Passive control of a biventricular assist device with compliant inflow cannulae.

Rotary ventricular assist device (VAD) support of the cardiovascular system is susceptible to suction events due to the limited preload sensitivity of these devices. This may be of particular concern with rotary biventricular support (BiVAD) where the native, flow balancing Starling response is diminished in both ventricles. The reliability of sensor and sensorless-based control systems which aim to control VAD flow based on preload has limitations, and, thus, an alternative solution is desired. This study introduces a compliant inflow cannula (CIC) which could improve the preload sensitivity of a rotary VAD by passively altering VAD flow depending on preload. To evaluate the design, both the CIC and a standard rigid inflow cannula were inserted into a mock circulation loop to enable biventricular heart failure support using configurations of atrial and ventricular inflow, and arterial outflow cannulation. A range of left (LVAD) and right VAD (RVAD) rotational speeds were tested as well as step changes in systemic/pulmonary vascular resistance to alter relative preloads, with resulting flow rates recorded. Simulated suction events were observed, particularly at higher VAD speeds, during support with the rigid inflow cannula, while the CIC prevented suction events under all circumstances. The compliant section passively restricted its internal diameter as preload was reduced, which increased the VAD circuit resistance and thus reduced VAD flow. Therefore, a CIC could potentially be used as a passive control system to prevent suction events in rotary left, right, and biventricular support.

Gregory SD ，Pearcy MJ ，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 a compliant inflow cannula reservoir to reduce suction events with extracorporeal rotary ventricular assist device support.

Limited preload sensitivity of rotary left ventricular assist devices (LVADs) renders patients susceptible to harmful atrial or ventricular suction events. Active control systems may be used to rectify this problem; however, they usually depend on unreliable sensors or potentially inaccurate inferred data from, for example, motor current. This study aimed to characterize the performance of a collapsible inflow cannula reservoir as a passive control system to eliminate suction events in extracorporeal, rotary LVAD support. The reservoir was evaluated in a mock circulation loop against a rigid cannula under conditions of reduced preload and increased LVAD speed in both atrial and ventricular cannulation scenarios. Both cases demonstrated the ease with which chamber suction events can occur with a rigid cannula and confirm that the addition of the reservoir maintained positive chamber volumes with reduced preload and high LVAD speeds. Reservoir performance was dependent on height with respect to the cannulated chamber, with lower placement required in atrial cannulation due to reduced filling pressures. This study concluded that a collapsible inflow cannula is capable of minimizing suction events in extracorporeal, rotary LVAD support.

Gregory SD ，Timms D ，Gaddum NR ，McDonald C ，Pearcy MJ ，Fraser JF ... -  《-》

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 ... -  《-》

Assessment of right pump outflow banding and speed changes on pulmonary hemodynamics during biventricular support with two rotary left ventricular assist devices.

The absence of an effective, easily implantable right ventricular assist device (RVAD) significantly diminishes long-term treatment options for patients with biventricular heart failure. The implantation of a second rotary left ventricular assist device (LVAD) for right heart support is therefore being considered; however, this approach exhibits technical challenges when adapting current devices to produce the lower pressures required of the pulmonary circulation. Hemodynamic adaptation may be achieved by either reducing the rotational speed of the right pump impeller or reducing the diameter of the right outflow cannula by the placement of a restricting band; however, the optimal value and influence of changes to each parameter are not well understood. Hemodynamics were therefore investigated using different banding diameters of the right outflow cannula (3-6.5 mm) and pump speeds (500-4500 rpm), using two identical rotary blood pumps coupled to a pulsatile mock circulation loop. Reducing the speed of the right pump from 4900 rpm (for left ventricle support) to 3500 rpm, or banding the Ø10 mm (area 78.5 mm²) right outflow graft to Ø5.4 mm (22.9 mm²) produced suitable hemodynamics. Pulmonary pressures were most sensitive to banding diameters, especially when RVAD flow exceeded LVAD flow. This occurred between Ø5.3 and Ø6.5 mm (22.05-38.5 mm²) and speeds between 3200 and 4400 rpm, with the flow imbalance potentially leading to pulmonary congestion. Total flow was not affected by banding diameters and speeds below this range, and only increased slightly at higher values. Both right outflow banding or right pump speed reduction were found to be effective techniques to allow a rotary LVAD to be used directly for right heart support. However, the observed sensitivity to diameter and speed indicate that challenges may be presented when setting appropriate values for each patient, and control over these parameters is desirable.

Timms D ，Gude E ，Gaddum N ，Lim E ，Greatrex N ，Wong K ，Steinseifer U ，Lovell N ，Fraser J ，Fiane A ... -  《-》