LVAD Pulsatility Assesses Cardiac Contractility: In Vitro Model Utilizing the Total Artificial Heart and Mock Circulation.

There is a need for a consistent, reproducible, and cost-effective method of determining cardiac recovery in patients who receive emerging novel therapeutics for advanced and end-stage heart failure (HF). With the increasing use of ventricular assist devices (VADs) in end-stage HF, objective device diagnostics are available for analysis. Pulsatility, one of the accessible diagnostic measures, is a variable gage of the differential between peak systolic and minimum diastolic flow during a single cardiac cycle. Following implantation of the VAD, HeartWare's HVAD records pulsatility regularly. Thus, we hypothesize that this measurement relates to the contractility of the heart and could be utilized as a metric for determining patient response to various therapeutics. In this study, therefore, we develop a translatable and effective predictive model characterizing pulsatility to determine HF status and potential HF recovery using the SynCardia Total Artificial Heart (TAH) in conjunction with a Donovan Mock Circulation System to create a simulation platform for the collection of pulsatility data. We set the simulation platform to patient conditions ranging from critical heart failure to a normal operating condition through the variation preload, afterload, and left ventricular (LV) pumping force or TAH "contractility." By manipulating these variables, pulsatility was found to accurately indicate significant (p < 0.05) improvements in LV contractility at every recorded afterload and preload, suggesting that it is a valuable parameter for the assessment of cardiac recovery in patients.

A Physical Heart Failure Simulation System Utilizing the Total Artificial Heart and Modified Donovan Mock Circulation.

With the growth and diversity of mechanical circulatory support (MCS) systems entering clinical use, a need exists for a robust mock circulation system capable of reliably emulating and reproducing physiologic as well as pathophysiologic states for use in MCS training and inter-device comparison. We report on the development of such a platform utilizing the SynCardia Total Artificial Heart and a modified Donovan Mock Circulation System, capable of being driven at normal and reduced output. With this platform, clinically relevant heart failure hemodynamics could be reliably reproduced as evidenced by elevated left atrial pressure (+112%), reduced aortic flow (-12.6%), blunted Starling-like behavior, and increased afterload sensitivity when compared with normal function. Similarly, pressure-volume relationships demonstrated enhanced sensitivity to afterload and decreased Starling-like behavior in the heart failure model. Lastly, the platform was configured to allow the easy addition of a left ventricular assist device (HeartMate II at 9600 RPM), which upon insertion resulted in improvement of hemodynamics. The present configuration has the potential to serve as a viable system for training and research, aimed at fostering safe and effective MCS device use.

Physiological characterization of the SynCardia total artificial heart in a mock circulation system.

The SynCardia total artificial heart (TAH) has emerged as an effective, life-saving biventricular replacement system for a wide variety of patients with end-stage heart failure. Although the clinical performance of the TAH is established, modern physiological characterization, in terms of elastance behavior and pressure-volume (PV) characterization has not been defined. Herein, we examine the TAH in terms of elastance using a nonejecting left ventricle, and then characterize the PV relation of the TAH by varying preload and afterload parameters using a Donovan Mock Circulatory System. We demonstrate that the TAH does not operate with time-varying elastance, differing from the human heart. Furthermore, we show that the TAH has a PV relation behavior that also differs from that of the human heart. The TAH does exhibit Starling-like behavior, with output increasing via preload-dependent mechanisms, without reliance on an alteration of inotropic state within the operating window of the TAH. Within our testing range, the TAH is insensitive to variations in afterload; however, this insensitivity has a limit, the limit being the maximum driving pressure of the pneumatic driver. Understanding the physiology of the TAH affords insight into the functional parameters that govern artificial heart behavior providing perspective on differences compared with the human heart.

Numerical model of full-cardiac cycle hemodynamics in a total artificial heart and the effect of its size on platelet activation.

The SynCardia total artificial heart (TAH) is the only Food and Drug Administration (FDA) approved device for replacing hearts in patients with congestive heart failure. It pumps blood via pneumatically driven diaphragms and controls the flow with mechanical valves. While it has been successfully implanted in more than 1300 patients, its size precludes implantation in smaller patients. This study's aim was to evaluate the viability of scaled-down TAHs by quantifying thrombogenic potentials from flow patterns. Simulations of systole were first conducted with stationary valves, followed by an advanced full-cardiac cycle model with moving valves. All the models included deforming diaphragms and platelet suspension in the blood flow. Flow stress accumulations were computed for the platelet trajectories and thrombogenic potentials were assessed. The simulations successfully captured complex flow patterns during various phases of the cardiac cycle. Increased stress accumulations, but within the safety margin of acceptable thrombogenicity, were found in smaller TAHs, indicating that they are clinically viable.