Current Controversies in Critical Care A regular feature of the American Journal of Critical Care, Current Controversies in Critical Care addresses the ethical and administrative issues faced by health care professionals working in today’s critical care environment. To send an eLetter or to contribute to an online discussion about this article, visit www.ajcconline.org and click “Respond to This Article” on either the full-text or PDF view of the article. We welcome letters regarding this feature and encourage the submission of scenarios for future discussion.

ORGAN DONATION: PRACTICALITIES AND ETHICAL CONUNDRUMS By Dana Lustbader, MD

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rgan transplantation is a modern medical marvel responsible for saving countless lives. However myth and misinformation continue to hinder organ donation, and this results in a shortage of vital organs. Organs used in transplant come from living donors, donors declared brain dead by neurologic criteria, or donors declared dead by cardiopulmonary criteria. This article explores the practical and ethical conundrums and barriers critical care providers face regarding organ donation from deceased donors in the intensive care unit (ICU).

Donation After Brain Death Brain death is defined as the irreversible loss of all brain function, including that in the brainstem. There are 3 cardinal findings in brain death: coma, absence of brainstem reflexes, and apnea. Patients who meet clinical criteria for brain death are medically and legally dead as established by the US Uniform Determination of Death Act,1 and discussion of organ donation may proceed. Although they entail 2 entirely different procedures, brain death determination and organ donation are, in fact, closely linked. Federal and state laws require a hospital representative to contact the hospital’s organ procurement organization (OPO) following the determination of brain death. There are 58 OPOs nationally and each hospital is associated with one of these agencies. The OPO is responsible for determining donor suitability and discussing organ donation with family members. Hospital personnel should not approach the family about organ donation as this leads to a lower consent rate due to a loss of trust that may develop between family members and hospital staff regardless of the level of communication skills possessed by the ICU team. OPOs track this so-called ©2014American Association of Critical-Care Nurses doi: http://dx.doi.org/10.4037/ajcc2014696

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pre-approach as a negative hospital quality metric. If a family member brings up organ donation with the ICU staff, it is suggested the provider inform the family member that an expert from the affiliated OPO will be there shortly to discuss this important opportunity. If possible, family members should be told that death is suspected prior to the actual determination of brain death. Consent for brain death examination and apnea testing should not be sought and is not required. The prerequisites for a brain death examination include normothermia, absence of sedative, toxins or neuromuscular blocking agents, and absence of extreme electrolyte or acid base abnormality. A urine toxicology screen may reveal opioids or benzodiazepines and need not be negative when these agents have been used as long as their clinical effect has worn off. A waiting period of 5 half-lives is appropriate for most sedatives. Additionally, a serum barbiturate level below 10 μg/mL is sufficient to perform the brain death assessment and need not be zero. There is no national consensus on timing of the brain death examination following the use of hypothermic protocols. Some institutions wait for the return of euthermia prior to proceeding, whereas others have a mandatory waiting period of 24 to 72 hours following rewarming thereby providing time for the more sluggish hepatic metabolism of various medications in the setting of hypothermia. Prior to performing the brain death examination, a brief 30 to 60 second apnea test on a spontaneous breathing mode (eg, pressure support) is worthwhile. If the patient triggers the respirator during this mini apnea test, the patient is not dead, and no further brain death testing is appropriate at this time. The brain death examination includes absent corneal reflex, absent oculocephalic reflex (doll’s eyes), and absent gag reflex. Documentation of absent motor

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Meticulous donor management following brain death determination increases the odds of procuring more viable organs per donor.

response to noxious stimuli, absent pupillary light response, and absent oculovestibular response (cold calorics) is required. These elements of the examination evaluate the brainstem function by assessing cranial nerve function. Prior to performing the 10-minute apnea test, an assessment of patient stability is made. Profound acidosis, shock, or hypoxemia may preclude the safe performance of an apnea test although it should be noted that most patients can have an apnea test safely performed. A recent baseline arterial blood gas test is required. The ventilator is then disconnected and 6 liters of oxygen is placed down the endotracheal tube. After 10 minutes, an arterial blood gas sample is drawn. A rise in PCO2 greater than 20 mm Hg from baseline or a PCO2 greater than 60 mm Hg in the setting of apnea is consistent with brain death. If an apnea test cannot safely be performed, a confirmatory test should be considered. These tests include electroencephalography, transcranial doppler ultrasonography, cerebral angiography, cerebral scintigraphy, or magnetic resonance imaging or angiography. There is no role for confirmatory testing if the clinical examination and apnea test support the diagnosis of brain death in patients more than 1 year old.2 In 2010, the American Academy of Neurology published practice parameters for adult brain death determination that support a single bedside clinical examination performed by a credentialed provider, plus a single apnea test for brain death determination.3 Despite these guidelines, many institutions still require 2 brain death examinations separated by an arbitrary observation interval anywhere from 6 to 24 hours long. There has been no national or international consensus on the purpose or timing of this interval or the purpose of the second examination.4 One reason for delaying the diagnosis of brain death, using repeat examinations, may have been to avoid a perception of physicians rushing to harvest organs if patients are declared brain dead too quickly. About the Author Dana Lustbader is an intesivist and the section head of Palliative Medicine, Critical Care Medicine at the North ShoreLIJ Health System in Manhasset, New York. Corresponding author: Dana Lustbader MD, Section Head, Palliative Medicine, Critical Care Medicine, North Shore-LIJ Health System, Manhasset, New York. Email: Lustbader@ nshs.edu.

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Lustbader et al5 found that an arbitrary 6-hour interval proposed in the brain death guidelines in New York State was actually harmful because the determination of death was delayed by about 20 hours on average and families remained in the ICU with a brain dead patient awaiting the second examination. Additionally, family members more likely declined organ donation as the observation interval increased. This delay in diagnosis of brain death as a result of a second examination resulted in negative consequences for organ donation and procurement of viable organs. In several patients, a second brain death examination was performed more than 1½ to 2 days after the first examination. No published data suggests that a second assessment by a different physician reduces error or the possibility of an erroneous brain death diagnosis.6 There may also be confusion among family members as to why a second brain death examination must be performed if a loved one is, in fact, dead. Explaining brain death to family members can be difficult because the patient remains warm and the ICU monitors often reveal normal vital signs. When discussing brain death it is important to use the word “death” or phrases like “the exam shows that she has died.” Sometimes it may be useful to invite family members to observe the clinical examination and apnea test if they wish. Hemodynamic instability begins immediately after brain death and is recognized by hypotension, cardiac arrhythmias, and diabetes insipidus. Cardiac death generally occurs hours to days after brain death due to hemodynamic collapse and neurogenic shock. Consented organ donors require vasoactive agents, thyroxin, and vasopressin to combat these derangements while donor suitability is being evaluated and organ procurement is arranged. Meticulous donor management following brain death determination increases the odds of procuring more viable organs per donor. Some states require an accommodation for people who oppose brain death determination based on religious or moral grounds. For example, certain Orthodox Jewish groups accept only cardiac death as a viable form of death. Accommodation may be provided for families with a religious basis for refusing the medical and legal definition of death. Some hospitals make the diagnosis of brain death

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Some states require an accommodation for people who oppose brain death determination based on religious or moral grounds.

and complete the death certificate but continue to provide mechanical ventilation until there is circulatory death. Because the patient is medically and legally dead, no vital signs are obtained or recorded, and no medications, fluids, or artificial nutrition are given. The respirator is simply maintained and the patient may be moved to another location for this accommodation if the ICU bed is needed. It is important to document that death has occurred to mitigate potential liability for withholding treatment. Failure to diagnose and document brain death may result in legal prolonged pain and suffering awards for the period in which the patient may have in fact been brain dead but not yet declared.7 Stories of patients living months or years in a brain dead state or even going through puberty while brain dead are simply false. Generally, these patients were in a persistent vegetative state and careful study of their clinical records reveals that an apnea test may not have been performed or some other confounder may have been overlooked. These myths erode public trust and the fundamental principle of only procuring vital organs from people who are dead— the dead donor rule.

Donation After Circulatory Death Organ donation after circulatory or cardiac death (DCD) refers to organ donation from a deceased donor who has been declared dead on the basis of cardiopulmonary criteria (permanent cessation of circulatory and respiratory function) rather than on neurological brain death criteria (irreversible cessation of brain function). Organ donation should be considered in any patient requiring mechanical ventilation for which a decision has been made to withdraw life-sustaining treatments and death is imminent. Most hospitals are required by the Joint Commission to have DCD policies and provide the option of organ donation for medically suitable terminally ill patients after cardiac death as part of routine end-of-life care.8 Most patients who die in the ICU do so after the withdrawal of life-sustaining treatments. DCD should be considered for any seriously ill patient for whom a decision has been made to withdraw mechanical ventilation in conjunction with a do not resuscitate (DNR) order. It is important to ensure the patient is not brain dead, because organ procurement in a deceased donor should proceed without extubation to optimize

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organ and tissue viability. A potential DCD donor is between 0 to 60 years old with cardiac death predicted to occur within an hour following extubation. This estimate is made with a predictive model called the Wisconsin Tool, which is based on spontaneous respiratory rate, negative inspiratory force, age, vasopressor requirement, oxygen saturation, level of hemodynamic instability, and body mass index. Once a decision is made to withdraw mechanical ventilation, the OPO should be notified. A trained professional from the OPO will discuss the option of organ donation with the family. Once consent is obtained from the authorizing party, the patient is brought to the operating room on the ventilator. The patient may be given preextubation medications to relieve anticipated dyspnea. These comfort medications are no different than those used for nondonors (eg, benzodiazepines, opioids). All medical care provided to the dying patient is delivered by the medical team. Care of the patient until death is similar to the care of nondonor patients for whom life-sustaining treatments are withdrawn. The only significant differences are that extubation occurs in the operating room and an intravenous bolus of 10 000 units of unfractionated heparin is administered immediately prior to extubation to preserve organ viability. This is the only medication given before death that directly benefits organ recipients and serves no purpose to the patient. The use of heparin is in the consent form and required to protect vital organs from microvascular injury and clot. The patient is extubated or decannulated to room air in the operating room. Family members may be present. Breathing tubes are not reinserted at any time as the patient has a DNR order and the goals are palliative. All noncomfort medications are discontinued including vasoactive agents. Death is based on hospital policy, which usually requires apnea and 2 to 5 minutes of asystole or pulseless electrical activity. Once the patient has died, the family is escorted out of the operating room. The organ recovery team then enters the operating room from another area and procurement begins. The organ recovery team never encounters the patient’s family during the DCD process and never renders medical care to the patient prior to death. If the patient does not die in a reasonable amount of time, the patient is returned to a location

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in the hospital for end-of-life care until death occurs. Failure to donate occurs in about 30% of DCD cases. Only the OPO staff determines when to discontinue the DCD process; a decision based on donor suitability and recipient information.

Controversies and Opportunities Why do you have to be dead to donate vital organs? What if a patient wants to donate both kidneys if death is near? There is growing debate about procuring vital organs from terminally ill hospitalized patients who wish to donate prior to discontinuing all life-sustaining treatments.9 When death is imminent, some patients or their families may want to save lives in the process. Certain homicide laws would have to be changed to make this legal. The dead donor rule stating that vital organs are only removed from deceased donors would no longer apply. The unintended consequences of this might be the perception that hospitals procure organs from living people against their will—a concept that could have a profoundly negative impact on the already dwindling donor pool.10 Uncontrolled DCD is a form of organ donation currently being explored for procurement of lungs from high-risk donors. This procedure involves patients receiving unsuccessful resuscitative efforts for cardiopulmonary arrest, generally following trauma. Once death is declared based on asystole, consent for organ donation is obtained from family members. Because the patient is dead, attempts to optimize the lungs may begin. After procurement, the lungs are perfused by an ex vivo extracorporeal lung machine for several hours while function is assessed. Preliminary studies demonstrate these lungs may be viable for transplant following several hours of ex vivo lung perfusion. Another interesting approach to optimize abdominal organs for transplant involves the use of extracorporeal membrane oxygenation (ECMO) immediately after cardiac death is declared in a donor.11 During ECMO, an intra-aortic balloon is

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inflated to obstruct the flow of blood to the brain to prevent reperfusion. Abdominal organs are reperfused to improve viability of liver and kidneys for donation. Despite the nearly 8000 deceased organ donors annually in the United States, 18 people die every day waiting for a lifesaving organ. Critical care providers are uniquely qualified to preserve the opportunity for organ donation for patients and families that value helping others during their own personal tragedy. eLetters Now that you’ve read the article, create or contribute to an online discussion on this topic. Visit www.ajcconline.org and click “Respond to This Article” in either the full-text or PDF view of the article.

FINANCIAL DISCLOSURES None Reported REFERENCES 1. Uniform Determination of Death Act, 12 uniform laws annotated 589 (West 1993 and West suppl 1997). 2. Wijdicks EF. The case against confirmatory tests for determining brain death in adults. Neurology. 2010;75:77-83. 3. Wijdicks EF, Varelas PN, Gronseth GS, Greer DM. Evidence based guideline update: determining brain death in adults. Neurology. 2010;74:1911-1918. 4. Greer DM, Varelas PN, Haque S, Wijdicks EF. Variability of brain death determination guidelines in leading US neurologic institutions. Neurology. 2008;70:284-289. 5. Lustbader D, O’Hara D, Wijdicks EF, et al. Second brain death examination may negatively affect organ donation. Neurology. 2011;6:119-124. 6. Wijdicks EF. The diagnosis of brain death. N Engl J Med. 2001;344:1215-1221. 7. Burkle CM, Schipper AM, Wijdicks EF. Brain death and the courts. Neurology. 2011;76:837-841. 8. Steinbrook R. Organ donation after cardiac death. N Engl J Med. 2007;357:209-213. 9. Truog RD, Miller FG, Halpern SD. The dead donor rule and the future of organ donation. New Eng J Med. 2013;369: 1287-1289. 10. Bernat JL. Life or death for the dead-donor rule? N Engl J Med. 2013;369:1289-1291. 11. Magliocca JF, Magee JC, Rowe SA, et al. Extracorporeal support for organ donation after cardiac death effectively expands the donor pool. J Trauma. 2005;58:1095-1102.

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Organ Donation: Practicalities and Ethical Conundrums Dana Lustbader Am J Crit Care 2014;23:81-84 doi: 10.4037/ajcc2014696 © 2014 American Association of Critical-Care Nurses Published online http://www.ajcconline.org Personal use only. For copyright permission information: http://ajcc.aacnjournals.org/cgi/external_ref?link_type=PERMISSIONDIRECT

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AJCC, the American Journal of Critical Care, is the official peer-reviewed research journal of the American Association of Critical-Care Nurses (AACN), published bimonthly by The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Telephone: (800) 899-1712, (949) 362-2050, ext. 532. Fax: (949) 362-2049. Copyright © 2014 by AACN. All rights reserved.

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Organ donation: practicalities and ethical conundrums.

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