7.0 Hemicraniectomy should be considered in patients in the early stages of extensive (malignant) middle cerebral artery territory ischemic stroke as a life-saving measure for patients willing to accept a significant risk of living with a degree of disability that may leave them dependent on others for their activities of daily living [Evidence Level A for patients age 18 – 60 years; Evidence Level B for patients 60 – 80 years].
7.1 Patient Selection
- Patients who meet the following criteria alone or in combination should be considered for hemicraniectomy [Evidence Level A]:
- Patients over the age of 18;
- Children under 18 years with progressive extensive (malignant) MCA syndrome [Evidence Level C];
- Malignant middle cerebral artery (MCA) infarct with evidence of significant edema and mass effect;
- Infarction size greater than 50% MCA territory on visual inspection, or an ischemic lesion volume greater than 150 cm3;
- Posterior fossa decompression can be considered in selected patients with significant cerebellar stroke with evidence of mass effect and / or hydrocephalus [Evidence Level C].
- If a potential patient’s location is initially outside a comprehensive stroke centre, the patient should have expedited transfer to a tertiary or quaternary centre where advanced stroke care and neurosurgical services are available [Evidence Level C].
7.2 Initial Clinical Evaluation
- Urgent consultation with a stroke specialist for assessment and for determination to involve neurosurgery [Evidence Level C].
- For patients who meet criteria for potential hemicraniectomy during initial assessment, an urgent neurosurgical consultation should be initiated, either in-person, by telephone or using telemedicine (Telestroke services) [Evidence Level C].
- Initiate a discussion with patient, family members and legal decision-maker regarding a potential hemicraniectomy [Evidence Level C].
- Key issues to be discussed with the patient and/or alternate decision-makers include: stroke diagnosis and prognosis if untreated, the risks of surgery, the possible and likely outcomes following surgery including the odds of living with severe disability, and the patient’s previously expressed wishes concerning treatment in the event of catastrophic illness and probability of living with severe handicap.
- The discussion with the patient and decision-makers should state more clearly that there is a survival benefit, but an uncertain impact on quality of life and disability. Furthermore that even with treatment, a good outcome (MRS 0-2) is rare.
7.3 Patient Management Prior to Hemicraniectomy Surgery
- In patients selected for decompressive hemicraniectomy, proceed urgently to surgery prior to significant decline in GCS or pupillary change [Evidence Level C]. Proceeding within 48 hours from stroke onset may provide benefit [Evidence Level B].
- Patients should be transferred to an intensive care unit or neuro step-down unit for close and frequent monitoring of neurological status prior to surgery [Evidence Level C].
- Monitoring should include assessments of level of consciousness (e.g., Canadian Neurological Scale Score), worsening symptom severity, and blood pressure at least hourly; more frequently as the individual patient condition requires [Evidence Level C].
- If changes in status occur, the stroke team and neurosurgeon should be notified immediately for re-evaluation of the patient [Evidence Level C]. Change in status may include level of drowsiness/consciousness, change in CNS score by greater than or equal to 1 point, or change in NIHSS score by greater than or equal to 4 points.
- Repeat CT scans are recommended for patients when deterioration in neurological status occurs [Evidence Level C].
- Patients with suspected elevation in intracranial pressure may be managed according to institutional protocols (e.g, administration of hyperosmolar therapy, head of bed elevation) [Evidence Level C].
The morbidity and mortality for the routine care of patients with malignant hemispheric strokes is higher than other stroke subgroups, and there is evidence to support that, in selected cases, hemicraniectomy may significantly reduce mortality but it could leave people with significant disability and possible dependence for activities of daily living. Consideration for hemicraniectomy must be individualized; there is a strong need for careful clinical consideration and patient selection. Decisions regarding hemicraniectomy involve several members of the multidisciplinary stroke team, including neurology, neurosurgery, intensive care and nursing through a collaborative and coordinated system of care.
- Timely access to diagnostic services such as neuro-imaging, with protocols for prioritizing potential stroke patients.
- Timely access to specialized stroke care (i.e. a neuro-intensive care unit) and neurosurgical specialists for consultation and patient management, including rapid referral process if neurosurgical services not available within the initial treating hospital.
- Access to organized stroke care, ideally stroke units with a critical mass of trained staff and an interdisciplinary stroke team.
- Education for Emergency Department, and hospital staff on the characteristics and urgency for management of severe stroke patients.
- Risk-adjusted mortality rates for severe stroke patients who undergo hemicraniectomy (in-hospital, 30-day and one year) (core).
- Percentage of hemicraniectomy patients who experience intraoperative complications and/or mortality during surgery or within first 24 hours post-operatively.
- Distribution of functional ability measured by standardized functional outcome tools at time of discharge from hospital and over time in the community (e.g., 90 days, 1 year).
- Mortality rates should be risk-adjusted for age, gender, stroke severity and comorbidities.
- Time interval measurements should start from symptom onset of known or from triage time in the Emergency Department as appropriate.
Health Care Provider Information
- Canadian Stroke Best Practices Acute Stroke Management Appendix Three: Screening and Assessment Tools for Acute Stroke Severity
- Canadian Stroke Best Practices Acute Stroke Management Table 2B: Recommended Laboratory Investigations for Acute Stroke and Transient Ischemic Attack
Evidence Table and Reference List
The benefit of decompressive hemicraniectomy (versus standard medical treatment) early following malignant middle cerebral artery (MCA) infarction in patients <60 years has been evaluated in three major RCTs, all of which had comparable inclusion criteria and primary outcome measures (DESTINY 1, HAMLET and DECIMAL). In the first DESTINY trial (Juttler et al. 2007), which randomized 32 patients to receive either surgical plus medical treatment or to conservative medical treatment only, there was a trend towards more favourable outcome (mRS 0-3) among patients in the surgical arm at 6 months (47% vs. 27%, (p=0.23; OR=2.44, 95% CI 0.55 to 10.83). Thirty-day survival was significantly higher among patients in the surgical arm (88% vs. 47%, OR=6.4, 95% CI 1.35 to 29.2). In the HAMLET trial (Hofmeijer et al. 2009), while there were no differences between groups in the proportion of patients who had experienced either a good (mRS 0-1) or poor (mRS 4-6) outcome at 1 year, surgery was associated with a 38% absolute risk reduction (95% CI 15 to 60, p=0.002) in 1-year mortality. Patients who received decompressive hemicraniectomy had significantly lower mean physical summary scores on the SF-36 Quality of Life scale, compared with those treated with medical care only (29 vs. 36; mean difference = −8, 95% CI -14 to -1, p = 0.02). No significant differences were found between the two treatment groups with respect to the mental summary score of the SF-36 score, mood, or the proportion of patients or carers dissatisfied with treatment. At 3 years follow-up, a significantly lower percentage of patients in the surgical group had died (26% vs. 63%, p=0.002) (Geurts et al. 2013). In the DECIMAL trial (Vahedi et al. 2007b), while there was no difference in the number of patients with mRS scores of 0-3 between groups at 6 months, a significantly higher proportion of surgical patients had mRS scores of 0-4 and there was also a survival advantage among patients in the surgical arm. The results from all three trials were pooled in a recent Cochrane review (Cruz-Flores et al. 2012), which reported that decompressive hemicraniectomy was associated with a significantly reduced risk of death at the end of follow-up (OR = 0.19, 95% CI 0.09 to 0.37) and the risk of death or severe disability (mRS > 4) at 12 months (OR = 0.26, 95% CI 0.13 to 0.51). Surgery was also associated with a non-significant trend towards increased survival with severe disability (mRS of 4 or 5; OR = 2.45, 95% CI 0.92 to 6.55). No significance between group differences were found for the combined outcome death or moderate disability (mRS 4-6) at the end of follow-up (OR = 0.56, 95% CI 0.27 to 1.15). In a more recent systematic review, which included the results from 7 trials, (Qureshi et al. 2016), similar findings were reported. The odds of a favourable outcome (mRS 0-3) and survival at 6-12 months were significantly increased for patients in the hemicraniectomy group (OR=2.04, 95% CI 1.03-4.02, p=0.04 and OR=5.56, 95% CI 3.40-9.08, p<0.001, respectively).
The upper age limit for decompressive hemicraniectomy in malignant MCA infarct has been a focus of debate, given that the evidence is conflicting. Using data from 276 patients, obtained from 17 case series McKenna et al. (2012) reported that patients 60 years of age and older who underwent surgery had a higher mortality rate and poorer outcome compared with younger patients. In the DECIMAL trial's surgical group, younger age correlated with better outcomes at 6 months (r = 0.64, p < 0.01) (Vahedi et al., 2007b). A recent retrospective study investigating decompressive hemicraniectomy in older adults compared the outcomes of individuals aged between 61-70 years and those > 70 years of age (Inamasu et al. 2013). The mortality rate was significantly higher among those in the older cohort (60% vs. 0%, p = 0.01). However, there is also evidence suggesting that older patients also benefit from surgery. Zhao et al (2012) randomized 47 patients, aged 18-80 years, 29 of whom were >60-80 years. Decompressive hemicraniectomy within 48 hours of stroke onset was associated with a significant overall reduction in mortality at both 6 (12.5% vs. 60.9 %, p = 0.001) and 12-month follow-up (16.7% vs. 69.6 %, p < 0.001). In the subgroup of older patients, significantly fewer patients in the surgical arm had an unfavourbale outcome (mRS 5–6) at 6 months (31.2% vs. 92.3%, ARR=61.1%; 95 % CI 34.1 to 88.0) with similar results reported at one year (ARR = 62.5%; 95% CI 38.8 to 86). Authors from the HAMLET trial reported that there was a trend towards greater benefit of surgery in patients between the ages of 51–60 compared with patients 50 years of age or younger (Hofmeijer et al. 2009). Most recently, in the DESTINY II trial (Juttler et al. 2014), 112 patients ≥61 years admitted with unilateral MCA infarction were randomized to receive conservative treatment or early surgical intervention. A significantly higher proportion of patients in the surgical group were alive and living without severe disability at 6 months (38% vs.18%, OR=2.91, 95% CI 1.06-7.49, p=0.04). Although no patients in either the surgical or medical care groups had good outcome (mRS score of 0-2) at 6 or 12 months, a significantly higher percentage of patients in the surgical group had mRS scores of 3-4 (38% vs. 16%) and a significantly lower percentage had mRS scores of 5-6 (62% vs. 84%).
Timing of surgical intervention is also an important consideration when deciding whether to perform decompressive hemicraniectomy. In the HAMLET trial there was a significant reduction in both mortality and poor outcome when patients were randomized to surgery within 48 hours of stroke onset, with no significant benefit when patients received surgery within 96 hours (Hofmeijer et al., 2009). However, in pooled analysis using the sub group results from the DECIMAL, DESTNY I and HAMLET trials examining the outcomes of patients treated within 24 hours vs. >24 hours following stroke onset, no differences in outcome were reported (Vahedi et al., 2007a). Taken together, these findings suggest that the appropriate time interval to perform decompressive hemicraniectomy may be within 48 hours, further research is needed to determine if earlier treatment (e.g., with 24 hours) is associated with superior outcomes.
There is insufficient evidence to recommend the use of corticosteroids to reduce cerebral edema and intracranial pressure following acute ischemic stroke. The results from a Cochrane review (Sandercock & Sloane 2011) included the results from 8 RCTs (466 participants). Pooling of data was only possible for the outcome of death. The use of corticosteroids (versus) placebo was not associated with a reduced risk of death at one month (OR=0.97, 95% CI 0.63-1.47, p=0.87) or one year after stroke (OR=0.87, 95% CI 0.57-1.34, p=0.53).