Early craniectomyin neurotrauma –pros and cons (RESCUEicp) hutchinso… · Decompressive...
Transcript of Early craniectomyin neurotrauma –pros and cons (RESCUEicp) hutchinso… · Decompressive...
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Early craniectomy in neurotrauma– pros and cons (RESCUEicp)
PJ HutchinsonProfessor of NeurosurgeryUniversity of Cambridge
UK
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Decompressive craniectomy (DC) in Traumatic Brain Injury
• Secondary DC– Removing a large bone flap to control raised
intracranial pressure
• Primary DC– Leaving the bone flap out following initial surgery for
a mass lesion• acute subdural haematoma
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Secondary DC for raised ICP
Primary DC for mass lesion
RESCUE-ASDH• 990 patients• On-going • ASDH that needs to
evacuated with a large bone flap
• Randomisation intra-operatively
DECRA• 155 patients• Published in 2011• 15-60 years• Severe diffuse TBI within 72 hours post-injury
• ICP > 20 mmHg,15 mins
RESCUEicp• 400 patients• Published 2016•10-65 years• Raised ICP refractory to protocol-based medical management
• ICP > 25 mmHg, 60 mins
Decompressive craniectomy for TBI
Kolias AG, Kirkpatrick PJ, Hutchinson PJ.
Nature Reviews Neurology 2013
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DECRA
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DECRA – EndpointsDC- similar mortality; increased rate of unfavourable
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September 7th 2016 21:00 GMTDisclosures and article at www.nejm.org
www.RESCUEicp.com
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Hypothesis
Decompressive craniectomy can improve outcomes
as a last-tier therapy for refractory post-traumatic
intracranial hypertension
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Study DesignProspective randomised study
Target study group:Ventilated TBI patients with refractory ICP
Advanced medical management (inc barbiturates)V
Surgical management (decompressive craniectomy)
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Study EndpointsEndpoints
Primary 6 months GOS-ESecondary 12 months GOS-E
24 months GOS-E(analysis pending)GCS at discharge from ICUControl of ICPLength of stay in ICUQuality of life (analysis pending)Health economic analysis (analysis pending)
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Extended Glasgow Outcome Scale (GOS-E)
GOS-E category Abbreviation ExplanationDeath Death DeadVegetative state VS Unable to obey commandsLower severe disability LSD Dependent on others for careUpper severe disability USD Independent at home
Lower moderate disability LMDIndependent at home and outside the home but with some physical or mental disability
Upper moderate disability UMD
Independent at home and outside the home but with some physical or mental disability, with less disruption than LMD
Lower good recovery LGR Able to resume normal activities with some injury-related problems
Upper good recovery UGR No injury-related problems
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Sample size400 patients to be randomised
15% difference in outcome at upper severe disability (independent at home) or better
Power 80%, p<0.05
Allowance for loss to follow-up (10%)
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52 centres20 countries
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Baseline characteristics
There were no significant between-group differences in the baseline characteristicsexcept for history of drug or alcohol abuse (P = 0.02).
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Treatments and Interventions
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Bifrontal DCfor diffuse brain injury/swelling
Dura opened, division of falx, frontal sinus cranialisation
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p=0.12
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p=0.01
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Outcome of “extra survivors” with craniectomy
6 monthsFor every 100 patients treated with surgical versus medical intent:• 22 more survivors
– 6 (27%) VS– 8 (36%) LSD– 8 (36%) USD or better
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12 monthsFor every 100 patients treated with craniectomy versus medical intent:• 22 more survivors
– 5 (23%) VS– 4 (18%) LSD– 13 (59%) USD or better
Outcome of “extra survivors” with craniectomy
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Sub group analysis
• Benefits may be greater in young patients (<40 years)
• supplementary appendix
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ICP data
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Complications and adverse events
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DECRA RESCUEicp
Recruitment<72hrspost-TBI 100% 56%
ICPthresholdlevel >20mmHg >25mmHg
ICPthresholdduration 15mininanyhour 1-12hours
PriorICPtherapies Tier1 Tiers1&2
Expectedmortality
Pooledmortality 18.7% 37.5%
Mortalityintwostudyarms 19%vs18% 26.9%vs48.9%
DichotomizationonGOSE LowerMD/UpperSD UpperSD/LowerSD
Documentedfollowup 6months 6and12months
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RESCUEicp- interpretation• Data informative for clinicians and families
• Class I evidence for using last-tier DC as a life-saving intervention for refractory raised ICP following TBI
• Patients with extremely severe TBI pathophysiology as a consequence of initial injury severity and/or host response
• Consequently, dichotomization at upper severe disability (= independent at home) was a reasonable outcome threshold (pre-specified analysis).
• At 6 months DC reduced mortality from TBI from 48.9% to 26.9%, but more DC patients were likely to be dependent (30.3% compared to 16.5%).
• At 12 months DC subjects continued improving and 45.4% were at least independent at home, versus 32.4% in the medical group
• For every 100 patients treated with - 22 extra survivors- 59% were at least independent at home
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RESCUEicp – interpretation• Caveats
• 37.2% crossover from the medical to DC arm – not sure of impact on results
• Data do not specifically cover the risks and complications of cranioplasty
• 12 months may be still too early for maturation of outcomes in DC
• Take home messages• The choice to provide rescue DC has to be individualized• We need to identify patients most likely to benefit. • We need to find ways to make the procedure better• We need to better understand physiology post-DC and modify Rx• We need to refine the cranioplasty timing and technique
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Conventional CT is the first line gold standard for imaging in TBI
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Brainstem lesions
But CT may miss important pathology that defines prognosiswhich is not improved with DC
Mannion RJ, Cross J, Bradley P, Coles JP, Chatfield D, Carpenter A, Pickard JD, Menon DK, Hutchinson PJ. A mechanism-based MRI classification of traumatic brainstem injury
and its relationship to outcome. J Neurotrauma 2007;24: 128-135.
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Diffuse axonal injury
But CT may misses important pathology that defines prognosiswhich is not improved with DC
DC is not a panacea!
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RESCUEicp - talking to families• DECRA & RESCUEicp provide information that aids discussions with
families
• We urge against using loaded terms such as “favourable” or “unfavourable”
• More desirable to simply state that the best evidence we have suggests that:– DC before other Rx options does not improve mortality or outcome– DC as a rescue when most interventions have failed reduces mortality– About 40% of the survivors are dependent– About 60% of the survivors are independent at home or better– It takes a long time (over a year) for the full benefit of DC to declare itself
• We should offer to provide details of outcome categories & clarify issues
»
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0,0
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eGOS MSC PSC
Quality of Life in TBI SF-36 data
Spectrum of Outcomes Following Traumatic Brain Injury- Relationship Between Functional Impairment and Health-Related Quality of Life.
Anastasia Tsyben, Mathew Guilfoyle, Ivan Timofeev, Fahim Anwar, Judith Allanson, Joanne Outtrim, David Menon, Peter Hutchinson, Adel Helmy
Acta Neurochir in press
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• Decisions to recommend decompressivecraniectomy must always be made not only in the context of its clinical indications but also after consideration of an individual patient's preferences and quality of life expectations.
• Martin Smith • Anesth Analg 2017
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Secondary Rescue Decompressive Craniectomy for TBI
Pros• Decreased mortality • 59% of survivors at least
independent at home• Improved ICP control• Reduction in intensive
medical treatment -barbiturates
Cons• Survival with disability
– 18% VS, 23% LSD• Increased complications• Requirement for cranioplasty• Requirement for rehabilitation• Translation to LMICs• Does not address primary
decompression for mass lesions (hence RESCUE-ASDH)
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Primary DCAcute subdural haematomas
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Acute Subdural Haematomas (ASDH)• Present in up to 1/3 of patients with severe TBI
• Often associated with underlying cerebral parenchymal injury
• Historically associated with a high mortality rate (between • 40-60%) and functional recovery which ranges from 19 to 45%
• Approximately 2/3 of patients with TBI undergoing emergency • cranial surgery have an ASDH evacuated
• 37% of patients undergoing craniotomy for ASDH have uncontrollable ICP
1. Bullock et al. Surgical management of acute subdural hematomas. Neurosurgery, 20062. Compagnone et al. The management of patients with intradural post-traumatic mass lesions: a multicentersurvey of current approaches to surgical management in 729 patients coordinated by the European Brain InjuryConsortium. Neurosurgery, 20053. Miller JD et al, J Neurosurg, 1981 Further experience in the management of severe head injury.
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RESCUE-ASDH trial§ Research question
§ Does decompressive craniectomy lead to better functional outcomes compared to craniotomy for adult head-injured patients undergoing evacuation of an acute subdural haematoma?
§ Randomised study of head-injured patients with acute subdural haematoma§ Patients randomised to craniotomy i.e. replacing bone flap
versus hemi-craniectomy i.e. leaving bone flap out
§ Sample size – 990 patients to detect 8% absolute difference in the rate of favourable outcome at 1 year
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RESCUEASDH.org
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RESCUE Acknowledgements • We thank the patients who participated in this
trial and their families• We also thank:
– All the collaborating clinicians and research staff (see appendix at NEJM.org for details)
– Members of the trial steering committee (independent chair Prof AB Bell) – Members of the data monitoring and ethics committee (independent chair Mr DM
Shaw)
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RESCUE-ASDH we welcome more centres!
rescueasdh.org
@rescueicp@rescueasdh@ag_kolias