Brain Death: An Update on New Important Initiatives Community of Practice Action Leader Meeting Organ Donation & Transplantation Alliance Nashville, TN March 19, 2013 You must be one of Dr. Frank’s patients! Jeffrey I. Frank, MD, FAAN, FAHA Professor of Neurology and Neurosurgery Director, Neurocritical Care University of Chicago Medicine

Disclaimer I am NOT a passionate about organ donation advocate My presence at this meeting IS NOT about enhancing organ donation My passion and presence IS about my role in: Improving contemporary understanding of brain death Assuring integrity in brain death diagnosis and patient/family management through better education of physicians and nurses, and better uniformity of policies Implications for organ donation but it NOT ABOUT organ donation (ODMT: DDWG)

Pre-Ventilator Era Any process that arrested breathing led to asystole and a cold, blue corpse Apnea Asystole

Now patients with severe brain dysfunction were on ventilators! Ventilator Era (1960’s) ? 1928 1952 1972 Now patients with severe brain dysfunction were on ventilators!

Spectrum of Brain Injury With Mechanical Ventilation Moderate: Awake or drowsy with disability Major: Coma with some brain function Extreme: No discernible brain function Required Definition

Brain Death History Harvard Report (1968) NIH Collaborative Study (1977) “Irreversible Coma” No brainstem reflexes “Flat” EEG Proposed brain death Defined the futility of brain death President’s Commission Report (1980) Affirmed the validity of brain death Proposed guidelines on how to approach brain death diagnosis Uniform Declaration of Death Act

Uniform Declaration of Death Act (1980) Basis for Brain Death Law Dead if irreversible cessation of either: Circulatory and respiratory functions, or All functions of the entire brain, including brain- stem (brain death) BRAIN DEATH IS THE IRREVERSIBLE CESSATION OF WHOLE BRAIN FUNCTION (HEMISPHERES AND BRAINSTEM)

AAN Creates Practice Parameter: Guideline 1995 AAN Creates Practice Parameter: Guideline

Brain Death in the U.S. Paradigm Shift Real mechanism of death President’s Commission Report UDDA Harvard Report NIH Study 1920 1965 2012 Transplant Reality Iron Lung Invented Modern mechanical ventilation (critical care) CT Scanner Invented Societal Evolution and Acceptance (death with a heart beat) Irreversible cessation of whole brain function = Death Real mechanism of death Can be reliably diagnosed Paradigm Shift

Brain Death Today Mechanism of death: Widely accepted Diagnosis: Important; Independent of OD Contemporary Imperative Mandatory, accurate, and expeditious diagnosis Respect for process Proactive management of physiology Thoughtful interaction with family/surrogates Thoughtful sequencing of involvement of health care teams and OPOs Profound variability in policy and practice

Guideline performance Pre-clinical testing Clinical examination Apnea testing Ancillary testing

Physicians Responsible for Brain Death Diagnosis

Preclinical Testing: Compliance with AAN Guidelines

Clinical Exam: Compliance with AAN Guidelines

Apnea Testing: Compliance with AAN Guidelines

Ancillary Testing

Variability in BD Determination Practice: a review of 226 brain dead organ donors (2011) Jenkins et all, Critical Care 1997 Claire Shappell MS2, Jeffrey Frank MD

AAN Approach to Determining Brain Death Part 1 Coma Part 2 Absent Reflexes Part 3 Apnea Loss of respiratory drive Brain Dead Patients must meet demonstrate all 3: Coma: lack of any response to external environment, must have known etiology and be irreversible, must rule out potential mimics Reflexes: absence of pupillary response, ocular movements (doll’s and calorics), corneal reflex, motor response to painful stimuli, pharyngeal and tracheal reflex (cough and gag) Apnea: absence of the respiratory drive to breathe, very specific way to test this, but basically involves disconnecting the patient from the ventilator and observing for efforts to breathe after a defined rise in CO2 level in the blood. Pupillary Known Cause Doll’s Eyes Cold Water Calorics Specific method of testing for apnea Irreversible Corneal Gag Cough “Pre-Requisites” Rise in CO2 with no breaths observed Neuroimaging compatible Motor

Sometimes, Part 4 Ancillary Tests Nuclear Medicine Blood Flow Study Electroencephalography (EEG) CT Angiography Conventional Angiography Required ONLY if clinical examination or apnea testing cannot be fully performed

Results: Overview and Part 1 Total Patients 226 Age, mean (SD), y 46 (16) Male Sex, No. (%) 115 (51) Cause of Death, No. (%) Intracranial Hemorrhage 95 (42) Trauma 59 (26) Anoxia 44 (19) Unknown 9 (4) Ischemic Stroke 8 (4) Other

Results: Brain Stem Reflexes Mean # of reflexes documented: 6 ±1.2 All reflexes documented (7 of 7): 101 (44.7%)

Apnea and Ancillary Studies Apnea Test # Donors (%) Completed 162 (71.7) Aborted 12 (5.3) Not Performed 46 (20.4)

Putting it all together All Brain Dead Organ Donors n=226 Coma Cause Known n=217 Normothermic (≥36°C) n=184 0.26 1.15 Reflexes Absent ± Redundant n=157 Apnea Test OR Ancillary Study n= 151

Conclusions 36.7% documented adherence to all AAN practice recommendations for brain death diagnosis 66.8% documented adherence to AAN recommendations with weaker brain stem reflex standard (± redundant reflexes) At least 1/3 of brain death determinations do NOT have documentation of necessary features of brain death Discuss Implications: Need better uniformity at least in DOCUMENTATION, but also probably in practice Need contemporization and universalization of local/institutional guidelines- federal Health Resources and Services Administration task force Better training in examination and documentation – U of C-led simulation workshops, future standard for education and credentialing of local leaders in BD diagnosis

What are we doing to improve the field? Educational/training endeavors Web-based training: Acute Review (CCF, Prpvencio) Webinars: Frank, Greer, Goldenberg, Provencio Simulation training: Basic training (Yale, Greer) “Champions”: Training Leaders (UofC, Frank, Goldenberg)

Brain Death Simulation Training November 12, 2012 Second International Brain Death Simulation Workshop: Training Future Leaders BD Clinical Cases Intoxication Isolated BS Injury Post CA w/o CE Grade V SAH Catastrophic Brain Injury Dummy Simulation Station DDNC Apnea Test Physiological Management Station Ancillary Tests Station Involuntary Movements Station MD/Family Interaction Station

What are we doing to improve the field? Educational/training endeavors Web-based training: Acute Review Simulation training: Basic training “Champions”: Training Leaders Creation of a national/international standard Re-evaluate protocols since the 2010 AAN Practice Parameters (WE NEED YOUR HELP) Lobby at a national level for uniformity Brain Death Ethics Subcommittee of NCS Taking leadership/ownership regarding Brain Death Education, Advocacy, Policy

Adaptation to Technology Perioperative MI and Cardiac Arrest End-Stage Cardiomyopathy VAD Insertion Death of Heart Muscle: Permanent Asystole Post-Event Scenario Permanent asystole Maintained perfusion through VAD Brain with continued blood flow Continuous Flow Ventricular Assist Device Systemic perfusion No heart beating Heart stops but device maintained systemic perfusion = Alive Heart Stops = Dead Brain Death = Dead

Summary Brain Death is an Important Diagnosis Shift in accountability and responsibility for the integrity of brain death diagnosis, patient/family management, and policies/advocacy Educational efforts Academic efforts Policy change Better uniformity “Growth means change and change involves risk, stepping from the known to the unknown”