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CARDIOVASCULAR
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Volume 6, 2001, No 1 |
Ethical
Issues Associated with the Determination of Patient Selection Criteria for Total
Artificial Heart Technology
K. A. Bramstedt
Background:
The supply of human donor hearts continues to fall short of clinical need.
While various educational efforts have been employed to encourage organ
donation, there are only approximately 2,200 human hearts donated each year, yet
there are approximately 4,100 patients waiting for a human donor heart at any
point in time. In
an effort to address the ongoing shortfall of human donor hearts, scientists
have designed several experimental artificial hearts intended for permanent
implantation, yet the transfer of this technology from animal to human use
presents ethical challenges when developing patient selection criteria.
Methods:
Reflecting on the goals of research as well as principles of research
ethics, an ethical analysis of seven potential patient subgroups was conducted
in an effort to identify ethically problematic variables for a human clinical
trial of total artificial heart technology.
Results:
Three of seven patient subgroups were identified as having ethically
problematic variables that warrant caution against their inclusion in human
clinical trials of total artificial heart technology.
These three subgroups are as follows: 1) patients who cannot be weaned
from extracorporeal support after bypass surgery; 2) patients of the Jehovah’s
Witness faith; 3) patients chosen based upon a categorical age limit.
Conclusion:
Clinical trial participants must be selected not by their medical status alone,
but also with ethical reflection and consideration of psychological and social
variables. Three
patient subgroups have been identified that present variables that are ethically
troublesome enough so as to warrant the exclusion of these subgroups from trial
participation.
(CVE. 2001; 6 (1): 58-61)
Key words: ethics, artificial heart technology, patient selection
Katrina
A. Bramstedt, Ph.D. (cand.), MA, BS
UCLA School of Medicine
CHS 52-242 MC 704118
Los Angeles, CA 90095-7041
USA
E-mail: bioethics@go.com
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