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In 1974, between 2 and 8% of the 50,000 adult patients undergoing cardiac surgery in this country succumbed in the early post-operative period from left ventricular failure, despite various methods of pharmacologic and/or mechanical support. Our laboratories have concentrated on the development, modification, evaluation, and validation of an abdominally positioned left ventricular assist device which has the potential of reducing these mortalities. Continuous testing in animals, for periods exceeding 2 mos, satisfied reliability, durability and longevity requirements. The cumulative results of these investigations were reviewed at the National Heart and Lung Institute on August 21, 1975. Authorization for clinical trials of the device according to specific criteria and protocols46 was approved on November 1, 1975. The ALVAD is now in the early stages of clinical testing. The results of the current experiments demonstrate that ventricular outflow impedance and prosthetic inflow impedance are the major determinants of left ventricular assist device hemodynamic effectiveness. By markedly reducing outflow impedance, the ALVAD profoundly lowers ventricular pressure-work and oxygen demands while simultaneously increasing ventricular performance and maintaining or augmenting systemic perfusion. Moreover, our studies indicate that improved device designs (intended for intermediate and long-term implantation) and maximal performance can be achieved by focusing on these central determinants.

Total THI/Gould LVAS experience includes 59 pneumatically and electrically-actuated blood pump evaluations (in calves, goats and sheep), including 23 studies with the Gould Model V energy converter. This experience has resulted in greater than 8 cumulative years of actuation, in vivo, including electrically-actuated LVAS durations up to 6 mos.

1) The implanted TAH offers a method of evaluating the effects of varying physiologic demands cardiac output and venous return. 2) Cardiac output and venous return measurements offer a method of evaluating system design of the device and driving and control-logic improvements in awake, unanesthetized animals. 3) The obtained cardiac function and venous return curves suggest that the present TAH is less responsive to increases in right atrial pressure than the natural heart, but is still completely controlled by venous return. Therefore, it is extremely important to make every effort to eliminate any factor causing excessive venous return.