Artificial Heart and Assist Devices: Directions, Needs, Costs, Societal and Ethical Issues
Authors: van Citters Robert L. , Bauer Catherine B. , Christopherson Lois K. , Eberhart Robert C. , Eddy David M. , Frye Robert L. , Jonsen Albert R. , Keller Kenneth H. , Levine Robert J. , McGoon Dwight C. , Pauker Stephen G. , Rackley Charles E. , Willman Vallee L. , Frommer Peter L. 
Published: November 2008

Abstract: A Working Group appointed by the Director of the National Heart, Lung, and Blood Institute (NHBLI) has reviewed the current status of mechanical circulatory support systems (MCSS), and has examined the potential need for such devices, their cost, and certain societal and ethical issues related to their use. The media have reported the limited clinical investigative use of pneumatically energized total artificial hearts (which actually replace the patient's heart) and left ventricular assist devices (which support or replace the function of the left ventricle by pumping blood from the left heart to the aorta with the patient's heart in place). However, electrically energized systems, which will allow full implantation, permit relatively normal everyday activity, and involve battery exchange or recharge two or three times a day, are currently approaching long‐term validation in animals prior to clinical testing. Such long‐term left ventricular assist devices have been the primary goal of the NHLBI targeted artificial heart program. Although the ventricular assist device is regarded as an important step in the sequence of MCSS development, the Working Group believes that a fully implantable, long‐term, total artificial heart will be a clinical necessity and recommends that the mission of the targeted program include the development of such systems. Past estimates of the potential usage of artificial hearts have been reviewed in the context of advances in medical care and in the prevention of cardiovascular disease. In addition, a retrospective analysis of needs was carried out within a defined population. The resulting projection of 17,000–35,000 cases annually, in patients below age 70, falls within the general range of earlier estimates, but is highly sensitive to many variables. In the absence of an actual base of data and experience with MCSS, projection of costs and prognoses was carried out using explicit sets of assumptions. The total cost of a left ventricular assist device, its implantation and maintenance for a projected average of 41/2 years of survival might be approximately $150,000 (in 1983 dollars). The gross annual cost to society could fall in the range of $2.5–$5 billion. Ethical issues associated with use of the artificial heart are not unique. For individual patients these relate primarily to risk‐benefit, informed consent, patient selection, and privacy. However, for society as a whole, the larger concern relates to the distribution of national resources. Issues of primary importance to clinical investigation have been examined and special guidelines for the clinical investigative phase of artificial heart research have been set forth. The Working Group believes that, except as part of NHLBI research protocols, public funds should not be available for clinical use of MCSS until their clinical effectiveness and reasonable cost‐effectiveness are demonstrated. The Working Group affirms the position of the 1973 panel in establishing “medical” suitability of the recipient (which is more complex than simply medical characteristics) as the primary criterion for decisions regarding the distribution of this costly and scarce resource. However, it is the judgment of the Working Group that cost and cost‐effectiveness are legitimate considerations in entitlement and reimbursement decisions. The issues of cost, distributive justice, and patient selection are not unique to artificial heart and ventricular assist device development, but highlight the need to direct attention to the issues often associated with increasingly complicated medical care.