Non-Heart-Beating Organ Transplantation

Medical and Ethical Issues in Procurement

Division of Health Care Services


Roger Herdman, Study Director

John T. Potts, Principal Investigator

Washington, D.C.

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--> Non-Heart-Beating Organ Transplantation Medical and Ethical Issues in Procurement Division of Health Care Services INSTITUTE OF MEDICINE Roger Herdman, Study Director John T. Potts, Principal Investigator NATIONAL ACADEMY PRESS Washington, D.C. 1997

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--> NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 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. 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 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 the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the U.S. Department of Health and Human Services (Contract No. 240-97-0012). The opinions expressed in this report are those of the authors and do not necessarily reflect the views of the sponsor. International Standard Book No. 0-309-06424-4 Additional copies of Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington Metropolitan area) or visit the NAP's on-line bookstore at For more information about the Institute of Medicine, visit the IOM home page at Copyright 1997 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religious since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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--> PRINCIPAL INVESTIGATOR JOHN T. POTTS, Jr., M.D., Distinguished Jackson Professor of Clinical Medicine and Director of Research, Massachusetts General Hospital, Boston Staff ROGER HERDMAN, M.D., Study Director KATHLEEN NOLAN, Research Assistant HEATHER CALLAHAN, Program Assistant INGRID BURGER, Research Assistant

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--> Preface In the spring of 1997, the Department of Health and Human Services (DHHS) contacted the Institute of Medicine (IOM) to express concern about the national state of organ donation and the supply of solid organs for transplantation to patients with terminal organ failures. Questions had been raised recently about the management of cadaver donors who died a cardiopulmonary death, called non-heart-beating donors (NHBDs). These questions focused on whether interventions undertaken in these donors to enhance the supply and quality of solid organs for transplantation were in the best interests of the donor patient or were, in fact, hastening death. Anticoagulants and vasodilators were singled out in particular for examination, but a subsequent letter from DHHS's general counsel (see Appendix A) framed the issue in more general terms: "Given a potential donor in an end-of-life situation, what are the alternative medical approaches that can be used to maximize the availability of organs from that donor without violating prevailing ethical norms regarding the rights and welfare of donors: The Institute will consider the alternative approaches, including the use of anticoagulants or vasodilators, from the scientific as well as the ethical point of view." Proper answers to these questions are necessary to maintain a successful national organ procurement and transplantation program that enjoys the confidence of, and attracts organ donation from, the American public. This report defines the various kinds of organ donors, including the four categories of NHBDs, and discusses the large and growing gap between supply and demand for donors and solid organs. The long, evolving history of NHBDs in transplantation is reviewed, and the data on current and potential supply, clinical results, and cost-effectiveness of these donors are presented. Also reported are the results of a survey of the NHBD protocols and activities of the 63 U.S. organ procurement organizations active in the late spring of 1997. The issues

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--> that flow from the information collected on this subject matter and that are relevant to the DHHS charge are identified. The data and issues are analyzed for the purposes of framing conclusions and recommendations that will illuminate the questions of alternative approaches and ethical and scientific norms mentioned in the department's letter. This report represents a new kind of effort by the IOM, that is, a report not by a committee but using a principal investigator (PI) model. The IOM asked John T. Potts, Jr., M.D., Distinguished Jackson Professor of Clinical Medicine and director of research, Massachusetts General Hospital, Boston, to serve as the principal investigator. "The National Academy of Sciences (NAS), the National Academy of Engineering (NAE), and the Institute of Medicine jointly administer the work of the National Research Council (NRC) in rendering independent advice to the federal government on scientific and technical matters. The current portfolio of activities in the Academy Complex reflects a variety of approaches in fulfilling this mission, including the use of principal investigators. PIs are appointed by the NRC chair. The plan for the conduct of an IOM study using PIs will generally include opportunities for soliciting the individual views of other scientific and technical experts and for public input via written comments and/or public hearings. The PIs are tasked with preparing a draft NRC or IOM report that represents the state of scientific and technical knowledge concerning the issues under investigation. The draft IOM report will be examined in accordance with the usual rigorous review procedures of the Academy and appropriately revised before being approved for release to the sponsor and the public."* A number of senior special experts were asked to provide their professional expertise and experience to inform and support this work. The IOM deeply appreciates the exemplary performance of all of these individuals. Their contributions to and support of this report enhance its value. They are recognized and their efforts described at the beginning of this report. It is important that these individuals are neither transplant personnel, nor members of, or directly involved with, transplant or organ procurement programs. They are independent experts in various fields of medicine, ethics, and the law and are generally knowledgeable about, but "at arm's length from," transplantation. Leading figures in the transplant community, federal government, and donor family and recipient groups, without exception, responded to the IOM's need for information from those with front-line, detailed experience and expertise in matters of solid organ procurement and transplantation. These individuals are noted and their contributions described in Appendix B. The opportunity given to the principal investigator, senior special experts, and IOM staff thereby was essential in providing a time to question and learn about real-world activities *   Principal Investigator Model (Updated 10/21/97). Section 3: Projects at the National Academy Complex Involving Principal Investigators (slightly edited).

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--> in transplantation. The IOM greatly appreciates the willingness of these individuals to assist this work. Others who were particularly helpful and made important contributions to this study include the leadership of the United Network for Organ Sharing (UNOS): Walter Graham, Mary Ellison, O. Patrick Daily, and Doug Heiney and its immediate past president, James Burdick. UNOS provided special summaries of national data not otherwise available. The IOM appreciates the assistance of Stephen Rose, Dan Rotrosen, and Nancy Blustein of the National Institute of Allergy and Infectious Disease and of Judith Braslow, Remy Aronoff, and Gwen Mayes of the Division of Transplantation, Health Resources and Services Administration. Jimmy Light and Anne Kowalski also provided important help, as did Stuart Youngner, Roger Evans, Carol Beasley, Richard Rettig, Tim Henderson, Lana Price, Sandy Zachary, Henry Desmarais, Louise Jacobbi, John Fung, Mel Worth, and Robert Epstein. The IOM received outstanding cooperation from the 63 U.S. organ procurement organizations. The information supplied by them and reported here in the survey in chapter 5 provided a picture of the state of affairs in NHBD organ procurement across the entire country that was vital to consideration of the questions the IOM was asked to address. The financial support of this work by the Department of Health and Human Services, in particular the strong interest and support of the Division of Transplantation, is gratefully acknowledged. Additional support was provided from internal funds of the Institute of Medicine. Institute staff who worked on this report were Roger Herdman, Kathleen Nolan, Heather Callahan, and Ingrid Burger. Acknowledgements Senior Special Experts The following Senior Special Experts attended and analyzed presentations from transplant and organ procurement experts on July 30, 1997. Based on this information, data provided by IOM staff, and their own experience and expertise in the fields of anesthesiology, bioethics, cardiology, critical care, law, medicine, neurology, nursing, physiology, and surgery, they provided advice to the principal investigator and IOM staff, discussed issues and recommendations, and reviewed early drafts of the report. FRANCOIS M. ABBOUD, M.D., Professor of Medicine and Physiology and of Biophysics; Chairman of Medicine; Edith King Pearson Professor of Cardiovascular Research; and Director, Cardiovascular Research Center, University of Iowa College of Medicine

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--> TOM L. BEAUCHAMP, Ph.D., Professor of Bioethics, Kennedy Institute of Ethics, Georgetown University ROBERT M. BERNE, M.D., Professor of Physiology, Emeritus, University of Virginia Health Sciences Center BARBARA J. DALY, Ph.D., R.N., Associate Professor, Case Western Reserve University School of Nursing ROBERT J. JOYNT, M.D., Ph.D., Distinguished University Professor and Professor of Neurology, University of Rochester JOHN P. KAMPINE, M.D., Ph.D., Professor and Chairman, Department of Anesthesiology, Medical College of Wisconsin LASALLE D. LEFFALL, Jr., M.D., Charles R. Drew Professor of Surgery, Department of Surgery, Howard University College of Medicine JOHN A. ROBERTSON, J.D., Thomas Watt Gregory Professor of Law, University of Texas at Austin School of Law

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--> Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   7 2   TRANSPLANTATION SUPPLY AND DEMAND   10     Supply   10     Demand   11     Improving Supply   14 3   BACKGROUND   20     The Historical Non-Heart-Beating Donor   20     Neurologic Criteria for Death   21 4   THE MODERN NON-HEART-BEATING DONOR   23     The Controlled NHBD   23     The Uncontrolled NHBD   25     Current Status of the NHBD in Transplantation   26 5   SURVEY OF ORGAN PROCUREMENT ORGANIZATION AND TRANSPLANT PROGRAM POLICIES   33     Interest in OPO NHBD Protocols   34     Protocol Statistics   34     Identification of Potential Donors   35     Approach to Family for Consent   37     OPO and Procurement Team Intervention Before Death   38     Medication   39     Withdrawal of Life Support and Declaration of Death   40

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-->     Withdrawal of Life Support and Declaration of Death   40     Uncontrolled NHBDs   42     Conclusion   43 6   ANALYSIS, FINDINGS, AND RECOMMENDATIONS   45     General Principles   45     Policies and Oversight   47     Medical Interventions and Ethics   50     Conflicts of Interest   55     Determination of Death   57     Families   61     REFERENCES   65     APPENDIXES         ALetter to the Institute of Medicine from the Department of Health and Human Services   73     BAgenda and Summary of Workshop on Medical and Ethical Issues in Maintaining the Viability of Organs for Transplantation   75     CU.S. Organ Procurement Organizations and Letter of Request for Non-Heart-Beating Donor Protocols   89