The Artificial Heart

Prototypes, Policies, and Patients

Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute

Division of Health Care Services

INSTITUTE OF MEDICINE

John R. Hogness and Malin VanAntwerp, Editors

NATIONAL ACADEMY PRESS
Washington, D.C.
1991



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The Artificial Heart: Prototypes, Policies, and Patients The Artificial Heart Prototypes, Policies, and Patients Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute Division of Health Care Services INSTITUTE OF MEDICINE John R. Hogness and Malin VanAntwerp, Editors NATIONAL ACADEMY PRESS Washington, D.C. 1991

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The Artificial Heart: Prototypes, Policies, and Patients NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W.Washington, D.C.20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard to appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education. Support for this project was provided by the National Institutes of Health, National Heart, Lung, and Blood Institute, pursuant to Contract No. NO1-HO-09008. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute. The artificial heart: prototypes, policies, and patients / Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute, Division of Health Care Services, Institute of Medicine; John R. Hogness and Malin VanAntwerp, editors. p. cm. “Support for this project was provided by the National Institutes of Health, National Heart, Lung, and Blood Institute, pursuant to contract no. NO1–HO–09008”—T.p. verso. Includes bibliographical references and index. ISBN 0-309-04532-0 (casebound) 1. National Heart, Lung, and Blood Institute. Artificial Heart Program. 2. Heart, Artificial. 3. National Heart, Lung, and Blood Institute. Artificial Heart Program. I. Hogness, John R. II. VanAntwerp, Malin. III. National Heart, Lung, and Blood Institute. IV. Title. [DNLM: 1. Heart, Artificial. 2. Program Evaluation. WG 169.5 I59a] RD598.35.A78I56 1991 617.4'120592—dc20 DNLM/DLC for Library of Congress 91-31142 CIP Copyright © 1991 by the National Academy of Sciences No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purpose of official use by the United States government. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemussen in Berlin.

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The Artificial Heart: Prototypes, Policies, and Patients COMMITTEE TO EVALUATE THE ARTIFICIAL HEART PROGRAM OF THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE John R. Hogness, * Chair, University of Washington, Seattle, Washington David Blumenthal, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts Lois K. Christopherson, Stanford University School of Medicine, Palo Alto, California Jay N. Cohn, University of Minnesota Medical School, Minneapolis, Minnesota Jacob E. Goldman, Softstrip, Inc., Norwalk, Connecticut James K. Kirklin, University of Alabama at Birmingham, Birmingham, Alabama Adrian M. Ostfeld, * Yale University School of Medicine, New Haven, Connecticut Donald L. Patrick, University of Washington, Seattle, Washington Stephen G. Pauker, New England Medical Center, Boston, Massachusetts Winfred M. Phillips, University of Florida College of Engineering, Gainesville, Florida Neil R. Powe, Johns Hopkins Medical Institutions, Baltimore, Maryland Frank E. Samuel, Jr., Government Strategy Associates, Washington, D.C. Ralph W. Schaffarzick, Blue Cross and Blue Shield Association, Auburn, California Margery W. Shaw, University of Texas Health Science Center at Houston, Houston, Texas George E. Thibault, Brockton/West Roxbury DVA Medical Center, West Roxbury, Massachusetts Milton C. Weinstein, * Harvard School of Public Health, Boston, Massachusetts Vallee L. Willman, St. Louis University Medical Center, St. Louis, Missouri *   Institute of Medicine member.

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The Artificial Heart: Prototypes, Policies, and Patients STUDY STAFF Division of Health Care Services Karl D. Yordy, Director Kathleen N. Lohr, Deputy Director Malin VanAntwerp, Study Director Jo Harris-Wehling, Staff Officer Holly Dawkins, Research Assistant Thelma Cox, Study Secretary

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The Artificial Heart: Prototypes, Policies, and Patients Acknowledgments THE COMMITTEE expresses its appreciation to the many individuals and organizations in the private and public sectors who provided insight into issues covered in this report. In particular, we thank Claude Lenfant, director of the National Heart, Lung, and Blood Institute in the U.S. Public Health Service, and Barbara L. Packard, project officer at the National Heart, Lung, and Blood Institute, for their support of the study, for the information provided to us from their institute, and for the opportunities to interact with them during committee meetings. The committee is especially grateful to the authors of its commissioned papers: H. Tristram Engelhardt, Jr., and Kevin W. Wildes of the Center for Medicine, Ethics, and Public Issues at Baylor College of Medicine; Marjorie Funk of the Yale University Department of Epidemiology and Public Health and School of Nursing; Louis P. Garrison, Jr., of the Project HOPE Center for Health Affairs; James H. Maxwell of the Massachusetts Institute of Technology Center for Technology, Policy and Industrial Development; and Gerson P. Rosenberg of the Division of Thoracic Surgery, Pennsylvania State University. The committee also appreciates the opportunities it had to interact with those who participated in its workshops, including these authors and the following: William A. Baumgartner, Johns Hopkins Hospital; G. William Dec, Massachusetts General Hospital; Peer M. Portner, Novacor Division, Baxter Healthcare Corporation; Stuart F. Seides, Washington Hospital Center; and Michael H. Shapiro, University of Southern California Law Center. The committee was particularly pleased to have as a guest at one of its meetings a heart transplant patient who had been the recipient of a tempo

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The Artificial Heart: Prototypes, Policies, and Patients rary ventricular assist device while awaiting a donor heart. The patient's spouse was also a guest at this meeting. Although these individuals must remain anonymous, their insights into the experience of living with a mechanical circulatory support device, if only temporarily, were very helpful to the committee. A number of researchers and developers in the mechanical circulatory support field and other knowledgeable individuals provided helpful information and views in response to committee requests. We especially appreciate the contributions by the 23 persons who made presentations at the committee's public meeting and whose names appear in Appendix A. We know that the time limits imposed on their presentations were constraining, although necessary, and thank them for traveling to Washington to state their views in person. Thanks are also due to the Division of Clinical Decision Making of the New England Medical Center and to the University of Washington School of Public Health and Community Medicine for special assistance in our work. Finally, and in particular, the committee would like to express its appreciation of the Institute of Medicine (IOM) staff who facilitated the work of this committee. We especially thank Malin VanAntwerp, whose diverse expertise in the fields of health care technology assessment, policy analysis, and medical device regulation was very useful to the study, as well as Jo Harris-Wehling and Holly Dawkins for their many substantive and procedural contributions to the committee's work. All three worked tirelessly to support the committee throughout the study and served capably as primary authors of report chapters. Richard A. Rettig, another member of the IOM professional staff, assisted in drafting the report, and Wallace K. Waterfall, director of the IOM Office of Communications, edited the report. We also appreciate very much the logistical support and manuscript preparation provided by Thelma Cox, the administrative help of H. Donald Tiller, and the assistance of Lisa Chimento and Nina Spruill, financial associates. In particular, the guidance and constant support provided by Kathleen N. Lohr, Deputy Director of the Division of Health Care Services, was invaluable.

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The Artificial Heart: Prototypes, Policies, and Patients Preface HEART DISEASE causes more than 700,000 deaths each year in the United States alone. Decades of research have led to drugs, medical devices, and procedures that provide effective treatment for many forms of heart disease, yet even today an individual suffering from end-stage heart disease faces a bleak outlook and has few treatment options. This Institute of Medicine (IOM) study of the artificial heart program of the National Heart, Lung, and Blood Institute (NHLBI) is particularly timely because, after more than 25 years of research, the program is nearing a historic milestone: the first model of a fully implantable, long-term ventricular assist device, designed to reverse the effects of heart failure for many individuals, will undergo clinical trials in 1992. Furthermore, long-term total artificial hearts are under development and scheduled for trials early in the next century. If these devices fulfill their developers' expectations, both the benefits to the patients receiving them and the technology's ultimate impact on the nation's health care system will be dramatic. The committee's intent was to conduct an independent, comprehensive study of this technology. As the devices are perfected and move into widespread use, this study will, we hope, provide long-term guidance to NHLBI and the broader health care community. At the same time, because our study has examined a family of technologies, many not yet tried in humans, the IOM committee and its consultants have had to rely on the best possible estimates of these devices ' ultimate performance. The issues reviewed here will require periodic reexamination as clinical trial data become available. This study follows a series of program reviews by groups under the

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The Artificial Heart: Prototypes, Policies, and Patients auspices of NHLBI and its predecessor institutes, dating from 1969 through 1985. The present two-phase study was commissioned by NHLBI 's director after a number of events in 1988 indicated the advisability of an independent review of the artificial heart program. The study's first phase was a planning effort by an IOM committee chaired by Theodore Cooper, M.D., chairman and chief executive officer of The Upjohn Company and former director of the National Heart and Lung Institute. That committee's 1989 report, The Artificial Heart Program of NHLBI: Plan for Evaluation, laid the groundwork for the present evaluation by identifying and elaborating on nine questions about NHLBI's future role in artificial heart development. These nine questions have guided this study, and the committee has chosen to examine a number of specific additional issues implicit in responding to these questions. Much has been accomplished over the 27 years of the artificial heart program's work. Many individual researchers in both academe and private industry have dedicated their careers to development of mechanical circulatory support systems (MCSSs) and warrant commendation for their efforts. All those who played a role in the artificial heart program's creation or who are (or have been) involved in directing and overseeing projects within the program deserve the credit they will appropriately receive once long-term devices come into routine clinical use. Additionally, although past financial support from the private sector has not been as extensive as it is likely to become, the firms and investors that have made possible much of today's research progress should be gratified by its probable outcome. Rarely has an important advance in health care been such a widely shared undertaking, accomplished in a truly collegial manner among academic researchers, private industry, and government, as has been R&D in the MCSS field. The committee is pleased to be able to comment on the credit that is due to all those involved. The present study's scope has been limited to long-term devices because those intended only for temporary support are not currently a focus of the artificial heart program. Similarly, we leave to the cardiothoracic surgeons and cardiologists who become expert in applying this technology the task of developing specific clinical indicators for the use of artificial hearts and criteria for the implanting surgeon's appropriate training and experience. These are important topics but are outside the scope of the NHLBI charge and the committee members' expertise. For some of the same reasons, we have not scrutinized the involvement of the NHLBI Devices and Technology Branch, the sponsor of the artificial heart program, in research concerning biomaterials, cardiovascular imaging, and other technological fields; in some of these areas, NHLBI is virtually the sole source of federal research support. The committee report does look into the appropriateness of using the existing research priority-setting and

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The Artificial Heart: Prototypes, Policies, and Patients funding mechanism for applied research of these types, but did not evaluate the substance of the projects themselves. Finally, the constraints of producing a document of reasonable length and balance required the committee to focus the written report on those issues not fully discussed by other advisory groups. Consequently, some of the committee's deliberations on more familiar topics are recorded in less depth than might otherwise have been the case. Entire books, for instance, could be and have been written about such concerns as ethical aspects of patient care, but the committee's discussions are distilled in a few pages. A decision was made to focus on issues of particular and perhaps overlooked import, instead of recording the entire depth and range of all the committee's deliberations. In developing this report, the committee has found itself indebted not only to the 1989 IOM planning committee, but also to those on the previous NHLBI review panels; several from these groups are also members of the current committee. We have not cataloged every recommendation of the prior studies, but their depth and substance have undergirded our work. The IOM planning committee suggested that the considerations outlined in its report “are appropriate for assessing other complex health technologies.” Similarly, this committee recognizes the broad applicability of the concepts, methods, and findings discussed in the pages that follow to decisions by manufacturers, third-party payers, and others. Those interested in the complex arena of government-supported research by academe and industry will also find several research policy issues discussed. We commend the National Heart, Lung, and Blood Institute for recognizing the importance of studies such as this, conducted by independent groups of individuals with relevant expertise. The committee hopes its report will be useful not only to NHLBI in decisions concerning the future of the artificial heart program, but also to clinicians, policymakers, researchers, health insurers, and others involved in developing, assessing, and applying new technologies that have as their goal the improvement of patient care. John R. Hogness, Chair Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute

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The Artificial Heart: Prototypes, Policies, and Patients Contents     Executive Summary   1  1   The Artificial Heart Program: Current Status and History   14  2   Total Artificial Hearts: Technological Potential and Research and Development Costs   26  3   Decisions for Future Research and Development   44  4   Clinical Effectiveness and Need for Long-Term Circulatory Support   65  5   Quality of Life and Mechanical Circulatory Support Systems   85  6   Cost-Effectiveness Analysis   107  7   The Appropriate Use of Technology   121  8   Ethical and Societal Issues   135  9   Roles of Government and Industry in Medical Technology Research, Development, and Use   151  10   Conclusions and Recommendations   173     APPENDIXES   199     A History and Methods of This Evaluation   201     B A Chronology of the National Heart, Lung, and Blood Institute Artificial Heart Program and Related Events   205

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The Artificial Heart: Prototypes, Policies, and Patients     C Technological Opportunities and Barriers in the Development of Mechanical Circulatory Support Systems (commissioned paper)   211     D Epidemiology of End-Stage Heart Disease (commissioned paper)   251     E Assessing the Cost-Effectiveness of the Development and Use of the Total Artificial Heart (commissioned paper)   262     Glossary   285     Index   289

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The Artificial Heart: Prototypes, Policies, and Patients The Artificial Heart

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