Maintaining the Option to DonateMaintaining the Option to Donate

Pre-Donor Management and Brain Death Pre-Donor Management and Brain Death DeclarationDeclaration

Michael Haley, MDMichael Haley, MDMedical Director - LifeShare of the CarolinasMedical Director - LifeShare of the Carolinas

Disclosure StatementDisclosure Statement

No Financial or Commercial Interest to DeclareNo Financial or Commercial Interest to Declare

Serve as Medical Director for LifeShare of the CarolinasServe as Medical Director for LifeShare of the Carolinas

ObjectivesObjectives

• Brief Overview of Donation Brief Overview of Donation – Recipient, Donor, and Regulatory ComplianceRecipient, Donor, and Regulatory Compliance

• Pathophysiology Associated with Brain Pathophysiology Associated with Brain Injury Injury

• Declaration of Death by Neurologic CriteriaDeclaration of Death by Neurologic Criteria• Review the Pathway to Organ Donation Review the Pathway to Organ Donation

and Identify Potential Areas in Which the and Identify Potential Areas in Which the Option to Donate may be LossOption to Donate may be Loss

Making the Case forMaking the Case forPreserving the Option to DonatePreserving the Option to Donate

• Recipient’s NeedRecipient’s Need

• Donor’s DesireDonor’s Desire

• Regulatory-Compliance Regulatory-Compliance

The Growing “Organ Gap”

Recipient Needs~18 people die each day due to the lack of a suitable organs for transplant (~6500 lives/yr)

Organ Procedure and Transplant Network and the Scientific Registry of Transplant Recipients from 1989-2009

.

This circle represents the United States ~310 million people

Over 100 million registered donors in the USA

This dot represents the 8,126 deceased donor in 2011

USA Deaths 2011 - 2,515,4588,126 represents 0.3% of all deaths

Psychological Effects of Donation Psychological Effects of Donation on Familieson Families

• 98% Would choose donation again98% Would choose donation again

• • 92% Identified positive aspects to the92% Identified positive aspects to the

donation process/experiencedonation process/experience– Donation was comforting Donation was comforting – Associated with less depressionAssociated with less depression

Clinical Transplantation. Vol 22 (3); 341–347, 2008

Hospital Compliance

ASPE.hhs.gov

Hospital Requirements (Centers for Medicare/Medicaid Services)– OPO- Organ Procurement Organization

Functions within their designated service area: 1)increasing the number of registered donors 2)coordinating the donation process

•Notification process •Declaration of brain death•Patient/family opportunity to donate •Performance Improvement (PI) program

LifeShare of the CarolinasFederally designated OPO for 40 hospitals in a 22 county area

The Pathway to Organ DonationThe Pathway to Organ Donation

Severe Brain Injury

Irrecoverable loss of brain

function

Vulnerable Period

Hours to Days in Length

Physiological Changes Associated with Brain Injury

Physiology Associated with Physiology Associated with Severe Brain InjurySevere Brain Injury

Brain InjuryBrain Injury

Elevated ICPElevated ICP

Compensatory HTNCompensatory HTN

Experimental studies demonstrate circulating epinephrine concentrations increase on the order of 200 to 1000-fold in association with increase in ICP

““Catecholamine Surge”Catecholamine Surge”

• Peripheral vasoconstriction• Tachycardia - Arrhythmias• Central redistribution of blood

• Pulmonary edema• Myocardial dysfunction• Endothelial dysfunction• Platelet activation-micro thrombi-DIC• Cytokine – Inflammatory activation

(SIRS)

Pre-Donor ManagementPre-Donor Management• ““Just Good Critical Care”Just Good Critical Care”

– Catastrophic Brain Injury GuidelinesCatastrophic Brain Injury Guidelines• Maintain MAP> 65 (IVF resuscitation Maintain MAP> 65 (IVF resuscitation

vasopressor support)vasopressor support)• Maintain oxygenation (Sat>90%)Maintain oxygenation (Sat>90%)• Monitor and correct electrolyte abnormalitiesMonitor and correct electrolyte abnormalities

• ““What is good for the patient is good for the donorWhat is good for the patient is good for the donor””

The Pathway to Organ DonationThe Pathway to Organ Donation

Severe Brain Injury

Irrecoverable loss of brain

function

Vulnerable Period

Healthcare providers often recognize poor outcome early on….

Healthcare providers can feel conflicted……

Ongoing Support vs. DNR-DNI or Limitation of Care

The Pathway to Organ DonationThe Pathway to Organ Donation

Severe Brain Injury

Irrecoverable loss of brain

function

Vulnerable Period

Withdraw of Care

Death by Neurologic

CriteriaVulnerable

Period

Physiologic Changes Physiologic Changes with Brain Deathwith Brain Death

Decline in Organ Function after Brain DeathDecline in Organ Function after Brain Death

Organ Dysfunction(Loss of Opportunity to Donate)

Physiologic ChangesPhysiologic Changes Hemodynamic InstabilityHemodynamic Instability Inflammatory responseInflammatory response

• Capillary leakCapillary leak• CoagulopathyCoagulopathy

Volume depletionVolume depletion HypothermiaHypothermia Hormonal AbnormalitiesHormonal Abnormalities

Pre-existing Co-morbiditiesPre-existing Co-morbidities&&

Associated Injury (trauma)Associated Injury (trauma)

TreatmentsTreatments•MannitolMannitol•SteroidsSteroids

•Volume ResuscitationVolume Resuscitation

Outcomes are better with organs obtained from live donors compared to organs from brain-dead donors as these physiologic insults are avoided

The Pathway to Organ DonationThe Pathway to Organ Donation

Severe Brain Injury

Irrecoverable loss of brain

function

Vulnerable Period

Withdraw of Care

Death by Neurologic

Criteria

Death by Neurologic CriteriaDeath by Neurologic Criteria

• <1% of all deaths in the US per year<1% of all deaths in the US per year– Estimated 15k/yr; ~2.5million deaths in US/yrEstimated 15k/yr; ~2.5million deaths in US/yr

• Historically---“Death”- permanent cessation of heart & breathing

• 1950’s Invention of artificial respirator

– Breathing supported even when people were in a deep coma.

– Invention forced doctors to rethink their definition of “death”

• 1968 Ad Hoc Committee of the Harvard Med SchoolAd Hoc Committee of the Harvard Med School– ““A Definition of Irreversible Coma” A Definition of Irreversible Coma” ((JAMAJAMA 1968;205:337–340) 1968;205:337–340)

• 1981 – The Uniform Death Determination Act– ““An individual who has sustained either (1) irreversible cessation of An individual who has sustained either (1) irreversible cessation of

circulatory and respiratory functions, or (2) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of all functions of the entire brainthe entire brain, including the brain stem, is dead.”, including the brain stem, is dead.”

Process of Brain Death DeclarationProcess of Brain Death Declaration

1.1. Clinical PrerequisitesClinical Prerequisites– Must evaluate for these confounding Must evaluate for these confounding

variables prior to consideration of brain variables prior to consideration of brain deathdeath

2.2. Neurological examNeurological exam

Clinical PrerequisitesClinical PrerequisitesPrior to Brain Death ConsiderationPrior to Brain Death Consideration

1st - Irreversible Cause -•Must have a proximate cause for the “brain death”

– TBI, ICH, SAH, CVA with associated edema, hypoxic-ischemic, etc.

– Often demonstrated by neuro-imaging

2nd - Exclude Potentially Reversible Conditions•Drug intoxication/poisons; electrolyte/acid-base disturbance; endocrine disturbance

3rd - Exclude Hypothermia (>32C)

Normal SAH TBI ICH

Brain Death Neurological ExamBrain Death Neurological Exam

ComaComa------Absent Brain Stem ReflexesAbsent Brain Stem Reflexes------ApneaApnea

•Coma:Coma:– No spontaneous movements, posturing, or localization-No spontaneous movements, posturing, or localization-

withdraw to stimuluswithdraw to stimulus

•Assess brainstem:Assess brainstem:– Midbrain- CN 3- pupil responseMidbrain- CN 3- pupil response– Pons- CN 4,5,6- corneal, occulocephalic, cold caloric testingPons- CN 4,5,6- corneal, occulocephalic, cold caloric testing– Medulla- CN 9,10- gag/cough and spontaneous respirationsMedulla- CN 9,10- gag/cough and spontaneous respirations

*Atropine test*Atropine test

•Apnea Test:Apnea Test:

Sound Easy…..Sound Easy…..

So Why Can Problems Arise With Brain So Why Can Problems Arise With Brain Death Declarations?Death Declarations?

Brain Dead Patients Move…Brain Dead Patients Move…• Movements present in 40% of heart-beating cadaversMovements present in 40% of heart-beating cadavers• Interpreting motor responses can be challenging- Interpreting motor responses can be challenging-

some demonstrate abnormal motor activity when some demonstrate abnormal motor activity when stimulated due to stimulated due to spinal reflexesspinal reflexes– Movements occur when a sensory stimulus arises from receptors in the Movements occur when a sensory stimulus arises from receptors in the

muscle, joints, and skin, resulting in a motor response that is entirely muscle, joints, and skin, resulting in a motor response that is entirely contained within the spinal cord.contained within the spinal cord.

• Spinal reflexes include:Spinal reflexes include:– Finger jerks/oscillations– Plantar flexion in one or both lower extremities– Head turning with stimulation– Triple flexion response to plantar stimulation– Stereotypic flexion of one or more limbsStereotypic flexion of one or more limbs– Facial myokymiaFacial myokymia– Lazarus signLazarus sign

Video of MovementsVideo of Movements

Confounding VariablesConfounding Variables May be Present May be Present

• Drug intoxication/poison; electrolyte/acid-base disturbance; endocrine disturbance

• Sedative Metabolism – Varies amongst individuals– Hypothermia slow drug metabolism

• Confirmatory Testing Confirmatory Testing

Brain Perfusion Scan Technetium 99 Isotope

EEGCerebral Angiogram

TCDs

Why is the Formal Declaration Why is the Formal Declaration of Brain Death Importantof Brain Death Important

• Provides family with a diagnosis of finality (no decision about “stopping” necessary)

• Allows “de-coupling” period from death and donation• Simultaneous “approach” at the time of brain

death notification is associated with a decreased donation rate by ~30% (Niles & Mattice, 1996)

The Pathway to Organ DonationThe Pathway to Organ Donation

Severe Brain Injury

Irrecoverable loss of brain

function

Vulnerable Period

Withdraw of Care

Death by Neurologic

Criteria

Donation after Brain Death

LifeShare of the CarolinasLifeShare of the Carolinas

2011 2012 2013

Referrals 10080 9984 9490

# Donors 83 87 84

Donor Mtg Time (hr) 19 25 21

Organs Recovered 322 340 338

Transplanted 274 271 259

Research 11 9 46

CaroMont Regional Medical CenterCaroMont Regional Medical Center2011 2012 2013

Referrals 1051 968 836

# Donors 7 4 6

Donor Mtg Time (hr) 17 30 25

Heart 2 0 2

Lung 6 0 1

Kidney 10 7 6

Liver 5 3 6

Pancreas 0 0 1

Intestine 0 0 1

Organs Recovered 23 10 17

Transplanted 22 10 11

Research 1 0 6

The Pathway to Organ DonationThe Pathway to Organ Donation

Severe Brain Injury

Irrecoverable loss of brain

function

Vulnerable Period

Withdraw of Care

Death by Neurologic

Criteria

Donation after Cardiac Death

(DCD)

Donation after Brain Death

Donation After Cardiac DeathDonation After Cardiac Death

• Prior to brain death laws, DCD was the way in which all organs were recovered for transplant from deceased donors (standard practice prior to the 1980s)

• 3 Separate reviews by the Institute of Medicine (IOM)3 Separate reviews by the Institute of Medicine (IOM)– ““ethically acceptable practice of end-of-life care, capable of ethically acceptable practice of end-of-life care, capable of

increasing the number of deceased-donor organs available for increasing the number of deceased-donor organs available for transplantation”transplantation”

DCD ProcessDCD Process• Withdraw of Care is decided upon prior to any

discussions about donation (DNR order entered)

• DCD is a patient/family driven process– Life Support removal- typically in operating room

• Cardiac Death Cardiac Death – Time from the onset of insufficient cardiac activity to generate a pulse Time from the onset of insufficient cardiac activity to generate a pulse

or blood flow (not necessarily the absence of all EKG activity) — to or blood flow (not necessarily the absence of all EKG activity) — to the declaration of death is 5 minutesthe declaration of death is 5 minutes

– Data suggest that circulation does not spontaneously return after it Data suggest that circulation does not spontaneously return after it has stopped for 2 minutes (has stopped for 2 minutes (auto-resuscitationauto-resuscitation))

• If death does not occur (typically within 60min) then recovery of If death does not occur (typically within 60min) then recovery of organs does not occur, end-of-life care continues organs does not occur, end-of-life care continues (up to 20% of cases)(up to 20% of cases)

National Trends in DCDNational Trends in DCD

0

20

40

60

80

100

Years‘02 ‘05 ‘08 ‘11

2002- n- 189 (3%)2006- n- 644 (8%)2011- n- 1055 (13%)

LifeShare of CarolinasLifeShare of Carolinas

2011-’13 – DCD- 2011-’13 – DCD- n-36n-36 (14%) (14%)

Changing Paradigm in Critical CareChanging Paradigm in Critical CareHope for Recovery Hope through Donation

Aggressive Care

Deteriorating Condition

Preparing Family- “Grave Prognosis”

Declaration of Death Family Support

Life Saving Donation

Donor Management

Preserving the option to donate

End of Life Discussions…

DNR-DNILimitation of CareDonation after Cardiac Death (DCD)

Goals of Care Discussions are being addressed earlier – if the patient has the ability to donate and is thought to be dead by neurological criteria then brain death testing should be pursued

ConclusionsConclusions

• Need for organs continues to outpace the availability• Medical management of potential donors can be time

consuming and requiring advanced critical care• Brain death declaration can be complex but is an essential

component to donation• National donor data shows an increase trend in DCD

donations• All healthcare providers need to be aware of the potential

vulnerable periods during the path to donation