Ethical Issues in the Implantation of the Total Artificial Heart

Fr, Woolley

doi:10.1056/nejm198402023100505

Cited by 24 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The approved protocol emphasized that the need for the patient's conscious understanding of the procedure, the current state of knowledge regarding artificial heart implantation, quality of life, and treatment alternatives were essential to truly informed patient consent. These criteria supplement earlier medical and psychological evaluation of the patient by the hospital selection committee (36).…”

Section: Legal and Ethical Considerationsmentioning

confidence: 91%

“…The critical issue in expansion of the protocol to include the third group is the ability to determine when death is imminent in a person suffering an acute cardiac event. The University of Utah Institutional Review Board (36) expressed such concerns when they designed the initial protocol. Similar ethical concerns were discussed by the Artificial Heart Working Group in their 1982 report (5).…”

Section: Legal and Ethical Considerationsmentioning

confidence: 99%

See 1 more Smart Citation

The Artificial Heart: Costs, Risks, and Benefits—An Update

Lubeck¹

1986

Int J Technol Assess Health Care

View full text Add to dashboard Cite

As discussed above, approximately 32,500 persons aged 55 to 70 years with end-stage heart disease may be potential candidates for the artificial heart each year. However, continued application of a protocol that requires informed consent by the patient effectively limits the pool to 12,000 annually. Estimates of the cost of the artificial heart include charges for the surgical procedure, device and console, and continuing medical surveillance. These estimates range from a low of $100,000 to a high of $300,000 per patient in the initial year. Assuming a five-year, 51% survival and an initial cost of $100,000, total program costs in the fifth year are projected to be $1.3 billion for a pool of 12,000 patients, and $3.8 billion for 32,500 patients. These projected costs are associated with anticipated increases in life expectancy. For those individuals destined to develop heart disease, the anticipated average increase is approximately half a year. In comparison, heart transplant patients who meet the surgical criteria but who do not receive a new heart do not survival beyond six months. In an era of limited resources, it is imperative that such a potentially expensive innovation as the artificial heart be compared carefully with other social and medical programs designed to extend life and improve its quality. Such a comparison will require a full understanding of the likely costs and benefits of the device. A viable artificial heart would greatly alter current treatment for end-stage cardiac disease. More patients would benefit from this therapy than currently benefit from heart transplants, and the costs of caring for these patients would increase substantially. The current state of development of the artificial heart provides an opportunity to collect data on investigational artificial heart performance, clinical results, patient status, and economic and social costs. This knowledge base would be invaluable for future technology assessments and policy decisions regarding third party reimbursement. Insofar as we may be faced with a multi-billion dollar annual investment in the future, detailed assessments of the artificial heart should be performed.

show abstract

Section: Legal and Ethical Considerationsmentioning

confidence: 91%

Section: Legal and Ethical Considerationsmentioning

confidence: 99%

The Artificial Heart: Costs, Risks, and Benefits—An Update

Lubeck¹

1986

Int J Technol Assess Health Care

View full text Add to dashboard Cite

show abstract

“…The Utah group may have successfully evaded the NIH's controls on human experimentation by seeking private support, but the procedures for gaining regulatory approval from its Institutional Review Board (IRB) and the Food and Drug Administration (FDA) did cause important delays. Before approving the research protocol submitted by Dr. DeVries, the Utah IRB thoroughly reviewed the risks and benefits of the implant and the procedures for obtaining informed consent (61). The board initially allowed implants in a very limited patient poolthose patients undergoing open heart surgery who could not be weaned from the heart-lung machine (61).…”

Section: Clinical Trials and Experimentationmentioning

confidence: 99%

“…Before approving the research protocol submitted by Dr. DeVries, the Utah IRB thoroughly reviewed the risks and benefits of the implant and the procedures for obtaining informed consent (61). The board initially allowed implants in a very limited patient poolthose patients undergoing open heart surgery who could not be weaned from the heart-lung machine (61). With IRB approval and after a short delay, the FDA accepted the Utah team's application for an investigational device exemption under the Medical Device Amendments of 1976.…”

Section: Clinical Trials and Experimentationmentioning

confidence: 99%

Obstacles to Developing and Using Technology: The Case of the Artificial Heart

Maxwell

Blumenthal

Sapolsky

1986

Int J Technol Assess Health Care

View full text Add to dashboard Cite

For some observers, the artificial heart represents the latest, and perhaps the most flagrant example of the health system's tendency to favor the rapid introduction of expensive but ineffective technologies over efforts to prevent disease and to improve access to care (5;6;19;44;45). Even if it can be perfected, they argue, its opportunity cost in terms of other foregone health benefits would be exorbitant. The ultimate failing of the health care system, it would seem, is its failure to establish mechanisms to select among alternative uses of resources. If such mechanisms had existed, some critics believe that the quest for an artificial heart never would have begun and certainly its premature clinical uses could have been prevented (6;45).

show abstract

Barney B. Clark, DDS

Gaffney¹

1984

Arch Gen Psychiatry

View full text Add to dashboard Cite

Ethical Issues in the Implantation of the Total Artificial Heart

Cited by 24 publications

References 0 publications

The Artificial Heart: Costs, Risks, and Benefits—An Update

The Artificial Heart: Costs, Risks, and Benefits—An Update

Obstacles to Developing and Using Technology: The Case of the Artificial Heart

Barney B. Clark, DDS

Contact Info

Product

Resources

About