Pulsatile control of rotary blood pumps: Does the modulation waveform matter?

OBJECTIVE: Mechanical support of a failing heart is typically performed with rotary blood pumps running at constant speed, which results in a limited control on cardiac workload and nonpulsatile hemodynamics. A potential solution to overcome these limitations is to modulate the pump speed to create pulses. This study aims at developing a pulsatile control algorithm for rotary pumps, while investigating its effect on left ventricle unloading and the hemodynamics. METHODS: The CentriMag (Levitronix GmbH, Zürich, Switzerland) rotary blood pump was implanted in 5 sheep and cannulated from the ventricular apex to the descending aorta. A modified controller was connected to the pump yielding direct speed control via analog voltage. Pump speed modulation patterns, including sine, saw tooth, triangle, and square waveforms with 2 different phase shifts, were synchronized with heartbeat. Various hemodynamic parameters, such as left ventricular pressure and volume, coronary flow, and arterial pressure, were analyzed to examine the influence of pump support. RESULTS: The pump speed modulation significantly affected left ventricular pressure and volume and arterial pressure, whereas coronary flow was not influenced by pump support mode. Stroke work in the pulsatile modes varied from 69% to 91% of baseline value and from 74% to 96% of constant speed value. Consequently, cardiac workload can be adjusted to provide relaxation, which may lead to myocardial recovery. CONCLUSIONS: A synchronized pulsing rotary blood pump offers a simple and powerful control modality for heart unloading. This technique provides pulsatile hemodynamics, which is more physiologic than continuous blood flow and may be useful for perfusion of the other organs.

Optimization of a miniature Maglev ventricular assist device for pediatric circulatory support.

A miniature Maglev blood pump based on magnetically levitated bearingless technology is being developed and optimized for pediatric patients. We performed impeller optimization by characterizing the hemodynamic and hemocompatibility performances using a combined computational and experimental approach. Both three-dimensional flow features and hemolytic characteristics were analyzed using computational fluid dynamics (CFD) modeling. Hydraulic pump performances and hemolysis levels of three different impeller designs were quantified and compared numerically. Two pump prototypes were constructed from the two impeller designs and experimentally tested. Comparison of CFD predictions with experimental results showed good agreement. The optimized impeller remarkably increased overall pump hydraulic output by more than 50% over the initial design. The CFD simulation demonstrated a clean and streamlined flow field in the main flow path. The numerical results by hemolysis model indicated no significant high shear stress regions. Through the use of CFD analysis and bench-top testing, the small pediatric pump was optimized to achieve a low level of blood damage and improved hydraulic performance and efficiency. The Maglev pediatric blood pump is innovative due to its small size, very low priming volume, excellent hemodynamic and hematologic performance, and elimination of seal-related and bearing-related failures due to adoption of magnetically levitated bearingless motor technology, making it ideal for pediatric applications.

Assessment of hydraulic performance and biocompatibility of a MagLev centrifugal pump system designed for pediatric cardiac or cardiopulmonary support.

The treatment of children with life-threatening cardiac and cardiopulmonary failure is a large and underappreciated public health concern. We have previously shown that the CentriMag is a magnetically levitated centrifugal pump system, having the utility for treating adults and large children (1,500 utilized worldwide). We present here the PediVAS, a pump system whose design was modified from the CentriMag to meet the physiological requirements of young pediatric and neonatal patients. The PediVAS is comprised of a single-use centrifugal blood pump, reusable motor, and console, and is suitable for right ventricular assist device (RVAD), left ventricular assist device (LVAD), biventricular assist device (BVAD), or extracorporeal membrane oxygenator (ECMO) applications. It is designed to operate without bearings, seals and valves, and without regions of blood stasis, friction, or wear. The PediVAS pump is compatible with the CentriMag hardware, although the priming volume was reduced from 31 to 14 ml, and the port size reduced from 3/8 to (1/4) in. For the expected range of pediatric flow (0.3-3.0 L/min), the PediVAS exhibited superior hydraulic efficiency compared with the CentriMag. The PediVAS was evaluated in 14 pediatric animals for up to 30 days, demonstrating acceptable hydraulic function and hemocompatibility. The current results substantiate the performance and biocompatibility of the PediVAS cardiac assist system and are likely to support initiation of a US clinical trial in the future.

Computational fluid dynamics analysis of a maglev centrifugal left ventricular assist device.

The fluid dynamics of the Thoratec HeartMate III (Thoratec Corp., Pleasanton, CA, U.S.A.) left ventricular assist device are analyzed over a range of physiological operating conditions. The HeartMate III is a centrifugal flow pump with a magnetically suspended rotor. The complete pump was analyzed using computational fluid dynamics (CFD) analysis and experimental particle imaging flow visualization (PIFV). A comparison of CFD predictions to experimental imaging shows good agreement. Both CFD and experimental PIFV confirmed well-behaved flow fields in the main components of the HeartMate III pump: inlet, volute, and outlet. The HeartMate III is shown to exhibit clean flow features and good surface washing across its entire operating range.

Incorporation of electronics within a compact, fully implanted left ventricular assist device.

The promise of expanded indications for left ventricular assist devices in the future for very long-term applications (10+ years) prompts sealed (i.e. fully implanted) systems and less-obtrusive and more reliable implanted components than their external counterparts in percutaneous configurations. Furthermore, sealed systems increase the fraction of total power losses dissipated intracorporeally, a disadvantage that must be carefully managed. We set out to incorporate the motor drive and levitation control electronics within the HeartMate III blood pump without substantially increasing the pump's size. Electronics based on a rigid-flex satellite printed circuit board (PCB) arrangement that could be folded into a very compact, dense package were designed, fabricated, and tested. The pump's lower housing was redesigned to accommodate these PCBs without increasing any dimension of the pump except the height, and that by only 5 mm. The interconnect cable was reduced from 22 wires to 10 (two fully redundant sets of 5). An ongoing test of the assembled pump in vitro has demonstrated no problems in 5 months. In addition, a 20-day in vivo test showed only 1 degrees C temperature rises, equivalent to pumps without incorporated electronics at similar operating conditions.