Implementation Science and Targeted Temperature Management: The Good News and the Bad* Eldar Søreide, MD, PhD Department of Anesthesiology and Intensive Care Stavanger University Hospital Stavanger, Norway; and Department of Clinical Medicine University of Bergen Bergen, Norway

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he concept of post–cardiac arrest targeted temperature management (TTM) is well established. The 2010 version of the international resuscitation guidelines reflects the key position TTM now has in postresuscitation care (1). Nevertheless, some authors (2) have challenged the scientific evidence for cooling the injured brain, and the optimal cooling temperature and length of cooling are still debated. In many countries, however, the dominating problem with TTM has been and still is very slow implementation into clinical practice (3, 4). For this reason, TTM has been used to illustrate the fact that scientific breakthrough in resuscitation science alone is not sufficient, and one must also include educational efficiency and successful local implementation in the equation to acquire improved survival (Formula for Survival) (5). In this issue of Critical Care Medicine, Morrison et al (6) present a TTM implementation study in a Canadian healthcare system, which previously had been shown to be a “slow adopter” (7) of TTM. It is highly commendable that they were able to plan and execute such a study to see if they could remedy the situation. The study included a large number of patients and was performed in a well-established research network. Scientifically, sound implementation studies are rarely performed and if done hard to get published in the critical care medicine literature. Morrison et al (6) present the applied methodology in a way easy to grasp for nonexperts in stepped wedge cluster randomized controlled trials. As such, the study could act as a primer for most of us. The good news from their study is that the implementation strategy did work, and that a simple and inexpensive strategy worked as good as a more complicated and resource-demanding one. This may be a generic finding with great impact when it comes to quality improvement (QI) in critical care medicine. The fact that the simpler approach triumphed is in accordance

*See also p. 954. Key Words: cardiac arrest; cluster randomized controlled trial; imple­ mentation science; resuscitation; targeted temperature management The author has disclosed that he does not have any potential conflicts of interest. Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. DOI: 10.1097/CCM.0000000000000911

Critical Care Medicine

with the famous quote by Albert Einstein: “Everything must be made as simple as possible. But not simpler” (8). What about the bad news? The increased implementation rate of “successful TTM” was not followed by an improvement in survival to discharge. How we should interpret this secondary outcome finding is not as straightforward as for the primary outcome. Should the finding be considered evidence that undermines the whole concept of TTM? Reading only the abstract, the reader may get the impression that improved hospital implementation of TTM does not convert a survival benefit. Before jumping to conclusions, we need to assess some aspects of the study design and how the authors themselves discuss their findings. To have a feasible primary outcome measure, it is understandable that the authors decided to use “the proportion of eligible patients receiving successful TTM, defined as a target temperature of 32–34°C within 6 hours of emergency department arrival” as their primary outcome (6). As acknowledged by the authors themselves, the definition of “successful TTM” was somewhat arbitrary. More patients achieved a target temperature below 34°C within 6 hours of hospitalization with the simple QI intervention. However, the overall use of TTM in the hospitals did not change and remained above 50%. It is not obvious from our current understanding that achieving the target temperature more rapidly will confer a survival benefit. We still do not know precisely what the effective time-window for TTM with respect to the reperfusion injury is (9), and patients who cool more rapidly have a worse prognosis (10, 11). Hence, this could very well explain the lack of improved survival noted with the otherwise successful QI initiative. It is also noteworthy that the same authors in another study from the same research network found use of hospital TTM to be associated with improved survival (12). Bottom line, we need more focus on implementation science to make sure that breakthrough therapies in critical care become daily clinical practice without undue delays (3, 13). The study by Morrison et al (6) is an excellent example of the kind of studies needed to achieve this goal. The study should, however, not be perceived as scientific proof that cooling post–cardiac arrest patients does not work. Lack of TTM implementation into daily practice is still a major concern in many countries (3, 4). Further, recent data indicate that due to the ongoing discussion around TTM, a substantial numbers of North-American hospitals have stopped using any form of TTM (14). This is a development not wanted by anyone, and a clinical practice definitely not supported by scientific data.

REFERENCES

1. Morrison LJ, Deakin CD, Morley PT, et al; Advanced Life Support Chapter Collaborators: Part 8: Advanced life support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation 2010; 122:S345–S421 www.ccmjournal.org

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Editorials 2. Nielsen N, Friberg H, Gluud C, et al: Hypothermia after cardiac arrest should be further evaluated—a systematic review of randomised trials with meta-analysis and trial sequential analysis. Int J Cardiol 2011; 151:333–341 3. Søreide E, Sunde K: Therapeutic hypothermia after out-of hospital cardiac arrest: How to secure worldwide implementation. Curr Opin Anaesthesiol 2008; 21:209–215 4. Dresden SM, O’Connor LM, Pearce CG, et al: National trends in the use of postcardiac arrest therapeutic hypothermia and hospital fac­ tors influencing its use. Ther Hypothermia Temp Manag 2015 Jan 7. [Epub ahead of print] 5. Søreide E, Morrison L, Hillman K, et al; Utstein Formula for Survival Collaborators: The formula for survival in resuscitation. Resuscitation 2013; 84:1487–1493 6. Morrison LJ, Brooks SC, Dainty KN, et al; on behalf of the Strategies for Post-Arrest Care Network: Improving Use of Targeted Temperature Management After Cardiac Arrest: A Stepped Wedge Cluster Randomized Controlled Trial. Crit Care Med 2015; 43:954–964 7. Berwick DM: Disseminating innovations in health care. JAMA 2003; 289:1969–1975

8. goodreads.com: Quotes about Einstein. Available at: http://www. goodreads.com/quotes/tag/einstein. Accessed January 5, 2015 9. Lampe JW, Becker LB: State of the art in therapeutic hypothermia. Annu Rev Med 2011; 62:79–93 10. Lyon RM, Richardson SE, Hay AW, et al: Esophageal tempera­ ture after out-of-hospital cardiac arrest: An observational study. Resuscitation 2010; 81:867–871 11. Benz-Woerner J, Delodder F, Benz R, et al: Body temperature regula­ tion and outcome after cardiac arrest and therapeutic hypothermia. Resuscitation 2012; 83:338–342 12. Drennan IR, Lin S, Thorpe KE, et al: The effect of time to defibrillation and targeted temperature management on functional survival after out-of-hospital cardiac arrest. Resuscitation 2014; 85:1623–1628 13. Weiss CH, Baker DW: The evolving application of implementation science in critical care. Crit Care Med 2014; 42:996–997 14. Polderman K, Nielsen N, Graffagnino C, et al: Therapeutic hypother­ mia in post-cardiac arrest. Ther Hypothermia Temp Manag 2014; 4:154–158

Futility After Cardiac Arrest: Another One Bites the Dust* Neha S. Dangayach, MD Stephan A. Mayer, MD, FCCM Departments of Neurology and Neurosurgery Institute for Critical Care Medicine Icahn School of Medicine at Mount Sinai New York, NY

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rognostication after sudden cardiac arrest used to be easy. Outcomes were uniformly dismal: epidemiologic studies in the 1990s reported survival to discharge in fewer than 5% of cases in New York and other U.S. cities (1). The primary role of the intensivist was to continue cardiopulmonary support while giving families enough time to come to terms with tragedy. Neurologists were taught that coma from hypoxic-ischemic injury was untreatable and irrecoverable. Targeted temperature management (TTM) for the treatment of cerebral reperfusion injury after cardiac arrest has since changed everything (2, 3). Hypoxic-ischemic encephalopathy is now a treatable disease. The publication of the first two landmark trials in 2002 have been followed by a multitude of single-center studies, demonstrating a consistent pattern of improved outcome among cardiac arrest patients treated with

*See also p. 965. Key Words: cardiac arrest; hypoxic-ischemic encephalopathy; myoclonic status epilepticus; prognosis The authors have disclosed that they do not have any potential conflicts of interest. Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. DOI: 10.1097/CCM.0000000000000913

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hypothermia (4). Although a recent trial showed that outcomes are similarly excellent whether patients are cooled to either 33°C or 36°C (5), cooling after cardiac arrest is clearly here to stay. With the advent of TTM, there is new hope, and outcomes have been steadily improving. But with a new game comes new rules, especially regarding prognostication (6). Intensivists and neurologists have learned to address prognosis only after a trial of maximally aggressive therapy before declaring neurological futility and recommending withdrawal of life support. This strategy was incorporated into the TTM trial, which may in part explain the remarkable 47% overall rate of good outcome in this study. The most authoritative evidence-based guideline for predicting prognosis after cardiac arrest was published in 2006 by the American Academy of Neurology (7). The upshot was a list of clinical and laboratory criteria that were felt to define an iron-clad “no-hope” situation. However, the studies used to support these findings were conducted before therapeutic hypothermia came into widespread use. Since 2006, a series of isolated reports of good neurological recovery have challenged the foundation of evidence supporting various no-hope criteria after cardiac arrest in patients who have been cooled. This process began with reports of good outcome in small numbers of patients with absent motor responses on day 3 or later (8), peak neuron-specific enolase levels exceeding the previously validated cut-point of 33 μg/L (9, 10), and bilaterally absent N20 responses on median nerve somatosensory-evoked potentials (11). We now know that exceptions to these conventional no-hope criteria can occur. Myoclonic status epilepticus (MSE) has long been considered a catastrophic finding among victims of cardiac arrest (12, 13). The 1994 article (13) that firmly established this concept May 2015 • Volume 43 • Number 5

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Implementation science and targeted temperature management: the good news and the bad.

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