Management of the Potential Organ Donor

1
Management of the Potential Organ Donor
Donation After Cardiac Death
Kenneth E. Wood, DOProfessor of Medicine and
AnesthesiologySenior Director of Medical
AffairsDirector, Critical Care Medicine and
Respiratory CareThe Trauma and Life Support
CenterUniversity of Wisconsin Hospital and
Clinics
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University of Wisconsin OPO Donation After
Brain and Cardiac Death
2004 Donors Thru 9-30-04
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University of Wisconsin Hospital Organ
DonationTrauma and Life Support Center

• Multi-disciplinary Med-Surg ICU
• 2000 admissions per year SMR 0.60

2001
2002
2003
Total
2004
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Potential Organ Donor Management Supply -
Relationship
Demand

• 80,319 patients awaiting transplant
• Waiting list grows by 16 per year

Waiting List
Average Wait
Death on List
Heart 350 days 14
Lung 788 days 12 Liver 817 days
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Kidney 1131 days 5
HRSA
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Deceased Organ DonorsDCD and DBD
UNOS data through 12/31/03
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Potential Organ Donor Management
- Demand Relationship
Supply
Year
Actual Donors
Lung Donors

HRSA
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Tremendous Variation in Donation Conversion Rates
in 300 Largest Hospitals
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Maximal Utilization and Optimal Management of
Potential Organ Donors

• Surveillance to identify patients with severe
  neurologic injury likely to progress to brain
  death
  
• Standardized method for brain death declaration
• Uniform request for consent
• Optimal medical management of donor

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Optimal Medical Management of the Potential Organ
Donor

• Continued intensity of support
• Focus shift from cerebral protective strategies
  to optimizing donor organs for transplantation
  
• Simultaneous critical care to organs of multiple
  patients
  
• Critical period
• Facilitates donor somatic survival
• Maintains organs to be procured best condition
• Donor management impact recipient function

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Case Presentation

• History
• 42 year-old sustained penetrating ocular injury
  from mid-shaft of golf club.
  
• Reportedly staggering at scene
• Intubated for ? responsiveness (GCS2) ?
  Medflight
  
• Clinical Course
• Emergent left Fronto-Temporal Craniotomy-Clip
  Temporal MCA
  
• Ventriculostomy
• ICP ? Requiring Osmotics/Barbiturates
• Pressor dependent hemodynamics
• Fronto-temporal craniectomy and temporal lobectomy

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Case Presentation

• DCD Operative Course
• Transferred to OR
• 30,000 Units Heparin
• 20 mg Phentolamine
• Extubation
• Declaration by intensivist
• 5 minute observation period
• Procurement warm ischemia 28 minutes

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Key Barriers to Increasing DCDControversies and
Questions

• Whether the patients are dead?
• Whether the practice constitutes active
  euthanasia?
  
• Whether there is a prohibitive conflict of
  interest for professionals and institutions?
  
• Whether there is adequate social support of dying
  patients and their families?
  
• Whether unethical and illegal practice is
  preventable?

Ethics Committee Society of Critical Care Medicin
e
Crit Care Med 2001 291826-1831
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Donation after Cardiac Death
Major Questions

• Who is eligible for DCD?
• Where will Death Occur?
• Who will Declare Death?
• What are the Pre-Donation Medications and
  Procedures?
  
• What happens if the patient does not expire?

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Definitions

• Heartbeating cadaver (HBC)
• Brain dead cadaver
• Non-heartbeating cadaver (NHBC)
• Death by traditional cardiopulmonary criteria
• Unresponsiveness
• Apnea
• Absent circulation
• Non-heartbeating organ donor (NHBOD)
• Death by C.P. criteria donor
• Controlled NHBOD
• Organ procurement follows a death that occurs
  after a planned withdrawal of life-support

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Categories of Non-Heart-Beating Donors

• Category 1- Dead on Arrival
• Category 2- Unsuccessful Resuscitation
• Category 3- Awaiting Cardiac Arrest
• Category 4- Cardiac arrest while brain dead

Koostra Transp Proceedings 1995 25(5) 2893-2894
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Institute of Medicine (IOM)Executive Summary

• 1. NHBDs are a medically and ethically acceptable
  source of organs
  
• 2. Written protocols approved locally and open to
  the public
  
• 3. Case by case decision to administer
  anticoagulants and vasodilators
  
• 4. Pre-mortem consent for any cannulation

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Institute of Medicine (IOM)Executive Summary

• Separate the responsibilities of attending
  physician from transplant/procurement physicians
  
• Determination of death after 5 minutes without
  monitored arterial pulse
  
• Families should be fully informed and offered
  option of attending life support withdrawal
  
• 8. Donors and families should not suffer
  financial penalties

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IOM Committee on Non-Heart-Beating
Transplantation II2000

• Recommendation 1 All OPOs should explore the
  option of non-heart-beating organ
  transplantation.
  
• Recommendation 2 The decision to withdraw
  life-sustaining treatment should be made prior to
  any discussion of organ and tissue donation.

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IOM Committee on Non-Heart-Beating
Transplantation II2000

• Recommendation 3 Observational studies of
  patients after the cessation of cardiopulmonary
  function need to be undertaken.
  
• Recommendation 4 Non-heart-beating organ and
  tissue donation should focus on the patient and
  the family.
  
• Recommendation 5 Develop a voluntary consensus
  on non-heart-beating donation practices.

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IOM Committee on Non-Heart-Beating
Transplantation II2000

• Recommendation 6 Adequate resources are required
  to cover costs of outreach, education and any
  increased costs associated with non-heart-beating
  organ and tissue recovery.
• Recommendation 7 Research should be undertaken
  to evaluate the impact of non-heart-beating
  donation on families, care providers, and the
  public.

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United States Organ Procurement Organization
Experience Donors / DCD 1995 2004
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US Average 2.65 organs recovered per DCD
donor 2.02 organs transplanted per DCD d
onor
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DCD Donors Recovered by DSA 2004
DSA
25 of DSAs (15) accounted for 79 of all DCDs
Recovered
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OPOs Performing ? 5 DCDs 2003

• Translife 8(9.3)
• Carolina 7(5.5)
• Lifecenter 6(15.4)
• Life Alliance 6(5.3)
• Lifenet 5(5.1)
• Washington 5(9.3)
• Golden State 5(9.6)
• Michigan 5(2.4)
• Total 229(10.4)
• U.S. 268(4.2)

• Gift of Life 50(14.5)
• Gift of Hope 29(9.4)
• UW 28(24.3)
• NEOB 21(10.5)
• Life Center 17(10.9)
• CORE 13(7.8)
• TRC 13(17.3)
• Lifequest 11(10.1)

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DCD Donors Recovered by Age Group 2004
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DCD Donors Recovered by Cause of Death 2004
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Maximal Utilization and Optimal Management of
Potential Organ Donors
Surveillance

• Declaration
• Consent

Medical Management
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National Survey End of Life Care-ICU

• 110 institutions with critical care training
  (74,502 patients)

8.5 mortality (6303)
6.2 Brain death (393)
93.8 end of life decisions (5910)
26 full resuscitation failed CPR (1544) range 4
- 79
14 withhold (797) range 0 - 67
24 DNR (1430) range 0-83
36 withdrawal (2139) range 0-79
Prendergast Am J Respir CCM 1998 1581163-67
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Potential Organ Donor Definitions

• Potential organ donor
• A patient who met the criteria for brain death
  with no absolute contra-indications to organ
  donation
  
• Conversion rate
• Actual donors
• Potential donors
• Referral rate
• Medically suitable referrals to OPO
• Potential donors
• Request rate
• Families asked to donate
• Potential donors
• Consent rate
• Families of medically suitable agreeing
• Families asked to donate

Sheehy NEJM 2003 349667-674.
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Potential Organ Donors USA
Potential Organ Donors (18,524)
Actual Donors 42 (7790)
Non-donors 58 (10,734)
No request 16 (2964)
Consent denied 39 (7224)
Other 3 (556)

• Med examiner
• Cardiac arrest
• No family

• Referral rate 80
• Request rate 84
• Consent rate 54
• (Consent obtained/consent requested 8308/15,550)
• Conversion rate 42

Sheehy NEJM 2003 349667-74
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Potential Organ Donors Lost in Maintenance

• Sheehy 2003

94 procured (7790/8308)

• Consented donors
• 10-25 Lopez Navidad Txp Proceed 1997
  293614-16
  
• 17 Grossman CCM 1996 24A76
• 8 Nygaard J Trauma 1990 30728-32

6 not procured (518/8308)

• Med Examiner
• Cardiac Arrest

• Literature estimates

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End of Life Care MICU
Global Cerebral Ischemia Post CPR
Retrospective
Proactive
Length of Stay
Spared Cost
All Died ? No Donors
Campbell CHEST 2003 123266-271
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Non-heart-beating Cadaveric Donation Potential
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Source for Kidney Transplantation

• 209 deaths ED and ICU
• 17 met criteria for controlled DCD
• 13/17 died within one hour of vent withdrawal
  (mean 2.3 hours)
  
• Estimated 10/17 acceptable donors ? supply of
  cadaveric kidneys by 48
  
• Estimated that 3-6X DCD vs brain dead donors

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Donors from Trauma

• Campbell CMAJ 1999 1601573-1576
• Kowalski Clin Txp 1996 10653-657

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Public Opinion Donation
Brain Dead Donation
DCD

• Preclude chance for recovery
• Possibility of misdiagnosis/error

Seltzer J Clin Ethics 2000 11347-357
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• Six working groups of conference participants
• to address specific DCD issues and fulfill
  objectives
  
• 1) determining death by a cardiopulmonary
  criterion,
  
• 2) assessing medical criteria to predict DCD
  candidacy following the withdrawal of life
  support,
  
• 3) protocols for successful DCD organ recovery
  and subsequent transplantation ,
  
• 4) initiating DCD in Donor Service Areas (DSA),
  
  
• 5) the allocation of DCD organs for
  transplantation,
  
• 6) the media, public perceptions, and DCD .

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End of Life Umbrella

• Care of the patient
• Care of the family
• Donation
• Autopsy

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Donation as an Integral Part of End of Life Care

• Discharging patients from Critical Care units is
  as important as admitting them.
  

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Palliative Care Within Experience of Illness,
Bereavement, and Risk
Life closure (planning for death)
Risk-reducing Care
Last hours of life care (dying)
Curative
Hospice Palliative Care
Presentation/diagnosis
Death
Risk
Symptom management/ Supportive Care
Bereavement Care
Risk Illness Bereavement
Patient
Family
Formal and Informal Caregivers
Hospice Palliative Care Programs
Discipline-specific Supportive Care Programs
End-of-life Care
Hospice
Frank Ferris, MD/Director, Palliative Care
Standards/Outcomes /San Diego Hospice/Printed in
CCM 2001 292332-2348
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Donation as an Integral Part of End of Life

• When the withdrawal of life support has been
  consensually decided by the attending physician
  and patient, or by the attending physician and
  family member or surrogate (particularly in the
  hospital setting of the intensive care unit), a
  routine opportunity for DCD should now be
  available to all families for consideration and
  to honor deceased donor wishes.

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Assessing Medical Criteria to Predict DCD
Candidacy Following the Withdrawal of Life
Support.

• This decision to withdraw or withhold treatments
  should be made on its own merit, having
  established the futility of any further
  treatment, and not for the purpose of organ
  donation.
• In the Intensive Care Unit, this clinical
  scenario has been referred to as Controlled DCD
  (versus Uncontrolled DCD which occurs when
  patients unexpectedly suffer cardiac arrest which
  the patient does not survive).

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Assessing Medical Criteria to Predict DCD
Candidacy Following the Withdrawal of Life
Support.

• Quality end-of-life care for a potential organ
  donor
  
• (as with any individual whose treatment is
  withdrawn)
  
• is the absolute priority of care
• and must not be compromised by the donation
  process.
  
• Quality end-of-life care for dying patients
  also
  
• includes an obligation to inform them or their
  family
  
• members of the option of organ donation.

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Assessing Medical Criteria to Predict DCD
Candidacy Following the Withdrawal of Life
Support.

• Each institution should have a policy and
  procedure that specifies a defined interval of
  time when efforts to proceed with DCD should
  cease and designates a hospital location where
  the patient may be moved for the continuation of
  end of life care.
• Once the decision is made to withdraw support in
  medical examiner/coroner cases the medical
  examiner (or coroner) should be notified as early
  as possible.

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Assessing Medical Criteria to Predict DCD
Candidacy Following the Withdrawal of Life
Support.

• The conditions to consider DCD
• irreversible brain injury,
• end-stage musculoskeletal disease,
• high spinal cord injury.
• Potential candidates for DCD include patients
• whose life sustaining treatment is under
  consideration
  
• for withdrawal, and who would likely die soon
  after the
  
• withdrawal/refusal of this treatment.

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Who Are the Candidates?

• Patients with severe neurological injury
• Intracranial hemorrhage, stroke, anoxia, trauma
• Do not meet the criteria for brain death
• No chance for meaningful recovery
• Family and physician elect to withdraw support

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DCD Application of UW OPO DCD Evaluation Tool
Organ Procurement Coordinator Role
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UW OPO - DCD Evaluation Tool Data 2003
43 Patients Evaluated for DCD
30 DCD Attempts
13 Rule-outs by OPO
4 Patients Expired
2 Patients Expired
11 Patients Expired
26 DCD Donors
in 120 Minutes
in
in 120 Minutes
13
15
87
85
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Revised UW DCD Tool Addition of Body Mass Index
(BMI) Parameter
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All patients evaluated 4/9/04 and earlier were
originally scored without BMI the scores were
re-calculated after the addition of the BMI
parameter.
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Prediction Instrument (Addition of BMI)
Classification Risks
Predicted
correct
Observed Actual
60 minutes
? 60 minutes
120 minutes
correct
Observed Actual
? 120 minutes
Lewis Prog in Txp 2003 13265-73
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Expiration Likelihood Within 60 and 120
Minutes-Original Instrument Plus Body Mass Index
Probability of expiration within 60 minutes
DCD tool score with additional points for BMI
Probability of expiration within 120 minutes
Lewis Prog in Txp 2003 13265-73
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Medications and interventions not relevant to the
withdrawal of treatment prior to the declaration
of death in a DCD patient

• After the decision to withdraw life sustaining
  therapy has been made (but before the process has
  begun) special transplant related medications may
  be administered or interventions may occur.
• Vasodilators, anticoagulants and anti-oxidants
• or the intervention of pre mortem vessel
  cannulation require specific informed consent
  that addresses
  
• the added potential risks of hastening death
• the potential benefit of improving the
  opportunity
  
• for successful transplantation.

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Medications and interventions not relevant to the
withdrawal of treatment prior to the declaration
of death in a DCD patient

• The intent of transplant related pre-recovery
  medications is to improve post-transplant organ
  function. Although it is possible that the death
  process may be unintentionally accelerated, these
  medications are not given to accelerate the dying
  process.
• It should be recognized that the ultimate goal of
  the dying patient or their surrogate, is for
  organ donation to be accomplished. When organ
  donation is desired, a good outcome fosters the
  patients and surrogates interests.

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Principle of Double Effect

• The principle of double effect is invoked in DCD
  circumstances by enabling the good of becoming an
  organ donor (after the withdrawal of life
  sustaining treatment and after the declaration of
  death)
• despite the theoretical and unintended effect
• of hastening (the inevitable) death by the
  administration of pre-recovery medications (such
  as heparin or vasodilators).
  
• The organ recovery process does not cause the
  death thus, the dead donor rule is also
  maintained.

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The Administration of Heparin

• The use of heparin has been considered
  controversial by possibly hastening the death of
  the donor.
  
• There is no evidence that heparin would cause
  sufficient bleeding after the withdrawal of
  treatment to be the cause of death.
  
• It should not be overlooked that the event of
  demise is the withdrawal of life support that
  affects the loss of circulation and respiration
  (and not the use of the heparin).

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Administration of Heparin

• There is a current standard that enables the
  administration of heparin at the time of the
  withdrawal of life sustaining treatment, and
  considered by work group participants to be a key
  component of best practice.
• The long term survival of the transplanted organ
  may be at risk if thrombi impede circulation to
  the organ after reperfusion. It is also
  conceivable that the omission of heparin could
  negatively impact organ recovery.

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Newsweek 1967 7087
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Brain Death Criteria (1967)

• You are dead when your doctor says you are.
  Death comes when the physician has done
  everything to save the patients life and comes to
  the point where he feels the patient cant live.
  Once a man makes up his mind to stop that
  respirator or cardiac pacemaker, from that
  minute, the patient is dead.

Carl Wasmuth, MD President, American College of L
egal Medicine (1967)
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Presidents Commission Ethical ProblemsUniform
Determination of Death Act (1981)

• An individual who has sustained either
• Irreversible cessation of circulatory and
  respiratory functions
  
• OR
• Irreversible cessation of all functions of the
  entire brain, including the brainstem, is dead
  
• A determination of death must be made in
  accordance with accepted standards

JAMA 1981 2462184-86
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Cessation is recognized by an appropriate
clinical examination that reveals at least the
absence of responsiveness, heart sounds, pulse,
and respiratory effort. However, the medical
circumstances of DCD may require the use of
confirmatory tests. The 1997 IOM report suggest
ed that accepted medical detection standards in
clude electrocardiographic changes consistent
with absent heart function by electronic
monitoring and zero pulse pressure as determined
by monitoring through an arterial catheter .
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Irreversibility is recognized by persistent
cessation of function during an appropriate
period of observation. The 2000 IOM report n
oted that irreversible cessation of cardiopulm
onary function can be interpreted to mean severa
l things 1) will not resume spontaneously 2)
cannot be restarted with resuscitation measures
3) will not be restarted on morally justifiable
grounds.
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When is death?

• No patient who satisfied the triad of apnea,
  absent circulation and unresponsiveness for at
  least 2 minutes had a restoration of spontaneous
  circulation. (108 patients)

Robinson J Exp Med 1912 16291-302
Willins Med J Rec 1924 11944-50
Stroud Am Heart J 1948 35910-23
Enselberg Arch Int Med 1952 9015-29
Rodstein Geriatrics 1970 2591-100
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Where Will the Death Occur?

• Operating Room
• Intensive Care Unit

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Who Will Declare Death?

• Physicians
• Primary physician, intensivist, on-call
  physician, resident, anesthesiologist
  
• Nurses

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What Happens if the Patient Does Not Expire?

• Occurs in approximately 5-10 of cases
• Pre-donation discussion with family, physicians
  and nurses
  
• Patient transferred to pre-determined unit
• Treating team remains responsible for patient care

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Ethical Axiom

• to adhere to the dead donor rule
• the retrieval of organs for transplantation
  should not cause the death of a donor
  
• Multiple organs should be removed
• only after death
• (Donation after Cardiac Death).

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Organs Recovered Per Donor 1995 - 2004
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Organs Transplanted Per Donor 1995 - 2004
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Do Transplants from DCD Donors Work?
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Donation After Cardiac DeathThe University of
Wisconsin Experience with Renal Transplantation

• Cooper JT, Chin L, Krieger NR, et al.
• American Journal of Transplantation 2004
  41490-1494
  

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DCD Renal TransplantationJanuary 1984 July 2000
1,471 Renal Transplants
382 DCD
1,089 DBD
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DCD Renal TransplantationDonor Variables
P-value
DCD
DBD
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DCD Renal TransplantationRecipient Variables
P-value
DBD
DCD
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DCD Renal TransplantationGraft Function
DCD
DBD
P-value
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DCD Renal TransplantationComplications1/94-7/00
P-value
DBD
DCD
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DCD Renal TransplantationGraft Survival
p0.054
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Kidney Primary Non-Function Rates by Donor Type
1995 - 2004
Primary non-function defined as primary failure
or graft thrombosis within 7 days of transplant
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Delayed Graft Function (DGF) DCD vs. Non-DCD
Kidneys (w/ and w/o ECD), 2000-2004
Percent
There were 454/41,218 non-DCD and 27/1,635 DCD
kidneys with missing DGF
information.
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Kidney Delayed Graft Function (Dialysis First
Week)2000-2004
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Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 10-39)
100
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 40)
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Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 50)
102
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 40)
103
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 50)
104
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 60)
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Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Kidney Transplants 1998-2003
N32,888
N1,177
N6,610
Includes adult, primary, kidney alone transplants
108
Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Kidney Transplants 1998-2003
(Donor Age 10-39)
N17,980
N575
Includes adult, primary, kidney alone transplants
109
Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Kidney Transplants 1998-2003
(Donor Age 60)
N60
N3,850
Includes adult, primary, kidney alone transplants
110
Adjusted Graft Survival Kidney Transplants at
3-Months, 1-Year and 3-Years by DCD and DGF
2000-2004
Adjusted for recipient age, sex, race, PRA, ESRD
cause, years of ESRD, HLA mismatch, year of
transplant, previous transplant, transfusions and
donor age, sex, race, hypertension, diabetes,
cause of death, creatinine, cold ischemia time
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Summary of Adjusted Kidney Graft Survival
Results by Donor Type and DGF
Adjusted for recipient age, sex, race, PRA, ESRD
cause, years of ESRD, HLA mismatch, year of
transplant, previous transplant, transfusions and
donor sex, race, diabetes, cold ischemia time
No patients in this group after Day 313, as
shown in previous slide
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DCD Donor Liver Transplants1995 - 2004
184
Year of Transplant
113
Adjusted Liver Graft Survival (1/1/2000 -
10/31/2003)
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Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Liver Transplants 1998-2003
N22,199
N303
Includes adult, primary, liver alone transplants
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Where Will the Death Occur?

• Operating Room
• Intensive Care Unit

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Who Will Declare Death?

• Physicians
• Primary physician, intensivist, on-call
  physician, resident, anesthesiologist
  
• Nurses

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What Happens if the Patient Does Not Expire?

• Occurs in approximately 5-10 of cases
• Pre-donation discussion with family, physicians
  and nurses
  
• Patient transferred to pre-determined unit
• Treating team remains responsible for patient care

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Ethical Axiom

• to adhere to the dead donor rule
• the retrieval of organs for transplantation
  should not cause the death of a donor
  
• Multiple organs should be removed
• only after death
• (Donation after Cardiac Death).

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Organs Recovered Per Donor 1995 - 2004
121
Organs Transplanted Per Donor 1995 - 2004
122
Do Transplants from DCD Donors Work?
123
Donation After Cardiac DeathThe University of
Wisconsin Experience with Renal Transplantation

• Cooper JT, Chin L, Krieger NR, et al.
• American Journal of Transplantation 2004
  41490-1494
  

124
DCD Renal TransplantationJanuary 1984 July 2000
1,471 Renal Transplants
382 DCD
1,089 DBD
125
DCD Renal TransplantationDonor Variables
P-value
DCD
DBD
126
DCD Renal TransplantationRecipient Variables
P-value
DBD
DCD
127
DCD Renal TransplantationGraft Function
DCD
DBD
P-value
128
DCD Renal TransplantationComplications1/94-7/00
P-value
DBD
DCD
129
DCD Renal TransplantationGraft Survival
p0.054
130
Kidney Primary Non-Function Rates by Donor Type
1995 - 2004
Primary non-function defined as primary failure
or graft thrombosis within 7 days of transplant
131
Delayed Graft Function (DGF) DCD vs. Non-DCD
Kidneys (w/ and w/o ECD), 2000-2004
Percent
There were 454/41,218 non-DCD and 27/1,635 DCD
kidneys with missing DGF
information.
132
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004
133
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 10-39)
134
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 40)
135
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 50)
136
Kidney Delayed Graft Function (Dialysis First
Week)2000-2004 (Donor Age 60)
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Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Kidney Transplants 1998-2003
N32,888
N1,177
N6,610
Includes adult, primary, kidney alone transplants
140
Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Kidney Transplants 1998-2003
(Donor Age 10-39)
N17,980
N575
Includes adult, primary, kidney alone transplants
141
Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Kidney Transplants 1998-2003
(Donor Age 60)
N60
N3,850
Includes adult, primary, kidney alone transplants
142
Adjusted Graft Survival Kidney Transplants at
3-Months, 1-Year and 3-Years by DCD and DGF
2000-2004
Adjusted for recipient age, sex, race, PRA, ESRD
cause, years of ESRD, HLA mismatch, year of
transplant, previous transplant, transfusions and
donor age, sex, race, hypertension, diabetes,
cause of death, creatinine, cold ischemia time
143
Summary of Adjusted Kidney Graft Survival
Results by Donor Type and DGF
Adjusted for recipient age, sex, race, PRA, ESRD
cause, years of ESRD, HLA mismatch, year of
transplant, previous transplant, transfusions and
donor sex, race, diabetes, cold ischemia time
No patients in this group after Day 313, as
shown in previous slide
144
DCD Donor Liver Transplants1995 - 2004
184
Year of Transplant
145
Adjusted Liver Graft Survival (1/1/2000 -
10/31/2003)
146
Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Liver Transplants 1998-2003
N22,199
N303
Includes adult, primary, liver alone transplants
147
Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Liver Transplants 1998-2003
(Donor Age 10-39)
N10,733
N153
Includes adult, primary, liver alone transplants
148
Kaplan-Meier Adult Graft Survival Primary
Deceased Donor Liver Transplants 2002-2003
N8,014
N164
Includes adult, primary, liver alone transplants
149
DCD Liver TransplantationStudy Period(1/1/93 -
7/31/02)
930 Organ donors
81 (8.7) DCD
849 (91.3) DBD
47 Multi-organ
33 Kidney only
553(65.1) Liver transplants
1 Pancreas only
36 (76.5) Liver transplants
11(23.4) Livers not used
150
DCD Liver Transplantation
DCD (n36)
DBD (n553)
p0.05 p0.0001
151
DCD Liver Transplantation
p 152
DCD Liver Transplantation
p 153
DCD Liver TransplantationComplications
p0.001,p04.
154
Patient Survival After Liver TransplantationDCD
vs. DBD
p0.01
Years Post Transplantation
155
Allograft Survival After Liver TransplantationDCD
vs. DBD
p0.006
Years Post Transplantation
156
Non-heart Beating (DCD) Lung Donation

• Timing of lung death and lung failure
• Lung may be more amenable to non-heart beating
  donation than kidney ? parenchyma cells
  immediately adjacent to alveolar spaces and O2
  source1
• Tissue high energy nucleotide phosphates normal 4
  hours2
  
• Pre-arrest hypoxia limited effect on pulmonary
  fxn3
  
• Successful animal models4
• Successful early human experience5

1. Corris Thorax 2002 57(suppl 11)ii53-ii56
2. DArmini J Surg Res 1995 59468-474
3. Mauney Ann Thoracic Surg 1996 6254-61
4. Egan J Heart Lung Txp 2004 233-10
5. Steen Lancet 2001 357825-829
157
Key Barriers to Increasing DCDEthical Arguements

• Nonmaleficience
• Physician prejudice
• Potential increase in physical suffering
• Procedure related/transfer to OR
• Deny the presence and support of loved ones
• Manipulation of care of dying patient
• Withholding sedation analgesia to avoid
  appearance of active euthanasia
  
• Hasten death if patient fails to succumb after
  withdrawal of life support
  
• Potential to jeopardize double effect
  principle
  
• Pragmatic slippery slopes
• Manipulation of timing of death
• Defining irreversible cardiopulmonary arrest
• Criteria for DCD
• Potential conflicts of interest

Van Norman Anesthesiology 2003 98763-773
158
Key Barriers to Increasing DCD

• Earlier recognition of futility ? withdrawal of
  support ? removes potential DCD donors from donor
  pool
  
• Perceived needs of the transplant recipient/team
  supplant the needs of the critically ill patient
  
• Failure to understand brain death
• Failure to include donation into Living Wills and
  Advanced Health Care Directives
  
• Approach to the neurologically impaired vs
  neurologically intact potential DCD population
  
• Use of medications and interventions NOT relevant
  to the withdrawal of support prior to
  declaration
  

159
Key Lesson Learned/Ongoing Efforts and Next Steps

• Ensure donation is an integral part of end of
  life care
  
• Clear separation of decision to withdraw support
  and decision for donations
  
• Clear DCD Policy
• Defined hospital champion and resourceEducation
  (current)
  
• Clinical triggers
• Timely notification
• Avert premature withdrawal
• DCD training programs
• DCD consultative services
• Education (proposed)
• Input from major critical care societies (SCCM,
  ATS, ACCP, ACS)
  
• ACGME curriculum requirements
• Regional symposia
• National meetings

160
Key Lessons Learned/Ongoing Efforts and Next Steps

• Research
• End of life integration
• Auto-resuscitation
• Predictive index of death
• Assessments of ischemic time
• Cost effective analysis
• Data collection and outcomes assessment
• Regulatory
• DCD policy
• Incorporate donation into Advanced Health Care
  Directives
  
• Accreditation
• Re-imbursement

161
SCCM Recommendations

• Informed consent is ethical cornerstone
• Organ procurement must not cause death and death
  must precede procurement
  
• Death must be certified by using standardized,
  objective and auditable criteria following state
  law
  
• Care is first and foremost directed towards the
  dying patient

CCM 2001 291826-1830
162
NHBOD Special Concerns

• Patient must be certified dead using objective
  standardized, auditable criteria not different
  from those utilized for non-NHBODs
  
• No patient may be certified by MD who
  participates in procurement/transplantation
  
• Decision to withdraw therapy should preferably be
  made before and must independent of any decision
  to donate
  
• Medications that alleviate pain and suffering are
  permissible

Asystole Apnea Unresponsiveness
5 minutes Not recommended
2 minutes recommended
CCM 2001 291826-1830
163
NHBOD Special Concerns

• No medication whose purpose is to hasten death
  should be given comfort medications, even if
  hastening death, are reasonable
  
• Medications that do not harm the patient and are
  required to improve chances of successful
  donation are acceptable
  
• Review practice, fair allocation, inform
  recipients, educate

CCM 2001 291826-1830
164
Role of Clinical Care Team in Donation

• Donor Medical Management Critical Care
  Management
  
• Integrative multi-disciplinary collaborative
  approach between OPO and Clinical Care Team

• Intensivists
• Pulmonary Consultants
• Cardiac Consultants
• Nursing
• Respiratory

• Hemodynamics
• Ventilatory Management
• Echocardiography
• Diagnostic Procedures

• Donor Management Team/Defined Champions
• Donor Family Support

165
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