"Decompressive Craniectomy in Diffuse Traumatic Brain Injury". The New England Journal of Medicine. 2016. 375:1119-1130. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Does decompressive craniectomy improve outcomes in patients with traumatic brain injury (TBI) and refractory intracranial hypertension?
Decompressive craniectomy for patients with TBI and refractory intracranial hypertension led to lower mortality rates than medical treatment alone at 6 months, but was associated with higher rates of vegetative state and severe disability.
The effectiveness of decompressive craniectomy as a last-tier intervention for patients with traumatic brain injury (TBI) and sustained and refractory intracranial hypertension was uncertain. While intracranial pressure control could be potentially better following surgery, concerns about the quality of survival (e.g., vegetative state, severe disability) persisted.
Conducted from 2004 through 2014, the Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intracranial Pressure (RESCUEicp) trial randomly assigned 408 patients with TBI and refractory elevated intracranial pressure to undergo decompressive craniectomy or to receive ongoing medical care. At 6 months, decompressive craniectomy resulted in lower mortality (26.9% vs. 48.9%) but higher rates of vegetative state (8.5% vs. 2.1%), lower severe disability (21.9% vs. 14.4%), and upper severe disability (15.4% vs. 8.0%) compared to medical care. The rates of moderate disability and good recovery were similar between the two groups.
Current guidelines do not provide specific recommendations for decompressive craniectomy in patients with TBI. Clinical decision-making should consider individual patient circumstances and preferences regarding survival with potential severe disability.
- Multicenter, parallel-group, superiority, randomized controlled trial - N=408 patients, 10 to 65 years of age, with TBI - Intervention: Decompressive craniectomy (n=201) - Control: Ongoing medical care (n=207) - Primary outcome: Extended Glasgow Outcome Scale (GOS-E) at 6 months - Secondary outcomes included GOS-E at 12 and 24 months, mortality, quality of life, intracranial pressure control, ICU length of stay, complications, and adverse events - Analysis: Intention-to-treat
- Inclusion criteria: Patients with TBI and refractory elevated intracranial pressure (>25 mm Hg) despite stage 1 and 2 management measures - Exclusion criteria: Bilateral fixed and dilated pupils, bleeding diathesis, non-survivable injury - Baseline characteristics: Groups were similar, except for history of drug or alcohol abuse
- Decompressive craniectomy with medical therapy or medical therapy alone as dictated by stage 3 treatment protocol for patients with intracranial pressure above 25 mm Hg for 1 to 12 hours despite stage 1 and 2 treatment measures. - Barbiturate infusion used in the medical group as needed after randomization
#### Primary Outcomes - At 6 months, lower mortality in the surgical group (26.9% vs. 48.9%), higher rates of vegetative state (8.5% vs. 2.1%), lower severe disability (21.9% vs. 14.4%), and upper severe disability (15.4% vs. 8.0%) compared to the medical group. Rates of moderate disability and good recovery were similar. - At 12 months, outcomes were consistent with those observed at 6 months.
- Better control of intracranial pressure in the surgical group. - Median time to discharge from ICU among survivors was shorter in the surgical group (15.0 days vs. 20.8 days, P=0.01). - A higher rate of adverse events was reported in the surgical group (16.3% vs. 9.2%, P=0.03).
- Outcomes were assessed by personnel aware of the group assignment, though blinded adjudication was conducted for GOS-E results. - A large proportion of medical group patients underwent craniectomy later, potentially diluting treatment effects. - Long-term data on cranial reconstruction not obtained. - The trial did not examine primary decompressive craniectomy.
Supported by the Medical Research Council, National Institute for Health Research, Cambridge Biomedical Research Centre, Academy of Medical Sciences and Health Foundation, Evelyn Trust.
- Full text article in The New England Journal of Medicine