Elizabeth A. Corteen

Decompressive craniectomy in traumatic brain injury: the randomized multicenter RESCUEicp study (www.RESCUEicp.com)

The RESCUEicp (Randomized Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of intracranial pressure) study has been established to determine whether decompressive craniectomy has a role in the management of patients with traumatic brain injury and raised intracranial pressure that does not respond to initial treatment measures. We describe the concept of decompressive craniectomy in traumatic brain injury and the rationale and protocol of the RESCUEicp study.

Decompressive craniectomy in traumatic brain injury: outcome following protocol-driven therapy

Although decompressive craniectomy following traumatic brain injury is an option in patients with raised intracranial pressure (ICP) refractory to medical measures, its effect on clinical outcome remains unclear. The aim of this study was to evaluate the outcome of patients undergoing this procedure as part of protocol-driven therapy between 2000-2003. This was an observational study combining case note analysis and follow-up. Outcome was assessed at an interval of at least 6 months following injury using the Glasgow Outcome Scale (GOS) score and the SF-36 quality of life questionnaire. Forty-nine patients underwent decompressive craniectomy for raised and refractory ICP (41 [83.7%] bilateral craniectomy and 8 [16.3%] unilateral). Using the Glasgow Coma Scale (GCS), the presenting head injury grade was severe (GCS 3-8) in 40 (81.6%) patients, moderate (GCS 9-12) in 8 (16.3%) patients, and initially mild (GCS 13-15) in 1 (2.0%) patient. At follow-up, 30 (61.2%) patients had a favorable outcome (good recovery or moderate disability), 10 (20.48) remained severely disabled, and 9 (18.4%) died. No patients were left in a vegetative state. Overall the results demonstrated that decompressive craniectomy, when applied as part of protocol-driven therapy, yields a satisfactory rate of favorable outcome. Formal prospective randomized studies of decompressive craniectomy are now indicated.

Assessing quality of life after traumatic brain injury: examination of the short form 36 health survey.

Measuring health-related quality of life (HRQoL) has an important role in the comprehensive assessment of patient recovery following traumatic brain injury (TBI). We examined the validity of domain and summary scores derived from the Medical Outcomes Survey 36-Item Short Form Health Questionnaire (SF-36) as outcome measures for TBI in a prospective study of 514 patients with a range of functional impairment (Glasgow Outcome Scale-Extended [GOSE] scores 3-8). Item scaling criteria for the eight domain scores were tested and principal component analysis was used to examine if physical and mental component summary scores were valid. External validity was assessed by comparison with GOSE. Mean response, variance, and distribution of the items were largely equivalent, and item-own scale correlations corrected for overlap all exceeded the threshold for equivalent contribution to domain scores and convergent validity. All corrected item-own scale correlations were greater than the respective item-other correlations indicating no scaling failures, and reliability coefficients for the domain scores were high and substantially more than the inter-domain correlations. Overall, criteria for summing items into domain scores were satisfied, and there was a significant relationship of increasing score with more favorable GOSE class across all domains. However, there were floor and/or ceiling effects in four of the eight domains, and principal component analysis of the domain scores demonstrated only a unidimensional structure to the data. We conclude that individual SF-36 domain scores are valid measures of HRQoL in TBI patients, but that the physical and mental component summaries should be interpreted with caution.

Decompressive craniectomy following traumatic brain injury: developing the evidence base

Abstract In the context of traumatic brain injury (TBI), decompressive craniectomy (DC) is used as part of tiered therapeutic protocols for patients with intracranial hypertension (secondary or protocol-driven DC). In addition, the bone flap can be left out when evacuating a mass lesion, usually an acute subdural haematoma (ASDH), in the acute phase (primary DC). Even though, the principle of “opening the skull” in order to control brain oedema and raised intracranial pressure has been practised since the beginning of the 20th century, the last 20 years have been marked by efforts to develop the evidence base with the conduct of randomised trials. This article discusses the merits and challenges of this approach and provides an overview of randomised trials of DC following TBI. An update on the RESCUEicp study, a randomised trial of DC versus advanced medical management (including barbiturates) for severe and refractory post-traumatic intracranial hypertension is provided. In addition, the rationale for the RESCUE-ASDH study, the first randomised trial of primary DC versus craniotomy for adult head-injured patients with an ASDH, is presented.

Primary decompressive craniectomy for acute subdural haematomas: results of an international survey

Dear Sir, Approximately two-thirds of patients with traumatic brain injury (TBI) undergoing emergency cranial surgery have an acute subdural haematoma (ASDH) evacuated [2]. These haematomas are frequently associated with underlying cerebral parenchymal injury, which further exacerbates brain swelling [5]. Therefore, even though craniotomy and evacuation comprise the established primary treatment for ASDH, leaving the bone flap out (i.e. decompressive craniectomy) is an option either because the brain is swollen beyond the confines of the cranium or because the patient is thought to be at high risk for worsening brain swelling during the ensuing days. The European Brain Injury Consortium survey, which was conducted in 2001, demonstrated that a decompressive craniectomy (DC) was undertaken in approximately onequarter of operations performed for ASDH [2]. Since then, there has been a resurgence of interest in the use of DC after TBI. A randomised controlled trial of early/neuroprotective DC in patients with severe diffuse TBI (but no mass lesions) was published in 2011 (DECRA), while another randomised study assessing the role of DC as a last-tier therapy for refractory post-traumatic intracranial hypertension (RESCUEicp) has now recruited 85 % of the required sample size [3, 4]. Nevertheless, there is only class III evidence with retrospective studies investigating the role of DC as a primary procedure for ASDH [1]. With the objective of examining current practice patterns of DC after TBI, we undertook a survey of members of the European Association of Neurosurgical Societies (EANS), Neurocritical Care Society, NeuroCritical Care Network (NCCNet), full members of the Society of British Neurological Surgeons (SBNS) and members of the British Neurosurgical Trainees Association (BNTA) during October and November 2011. We used a secure online survey tool to disseminate the questionnaires. The questionnaire survey was approved by the Academic Committee of the SBNS (project no. NE0026). In this letter, we wish to discuss the results of our survey regarding the use of primary DC for ASDH. As part of the survey, we asked the following question: “When evacuating a traumatic ASDH, how often do you perform a primary DC (i.e. leave the bone flap out)”? This question was answered by 283 neurosurgeons (201 board-certified Consultants or equivalent; 82 trainees). There were 138 UK/Irish, 110 from other European countries, 13North American and 22 respondents from various other countries (see Appendix 1). We decided to group together the responses of neurosurgeons working in countries with national representation to the EANS in order to have two similar-sized groups (UK/Irish A. G. Kolias : L. M. Li : I. Timofeev : E. A. Corteen : T. Santarius : J. D. Pickard : P. J. Kirkpatrick : P. J. Hutchinson Division of Neurosurgery, Addenbrooke’s Hospital & University of Cambridge, Cambridge, UK

Inappropriate acute neurosurgical bed occupancy and short falls in rehabilitation: implications for the National Service Framework

Patients undergoing neurosurgical intervention may require different types of organized rehabilitation. A prospective study was performed of the care needs of neurosurgical inpatients between the ages of 16 and 70 years who were in acute wards for more than 2 weeks. Only 58% of bed occupancy days were devoted to essential acute neurosurgical ward management. This figure was even lower for patients admitted with subarachnoid haemorrhage (36%) or traumatic brain injury (38%). Overall, 21% of bed days would have more appropriately spent in ‘rapid access’/acute rehabilitation beds, 13% in ‘active participation’ rehabilitation beds and 5% in cognitive/behavioural rehabilitation units. Addressing this unmet need would increase the availability of acute neurosurgery beds, without needing to build and staff more neurosurgery wards.

Decompressive craniectomy for traumatic brain injury: The jury is still out

The publication of the results of the DECRA (DECompressive CRAniectomy trial which recruited patients in Australia, New Zealand and Saudi Arabia) study is a fundamental event in the history of decompressive craniectomy for traumatic brain injury (TBI). Since 1902, when Kocher described ‘if there is no CSF pressure, but brain pressure exists, then pressure relief must be achieved by opening the skull’, the popularity for this operation has waxed and waned, with enthusiasm in the 1970s followed by nihilism in the 1980s, and a renaissance in the 1990s. On behalf of the RESCUEicp investigators (Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of ICP – www.rescueicp. com), we congratulate the DECRA investigators on completing their study. This is a major achievement given the various hurdles to recruitment. Historically, there have been two major concerns regarding this operation. Firstly, it may be performed unnecessarily in patients who would have had a good prognosis even with medical treatment alone i.e. decompressive craniectomy is not required yet is subjecting the patient to the risk of the complications of both the initial surgery (in the DECRA series; haematoma 11% in the surgical arm vs. 3% in the medical arm; hydrocephalus 10% in the surgical arm vs. 1% in the medical arm) and cranioplasty. Secondly, the operation may increase survival but at the expense of increased rate of vegetative state and severe disability. One of the most interesting findings from the DECRA study is that decompressive craniectomy did not, by lowering intracranial pressure (ICP), result in a reduction in mortality. The critical figure is the figure of mean ICP before and after randomisation (figure 1 of reference 1), which shows that although the ICP was lower in the decompressive craniectomy group, the ICP was not excessively high (i.e. remained less than 25 mmHg) in the medical group. Our data have shown that the ICP threshold for a difference in outcome is around 25 mmHg. It may be that decompressive craniectomy will not improve outcome unless ICP is significantly raised and refractory to medical management over a longer time period, as otherwise its beneficial effects are balanced out (or even exceeded) by its complications. The other concern regarding decompressive craniectomy is that although there is likely to be an increase in arterial cerebral blood flow, there is a risk of cortical venous occlusion and reduction in cellular oxygen delivery through diffusion hypoxia. Another important finding from the DECRA study, discussed by the authors, is the pupil reactivity baseline characteristic (table 1 of reference 1): in the decompressive craniectomy group, 27% of patients had neither pupil reacting, compared to 12% in the standard care group. This along with the low median Glasgow Coma Scale (GCS) motor response indicates that the DECRA included predominantly patients with significant diffuse axonal injury and possibly some with brainstem injury. These patients, who did not exhibit significant intracranial hypertension (mean ICP was less than 25 mmHg), may have been shifted from mortality to unfavourable outcomes by decompressive craniectomy resulting in low overall mortality, but very high proportion of unfavourable outcome. It may be that patients with diffuse axonal injury but not very high ICP should be

Surgical management of acute subdural haematomas: current practice patterns in the United Kingdom and the Republic of Ireland.

Abstract Introduction. Uncertainty remains as to the role of decompressive craniectomy (DC) for primary evacuation of acute subdural haematomas (ASDH). In 2011, a collaborative group was formed in the UK with the aim of answering the following question: “What is the clinical- and cost-effectiveness of decompressive craniectomy, in comparison with craniotomy for adult patients undergoing primary evacuation of an ASDH?” The proposed RESCUE-ASDH trial (Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma) is a multicentre, pragmatic, parallel group randomised trial of DC versus craniotomy for adult head-injured patients with an ASDH. In this study, we used an online questionnaire to assess the current practice patterns in the management of ASDH in the UK and the Republic of Ireland, and to gauge neurosurgical opinion regarding the proposed RESCUE-ASDH trial. Materials and methods. A questionnaire survey of full members of the Society of British Neurological Surgeons and members of the British Neurosurgical Trainees Association was undertaken between the beginning of May and the end of July 2012. Results. The online questionnaire was answered by 95 neurosurgeons representing 31 of the 32 neurosurgical units managing adult head-injured patients in the UK and the Republic of Ireland. Forty-five percent of the respondents use primary DC in at least 25% of patients with ASDH. In addition, of the 22 neurosurgical units with at least two Consultant respondents, only three units (14%) showed intradepartmental agreement regarding the proportion of their patients receiving a primary DC for ASDH. Conclusion. The survey results demonstrate that there is significant uncertainty as to the optimal surgical technique for primary evacuation of ASDH. The fact that the majority of the respondents are willing to become collaborators in the planned RESCUE-ASDH trial highlights the relevance of this important subject to the neurosurgical community in the UK and Ireland.

Decompressive craniectomy for acute subdural hematomas: time for a randomized trial.

Dear Sir, We thank Honeybul et al. for their thoughtful comments on our paper. Decompressive craniectomy (DC) has fallen in and out of vogue a number of times in the last few decades. Historically, the main concern has been that DC may be shifting patients from mortality to vegetative state or severe disability. In order to obtain class I evidence, two randomized multicenter trials were launched in 2002–2004: the RESCUEicp and the DECRA. The DECRA study failed to show clinical benefit with early/neuroprotective DC for severe diffuse TBI (no mass lesions) [2]. The RESCUEicp (www.rescueicp.com), which is examining the role of DC as a last-tier therapy for post-traumatic refractory raised ICP (≥25 mmHg), is ongoing and has now recruited 88 % of the required sample size [4]. However, the role of primary DC for evacuation of acute subdural hematomas (ASDH) has not been the subject of any randomized trials to date. As a result, there exists significant variation in the surgical technique employed for the primary evacuation of an ASDH [5]. The well-written paper by Honeybul et al. [3] includes “72 patients who had a unilateral DC following evacuation of an intracranial mass lesion”. The type of mass lesions of this cohort is not defined. To the best of our knowledge, our study is the first to utilize prognostic scores in a cohort of consecutive patients with ASDH in an attempt to compare craniotomy with DC. Our paper is a retrospective cohort comparison study (non-randomized) and by definition does not comprise level I evidence [6]. Importantly, this is the first study to show that unadjusted 6-month outcomes were similar between the craniotomy and DC groups even though the patients who underwent DC were more severely injured. In addition, the standardized morbidity ratio of the DC group is lower than in the craniotomy group, even though the 95 % confidence intervals overlap. While more detailed analyses would certainly improve the statistical sophistication of our results, we felt that this was unlikely to provide a definitive answer to the question posed. Despite the limitations posed by the study design and sample size, our findings lend support to the hypothesis that primary DC may be more effective than craniotomy for selected patients with ASDH. The only way to definitely accept or refute this hypothesis is to perform a multicenter, pragmatic, parallel-group randomized trial in order to compare the clinical and cost-effectiveness of DC versus simple craniotomy for the management of head-injured patients undergoing evacuation of an ASDH. The Brain Trauma Foundation has already identified DC versus craniotomy as the top key issue for future investigation likely to improve the care of patients with ASDH [1]. We are glad that the authors agree that a randomized trial is needed and would welcome their participation in the planned RESCUE-ASDH trial (Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Sub-Dural Haematoma). A. G. Kolias (*) : L. M. Li :M. R. Guilfoyle : I. Timofeev : E. A. Corteen : J. D. Pickard : P. J. Kirkpatrick : P. J. Hutchinson Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke’s Hospital & University of Cambridge, Box 167, Level 3, A Block, Hills Road, Cambridge CB2 0QQ, UK e-mail: angeloskolias@gmail.com

Fixed, Dilated Pupils Following Traumatic Brain Injury: Historical Perspectives, Causes and Ophthalmological Sequelae

Pupillary abnormalities are commonly seen in patients presenting with severe traumatic brain injury (TBI). The objectives of this study were to determine the underlying condition responsible, the natural history of recovery of third nerve palsy and the ultimate clinical outcome in 60 patients admitted to a regional neurosurgical centre with a diagnosis of TBI and unilateral or bilateral fixed, dilated pupils (FDP). In approximately three-quarters of cases, some form of road traffic incident was the mechanism of injury. In patients presenting with a unilateral FDP, the CT-defined condition was most commonly diffuse brain injury (49%) with no obvious lateralising condition. In 34% of cases CT demonstrated a lateralising condition ipsilateral to the side of the FDP and in 9% cases the FDP was contralateral to the side of the CT abnormality. Of those patients who survived an FDP, 72% were left with some form of ophthalmological deficit. Most patients with bilateral FDP did not survive (88%); however, of those who did survive, none was left in a persistent vegetative state or with any ophthalmological sequelae. A FDP is a grave prognostic sign following TBI commonly resulting in long term ophthalmological sequelae; however, a favourable outcome is still attainable.