innovative practices to increase pediatric organ donation for the donation and transplantation...
TRANSCRIPT
Innovative Practices to Increase Pediatric Organ Donation
For the Donation and Transplantation
Community of Practice
June 12, 2014
Welcome to the Pediatric Webcast
Planning Committee Members
Thomas Nakagawa, M.D., FAAP, FCCMWake Forest Baptist Health, Brenner Children’s Hospital. Winston-Salem, NC
LeAnn Swanson, MPHExecutive Director, Organ Donation and Transplantation Alliance
Teresa M. Beigay, DrPHDirector of Special Donation Initiatives. Dept of Health and Human Services, HRSA, HSB. Division of Transplantation
Roxane Cauwels, BSN, MBADTCP Consultant, Organ Donation and Transplantation Alliance
Presenters Lori West, MD, DPhil, FRCPC
Professor of Pediatrics, Surgery and ImmunologyCanada Research Chair (Tier 1) in Cardiac TransplantationDirector, Canadian National Transplant Research ProgramInterim Director and Research Director, Alberta Transplant
Institute University of Alberta
Mudit Mathur, MDAssociate Professor of PediatricsLoma Linda University Children’s Hospital
Sarah Grays, RN-NIC, CPTC Donation Development Specialist, OneLegacy
Alexandra Glazier, JD, MPHVice President and General Counsel, New England Organ Bank
Thomas Nakagawa, MD, FAAP, FCCMProfessor, Anesthesiology and PediatricsSection Head, Pediatric Critical CareWake Forest Baptist Health, Brenner Children’s HospitalDirector, Pediatric Critical Care and Respiratory CareWake Forest University School of Medicine
Objectives
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
The current pediatric wait list numbers
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 50-60 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
0
500
1000
1500
2000
2500
Donors
Death Removal
Waiting ListAdditionsTransplants
Data compiled from OPTN 2014
Pediatric patients: birth to 18 years of age
Pediatric Deaths on the WaitlistPediatric Data: 1995 - 2013
0
50
100
150
200
250
300
Pediatric patients: birth to 18 years of ageData compiled from OPTN 2014
Pediatric Deaths on the WaitlistPediatric Data: 1995 - 2013
0
50
100
150
200
250
300
Pediatric patients: birth to 18 years of ageData compiled from OPTN 2014
0
10
20
30
40
50
60
70
80
90
100
Waitlist removalsToo sick to transplant
Pediatric Waitlist Patient by Organ Type
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.
DCDD donors
UNOS. OPTN data. 2014
Pediatrics patients < 18 years of age
0
20
40
60
80
100
120
140
199319951997 19992001 20032005 20072009 201120130
200
400
600
800
1000
1200
1995 1997 1999 2001 2003 2005 2007 2009 2011 2013
Adult DCDD donors Pediatric DCDD donors
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
1053 DCD donors2011 115 pediatric
1102 DCD donors 2012 124 pediatric
1205 DCD donors 2013 134 pediatric
Smaller pediatric DCDD donors
UNOS. OPTN data. March 7, 2014
Pediatrics patients < 18 years of age
0
5
10
15
20
25
30
35
2006 2009 2012
Pediatric DCDD donors < 1 year of age
Number of Donors
2006 2
2007 6
2008 1
2009 10
2010 9
2011 12
2012 33
2013 27
Celebrating our success and accepting challenges with pediatric donation
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 and lost opportunities for donation
• 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-of-life care and the process of withdrawal of life-sustaining 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
Utilization of ABO incompatible neonatal hearts
Lori West, MD, DPhil, FRCPCProfessor 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, DPhilDepartments of Pediatrics, Surgery and
Immunology
The ABO blood group system as a barrier in organ transplantation
Transplantation of ABO-incompatible organs:
• 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
Widespread hemorrhage
Occlusive intravascular thrombus
Hyperacute rejection in setting of cardiac graft
• 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
The need for donor organs intentional ABOi transplantation
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 antibody-mediated 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 infantsFactor #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 infantsFactor #2: relative risks of death
• Especially compelling patient population due to high risk of death awaiting transplant
PEDIATRIC HEART TRANSPLANTATIONConditional Kaplan-Meier Survival
(Transplants: 1/1982-6/2008)
30
40
50
60
70
80
90
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Years
( N =1,422) Year 1< ( N =2,272) Years 1-10( N=2,399) Years 11-17 ( N =6,093) Overall
0-<1 vs. 1-10: p = 0.0138; 0-<1 vs. 11-17: p < 0.0001;1-10 vs. 11-17: p < 0.0001.
Half-life: <1: 21.4; 1-10: 19.3 Years; 11-17: 15.2 Years
Su
rviv
al
(%)
2010ISHLT
J Heart Lung Transplant. 2010 Oct; 29 (10): 1083-1141
Wait list mortality
Num
ber
of T
rans
plan
ts
ISHLT
Age at transplantation
Almond et al. 2009, Circulation
Heart Transplantation in Childhood
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 infantsFactor #3: immunologic malleability
• Introduction of foreign antigens during immunologic immaturity may prevent subsequent development of immune response (‘neonatal tolerance’)
Isohemagglutinin ontogeny after ABO-incompatible heart transplantation (‘A into O’)
Fan et al., Nat Med, 2004 Donor-specific B-cell tolerance after ABO-incompatible infant heart transplantation
6 months 1 year
Age
Iso
hem
agg
lutin
in
titre
Birth
Anti-A
Anti-BA
Isohemagglutinin ontogeny after ABO-incompatible heart transplantation (‘B into O’)
Fan et al., Nat Med, 2004 Donor-specific B-cell tolerance after ABO-incompatible infant heart transplantation
6 months 1 year
Age
Iso
hem
agg
lutin
in
titre
Birth
Anti-A
Anti-BA
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 donor-specific 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 16Summer 2012
Maximizing donation potential
Neonatal donation
Potential Organ Donors in Newborns Undergoing Circulatory Determination of
Death
Mudit Mathur, MDAssociate Professor, Pediatric Critical Care, Loma
Linda UniversityPediatric 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)
• Modes of death: Brain death, DNR, Death despite CPR, elective withdrawal
• Withdrawal of life support most common (40-60% of all deaths)
Withdrawal Potential DCDD Donor
Neonatal Organ Donor Potential
NICU DCDD Donor Potential similar to PICU data (5.5-8.7%)
Featured Articles
Kidney transplantationCan’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
Bhayana et al. Transplantation 2010; 90 (3): 248-54
Pediatric En Bloc Kidney Transplantation to Adult Recipients: More Than Suboptimal?
Butani et al. Outcomes of children receiving en bloc renal transplants from small pediatric donors. Pediatr Transpl 2013; 17: 55-58
• 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
How about pediatric recipients?
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. Brain death2. Death despite CPR 3. Death with DNR order in place4. 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
Personal Communication with Dr. Richard V. Perez, 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)
Clinical Experience at 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, CPTCDonation Development Specialist
OneLegacy, Los Angeles, CA
Anencephalic infant donors
Learning from OneLegacy’s Angel BabiesSarah Grays, RNC-NIC, CPTC
Becky Hill, CPTC
The Littlest Donors
• 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
OneLegacy
•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.
Why Re-Examine Now?
to assist OPO’s, donor hospitals, and donor families
Challenges Faced & Tools Developed
• Remain within scope of policy/procedure.• Enable all OPO Coordinators to facilitate.• Provide guidance to hospital staff.
Challenges accepted!
Goal: Facilitate Case as Standard DCD
Baby born, ventilation occurs as requested by family/clinically
indicated
Tissue (heart valves) evaluated
for transplant
Family time with baby
Intra Uterine Fetal Demise
Donation Scenarios
MD intubates, UAC placed;
withdrawal time set
Family time with baby
Ventilation withdrawn and
comfort care instituted per hospital policy
Baby expires ≤ 2 hrs
Recovery of enbloc kidneys,
liver for Cytonet, tissues for transplant
Baby expires > 2 hrs and ≤ 3 hrs
Recovery of liver for Cytonet, tissues for transplant
Baby expires > 3 hrs
No recovery of organs, evaluation
of tissues for transplant and
liver for Cytonet
Baby born, does not require ventilation
Family time with baby and follow to determine if
ventilation needed
Ventilation needed;
determine if donation is still an
option
No plans to ventilate, hospital provides comfort
care per policy
Family time with baby until baby
expires
Evaluation of tissues for
transplant and liver for Cytonet
• 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: L&D/NICU New Territory
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
• 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
Challenge: Readiness for Recovery
Checklist Examples
Checklist Examples
Checklist Examples
9 infants5 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
Outcomes
OneLegacy’s Angel Babies
• 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
Inspiration: Colin & the Perry Family
• 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 Arriana
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 Samuel
• 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 Ezekiel
• 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 Nova
• 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
Baby Lennox
• Staff of Riverside County L&D and NICU join OneLegacy staff after Baby Samuel’s liver and heart valve donation.
Hospital & OneLegacy Staff learned from parents of Arriana and Colin at OneLegacy 2013 Donation and Transplantation Symposium.
Hospital Partner Participation and Support
• Angel Baby families meeting to place roses 2014 Donate Life
• Colin’s parents placing his rose on • 2013 Donate Life Rose Parade Float• Carrying Colin has over 13,000
followers ; • documentary coming soon.
Community Awareness
• 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
Moving Forward
Ethical and Legal Perspectives on Brain Death
Alexandra Glazier, JD, MPHVice 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 MedicineDirector, Pediatric Critical Care and Respiratory
CareWake Forest Baptist Health, Brenner Children’s
Hospital
Ethical and Legal Perspectives on Brain Death
Alexandra K Glazier, JD MPHVP & 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
Confirmatory tests Second opinion Death certificate issued State law defining death
Communication Family Staff Court Public
Preparing families for the death of their child
Thomas A. Nakagawa, MD, FAAP, FCCMProfessor, 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
Preparing families for the death of their child
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
Communicating with Families
Helping families understand the death of their child
• 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
Avoiding confusing terminology
• 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.”
Avoiding confusing terminology and providing options
• 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”
Avoiding confusing terminology and providing options
• 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
When death has been declared
• 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
Newspaper Article
High profile cases are a call to action
• 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
What if the family refuses to have medical therapies discontinued
• Continued communication is vital• Continued support for the family
should be provided• Development of an escalation plan
– Multidisciplinary involvement• Critical care specialists• Nursing• Respiratory care• Hospital administration• Risk management • Hospital legal counsel • Public relations
Development of an escalation plan• 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
Consequences of continuing to provide medical therapies for a corpse
• 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 life-
sustaining medical therapies
• Delays the grieving process for the family• Potential loss of organs recovered for
donation
Important considerations
• 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
DiscussionQuestions and Answers
• To ask a question, please follow the prompts on your screen.
Organ Donation Toolbox
http://www.organdonationalliance.org/educational-resources/toolbox
For more information and educational material about pediatric donation visit