Preload Sensitivity with TORVAD Counterpulse Support Prevents Suction and Overpumping.

PURPOSE: This study compares preload sensitivity of continuous flow (CF) VAD support to counterpulsation using the Windmill toroidal VAD (TORVAD). The TORVAD is a two-piston rotary pump that ejects 30 mL in early diastole, which increases cardiac output while preserving aortic valve flow. METHODS: Preload sensitivity was compared for CF vs. TORVAD counterpulse support using two lumped parameter models of the cardiovascular system: (1) an open-loop model of the systemic circulation was used to obtain ventricular function curves by isolating the systemic circulation and prescribing preload and afterload boundary conditions, and (2) a closed-loop model was used to test the physiological response to changes in pulmonary vascular resistance, systemic vascular resistance, heart rate, inotropic state, and blood volume. In the open-loop model, ventricular function curves (cardiac output vs left ventricular preload) are used to assess preload sensitivity. In the closed-loop model, left ventricular end systolic volume is used to assess the risk of left ventricular suction. RESULTS: At low preloads of 5 mmHg, CF support overpumps the circulation compared to TORVAD counterpulse support (cardiac output of 3.3 L/min for the healthy heart, 4.7 with CF support, and 3.5 with TORVAD counterpulse support) and has much less sensitivity than counterpulse support (0.342 L/min/mmHg for the healthy heart, 0.092 with CF support, and 0.306 with TORVAD counterpulse support). In the closed-loop model, when PVR is increased beyond 0.035 mmHg s/mL, CF support overpumps the circulation and causes ventricular suction events, but TORVAD counterpulse support maintains sufficient ventricular volume and does not cause suction. CONCLUSIONS: Counterpulse support with the TORVAD preserves aortic valve flow and provides physiological sensitivity across all preload conditions. This should prevent overpumping and minimize the risk of suction.

Scaling the Low-Shear Pulsatile TORVAD for Pediatric Heart Failure.

This article provides an overview of the design challenges associated with scaling the low-shear pulsatile TORVAD ventricular assist device (VAD) for treating pediatric heart failure. A cardiovascular system model was used to determine that a 15 ml stroke volume device with a maximum flow rate of 4 L/min can provide full support to pediatric patients with body surface areas between 0.6 and 1.5 m. Low-shear stress in the blood is preserved as the device is scaled down and remains at least two orders of magnitude less than continuous flow VADs. A new magnetic linkage coupling the rotor and piston has been optimized using a finite element model (FEM) resulting in increased heat transfer to the blood while reducing the overall size of TORVAD. Motor FEM has also been used to reduce motor size and improve motor efficiency and heat transfer. FEM analysis predicts no more than 1°C temperature rise on any blood or tissue contacting surface of the device. The iterative computational approach established provides a methodology for developing a TORVAD platform technology with various device sizes for supporting the circulation of infants to adults.

Preservation of native aortic valve flow and full hemodynamic support with the TORVAD using a computational model of the cardiovascular system.

This article describes the stroke volume selection and operational design for the toroidal ventricular assist device (TORVAD), a synchronous, positive-displacement ventricular assist device (VAD). A lumped parameter model was used to simulate hemodynamics with the TORVAD compared with those under continuous-flow VAD support. Results from the simulation demonstrated that a TORVAD with a 30 ml stroke volume ejecting with an early diastolic counterpulse provides comparable systemic support to the HeartMate II (HMII) (cardiac output 5.7 L/min up from 3.1 L/min in simulated heart failure). By taking the advantage of synchronous pulsatility, the TORVAD delivers full hemodynamic support with nearly half the VAD flow rate (2.7 L/min compared with 5.3 L/min for the HMII) by allowing the left ventricle to eject during systole and thus preserving native aortic valve flow (3.0 L/min compared with 0.4 L/min for the HMII, down from 3.1 L/min at baseline). The TORVAD also preserves pulse pressure (26.7 mm Hg compared with 12.8 mm Hg for the HMII, down from 29.1 mm Hg at baseline). Preservation of aortic valve flow with synchronous pulsatile support could reduce the high incidence of aortic insufficiency and valve cusp fusion reported in patients supported with continuous-flow VADs.

Admittance to detect alterations in left ventricular stroke volume.

BACKGROUND: Implantable cardioverter-defibrillators monitor intracardiac electrograms (EGMs) to discriminate between ventricular and supraventricular tachycardias. The incidence of inappropriate shocks remains high because of misclassification of the tachycardia in an otherwise hemodynamically stable individual. Coupling EGMs with an assessment of left ventricular (LV) stroke volume (SV) could help in gauging hemodynamics during an arrhythmia and reducing inappropriate shocks. OBJECTIVE: The purpose of this study was to use the admittance method to accurately derive LV SV. METHODS: Ultrasonic flow probe and LV endocardial crystals were used in canines (n = 12) as the standard for LV SV. Biventricular pacing leads were inserted to obtain admittance measurements. A tetrapolar, complex impedance measurement was made between the Bi-V leads. The real and imaginary components of impedance were used to discard the myocardial component from the blood component to derive instantaneous blood conductance (Gb). Alterations in SV were measured during right ventricular pacing, dopamine infusion, and inferior vena cava occlusion. RESULTS: Gb tracks steady-state changes in SV more accurately than traditional magnitude (ie, |Y|, without removal of the muscle signal) during right ventricular pacing and dopamine infusion (P = .004). Instantaneous LV volume also was tracked more accurately by Gb than ∣Y∣ in the subset of subjects that underwent inferior vena cava occlusions (n = 5, P = .025). Finite element modeling demonstrates that admittance shifts more sensitivity of the measurement to the LV blood chamber as the mechanism for improvement (see Online Appendix). CONCLUSION: Monitoring LV SV is possible using the admittance method with biventricular pacing leads. The technique could be piggybacked to complement EGMs to determine if arrhythmias are hemodynamically unstable.

Analysis of the spatial sensitivity of conductance/admittance catheter ventricular volume estimation.

Conductance catheters are known to have a nonuniform spatial sensitivity due to the distribution of the electric field. The Geselowitz relation is applied to murine and multisegment conductance catheters using finite element models to determine the spatial sensitivity in a uniform medium and simplified left ventricle models. A new formulation is proposed that allows determination of the spatial sensitivity to admittance. Analysis of FEM numerical modeling results using the Geselowitz relation provides a true measure of parallel conductance in simplified left ventricle models for assessment of the admittance method and hypertonic saline techniques. The spatial sensitivity of blood conductance (Gb) is determined throughout the cardiac cycle. Gb is converted to volume using Wei's equation to determine if the presence of myocardium alters the nonlinear relationship through changes to the electric field. Results show that muscle conductance (Gm) from the admittance method matches results from the Geselowitz relation and that the relationship between Gb and volume is accurately fit using Wei's equation. Single-segment admittance measurements in large animals result in a more evenly distributed sensitivity to the LV blood pool. The hypertonic saline method overestimates parallel conductance throughout the cardiac cycle in both murine and multisegment conductance catheters.

Application of the Geselowitz relationship to the murine conductance catheter.

Conductance catheters are known to have a nonuniform spatial sensitivity due to the distribution of the electric field. The Geselowitz relation is applied to the murine conductance catheter using a finite element model to determine catheter's spatial sensitivity in uniform media. Further analysis of FEM numerical modeling results using the Geselowitz relation provides a true measure of parallel conductance in a simplified murine left ventricle for assessment of the admittance method and hypertonic saline techniques. The spatial sensitivity of blood conductance (G(b)) is determined throughout the cardiac cycle. G(b) is converted to volume using Wei's equation to determine if the presence of myocardium alters the nonlinear relationship through changes to the electric field shape. Results show that the admittance method correctly calculates G(b) in comparison to the Geselowitz relation, and that the relationship between G(b) and volume is accurately fit using Wei's equation.

A bio-telemetric device for measurement of left ventricular pressure-volume loops using the admittance technique in conscious, ambulatory rats.

This paper presents the design, construction and testing of a device to measure pressure-volume loops in the left ventricle of conscious, ambulatory rats. Pressure is measured with a standard sensor, but volume is derived from data collected from a tetrapolar electrode catheter using a novel admittance technique. There are two main advantages of the admittance technique to measure volume. First, the contribution from the adjacent muscle can be instantaneously removed. Second, the admittance technique incorporates the nonlinear relationship between the electric field generated by the catheter and the blood volume. A low power instrument weighing 27 g was designed, which takes pressure-volume loops every 2 min and runs for 24 h. Pressure-volume data are transmitted wirelessly to a base station. The device was first validated on 13 rats with an acute preparation with 2D echocardiography used to measure true volume. From an accuracy standpoint, the admittance technique is superior to both the conductance technique calibrated with hypertonic saline injections, and calibrated with cuvettes. The device was then tested on six rats with 24 h chronic preparation. Stability of animal preparation and careful calibration are important factors affecting the success of the device.

Left ventricular epicardial admittance measurement for detection of acute LV dilation.

There are two implanted heart failure warning systems incorporated into biventricular pacemakers/automatic implantable cardiac defibrillators and tested in clinical trials: right heart pressures, and lung conductance measurements. However, both warning systems postdate measures of the earliest indicator of impending heart failure: left ventricular (LV) volume. There are currently no proposed implanted technologies that can perform LV blood volume measurements in humans. We propose to solve this problem by incorporating an admittance measurement system onto currently deployed biventricular and automatic implantable cardiac defibrillator leads. This study will demonstrate that an admittance measurement system can detect LV blood conductance from the epicardial position, despite the current generating and sensing electrodes being in constant motion with the heart, and with dynamic removal of the myocardial component of the returning voltage signal. Specifically, in 11 pigs, it will be demonstrated that 1) a physiological LV blood conductance signal can be derived; 2) LV dilation in response to dose-response intravenous neosynephrine can be detected by blood conductance in a similar fashion to the standard of endocardial crystals when admittance is used, but not when only traditional conductance is used; 3) the physiological impact of acute left anterior descending coronary artery occlusion and resultant LV dilation can be detected by blood conductance, before the anticipated secondary rise in right ventricular systolic pressure; and 4) a pleural effusion simulated by placing saline outside the pericardium does not serve as a source of artifact for blood conductance measurements.

Accuracy considerations in catheter based estimation of left ventricular volume.

Cardiac volume estimation in the Left Ventricle from impedance or admittance measurement is subject to two major sources of error: parallel current pathways in surrounding tissues and a non uniform current density field. The accuracy of volume estimation can be enhanced by incorporating the complex electrical properties of myocardium to identify the muscle component in the measurement and by including the transient nature of the field non uniformity. Cardiac muscle is unique in that the permittivity is high enough at audio frequencies to make the muscle component of the signal identifiable in the imaginary part of an admittance measurement. The muscle contribution can thus be uniquely identified and removed from the combined muscle - blood measurement. In general, both error sources are transient and are best removed in real time as data are collected. This paper reviews error correction methods and establishes that the relative magnitudes of the error concerns are different in small and large hearts.

Dynamic correction for parallel conductance, GP, and gain factor, alpha, in invasive murine left ventricular volume measurements.

The conductance catheter technique could be improved by determining instantaneous parallel conductance (G(P)), which is known to be time varying, and by including a time-varying calibration factor in Baan's equation [alpha(t)]. We have recently proposed solutions to the problems of both time-varying G(P) and time-varying alpha, which we term "admittance" and "Wei's equation," respectively. We validate both our solutions in mice, compared with the currently accepted methods of hypertonic saline (HS) to determine G(P) and Baan's equation calibrated with both stroke volume (SV) and cuvette. We performed simultaneous echocardiography in closed-chest mice (n = 8) as a reference for left ventricular (LV) volume and demonstrate that an off-center position for the miniaturized pressure-volume (PV) catheter in the LV generates end-systolic and diastolic volumes calculated by admittance with less error (P < 0.03) (-2.49 +/- 15.33 microl error) compared with those same parameters calculated by SV calibrated conductance (35.89 +/- 73.22 microl error) and by cuvette calibrated conductance (-7.53 +/- 16.23 microl ES and -29.10 +/- 31.53 microl ED error). To utilize the admittance approach, myocardial permittivity (epsilon(m)) and conductivity (sigma(m)) were calculated in additional mice (n = 7), and those results are used in this calculation. In aortic banded mice (n = 6), increased myocardial permittivity was measured (11,844 +/- 2,700 control, 21,267 +/- 8,005 banded, P < 0.05), demonstrating that muscle properties vary with disease state. Volume error calculated with respect to echo did not significantly change in aortic banded mice (6.74 +/- 13.06 microl, P = not significant). Increased inotropy in response to intravenous dobutamine was detected with greater sensitivity with the admittance technique compared with traditional conductance [4.9 +/- 1.4 to 12.5 +/- 6.6 mmHg/microl Wei's equation (P < 0.05), 3.3 +/- 1.2 to 8.8 +/- 5.1 mmHg/microl using Baan's equation (P = not significant)]. New theory and method for instantaneous G(P) removal, as well as application of Wei's equation, are presented and validated in vivo in mice. We conclude that, for closed-chest mice, admittance (dynamic G(P)) and Wei's equation (dynamic alpha) provide more accurate volumes than traditional conductance, are more sensitive to inotropic changes, eliminate the need for hypertonic saline, and can be accurately extended to aortic banded mice.