A

History and Methods of This Evaluation*

IN OCTOBER 1988, the director of the National Heart, Lung, and Blood Institute (NHLBI) requested that the Institute of Medicine (IOM) evaluate the NHLBI artificial heart program. NHLBI's request was made in light of a growing consensus among many groups, including the National Institutes of Health, Congress, federally funded researchers, and private industry associated with artificial heart research and development, that a new evaluation of the priorities of the NHLBI artificial heart program was needed to help chart the program's future.

The issue was raised in part by a decision by NHLBI in May 1988 to cancel, in the first year of funding, four five-year contracts for developing and integrating systems for a total artificial heart. Expressing concern about the feasibility of developing a safe, effective implantable total artificial heart, and citing budgetary concerns, NHLBI decided to place greater emphasis on programs that supported research and development of left ventricular assist devices. The agency reasoned that progress in developing ventricular assist devices could be applied to future work on the total artificial heart, because both devices share many of the same technological and scientific barriers to development.

NHLBI's decision to cancel the four projects was not well received by the contractors and certain professional and industry organizations, and

*

Sections of this description of the Institute of Medicine studies and their methods are adapted from The Artificial Heart Program of NHLBI: Plan for Evaluation, published by the Institute of Medicine. Washington, D.C.: National Academy Press, 1989 (reprinted in Artificial Organs1990; 14:227-242).



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The Artificial Heart: Prototypes, Policies, and Patients A History and Methods of This Evaluation* IN OCTOBER 1988, the director of the National Heart, Lung, and Blood Institute (NHLBI) requested that the Institute of Medicine (IOM) evaluate the NHLBI artificial heart program. NHLBI's request was made in light of a growing consensus among many groups, including the National Institutes of Health, Congress, federally funded researchers, and private industry associated with artificial heart research and development, that a new evaluation of the priorities of the NHLBI artificial heart program was needed to help chart the program's future. The issue was raised in part by a decision by NHLBI in May 1988 to cancel, in the first year of funding, four five-year contracts for developing and integrating systems for a total artificial heart. Expressing concern about the feasibility of developing a safe, effective implantable total artificial heart, and citing budgetary concerns, NHLBI decided to place greater emphasis on programs that supported research and development of left ventricular assist devices. The agency reasoned that progress in developing ventricular assist devices could be applied to future work on the total artificial heart, because both devices share many of the same technological and scientific barriers to development. NHLBI's decision to cancel the four projects was not well received by the contractors and certain professional and industry organizations, and * Sections of this description of the Institute of Medicine studies and their methods are adapted from The Artificial Heart Program of NHLBI: Plan for Evaluation, published by the Institute of Medicine. Washington, D.C.: National Academy Press, 1989 (reprinted in Artificial Organs1990; 14:227-242).

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The Artificial Heart: Prototypes, Policies, and Patients when members of Congress objected, the decision was subsequently rescinded. As of this writing, the four total artificial heart projects are proceeding according to contractors' original plans and with funding committed through September 30, 1993. See Appendix B for a chronology of the NHLBI artificial heart program and related events. Because of the breadth and complexity of issues involved in evaluating a program like the NHLBI artificial heart program, IOM and NHLBI agreed to a two-stage approach: a 5-month planning study and subsequent 15-month evaluation study. The purpose of the planning study was to identify the scope and particular tasks of the evaluation. Accordingly, in May 1989, the IOM established a committee to undertake the five-month planning study. The planning committee focused on the following question: on what bases can rational decisions regarding allocation of artificial heart research and development funds be made? It then identified nine evaluation questions for use in answering this central question, and drafted a work plan for the subsequent study committee. These nine questions were incorporated into the charge of the second study committee, along with a tenth question addressing communication and cooperation in mechanical circulatory support system research. The questions are listed in Chapter 1, Table 1.3. The second IOM committee comprised 17 members with expertise in the fields of cardiothoracic surgery, bioengineering, cardiovascular and internal medicine, epidemiology and decision analysis, program planning and evaluation, ethics, health policy, economics, law, social sciences, and third-party payment. In the course of the study, the committee met four times, sponsored a public meeting, and held two workshops in conjunction with its second and third meetings. The list of those making presentations at the public meeting follows at the end of this appendix. The committee also commissioned five background papers from outside experts as resource materials for the workshops, and as background for sections of the committee's report. The committee reviewed a considerable body of medical, scientific, and health policy literature, including earlier reports on the artificial heart from expert groups established by NHLBI, journal articles, and other documents on artificial heart technologies. The committee solicited, in addition to public meeting presentations, the views of more than 75 individuals who could offer insight into issues pertaining to the study. The committee's deliberations covered a total of nine days, including numerous small-group discussions of specific topics and conference-call discussions. The second IOM committee's report, which forms the main portion of this book, was reviewed twice by all committee members. Consistent with the procedures of IOM and the National Academy of Sciences, the final report was also evaluated through the report review process established by the National Research Council, by a group of anonymous experts possess-

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The Artificial Heart: Prototypes, Policies, and Patients ing relevant expertise. The report was published by the National Academy Press in the fall of 1991. ADDENDUM Presenters at the Public Meeting on July 13, 1990 George J. Annas, J.D., M.P.H., Professor of Health Law and Director, Law, Medicine and Ethics Program, Boston University School of Public Health Kenneth L. Baughman, M.D., Cardiovascular Division, Johns Hopkins School of Medicine Harvey S. Borovetz, Ph.D., Department of Surgery, University of Pittsburgh Stanley A. Briller, M.D., Department of Surgery, Allegheny General Hospital, Pittsburgh Kenneth C. Butler, Director, Engineering, Nimbus, Inc., Rancho Cordova, California Jack G. Copeland, M.D., Department of Surgery, University of Arizona Health Sciences Center, Tucson (for the Society of Thoracic Surgeons) O. Howard Frazier, M.D., Chief, Transplant Service, and Co-Director, Cullen Cardiovascular Research Laboratories, Texas Heart Institute, Houston William A. Gay, Jr., M.D., Professor and Chairman, Department of Surgery, University of Utah School of Medicine, Salt Lake City Leonard A.R. Golding, M.D., Acting Chairman, Department of Artificial Organs, Cleveland Clinic Bartley P. Griffith, M.D., Department of Surgery, University of Pittsburgh J. Donald Hill, M.D., Chairman, Department of Cardiovascular Surgery, Presbyterian Hospital–Pacific Medical Center, San Francisco Robert K. Jarvik, M.D., Jarvik Research, New York, New York Thomas E. Kottke, M.D., Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, Minnesota George J. Magovern, M.D., Chairman, Department of Surgery, Allegheny General Hospital, Pittsburgh Alan Millner, Ph.D., Principal Scientist, ABIOMED, Inc., Danvers, Massachusetts John C. Norman, M.D., Humana Heart Institute International, Louisville, Kentucky Yukohiko Nosé, M.D., Department of Surgery, Baylor College of Medicine, Houston

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The Artificial Heart: Prototypes, Policies, and Patients Donald B. Olsen, D.V.M., Director, Institute for Biomedical Engineering, University of Utah, Salt Lake City D. Glenn Pennington, M.D., Department of Surgery, St. Louis University Medical Center (for the American Society for Artificial Internal Organs) William S. Pierce, M.D., Evan Pugh and Jane A. Fetter Professor of Surgery and Chief, Division of Artificial Organs, Pennsylvania State University College of Medicine, Hershey Victor L. Poirier, President, Thermo Cardiosystems Inc., Woburn, Massachusetts Peer M. Portner, Ph.D., President, Novacor Division, Baxter Healthcare Corporation, Oakland, California Robert L. Whalen, President, Whalen Biomedical Inc., Cambridge, Massachusetts