Chest
Ethics in Cardiopulmonary MedicineThe Total Artificial Heart: An Ethics Perspective on Current Clinical Research and Deployment
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Clinical Benefits
The ability to replace a failed heart would be life-prolonging for patients who are awaiting transplants as well for those who are not transplant candidates. Investment in TAH research continues to yield insights into cardiovascular physiology and clinical problems such as anticoagulation which have wider clinical utility.11, 12 TAH research is also a potent symbol of hope and social commitment to patients with heart disease and their families, much like chemotherapy research is for those dying
CLINICAL APPLICATION OF THE TAH
Each year, 17,000 to 35,000 persons die of presenescent heart failure, 5,000 to 11,000 become eligible for kidney transplantation, and 5,000 to 10,000 become eligible for liver or pancreas transplants.18 Not all of these individuals will receive new organs—donor organs are scarce, the cost of transplantation is high, and it is incompletely reimbursed.
TAH RESEARCH WITH HUMAN SUBJECTS
Research with human subjects is limited in order to protect individuals from being abused by the researchers or society's pursuit of grander social objectives.36 In 1982, the FDA granted an investigational device exemption for permanent TAH implantation because of the absence of other life-prolonging therapies for patients with endstage cardiomyopathy or who are unable to come off circulatory assistance after heart surgery.4, 15 This exemption was justified by these patients' dire need and by
TAH CONSENT AND TERMINATION
Several consent issues are raised by TAH implantation including: 1) whether it is possible to obtain TAH consent from critically ill patients, and 2) whether and by what mechanism the TAH may be discontinued in advance of a patients death.
Despite their dire clinical circumstances, patients do seem capable of giving meaningful consent to TAH implantation. 10,39 The fact that potential recipients have refused the TAH after becoming aware of its comorbidity demonstrates that dire need does not
CONCLUSION
The TAH poses ethical and public policy issues that are as formidable as the scientific and technical difficulties of TAH development. The task at hand is to develop effective therapies for patients dying prematurely of cardiac failure. The relative shortage of donor hearts will lead to continued interest in the TAH both as a permanent device and as a form of pre-transplantation management despite criticisms of this device. For public policy, the most pressing need is for an innovative policy
ACKNOWLEDGMENT
The authors gratefully acknowledge the assistance of Stephen Toulmin, Carol Stocking, and Diane Puklin in reviewing this manuscript. This work was supported by grants from the Henry J. Kaiser Family Foundation, the Andrew W. Mellon Foundation, and the National Fund for Medical Education. Dr. Miles is a Henry J. Kaiser Family Foundation Scholar in General Internal Medicine. The views expressed in this work are those of the authors alone and do not necessarily reflect the views of the University
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