The Artificial Heart Prototypes, Policies, and Patients (1991) / Chapter Skim
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Appendix B: A Chronology of the National Heart, Lung, and Blood Institute Artificial Heart Program and Related Events
Appendix B: A Chronology of the National Heart, Lung, and Blood Institute Artificial Heart Program and Related Events
Pages 205-210
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From page 205... ...
NHI establishes the Artificial Heart Program Office when congressional funds are made available. The National Advisory Heart Council endorses the proposal that the artificial heart program be approached on a systems development basis because it perceives the problems of development to be *
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From page 206... ...
NIH requests $40 million for fiscal years 1965-1968. 1966 NIH Director James Shannon, who has stated that a full-scale effort to develop an artificial heart is premature, writes to the Surgeon General and the Secretary of the Department of Health, Education, and Welfare stating that he does not think that total cardiac replacement is feasible at the current time and that concentration of money and effort toward this end would curtail development of alternative strategies to reduce end-stage heart disease mortality and morbidity.
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From page 207... ...
-sponsored Artificial Heart Assessment Panel, composed of members primarily from outside the biomedical research field, issues a report, The Totally Implantable Artificial Heart: Legal, Social, Ethical, Medical, Economic, Psychological Implications, that focuses on the implications beyond the scientific and technical aspects of the artificial heart program. The panel's charge is limited to an assessment of problems that would be expected to arise from introduction and diffusion of a clinically effective artificial heart.
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From page 208... ...
It concludes that use of total heart replacement can be justified only when massive and irreversible heart damage has occurred. The working group further recommends that the following ethical issues be addressed before clinical testing is initiated: the procedure for obtaining informed consent, the potential influence on decision making and possible emotional trauma resulting from extensive publicity, the quality of life to be anticipated following insertion of the device, and the uncertainty, at the current stage of development, of the long-term future of the patient.
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From page 209... ...
The working group endorses continued governmental support of the development of circulatory support devices, and urges NIH to resume funding to develop a totally implantable permanent heart. 1988 In January, largely on the 1985 recommendation of the working group, NHLBI awards contracts worth more than $22 million to four research groups)
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From page 210... ...
In May, IOM is awarded a contract to conduct the planning study. In August, NHLBI releases a request for proposal for a Clinical Evaluation of Implantable Ventricular Assist Systems for Human Subjects with Chronic Refractory Heart Failure, and funds a contract to produce 30 medical-grade totally implantable LVADs for use in patients with end-stage heart disease.
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