NonHeart Beating Organ Donation

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Non-Heart Beating Organ Donation

• (NHBOD)

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(No Transcript)
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Scope of the talk

• What is NHBOD?
• Why are we interested?
• What are the problems?
• How can we go forward?

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What is NHBOD?
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Organ donation from

• Cadaver pronounced dead on the basis of loss of
  cardiac function prior to the start of the organ
  retrieval process. As opposed to
• Cadaver pronounced dead on the basis of
  irreversible loss of brainstem function, (whose
  heart is beating at the initiation of organ
  retrieval)
• Both follow the dead donor rule

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History

• 1950s first ICUs created in Scandinavia
• Ventilation of severely brain injured patients
  possible
• 1957 Pope Pius XII
• Resuscitation is extra-ordinary and can be
  withdrawn prior to circulatory arrest
• Precise moment of death cannot be determined by
  religious or moral principle and so relied on
  clinical means
• 1959
• Diagnosis of brain death by EEG
• Description of coma dépassé

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More history

• 1960s Improvements in immunosuppression and
  dialysis
• Ability to wait for transplant
• Concerns over quality of NHBOD organs
• Consideration of brain dead patients as donors
• Ad hoc Committee of the Harvard Medical School to
  Examine the Definition of Brain Death (1968)

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Yet more history

• Late 70s early 80s rationalization of equivalence
  between neurological and cardiac death
• NHBOD virtually ceases
• 1981 Uniform Determination of Death Act
  (Presidents Commission)
• An individual who has sustained either (1)
  irreversible cessation of circulatory and
  respiratory functions, or (2) irreversible
  cessation of all functions of the entire brain,
  including the brain stem, is dead.
• Potential recipient population continues to rise
• HBD rates start to decrease from the early 1990s
• 1993 Pittsburgh protocol for NHBD renews interest
• 1995 Maastricht International Conference

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Maastricht NHBOD groups
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Maastricht Groups 1 2

• Group 1 - unknown/excessive WIT
• Group 2 - Require availability of a team on an
  emergent basis and possible intervention prior to
  assent (unless advance directive)
• In addition

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Maastricht Groups 3 4

• Group 3 are the primary group of interest
• Expected to die
• Active therapy withdrawn
• auto-resuscitation not recorded after 2 minutes
  of apnoea, unresponsiveness, pulselessness
• Group 4 should really proceed to HBD

Weak evidence (108 patients) NB recent local
experience
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NHBOD the process

• Active therapy is withdrawn
• Transplant coordinator is contacted
• Suitability for NHBOD or tissue donation assessed
• Asystole occurs
• Death is certified after ? Minutes
• Family pay last respects
• standoff time ? Minutes
• (total post asystole gt2 required no more than 5
  necessary SCCM)
• In situ cooling
• To theatre retrieval

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Why are we interested?
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Currently in the UK

• HBD donor rates falling
• Indications for transplant are broadening
• Waiting list for transplant is increasing
• Government is VERY keen to promote NHBOD
• It doesnt seem greatly concerned about how its
  introduced
• A number of units have NHBOD programs
• All have differing guidelines
• Pre-assent cannulation has been used

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Are families interested?

• Donation is important to some families
• Pursuing their relatives wishes
• Altruism
• May aid the grieving process
• Lay public do not seem to distinguish between
  neurological and cardiac death
• Families may request donation in non-brainstem
  dead patients and find it difficult to understand
  why this is not possible in some units.

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What are the problems?
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Dilemmas

• Decisions on withdrawal of care
• Mode of withdrawal of care
• Pre-mortem intervention
• Location of withdrawal of therapy
• Manner of certification of death
• Quality of NHBOD vs. certainty of death

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Decisions on withdrawal of care

• Could physicians be biased in assessing QOL in
  e.g. handicapped patients
• Is there a conflict of interest in physicians
  withdrawing therapy in potential NHBOD patients

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Mode of withdrawal of therapy

• Process of withdrawal of active therapy
• Inadequate analgesia/sedation (avoiding
  accusation of euthanasia)
• (More than) adequate analgesia/sedation (risk of
  accusation of euthanasia)

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Pre-mortem pre-assent intervention

• Pre-mortem
• Clearly illegal in the UK (including elective
  ventilation, cannulation, drugs, etc)
• Pre-assent
• Two or three areas in the USA have sanctioned
  pre-mortem cannulation whilst attempting to
  obtain relative assent
• The Netherlands also sanctions this process
• At least one unit in the UK did use this technique

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Location of withdrawal of therapy

• Operating theatres minimizes WIT but is inimical
  to family
• Bedside is more family friendly but implies a
  greater WIT

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NHBOD vs. certainty of death

• NHBOD is more likely to produce useful organs
  if WIT is short
• Concerns over whether the donor is really dead
  suggest longer stand off times
• Cardiac resuscitation may occur after prolonged
  asystole
• Cerebral resuscitation (normothermic) may occur
  successfully after 15 minutes (? longer)

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Manner of certification of death
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What is death?
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Death Its not easy

• A headless corpse was found recently in Germany.
  The Police said that they were keen to find the
  missing head
• In order to ascertain the cause of death

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What is death?

• Brain death
• Flat EEG
• Lack of cerebral perfusion
• Death of the whole brain or the brain as a whole
• Brain stem death
• Preconditions/exclusions/clinical tests
• Cessation of cardiac function, apnoea,
  unresponsiveness
• Irreversible?
• Is a patient on bypass dead? (suggests
  preconditions for diagnosis)
• Death of all cells?
• Putrefaction?
• When a doctor says so
• What does irreversible mean?

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What does irreversible mean?

• Not reversible despite the application of any and
  all measures (Maastricht 1 2?)
• Not reversible in the absence of intervention
  (i.e. not spontaneously reversible) (Maastricht 3
  4?)

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Sir We report the case of a 21-year-old woman
who recovered completely after 45 min accidental
submersion in cold salt water.
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The criteria for inclusion were a witnessed
cardiac arrest, ventricular fibrillation or
non-perfusing ventricular tachycardia as the
initial cardiac rhythm, a presumed cardiac origin
of the arrest, an age of 18 to 75 years, an
estimated interval of 5 to 15 minutes from the
patients collapse to the first attempt at
resuscitation by emergency medical personnel, and
an interval of no more than 60 minutes from
collapse to restoration of spontaneous
circulation.
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Resuscitation after cardiac arrest
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Spontaneous reversal of cardiac arrest

• Enselberg C. The dying human heart.
  Electrocardiographic study of forty-three cases,
  with notes upon resuscitative attempts. Arch
  Intern Med 1952901529.
• Showed spontaneous cardiac activity could return
  after more than 1 minute of asystole, apnoea and
  unresponsiveness.
• Youngner S, Arnold R, DeVita M. When is death?
  Hastings Center Reports 1999291421.
• Reviewed data from 108 patients who were observed
  dying. In those five studies, no patient who
  satisfied the triad of apnea, absent circulation,
  and unresponsiveness for at least 2 minutes had a
  restoration of spontaneous circulation

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Cerebral resuscitation

• At normothermia, 15 minutes seems to be the
  current documented maximum duration of
  circulatory arrest that can be tolerated
• There are basic science studies that suggest that
  this is not the upper limit.
• Active resuscitation will prolong the time after
  asystole after which cerebral function can be
  restored

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When are these patients dead?

• Brainstem dead patient on ventilator
• Non potential NHBOD patient who refuses CPR
• Potential NHBOD patient who accepts CPR
• Potential NHBOD patient who refuses CPR

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Timing of death

• Death is a process rather than an event
• There is enough evidence to suggest that there is
  no absolute cut off in terms of duration of
  asystole at which death can be defined.
• Pronouncing death is to do with circumstances and
  intent as much as physiology
• A DECISION not to invoke further therapy is the
  essential prerequisite.

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Definitions of death

• An individual who has sustained either (1)
  irreversible cessation of circulatory and
  respiratory functions, or (2) irreversible
  cessation of all functions of the entire brain,
  including the brain stem, is dead. (The
  Presidents Commission, 1981)
• Death is defined as the irreversible loss of the
  capacity for consciousness, combined with the
  irreversible loss of the capacity to breathe (The
  Royal College of Surgeons, 1995)
• There is no legal definition of death in the UK
  (when a Doctor says youre dead)

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2001

• A non-heartbeating cadaver (NHBC) is a corpse
  whose death has been determined using
  traditional or cardiopulmonary criteria. The
  three required elements of the criteria are
  simultaneous and irreversible
• unresponsiveness,
• apnea
• absent circulation. Loss of circulation denotes
  no mechanical cardiac function. It is possible
  that electrical cardiac activity (in the absence
  of contraction) may continue after death.

Heart transplantation from NHBOD
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Principles of diagnosing death

• Should always be pronounced on the basis of
  brainstem death or by a STANDARDIZED cardiac
  death protocol. May allow NHBD where
  consent/assent is given
• Should give confidence to the public that the
  process is safe

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A (partial) solution

• Much of the debate is what if
• The heart could be restarted
• And the brain were to be undamaged (by the
  arrest)
• This may be an issue in Maastricht 1 2 but less
  likely in 3 4
• But the debate might be
• It would not be in the patients interest to do
  so whether it were possible or not.
• This requires detailed knowledge of the patients
  history
• If organ donation were to take place can we
  assure the public that the donor would be
  unconscious.

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Circulation and consciousness

• Loss of circulation always results in loss of
  whole brain function within seconds and may
  precede complete circulatory arrest.
• There is NO evidence that consciousness can be
  present in the absence of cardiac output

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How can we go forward?
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National approach to NHBOD

• After
• public consultation
• Agreement amongst professional bodies
• Nationally agreed protocols for NHBOD
• All units to use these protocols

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Withdrawal of active therapy

• Should be undertaken in the same way for all
  patients
• All such patients should be referred to the
  Transplant Coordinators (for potential organ or
  tissue donation)
• Medical involvement in donation should be by a
  consultant other than the one involved in
  withdrawal of therapy decision

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Diagnosis of death

• Should be diagnosed in a standardized way (in ICU
  or ward or in the community)
• Should be independent of the potential donor
  status of the patient
• Should precede any intervention that is not in
  the interests of the patient

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A scheme for diagnosing death
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• A diagnosis of death may only be considered in a
  person for whom active therapy has either been
  withdrawn or is deemed by a doctor to be futile
• A person is said to have died when a diagnosis of
  death is made by a doctor
• Death is irreversible loss of brainstem function
• Diagnosis of irreversible loss of brainstem
  function in a person receiving artificial
  ventilation
• is dependent on satisfaction of the
  pre-conditions, exclusions and the proper
  performance of brainstem death tests, as
  described in the Code of Practice

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• Diagnosis of irreversible loss of brainstem
  function in a person not receiving artificial
  ventilation may be made following
• Cessation of mechanical heart function followed
  by
• Apnoea for a period of not less than 5 minutes
  starting from the time of complete cessation of
  mechanical heart function (apnoea will likely
  precede cessation of mechanical heart function
  but timing of the necessary period of apnoea
  should commence upon loss of mechanical heart
  function).

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• A subsequent confirmation of the absence of
  mechanical heart function not less than 5 minutes
  after (a) the patient being observed during the
  intervening period to confirm apnoea
• Diagnosis of complete absence of cardiac function
  should be appropriate to the environment in which
  the death occurs, e.g.
• Lack of pulse and heart sounds and a lack of a
  pressure waveform on an intra-arterial blood
  pressure monitor, or lack of cardiac motion on
  ECHO in critical care areas where these
  modalities have been applied before death or in
  the case of ECHO, are available. Anything other
  than an agonal rhythm, ventricular fibrillation
  or asystole on ECG should prompt re-checking for
  lack of mechanical heart function.
• lack of pulse and heart sounds in a patient on a
  general ward or in the community

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• Brainstem function should be assessed after not
  less than 5 minutes of apnoea by
• bilateral lack of response to supra-orbital
  pressure (or a noxious stimulus in the
  distribution of the trigeminal nerve, performed
  bilaterally if possible)
• Where the eyes are accessible and not subject to
  local trauma
• bilateral lack of pupillary response to light
  (omit in the blind or visually impaired)
• lack of corneal reflex.
• Inability to test brainstem function by ANY of
  the above tests should result in an observation
  for apnoea and lack of cardiac mechanical
  function (as described above) for a period of not
  less than 10 minutes.

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• Any detection of respiratory, cardiac or
  brainstem function by these tests should prompt a
  repeat examination in not less than 5 minutes
  time (10 minutes if brainstem function cannot be
  assessed) and the patient observed for the
  intervening period to confirm apnoea and lack of
  mechanical heart function.

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Will NHBOD make a difference

• Currently NHBOD contributes lt1 of the number of
  transplants in USA
• But can be 10 in individual programs
• In Holland 50 of cadaveric transplants are from
  NHBOD
• In the UK it will not make a contribution unless
  it is widespread
• If it is widespread then it must be performed in
  a standardized manner in all units.
• A nationally agreed process for diagnosing death
  would be helpful
• The public must be aware and understand the
  process

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Thank you

• For your attention