Surgical Decompression for Space-Occupying Cerebral Infarction
Marjolein Geurts, H. Bart van der Worp, L. Jaap Kappelle, G. Johan Amelink, Ale Algra, Jeannette Hofmeijer
2013
Stroke
The design of HAMLET (ISRCTN94237756) has been reported previously. 1 In brief, adult patients ≤60 years of age with space-occupying hemispheric infarction were randomly assigned to surgical decompression or to best medical treatment. The trial was approved by institutional review boards, and written informed consent was obtained for each patient. The primary outcome measure was functional outcome as measured with the modified Rankin Scale at 1 year, dichotomized between good (modified Rankin
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... ale, 0-3) and poor (modified Rankin Scale, 4, 5, or death). Predefined secondary outcome measures included functional outcome at 3 years, and case fatality, functional dependence assessed with the Barthel Index, quality of life assessed with the Medical Outcomes Study 36-item short-form health survey and a visual analogue scale, symptoms of depression measured by the Montgomery and Åsberg Depression Rating Scale, and caregiver strain assessed with the caregiver strain index at 1 and at 3 years. Background and Purpose-We assessed whether the effects of surgical decompression for space-occupying hemispheric infarction, observed at 1 year, are sustained at 3 years. Methods-Patients with space-occupying hemispheric infarction, who were enrolled in the Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial within 4 days after stroke onset, were followed up at 3 years. Outcome measures included functional outcome (modified Rankin Scale), death, quality of life, and place of residence. Poor functional outcome was defined as modified Rankin Scale >3. Results-Of 64 included patients, 32 were randomized to decompressive surgery and 32 to best medical treatment. Just as at 1 year, surgery had no effect on the risk of poor functional outcome at 3 years (absolute risk reduction, 1%; 95% confidence interval, −21 to 22), but it reduced case fatality (absolute risk reduction, 37%; 95% confidence interval, 14-60). Sixteen surgically treated patients and 8 controls lived at home (absolute risk reduction, 27%; 95% confidence interval, 4-50). Quality of life improved between 1 and 3 years in patients treated with surgery. Conclusions-In patients with space-occupying hemispheric infarction, the effects of decompressive surgery on case fatality and functional outcome observed at 1 year are sustained at 3 years. Clinical Trial Registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN94237756. (Stroke. 2013;44:2506-2508.) The online-only Data Supplement is available with this article at http://stroke.ahajournals.org/lookup/suppl/
doi:10.1161/strokeaha.113.002014
pmid:23868265
fatcat:ajdoajrsp5f7hbptsn6axokoxm