Annales Françaises d’Anesthésie et de Réanimation 28 (2009) 187–190
INFORMATION PROFESSIONNELLE
Guidelines for indications for the use of extracorporeal life support in refractory cardiac arrest§ Conseil Société Société Société Société Société Société Société
français de réanimation cardiopulmonaire (CFRC) française d’anesthésie et de réanimation (Sfar) française de cardiologie (SFC) française de chirurgie thoracique et cardio-vasculaire (SFCTCV) française de médecine d’urgence (SFMU) française de pédiatrie (SFP)–Groupe francophone de réanimation et d’urgence pédiatriques (GFRUP) française de perfusion (SOFRAPERF) de réanimation de langue française (SRLF)
WORKING GROUP Coordonnator: Bruno Riou (
[email protected]) Service d’accueil des urgences, GH Pitié-Salpétrière, université Pierre-et-Marie-Curie, Paris-6, 47–83, boulevard de l’Hôpital, 75651 Paris cedex 13, France Experts: Frédéric Adnet, Frédéric Baud, Alain Cariou, Pierre Carli, Alain Combes, Denis Devictor, Jean-Luc Dubois-Randé, Jean-Louis Gérard, Pierre-Yves Gueugniaud, Agnès RicardHibon, Olivier Langeron, Pascal Leprince, Dan Longrois, Alain Pavie, Philippe Pouard, Jean-Christophe Rozé, Jean-Noël Trochu, André Vincentelli. 1. INTRODUCTION Around 50,000 cardiac arrests (CA) occur each year in France and survival remains as low as 3 to 5%. Cardiopulmonary resuscitation (CPR) includes several treatment techniques for CA that are regularly updated in French, European, and international guidelines [1–3]. Extracorporeal life support (ECLS) has been suggested as a therapeutic option in refractory CA since 1976 [4]. However, the use of this technique has remained limited to hypothermic CA and to CA occurring during the perioperative period of cardiothoracic surgery, mainly because the results of the initial trials were deceptive [5,6]. The ease of use of more recent miniaturized ECLS devices has DOI of original article: 10.1016/j.annfar.2008.12.011. Under the auspices of the French Direction générale de la santé, Direction des hôpitaux et de l’organisation des soins, and ministère de la Santé, de la Jeunesse, des Sports et de la Vie Associative.
permitted a wider use of the technique in cardiac surgery departments and intensive care units (ICU). Encouraging results have been published recently by several teams in France and Taiwan, in single centre retrospective and prospective cohorts. In these studies, most CA were from toxic or cardiac causes and occurred in the hospital [7–9]. In these highly selected cohorts, survival with good neurological outcome has been observed in up to 20 to 30% of cases [7–9]. Nevertheless, the preliminary results of the use of ECLS in out-of-hospital CA in France are very poor, with less than 1% survival being observed [10]. It should be emphasized that the time delay to commencing ECLS in out-ofhospital CA was far greater than that previously reported in inhospital CA. These contrasting results lead physicians who perform CPR to question the indications and contra-indications of ECLS in these conditions and the French health authorities to question the value of such costly techniques (real cost as well as use of important and highly specialized human resources). The authors shared the following concerns that require emphasis: that an uncontrolled development of ECLS in out-of-hospital CA may lead to its abandonment because of very poor favourable outcome; that ECLS may lead to the survival of patients with poor neurological recovery and the associated considerable suffering for the patient and its relatives (although further evolution to brain death has been observed in most of these surviving patients with poor neurological outcome) [7–9]; that nonhomogeneous criteria may be applied in France for the use of ECLS in case of refractory CA because of the lack of any published data on its indications and contra-indications.
§
0750-7658/$ see front matter ß 2009 Published by Elsevier Masson SAS. doi:10.1016/j.annfar.2008.12.026
Therefore, French medical scientific societies, under the auspices of the French Ministry of Health, selected a group of
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experts to propose guidelines that could help physicians performing CPR for refractory CA in deciding if ECLS should be used or not. The following text reflects a consensus obtained by these experts coming from different scientific and medical background at the present time. It should be noted that the views expressed are very likely to be modified in the near future because this topic is evolving rapidly. 2. OBJECTIVES To identify indications and contra-indications of ECLS in refractory CA occurring both in and out of the hospital. The Expert group was unanimous in stating that, at the present time, indications should be considered only as provisional since this rarely performed technique has not yet proven benefit and is not yet widely available. 3. DEFINITION AND IMPORTANT ELEMENTS LEADING TO A CHANGING PARADIGM Refractory CA is usually defined by the lack of return of spontaneous circulation (ROSC) within a period of at least 30 min of CPR under medical direction in the absence of preexisting hypothermia [1–3]. This definition is mainly used to authorize CPR teams to stop resuscitation in a situation without any hope of survival. The concept of lack of any hope of survival has been largely demonstrated in the literature but, in fact, is supported by the two following points: the absence of the likelihood of restoring cardiac activity following CA requiring more than 30 min of unsuccessful CPR; the poor chance of obtaining good neurological recovery in these conditions. However, the new possibility of using ECLS diminishes the importance of the first of these two points, at least initially. If ECLS is used, the issue of spontaneous cardiac activity should be considered only after starting the technique, since it is possible to observe spontaneous cardiac recovery (for example, following the elimination of a toxic drug or recovery of myocarditis). Further considerations are the use of further therapeutic options that can reverse cardiac failure (rewarming during deep hypothermia, coronary artery bypass and/or coronary angioplasty) or replacing the failing heat (artificial heart, cardiac transplantation). Thus, we are facing a change in paradigm, since refractory CA might be now defined only by considering the possibility of obtaining a good neurological recovery, which might become the key decisional factor. From a pathophysiological point of view, two points are essential for the decision whether or nor to continue CPR: the duration of CA without cardiac output (no-flow) before CPR; the duration of CA with low cardiac output (low-flow) during CPR. These two points contributes equally to the usual definition of refractory CA. Knowing the duration of no-flow presupposes that the CA was witnessed. A zero no-flow duration implies that RCP was immediately performed by witnesses and CA without
no-flow is probably the ideal target for ECLS. The no-flow duration is obviously of paramount importance since it is considered as the main variable that determines the neurological prognosis. Nevertheless, in some circumstances, this no flow duration may loss its importance. This is the case when hypothermia occurs before CA, protecting cerebral nervous system from ischemia. Good neurological recovery has been reported after very prolonged duration of no-flow in deeply hypothermic patients. In other cases, the determination of the no-flow duration may not be accurate, mainly when loss of circulation does not coincide with loss of consciousness. Therefore, when vital signs (spontaneous movements, lack of pupil dilation or persisting pupils reactivity or even the presence of inspiratory gasps although these probably suggest poor neurological outcome) are observed during CPR, the no-flow duration is questionable. Equally, certain cardiac dysrhythmias (ventricular tachycardia, ventricular fibrillation, torsades de pointes) should also lead the physician to question the value of no-flow duration. Although its importance is probably less, the low-flow duration should also be considered. In the report by Chen et al. [9], low-flow duration was highly linked to mortality rate, with less than 10% survival after more than 100 min of CPR, a value similar to that observed without ECLS. A prolonged low-flow duration is an independent risk of poor neurological outcome and participates to the multiple organ failure syndrome observed after CA. This issue should be taken into account for out-ofhospital CA since the duration of transportation from the scene to the ECLS centre is usually known by the emergency team, at least with a good approximation. In the case of poisoning with cardiac drugs, a prolonged CPR duration should not be considered as a contra-indication to ECLS because survivals with good neurological recovery have been reported [7]. Thus, in the case of cardiac drug intoxication, CPR should not be continued on scene for 30 min but the patient should be rapidly transported to an ECLS centre, according to existing recommendation of ECLS in these cases [11]. The rapid spread in the use of automatic cardiac massage device by prehospital emergency teams although their efficiency and safety have not been demonstrated [12] should not modify the maximum recommended delay to perform ECLS. Finally, monitoring endtidal CO2 (ETCO2) reflects cardiac output produced during CPR and an ETCO2 value of less than 10 mmHg (measured after 20 min of CPR under medical supervision) is known to be associated with a poor neurological outcome [13]. ECLS should not be used in patients with certain comorbidities. These are clinical situations that preclude administration of invasive treatment (for example, admission into ICU, major surgery, coronary angioplasty for example). Age should not be a limitation since it should not be considered a sufficient reason to limit admission to the ICU. It should be emphasized that the present guidelines provided by our Expert group (level 5 recommendations) [14] on the use of ECLS in refractory CA should not modify the scientific basis for normal CPR that should be followed for most refractory CA since these are based on considerable clinical evidence as well as regularly updated guidelines [1–3]. Modification of the
Information professionnelle / Annales Françaises d’Anesthésie et de Réanimation 28 (2009) 187–190
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Fig. 1. A suggested algorithm to decide whether extracorporeal life support (ECLS) could be used in treating refractory cardiac arrest (CA). CPR: cardiopulmonary resuscitation; VT: ventricular tachycardia; VF: ventricular fibrillation; TP: torsades de pointes; ETCO2: end-tidal CO2 (measured 20 min after the onset of medical CPR). *: CPR duration > 100 min could be accepted in case of poisoning with cardiac drugs. y: indications accepted by ILCOR [11]. Comorbidities are those which should contraindicate invasive care (admission into ICU, major surgery, coronary angioplasty for example). The low-flow duration encompasses basic CPR (witness and/or paramedics) and medical CPR.
definition of refractory CA that enables physicians to stop futile resuscitation when the duration of unsuccessful CPR is more than 30 min in the absence of ECLS is not required. In contrast, when ECLS can be used, it is not necessary to wait for 30 min to decide to perform ECLS. It should be noted that, particularly in out-of-hospital CA, the delay in starting ECLS will be usually greater than 30 min. However, it is not appropriate to consider ECLS when CPR has lasted less than 15 min. 4. PROPOSITION A simple algorithm that could be used in emergency condition is proposed by our Expert Group (Fig. 1). Because of the easy use of miniaturized ECLS devices, there is some temptation to consider that this technique could be applied more widely. However, care of a patient receiving ECLS requires strict cooperation between prehospital and hospital teams. Management of therapeutic measures needed to reverse cardiac dysfunction or replace cardiac function and management of their related complications requires highly trained multidisciplinary teams. Direct surgical access to femoral vessels is recommended and requires the skills of a trained surgeon. Management of ECLS
also requires a team trained in critical care. The preparation and maintenance of ECLS device is ideally performed by a bypass-pomp technician, although this can be performed by other trained personnel. The only pediatric specificities concerns children of less than 15 kg and the technical difficulties associated with ECLS implantation, which requires a surgeon, trained in pediatric surgery, and the need for both adequate ECLS and homologous blood for the onset of ECLS. In case of hypothermic CA, it is not really possible to estimate neurological injury during the no-flow and low-flow periods. However, even highly trained teams with ECLS in those circumstances (drowning, avalanches) have also limited their indications of ECLS to the cases with favourable prognosis criteria (for example, patients found buried in snow surrounded by an air cavity) or have used some biological variables, such as the serum potassium level to help in deciding whether or not to use ECLS. 5. PERSPECTIVES The use of this algorithm by physicians who care for patients with refractory CA should enable homogenization of
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ECLS clinical practice in France and should represent an appropriate response to the French citizens from medical as well as ethical points of view. In addition, development of ECLS should be associated with thinking about access to care and quality of care. It should be emphasized that the indications of ECLS should only be considered as provisional since this complex technique is not yet widely and consistently available in France, mainly because it requires highly trained and equipped team; thus, concerning only a few patients. Moreover, the present recommendations are based on clinical results of highly selected cohorts originating from single centre studies performed with highly trained and equipped teams caring mainly in-hospital refractory CA. There is a need to develop registries in the future to validate these recommendations and to define further the indications and contra-indications of ECLS in refractory CA. Furthermore, the use of ECLS is now developed for many other indications, such as critical care after CA resuscitation or recurring CA [15]. The Expert group has identified several gaps in current knowledge that should be the subject of future research: assessment of the accuracy of the measurement of the time delay during CPR since this timing is of paramount importance for survival and neurological outcome; assessment of the information provided by biomarkers in deciding whether to use or not ECLS (serum potassium level following hypothermic CA, lactates, pH, creatinine levels); assessment of cardiac output obtained during CPR; assessment of the efficacy and safety of automatic cardiac massage devices; emerging new technique for early neurological assessment. Lastly, it should be emphasized that the more efficient methods to increase survival in CA remain those that permit the reduction of the no-flow period (training in basic life support in the general population, automatic defibrillation). In France, a renewed major effort should be undertaken to provide basic CPR population training, particularly in schools and colleges. Acknowledgement We thank Dr David J. Baker, DM, FRCA for reviewing the manuscript.
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