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Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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Page 1: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Alex ManaraRegional Clinical Lead in Organ Donat ion

South West RegionFrenchay Hospital, Bristol

Page 2: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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2. Increased diagnosis of brain stem death

3. Increased donation after cardiac death

Diagnosis of Death Masterclass

Page 3: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

20461928

17161628 1575

14951370 1338

1243 12681161 1165

0

500

1000

1500

2000

2500

2003/04 2004/05 2005/06 2006/07 2007/8 2008/9

BSD possible diagnosis Patient confirmed BSD

Incidence of Brainstem Death on ICU(< 75 years, non-cardiac ICUs)

Page 4: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Incidence of Brainstem Death on ICU(< 75 years, non-cardiac ICUs)

350 missed potential donors

172 actual donors

619 additional transplanted patients

Extra 2.8 donors pmp

20461928

17161628 1575

14951370 1338

1243 12681161 1165

0

500

1000

1500

2000

2500

2003/04 2004/05 2005/06 2006/07 2007/8 2008/9

BSD possible diagnosis Patient confirmed BSD

Page 5: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

7.2

6.112.7

6.7

6.2

5.97.7

7.9

13.5

6.712.1

6.25.7

Actual DCD donors pmp

DCD variation in the UK?PDA data, April 2012 March 2013

Page 6: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Patient should not be killed as a result of donating organs

Patient should not be killed to allow organs to be donated

Dead Donor Principle

Dying is a process Death is a defined point in that process

Page 7: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Clear and consistent guidelines based on evidence are needed to fulfill medical, ethical, and legal obligation and to ensure public trust

Page 8: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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600,000 UK deaths per annum (1,200 BSD)

56 million deaths per annum worldwide

Death according to Google

We should know all there is to know about how to diagnose death

Page 9: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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Confirming Death

Cessation of heart beatCessation of breathingUnresponsivenessRelatively easy to makeReproducibleRecognizable

Page 10: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Technological advances have changed our views on the line between life and death

ECMO Ventricular Assist Devices

Advanced CPR ICU Care

Transplantation

Page 11: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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The Law

There is no statutory definition of death in the United

Kingdom (Unlike USA)

The determination of death using neurological criteria

has been accepted by the courts of England and Wales.

Otherwise you re dead when a doctor says so = accepted

medical practice

Page 12: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Virtually no national or professional guidance on diagnosing death using circulatory criteria until the last decade

Variation in Practice in Circulatory Criteria

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Variation in Practice

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Variation in Practice in Neurological Criteria

Variable practice when guidelines not specific

Guidelines not always followed even when specific

Page 15: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Media, variability in practices, suspicion

Page 16: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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What is accepted medical practice?

Page 17: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

"In principle an international guideline on death is a very good idea. It is likely to help in terms of the movement of doctors between countries and, importantly, with public confidence."

Consistency

"Italians and Brits are probably built in the same way. It makes sense to have the same criteria for death for both."

Dr Jerry Nolan, June 2013 http://www.bbc.co.uk/news/health-22730360

Page 18: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Operational Definition of Human Death

Death occurs when there is permanent loss of capacity for consciousnessand loss of all brainstem functions.

This may result from permanent cessation of circulation and/or after catastrophic brain injury.

In the context of death determination, permanentrefers to loss of function that cannot resume

spontaneously and will not be restored through intervention.

Page 19: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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All Death is Brain Death

Permanent loss of consciousness

+Permanent loss of all brainstem funct ions

Cardio- respiratory determinat ion of death

Neurological determinat ion of

death

Somatic determinat ion of

death

Page 20: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

PERMANENT

The dying process will not be reversed

IRREVERSIBLE

The dying process cannot be reversed

Dying is a process Death is a defined point in that process

No intervention that may interrupt the dying processPost mortem interventions with potential to restore

cerebral perfusion

Page 21: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

A. Cardiorespiratory arrest without CPR (end-of-life care / withdrawal / withholding of life

sustaining therapies)

B. Cardiorespiratory arrest following termination of CPR (hypoxic or primary cardiac arrest)

C-1Cessation of circulation and breathing

C-2Cessation of circulation and breathing

with no possibility to resume spontaneously

C-3Cessation of circulation and breathing

with no possibility to resume

If CPR provided, resumption of circulation

theoretically possible

Biological events after death

Circulatory Dying SequencePreconditions & Confounders, Minimum Acceptable Clinical

Standard, and Additional Testing defined for C-1, C-2, C-3

Page 22: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

A. Cardiorespiratory arrest without CPR (end-of-life care / withdrawal / withholding of life sustaining

therapies)

B. Cardiorespiratory arrest following termination of CPR (hypoxic or primary cardiac arrest)

C-1Cessation of circulation and breathing

C-2Cessation of circulation and breathing with no

possibility to resume spontaneously

C-3Cessation of circulation and breathing with no

possibility to resume

Biological events after death

N-3

Cessation of brain function with no

possibility to resume spontaneously

N-2Cessation of brain function

Increasinglikelihood

over time of no possibility to resume

brain function

Neurological and Circulatory Dying Sequence

Page 23: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Decision to abandon CPR

C1 C2

WLST

Loss of circulationApnoeaUnresponsiveness

Continuous observationECG asystoleIABPEcho

5 minutes after WLST

5 min after CPR? 7 minutes

Declaration of deathPermanence

Page 24: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

2012

Page 25: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Dr Michael DeVitaDr Michael DeVitaUniversity of Pit tsburghUniversity of Pit tsburgh

Page 26: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

DCD in the UK 2000 - 2012

Page 27: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

3.7 days old donor

Lined and given heparin

Extubated in theatre

Waited 75 seconds of PEA before

retrieval of heart

Best interests of the recipient

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Page 29: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

No reports in absence of CPR

Low quality (but only) evidence

67% Case reports 33% letters to editor

32 patients reported by 2008

16 different countries

Duration of CPR 6 88 minutes

Final rhythm asystole (not EMD) in 67%

Auto-resuscitation

Current criteria for stopping CPR do not define irreversibility of the loss of the circulat ion

Page 30: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

C1 C3

WLST

Loss of circulationApnoeaUnresponsiveness

Circulatory IrreversibilityOr

Neurological Irreversibility

5 minutes after WLST

5-min after CPR? 7 minutes

Declaration of deathIrreversibility

C2

Declaration of deathPermanence

Time unknown

Page 31: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

C2 C3

Declaration of deathIrreversibility

Declaration of deathPermanence

Time unknown

Can the circulation / brain function be restarted after 5 minutes of asystole?Are the criteria for stopping CPR infallible?Can the heart be restarted after failed CPR?Is the brain unresponsive after failed CPR?

Page 32: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Using most sensitive criteria for stopping CPR at scene

Non shockable rhythmNon witnessed arrestLate arrival of EMSNo return of circulation

Clinical judgement still required

1 in 200 will still survive

Page 33: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Controlled DCDThoracotomy and clamp across aortic archCPB 23 min after arrestHeart in Sinus Rhythm 28 minutes after arrestSuccessfully weaned from CPB with good function

What is cardiac irreversibility?

Page 34: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Is the Brain Dead after Failed CPR

January 2008 November 2009Failed CPR patients (30 minutes)Manual vs mechanical CPR compared for potential uDCD3 of 48 patients had ROSC during transport (6%)1 patient made a good neurological recovery

the devices do improve brain perfusion

Current criteria for stopping CPR do not define irreversibility of circulat ion or neurological funct ion

Page 35: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

PERMANENT

The dying process will not be reversed

IRREVERSIBLE

The dying process cannot be reversed

Dying is a process Death is a defined point in that process

No intervention that may interrupt the dying processPost mortem interventions with potential to restore

cerebral perfusion

Page 36: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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What is accepted medical practice?

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Neurological Determination of Death in UK

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2008 Guidelines

Attempts further

standardisation

Primarily a clinical diagnosis

Clinical judgement still

required

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History

Improved ICU care of comatose patients

Coma depassé described in Paris in 1959

Deep irreversible coma,

apnoea, loss of brainstem reflexes, DI, CVS instability, poikilothermia

Inevitably followed by asystole

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Cardiac Prognosis After NDD

Pallis 1987:

1300 patients all developed cardiorespiratory arrest even with full

support

Hung et al 1995:

73 adults and children

Full and continued CVS support

All became asystolic; within 10 days

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Neurological Determination of Death in UK

1. Patient in deep apnoeic coma

Page 42: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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Neurological Determination of Death in UK

2. Known cause capable of causing ND

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Neurological Determination of Death in UK

Primary hypothermia

Metabolic disturbances

Alcohol

Depressant drugs

Muscle relaxants

3. No reversible causes / confounding factors

Page 44: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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Neurological Determination of Death in UK

Temperature > 34o C

Na+ < 160 mmol/L

K+ > 2 mmol/L

Glucose > 3 mmol/L < 20mmol/L

Phosphate > 0.5 mmol/L < 3 mmol/L

Magnesium

3. No reversible causes / confounding factors - Metabolic

Serum Na+ > 115mmol/L?

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Neurological Determination of Death in UK

Clinical judgement essential

Impossible to create rules covering every situation

Difficulties mainly with thiopentone and midazolam

Plasma concentrations not good predictors of effect

Use of antagonists may help

Ideally use non cumulative drugs propofol, remifentanil

3. No reversible causes / confounding factors - Sedatives

Page 46: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

2 experienced clinicians1 must be a consultantBoth registered for > 5 yearsUnconnected to transplantat ionNo ulterior mot ive for making diagnosis

Page 47: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Two sets must always be performedTime interval between sets variableAllow 6 hours from onset of apnoeaMin 24 hours after cardiac arrest

Page 48: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Improved psychological outcome in relat ives witnessing CPR32% consultants and 42% nurses had experience of relat ives presence69% thought it beneficial80% thought spinal ref lexes problematic

Pugh et al BMJ 2000

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Neurological Determination of Death in UK

4. Absent brainstem reflexes

Page 50: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Anatomy of the brainstem reflexes

pupillary light reflex (II / III)

corneal reflex (V / VII)

motor response in cranial nerve territory to somatic stimulation in any area (V / VII)

cold caloric vestibulo-ocular reflex (VIII/ III, IV, VI)

gag or cough reflex (IX / X)

Page 51: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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Neurological Determination of Death in UK

Must be done last after other reflexes absent

Undertaken no more than twice

Achieve CVS stability at PaCO2 > 6kPa before

disconnection

Disconnect for 5 minutes

Return PaCO2 to normal on reconnection

Apnoea Test

Page 52: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Scripko P. The neurologist 2011; 17:237-40

Bilateral finger tremor Ocular microtremor Repetitive leg movements Facial myokymiasEyelid opening Undulating toe reflexDeep tendon reflexes Respiratory-like reflexLazarus sign Limb movementsCyclical pupillary constriction and dilationCremasteric, plantar and abdominal reflexesTriple flexion of the lower extremities

Page 53: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

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Neurological Determination of Death in UK

4 vessel cerebral angiography

CT angiography

MRI angiography

EEG

TCD

SPECT

Brain stem evoked potentials

Response to 2mg atropine

ICP > MAP

5. Ancillary Tests

Page 54: Alex Manara Regional Clinical Lead in Organ Donation South ...odt.nhs.uk/pdf/Diagnosis_of_death.pdf · Virtually no national or professional guidance on diagnosing death ... with

Legally accepted diagnosisTime of death - 1st set complete? Coroner informed Early involvement of SN-ODDiscontinuation of ventilator support orChange to donor maintenance

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Whole Brain Death ?

http://video.bloodservices.ca/Streaming/nddvideo/

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Reducing Variability in Practice

Guidelines Helpful but limited value

CLODs Professional Development Programme

Development of international approach to confirmation

Prospective observational studies on onset of asystole