National Collaborating Centre for Chronic Conditions at the Royal College of Physicians

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1 13. Surgery for acute stroke 13.2 Surgical referral for decompressive hemicraniectomy Reference Gupta R, Connolly ES, Mayer S et al. Hemicraniectomy for massive middle cerebral artery territory infarction: a systematic review. [Review] [29 refs]. Stroke. 2004; 35(2): Ref ID: 2591 Evidence table REF 2: Which patients should be referred for decompressive hemicraniectomy? Study type Number of Patient Intervention Comparison Length of Evidence patients characteristics follow-up level Systematic review (12 case series studies) 3 N=129 Patients who underwent hemicraniectomy for a middle cerebral artery (MCA) territory infarct or MCA plus another vascular territory infarct Patient population: Mean age 50 yrs, 53% male, mean time to surgery 59.3 hrs Patients who underwent hemicraniectomy for a middle cerebral artery (MCA) territory infarct or MCA plus another vascular territory infarct NA 1 to 3 months Outcome measures Outcomes were classified as follows: Functionally independent Barthel Index (BI) 90; modified Rankin Scale (mrs), 0 to 1; Glasgow Outcome Scale (GOS), 5 Mild to moderate disability BI, 60 to 85; mrs, 2 to 3; GOS, 4 Severely disabled BI <60; mra, Source of funding None reported

2 4 or 5; or GOS, 2 to 3 Death Poor outcomes BI <60, mrs > 3, death or placement in an institution Effect *Functional outcome and mortality 58 (42%) had a good outcome (functionally independent or mild to moderate disability), 80 (58%) poor outcomes (severe disability or death) and the mortality rate was 24% *Age There was a significant difference in the proportion of patients severely disabled or dead who were older than 50 yrs compared with those 50 yrs or younger (60/75 > 50 yrs (80%) vs 20/63 (32%) 50 yrs; p< ). The mortality rate was also significantly higher (24/75 (32%) > 50 yrs vs 9/63 (14%) 50 yrs; p<0.012) *Time to surgery There were no statistical differences in outcome when patients who had undergone surgery within 24 hrs compared with those after 48 hrs (NS). *Brainstem compression There were no statistical differences in outcome for patients who showed signs of herniation before decompression compared with those who underwent surgery before signs of brainstem compression (NS). *Vascular territorities Comparison of MCA territory infarcts with MCA plus involvement of other territories was no statistically significant (NS). Hemicraniectomy on the left side did not show a statistical difference compared with the right side (NS).

3 Vahedi K, Hofmeijer J, Juettler E et al. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials.[see comment]. Lancet Neurology. 2007; 6(3): Ref ID: 2588 Pooled analysis (3 RCTs Europe) 1++ N=93 Patients between 18 and 60 yrs with spaceoccupying MCA infarction and treated within 48 hrs after stroke onset Inclusion criteria included: decrease in the level of consciousness to a scroe of 1 or greater on item 1a of the NIHSS, signs on CT of an infarct of at least 50% of the MCA territory, or infarct volume > 145 cm 3 Decompressive surgery Conservative treatment 12 months Mortality Functional outcome Planned sub group analysis (age, time to surgery and aphasia) Exclusion criteria: Life expectancy < 3 yrs Patient population: mean age 45.4 yrs, 49%, previous TIA/ stroke 9%, median NIHSS 22.5, hours to randomisation

4 23.1 Baseline differences: Individual trials in DESTINY the conservatively treated group had a higher NIHSS score than the surgically treated group, and in DECIMAL mean SBP was higher in the conservatively treated group than the surgical group Between trials Time to randomisation was significantly longer in DESTINY and HAMLET than DESTINY. Effect *Functional outcome At 12 months, a statistically higher proportion of patients treated conservatively has an mrs > 4 compared with those treated surgically (76.2 vs 25.5%; OR 0.10; 95%CI 0.04 to 0.27; p<0.0001). The difference between surgery and conservative management for the outcome of mrs < 3 was no statistically different at 12 months (NS). *Mortality At 12 months, there was a statistical higher mortality rate associated with conservative management compared with surgery (71.4 vs 21.6%; OR 0.10; 95%CI 0.04 to 0.27; p<0.0001)

5 *Planned sub-group analysis (see table below) Surgery was beneficial in all predefined subgroups (age [above and below 50 yrs], presence of aphasia and time to randomisation) Outcome Outcome/patients OR p Conservative Surgery Age < 50 yrs 22/31 8/ (0.03 to 0.35) P< Age 50 yrs 10/11 5/ (0.02 to 0.76) P= Time to randomisation < 24 hrs 21/26 9/ (0.04 to 0.43) P= Time to randomisation 24 hrs 11/16 4/ (0.03 to 0.54) P= No aphasia 14/17 5/ (0.01 to 0.31) P< Aphasia 18/25 8/ (0.04 to 0.50) P=0.0003