In vivo hemodynamic performance of the Cleveland Clinic CorAide blood pump in calves.

BACKGROUND: The Cleveland Clinic CorAide left ventricular assist system is based on a small implantable continuous-flow centrifugal blood pump with a completely suspended rotating assembly designed for long-term circulatory support (5 to 10 years). METHODS: Between June 1999 and August 2000, the CorAide blood pump was implanted in 10 calves for 1 month and in 3 calves for 3 months. RESULTS: The mean pump flow and arterial pressure were 6.1 +/- 1.1 L/min and 97 +/- 5 mm Hg, respectively. The mean plasma free-hemoglobin level after postoperative day 3 was 2.0 +/- 1.8 mg/dL. Renal and hepatic function remained normal in all cases. There was no incidence of mechanical failure, hemolysis, bleeding, or systemic organ dysfunction in any of the cases. Significant findings at autopsy were limited to two cases of renal infarction, one of which was associated with an outflow graft infection. CONCLUSIONS: The CorAide blood pump is easily implanted, reliable, nonhemolytic, and nonthrombogenic, positioning it as a leading third-generation, continuous-flow left ventricular assist system with a completely suspended rotor.

Anatomic fitting studies of a total artificial heart in heart transplant recipients. Critical dimensions and prediction of fit.

Anatomic fitting studies of the Cleveland Clinic-Nimbus total artificial heart were performed in 33 patients undergoing heart transplantation. The pump fit in the pericardial space in 20 men (80%) and 4 women (50%). There was no significant difference between the Fit and Non-Fit groups in external chest dimensions. Among 42 intrathoracic dimensions, the distance from the center of the mitral valve to the diaphragm (Fit: 5.6 +/- 2.2 cm, Non-Fit: 3.6 +/- 0.4 cm, p < 0.00001) and the distance from the caudal end of the pulmonary valve to the diaphragm (Fit: 9.4 +/- 1.6 cm, Non-Fit: 6.3 +/- 0.8 cm, p < 0.0001) were the most critical. To predict anatomic fit, an index (A x B x C) was obtained from chest X-ray measurements (A, the craniocaudal distance from the dorsal region of the 8th left rib to the left diaphragm; B, the maximum left chest width; and C, the maximum anteroposterior sternum-vertebrae dimension). The pump fit in 88.5% of the patients with an index above 1200 cm3, whereas it fit in only 14.3% of the patients with an index below 1200 cm3 (p < 0.001). This index was an easily obtainable, good predictor of anatomic fit.

In vitro evaluation of automatic control performance of a total artificial heart with changes in pump orientation.

Unlike in animal experiments, the pump orientation of a total artificial heart (TAH) can change remarkably in humans with the recipient's posture (upright, supine, or prone), thus affecting its filling characteristics. The left master alternate control mode of the Cleveland Clinic-Nimbus (CC-N) TAH adjusts beat rate by maintaining the left pump at 90% filling, producing a Frank-Starling like preload sensitivity. In order to verify that the CC-N TAH functions properly regardless of the gravity effects on pump filling, the preload sensitivity curves of the CC-N TAH were evaluated on a mock circulatory loop with the simulated supine (right pump up) and prone (left pump up) positions in humans. The right preload sensitivity was slightly higher when the right pump was up versus down, and likewise the left preload sensitivity was higher when the left pump was up versus down. Despite these gravity effects on pump filling, right and left preload sensitivity remained within physiologic range and the automatic control of the CC-N TAH functioned properly without significant postural effects.

Assessment of circulating blood volume in calves with a total artificial heart.

Measurement of the circulating blood volume (CBV) is essential to a proper understanding of the hemodynamic performance of total artificial hearts (TAHs). Recently, the authors employed CBV measurements using indocyanine green dye in calves with a TAH. The advantages of this method over previous methods using radionuclides include simplicity, low cost, and the capability of repeated and frequent measurements. Reproducibility of the measurements was demonstrated in three normal calves with a relative standard deviation of 3.9 +/- 2.4%. CBV was measured in eight calves with the Cleveland Clinic-Nimbus TAH and compared with that of seven calves that underwent mitral valve replacement. Small standard deviations in pre operative values in both TAH and mitral valve replacement groups demonstrated the precision of CBV measurements. Although there was no change in CBV in the mitral valve replacement group, CBV in the TAH group increased to more than twice the pre operative value after 2 weeks. Although the right atrial pressure increased similarly after TAH implantation, there was no correlation (r = 0.08) between the right atrial pressure and CBV, which suggested a possible inaccuracy in estimating CBV from the right atrial pressure. A negative correlation between the hematocrit value and CBV suggested that hemodilution might be one of the causes of anemia observed in our TAH animals.

Hemodynamic changes with posture in calves with total artificial heart.

Hemodynamic changes with posture, sitting versus standing, were analyzed in five Holstein calves with the Cleveland Clinic-Nimbus TAH. This total artificial heart (TAH) has a left master alternate control mode that adjusts the pump rate and consequently pump flow proportional to the pulmonary venous return to the left pump (AUTO period). However, in this series of experiments, the pump reached its maximum beat rate within 1-5 days post operatively, after which pump flow could not increase (MAX period). Hemodynamic parameters (RAP, LAP, PAP, AoP, and pump flow) were obtained every 15-20 min throughout the experiments for as long as 120 days and averaged for each posture for each period. During the AUTO period, the flow while standing was significantly higher than that while sitting (standing: 8.7 +/- 0.2 L/min; sitting: 7.5 +/- 0.4 L/min; p < 0.05), and the systemic vascular resistance (SVR) was significantly lower (standing: 895 +/- 93 dyne.sec.m-5; sitting: 1,041 +/- 124 dyne.sec.m-5; p < 0.05). During the MAX period, the AoP and SVR standing were significantly lower than those sitting (AoP standing: 91 +/- 7 mmHg; AoP sitting: 98 +/- 7 mmHg; p < 0.05; SVR standing: 652 +/- 75 mmHg; SVR sitting: 730 +/- 96 mmHg; p < 0.05). The Cleveland Clinic-Nimbus TAH responded well to these changes in position, increasing pump flow and maintaining the AoP during the AUTO period.

Effects of a total artificial heart right stroke volume limiter on left-right hemodynamic balance.

In a completely implantable total artificial heart (TAH), the left-right flow difference attributable to higher volumetric efficiency of the right pump and bronchial artery shunting has always been a significant problem. The automatic control of the Cleveland Clinic-Nimbus TAH accommodates for the left-right flow difference when the beat rate is below maximum (AUTO range). However, at its maximum beat rate (MAX), high left atrial pressure (LAP) (greater than 25 mmHg) with relatively low right atrial pressure (RAP) (less than 8 mmHg) were observed both in vitro and in vivo, suggesting the need for a stroke volume limiter (SVL) of the right pump. In vitro volume loading tests showed 10%, 15%, and 20% SVLs prevented a disproportionate increase of LAP. In vivo studies in five Holstein calves also showed a balanced LAP-RAP relationship with 10% and 15% SVLs at MAX. The left pump flow was not affected by this range of SVLs either in vitro or in vivo. Pulmonary function was maintained with either size SVL, with autopsies revealing absence of pulmonary congestion and minimal pleural effusions in two calves surviving for more than 1 month. Although additional studies are needed to determine the appropriate size of the SVL, both 10% and 15% SVLs were effective in maintaining left-right hemodynamic balance in this TAH.