Decompressive Craniectomy-The Price Is Right?* Santosh B. Murthy, MD, MPH Neeraj S. Naval, MD Division of Neurosciences Critical Care Department of Anesthesiology and Critical Care Medicine Johns Hopkins University School of Medicine Baltimore, MD

or decades, there has been clinical equipoise regard­ ing the ideal therapy for the management of refrac­ tory intracranial hypertension (RICH) following traumatic brain injury (TBI). The Brain Trauma Foundation (BTF) guidelines currently recommend barbiturate coma and decompressive hemicraniectomy (DCH) as secondline treatment options for RICH (1, 2). Small single-center prospective studies have suggested a functional and survival benefit to using barbiturate coma for RICH (3, 4). On the other hand, although DCH has been shown to unequivocally reduce mortality and ameliorate functional outcomes when performed early for large hemispheric cerebral infarction, the Decompressive Craniectomy in diffuse traumatic brain injury trial questioned the efficacy of DCH in improving functional outcomes following TBI, despite being associated with shorter length of stay or the need for mechanical ven­ tilation (5). At a pathophysiologic level, it is believed that transcalvarial herniation of the brain that occurs as a part of DCH may result in “axonal stretch” exacerbating the pri­ mary brain injury (6). Neither of these therapies are however without side effects. For instance, while barbiturate coma negatively impacts long-term cognitive profiles of patients and may contribute to systemic complications, DCH is asso­ ciated with surgical complications which may deleteriously affect outcomes as well (3, 5). In this issue of Critical Care Medicine, Alali et al (7) compare the cost-utility benefit of two therapies used in the treatment of RICH in patients with TBI—barbiturate coma and DCH. For this purpose, they constructed a Markov model to analyze the effectiveness of the two treatment modalities. The outcome measures studied were quality-adjusted survival and overall cost. Their results suggested that DCH offered a clear favorable ben­ efit in terms of a gain of 1.5 quality-adjusted life years (QALYs) in comparison to barbiturate coma, with an incremental costeffectiveness ratio of $9,565/QALY. This is a relatively novel and interesting attempt to define outcomes in economic terms,

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*See also p. 2235. Key Words: barbiturate; decompressive hemicraniectomy; intracranial hypertension; Markov model; traumatic brain injury The authors have disclosed that they do not have any potential conflicts of interest. Copyright © 2014 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins DOI: 10.1097/CCM.0000000000000561

Critical Care Medicine

especially given that high-quality clinical evidence does not yet exist supporting one intervention over the other. Although the Markov model has several advantages, par­ ticularly the fact that the design facilitates cross over to the other treatment in the event of failure of one therapy, its use is hampered by some inherent shortcomings. Markov models necessitate oversimplification of highly complex biological processes; in this case, the flawed assumption that TBI with RICH is a homogenous entity. Decision regarding appropriate intervention for refractory intracranial pressure (ICP) eleva­ tion may be based on nature of injury (focal/hemispheric or diffuse; associated extra-axial or intra-axial hemorrhage or diffuse axonal injury) and cannot be based purely on eco­ nomic impact of each intervention. Extracranial factors such as systemic hypotension seen with polytrauma may also dictate optimal management of RICH. The model does not address patients with neurological deterioration secondary to cerebral herniation in the absence of RICH (in which case there is a theoretical benefit of DCH over pharmacological coma). Fur­ thermore, the severe paucity of randomized controlled trials comparing the two interventions in question undermines the predictive power of any proposed model. Finally, estimation of the long-term quality of life estimated using Glasgow Outcome Scale at 6 months is based on the assumption that neurological recovery remains static after 6 months. On the contrary, a size­ able 36% of patients with TBI have improvement in functional outcome between 6 months and 1 year (8). With growing TBI burden and recent healthcare reform, comparative effectiveness research is the need of the hour. However, such research should be complimentary to clinical trials comparing clinical efficacy of both approaches and may be especially useful as a “tie-breaker” of sorts if the compara­ tive effectiveness based on clinical outcome studies is roughly equivalent. The ongoing randomized trial Randomised Evalua­ tion of Surgery with Craniectomy for Uncontrollable Elevation of Intra-Cranial Pressure (9) proposes to compare outcomes of DCH versus maximal medical therapy (including barbitu­ rates). Using cost-utility benefit as a substitute for such clinical outcome driven studies would be tantamount to putting the cart before the horse. After all, how does one truly measure the price of a human life, even a neurologically devastated one? There is a bigger picture we may be missing in the back­ ground—are we truly justified in our fixation with 20 mm Hg as the upper limit of “ideal” ICP? The Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure trial attempted to resolve this debate by showing no difference in outcomes in patients with TBI treated in ICP-driven BTF guideline-based or clinicoradiological examination-based arms (10). This trial, despite its many limitations, challenged the dogma that treating an ICP greater than 20 mm Hg should universally be considered “standard of care.” In our quest for standardiz­ ing management of patients with TBI, have we in essence over­ simplified the differing mechanisms of injury by standardizing w w w .c c m jo u r n a l.o r g

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TBI management in place of individualizing therapy based on cerebral autoregulatory potential (11)? As mentioned previ­ ously, both barbiturate coma and DCH have their fair share of complications. In our quest to achieve the arbitrarily defined “optimum” ICP control, are we really subjecting our patients to unnecessary and potentially unsafe treatments?

4. Roberts I, Sydenham E: Barbiturates for acute traumatic brain injury. Cochrane Database Syst Rev 2012; 12:CD000033

REFERENCES

7. Alali AS, Naimark DMJ, Wilson JR, et al: Economic Evaluation of Decompressive Craniectomy Versus Barbiturate Coma for Refractory Intracranial Hypertension Following Traumatic Brain Injury. Crit Care Med 2014; 42:2235-2243

1. Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, et al: Guidelines for the management of severe traumatic brain injury. XI. Anesthetics, analgesics, and sedatives. J Neurotrauma 2007; 24(Suppl 1):S71-S76 2. Bullock MR, Chesnut R, Ghajar J, et al; Surgical Management of Traumatic Brain Injury Author Group: Surgical management of trau­ matic parenchymal lesions. Neurosurgery 2006; 58:S25-S46; dis­ cussion Si-Siv 3. Marshall GT, James RF, Landman MP, et al: Pentobarbital coma for refractory intra-cranial hypertension after severe traumatic brain injury: Mortality predictions and one-year outcomes in 55 patients. J Trauma 2010; 69:275-283

5. Cooper DJ, Rosenfeld JV, Murray L, et al; DECRA Trial Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group: Decompressive craniectomy in diffuse traumatic brain injury. N Engl J Med 2011; 364:1493-1502 6. Cooper PR, Hagler H, Clark WK, et al: Enhancement of experimental cerebral edema after decompressive craniectomy: Implications for the management of severe head injuries. Neurosurgery 1979; 4:296-300

8. Corral L, Ventura JL, Herrero JI, et al: Improvement in GOS and GOSE scores 6 and 12 months after severe traumatic brain injury. Brain Inj 2007; 21:1 225-1231 9. RESCUE-ICP Study. Available at: http://www.rescueicp.com. Accessed February 14, 2014 10. Chesnut RM, Temkin N, Carney N, et al; Global Neurotrauma Research Group: A trial of intracranial-pressure monitoring in trau­ matic brain injury. N Engl J Med 2012; 367:2471-2481 11. Lazaridis C, DeSantis SM, Smielewski P, et al: Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg 2014; 120:893-900

Safety and Quality as a “Way of Life” in the PICU: Where Does the Morbidity and Mortality Conference Fit In?* ... among the moral duties incumbent on a physician, [is] ... candor, which makes him open to conviction, and ready to acknowledge and rectify his mistakes. An obstinate adherence to an unsuccessful method of treating a disease, must be owing to a high degree of self-conceit, and a belief of the infallibility of a system ( 1) . . .

Andrew C. Argent, MD Division of Paediatric Critical Care and Children's Heart Disease School of Child and Adolescent Health University of Cape Town; and Paediatric Intensive Care Unit Red Cross War Memorial Children’s Hospital Cape Town, South Africa

practice (2). They are a requirement of the Accreditation Coun­ cil for Graduate Medical Education (ACGME) for residency programs (although specific requirements differ by discipline) and are recommended by the Institute of Medicine (3) but are not implemented in all hospitals across the United States.

*See also p. 2252.

n the ideal world, safe, high-quality healthcare would be delivered to all within an affordable budget. The reality is less than ideal with high healthcare-related morbidity and limited access to care despite considerable expenditure. If that situation is to improve, it is essential that physicians (and other healthcare workers) be prepared to acknowledge mistakes and change patterns of behavior. Morbidity and mortality confer­ ences (MMCs)—in which physicians particularly have been challenged to reflect on what happened to patients in their care and whether they could have performed better—have been conducted for many decades after their origins in surgical

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Key Words: morbidity and mortality conferences; patient safety; pediatric intensive care; quality improvement; Dr. Argent is employed by the Red Cross War Memorial Children’s Hos­ pital, received a Wellcome Grant for a study entitled “Pathways to Care of critically ill children,” received support for development of educational presentations from Johnson and Johnson (presentation on burns on behalf of J and J for a burns course run at the Red Cross War Memo­ rial Children's Hospital), and received support for travel from various congresses (received funding to cover congress registration, travel, and accommodation as an invited speaker at various national and interna­ tional congresses). Copyright © 2014 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins DOI: 10.1097/CCM.0000000000000562 October 2014* Volume 42 • Number 10

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