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 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 ... -  《-》

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 《-》

In vitro and in vivo characterization of three different modes of pump operation when using a left ventricular assist device as a right ventricular assist device.

Dual rotary left ventricular assist devices (LVADs) have been used clinically to support patients with biventricular failure. However, due to the lower vascular resistance in the pulmonary circulation compared with its systemic counterpart, excessively high pulmonary flow rates are expected if the right ventricular assist device (RVAD) is operated at its design LVAD speed. Three possible approaches are available to match the LVAD to the pulmonary circulation: operating the RVAD at a lower speed than the LVAD (mode 1), operating both pumps at their design speeds (mode 2) while relying on the cardiovascular system to adapt, and operating both pumps at their design speeds while restricting the diameter of the RVAD outflow graft (mode 3). In this study, each mode was characterized using in vitro and in vivo models of biventricular heart failure supported with two VentrAssist LVADs. The effect of each mode on arterial and atrial pressures and flow rates for low, medium, and high vascular resistances and three different contractility levels were evaluated. The amount of speed/diameter adjustment required to accommodate elevated pulmonary vascular resistance (PVR) during support with mode 3 was then investigated. Mode 1 required relatively low systemic vascular resistance to achieve arterial pressures less than 100 mm Hg in vitro, resulting in flow rates greater than 6 L/min. Mode 2 resulted in left atrial pressures above 25 mm Hg, unless left heart contractility was near-normal. In vitro, mode 3 resulted in expected arterial pressures and flow rates with an RVAD outflow diameter of 6.5 mm. In contrast, all modes were achievable in vivo, primarily due to higher RVAD outflow graft resistance (more than 500 dyn·s/cm(5)), caused by longer cannula. Flow rates could be maintained during instances of elevated PVR by increasing the RVAD speed or expanding the outflow graft diameter using an externally applied variable graft occlusion device. In conclusion, suitable hemodynamics could be produced by either restricting or not restricting the right outflow graft diameter; however, the latter required an operation of the RVAD at lower than design speed. Adjustments in outflow restriction and/or RVAD speed are recommended to accommodate varying PVR.

Stevens MC ，Gregory SD ，Nestler F ，Thomson B ，Choudhary J ，Garlick B ，Pauls JP ，Fraser JF ，Timms D ... -  《-》

Banding the Right Ventricular Assist Device Outflow Conduit: Is It Really Necessary With Current Devices?

Implantable left ventricular assist devices (LVADs) have been adapted clinically for right-sided mechanical circulatory support (RVAD). Previous studies on RVAD support have established the benefits of outflow cannula restriction and rotational speed reduction, and recent literature has focused on assessing either the degree of outflow cannula restriction required to simulate left-sided afterload, or the limitation of RVAD rotational speeds. Anecdotally, the utility of outflow cannula restriction has been questioned, with suggestion that banding may be unnecessary and may be replaced simply by varying the outflow conduit length. Furthermore, many patients have a high pulmonary vascular resistance (PVR) at the time of ventricular assist device (VAD) insertion that reduces with pulmonary vascular bed remodeling. It is therefore important to assess the potential changes in flow through an RVAD as PVR changes. In this in vitro study, we observed the use of dual HeartWare HVAD devices (HeartWare Inc., Framingham, MA, USA) in biventricular support (BiVAD) configuration. We assessed the pumps' ability to maintain hemodynamic stability with and without banding; and with varying outflow cannulae length (20, 40, and 60 cm). Increased length of the outflow conduit was found to produce significantly increased afterload to the device, but this was not found to be necessary to maintain the device within the manufacturer's recommended operational parameters under a simulated normal physiological setting of mild and severe right ventricular (RV) failure. We hypothesize that 40 cm of outflow conduit, laid down along the diaphragm and then up over the RV to reach the pulmonary trunk, will generate sufficient resistance to maintain normal pump function.

Lo C ，Gregory S ，Stevens M ，Murphy D ，Marasco S ... -  《-》