Traumatic brain injury (TBI) is major cause of morbidity and mortality in the United States, as 60% of TBI patients survive with severe disability or die.1-3 This results in a yearly cost within the United States of greater than $60 billion.4 Decompressive hemicraniectomy is often utilized in the treatment of refractory intracranial hypertension secondary to TBI, as well as intracerebral hemorrhage, stroke, subarachnoid hemorrhage, and intracranial tumors. Although commonly employed, the benefits of this technique remain controversial, with a paucity of randomized trials to assess its efficacy. There has only been 1 prospective, randomized trial of 27 patients to assess the role of decompressive craniectomy, which showed a trend toward beneficial outcome in those receiving surgical treatment.5,6 Despite these findings and the proposed guidelines for the treatment of patients with TBI,7-13 the benefits of surgical therapy remain unclear.
To this end, Cooper et al recently published the results of their randomized clinical trial that assessed the benefits of craniectomy in TBI patients.14 From 2002 to 2010, 155 of 3478 eligible adults (age 15 to 59) with Glasgow Coma Scale of 3 to 8 were randomized within 3 days of admission to receive either standard maximal medical therapy or bifrontotemporoparietal decompressive craniectomy. Patients were excluded if they had dilated, unreactive pupils, mass lesions (unless too small to require surgery), spinal cord injury, or cardiac arrest at the scene of the injury. Patients in the surgical arm received decompression if intracranial pressures were increased for more than 15 minutes (continuously or intermittently) within a 1-hour period, despite optimized first-tier interventions (optimized sedation, the normalization of arterial carbon dioxide pressure, and the use of mannitol, hypertonic saline, neuromuscular blockade, and external ventricular drainage). Patients in the surgical arm received a standardized large bifrontotemporoparietal craniectomy with bilateral dural opening without division of the sagittal sinus and falx cerebri.
Interestingly, the results demonstrated that despite decreased time with intracranial pressures above the treatment threshold, fewer interventions for increased intracranial pressure, fewer days in the intensive care unit, and fewer days in the hospital, patients receiving decompressive craniectomy had worse long-term outcomes than those receiving maximal medical management (OR = 1.84; 95% confidence interval [CI], 1.05 to 3.24; P = 0.03).14
Some limitations of the trial include the small number of overall number of patients randomized from the available number of patients screened, which could reflect selection bias. Although the assessment of outcome was carried out in a blinded fashion, medical and surgical teams cannot be blinded. Additionally, although the 2 groups were well matched, there was a significantly higher number of patients with bilateral non-reactive pupils in the surgically treated arm.
Further questions concerning the optimal surgical therapy and timing of operative intervention remain open to question. Some surgeons prefer a unilateral procedure, which may be associated with fever complications,15 and some section the falx cerebri and divide the sagittal sinus. The threshold for surgical intervention is open to debate. For example, the duration of refractory elevated ICP may have been too short for some practitioners, while others may feel that the decision for craniectomy should be made at an early stage prior to the development of refractory ICP.
Moving forward, the RESCUE study (Randomized Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intracranial Pressure), which is currently underway, may provide further answers.16 Recently, 294 of the planned 400 patients have been enrolled to receive either craniectomy or standard care (including the use of barbiturates) when maximal medical therapy cannot control intracranial pressure, with a threshold of 25 mm Hg (rather than 20 mm Hg) for more than 1 to 12 hours (rather than 15 minutes). The RESCUE study also allows for evacuation of a hematoma prior to randomization, and surgical procedures may be unilateral or bilateral craniectomy.
In conclusion, although the DECRA study may appear to demonstrate that, in general, patients with TBI have worse outcomes following decompressive hemicraniectomy, future studies are necessary to better delineate which subsets of patients may benefit from this maneuver. While decompressive craniectomy following severe diffuse traumatic brain injury has been shown to reduce intracranial pressure and thereby facilitate maintenance of cerebral perfusion, the optimal timing, target population, and effect on survivor outcome of decompression remain topics of debate. At first glance this small, randomized, non-blinded study seems to suggest that in those with brief, modest ICP elevations unresponsive to first line medical therapy, proceeding to second line medical therapy and reserving surgical decompression for the approximately 25% of patients that fail these maneuvers leads to better outcomes than proceeding to immediate decompression. However, given the lack of criteria for cross-over, the unequal distribution of pupillary abnormalities, the unknowns surrounding the large number of “screened” but unenrolled, and the timing of outcomes assessment leads one to question even this limited conclusion. In short, the data in no way allow anyone to accept the broad conclusion that early decompression in those with “refractory intracranial hypertension” is associated with more unfavorable outcomes, as so elegantly shown in their manuscript, since the patient population studied did not have refractory intracranial hypertension.
Ricardo J. Komotar
Robert M. Starke
E. Sander Connolly
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