BACKGROUND AND PURPOSE: Surgical decompression reduces mortality and increases 
the probability of a favorable functional outcome after space-occupying 
hemispheric infarction. Its cost-effectiveness is uncertain.
METHODS: We assessed clinical outcomes, costs, and cost-effectiveness for the 
first 3 years in patients who were randomized to surgical decompression or best 
medical treatment within 48 hours after symptom onset in the Hemicraniectomy 
After Middle Cerebral Artery Infarction With Life-Threatening Edema Trial 
(HAMLET). Data on medical consumption were derived from case record files, 
hospital charts, and general practitioners. We calculated costs per 
quality-adjusted life year (QALY). Uncertainty was assessed with bootstrapping. 
A Markov model was constructed to estimate costs and health outcomes after 3 
years.
RESULTS: Of 39 patients enrolled within 48 hours, 21 were randomized to surgical 
decompression. After 3 years, 5 surgical (24%) and 14 medical patients (78%) had 
died. In the first 3 years after enrollment, operated patients had more QALYs 
than medically treated patients (mean difference, 1.0 QALY [95% confidence 
interval, 0.6-1.4]), but at higher costs (mean difference, €127,000 [95% 
confidence interval, 73,100-181,000]), indicating incremental costs of €127,000 
per QALY gained. Ninety-eight percent of incremental cost-effectiveness ratios 
replicated by bootstrapping were >€80,000 per QALY gained. Markov modeling 
suggested costs of ≈€60,000 per QALY gained for a patient's lifetime.
CONCLUSIONS: Surgical decompression for space-occupying infarction results in an 
increase in QALYs, but at very high costs.
CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Unique 
identifier: ISRCTN94237756.