A pooled analysis of 3 European randomized trials has shown that in patients with space-occupying hemispheric infarction, surgical decompression initiated within 48 hours of stroke onset strongly reduces the risk of death and increases the chance of a favorable functional outcome at 1 year. However, this large reduction in case fatality comes at the expense of an increased risk of moderately severe or severe disability at 1 year, 1 and the majority of survivors have global cognitive impairment.2 Some authors have therefore expressed concerns about the effect of decompressive surgery on long-term quality of life.3 It is unknown whether the effects of surgery at 1 year are sustained over a longer follow-up period. We assessed outcomes 3 years after inclusion in the randomized Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial (HAMLET).
MethodsThe 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 Scale, 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-...