Hutchinson, Peter J

Kolias, Angelos G

Menon, David K

English

Apollo (Cambridge)

Corr e spondenceT h e  n e w  e ngl a nd  j o u r na l  o f  m e dic i n en engl j med 375;24 nejm.org December 15, 2016 2401Craniectomy for Traumatic Intracranial HypertensionTo the Editor: In the Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Ele-vation of Intracranial Pressure (RESCUEicp) trial reported by Hutchinson and others (Sept. 22 is-sue),1 mortality among patients with severe trau-matic brain injury (TBI) and refractory intracra-nial hypertension who underwent decompressive craniectomy was lower than that among patients who received medical care. However, at 6 months, patients in the surgical group were more likely to have severe disability (as assessed with the use of the Extended Glasgow Outcome Scale [GOS-E]2) than patients in the medical group. At 12 months, a higher percentage of patients in the surgical group than in the medical group had a favorable outcome.Although most patients in the surgical group underwent a bifrontal decompressive craniectomy (63%), an analysis according to the type of sur-gery (i.e., bifrontal or unilateral craniectomy) was not performed. This analysis would be helpful given that in the United States, unilateral de-compressive craniectomy is a more common sur-gical decompression procedure than bifrontal decompressive craniectomy.This trial included children as young as 10 years of age. Since among patients with severe TBI, school-aged children generally tend to have better outcomes than adults,3,4 these patients per-haps should be assessed with a pediatric version of the GOS-E in a separate subgroup analysis.5Jimmy W. Huh, M.D. Shih‑Shan Lang, M.D. Todd J. Kilbaugh, M.D.Children’s Hospital of Philadelphia Philadelphia, PA huh@ email . chop . eduNo potential conflict of interest relevant to this letter was re-ported.1. Hutchinson PJ, Kolias AG, Timofeev IS, et al. Trial of decom-pressive craniectomy for traumatic intracranial hypertension. N Engl J Med 2016; 375: 1119-30.2. Jennett B, Snoek J, Bond MR, Brooks N. Disability after severe head injury: observations on the use of the Glasgow Out-come Scale. J Neurol Neurosurg Psychiatry 1981; 44: 285-93.3. Coronado VG, Xu L, Basavaraju SV, et al. Surveillance for traumatic brain injury-related deaths — United States, 1997-2007. MMWR Surveill Summ 2011; 60: 1-32.4. Emami P, Czorlich P, Fritzsche FS, et al. Impact of Glasgow Coma Scale score and pupil parameters on mortality rate and outcome in pediatric and adult severe traumatic brain injury: a retrospective, multicenter cohort study. J Neurosurg 2016 April 1 (Epub ahead of print).5. Beers SR, Wisniewski SR, Garcia-Filion P, et al. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma 2012; 29: 1126-39.DOI: 10.1056/NEJMc1613479To the Editor: The RESCUEicp trial showed that among patients with traumatic intracranial hypertension, decompressive craniectomy, as com-pared with medical therapy, reduced mortality and increased rates of vegetative state, lower se-vere disability, and upper severe disability. Can the authors indicate whether patients in the sur-gical group had already undergone cranioplasty (replacement of the bone flap over the defect) when functional outcome was assessed at 6 months? Cranioplasty improves cerebral perfusion and re-verses abnormal physiological features of cerebro-spinal fluid caused by decompressive craniectomy,1,2 this week’s letters2401 Craniectomy for Traumatic Intracranial Hypertension2404 Dietary Sodium and Cardiovascular Disease Risk2408 Multiple Variants of Klebsiella pneumoniae Producing Carbapenemase in One Patient e50 Betrixaban in Acutely Ill Medical PatientsThe New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 5, 2019. For personal use only. No other uses without permission.  Copyright © 2016 Massachusetts Medical Society. All rights reserved. T h e  n e w  e ngl a nd  j o u r na l  o f  m e dic i n en engl j med 375;24 nejm.org December 15, 20162402and in clinical practice it is often associated with improvement in neurologic status.3If patients in the surgical group did not un-dergo cranioplasty before the outcome assess-ment at 6 months, the benefit of decompressive craniectomy may have been underestimated. Would the authors consider reporting the rate of cranioplasty at 6 months among patients in the surgical group? Also, would they consider per-forming a post hoc subgroup analysis to shed light on whether cranioplasty changes the effect of initial decompressive surgery on functional outcome at 6 months?Thomas Gaberel, M.D., Ph.D.University Hospital of Caen Caen, France thomas . gaberel@ hotmail . frSherry H.Y. Chou, M.D.University of Pittsburgh Pittsburgh, PAClement Gakuba, M.D., Ph.D.Harvard Medical School Boston, MANo potential conflict of interest relevant to this letter was re-ported.1. Winkler PA, Stummer W, Linke R, Krishnan KG, Tatsch K. Influence of cranioplasty on postural blood flow regulation, cerebrovascular reserve capacity, and cerebral glucose metabo-lism. J Neurosurg 2000; 93: 53-61.2. Nalbach SV, Ropper AE, Dunn IF, Gormley WB. Craniectomy-associated Progressive Extra-Axial Collections with Treated Hydrocephalus (CAPECTH): redefining a common complication of decompressive craniectomy. J Clin Neurosci 2012; 19: 1222-7.3. Bender A, Heulin S, Röhrer S, et al. Early cranioplasty may improve outcome in neurological patients with decompressive craniectomy. Brain Inj 2013; 27: 1073-9.DOI: 10.1056/NEJMc1613479To the Editor: In the RESCUEicp trial, the di-chotomization of “favorable outcomes” in the pa-tients depends on the definition of a “favorable” outcome. The conventional definition in patients with TBI is full independence at 6 months (moder-ate disability or better).1 In the RESCUEicp trial, the proportion of patients with these favorable outcomes was just 26.6% in the medical group and 27.4% in the surgical group, as compared with the reported “favorable outcomes” (34.6% in the medical group and 42.8% in the surgical group; P = 0.12). Figure 2 of the article may not precisely reflect this result. In the surgical group, all “22 more survivors” described were in a vegeta-tive state or were severely disabled. None were independent (a favorable outcome according to the conventional definition).Furthermore, the increased rate of survival at 6 months may relate to high mortality among patients in the medical group (48.9%), as compared with 18% mortality among pa-tients in the medical group of the Decompres-sive Craniectomy (DECRA)2 trial. In both the DECRA and RESCUEicp trials, decompressive craniectomy was a last-tier intervention, and the proportion of patients with conventional favorable outcomes after craniectomy in the DECRA trial (30%) was similar to that in the RESCUEicp trial. In both trials, decompressive craniectomy in-creased disability and did not increase full inde-pendence in survivors.D. James Cooper, M.D. Alistair Nichol, Ph.D. Carol Hodgson, Ph.D.Australian and New Zealand Intensive Care Research Centre Melbourne, VIC, Australia jamie . cooper@ monash . eduNo potential conflict of interest relevant to this letter was re-ported.1. Roozenbeek B, Lingsma HF, Perel P, et al. The added value of ordinal analysis in clinical trials: an example in traumatic brain injury. Crit Care 2011; 15: R127.2. Cooper DJ, Rosenfeld JV, Murray L, et al. Decompressive cra-niectomy in diffuse traumatic brain injury. N Engl J Med 2011; 364: 1493-502.DOI: 10.1056/NEJMc1613479To the Editor: The RESCUEicp trial showed a significant superiority of decompressive craniec-tomy over medical management in preventing death among patients with TBI and refractory intracranial hypertension. These results appear to be contrary to the results of the DECRA trial. In addition, mortality among patients in the medical group of the RESCUEicp trial was 48.9%, as compared with 18% among patients in the medical group in the DECRA trial.Another point that merits mention is that 37.2% of the patients in the medical group in the RESCUEicp trial underwent decompressive crani-ectomy because of clinical deterioration. There-fore, it is reasonable to speculate that the medi-cal therapy received after randomization may not have been adequate in the medical group. Although treatment with barbiturates is often regarded as a final-tier treatment, their efficacy in controlling refractory elevation of intracranial pressure is controversial.1 It may be necessary to increase the intensity of medical treatment to manage uncontrolled intracranial pressure. Fur-ther explanation of this aspect of the trial would be appreciated.The New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 5, 2019. For personal use only. No other uses without permission.  Copyright © 2016 Massachusetts Medical Society. All rights reserved. Correspondencen engl j med 375;24 nejm.org December 15, 2016 2403Shen Hu, M.D Daming Wang, M.D.Beijing Hospital Beijing, China 379882975@ qq . comNo potential conflict of interest relevant to this letter was re-ported.1. Roberts I, Sydenham E. Barbiturates for acute traumatic brain injury. Cochrane Database Syst Rev 2012; 12: CD000033.DOI: 10.1056/NEJMc1613479To the Editor: In the RESCUEicp trial involving patients with refractory traumatic intracranial hypertension, decompressive craniectomy result-ed in lower mortality than mortality among pa-tients who received medical care. However, sur-vivors tended to cluster in the GOS-E category of upper severe disability. Whether this degree of disability is acceptable will depend on the pa-tient, his or her family, and societal influences.This trial further showed that decreasing intra-cranial pressure does not treat primary brain in-jury. Mediation of the secondary injuries (hernia-tion and ischemia) resulting from traumatic intracranial hypertension does not directly ad-dress the variable underlying pathophysiological processes. Thus, the degree of injury in the “rescued” patients in the RESCUEicp trial mani-fested itself as severe disability.The RESCUEicp trial joins a large and grow-ing body of “failed” randomized, controlled trials involving treatment of patients with TBI and in-tracranial pressure,1-4 and the best consequence of this trial would be to end the era of focusing on intracranial pressure alone and of applying one management algorithm to all manifestations of intracranial hypertension. Until clinicians and clinical researchers begin to target the various pathophysiological processes underlying elevated intracranial pressure, the list of large, negative trials is likely to continue to grow.Randall M. Chesnut, M.D.University of Washington Seattle, WA chesnutr@ uw . eduNo potential conflict of interest relevant to this letter was re-ported.1. Andrews PJD, Harris BA, Murray GD. Hypothermia for intra-cranial hypertension after traumatic brain injury. N Engl J Med 2016; 374: 1385.2. Cooper DJ, Rosenfeld JV, Murray L, et al. Decompressive cra-niectomy in diffuse traumatic brain injury. N Engl J Med 2011; 364: 1493-502.3. Wright DW, Yeatts SD, Silbergleit R, et al. Very early admin-istration of progesterone for acute traumatic brain injury. N Engl J Med 2014; 371: 2457-66.4. Chesnut RM, Temkin N, Carney N, et al. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med 2012; 367: 2471-81.DOI: 10.1056/NEJMc1613479The authors reply: In reply to Huh et al. and Gaberel and colleagues: exploratory analyses to evaluate craniectomy sites and pediatric outcomes, both of which are important issues, are ongoing. Also, the timing of cranioplasty may affect out-comes after TBI. The initiation of a prospective registry for cranioplasties in the United Kingdom is under way.1With regard to the comments by Cooper et al. and Hu and Wang, the contrasting results of the DECRA and RESCUEicp trials are due to differ-ent hypotheses, inclusion criteria, and therapeutic protocols. The DECRA trial, as compared with the RESCUEicp trial, enrolled patients with a lower intracranial-pressure threshold (20 mm Hg vs. 25 mm Hg) for shorter intervals (15 minutes vs. 1 to 12 hours), after lower intensities of therapy (stage 1 interventions vs. stage 1 and 2 interven-tions), and within a shorter interval after injury (all patients enrolled within 72 hours after in-jury vs. 44% of patients enrolled >72 hours after injury). Patients with intracranial hematomas were enrolled in the RESCUEicp trial, but they were not enrolled in the DECRA trial. At enroll-ment, the populations also differed with respect to expected outcome; the requirement for stage 2 interventions increases the relative risk of death by 60%.2 Hence, at 6 months, the pooled mortal-ity of 37.5% in the RESCUEicp trial versus 18.7% in the DECRA trial is unsurprising.In addition, our primary analysis showed a significant between-group difference in the GOS-E distribution and a substantial reduction in mor-tality with surgery; this finding differed from that of the DECRA trial, in which mortality was similar in the two groups. The severity of injury in the RESCUEicp trial underpinned dichotomi-zation in the prespecified sensitivity analysis at upper severe disability (independent at home) or better. Given the high expectation of a poor out-come, the use of a “conventional” dichotomy would be as inappropriate as the use of it in populations with mild TBI (in whom disability-free survival is often attainable). This approach is concordant with recent recommendations.3 Up-The New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 5, 2019. For personal use only. No other uses without permission.  Copyright © 2016 Massachusetts Medical Society. All rights reserved. T h e  n e w  e ngl a nd  j o u r na l  o f  m e dic i n en engl j med 375;24 nejm.org December 15, 20162404per severe disability is a better outcome than a modified Rankin score of 4 (on a scale from 0 [no symptoms] to 6 [death]), the threshold that has driven the use of craniectomy in patients with ischemic stroke (Table 1).4Also, barbiturates were an option in patients in the medical group after randomization. The fact that 37.2% of patients in the medical group eventually underwent a craniectomy, whereas 9.4% of patients in the surgical group required barbiturates, indicates that the failure to control intracranial pressure was greater in the medical group.We agree with Chesnut about the acceptability of disability but question the statement regarding “failed” trials. The DECRA trial and the European Study of Therapeutic Hypothermia (32°C–35°C) for Intracranial Pressure Reduction after Traumatic Brain Injury (the Eurotherm3235 Trial) were valuable because they showed that craniectomy and hypothermia, respectively, are not beneficial as stage 2 interventions. The progesterone trial by Wright et al., which was cited by Chesnut as a failed trial, did not address intracranial hyper-tension. We think that the treatment of intracra-nial hypertension will remain important, since it is a driver of increased mortality.5 Integration of intracranial-pressure waveform analysis (in order to characterize autoregulation) with multimodal-ity monitoring (microdialysis, brain oxygenation, and electrocorticography) can identify patho-physiological subgroups and may allow targeted treatment after TBI.Peter J. Hutchinson, Ph.D., F.R.C.S. (SN) Angelos G. Kolias, Ph.D., M.R.C.S. David K. Menon, F.Med.Sci.University of Cambridge Cambridge, United Kingdom pjah2@ cam . ac . ukSince publication of their article, the authors report no fur-ther potential conflict of interest.1. Kolias AG, Bulters DO, Cowie CJ, et al. Proposal for estab-lishment of the UK Cranial Reconstruction Registry (UKCRR). Br J Neurosurg 2014; 28: 310-4.2. Stocchetti N, Zanaboni C, Colombo A, et al. Refractory in-tracranial hypertension and “second-tier” therapies in traumatic brain injury. Intensive Care Med 2008; 34: 461-7.3. Maas AI, Murray GD, Roozenbeek B, et al. Advancing care for traumatic brain injury: findings from the IMPACT studies and perspectives on future research. Lancet Neurol 2013; 12: 1200-10.4. Vahedi K, Hofmeijer J, Juettler E, et al. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol 2007; 6: 215-22.5. Hutchinson PJ, Kolias AG, Czosnyka M, Kirkpatrick PJ, Pick-ard JD, Menon DK. Intracranial pressure monitoring in severe traumatic brain injury. BMJ 2013; 346: f1000.DOI: 10.1056/NEJMc1613479Dietary Sodium and Cardiovascular Disease RiskTo the Editor: Cogswell et al. (Aug. 11 issue)1 argue that the reported association between low sodium intake and increased cardiovascular risk does not fulfill the criteria for causality, and they therefore conclude that low sodium intake should be recommended. We wish to call attention to several issues in their assessment of the avail-able data.First, the criticism by Cogswell et al. with regard to fasting urinary sodium estimates of Scale and Category DefinitionExtended Glasgow Outcome ScaleUpper severe disability Patient does not require assistance at home (or can be left alone for at least 8 hr) but requires assistance outside the homeLower severe disability Patient is dependent on others for careModified Rankin scale*Moderately severe disability (a score of 4) Patient is unable to walk without assistance and unable to attend to his or her own bodily needs without assistanceSevere disability (a score of 5) Patient is bedridden, incontinent, and requires constant nursing care and attention*  Scores on the modified Rankin scale, which assesses the degree of disability or dependence in daily activities, range from 0 (no symptoms) to 6 (death).Table 1. Definitions of Severe Disability According to the Extended Glasgow Outcome Scale and the Modified Rankin Scale.The New England Journal of Medicine Downloaded from nejm.org at CAMBRIDGE UNIVERSITY LIBRARY on August 5, 2019. For personal use only. No other uses without permission.  Copyright © 2016 Massachusetts Medical Society. All rights reserved. 

Craniectomy for Traumatic Intracranial Hypertension.

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Craniectomy for Traumatic Intracranial Hypertension.

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