design and development of this cavopulmonary assist device, building upon previous numerical work and experimental prototype testing.

Mechanical circulatory support device-heart hysteretic interaction can predict left ventricular end diastolic pressure.

The full potential of mechanical circulatory systems in the treatment of cardiogenic shock is impeded by the lack of accurate measures of cardiac function to guide clinicians in determining when to initiate and how to optimally titrate support. The left ventricular end diastolic pressure (LVEDP) is an established metric of cardiac function that refers to the pressure in the left ventricle at the end of ventricular filling and immediately before ventricular contraction. In clinical practice, LVEDP is typically only inferred from, and poorly correlates with, the pulmonary capillary wedge pressure (PCWP). We leveraged the position of an indwelling percutaneous ventricular assist device and advanced data analysis methods to obtain LVEDP from the hysteretic operating metrics of the device. We validated our hysteresis-derived LVEDP measurement using mock flow loops, an animal model of cardiac dysfunction, and data from a patient in cardiogenic shock to show greater measurement precision and correlation with actual pressures than traditional inferences via PCWP. Delineation of the nonlinear relationship between device and heart adds insight into the interaction between ventricular support devices and the native heart, paving the way for continuous assessment of underlying cardiac state, metrics of cardiac function, potential closed-loop automated control, and rational design of future innovations in mechanical circulatory support systems.

Pneumatically-driven external pressure applicator to augment Fontan hemodynamics: preliminary findings.

BACKGROUND: This study investigated the application of circumferentially applied, external pressure to the lower extremities as a preventative measure and long-term clinical treatment strategy for Fontan patients. OBJECTIVE: We hypothesized that the application of circumferential pressure to the lower limbs will augment venous return and thus cardiac output. METHODS: Two patients (an extra-cardiac and intra-atrial Fontan) were evaluated. Both trials were conducted during a routine cardiac catheterization. The aortic and inferior vena cava (IVC) pressures were recorded. We applied three different external pressures to the lower limbs based on the patient's diastolic pressure. Each pressure was applied with a one-minute rapid inflate/deflate period for a total of five cycles and a rest period between pressure intervals. RESULTS: Patient 1 (age 37, female) demonstrated pressure rises of 10-15 mmHg in both the aortic and IVC pressures. Patient 2 (age 24, male) had undetectable pressure rise during the first pressure cycles and notable pressures rise of approximately 8-12 mmHg during the third cycle. CONCLUSIONS: External pressure application redistributes blood volume or cardiac output as a result of impedance in the lower extremities, enhancing venous pressure and return. Our findings strongly suggest an acute benefit from the implementation of external mechanical compression of the lower vasculature to increase cardiac output in Fontan patients.

Numerical, hydraulic, and hemolytic evaluation of an intravascular axial flow blood pump to mechanically support Fontan patients.

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.