Acta Neurochir (2006) [Suppl] 96: 11–16 6 Springer-Verlag 2006 Printed in Austria Decompressive craniectomy in traumatic brain injury: outcome following protocol-driven therapy I. Timofeev1, P. J. Kirkpatrick1, E. Corteen1, M. Hiler1, M. Czosnyka1, D. K. Menon2,3, J. D. Pickard1,3, and P. J. Hutchinson1 1 Department of Neurosurgery, Addenbrooke’s Hospital, Cambridge, UK 2 Department of Anesthesia, Addenbrooke’s Hospital, Cambridge, UK 3 Wolfson Brain Imaging Centre, University of Cambridge, UK Summary Although decompressive craniectomy following traumatic brain injury is an option in patients with raised intracranial pressure (ICP) refractory to medical measures, its e¤ect 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. Fortynine 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 (20.4%) 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. Keywords: Head injury; traumatic brain injury; decompressive craniectomy; ICP; brain edema; intracranial hypertension; Glasgow Outcome Scale. cerebral perfusion pressure (CPP) b 60–70 mmHg, and a number of therapeutic approaches are employed to reduce ICP and augment CPP in order to achieve these targets. In patients with post-traumatic cerebral swelling resistant to optimal medical therapy, decompressive craniectomy may be considered. Despite observations that craniectomy leads to reduction in ICP [3, 30, 31, 35], it is still unclear how this translates into clinical outcome. Although prospective randomized evaluation of the e¤ects of decompressive craniectomy is required, this operation continues to be used empirically in the management of patients with traumatic brain injury. In Cambridge, decompressive craniectomy is used as a part of protocol-driven intensive care management of patients with severe head injury [18] (Fig. 1), when other means of controlling elevated ICP are exhausted. It is also used in selected cases where malignant post-traumatic cerebral swelling is evident from the outset. Encouraged by our previous observations [31], we have evaluated the outcome following decompressive craniectomy in another consecutive cohort of 49 patients. Introduction Severe traumatic brain injury is associated with high mortality and morbidity. Treatment of patients who present in coma following severe head injury aims to protect the brain from further insults, optimize cerebral metabolism, and prevent secondary injury. Intracranial pressure (ICP) monitoring is now wellestablished in neuro-intensive care. Recent guidelines [10] recommend target levels of ICP < 25 mmHg and Materials and methods Study design This study is a retrospective observational cohort study with crosssectional analysis of outcome. Hospital records, intensive care charts, and computed tomography (CT) scans of patients who underwent decompressive craniectomy following traumatic brain injury consecutively during the period 2000–2003 were retrospectively analyzed. Physiological parameters recorded for 24 hours before and 12 Fig. 1. Protocol of intensive care management of head injured patients I. Timofeev et al. Decompressive craniectomy in traumatic brain injury: outcome following protocol-driven therapy after operation were compared. Outcome was assessed using the Glasgow Outcome Score (GOS) [14] recorded at follow-up assessment at least 6 months following the injury. Data were obtained from patients’ medical records and a prospectively collected head injury outcome database. SF-36 quality of life survey [29] questionnaires were mailed to surviving patients with favorable outcome (good recovery or moderate disability) for more detailed evaluation of their social and physical rehabilitation. The response rate for the postal questionnaire was 60%. Statistical analysis Data were analyzed using SPSS 13.0 for Windows (SPSS Inc., Chicago, IL, USA). Following distribution analysis (KolmogorovSmirnov and Shapiro-Wilk tests), mean values G SD were used for data following normal distribution, and median values G interquartile range (IQR) for non-parametric data. Means and medians of physiological variables before and after craniectomy were compared using paired t-test, Wilcoxon, and sign tests, respectively. P value of <0.05 was considered significant. Pearson and Spearman rank coe‰cients were used to test the strength of correlations. Results Patient characteristics Demographic data from the study population as well as mechanisms and severity of injury are summarized in Table 1. The majority of patients had a Table 1. Summary of patient characteristics (n ¼ 49) Age 28 (range 9–67) Gender – Male – Female 37 (75%) 12 (25%) Mechanism of injury – Road Tra‰c Accident – Fall – Assault – Other 29 (60%) 11 (22%) 5 (10%) 4 (8%) Severity of injury GCS-based head injury grade: – Severe (3–8) – Moderate (9–12) – Mild (b 13) 40 (82%) 8 (16%) 1 (2%) Preoperative CT Marshall grade (n ¼ 27): – I – II – III – IV – V – VI — 4 (15%) 13 (48%) 5 (18%) 1 (4%) 4 (15%) Injury severity score: median (IQR), n ¼ 30 APACHE score: mean (SD), n ¼ 30 Major extracranial injury Non-cranial surgery Median (IQR) ICU stay (days) 25 (16–27) 17 (6.7) 18 (37%) 12 (25%) 19 (range 14–26) 13 post-resuscitation Glasgow Coma Scale (GCS) score of less than 8. The only patient who presented with mild head injury (GCS 13) deteriorated later and required intubation and intensive care management. Two patients had bilateral dilated unreactive pupils on admission; both subsequently died. A significant proportion of patients had a major intracranial injury (37%), and 25% of patients underwent non-cranial surgical procedures. Based on preoperative CT scan appearance, most patients had a di¤use brain injury (Marshall grade II–III) [16]. Initial ICP control measures All patients were managed according to an ICP- and CPP-driven protocol [18] (Fig. 1), which aims to maintain ICP < 25 mmHg and CPP b 60 mmHg. Therapeutic hypothermia was used in 44 (93.6%) patients, mannitol in 42 (89.4%) patients, hypertonic saline in 9 (19.1%) patients, external ventricular drainage in 13 (27.7%) patients, and barbiturate-induced coma in 15 (31.9%) patients. Decompressive craniectomy was considered when all medical measures to control ICP failed to achieve sustained optimal levels of ICP and CPP, and occasionally it was considered as an alternative to barbiturate therapy. Surgical details Decompressive craniectomy was performed on median day 2 (IQR 1;3) after injury. In 24 (49%) patients the operation was performed within 24 hours, and in 32 (65.3%) patients within 48 hours from the time of admission. Forty-one (83.7%) patients underwent bifrontal decompressive craniectomy, and 8 (16.3%) had a unilateral procedure. In all cases the dura was opened, and in cases of bifrontal decompressive craniectomy the falx cerebri was divided anteriorly if deemed necessary by the operating surgeon. Complications associated with the operation were observed in 4 (8%) patients. Two patients su¤ered intracranial hemorrhage and 1 patient had an acute subdural hematoma in the early postoperative period, which required evacuation. One patient developed a cerebral abscess, which was treated with needle aspiration and antibiotics. ICP data Decompressive craniectomy led to a reduction in ICP pressure in all patients for whom pre- and post- I. Timofeev et al. 14 Fig. 2. Clinical outcome of patients at 6þ months assessed by Glasgow Outcome Scale score operative ICP monitoring data was available (n ¼ 27). Mean G SD ICP during the 24-hour period prior to surgical decompression was 25 G 6 mmHg as compared to 16 G 6 mmHg for the 24 hours following an operation, and the di¤erence is statistically significant ( p < 0:01). Outcome The GOS showed favorable recovery in 30 (61.2%) patients (24 [49%] patients with good recovery and 6 [12.2%] patients with moderate disability), 10 (20.4%) patients remained severely disabled, and 9 (18.4%) patients died (Fig. 2). No patient was left in persistent vegetative state. Four out of 9 patients presenting with an initial GCS of 3 were severely disabled and 2 died; however, 3 (33.3%) patients in this group had a favorable outcome. In general, outcome was related to initial GCS score (p ¼ 0:004), but there was no association with age, gender, or timing of operation with the GOS. Interestingly, in the 5 patients over 50 years of age, the rate of favorable outcome was not di¤erent than in younger patients (60%), although the numbers were too small to perform further statistical analysis. Mortality in this group accounted for the remaining 40% of patients, with no patients left severely disabled. Eighteen out of 30 patients with favorable outcome responded to the SF-36 quality of life survey (60% response rate). The summary for all 8 domains is presented in Table 2 and compares general population levels [13]. At least 10 out of 40 surviving patients returned to work (information on re-employment was Table 2. SF-36 quality of life survey following decompressive craniectomy (n ¼ 18). Numbers represent mean G SD scores for each SF-6 domain in decompressive craniectomy patients and general population controls. The latter values were obtained from the results of a recent large-scale population survey [13] SF-36 Domain Physical Functioning (PF) Role limitation due to Physical problems (RP) General Health perception (GH) Bodily Pain (BP) Role limitation due to Emotional problems (RE) Energy Vitality score (EV) Social Functioning (SF) Mental Health (MH) Decompressive Craniectomy mean G SD Controls mean G SD 67.5 G 32 45.8 G 46 87.9 G 20 87.2 G 22 60.1 G 22 64.8 G 35 51.9 G 47 71.0 G 20 78.8 G 23 85.8 G 21 50.3 G 22 48.8 G 28 62.9 G 27 58.0 G 20 82.8 G 23 71.9 G 18 not available for 14 patients). Cranioplasty was performed in 30 patients (75% of survivors) at the time of analysis. Post-traumatic hydrocephalus, which required a shunting procedure, was observed in 6 (15%) of the 40 survivors. Discussion Decompressive craniectomy continues to be used as a treatment measure for advanced cerebral edema and intractable intracranial hypertension. It has been applied to patients with malignant cerebral swelling following middle cerebral artery thrombosis [5, 19, 22, 25] and in other conditions leading to brain edema [2, Decompressive craniectomy in traumatic brain injury: outcome following protocol-driven therapy 7, 8, 20, 26, 28]. The indications for decompressive craniectomy following traumatic brain injury are not universally defined. Currently, the procedure is considered when medical treatment measures fail to control ICP or when malignant intracranial hypertension is present on admission. Although decompressive craniectomy may lead to an improvement in physiological parameters [4, 12, 32], the impact of this procedure on clinical outcome and social rehabilitation has not been clearly established. Present evidence is based on observational studies or case reports, with the single exception of a small pilot prospective randomized trial [27]. Outcome data from the published case series varies significantly. Although mortality rates quoted by di¤erent centers fall in the range of 20% G 5%, the rates of reported favorable outcome and severe disability are considerably di¤erent. The proportion of patients achieving a favorable outcome (GOS: good recovery/moderate disability) after decompressive craniectomy has been reported to be as low as 30–40% [1, 6, 21, 23] and as high as 60–70% [9, 15, 27, 31]. One of the other serious concerns raised with regard to decompressive craniectomy is that the operation may reduce mortality, but increase the subset of patients with severe disability and persistent vegetative state. Indeed, some authors report high levels of severe disability [21, 23] and persistent vegetative state [6]. The discrepancy in published outcome data may, to some extent, be explained by di¤erence in patient selection, indications, timing and technique of surgery, as well as an assessment of outcome. In our unit, decompressive craniectomy is used as part of a protocol-based management of severe head injury (Fig. 1). The multidisciplinary decision to perform surgical decompression involves liaison between a senior neurosurgeon and neuro-intensivist. We have previously reported high rates of favorable outcome in a smaller series of patients [31], and the results of this study are consistent with our earlier findings. The current study shows that favorable outcome can be achieved in a large proportion of patients presenting with severe and potentially fatal head injury, with at least one-quarter returning to work. A high rate of severe disability or vegetative state after surgical decompression is not supported by our findings, as no patient was left in a vegetative state and the severe disability rate was not higher than generally accepted. In terms of quality of life, the response to the SF-36 questionnaire indicates that patients with favorable clinical 15 outcome continue to experience physical and emotional consequences of their injury. The mean scores for patients’ quality of life di¤er from a general population in all SF-36 domains; however, the large SDs reflect di¤erences in response between individuals and suggest that some patients rate their quality of life as high. Although the complication rate associated with surgery [17, 24, 33, 34] is low, the impact on outcome and the exact relationship with craniectomy requires further evaluation. 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