In Vivo Evaluation of Active and Passive Physiological Control Systems for Rotary Left and Right Ventricular Assist Devices.

Preventing ventricular suction and venous congestion through balancing flow rates and circulatory volumes with dual rotary ventricular assist devices (VADs) configured for biventricular support is clinically challenging due to their low preload and high afterload sensitivities relative to the natural heart. This study presents the in vivo evaluation of several physiological control systems, which aim to prevent ventricular suction and venous congestion. The control systems included a sensor-based, master/slave (MS) controller that altered left and right VAD speed based on pressure and flow; a sensor-less compliant inflow cannula (IC), which altered inlet resistance and, therefore, pump flow based on preload; a sensor-less compliant outflow cannula (OC) on the right VAD, which altered outlet resistance and thus pump flow based on afterload; and a combined controller, which incorporated the MS controller, compliant IC, and compliant OC. Each control system was evaluated in vivo under step increases in systemic (SVR ∼1400-2400 dyne/s/cm(5) ) and pulmonary (PVR ∼200-1000 dyne/s/cm(5) ) vascular resistances in four sheep supported by dual rotary VADs in a biventricular assist configuration. Constant speed support was also evaluated for comparison and resulted in suction events during all resistance increases and pulmonary congestion during SVR increases. The MS controller reduced suction events and prevented congestion through an initial sharp reduction in pump flow followed by a gradual return to baseline (5.0 L/min). The compliant IC prevented suction events; however, reduced pump flows and pulmonary congestion were noted during the SVR increase. The compliant OC maintained pump flow close to baseline (5.0 L/min) and prevented suction and congestion during PVR increases. The combined controller responded similarly to the MS controller to prevent suction and congestion events in all cases while providing a backup system in the event of single controller failure.

Gregory SD ，Stevens MC ，Pauls JP ，Schummy E ，Diab S ，Thomson B ，Anderson B ，Tansley G ，Salamonsen R ，Fraser JF ，Timms D ... -  《-》

A compliant, banded outflow cannula for decreased afterload sensitivity of rotary right ventricular assist devices.

Biventricular support with dual rotary ventricular assist devices (VADs) has been implemented clinically with restriction of the right VAD (RVAD) outflow cannula to artificially increase afterload and, therefore, operate within recommended design speed ranges. However, the low preload and high afterload sensitivity of these devices increase the susceptibility of suction events. Active control systems are prone to sensor drift or inaccurate inferred (sensor-less) data, therefore an alternative solution may be of benefit. This study presents the in vitro evaluation of a compliant outflow cannula designed to passively decrease the afterload sensitivity of rotary RVADs and minimize left-sided suction events. A one-way fluid-structure interaction model was initially used to produce a design with suitable flow dynamics and radial deformation. The resultant geometry was cast with different initial cross-sectional restrictions and concentrations of a softening diluent before evaluation in a mock circulation loop. Pulmonary vascular resistance (PVR) was increased from 50 dyne s/cm(5) until left-sided suction events occurred with each compliant cannula and a rigid, 4.5 mm diameter outflow cannula for comparison. Early suction events (PVR ∼ 300 dyne s/cm(5) ) were observed with the rigid outflow cannula. Addition of the compliant section with an initial 3 mm diameter restriction and 10% diluent expanded the outflow restriction as PVR increased, thus increasing RVAD flow rate and preventing left-sided suction events at PVR levels beyond 1000 dyne s/cm(5) . Therefore, the compliant, restricted outflow cannula provided a passive control system to assist in the prevention of suction events with rotary biventricular support while maintaining pump speeds within normal ranges of operation.

Gregory SD ，Schummy E ，Pearcy M ，Pauls JP ，Tansley G ，Fraser JF ，Timms D ... -  《-》

In Vitro Evaluation of an Immediate Response Starling-Like Controller for Dual Rotary Blood Pumps.

Rotary ventricular assist devices (VADs) are used to provide mechanical circulatory support. However, their lack of preload sensitivity in constant speed control mode (CSC) may result in ventricular suction or venous congestion. This is particularly true of biventricular support, where the native flow-balancing Starling response of both ventricles is diminished. It is possible to model the Starling response of the ventricles using cardiac output and venous return curves. With this model, we can create a Starling-like physiological controller (SLC) for VADs which can automatically balance cardiac output in the presence of perturbations to the circulation. The comparison between CSC and SLC of dual HeartWare HVADs using a mock circulation loop to simulate biventricular heart failure has been reported. Four changes in cardiovascular state were simulated to test the controller, including a 700 mL reduction in circulating fluid volume, a total loss of left and right ventricular contractility, reduction in systemic vascular resistance ( SVR) from 1300 to 600 dyne  s/cm5, and an elevation in pulmonary vascular resistance ( PVR) from 100 to 300 dyne  s/cm5. SLC maintained the left and right ventricular volumes between 69-214 mL and 29-182 mL, respectively, for all tests, preventing ventricular suction (ventricular volume = 0 mL) and venous congestion (atrial pressures > 20 mm Hg). Cardiac output was maintained at sufficient levels by the SLC, with systemic and pulmonary flow rates maintained above 3.14 L/min for all tests. With the CSC, left ventricular suction occurred during reductions in SVR, elevations in PVR, and reduction in circulating fluid simulations. These results demonstrate a need for a physiological control system and provide adequate in vitro validation of the immediate response of a SLC for biventricular support.

Stephens AF ，Stevens MC ，Gregory SD ，Kleinheyer M ，Salamonsen RF ... -  《-》

Physiological control of dual rotary pumps as a biventricular assist device using a master/slave approach.

Dual rotary left ventricular assist devices (LVADs) can provide biventricular mechanical support during heart failure. Coordination of left and right pump speeds is critical not only to avoid ventricular suction and to match cardiac output with demand, but also to ensure balanced systemic and pulmonary circulatory volumes. Physiological control systems for dual LVADs must meet these objectives across a variety of clinical scenarios by automatically adjusting left and right pump speeds to avoid catastrophic physiological consequences. In this study we evaluate a novel master/slave physiological control system for dual LVADs. The master controller is a Starling-like controller, which sets flow rate as a function of end-diastolic ventricular pressure (EDP). The slave controller then maintains a linear relationship between right and left EDPs. Both left/right and right/left master/slave combinations were evaluated by subjecting them to four clinical scenarios (rest, postural change, Valsalva maneuver, and exercise) simulated in a mock circulation loop. The controller's performance was compared to constant-rotational-speed control and two other dual LVAD control systems: dual constant inlet pressure and dual Frank-Starling control. The results showed that the master/slave physiological control system produced fewer suction events than constant-speed control (6 vs. 62 over a 7-min period). Left/right master/slave control had lower risk of pulmonary congestion than the other control systems, as indicated by lower maximum EDPs (15.1 vs. 25.2-28.4 mm Hg). During exercise, master/slave control increased total flow from 5.2 to 10.1 L/min, primarily due to an increase of left and right pump speed. Use of the left pump as the master resulted in fewer suction events and lower EDPs than when the right pump was master. Based on these results, master/slave control using the left pump as the master automatically adjusts pump speed to avoid suction and increases pump flow during exercise without causing pulmonary venous congestion.

Stevens MC ，Wilson S ，Bradley A ，Fraser J ，Timms D ... -  《-》

In Vitro Comparison of Active and Passive Physiological Control Systems for Biventricular Assist Devices.

Pauls JP ，Stevens MC ，Schummy E ，Tansley G ，Fraser JF ，Timms D ，Gregory SD ... -  《-》