Welcome to the
Pediatric Webcast
Innovative Practices to Increase
Pediatric Organ Donation
For the Donation and Transplantation
Community of Practice
June 12, 2014
Thomas Nakagawa, M.D., FAAP, FCCM
Wake Forest Baptist Health, Brenner Children’s Hospital.
Winston-Salem, NC
LeAnn Swanson, MPH
Executive Director, Organ Donation and Transplantation
Alliance
Teresa M. Beigay, DrPH
Director of Special Donation Initiatives. Dept of Health and
Human Services, HRSA, HSB. Division of Transplantation
Roxane Cauwels, BSN, MBA
DTCP Consultant, Organ Donation and Transplantation Alliance

Lori West, MD, DPhil, FRCPC
Professor of Pediatrics, Surgery and Immunology
Canada Research Chair (Tier 1) in Cardiac Transplantation
Director, Canadian National Transplant Research Program
Interim Director and Research Director, Alberta Transplant Institute
University of Alberta

Mudit Mathur, MD
Associate Professor of Pediatrics
Loma Linda University Children’s Hospital

Sarah Grays, RN-NIC, CPTC
Donation Development Specialist, OneLegacy

Alexandra Glazier, JD, MPH
Vice President and General Counsel, New England Organ Bank

Thomas Nakagawa, MD, FAAP, FCCM
Professor, Anesthesiology and Pediatrics
Section Head, Pediatric Critical Care
Wake Forest Baptist Health, Brenner Children’s Hospital
Director, Pediatric Critical Care and Respiratory Care
Wake Forest University School of Medicine

To review the current need for pediatric
organs

To discuss innovative practices to increase
organs from potential pediatric donors

To examine ethical and legal perspectives
on brain death




1,946 children are waiting for a needed
organ*
Children make up 1.5 % of the total national
waitlist
Approximately 130 children die annually
waiting for a needed organ and another 5060 children are removed from the national
waiting list because their condition
deteriorates making them ineligible for
organ transplantation
Children less than 1 year of age have the
highest death rate waiting for an organ
*OPTN data. Accessed June 9, 2014
www.OPTN.org
Pediatric Data: 1995 - 2013
2500
2000
Donors
Death Removal
1500
1000
Waiting List
Additions
Transplants
500
19
9
19 5
96
19
9
19 7
98
19
9
20 9
00
20
0
20 1
02
20
03
20
0
20 4
05
20
0
20 6
07
20
0
20 8
09
20
1
20 0
11
20
1
20 2
13
0
Pediatric patients: birth to 18 years of age
Data compiled from OPTN 2014
Pediatric Deaths on the Waitlist
Pediatric Data: 1995 - 2013
300
250
200
150
100
50
13
20
12
20
11
20
10
20
09
20
08
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
20
99
19
98
19
97
19
96
19
19
95
0
Pediatric patients: birth to 18 years of age
Data compiled from OPTN 2014
Pediatric Deaths on the Waitlist
Pediatric Data: 1995 - 2013
100
90
300
80
250
70
60
200
50
150
40
30
100
20
Waitlist removals
Too sick to transplant
50
10
0
13
20
12
20
11
20
10
20
09
20
08
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
20
99
19
98
19
97
19
96
19
19
95
0
Pediatric patients: birth to 18 years of age
Data compiled from OPTN 2014
Data from OPTN June 9, 2014
RESULTS
• Pediatric organ recipients increased from 1170-1475
• Pediatric donors provided the majority of organs for pediatric
recipients
• The number of recipients of pediatric donor organs was stable
over the 10 years, however organs recovered from pediatric DNDD
decreased by 13%
•Adults received the majority of pediatric donor organs. This
decreased over the study period and children received an
increasing percentage of donor organs (from 66% to 69%) from
pediatric donors.
RESULTS
• DCDD organs were transplanted into pediatric recipients equally from
both adult and pediatric donors
• Pediatric recipients of DCDD organs were infrequent, representing fewer
than 10% of DCDD organ recipients. However, there was a steady
increased from 1 to 31 over the 10 years studied
• Pediatric candidates dying waiting fro an organ decreased from 262 to
110. Pediatric candidates awaiting transplant has remained relatively
stable over the study.
Adult DCDD donors
Pediatric DCDD donors
1200
140
1000
120
100
800
80
600
60
400
40
200
20
0
0
1995 1997 1999 2001 2003 2005 2007 2009 2011 2013
1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013
645 DCD donors 2006
77 pediatric
793 DCD donors 2007
66 pediatric
847 DCD donors 2008
73 pediatric
747 DCD donors 2009
81 pediatric
939 DCD donors 2010
72 pediatric
UNOS. OPTN data. 2014
1053 DCD donors2011
115 pediatric
Pediatrics patients < 18 years of age
1102 DCD donors 2012
124 pediatric
1205 DCD donors 2013
134 pediatric
Pediatric DCDD donors < 1 year of age
35
Number of Donors
30
2006
2
2007
6
2008
1
20
2009
10
15
2010
9
10
2011
12
2012
33
2013
27
25
5
0
2006
2009
2012
UNOS. OPTN data. March 7, 2014
Pediatrics patients < 18 years of age

Despite our successes, children and adults
continue to die waiting for a life saving organ
transplant

The gap between donors and those waiting for a
live saving transplant continues to increase

The number of brain dead donors continues to
decrease annually

We continue to have missed opportunities for
donation during withdrawal of life-sustaining
medical therapies
•
•
•
•
Withdrawal of life-sustaining medical therapies
should be viewed as a process and not an event
During this process there are many times where
the OPO could be engaged in discussions
regarding end-of-life care with the family
Donation should be included as a part of end-oflife care and the process of withdrawal of lifesustaining medical therapies
Donation should not be the primary
conversation about withdrawal of life-sustaining
medical therapies and end-of-life care
Transplant outrage has a solution:
more organ donors
Lori West, MD, DPhil, FRCPC
Professor of Pediatrics, Surgery and Immunology
Canada Research Chair (Tier 1) in Cardiac Transplantation
Director, Canadian National Transplant Research Program
Interim Director and Research Director, Alberta Transplant Institute
University of Alberta
“Utilization of ABO Incompatible
Neonatal Hearts”
Lori J. West, MD, DPhil
Departments of Pediatrics, Surgery and
Immunology
The ABO blood group system as a
barrier in organ transplantation
Transplantation of ABO-incompatible organs:
‘Hyperacute’ rejection
• Binding of pre-formed antibodies to cognate
antigens expressed on graft endothelium
• Activation of complement locally
• Recruitment of inflammatory mediators
• Rapid widespread thrombosis of graft vasculature
Hyperacute rejection in
setting of cardiac graft
Occlusive intravascular
thrombus
Widespread hemorrhage
The need for donor organs
intentional ABOi transplantation
• Disproportionate competition for O donors
disadvantages O recipients
• Kidney – mostly adult
• Heart – to date, infants/young children
• Liver – mixed
• Different reasons; different regimens;
different tissues; different immunologic
issues
ABO system in solid organ
transplantation
Recognition of risk of antibody-mediated
rejection (hyperacute and/or delayed) in the
setting of ABO-incompatible transplantation
• Avoidance or management of accidental
ABO-incompatible transplantation
• Planning and management of intentional
ABO-incompatible organ transplantation
ABO-incompatible heart
transplantation?
Risk:benefit decision-making differs
substantially from kidney transplants
• Lack of effective ‘dialysis equivalent’ for
rescue in case of graft failure due to HAR
• Susceptibility of heart graft to antibodymediated damage
• Graft loss = patient death
– thus higher risk of death gives rise to
conservative approach in attempting to cross
‘historical’ barriers such as ABO
Historical reports of ABOi heart
transplantation
• Cooper DKC Transplant. Proceedings 1990; 22:1457
– Global clinical survey of cardiac transplantation
between ABO blood group-incompatible
recipients and donors
– 8 reported cases, all adults, all accidental
– Heavy morbidity, high mortality
• Additional rare case reports – mostly poor
outcomes
• Likely exacerbated by passive administration of
unrecognized anti-donor ABO antibodies in blood
products
The special case of infants
• Factor #1: antibody responses
• Factor #2: relative risks of death
• Factor #3: immunologic malleability
The special case of infants
Factor #1: antibody responses
• Antibody production to protein antigens
– Reasonably predictable response in infancy
– Polio, pertussis, diphtheria, HLA
• Antibody production to carbohydrate antigens
– Generally poor before age 2 years
– H. influenzae, pneumococcus, meningococcus,
ABO
• Thus, infants lack the essential mediators of
HAR that make ABOi transplantation risky
The special case of infants
Factor #2: relative risks of death
• Especially compelling patient population
due to high risk of death awaiting
transplant
PEDIATRIC HEART TRANSPLANTATION
Conditional Kaplan-Meier Survival
(Transplants: 1/1982-6/2008)
100
Half-life: <1: 21.4; 1-10: 19.3 Years; 11-17: 15.2 Years
Survival (%)
90
80
70
0-<1 vs. 1-10: p = 0.0138;
0-<1 vs. 11-17: p < 0.0001;
1-10 vs. 11-17: p < 0.0001.
60
50
40
)N = 1,422(Year
1<
)N =2,399(Years 11-17
)N = 2,272(Years 1-10
)N = 6,093(Overall
30
0
1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16 17 18 19 20
Years
ISHLT
2010
J Heart Lung Transplant. 2010 Oct; 29 (10): 1083-1141
Heart Transplantation
in Childhood
Wait list mortality
Number of Transplants
Age at transplantation
ISHLT
Almond et al. 2009, Circulation
Isohemagglutinin ontogeny in normal
human infants (blood type O)
International ABOi ‘Infant’ Heart
Transplant Activity
(1996-2012)
American Journal of Transplant
2010
Clinical conclusions to date
• ABOi heart transplantation can be performed without
aggressive maneuvers in young children
• Antibody-removal strategies have been used
successfully to allow ABOi heart tx in older children and
rare adult pts; upper ‘threshold’ of safe antibody titres is
unclear
• AMR has been reported only rarely, of varying severity
and responsiveness to treatment, but prediction is still
unclear
• Comparable clinical outcomes to ABOc transplants have
been reported in the ‘mid to long-term’
• Waiting list mortality for infants has dropped; organ
wastage has decreased
Kaplan-Meier survival after
ABOi transplantation
The special case of infants
Factor #3: immunologic malleability
• Introduction of foreign antigens during
immunologic immaturity may prevent
subsequent development of immune
response (‘neonatal tolerance’)
Isohemagglutinin titre
Isohemagglutinin ontogeny after ABOincompatible heart transplantation (‘A into O’)
Anti-B
A
Anti-A
Birth
6 months
1 year
Age
Fan et al., Nat Med, 2004
Donor-specific B-cell tolerance after ABO-incompatible infant heart transplantation
Isohemagglutinin titre
Isohemagglutinin ontogeny after ABOincompatible heart transplantation (‘B into O’)
Anti-B
A
Anti-A
Birth
6 months
1 year
Age
Fan et al., Nat Med, 2004
Donor-specific B-cell tolerance after ABO-incompatible infant heart transplantation
Tolerance was defined (ie, measured) by:
• Absence or deficiency with time after transplant of antibody
production to donor blood group as measured in
agglutination assays
• Absence of intragraft complement components and other
evidence of AMR
• Supported by studies of cultured PBMC showing donorspecific hyporesponsiveness in vitro (ab production by ELISA
and ASC by ELISPOT)
• Persistence of donor antigen expression in graft
• Absence of donor-specific B cells in PBC
•
Fan et al., Nat Med, 2004, Donor-specific B-cell tolerance after ABO-incompatible infant
heart transplantation
Plate 1 Patient Samples
Caleb, age 16
Summer 2012
Potential Organ Donors in
Newborns Undergoing Circulatory
Determination of Death
Mudit Mathur, MD
Associate Professor, Pediatric Critical Care, Loma
Linda University
Pediatric Intensivist, Huntington Hospital
Objectives
• Review newborn organ donation potential
• DCDD kidney donation and outcomes
– Adult recipients
– Pediatric recipients
• Hepatocyte transfusion as a bridge to
transplantation (experimental)
Brain death- rarity in NICU
• Mechanisms-non trauma, focal bleeds-maybe
less edema?
• Open fontanelle, non-fused sutures: lower ICP?
• Withdrawal before progression?
• Brain death criteria limitations-not any more
– 2011 update (Nakagawa et al, Crit Care Med 2011)
– Defines gestational age (>37 weeks)
– Defines inter-examination interval (24 hours)-may be
shortened if ancillary study consistent with BD
– Clarifies ancillary study preferred (CBF)
Neonatal Organ Donor Potential
• Modes of death: Brain death, DNR, Death
despite CPR, elective withdrawal
• Withdrawal of life support most common (4060% of all deaths)
Withdrawal
Potential DCDD
Donor
Featured Articles
NICU DCDD Donor Potential similar to PICU data (5.5-8.7%)
Kidney transplantation
Can’t we just continue dialysis?
• >95,000 wait-listed for kidney transplant (>80%
of the >120, 000 waitlist!)
• 35,000 added to the list annually (about 17,000
cadaveric and living donor transplants per year)
• 5% mortality for each year on dialysis
• 5,000 kidney waitlist deaths/year
Pediatric En Bloc Kidney Transplantation to
Adult Recipients: More Than Suboptimal?
Bhayana et al. Transplantation 2010; 90 (3): 248-54
How about pediatric recipients?
• Small en bloc kidneys into 8 pediatric
recipients
• Donors 4-22 kg
• One kidney lost to intraoperative thrombosis,
other remained viable
• All grafts increased in size
• Median eGFR was 130 mL/min/1.73 m2 size
Butani et al. Outcomes of children receiving en bloc renal transplants from small
pediatric donors. Pediatr Transpl 2013; 17: 55-58
American Academy of Pediatrics
Exploring Neonatal Donor Potential
• Discharges from our 84 bed NICU over 10 years
(November 2002-October 2012)
• All deaths categorized into four modes:
1.
2.
3.
4.
Brain death
Death despite CPR
Death with DNR order in place
Withdrawal of life support
• Examined patients undergoing withdrawal for
cause of death and criteria for kidney donation
Inclusion Criteria
• > 1.8 kg
• DCD warm ischemia ≤ 120 min
• Acute kidney injury okay unless donor is
anuric
Exclusion Criteria
•
•
•
•
•
Presence of tumor, systemic infection, or HIV
Renal replacement therapy
Urine output < 0.5 mL/kg/h
Creatinine ≥ 1.5 mg/dL
Death >120 minutes after withdrawal
Results
•
•
•
•
Total NICU discharges: 11,201
Deaths: 609
Weight ≥ 1.8 kg at the time of death: 359
Mode of Death
– Brain deaths: 0
– Death despite CPR: 55 (15.1%)
– DNR: 145 (40.6%)
– Withdrawal: 159 (44.3%)
Mode of Death (n=359)
Results
• 159/359 (44%) patients withdrawn from life
support
• Age: 1 day to 214 days
• Weight 1800 to 9845 grams at the time of
death
Potential Newborn DCDD
• Ventilator withdrawn in all 159, also inotropes
in 57, ECMO in 7 patients
• 100 patients had at least one exclusion
criteria, time of withdrawal not recorded in 2
patients leaving 57 DCDD eligibles
• WIT <60 min in 42 babies
• WIT 60-120 min in 15 babies
Cause of Death
Newborn Donor Potential
• No brain deaths
• 42-57 newborns (26-36% after withdrawal were
potential DCDD kidney donors)
• A NICU DCDD program would provide about
1.7-4 additional paired kidneys per year for
transplantation at our center
(based on 40% DCDD and 70 % PICU brain death
consent rate)
The true potential-DCDD
• Brain death is rare in NICU-very few donors now,
in the future??
• In California alone there are 89 Level IIIB and C
NICUs with a total of 2726 NICU beds: 55-120
additional paired DCDD kidneys available for
transplant each year
• Nationally: 677 Level III B and C NICUs with
24,043 beds: 487 to 1145 paired donor kidneys
Clinical Experience at UC Davis
• Over 200 kidney transplants from donors < 20
kg
• About 40% DCDD
• Over 20 newborn donors
(Results to be presented at ATC conference, July
2014)
Personal Communication with Dr. Richard V. Perez, UC Davis
Neonatal Donation-Challenges
• Many NICUs
• No BD, few potential DCDD donors/year
• Donation not considered an option by most
NICU staff
• Few accepting transplant centers-outcomes,
surgical technique
Answer: Education, Education, Education
Hepatocyte Transplantation
• Challenges:
– Quantity, Quality
– Duration of clinical effect
– Viability/Interaction with native hepatocytes?
– Immune suppression needed? Duration?
• Advantages:
– Lower cost and morbidity, repeatability, OLT
option preserved
Hepatocyte Donor Selection
•
•
•
•
•
•
Brain Dead, DCDD Neonatal Donors
Non-transplantable livers
Consent for research
Neonatal – Birth (32 weeks) to 28 days
> 2000 gms
DCD WIT – Neonate – 180 Minutes
Hepatocyte Processing
• Cannulated, flushed free of transport
solutions
• Enzymatically digested, capsule removed
• Cells concentrated, washed through a series of
spins on the centrifuge
• Pooled into a single cell suspension
• Cryopreserved and stored for testing and
release
Hepatocyte Transplantation Studies
• Human Heterologous Liver Cells for Infusion in
Children With Urea Cycle Disorders
(SELICA III), NCT01195753
• Hepatocyte Transplantation for Acute
Decompensated Liver Failure: NCT01345565
Case series-hepatocyte transplant
• Ribes-Koninckx C et al. Cell Transplant.
2012;21(10):2267-82: Clinical outcome in four
infants with inherited metabolic diseases.
• Beck et al. Nephrol Dial Transplant. 2012
Jul;27(7):2984-9.Liver cell transplantation in
severe infantile oxalosis- bridge to OLT?
Preliminary Results
• Liver cell therapy in 16 children with urea
cycle defects vs. 63 historical controls
• Nine completed the trial per protocol
• Time to first moderate (NH3 250-500) or
severe (>500) hyperammonemic events was
delayed
• Incidence of moderate and severe
hyperammonemic events lowered
•
Opladen et al, Molecular Genetics and Metabolism 2014,
Neonatal Donation: The Potential
• Many NICUs
• Unrecognized opportunities for DCDD (>2500
grams?, WIT 120 min)
• Evaluate donor kidneys with Pulsatile Pump
Preservation
• Consider liver donation-hepatocytes (>2000
grams, WIT 180 min)
• Societal benefits
• Potential psychological benefits for the family
Sarah Grays, RN-NIC, CPTC
Donation Development Specialist
OneLegacy, Los Angeles, CA
The Littlest Donors
Learning from OneLegacy’s Angel Babies
Sarah Grays, RNC-NIC, CPTC
Becky Hill, CPTC
OneLegacy
• Covers the 7 county
greater Los Angeles area
• Serves over 200 hospitals,
11 transplant centers,
community of 19M people
• Approached by 8 families
of infants with anencephaly
over 18 months
Why Re-Examine Now?
•Medical Advancements Able to meet
families desire to donate
•The Internet Families have new access to
information and peer support
•Giving Meaning to Life Possibility gives
added meaning to baby’s life
Every organ, every donor, every time.
Challenges Faced
& Tools Developed
to assist OPO’s, donor hospitals, and donor families
Goal: Facilitate Case as Standard DCD
• Remain within scope of policy/procedure.
• Enable all OPO Coordinators to facilitate.
• Provide guidance to hospital staff.
Challenges accepted!
Donation Scenarios
Intra Uterine Fetal
Demise
Baby born,
ventilation occurs
as requested by
family/clinically
indicated
Baby born, does
not require
ventilation
Family time with
baby
MD intubates,
UAC placed;
withdrawal time
set
Family time with
baby and follow
to determine if
ventilation
needed
Tissue (heart
valves) evaluated
for transplant
Family time with
baby
Ventilation
withdrawn and
comfort care
instituted per
hospital policy
Ventilation
needed;
determine if
donation is still an
option
No plans to
ventilate, hospital
provides comfort
care per policy
Baby expires
≤ 2 hrs
Baby expires
> 2 hrs and ≤ 3 hrs
Baby expires
> 3 hrs
Family time with
baby until baby
expires
Recovery of
enbloc kidneys,
liver for Cytonet,
tissues for
transplant
Recovery of liver
for Cytonet,
tissues for
transplant
No recovery of
organs, evaluation
of tissues for
transplant and
liver for Cytonet
Evaluation of
tissues for
transplant and
liver for Cytonet
Challenge: L&D/NICU New Territory
• Unfamiliar with donation/DCD in general



Great opportunity for education
Each hospital took ownership in the process
(administration, Ethics engaged)
Staff requested to be involved in these cases
• Unique atmosphere


Closed environment/increased sensitivity
Vocabulary unique to NICU
Challenge: Assessing a Donor in Utero
Challenge: Assessing a Donor in Utero
Challenge: Wide Variability After Birth
Challenge: Wide Variability After Birth
Challenge: Limited Blood & Access
Challenge: Readiness for Recovery
• Questions







Withdrawal in NICU v. OR?
How far away is the OR?
Is there an L&D OR that could be utilized?
Will the parents be holding the infant after extubation?
Who will be monitoring the saturations?
How will the patient be transported in the 5 minute wait time?
Is this an outlying hospital?
• Pediatric instrumentation
• Surgeon/staff activation to hospital
• Hospital staff preparation and emotional support
Checklist Examples
Checklist Examples
Checklist Examples
Outcomes
9 infants
5 prepared for donation but did not meet criteria


3 born alive but did not meet weight and/or gestational age criteria
2 stillborn
2 started as DCD/intubated, became unstable


1 liver recovered, patient died on vent, taken to OR after CTOD
1 liver recovered, family wished no pressors, taken to OR after CTOD
2 heart valves for transplant recovered
OneLegacy’s Angel Babies
Inspiration: Colin & the Perry Family
• Prepared for liver pathway
• Mom’s blood drawn for
serologies
• Labor induced per
schedule
• Organ & Tissue Outcome:
• Rule Out: stillborn, for
liver, too small for heart
valves
• Website: Carrying Colin
Baby Arriana
• Prepared for DCD pathway
• Emergent C-section done
at 36 1/7 weeks
• Born at 2046 grams
• Intubated at birth, lines
placed
• Passed away on vent as
teams rapidly mobilized
• Family spent time with
baby
• Organ Outcome:
• Liver recovered for
Cytonet; used for research
Baby Samuel
Prepared for DCD pathway
• Born 41 weeks NVD, 3210
grams
• Intubated 4 hours later after
respiratory distress
• Rapidly declined; no pressors
per family, died on vent and
went to OR after death
Organ & Tissue Outcome:
• Liver recovered for Cytonet
• Heart Valves recovered for
transplant
Baby Ezekiel
• Prepared for DCD pathway
• Induced at EGA 37 weeks
• Dubowitz at birth 33-34
weeks
• Intubated to extend time
with family
• Organ & Tissue Outcome:
• Rule Out: weight/actual
gestational age
• Same dedicated hospital team
delivered his baby sister in
May
Baby Nova
• In early prep for DCD
pathway
• Mom went into early
labor at EGA 34 2/7
• Organ & Tissue Outcome:
• Rule Out:
stillborn/size/age
• Donate Life Flag
raised in baby’s honor
Baby Lennox
• Prepared for DCD
pathway
• Scheduled C-section at
EGA 38 weeks
• Born at 2195 grams
• Dubowitz to 36 weeks
• Organ/Tissue Outcome:
• Rule Out for kidneys,
gestational age at birth
Hospital Partner Participation and
Support
Hospital & OneLegacy Staff learned
from parents of Arriana and Colin at
OneLegacy 2013 Donation and
Transplantation Symposium.
• Staff of Riverside County L&D and
NICU join OneLegacy staff after
Baby Samuel’s liver and heart valve
donation.
Community Awareness
• Colin’s parents placing his rose on
• 2013 Donate Life Rose Parade Float
• Carrying Colin has over 13,000
followers ;
• documentary coming soon.
• Angel Baby families meeting to place
roses 2014 Donate Life
Moving Forward
• Share best practices amongst OPO’s/Donor hospitals
• More doctors to recover or transplant tiny kidneys.
• Raise awareness of all donation potential in the NICU.
“Imagine a love so strong that saying hello and goodbye
• at the same time is worth the sorrow.”
• - Colin’s Parents, 2013 Donor Remembrance Ceremony
Alexandra Glazier, JD, MPH
Vice President and General Counsel
New England Organ Bank
Thomas A. Nakagawa, MD, FAAP, FCCM
Professor, Anesthesiology and Pediatrics
Section Head, Pediatric Critical Care
Wake Forest University School of Medicine
Director, Pediatric Critical Care and Respiratory Care
Wake Forest Baptist Health, Brenner Children’s Hospital
Ethical and Legal Perspectives on
Brain Death
Alexandra K Glazier, JD MPH
VP & General Counsel, New England Organ Bank
Faculty, Boston University School of Law
Chair, OPTN/UNOS Ethics
Defining Death
Defining Death – Legal perspective
 Uniform Determination of Death Act
(UDDA)


State law
Establishes legal standard
 Death = irreversible cessation of


circulatory and respiratory functions
all functions of the entire brain, including brain stem
 In accordance with accepted medical
standards

Medical diagnosis of absence of neurological function
Defining Death – Legal perspective
 Irreversible: Lost function cannot possibly be
restored
 Permanent: Lost function will not be restored
 No spontaneous recovery possible
 No medical attempts will be made to restore
 Death based on neurologic criteria (brain
death)
 Death based on circulatory criteria (asystole)
Legal Consequences to Death
Declaration
 Rights and Duties






Organ Donation
Burial
Criminal charges
Inheritance
Social Security
Pensions
 No legal duty to continue to provide medical
care to a deceased patient
Legal Consequences to Death
Declaration
 Continuation of support for purposes of
organ donation
 Legal obligation to preserve the opportunity
of donation

Uniform Anatomical Gift Act

CMS
Defining Death – Ethical Perspective
 Dead Donor Rule



Recovery of donated organs cannot cause the death of the
donor
Public trust
Ethical debate regarding the necessity of the DDR
 Futility
 Medical resources should not be expended on the
deceased
Defining Death – Ethical Perspective
 Allowing families to define death?
 Death is a diagnosis not a treatment option
 Public policy
Hard Cases Make Bad Law
 McMath Case: Family rejected death
declaration based on neurological criteria
 The law is clear
 Its application is hard
Hard Cases Make Bad Law
 Tools for handling escalating conflict over a
brain death declaration
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Confirmatory tests
Second opinion
Death certificate issued
State law defining death
 Communication
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Family
Staff
Court
Public
Thomas A. Nakagawa, MD, FAAP, FCCM
Professor, Anesthesiology and Pediatrics
Section Head, Pediatric Critical Care
Wake Forest University School of Medicine
Director, Pediatric Critical Care and Respiratory Care
Wake Forest Baptist Health, Brenner Children’s Hospital
 Conversations with families about death and dying
are difficult but necessary so parents can
understand and begin preparing for the loss of their
child
• Conversations should be open and honest
• We must work to improve our communication to
prepare families for a devastating outcome
• We have a responsibility to care not only for the
child, but also the family and guide them through
this process
• This process starts when the critically ill child is first
admitted to the PICU
• Allow families to be present during the
clinical examination and apnea test
• Communication should be in simple
terminology allowing parents and family
members to understand their loved one
has died
• Brain death
– Medical term
– Describes the death of an organ
• Utilize terminology that describes the death of the
individual:
– More appropriate communication
• “Your loved one has suffered a severe injury to the
brain that is not recoverable. Your loved one has
died.”
• Life support
– When used in the context of brain death, we are not
supporting life since death has been declared
• Avoid providing options for termination
of mechanical support and medical
therapies following declaration of death
• “Your loved has died. We need to withdraw life
support”
• More appropriate communication
– “Your loved one has died. Medical therapies used to
help your loved one get better are no longer
indicated since death has occurred. These medical
therapies will be stopped”
• It should be made clear that once death
has been declared no further treatment
options exist and all medical therapies
stop, unless organ donation is planned
• Physicians have no obligation to treat a patient
declared dead
• Families no longer have options about continuing
medical therapies
• Appropriate emotional support for the family
should continue to be provided
• Review current institutional brain death guidelines
and ensure they reflect the most recent
SCCM/AAP/CNS guidelines for the determination
of brain death in infants and children
• Ensure that there is language that specifically
states that, “once death has been declared using
currently accepted guidelines, the family will be
given appropriate time to grieve with their child
before mechanical support is discontinued.”
• Policies and guidelines should reflect a specific
time period, ie 4 hours
• Continued communication is vital
• Continued support for the family should be
provided
• Development of an escalation plan
– Multidisciplinary involvement
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Critical care specialists
Nursing
Respiratory care
Hospital administration
Risk management
Hospital legal counsel
Public relations
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Minimum Level:
– Concerns raised by the family
or barriers to communication
exist about the medical process
• Ongoing communication
with the family
• Third independent
examination to confirm
brain death
• Ensure appropriate
documentation of brain
death in accordance with
hospital policy
• Risk management and
hospital legal staff are
made aware of an
escalating situation
•
Maximum level:
– Family is in direct opposition to
the plan of care
• Plans are established about
ongoing mechanical
support and medical staff
involvement with the
patient
• Hospital administration,
risk management and
hospital legal staff
intervene with the family
• Work to ensure physicians
and the healthcare team
are removed from the
middle of this dispute
• Emotional distress and conflict for medical team
– Continue ventilator support and treatment for person
who has been declared dead
• Daily rounds
• Charting vital signs
• Providing fluids , medication, and nutrition
• Resource utilization
– Other critically ill patients may be denied lifesustaining medical therapies
• Delays the grieving process for the family
• Potential loss of organs recovered for donation
• We can never forget that a family has suffered
the loss of their child
• Conversations and interactions with the family
must be done with compassion and respect
• We must do our best and continue to
emotionally support the family during their
time of crisis
• To ask a question, please follow the
prompts on your screen.
Organ Donation Toolbox
http://www.organdonationalliance.org/educationalresources/toolbox