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Objective: Controversy exists regarding the optimal pumping method for left ventricular assist devices. The purpose of this investigation was to test the hypothesis that pulsatile left ventricular assist synchronized to the cardiac cycle provides superior left ventricular unloading and circulatory support compared with continuous-flow left ventricular assist devices at the same level of ventricular assist device flow. Methods: Seven male pigs were used to evaluate left ventricular assist device function using the TORVAD synchronized pulsatile-flow pump (Windmill Cardiovascular Systems, Inc, Austin, Tex) compared with the Bio-Medicus BPX-80 continuous-flow centrifugal pump (Medtronic, Inc, Minneapolis, Minn). Experiments were carried out under general anesthesia, and animals were instrumented via a median sternotomy. Hemodynamic measurements were obtained in the control state and with left ventricular assistance using the TORVAD and BPX-80 individually. Left ventricular failure was induced with suture ligation of the mid-left anterior descending coronary artery, and hemodynamic measurements were repeated. Results: During left ventricular assist device support, mean aortic pressure and total cardiac output were higher and left atrial pressure was lower with pulsatile compared with continuous flow at the same ventricular assist device flow rate. During ischemic left ventricular failure, pulsatile left ventricular support resulted in higher total cardiac output (5.58 AE 1.58 vs 5.12 AE 1.19, P < .05), higher mean aortic pressure (67.8 AE 14 vs 60.2 AE 10, P < .05), and lower left atrial pressure (11.5 AE 3.5 vs 13.9 AE 6.0, P < .05) compared with continuous flow at the same left ventricular assist device flow rate. Conclusion: Synchronized, pulsatile left ventricular assistance produces superior left ventricular unloading and circulatory support compared with continuous-flow left ventricular assist at the same flow rates.

A study of mechanical heart valve behavior in the pulmonary position as a function of pulmonary vascular resistance is reported for the St. Jude Medical bileaflet (SJMB) valve and the MedicalCV Omnicarbon (OTD) tilting disk valve. Tests were conducted in a pulmonic mock circulatory system and impedance was varied in terms of system pulmonary vascular resistance (PVR). An impedance spectrum was found using instantaneous pulmonary artery pressure and flow rate curves. Both valves fully opened and closed at and above a nominal PVR of 3.0 mmHg/L/min. The SJMB valve was prone to leaflet bounce at closure, but otherwise completely closed, at settings above and below this nominal setting. At PVR values at and below 2.0 mmHg/L/min, the SJMB valve exhibited two types of leaflet aberrant behavior: single leaflet only closure while the other leaflet fluttered, and incomplete closure where both leaflets flutter but neither remain fully closed. The OTD valve fully opened and closed to a PVR value of 1.6 mmHg/L/min. At lower values, the valve did not close. Valves designed for the left heart can show aberrant behavior under normal conditions as pulmonary valves.

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 to 1.5 m2. 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.

The purpose of this investigation is to utilize a computational model to compare a synchronized valveless pulsatile left ventricular assist device to continuous flow left ventricular assist devices at the same level of device flow, and to verify the model with in vivo porcine data. A dynamic system model of the human cardiovascular system was developed to simulate support of a healthy or failing native heart from a continuous flow left ventricular assist device or a synchronous, pulsatile, valveless, dual piston positive displacement pump. These results were compared to measurements made during in vivo porcine experiments. Results from the simulation model and from the in vivo counterpart show that the pulsatile pump provides higher cardiac output, left ventricular unloading, cardiac pulsatility, and aortic valve flow as compared to the continuous flow model at the same level of support. The dynamic system model developed for this investigation can effectively simulate human cardiovascular support by a synchronous pulsatile or continuous flow ventricular assist device.

This paper describes the stroke volume selection and operational design for the TORVAD™, a synchronous, positive-displacement ventricular assist device (VAD). A lumped parameter model was used to simulate hemodynamics with the TORVAD™ compared to 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 advantage of synchronous pulsatility, the TORVAD™ delivers full hemodynamic support with nearly half the VAD flow rate (2.7 L/min compared to 5.3 L/min for the HMII) by allowing the left ventricle to eject during systole, thus preserving native aortic valve flow (3.0 L/min compared to 0.4 L/min for the HMII, down from 3.1 L/min at baseline). The TORVAD™ also preserves pulse pressure (26.7 mmHg compared to 12.8 mmHg for the HMII, down from 29.1 mmHg 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.

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This paper presents an approach for real-time estimation of the systemic vascular resistance (SVR) of heart failure patients who have a left ventricular assist device (LVAD). Notably, an approach is described that relies only on sensing that is built into the LVAD, so no additional sensors or measurements are required. The estimation of SVR is accomplished using a variant of the extended Kalman filter (EKF) algorithm, making use of a reduced-order systemic circulation model, and requires LVAD flowrate as an input to the systemic circulation and measurement of the LVAD differential pressure. Experiments using a hybrid mock circulatory loop (hMCL) are used to show the efficacy of this approach for both types of LVAD pumping modalities; i.e., continuous flow (CF) turbomachines and pulsatile flow (PF) positive-displacement pumps. The mock loop uses a real-time hardware-in-the-loop simulation of the cardiovascular system (CVS) where physiological parameters and particularly the SVR can be set to known values, allowing a basis for evaluating the accuracy of the estimation algorithms. It was found that SVR value estimates were accurate within 1.3% and 0.7% compared to the set model values for the continuous and PF LVADs, respectively. The use of this SVR estimation approach utilizing built-in LVAD sensing technology has potential for use in further real-time estimation endeavors, monitoring of patient physiology, and providing alerts to physicians.