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Meta-Analysis
. 2012 Jan 18;1(1):CD003435.
doi: 10.1002/14651858.CD003435.pub2.

Surgical decompression for cerebral oedema in acute ischaemic stroke

Salvador Cruz-Flores  1 , Eivind Berge, Ian R Whittle
Affiliations
Meta-Analysis

Surgical decompression for cerebral oedema in acute ischaemic stroke

Salvador Cruz-Flores et al. Cochrane Database Syst Rev. .

Abstract

Background: Large cerebral infarction has a high case fatality. Despite the use of conventional medical treatments such as hyperventilation, mannitol, diuretics, corticosteroids and barbiturates, the outcome of this condition remains poor. Decompressive surgery to relieve intracranial pressure is performed in some cases, although evidence of any clinical benefits has not been available until recently. This is an update of a Cochrane review first published in 2002.

Objectives: To examine the effects of decompressive surgery in patients with massive acute ischaemic stroke complicated with cerebral oedema, and to judge whether decompressive surgery is effective in improving survival or survival free of severe disability.

Search methods: We searched the Cochrane Stroke Group's Trials Register (last searched October 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 7), MEDLINE (1966 to October 2010), EMBASE (1980 to October 2010) and Science Citation Index (October 2010). We also searched the reference lists of all relevant articles.

Selection criteria: Randomised controlled studies of decompressive surgery plus medical treatment versus medical treatment alone in patients with clinically and radiologically confirmed cerebral infarcts complicated with cerebral oedema.

Data collection and analysis: One author assessed the titles and retrieved the relevant studies. The same author extracted data, with discussion among all authors for clarification. Outcomes were death at the end of follow-up, death or disability defined as the modified Rankin Scale (mRS) > 3 at the end of follow-up, death or severe disability defined as mRS > 4 at 12 months and disability defined as mRS 4 or 5 at 12 months. The results are given using the Peto odds ratio (Peto OR) with 95% confidence intervals (CIs).

Main results: We included three trials in this review, involving 134 patients who were 60 years of age or younger. The time window for the intervention was 30 hours from stroke onset in two studies and 96 hours in one study. All trials were stopped early. Surgical decompression reduced the 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 disability defined as mRS > 4 at 12 months (OR 0.26, 95% CI 0.13 to 0.51). Death or disability defined as mRS > 3 at the end of follow-up was no different between the treatment arms (OR 0.56, 95% CI 0.27 to 1.15).

Authors' conclusions: Surgical decompression lowers the risk of death and death or severe disability defined as mRS > 4 in selected patients 60 years of age or younger with a massive hemispheric infarction and oedema. Optimum criteria for patient selection and for timing of decompressive surgery are yet to be defined. Since survival may be at the expense of substantial disability, surgery should be the treatment of choice only when it can be assumed, based on their preferences, that it is in the best interest of patients. Since all the trials were stopped early, an overestimation of the effect size cannot be excluded.

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Conflict of interest statement

Dr S Cruz‐Flores was a site principal investigator for the HEADDFIRST trial supported by the National Institute of Neurological Diseases and Stroke. The trial is mentioned in this review. However, its results have not been published and therefore are not included in the review.

Figures

1.1
1.1. Analysis
Comparison 1 Primary outcome measure: Death at the end of follow‐up, Outcome 1 Death at the end of follow‐up.
2.1
2.1. Analysis
Comparison 2 Secondary outcome measures, Outcome 1 Death or disability defined as mRS > 3 at end of follow‐up.
2.2
2.2. Analysis
Comparison 2 Secondary outcome measures, Outcome 2 Death or severe disability defined as mRS > 4 at 12 months.
2.3
2.3. Analysis
Comparison 2 Secondary outcome measures, Outcome 3 Severe disability among survivors defined as mRS 4 to 5 at 12 months.
2.4
2.4. Analysis
Comparison 2 Secondary outcome measures, Outcome 4 Death or moderate to severe disability.
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References

References to studies included in this review

DECIMAL 2007 {published data only}
    1. Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, et al. DECIMAL investigators. Sequential‐design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial). Stroke 2007;38(9):2506‐17. [DOI: 10.1161/STROKEAHA.107.485235] - DOI - PubMed
DESTINY 2007 {published data only}
    1. Juttler E, Schwab S, Schmiedek P, Unterberg A, Hennerici M, Woitzik J, et al. DESTINY Study Group. Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery (DESTINY): a randomized, controlled trial. Stroke 2007;38(9):2518‐25. [DOI: 10.1161/STROKEAHA.107.485649] - DOI - PubMed
HAMLET 2009 {published data only}
    1. Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, Gijn J, Worp HB, et al. HAMLET investigators. Surgical decompression for space‐occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life‐threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurology 2009;8(4):326‐33. - PubMed

References to studies awaiting assessment

DEMITUR Trial {published data only}
    1. Kumral E. Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery: a randomised, controlled trial in a Turkish population. http://www.strokecenter.org/trials/clinicalstudies/decompressive‐surgery... 2009.
HEADDFIRST {published data only}
    1. Frank JI. A randomised multi‐center trial of hemicraniectomy and durotomy for deterioration from infarction related swelling: HEADDFIRST. http://www.strokecenter.org/trials/clinicalstudies/hemicraniectomy‐and‐d... 2000. - PMC - PubMed
    1. Frank JI, Krieger D, Chyatte DM, Cancian S. HEADDFIRST: Hemicraniectomy and durotomy upon deterioration from massive hemispheric infarctions. A proposed multicenter, prospective randomized study. Stroke 1999;30:243.

References to ongoing studies

DESTINY 2 {published data only}
    1. Juettler E. Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2: a prospective open randomised multicenter comparative trial. ControlIed‐trials.com/ISRCTN21702227/stroke 2009.
HeMMI 2004 {published data only}
    1. Jamora RD, Nigos J, Collantes ME, Chua A, Gan R. Hemicraniectomy for malignant middle cerebral artery infarcts (HeMMI). www.strokecenter.org/trials/TrialDetail.aspx?tid=575. 2004.

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