The control strategy for ventricular support with a centrifugal blood pump was examined in this study. The control parameter was the pump rpm that determines pump flow. Optimum control of pump rpm that reflects the body's demand is important for long-term, effective, and safe circulatory support. Moreover, continuous, reliable monitoring of ventricular function will help successfully wean the patients from the ventricular assist device (VAD). The control strategy in this study includes determination of the target pump rpm that can provide the flow required by the body, fine-rpm-tuning to minimize deleterious effects such as suction in the ventricle, and assessment of ventricular function for successful weaning from VADs. To determine the target pump rpm, we proposed to use the relation between the native heart rate and cardiac output, and the relation between the pump rpm and centrifugal pump output. For fine-tuning of the pump rpm, the motor current waveform was used. We computed the power spectral density of the motor current waveform and calculated the ratio of the fundamental to the higher order components. When this ratio was larger than approximately 0.2, we assumed there would be a suction effect in the ventricle. As for assessment of ventricular function, we used the amplitude of the motor current waveform. The control system implemented using a DSP functioned properly in the mock circulatory loop as well as in acute animal experiments. The motor current also showed a good correlation with the ventricular pressure in acute animal experiments.

In this study, the effects on varying cardiac function during a left ventricular (LV) bypass from the apex to the descending aorta using a centrifugal blood pump were evaluated by analyzing the left ventricular pressure and the motor current of the centrifugal pump in a mock circulatory loop. Failing heart models (preload 15 mm Hg, afterload 40 mm Hg) and normal heart models (preload 5 mm Hg, afterload 100 mm Hg) were simulated by adjusting the contractility of the latex rubber left ventricle. In Study 1, the bypass flow rate, left ventricular pressure, aortic pressure, and motor current levels were measured in each model as the centrifugal pump rpm were increased from 1,000 to 1,500 to 2,000. In Study 2, the pump rpm were fixed at 1,300, 1,500, and 1,700, and at each rpm, the left ventricular peak pressure was increased from 40 to 140 mm Hg by steps of 20 mm Hg. The same measurements as in Study 1 were performed. In Study 1, the bypass flow rate and mean aortic pressure both increased with the increase in pump rpm while the mean left ventricular pressure decreased. In Study 2, a fairly good correlation between the left ventricular pressure and the motor current of the centrifugal pump was obtained. These results suggest that cardiac function as indicated by left ventricular pressure may be estimated from a motor current analysis of the centrifugal blood pump during left heart bypass.

A console based implantable motor-driven left ventricular assist device (LVAD) was developed and tested. Ten sheep weighing 42-73 kg (mean, 54.4 kg) were used as the experimental animals. Four animals survived 5-12 h (mean, 9.5 h). The mean pump flow was 1.63 L/min, ranging from 0.8 to 2.5 L/min. The cause of termination was respiratory failure in 3 animals, bleeding in 2, ventricular fibrillation in 2, vent tube obstruction in 1, thrombus formation in 1, and mechanical failure of the driving console in 1. Following the in vivo studies, the computer regulated controller was tested in a mock circulatory system. The LVAD provided 5.34 L/min of maximum output against a mean afterload of 80 mm Hg with a filling pressure of 15 mm Hg when the pump rate was 80 bpm in the fixed rate mode. With an increase in the pump afterload from 80 to 140 mm Hg, the total system efficiency varied from 7.81 to 8.34% when the pump preload was 15 mm Hg. An ultracompact, completely implantable electromechanical VAD has been under development. This device should fit in a 60 kg adult. As the next step, we are preparing to implant this ultracompact implantable VAD with an electronic controller in an animal model with better results being expected.

In this study, we analyzed the extent and pattern of regression of left ventricular (LV) hypertrophy after aortic valve replacement in patients with aortic stenosis (AS) and compared the results with those of another group of patients with aortic regurgitation (AR). Seventy patients who underwent isolated aortic valve replacement were divided into 2 groups. Group 1 was comprised of 29 patients who underwent aortic valve replacement for aortic stenosis, and Group 2 of 41 patients who underwent aortic valve replacement for aortic regurgitation. A third group of 10 healthy subjects served as a healthy control group. Echocardiographic studies were done before the operation and 5 years postoperatively. At follow-up, a significant reduction in the left ventricular mass was found in both groups, but it remained significantly greater than in the healthy control group. The ratio of LV wall thickness to radius (th/r) in Group 1 decreased significantly, and at follow-up it was within the normal value. In Group 2, the th/r ratio increased, and at follow-up it was within the normal value. After aortic valve replacement, the wall thickness remained significantly greater than normal for patients with AS, and the chamber radius remained significantly greater than normal for patients with AR. For these reasons, LV hypertrophy still existed in both groups at postoperative follow-up. The actuarial survival rate was 85.3% at 16 years for Group 1 and 83.4% at 18 years for Group 2. There was no significant difference in the long-term survival rates between the 2 groups. Actuarial freedom from valve-related events was 91.9% at 16 years for Group 1 and 82% at 18 years for Group 2. There was no significant difference in the valve-related event free curves between groups. After 5 years of follow-up, th/r reached normal for both groups, indicating remodeling of the LV geometry after aortic valve replacement.

Control of ventricular assist devices (VADs) for native heart preservation should be attempted, and it could be one strategy for dealing with the shortage of donors in the future. In the application of a nonpulsatile blood pump for ventricular assistance from its apex to the aorta, the bypass flow and hence motor current of the pumps change in response to the ventricular pressure change. Utilizing these intrinsic characteristics of the continuous flow pumps, this study investigated whether or not motor current could be used as an index for continuous monitoring of native cardiac function. In Study 1, a centrifugal blood pump (CFP) VAD was installed between the apex and descending aorta of a mock circulatory loop. In this model, a baseline with a preload of 10 mm Hg, afterload of 40 mm Hg, and left ventricular (LV) systolic pressure of 40 mm Hg was used. The pump rpm were fixed at 1,300, 1,500, and 1,700, and LV systolic pressure was increased up to 140 mm Hg by a step of 20 mm Hg while observing the changes in LV pressure, motor current, pump flow, and aortic pressure. In Study 2, in vivo experiments were performed using 5 sheep. A left heart bypass model was created using a centrifugal pump from the ventricular apex to the descending aorta. The LV pressure was varied through administration of dopamine while observing the changes in LV pressure, pump flow, motor current, and aortic pressure at 1,500 and 1,700 rpm. An excellent correlation was observed both in vitro and in vivo studies in the relationship between motor current and LV pressure. In Study 1, the correlation coefficients were 0.77, 0.92, and 0.99 for 1,300, 1,500, and 1,700 rpm, respectively. In Study 2, they were 0.90 (Animal 1), 0.82 (Animal 2), 0.89 (Animal 3), 0.93 (Animal 4), and 0.70 (Animal 5) respectively for 1,500 rpm, and 0.94 (Animal 2), 0.85 (Animal 3), 0.94 (Animal 4), and 0.89 (Animal 5) respectively, for 1,700 rpm. The relationship between motor current and pump flow and LV pressure showed an unstable correlation in an in vivo study. These results suggest that motor current amplitude monitoring could be useful as an index for the control of VADs for native heart preservation.