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THE GRAY ZONE
CONSENSUS ON NON-HEART-BEATING DONOR CRITERIA REMAINS ELUSIVE

Experts in the transplant community say there are several reasons why they hope neurologists who consult in end-of-life organ donation decisions will consider proposals to use non-heart-beating donors (NHBDs). Chief among them are the sobering statistics on organ transplants.

There were approximately 79,000 people on the national transplant waiting list last year, three times more than the number of available organs, according to the United Network of Organ Sharing (UNOS), and each year, nearly 5,500 people die waiting for donor organs.

Many experts, including those who contributed to two Institute of Medicine reports in 1997 and 2000 urging adoption of the non-heart-beating donor protocols, view wider use of NHBD criteria as a way to reduce that number.

NHBDs account for just over one percent of the total number of organ transplants, while 98 percent are done with organs from brain dead donors. UNOS will hold two focus group discussions at the upcoming AAN Annual Meeting in April to “try to address these and other concerns.”

COMPLICATED DECISIONS

In interviews with Neurology Today, transplant surgeons and neurologists in intensive care units shared their perspectives on the proposals to use NHBDs. Igal Kam, MD, Chief of Transplant Surgery at the University of Colorado Health Sciences Center in Denver, explained that the center's ICU doctors make the decisions if and when to withdraw life support for potential donors, and families are approached about donation consent only after a decision has been reached.

“There are very strict criteria we must follow and a donor must meet,” he said. “We try very hard to disassociate ourselves from discussions about death decisions in transplants. Our need for organs is not the driving force and we are very hesitant to apply NHBD criteria for organ removal.”

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Dr. Igal Kam: “We try very hard to disassociate ourselves from discussions about death decisions in transplants. Our need for organs is not the driving force and we are very hesitant to apply NHBD criteria for organ removal.”

“While these patients could be a good source of organs,” he continued, “when it comes to cardiac death and life support there are a lot of unresolved ethical questions. When we talk about brain death there's no problem. But when we have a patient who might meet the NHBD criteria it is still a gray zone. There should be specific guidelines and criteria, but right now every organ procurement organization is creating their own.”

ETHICAL CONCERNS

Arthur Caplan, PhD, Director of the University of Pennsylvania Center for Bioethics, says it may not be possible to develop a national set of NHBD protocols. Unlike those used for determining brain death, NHBD decisions are likely to remain very difficult, Dr. Caplan said.

“In principle, there's nothing wrong with using people meeting non-heart-beating criteria as donors. The main problem is that unlike brain death, where there are established procedures to be followed, there's no consensus on cardiac death. I see the potential for what I call ‘policy creep’ where different rules are being made up at different institutions.”

Dr. Caplan continued, “For brain death it's written down. But with non-heart-beating donors this isn't true. One organ procurement organization requires a hospital to wait ten minutes before beginning a procedure while another only requires two.”

Without a broad consensus statement on cardiac death donation from national medical organizations, Dr. Caplan said, most hospitals are going to remain nervous about terminating life support.

“There are two basic rules in organ recovery: the patient must be declared dead and doctors can't do anything to hasten death,” Dr. Caplan continued. “You can't give medication to lower blood pressure or slow breathing if a donor is almost dead. That violates core ethical standards, but some non-heart-beating protocols come pretty close. Hospitals don't talk about it, but they do it.”

NEGATIVE PUBLICITY

In 1997 the Cleveland Clinic found itself in the middle of an avalanche of negative media, including an unflattering segment on CBS's “60 Minutes,” over its protocols for organ donation. The furor was primarily over part of the clinic's policy that would have allowed physicians to administer two drugs prior to termination of life support, the anticoagulant heparin and the antihypertensive, phentolamine mesylate. The drugs prevent blood clots and widen blood vessels to enhance donor organ quality and transplant graft results.

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Dr. Arthur Caplan

The clinic was accused of everything from removing organs before NHBD patients were dead to actually administering drugs to kill them. In fact, the clinic's protocols restricted use of the two drugs to a very narrow group of potential donors and required patients to have suffered uniform devastating brain injury with a negative neurological prognosis. Only physicians who cared for the patients could pronounce death, and the organs could only be removed 15 minutes after cessation of heart beat and respiration. In addition, no member of the hospital staff could approach the family about donation; the family had to bring the subject up independently.

The protocols, which were in place for 10 months before the media reports, were so conservative that not one patient had been found eligible under the criteria. Still, the Ohio Attorney General's office and the state Pharmacy Board investigated, a 20-page report was compiled, and the clinic was ordered to stop using the protocols.

PREDICTING OUTCOMES

Neurologist Jeffrey Frank, MD, developed the Cleveland Clinic protocols to be “ultra conservative.” Today an Assistant Professor and Director of Neuromedical and Neurosurgical Intensive Care at the University of Chicago, he said the issue is whether it is possible to accurately predict the recoverability of individual patients in order to determine eligibility for NHBD.

“In my experience, most [ICU physicians] are not good at predicting neurological outcomes. This is simply an awkward reality of brain injuries,” he said, adding that death is not imminent in these patients unless comfort measures are changed and life support is withdrawn.

“At the Cleveland Clinic it was an eligibility protocol, not just an NHBD protocol. While NHB donation is accepted at many medical centers across the US, I'm not enthusiastic about this mechanism of donation,” said Dr. Frank. “I believe that the science of neurological prognostication is not mature enough to assure uniform quality in patient eligibility determinations using these protocols.”

TOO MUCH GUESSWORK

Stephan Mayer, MD, Associate Professor of Neurology at Columbia-Presbyterian Medical Center in New York City and Director of the Neuro-Intensive Care Unit, agrees that little has been done to ease hospital jitters over NHBD.

“Non-heart-beating donation works as a concept, but there are many questions about how it works in the real world,” he noted. “With brain death decisions there's no guesswork and no controversy.”

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Dr. Stephan Mayer: “Non-heart-beating donation works as a concept, but there are many questions about how it works in the real world.”

But withdrawing life support in NHBD donor decisions introduces the ethical question of the physician's role in keeping patients alive. “The criteria that are followed, requiring that the heart has to have been stopped for a certain number of minutes before the organs can be removed, conjures up the wrong image to many members of the public. They picture us rushing the patient from the ICU to the operating room where a transplant team is waiting to go to work. To the public, the whole thing reads like a Robin Cook novel.”

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Dr. Michael Williams: “Ive seen a patient with too much brain stem function and a strong respiratory drive who I felt would probably not die if support were withdrawn, and that proved to be the case.”

Dr. Mayer continued: “I'll cooperate with hospital protocols, but I always advise people to look at Cleveland Clinic's experience,” he said. “The fact remains that these decisions are never black and white. Brain death is beyond debate. Clinically it's very clear and you won't face questions about coercion. Society may not be ready for non-heart-beating protocols where organs will be removed.”

GRAY ZONE

Michael Williams, MD, Professor of Neurology and Neurosurgery at Johns Hopkins University School of Medicine in Baltimore, MD, agrees that decisions involving NHBD are always difficult.

“We neurologists are used to seeing comatose patients and better understand the loss of neurological function. But in my experience I've seen patients with too much brain stem function and a strong respiratory drive who I felt would probably not die if support were withdrawn, and that proved to be the case,” he said. “The sense of discomfort most of us feel is making a prediction about a patient in this scenario. Many of us have seen a patient we thought would die quickly remain alive for some time after life support removal. That's the gray zone.”

FAMILY CONSENT

Under a grant from Health Resources and Services Administration, Dr. Williams is in the final stages of a project to determine ways of increasing family consent to NHBD when a loved one is near death. He finds that interdisciplinary hospital teams can effectively ease concerns by spending time with families collectively and individually, answering their questions and discussing ethical and physiological issues of donation and termination of life support, including cardiac and brain death.

Teams of ICU doctors and nurses, transplant surgeons, nurses, and hospital chaplains first receive classroom training in the issues and the goal, and then practice different approaches with surrogate “families.”

“No one has taught them all together before to my knowledge,” he said. After the sessions the families provide feedback on verbal and nonverbal perceptions, explaining what they found confusing or what put them off. In the first round the consent rate went from 35 percent to between 60 and 65 percent.

“We've just finished the second round, which involved more training and feedback to team members. The results have not been tabulated yet, but we think we'll see similar results. What is remarkable is that I saw team members immediately begin applying these interpersonal skills with real patients and families,” said Dr. Williams. “Discussing organ donation with the families is our obligation. We feel that if we take care of the families, consent rate will take care of itself.”

PROTOCOLS FOR NON-HEART-BEATING ORGAN TRANSPLANTS

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No caption available.

  • An interval of at least five minutes must be allowed to elapse between cardiopulmonary arrest and the declaration of death.
  • The period of cardiopulmonary arrest must be verified by electrocardiographic and arterial pressure monitoring.
  • Controlled non-heart-beating donation occurs after life-sustaining treatment has been withdrawn, cardiopulmonary function has ceased, and death has been declared.
  • Most non-heart-beating donation protocols stipulate that if death does not occur within one hour, organ recovery will not be carried out. Instead, the patient will remain in an intensitve care unit and will continue to receive palliative care until death occurs.

Source: Non-Heart-Beating Organ Transplantation: Practice Protocols. Committee on Non-Heart-Beating Transplantation II: The Scientific and Ethical Basis for Practice and Protocols, Division of Health Care Services. Institute of Medicine. 2000.

DIFFERENCES ON NHBD PROTOCOLS FOR ORGAN DONATION

Despite back-to-back Institute of Medicine (IOM) reports advising adoption of a uniform set of non-heart-beating organ donation (NHBD) protocols, hospitals and organ procurement organizations continue to follow their own criteria, and these vary widely.

In the 1997 IOM report, experts in ethics and law, organ procurement and transplantation, and patient care found considerable variation between organ provider organizations (OPOs) and hospitals in several areas, including declaration of death criteria, postmortem medical interventions to preserve organs, and attention to family options.

The panel presented a set of protocols for non-heart-beating donors (NHBD) organ donation and recommended all OPOs adopt them. Two years later, at the request of the Department of Health and Human Services, the Institute convened another panel to revisit the issue and design a dissemination, communication and consensus effort to be sponsored by the Division of Transplantation of the Health Resources and Services Administration. That panel made seven recommendations (see page 8).

The Gift of Life Donor Program in Philadelphia initiated a NHBD protocol in 1995 after increasing requests from families with loved ones who were critically injured but did not meet brain death criteria. Since then 28 area hospitals have implemented their NHBD protocols and 137 liver and kidney transplants have been successfully completed, said Richard Hasz, Vice President of Clinical Services.

“We follow the IOM protocols,” he told Neurology Today. “The family is not approached about donation until they have already made the decision to end artificial support after discussing it with the doctors. We wait at least five minutes after the heart stops before beginning the procedure, just as the IOM protocol advises.”

Not all OPOs do likewise, however. Debbie Seem, Professional Services Coordinator for the United Network for Organ Sharing (UNOS) in Richmond, VA, says there are no national statistics on specific OPOs and their NHBD protocols. But she agrees there is a wide range of criteria being used. “It can range from three minutes up to ten minutes.”

According to UNOS, 129 NHBD procedures were performed as of October 2001, the latest figures available, up from 117 organ recoveries in 1999 and 84 the year before. Since 1993, a total of 716 procedures have been performed and Ms. Seem said 122 of 261 transplant centers have performed at least one transplant under NHBD protocols.

Yet even the number of procedures using NHBD criteria varies. According to a membership survey by the Falls Church, VA-based Association of Organ Procurement Organizations, NBH donations increased from 110 to 165 last year.

Ms. Seem says barriers to broader acceptance continue to limit the availability of organs, although there are some signs of improvement. “The number of non-heart-beating donors is increasing, but there remain concerns about the protocols and the quality of these organs, even though we find they work just as well as those from other cadavers.”

The Gift of Life program has provided organs to 260 transplant patients using the NHBD criteria, one of the highest rates in the country, and Mr. Hasz says the families of donors tend to be very receptive.

BACKGROUND: TRANSPLANTATION OF ORGANSFROM CARDIAC DEATH

  • State laws governing the declaration of death in the US recognize both cardiac and brain death criteria in determining death.
  • In the early history of organ transplantation, all cadaveric (non-living) organ donors were pronounced dead by loss of heart function or cardiac death criteria. This changed in the late 1960s to early 1970s as brain death criteria were developed and applied in the United States.
  • Today, most deaths are still declared on the basis of the irreversible cessation of cardiac function. The overwhelming majority of cadaveric organ donors have been declared dead with brain death criteria.
  • Some transplant centers have continued to recover organs for transplantation from donors who are declared dead with cardiac criteria. The number of such donors is very low because of organ damage that occurs from loss of blood flow. However, because of the severe shortage of life-saving organs for transplantation, the option of organ donation following cardiac death criteria is increasingly being explored.
  • Many transplant institutions have established these protocols for organ recovery from donors who are described as “non-heartbeating” donors to distinguish them from donors who are brain dead but whose hearts continue to beat because of mechanical respiration. This distinction is made so that the circumstances pertaining to blood flow through the organs are clearly understood and can be verified as having had no adverse effects on organ function.

Source: United Network of Organ Sharing.

IOM'S 2000 NHBD RECOMMENDATIONS

  1. All OPOs should explore the option of NHBD organ transplantation, in cooperation with local hospitals, health care professionals, and communities. A protocol must be in place in order for donation to proceed.
  2. The decision to withdraw life-support should be made independently of and prior to any staff-initiated discussion of donation.
  3. Observational studies of patients after the cessation of cardiopulmonary function need to be undertaken by appropriate experts.
  4. NHBD donation should focus on the patient and the family, and follow clear mechanisms for identifying and covering all organ donation costs.
  5. Efforts to develop voluntary consensus on non-heart-beating donation practices and protocols should be continued.
  6. Adequate resources must be provided to cover the costs of outreach, education and support for OPOs, providers, and the public, and any increased costs associated with NHBD recovery.
  7. Data collection and research should be undertaken to evaluate the impact of NHBD donation on families, care providers, and the public.