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This study was designed to compare the relative merits of soft and rigid artificial ventricles. A cascade mock circulation was used to measure cardiac output under different circumstances. The data show that these soft air driven ventricles show a Starling's-like response over a wider range of filling pressures than identical, but rigid, ventricles. Compression of soft ventricles by high intrathoracic pressures was simulated in vitro. Air pressures up to +20 mm Hg did not seriously affect soft ventricles. Cardiac tamponade was simulated by compressing the ventricle in a closed fluid compartment. Tamponade became severe when volume reduction of the ventricle rose to 60 ml. Hemolysis caused by soft and rigid ventricles was tested in a blood bag set-up and was 48-82% higher in the rigid ventricle, depending on the driving conditions. Possibly, this could be explained by the authors' finding that rigid ventricles showed a 20% higher intraventricular dP/dtmax value than soft ventricles. Soft ventricles were implanted in three calves as a total artificial heart (TAH). Implantation without quick connectors was easy because the surgeon could easily fold and compress the ventricles. No physiological complications of softness were observed. Blood damage in the animals was low (less than 5 mg/dl). The authors conclude that soft ventricles show distinct surgical and functional advantages over rigid ventricles.

We remodeled and tested our semisoft 20cc ventricle and made a new bileaflet flap inflow valve. Housings, bases, outflow valve, and a newly designed diaphragm were all made by vacuum forming and put together by radiofrequency welding or glue. In vitro, the ventricle produced a cardiac output of 2.5 to 3.0 L/min and showed reliable durability results. Hematological testing showed no important thrombogenicity of the new valve. Cardiac output was higher than expected for the volume of the ventricle, perhaps because of stretching or flow through. Animal experiments with the left ventricular assist device (LVAD) version was done at Ohio State University. Earlier in Utah, we did 20 cc total artificial heart (TAH) implantations and LVAD experiments in lambs and recently in calves with the 60cc TAH version. A soft ventricle is easy to implant and low in production costs.

The quick connect system and mechanical disk valves used in total artificial hearts (TAH) are sources of thrombogenesis and blood damage. Our soft TAH, which has no quick connectors, can be squeezed and bent, making it easily implantable, and blood damage is reduced by the use of trileaflet and biflap polyurethane valves. The soft ventricles were made by vacuum forming, after which the pieces were welded together by radiofrequency heat sealing. A rapid clamshell can be pushed and slipped over the soft heart to prevent deformation of the ventricle. Three calves have had the 60 cc soft TAH implanted, both with and without a clamshell. The cardiac outputs were as high as 7 L/min, without a vacuum applied during diastole. Two lambs received the 20 cc TAH (as an acute experiment); it fit and functioned well. One healthy lamb received a 20 cc left ventricular assist device (LVAD) with a pulsating artificial atrium as a survival experiment. The lamb survived for 8 days, after which the device was removed and the lamb returned to the meadow. Thrombosis in the TAH was minimal, and the plasma free hemoglobin values in all the TAH and LVAD experiments were usually lower than 5 mg/dl and often lower than 2 mg/dl.

Device-induced thrombogenesis was studied in an in vitro model using human blood circulated through an artificial ventricle. A new constant pressure filtration technique was used to detect circulating microemboli, the activated partial thromboplastin time (APTT) test was used to monitor the blood for the presence of anticoagulant activity of heparin, and hemolysis was quantified by measuring the plasma free hemoglobin level. Circulation of blood through a 20-ml stroke volume pneumatically driven ventricle for 6-9 h resulted in a significant reduction of APTT, indicating the loss of the anticoagulant effect of heparin. Microemboli concentration was minimal until the APTT decreased below 125 s, at which time the microemboli concentration increased rapidly. This was presumed to be due to the formation of thrombi following a decrease in heparin activity. A significant increase in hemolysis was also noted when blood was pumped. None of these changes was noted in the nonpumped control blood. Spontaneous loss of heparin activity in blood circulated by a pneumatically driven pump may have clinical implications and may help understanding of the problems associated with device-induced thrombogenesis.

Implantable prosthetic ventricles and trileaflet valves made by vacuum forming have been developed and implant tested. All components are made from Pellethane. Recognizing the need for smaller as well as larger ventricles, designs with effective stroke volumes of 50, 85, 100 and 130 cc have been tested with several valve types. The pneumatically driven Utah ventricular assist device (UVAD) can be used as a total artificial heart (TAH) or ventricular assist device (VAD) by using the appropriate inflow and outflow adapters. In vitro durability testing has demonstrated ventricular lifetime beyond two years and valve lifetime to nearly one and one half years. The polymer valves have lower regurgitation than mechanical valves. Animal implantation experience includes 21 TAH implants and 16 left ventricular assist device (LVAD) implantations. TAH survival ranges from 2 to 210 days. LVAD animals have lived up to 116 days before elective termination. The animal were healthy and grew normally. The devices exhibit a "Starling's Law" response. One TAH animal survived 72 days before successful explantation followed by transplantation. At autopsy, this animal had no renal infarcts. Hematology data has demonstrated the existance of little or no intravascular hemolysis (PF Hb less than 5 mg%). The "Philadelphia" version of the UVAD vacuum formed ventricles are small enough to be implanted without thrombus provoking connectors. Eight animals have received this TAH and survived up to 120 days. Vacuum forming offers a rapid and inexpensive way to produce reliable and effective total artificial hearts and valves for widespread, temporary clinical application in any size adult human.