James H. Donachy

An electric artificial heart for clinical use.

Advances in microelectronics, high-strength magnets, and control system design now make replacement of the heart using an implantable, electrically powered pump feasible. The device described herein is a compact, dual pusher plate unit with valved polyurethane sac-type ventricles positioned at either end. The power unit consists of a small, brushless direct current motor and a motion translator. A microprocessor control system is used to regulate heart beat rate and provide left-right output balance. Bench studies lasting for as long as 1 year have been performed. Heart replacement with the electric heart has been performed in 18 calves since 1984. The longest survivor lived for more than 7 months. Among the causes of termination were component failure, thromboembolic complications, and bleeding. No major problem has been identified that precludes prolonged use of the electric heart. In the future the patient with end-stage heart disease will have an electric artificial heart as one therapeutic option.

Complete Left Ventricular Bypass With a Paracorporeal Pump: Design and Evaluation

A multidiscipline group was established at The Pennsylvania State University to design and evaluate mechanical circulatory assist devices and the artificial heart. The group has designed a left ventricular to aortic assist system which consists of a sac-type pump, a synchronization unit, a pneumatic power unit, and appropriate monitoring apparatus. The assist system has been evaluated for long-term circulatory assistance in a series of ten calves. The assist pump was placed in the paracorporeal position. The longest period of continuous pumping was over eight months. The last four calves have had synchronized assist pumping which has permitted prolonged ventricular decompression and assist pump flow rates as high as 10 L/min. Three of these four calves had no evidence of thromboemboli. Additional animal studies will be required before clinical use of such an assist pump system can be safely undertaken.

Total artificial heart implantation in calves with pump on an angled port design.

The APP was employed in our 21st TAH calf and has now been implanted in a total of 11 animals. The APP has a dynamic stroke volume of 105 ml, an ejection fraction of 75%, and a peak flow of 14 L/min. The TAH features 2 APPs which have polysulfone cases and contain smooth, seam-free polyurethane sacs. Concavoconvex Bjork-Shiley valves are used. The pumps are pneumatically driven but may be easily converted to pusher-plate drive. A pneumatic drive console and an automatic control unit complete the system. The automatic control unit permits independent control of the right and left hearts as a function of left atrial and aortic pressure respectively. The average survival of the APP TAH calves has been 65 days. Hematologic study has revealed basically normal results with minimal elevation of serum hemoglobin and lactic acid dehydrogenase (LDH), indicative of a low level of hemolysis. Elelvation of central venous pressure (CVP) and total blood volume continue to be a problem with some TAH calves but not all. The APP has led to a dramatic increase in duration of survival and decrease in thromboembolism.

A completely implanted left ventricular assist device : chronic in vivo testing

A completely implantable left ventricular assist device (LVAD) designed for permanent circulatory support has recently been tested in animals without the use of percutaneous leads, using transcutaneous energy transmission and wireless telemetry. The LVAD consists of a brushless DC motor and rollerscrew energy converter, a pusher plate actuated blood pump with a seamless segmented polyurethane blood sac, Bjork-Shiley Delrin disk monostrut valves, an implanted compliance chamber, an implanted electronic controller and battery, and a transcutaneous energy transmission system. The blood pump/energy converter assembly weighs 565 g and displaces 295 cc. The dynamic stroke volume is 60 ml, and the maximum output is 9 L/min. Pump output is automatically controlled to maintain full stroke volume as preload varies. Hall effect sensors for detecting rotary position of the motor are the only sensors used. Six bovine implants were performed, with durations of 84, 208, 244, 130, 70 (ongoing), and 15 (ongoing) days. Four animals used two-way telemetry, whereas the remaining two used one-way (outgoing) telemetry. These first chronic in vivo tests with the Penn State completely implanted LVAD system have demonstrated that it is a feasible solution to long-term ventricular support.

In vivo determinants of energy consumption in electric motor driven artificial hearts.

To identify factors responsible for energy consumption, a retrospective investigation of the in-vivo performance of the 100 ml electric motor-driven left ventricular assist device (ELVAD), and the e-motor 100 ml total artificial heart, was undertaken. Multivariate regression analysis of the device parameters demonstrated that device flow, and estimated outlet pressure, were the most significant independent variables for predicting changes in motor power. Weighted least-square curvefit, using the product of these two variables, showed that changes in energy consumption can be well predicted for the ventricular assist device (r2 = 0.732). However, by applying the same model to the total artificial heart (ETAH), less favorable results were achieved (r2 = 0.422). In this model, device flow seemed to be more important in predicting energy consumption for the ETAH compared to the ELVAD. Therefore, changing the model by using flow to the third order significantly improved the fit (r2 = 0.6706) for the ETAH, and could compensate in part for the greater variability of the values and increased number of outliers in this group.

A New Prosthesis for Reconstruction of the Left Ventricular Outflow Tract

A new left ventricular outflow tract prosthesis is described. It consists of a tightly woven Dacron graft with one end modified by being wrapped around a thin perforated stainless steel tube to form a rigid left ventricular insertion port and the other end anastomosed to a Hancock xenograft valved conduit for suture to the arterial system. The prosthesis is simple in design and flexible enough to permit anastomosis to any portion of the abdominal aorta. In addition, since the entire blood conduit consists of a porous woven arterial graft and a tissue valve, anticoagulants are not required. The prosthesis has been successfully employed in a 7-year-old boy who had undergone two previous open-heart operations for resection of a subaortic ring but who had persistent evidence of severe residual stenosis. We believe this conduit has advantages over present commercially available units.

An annular compliance chamber for the Pennsylvania state university electric total artificial heart

To eliminate the need for a separate parapleural compliance chamber, we are currently investigating the feasibility of an annular compliance chamber. This chamber wraps around the energy converter and fits between the blood pumps of the Pennsylvania State University electric total artificial heart. For the 100 cc total artificial heart, the compliance chamber volume is 76 ml and the tissue contacting surface area is approximately 85 cm2. The chamber is made of Dacron velour covered segmented polyether polyurethane urea. The annular compliance chamber was evaluated in vitro by comparing pump balance control performance against that obtained with an open vent. In the CVP range of 5-12 mmHg, LAP was maintained within 1 mmHg of the values obtained with a vent. Studies continue to determine the range of volumes over which the chamber is effective, differences in rates of diffusion, and performance during changes in barometric pressure.