Optimization of axial-pump pressure sensitivity for a continuous-flow total artificial heart.

BACKGROUND: In this study, we describe the potential advantages of a continuous-flow total artificial heart (CFTAH) comprising two small, non-pulsatile pumps with optimized responsiveness to the pressure gradient. METHODS: We modified a MicroMed DeBakey axial-flow pump by increasing its inducer-impeller inlet angle, thereby increasing its pressure responsivity. We obtained the in vitro pressure gradient response and compared it with those of the clinically used, unmodified MicroMed DeBakey pump, Jarvik 2000 FlowMaker and HeartMate II. RESULTS: The modified pump showed an increased response to changes in the pressure gradient at pump flow rates of between 2 and 4 liters/min. The maximum pressure responsivity of the modified pump was 2.5 liters/min/mm Hg; the corresponding maximum responsivities of the Jarvik 2000, HeartMate II and MicroMed DeBakey ventricular assist devices (VADs) were 0.12, 0.09 and 0.38 liters/min/mm Hg, respectively. CONCLUSIONS: Because of the inherent properties of non-pulsatile pumps, the CFTAH may potentially respond to changes in inflow and outflow pressures while maintaining physiologic flow rates sufficient for normal daily activity. In addition, the hemodynamic interplay between the two optimized pumps should allow a physiologic response to normal flow imbalances between the pulmonary and systemic circulations. Improved responsiveness to inflow pressure may further simplify and improve the CFTAH and affect its potential clinical use as a meaningful therapy for terminal heart failure.

Continuous flow total artificial heart: modeling and feedback control in a mock circulatory system.

We developed a mock circulatory loop and used mathematical modeling to test the in vitro performance of a physiologic flow control system for a total artificial heart (TAH). The TAH was constructed from two continuous flow pumps. The objective of the control system was to maintain loop flow constant in response to changes in outflow resistance of either pump. Baseline outflow resistances of the right (pulmonary vascular resistance) and the left (systemic vascular resistance) pumps were set at 2 and 18 Wood units, respectively. The corresponding circuit flow was 4 L/min. The control system consisted of two digital integral controllers, each regulating the voltage, hence, the rotational speed of one of the pumps. The in vitro performance of the flow control system was validated by increasing systemic and pulmonary vascular resistances in the mock loop by 4 and 8 Wood units (simulating systemic and pulmonary hypertension conditions), respectively. For these simulated hypertensive states, the flow controllers regulated circuit flow back to 4 L/min within seconds by automatically adjusting the rotational speed of either or both pumps. We conclude that this multivariable feedback mechanism may constitute an adequate supplement to the inherent pressure sensitivity of rotary blood pumps for the automatic flow control and left-right flow balance of a dual continuous flow pump TAH system.

Ambulatory oxygenator right ventricular assist device for total right heart and respiratory support.

BACKGROUND: Our goal is ambulatory total respiratory and right heart assistance allowing a bridge to lung transplant. To that end, we have coupled a compact paracorporeal gas exchange device with a right ventricular assist device (RVAD) to create an "OxyRVAD." METHODS: Through a limited left thoracotomy, the main pulmonary artery (PA) and right atrium (RA) were exposed in 5 anesthetized sheep. After a systemic heparin bolus, a 12-mm outer diameter crimped graft glued to tubing was anastomosed (end to side) to the main PA and a VAD atrial cannula was placed through the RA appendage. The chest was drained and closed, then the PA graft flowed at 1 to 2 L/min as a shunt to the RA overnight. The next day, the animal was reanticoagulated, and the shunt cannulae clamped and divided. The OxyRVAD unit, consisting of commercially available components including an axial flow pump and low-resistance cardiopulmonary bypass gas exchange device, was interposed. Pumping from RA to PA was maintained at 3 L/min. RESULTS: Five consecutive sheep survived the implant, and stood and ate normally after initiation of the OxyRVAD. Three survived the full 2-week study, and a fourth was sacrificed on day 13 owing to a storm-related power failure. For these 4 sheep, pump flow was stable at 3 L/min. Carbon dioxide removal was constant and total during the experiment at 200 +/- 19 mL/min. Oxygen transfer was 144 +/- 44 mL/min. One sheep had progressive thrombocytopenia and was sacrificed on day 5 after implant. CONCLUSIONS: Our ambulatory OxyRVAD can provide total assistance for the right heart and lungs in normal awake sheep for 14 days.

Suction detection for the MicroMed DeBakey Left Ventricular Assist Device.

The MicroMed DeBakey Ventricular Assist Device (MicroMed Technology, Inc., Houston, TX) is a continuous axial flow pump designed for long-term circulatory support. The system received CE approval in 2001 as a bridge to transplantation and in 2004 as an alternative to transplantation. Low volume in the left ventricle or immoderate pump speed may cause ventricular collapse due to excessive suction. Suction causes decreased flow and may result in patient discomfort. Therefore, detection of this critical condition and immediate adaptive control of the device is desired. The purpose of this study is to evaluate and validate system parameters suitable for the reliable detection of suction. In vitro studies have been performed with a mock loop allowing pulsatile and nonpulsatile flow. Evidence of suction is clearly shown by the flow waveform reported by the implanted flow probe of the system. For redundancy to the implanted flow probe, it would be desirable to use the electronic motor signals of the pump for suction detection. The continuously accessible signals are motor current consumption and rotor/impeller speed. The influence of suction on these parameters has been investigated over a wide range of hydrodynamic conditions, and the significance of the respective signals individually or in combination has been explored. The reference signal for this analysis was the flow waveform of the ultrasonic probe. To achieve high reliability under both pulsatile and nonpulsatile conditions, it was determined that motor speed and current should be used concurrently for suction detection. Using the amplified differentiated current and speed signals, a suction-detection algorithm has been optimized, taking into account two different working points, defined by the value of the current input. The safety of this algorithm has been proven in vitro under pulsatile and nonpulsatile conditions over the full spectrum of possible speed and differential pressure variations. The algorithm described herein may be best utilized to provide redundancy to the existing flow based algorithm.