B

A Chronology of the National Heart, Lung, and Blood Institute Artificial Heart Program and Related Events*

1963

Prominent medical and other scientific researchers testify before Congress that it would be possible to develop an artificial heart if more funds, particularly for bioengineering, were available.

The National Heart Advisory Council recommends a long-range program of research to develop a permanently implantable artificial heart that could be used to replace a failing natural heart.

1964

The director of the National Heart Institute (NHI) convenes an ad hoc advisory group that includes leading investigators in the artificial heart field. The group urges the institute to expedite the development of the artificial heart and to use contracts for research and development.

NHI establishes the artificial heart program with special congressional approval and an appropriation of $581,000. The intent is to develop a totally implantable mechanical heart. Six contracts are awarded to support comprehensive analyses of technical development issues and of needs for the artificial heart.

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

*  

Terms used in the chronology are consistent with those used at the times noted. They differ in some cases from the terms used in the Institute of Medicine committee's report. Italics indicate related events.



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The Artificial Heart: Prototypes, Policies, and Patients B A Chronology of the National Heart, Lung, and Blood Institute Artificial Heart Program and Related Events* 1963 Prominent medical and other scientific researchers testify before Congress that it would be possible to develop an artificial heart if more funds, particularly for bioengineering, were available. The National Heart Advisory Council recommends a long-range program of research to develop a permanently implantable artificial heart that could be used to replace a failing natural heart. 1964 The director of the National Heart Institute (NHI) convenes an ad hoc advisory group that includes leading investigators in the artificial heart field. The group urges the institute to expedite the development of the artificial heart and to use contracts for research and development. NHI establishes the artificial heart program with special congressional approval and an appropriation of $581,000. The intent is to develop a totally implantable mechanical heart. Six contracts are awarded to support comprehensive analyses of technical development issues and of needs for the artificial heart. 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 *   Terms used in the chronology are consistent with those used at the times noted. They differ in some cases from the terms used in the Institute of Medicine committee's report. Italics indicate related events.

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The Artificial Heart: Prototypes, Policies, and Patients largely engineering in nature, and thus amenable to the same general approach as that being concurrently used in the space program. The President's Commission on Heart Disease, Cancer, and Stroke recommends development of the artificial heart. 1965 Congress invites the National Institutes of Health (NIH) to state for the record how much money in addition to its current budget it would require to start a planning program to develop the artificial heart. 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. 1967 Director Shannon persuades Congress that the artificial heart can be developed for less money than currently appropriated (i.e., $10 million per year). He renames the program “The Artificial Heart-Myocardial Infarction Program” and allocates $8.5 million to research contracts, of which $2.9 million is used to support research on electrical, nuclear, and other power sources. In South Africa, Christiaan Barnard performs the first human heart transplant. 1969 Denton Cooley of the Texas Heart Institute performs a human artificial heart implant to keep a patient who had postoperative complications alive until a donor heart could be found and transplanted. The patient survives 64 hours on the device, but dies 32 hours after the transplant. Emphasis in the artificial heart program shifts from separate development of each component to integrating existing components to produce a fully implantable cardiac assist device for testing in animals. The proceedings of the first Artificial Heart Conference, sponsored by NHI's artificial heart program, are published. The proceedings note that the philosophy of the artificial heart program is to stress rehabilitation rather than mere prolongation of life. The NHI-sponsored Ad Hoc Task Force on Cardiac Replacement, consisting of 10 members, 9 of whom are drawn from the medical community, publishes a report, Cardiac Replacement: Medical, Ethical, Psychological, and Economic Implications. The task force concludes that the most serious technical problem confronting the

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The Artificial Heart: Prototypes, Policies, and Patients artificial heart program is the development of materials entirely compatible with human blood. In addition, it notes in the body of the report that there is currently no way to use external wires or hoses (for air or fluid) without exposing patients to risk of potentially lethal infections. The prospect of a totally implantable power source is deemed to be years away. The task force in its recommendations states that ventricular assist devices (VADs), specifically a left ventricular assist device (LVAD) that would augment the ability of the heart's left ventricle to pump blood into the aorta, are considered to be a promising area of research. 1973 The National Heart and Lung Institute (NHLI)-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. Although the panel is not asked to review technical issues or to consider whether a total artificial heart (TAH) is feasible, it strongly advises against use of nuclear-driven energy converters. This convinces the Atomic Energy Commission to terminate support in this area. The panel also urges NIH to establish a permanent, interdisciplinary, and representative group of public members to monitor and to help formulate guidelines for the artificial heart program. NHLI sponsors a workshop on the left ventricular assist pump. The resulting document, Report on Left Ventricular Assist Device Teco-Models VII & X, concludes that a basic materials problem exists that must be resolved before clinical use of the device is warranted; it also recommends that continued research on the LVAD should progress in an orderly and stepwise fashion, i.e., through bench testing and animal testing, before clinical use of the device can be warranted. 1974 The artificial heart program is moved into the NHLI Division of Heart and Vascular Diseases to improve administrative and programmatic functions. Emphasis in the program continues to be on VADs. Research on nuclear power sources is halted. 1975 Authorization is given to begin clinical trials of an LVAD for temporary use in patients who are unable to resume cardiac function after open heart surgery.

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The Artificial Heart: Prototypes, Policies, and Patients 1977 The National Heart, Lung, and Blood Institute (NHLBI) Cardiology Advisory Committee publishes the report Mechanically Assisted Circulation: The Status of the NHLBI Program and Recommendations for the Future. The committee recommends that highest priority be given to the NHLBI LVAD program, starting with short-term devices and progressing through intermediate to long-term circulatory support as progress warrants. It also concludes that the most pressing demand is for cardiac assistance in the immediate postoperative period for weaning patients from cardiopulmonary bypass. 1978 Phillip Oyer of Stanford University performs the first bridge to transplant with an electrically powered assist device; several days later, Jack Norman of the Texas Heart Institute performs the first bridge to transplant with an air-driven device. In both cases, the patients are successfully transplanted. 1980 NHLBI sponsors an evaluation of its artificial heart program. The resulting report, Mechanically Assisted Circulation: Report of the NHLBI Advisory Council Working Group on Circulatory Assistance and the Artificial Heart, concludes that the program has been productive and is adequately funded and administered. It stresses continued research of ventricular assist system technology. 1981 Researchers Willem Kolff, William DeVries, and Robert Jarvik at the University of Utah apply to the Food and Drug Administration (FDA) for an investigational device exemption to allow implantation of a TAH into a human. Their request is approved. In light of the Utah research, NHLBI sponsors a working group to evaluate the technical, social, ethical, and economic issues surrounding the TAH. In its report, Report of the Artificial Heart Working Group, the working group recommends continued research on temporary and permanent VADs and the TAH. 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. To sustain a patient who has suffered a myocardial infarction during a triple bypass procedure, Denton Cooley uses an artificial

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The Artificial Heart: Prototypes, Policies, and Patients heart until a suitable human heart becomes available. The patient survives 54 hours before receiving a donor heart. 1982 William DeVries implants the Jarvik-7 artificial heart into Barney Clark, a patient with end-stage cardiomyopathy, under an investigational device exemption granted by FDA that permits use of the artificial heart in patients unable to come off a heart-lung machine or in patients with chronic degenerative heart disease. Barney Clark lives 112 days. 1984/1985 The Jarvik-7 heart is implanted in four more patients, including one in Sweden. 1985 The NHLBI-sponsored Working Group on Mechanical Circulatory Support of the NHLBI publishes a report, Artificial Heart and Assist Devices: Directions, Needs, Costs, Societal and Ethical Issues. 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 groups1 to continue research and development of the TAH. In February, responding to requests from the scientific community and others, William DeVries and colleagues publish several articles in theJournal of the American Medical Association (JAMA) that detail the medical history of each of the four total artificial heart implants that he performed. In May, NHLBI announces that institute support for developing and integrating systems for a TAH will be suspended as of September. NHLBI Director Claude Lenfant states that the decisive factors behind the suspension of funding are that implantable LVADs are nearly ready for human testing and that NHLBI does not have sufficient funding to support both human testing of LVADs and continued development of the TAH. Dr. Lenfant notes that he was also influenced by DeVries ' JAMAarticles and by other reports of complications suffered by bridge patients who remained on the Jarvik-7 for longer than a few weeks. 1   The four groups awarded contracts were ABIOMED, Inc., Danvers, Massachusetts; Nimbus Company, Rancho Cordova, California; Pennsylvania State University Medical Center, Hershey, Pennsylvania; and the University of Utah Institute of Biomedical Engineering, Salt Lake City, Utah.

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The Artificial Heart: Prototypes, Policies, and Patients Dr. Lenfant's announcement of the funding suspension is not well received by four TAH contractors. Senator Orrin Hatch (RUT), ranking Republican on the Senate committee that authorizes the NIH, and Senator Edward Kennedy (D-MA), chairman of that committee, take the lead in pressuring NIH to restore funding to the TAH systems development. Senator Hatch, with the backing of Senator Kennedy, drafts legislation that would require NIH to fulfill existing contracts like those supporting the TAH development before starting any new programs and prohibits the agency from cutting existing programs by more than 10 percent. In support of their action, the senators note that the NHLBI Advisory Council that ratified NHLBI's decision had appealed for more funding to continue the artificial heart program. NIH subsequently restores funding to the TAH contractors. 1989 NHLBI asks the Institute of Medicine (IOM), through its Council on Health Care Technology, to undertake an evaluation of NHLBI's artificial heart program. Given the breadth of the proposed study, the IOM and NHLBI agree that it should be conducted in two phases. The first is to be a five-month planning phase involving a committee to define the scope of study and the specific tasks to be accomplished. The second is the evaluation itself, which will be a more lengthy evaluation by another committee to be appointed by the IOM. By April, the Jarvik-7 total artificial heart has been used in 92 patients as a potential bridge before transplantation: 63 received new donor hearts and 35 survived. 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. 1990 In March, IOM is awarded a contract to conduct the evaluation proposed in the 1989 IOM planning committee's report, The Artificial Heart Program of NHLBI: Plan for Evaluation;in mid-year, the NHLBI funds contracts with St. Louis University and the University of Pittsburgh for a joint clinical trial of 20 Novacor LVADs. 1991 In mid-year, IOM completes its evaluation for NHLBI and issues its report, The Artificial Heart: Prototypes, Policies, and Patients.