Preliminary Results of Randomized Controlled Study on Decompressive Craniectomy in Treatment of Malignant Middle Cerebral Artery Stroke

Abstract

Background and Objective. Studies on decompressive craniectomy (DCE) after a malignant middle cerebral artery (MCA) stroke in selected population show an increased probability of survival without increasing the number of very severely disabled. Cerebral infarct volume (CIV) as a triage criterion for performing surgery has not been discussed in literature. The aim of this study was to investigate the value of CIV and initial National Institutes of Health Stroke Scale (NIHHS) and Glasgow Coma Scale (GCS) scores as possible triage criteria in the surgical treatment of patients with “malignant” MCA stroke. Material and Methods. According to the study protocol, 28 patients with a malignant MCA stroke were included and analyzed prospectively. The patients were randomly divided either into the DCE plus best medical treatment (BMT) group or BMT alone group. CIV and NIHHS and GCS scores were measured at time of enrollment in every case. Clinical outcome was evaluated 1 year after the treatment. Results. Six patients survived: 5 in the DCE group (none of them was older than 60 years) and 1 in the BMT group (P=0.03/0.06). Among survivors, none had a cerebral infarct volume of more than 390 cm3 (P=0.05). All survivors in the DCE group had favorable outcomes. There was no significant difference in the NIHSS and GCS scores between the groups and survivors/nonsurvivors (P>0.05). Conclusions. Decompressive surgery in the selected patients is likely to increase the probability of survival with a favorable outcome without increasing the number of severely disabled survivors. Patients with CIV of more than 390 cm3 may be bad candidates for DCE, and the prognosis is likely to be bad regardless the treatment strategy. The initial NIHHS and GCS scores did not prove any prognostic value in outcome.

Early decompressive craniectomy for malignant cerebral infarction

“…26 Inclusion criteria for the individual trials were similar, with exception of the prespecified age ranges (table). Baseline patient characteristics of the treatment groups were well-matched with exception of Jüttler et al 25 and Slezins et al, 23 which reported higher mean NIH Stroke Scale scores in the medically managed group. Slezins et al 23 also reported a lower mean age in the patients undergoing DC.…”

“…Hofmeijer et al 5 reported a post hoc analysis of 39 patients enrolled in HAMLET within 48 hours of stroke onset, but did not report baseline patient characteristics or whether their initial randomization stratification was maintained in this subgroup. 5,27 Secondary to these concerns, Slezins et al 23 and Hofmeijer et al 5 both received an unclear risk of bias rating. A full risk of bias rating table is included in figure e-1.…”

“…Slezins et al 23 is a brief preliminary report that does not comprehensively detail study methodology. Hofmeijer et al 5 reported a post hoc analysis of 39 patients enrolled in HAMLET within 48 hours of stroke onset, but did not report baseline patient characteristics or whether their initial randomization stratification was maintained in this subgroup.…”

“…independently abstracted patient ages (dichotomized: #60 years or .60 years) and mRS scores at 12 months from each eligible trial. Patient ages from Slezins et al 23 were obtained via correspondence with the author. Any discrepancies between the authors were resolved by review and consensus.…”

“…Six RCTs comprising 289 patients met our inclusion criteria: 4 completed trials of early DC, the published preliminary results from a trial of early DC, and a subgroup analysis comprised of patients randomized within 48 hours from Hemicraniectomy After Middle Cerebral Artery Infarction With Life-threatening Edema Trial (HAMLET), a DC trial which enrolled patients up to 96 hours from onset (table). 5,10,11,[23][24][25] One study was excluded, Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial (HeADDFIRST), which enrolled patients up to 96 hours from onset and, notably, intentionally delayed DC until patients had severe clinical or radiographic deterioration. 26 Inclusion criteria for the individual trials were similar, with exception of the prespecified age ranges (table).…”