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Protocols for uncontrolled donation after circulatory death
Comment
Protocols for uncontrolled donation after circulatory death Organ shortages have led some countries, including Spain, France, and the USA, to start programmes of uncontrolled donation after circulatory death.1 In these protocols, donors are people who have had unexpected out-ofhospital cardiac arrest. After ordinary life support attempts (30 min of advanced cardiopulmonary resuscitation [CPR]) by an emergency medical service are judged futile, patients are transported to the hospital with continuing mechanical chest compression and other interventions to preserve the organs, and declared dead at the hospital after a no-touch period of asystole (usually 5 min). Then, normothermic extracorporeal membrane oxygenation (ECMO) or in-situ cooling is started to preserve the organs until authorisation for donation is given by the family.1 Although uncontrolled donation after circulatory death protocols have good results in terms of graft survival, they also raise several ethical concerns.1 Criticism has mainly focused on whether use of invasive measures to preserve organs is acceptable before the patient’s wishes have been established or the family has given authorisation.2 However, a more important concern is that some donors might not have irreversibly lost either circulatory function or all brain function at the time of organ retrieval.1 This concern is reinforced by findings on the effect that non-conventional resuscitation procedures and organ preservation techniques can have on donors’ vital functions.3–7
Patient Uncontrolled donation after circulatory death protocol
Standard CPR for minimum of 30 min
Increasing evidence suggests that some people with cardiac arrest, for whom ordinary out-ofhospital resuscitation efforts have failed, can benefit from continuing CPR combined with other nonconventional resuscitation procedures (figure). These procedures are intended to treat the cause of cardiac arrest as soon as possible while preserving neurological function. Non-conventional resuscitation involves several techniques, including thrombolysis treatment during CPR,3,8 transfer to the intensive care unit with induced mild hypothermia,5,6 ECMO as a bridge to extracorporeal life support devices in the intensive care unit,4 percutaneous coronary intervention in a catheterisation laboratory,9 and, if needed, insertion of an intra-aortic balloon pump.6 Emergency and intensive care services in many countries, including Austria, Sweden, Japan, France, and the USA, have reported that various combinations of these techniques are associated with promising survival rates with good neurological outcomes (cerebral performance categories scale 1–2) after discharge from hospital.3,5,9,10 As a result of increasing evidence to support the effectiveness of such interventions in selected patients, international resuscitation guidelines have been modified and now recommend treatment of the known or suspected causes of refractory cardiac arrest before CPR is discontinued.11,12 Uncontrolled donation
Potential donor
Transfer to hospital with chest compression
No-touch period of asystole
Declaration of death according to circulatory criteria
Organ preservation techniques; balloon obturator
Authorisation given for organ donation
Discharge from hospital
Patient
Nonconventional resuscitation protocol
Optimum CPR guided by (suspected or known) cause of cardiac arrest
Transfer to hospital with continuing CPR and nonconventional resuscitation procedures
Organ retrieval
Nonconventional resuscitation procedures in hospital
Return of spontaneous circulation
Survival with good quality of life Potential donor Death according to circulatory or neurological criteria
Authorisation given for organ donation
Organ retrieval
Figure: Management options for patients with out-of-hospital cardiac arrest CPR=cardiopulmonary resuscitation.
www.thelancet.com Vol 379 April 7, 2012
1275
Comment
programmes that overlook this recommendation might be failing to offer the updated standard of treatment to certain patients with out-of-hospital cardiac arrest. Moreover, some interventions that are strictly intended to preserve the organs—eg, vasodilators, anticoagulants, and preservation fluids— can actually compromise the patient’s chances of survival.13 However, not all patients with out-ofhospital cardiac arrest are likely to benefit from nonconventional resuscitation procedures.10 Criteria should be developed to classify patients as either entitled to these innovative therapies or suitable for organ donation. Another concern is that ECMO, while intended to preserve the organs, can restore the donor’s brain function by reinstituting brain blood flow and, according to a panel of experts from the Health Resources and Services Administration, can “retroactively negate the cause of death” of patients already declared dead.14 To avoid this situation and ensure that the patient’s condition is irreversible, Wall and co-workers1 and Bernat and his colleagues14 recommend blocking the aorta with a balloon obturator to separate the brain from the organs being perfused.1,14 Although this procedure might prevent patients from regaining consciousness,14 it can also be seen as contributing to death.1 If uncontrolled donation after circulatory death programmes are to achieve their full potential for increasing organ supply, these ethical challenges need to be satisfactorily and transparently addressed. We suggest three options for management of patients with out-of-hospital cardiac arrest. First, uncontrolled donation after circulatory death should be considered only when available therapeutic options are unsuccessful or not clinically indicated, to avoid precluding some potentially recoverable patients from receiving optimum treatment. Second, only individuals with an irreversible loss of consciousness should be candidates for organ donation. Finally, families of patients who are potentially suitable for uncontrolled donation after circulatory death should be told that the patient has been transferred to the hospital with continuing chest compressions solely to maintain the viability of organs for transplantation. Existing uncontrolled donation after circulatory death protocols might compromise donors’ interests 1276
and potentially threaten the favourable public perception of organ donation. Strategies to increase the organ supply that come at the price of a substantial violation of ethical standards will not solve the problem of organ shortage. *David Rodríguez-Arias, Iván Ortega Deballon Institute of Philosophy, Centre for Human and Social Sciences, Spanish National Research Council CSIC, 28037 Madrid, Spain (DR-A); and Helicopter Emergency Medical Service, Madrid, Spain and Alcalá de Henares University Nursing School, Alcalá de Henares, Spain (IOD) [email protected] IOD is employed by the Comunidad de Madrid Helicopter and Ambulance Emergency Medical Service (SUMMA 112) and works as an emergency flying nurse practitioner. DRA declares that he has no conflicts of interest. We thank Carissa Véliz, William Harvey, Walter Glannon, Stuart Youngner, Maxwell Smith, Neil Lazar, and Scott A Singer for their suggestions. This work was financially supported by the Kontuz! project (FFI2011-24414). DRA received the Phyllis and Albert Sussman Accommodation Subsidy for a stay at The Hastings Center while he participated in the writing of this Comment. 1
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Wall SP, Kaufman BJ, Gilbert AJ, et al. Derivation of the uncontrolled donation after circulatory determination of death protocol for New York City. Am J Transplant 2011; 11: 1417–26. Childress JF. Organ donation after circulatory determination of death: lessons and unresolved controversies. J Law Med Ethics 2008; 36: 766–71. Lederer W, Lichtenberger C, Pechlaner C, Kinzl J, Kroesen G, Baubin M. Long-term survival and neurological outcome of patients who received recombinant tissue plasminogen activator during out-of-hospital cardiac arrest. Resuscitation 2004; 61: 123–29. Massetti M, Tasle M, Le Page O, et al. Back from irreversibility: extracorporeal life support for prolonged cardiac arrest. Ann Thorac Surg 2005; 79: 178–84. Nagao K, Kikushima K, Watanabe K, et al. Early induction of hypothermia during cardiac arrest improves neurological outcomes in patients with out-of-hospital cardiac arrest who undergo emergency cardiopulmonary bypass and percutaneous coronary intervention. Circ J 2010; 74: 77–85. Nielsen N, Sandhall L, Schersten F, Friberg H, Olsson SE. Successful resuscitation with mechanical CPR, therapeutic hypothermia and coronary intervention during manual CPR after out-of-hospital cardiac arrest. Resuscitation 2005; 65: 111–13. Thiagarajan RR, Brogan TV, Scheurer MA, Laussen PC, Rycus PT, Bratton SL. Extracorporeal membrane oxygenation to support cardiopulmonary resuscitation in adults. Ann Thorac Surg 2009; 87: 778–85. Böttiger BW, Bode C, Kern S, et al. Efficacy and safety of thrombolytic therapy after initially unsuccessful cardiopulmonary resuscitation: a prospective clinical trial. Lancet 2001; 357: 1583–85. Olivecrona G, Noc M. PCI during CA and ongoing chest compresions. Interv Cardiol 2011; 6: 12–16. Riou B, Adnet F, Baud F, et al. Recommandations sur les indications de l’assistance circulatoire dans le traitment des arrêts cardiaques réfractaires. Ann Fr Anesth Réanim 2009; 28: 182–86. Nolan JP, Soar J, Zideman DA, et al. European Resuscitation Council guidelines for resuscitation 2010 section 1. Executive summary. Resuscitation 2010; 81: 1219–76. Vanden Hoek TL, Morrison LJ, Shuster M, et al. Part 12: cardiac arrest in special situations: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2010; 122 (suppl 3): S829–61. Zeiler K, Furberg E, Tufveson G, Welin S. The ethics of non-heart-beating donation: how new technology can change the ethical landscape. J Med Ethics 2008; 34: 526–29. Bernat JL, Capron AM, Bleck TP, et al. The circulatory-respiratory determination of death in organ donation. Crit Care Med 2010; 38: 963–70.
www.thelancet.com Vol 379 April 7, 2012
Protocols for uncontrolled donation after circulatory death Organ shortages have led some countries, including Spain, France, and the USA, to start programmes of uncontrolled donation after circulatory death.1 In these protocols, donors are people who have had unexpected out-ofhospital cardiac arrest. After ordinary life support attempts (30 min of advanced cardiopulmonary resuscitation [CPR]) by an emergency medical service are judged futile, patients are transported to the hospital with continuing mechanical chest compression and other interventions to preserve the organs, and declared dead at the hospital after a no-touch period of asystole (usually 5 min). Then, normothermic extracorporeal membrane oxygenation (ECMO) or in-situ cooling is started to preserve the organs until authorisation for donation is given by the family.1 Although uncontrolled donation after circulatory death protocols have good results in terms of graft survival, they also raise several ethical concerns.1 Criticism has mainly focused on whether use of invasive measures to preserve organs is acceptable before the patient’s wishes have been established or the family has given authorisation.2 However, a more important concern is that some donors might not have irreversibly lost either circulatory function or all brain function at the time of organ retrieval.1 This concern is reinforced by findings on the effect that non-conventional resuscitation procedures and organ preservation techniques can have on donors’ vital functions.3–7
Patient Uncontrolled donation after circulatory death protocol
Standard CPR for minimum of 30 min
Increasing evidence suggests that some people with cardiac arrest, for whom ordinary out-ofhospital resuscitation efforts have failed, can benefit from continuing CPR combined with other nonconventional resuscitation procedures (figure). These procedures are intended to treat the cause of cardiac arrest as soon as possible while preserving neurological function. Non-conventional resuscitation involves several techniques, including thrombolysis treatment during CPR,3,8 transfer to the intensive care unit with induced mild hypothermia,5,6 ECMO as a bridge to extracorporeal life support devices in the intensive care unit,4 percutaneous coronary intervention in a catheterisation laboratory,9 and, if needed, insertion of an intra-aortic balloon pump.6 Emergency and intensive care services in many countries, including Austria, Sweden, Japan, France, and the USA, have reported that various combinations of these techniques are associated with promising survival rates with good neurological outcomes (cerebral performance categories scale 1–2) after discharge from hospital.3,5,9,10 As a result of increasing evidence to support the effectiveness of such interventions in selected patients, international resuscitation guidelines have been modified and now recommend treatment of the known or suspected causes of refractory cardiac arrest before CPR is discontinued.11,12 Uncontrolled donation
Potential donor
Transfer to hospital with chest compression
No-touch period of asystole
Declaration of death according to circulatory criteria
Organ preservation techniques; balloon obturator
Authorisation given for organ donation
Discharge from hospital
Patient
Nonconventional resuscitation protocol
Optimum CPR guided by (suspected or known) cause of cardiac arrest
Transfer to hospital with continuing CPR and nonconventional resuscitation procedures
Organ retrieval
Nonconventional resuscitation procedures in hospital
Return of spontaneous circulation
Survival with good quality of life Potential donor Death according to circulatory or neurological criteria
Authorisation given for organ donation
Organ retrieval
Figure: Management options for patients with out-of-hospital cardiac arrest CPR=cardiopulmonary resuscitation.
www.thelancet.com Vol 379 April 7, 2012
1275
Comment
programmes that overlook this recommendation might be failing to offer the updated standard of treatment to certain patients with out-of-hospital cardiac arrest. Moreover, some interventions that are strictly intended to preserve the organs—eg, vasodilators, anticoagulants, and preservation fluids— can actually compromise the patient’s chances of survival.13 However, not all patients with out-ofhospital cardiac arrest are likely to benefit from nonconventional resuscitation procedures.10 Criteria should be developed to classify patients as either entitled to these innovative therapies or suitable for organ donation. Another concern is that ECMO, while intended to preserve the organs, can restore the donor’s brain function by reinstituting brain blood flow and, according to a panel of experts from the Health Resources and Services Administration, can “retroactively negate the cause of death” of patients already declared dead.14 To avoid this situation and ensure that the patient’s condition is irreversible, Wall and co-workers1 and Bernat and his colleagues14 recommend blocking the aorta with a balloon obturator to separate the brain from the organs being perfused.1,14 Although this procedure might prevent patients from regaining consciousness,14 it can also be seen as contributing to death.1 If uncontrolled donation after circulatory death programmes are to achieve their full potential for increasing organ supply, these ethical challenges need to be satisfactorily and transparently addressed. We suggest three options for management of patients with out-of-hospital cardiac arrest. First, uncontrolled donation after circulatory death should be considered only when available therapeutic options are unsuccessful or not clinically indicated, to avoid precluding some potentially recoverable patients from receiving optimum treatment. Second, only individuals with an irreversible loss of consciousness should be candidates for organ donation. Finally, families of patients who are potentially suitable for uncontrolled donation after circulatory death should be told that the patient has been transferred to the hospital with continuing chest compressions solely to maintain the viability of organs for transplantation. Existing uncontrolled donation after circulatory death protocols might compromise donors’ interests 1276
and potentially threaten the favourable public perception of organ donation. Strategies to increase the organ supply that come at the price of a substantial violation of ethical standards will not solve the problem of organ shortage. *David Rodríguez-Arias, Iván Ortega Deballon Institute of Philosophy, Centre for Human and Social Sciences, Spanish National Research Council CSIC, 28037 Madrid, Spain (DR-A); and Helicopter Emergency Medical Service, Madrid, Spain and Alcalá de Henares University Nursing School, Alcalá de Henares, Spain (IOD) [email protected] IOD is employed by the Comunidad de Madrid Helicopter and Ambulance Emergency Medical Service (SUMMA 112) and works as an emergency flying nurse practitioner. DRA declares that he has no conflicts of interest. We thank Carissa Véliz, William Harvey, Walter Glannon, Stuart Youngner, Maxwell Smith, Neil Lazar, and Scott A Singer for their suggestions. This work was financially supported by the Kontuz! project (FFI2011-24414). DRA received the Phyllis and Albert Sussman Accommodation Subsidy for a stay at The Hastings Center while he participated in the writing of this Comment. 1
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Wall SP, Kaufman BJ, Gilbert AJ, et al. Derivation of the uncontrolled donation after circulatory determination of death protocol for New York City. Am J Transplant 2011; 11: 1417–26. Childress JF. Organ donation after circulatory determination of death: lessons and unresolved controversies. J Law Med Ethics 2008; 36: 766–71. Lederer W, Lichtenberger C, Pechlaner C, Kinzl J, Kroesen G, Baubin M. Long-term survival and neurological outcome of patients who received recombinant tissue plasminogen activator during out-of-hospital cardiac arrest. Resuscitation 2004; 61: 123–29. Massetti M, Tasle M, Le Page O, et al. Back from irreversibility: extracorporeal life support for prolonged cardiac arrest. Ann Thorac Surg 2005; 79: 178–84. Nagao K, Kikushima K, Watanabe K, et al. Early induction of hypothermia during cardiac arrest improves neurological outcomes in patients with out-of-hospital cardiac arrest who undergo emergency cardiopulmonary bypass and percutaneous coronary intervention. Circ J 2010; 74: 77–85. Nielsen N, Sandhall L, Schersten F, Friberg H, Olsson SE. Successful resuscitation with mechanical CPR, therapeutic hypothermia and coronary intervention during manual CPR after out-of-hospital cardiac arrest. Resuscitation 2005; 65: 111–13. Thiagarajan RR, Brogan TV, Scheurer MA, Laussen PC, Rycus PT, Bratton SL. Extracorporeal membrane oxygenation to support cardiopulmonary resuscitation in adults. Ann Thorac Surg 2009; 87: 778–85. Böttiger BW, Bode C, Kern S, et al. Efficacy and safety of thrombolytic therapy after initially unsuccessful cardiopulmonary resuscitation: a prospective clinical trial. Lancet 2001; 357: 1583–85. Olivecrona G, Noc M. PCI during CA and ongoing chest compresions. Interv Cardiol 2011; 6: 12–16. Riou B, Adnet F, Baud F, et al. Recommandations sur les indications de l’assistance circulatoire dans le traitment des arrêts cardiaques réfractaires. Ann Fr Anesth Réanim 2009; 28: 182–86. Nolan JP, Soar J, Zideman DA, et al. European Resuscitation Council guidelines for resuscitation 2010 section 1. Executive summary. Resuscitation 2010; 81: 1219–76. Vanden Hoek TL, Morrison LJ, Shuster M, et al. Part 12: cardiac arrest in special situations: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2010; 122 (suppl 3): S829–61. Zeiler K, Furberg E, Tufveson G, Welin S. The ethics of non-heart-beating donation: how new technology can change the ethical landscape. J Med Ethics 2008; 34: 526–29. Bernat JL, Capron AM, Bleck TP, et al. The circulatory-respiratory determination of death in organ donation. Crit Care Med 2010; 38: 963–70.
www.thelancet.com Vol 379 April 7, 2012