after commentary, terms such as “alluring” are used to describe this technology's potential to reduce suffering and death from heart disease. Because many patients cannot be helped by any technology other than a TAH, the questions of who should and who can have access to the device become critical. The second section of the chapter addresses issues directly pertinent to the TAH such as ethically determining and providing access to care, and developing criteria for use in clinical trials and routine medical practice.

In the final section, methods of protecting individual patients' autonomy are considered in the context of clinical trials and routine use. These issues include the informed consent process, use of advance directives, and NHLBI funding as a means of promoting appropriate clinical investigation and use of new mechanical circulatory support systems (MCSSs).

Although this chapter specifically refers to the TAH, most of the ethical principles discussed, such as the equitable allocation of resources and required informed consent, also apply to long-term ventricular assist devices (VADs). Ethical issues concerned with temporary or bridge use of MCSSs, however, such as their effect on the distribution of donor hearts for transplantation, are not considered. These issues have been examined in detail in other contexts (Annas, 1985; Robertson, 1987; Miles et al., 1988) and are likely to disappear if long-term devices are proven effective and become available for general clinical use.

ISSUES RAISED BY INCOMPLETE TECHNOLOGIES

Health care technologies differ in many ways such as purpose, necessity, ease of use, stage of development, cost, and effectiveness in improving patient longevity and quality of life. One approach to differentiation within a taxonomy of health care technologies is to consider the subset of “incomplete” measures that partially treat or palliate critical medical problems in individuals.2 The focus here is on those incomplete technologies—ranging from cardiac pacemakers to bone marrow and other types of transplantation to dialysis for end-stage renal disease—whose costs, given finite national resources for health care, raise particular questions about their appropriate and equitable use. Under this category of equitable and appropriate use are decisions about the distribution of benefits and costs, as well as questions about the procedures or mechanisms for ensuring access to the benefits. Whether, how, and in what fashion to make such technologies available

2  

Complete technologies, in contrast, satisfactorily resolve a disease state. An illustration of a complete technology is gallbladder removal, which restores full function to the patient, whereas an incomplete technology might relieve suffering from the disease once it becomes evident.



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