Organ transplantation is one of the greatest achievements of modern medicine, which full expansion is limited by the shortage of organs to cope with the transplantation needs of patients.1 The decrease in the incidence of events that lead to devastating brain injury (DBI) and improvements in neurocritical care are determining a decline in mortality relevant to organ donation2 and in the incidence of brain death (BD)3 in developed countries. It is hence imperative to look for alternative ways of increasing organ availability.
Several critical care societies support the concept that donation should be an integral component of end-of-life care.4-8 This concept is embedded in the progressively more accepted principle that decision making at the end-of-life should be based, not only on clinical criteria, but also on moral, societal, and welfare considerations.9 Therefore, offering the option of organ donation can be seen as a duty of professionals responsible for the care of patients who could be possible organ donors from the perspective of patients they care for.
The Spanish Society of Intensive Care Medicine and Coronary Units and the Spanish National Transplant Organization have recently released national recommendations on Intensive Care to facilitate Organ Donation (ICOD). ICOD is defined as the initiation or continuation of intensive care measures in patients with a DBI in whom medical or surgical treatment for curative purposes is deemed futile, and who are considered possible organ donors, with the aim of incorporating the option of donation after brain death (DBD) into their end-of-life care plans.
In Spain, ICOD is supported by the legal and ethical framework and professional codes of practice.6-8,10-14 ICOD, in the form of continuing intensive care beyond futility to enable organ donation, is also a reality in other countries.15-17 On the contrary, elective nontherapeutic ventilation (ENTV) is a rare practice. Most publications available on ICOD have exclusively focused on its ethical, legal, and philosophical aspects.18-31 Only a Spanish study has recently provided a broad overview of the implementation of ICOD, also describing its associated challenges.32 However, a major limitation of this study was that it only focused on patients who had actually died as a result of a DBI and in whom the option of ICOD had been discussed with their families. It hence failed to focus on all patients in whom ICOD had been considered, regardless of their final outcome—death, undesirable neurological states, or clinical improvement. The possibility that patients are subject to ICOD and later they experience unexpected outcomes is possibly one of the most important concerns about this practice. A second limitation of the said study was that it had not been designed to identify best practices in ICOD.
In 2006, the donor coordination unit at the Hospital San Pedro (La Rioja) conceived a dedicated protocol on ICOD, which was subsequently adopted by the Hospital Universitario Virgen de las Nieves (Granada) in 2011. The aim of this manuscript is to describe the experience with ICOD at these two hospitals under a common protocol, with a focus on all patients in whom this option has been posed, regardless of their final outcome, and to evaluate the impact of ICOD on organ donation and transplantation activities.
PATIENTS AND METHODS
Terms relevant to this article are summarized in Table 1.
Hospital San Pedro serves a population of 315 000 inhabitants and counts on 503 beds, including 17 intensive care unit (ICU) beds. It has a neurology, but not a neurosurgery service. Hospital Universitario Virgen de las Nieves serves 915 000 inhabitants and counts on 944 beds. The ICU has 48 beds, including 12 for neurocritical patients. The hospital has neurosurgery and neurology services. Both hospitals have donor coordination teams composed of ICU physicians and nurses.
Protocol for ICOD
a) Systematic referral of patients with a DBI to the donor coordinator
Patients with a DBI (Glasgow Coma Scale [GCS] <9, in the absence of sedation and other confounding factors) are referred to the donor coordinator (DC) once the treating team has decided that further medical or surgical treatment with a curative purpose will not be attempted based on futility. The DC does not participate of this decision, which is made by an independent multidisciplinary team. Referral occurs whether the patient is being treated at the ICU, the emergency room, or a hospital ward, and whether the patient is invasively ventilated or not.
b) Strict selection criteria of patients with a DBI as possible donors
The DC only considers the possibility of ICOD if:
- ▪BD is a likely outcome within a short period. The likelihood of BD is evaluated based on clinical criteria (GCS and brain stem reflexes assessed under the appropriate clinical conditions) and signs of intracranial hypertension and herniation in the CT scan.
- ▪There are no apparent medical contraindications to donation, based on information available on the clinical chart and obtained from the relatives.
c) Assessment of the patient’s wishes about organ donation
The DC checks the Advanced Directives Registry.11-14 The protocol does not proceed if the patient has registered his opposition to posthumous donation. If the patient has registered their will to donate, this information is shared with their family. If no registration exists, information is gathered from the family on whether organ donation was consistent with the patient’s wishes and values.
d) Informed consent for ICOD
The interview to discuss organ donation and ICOD (early interview) is framed under a continuous information process. First, the treating team informs the family of the patient’s ominous prognosis and the decision that further therapeutic measures will not be attempted and care will shift to palliative and end-of-life care. The early interview, which is always led by the DC, is only initiated after verifying that the relatives have understood and accepted the situation and have the capacity to make decisions. The moment to initiate this early interview and the pace in the provision of information is always determined by the emotional status of the family. The so-called anticipated grief is managed through an aid relationship, where respect, empathy, and authenticity are the pillars of communication.
If unknown, the DC explores the wishes of the patient during the interview. If the patient and the family are favorable toward donation, the DC explains: (i) the measures required to ensure the preservation of organs until BD, stressing that there is no therapeutic aim and that the comfort of the patient will be paramount; (ii) that BD usually occurs within 24 to 72 hours,32,33 but it may take longer or even not occur; (iii) that the patient may finally not be a suitable organ donor.
The DC agrees with the family on a maximum observation period and the plan, should BD not occur or relatives wish to revoke consent.
e) Specific management of possible organ donors within the ICU
The comfort of the patient during the dying process is paramount—analgesia is provided with sedatives when required. Measures to ensure the preservation of potentially transplantable organs are initiated/continued, inclusive of admission to the ICU, respiratory, and hemodynamic support. Other futile interventions are avoided. The DC must complete the evaluation of donor/organ suitability. Once BD occurs, consent for organ recovery is obtained. If the patient does not evolve to BD within the time agreed with the relatives or if the family revokes consent, measures are reoriented to only ensure the comfort of the patient and to end-of-life care.
Study Design and Data Analysis
This is a retrospective observational study. The investigators reviewed the clinical chart of patients with a DBI in whom further treatment was deemed futile, who were selected as possible organ donors by the DC, and in whom an interview with the family was held to discuss the option of ICOD during the period extending from January 1, 2011, to December 31, 2015.
Demographic and clinical data of the patient population are described. To represent the severity of the brain injury, the GCS, the intracerebral hemorrhage score,34 the Ischemic Stroke Predictive Risk Score, and the World Federation of Neurological Surgeons scale35 have been used. The circumstances of the family approach, the frequency of consent to ICOD, the clinical outcome of patients subject to ICOD, and the deceased donation pathway are described.
Qualitative variables are represented by absolute numbers and percentages. Quantitative variables are presented as mean and standard deviation. The analysis has been performed with the statistical package, SPSS 25.0.
The study was approved by the institutional review board of both centers.
The option of ICOD was discussed with the families of 131 patients with a DBI in whom further treatment had been deemed futile by the treating team, BD was a likely outcome, and had no apparent medical contraindications to organ donation.
The demographics and clinical characteristics of patients are shown in Table 2.
The interview with the relatives was most frequently held in the emergency room (87; 66%), followed by the neurology ward (24; 18%), the ICU (17; 13%), the neurosurgery ward (2; 2%), and the anesthesia unit (1; 1%). The conversation took place when the decision had been made not to intubate/ventilate the patient with a therapeutic purpose in 66 (50%) patients and when the decision had been made not to continue with the already initiated invasive ventilation in the remaining 65. The time between hospital admission and the interview was less than 24 hours in 107 (82%) cases.
The donation pathway is summarized in Figure 1.
Consent for ICOD was obtained in 125 (95%) cases. The 6 patients without consent for ICOD were all not intubated/ventilated at the time of the early interview.
ICOD was initiated in all 125 consented cases, inclusive of 60 patients who were subject to ENTV.
All patients with consent for ICOD died: 101 (81%) evolved to BD, 18 (14%) died after the decision to withdraw life-sustaining treatment (WLST) and 6 (5%) after an unexpected cardiac arrest. The reason for the WLST was medical unsuitability to organ donation identified after ICOD had been initiated in 4 cases and exceeded time of observation agreed with the family and/or family decision in the remaining 14 patients. Donation after circulatory death was not considered in any of these patients, although only 1 was younger than 70 years.
Ninety-nine (98%) patients transitioned to actual DBD. The reason why 2 brain-dead patients were not converted into actual organ donors were medical contraindications to organ donation.
Seventy-nine (80%) actual donors were converted into utilized DBD donors, with 49 kidneys, 62 livers, 5 lungs, 2 hearts, and 1 pancreas transplanted. This represented 1.2 organs transplanted per actual donor, and 1.5 organs transplanted per utilized donor.
ICOD contributed to 33% of actual donation activity in both hospitals during the study period, with variations between the 2 hospitals (Figure 2).
All patients with an early interview for ICOD died. Time until death for patients for whom consent was obtained for ICOD is represented in Table 3.
The Royal Devon and Exeter Hospital was the first to publish the concept of ENTV to refer to the ventilation of patients with a DBI at risk of imminent death with the purpose of enabling evolution to BD and organ donation.36 In Spain, the term ICOD is preferred to stress that care for the dying patient remains paramount and to clarify that measures, other than ENTV, are required to enable organ donation in this context.32
ENTV was heavily criticized during the 1990s and abandoned in the United Kingdom under the doubt of its legality.37 The debate has been served since then, but with a conversion into a progressively more favorable attitude toward the practice.18,23-31 Scholars have debated about the risk of harming possible donors and their families for the benefit of others.19,20 On the other hand, the emerging concept that donation should be an integral component of end-of-life care4,5,7,8 makes not considering organ donation in a dying patient an approach not respectful with the fundamental principle of autonomy. Decision making at the end-of-life should take account of the wishes and beliefs of the individual.
In Spain, ICOD is properly grounded on the legal, deontological, and ethical framework, because it respects the patient’s dignity and allows professionals to comply with their duties toward patients and their families.6-8,10-14 Although the practice of continuing intensive care to enable the determination of death by neurological criteria and DBD is routine practice in some countries,15-17 this is not the case in many others, particularly when the decision to withdraw care is made outside of the ICU.15,38 Moreover, ENTV still raises debates in the international fora.
In this context, we aimed at sharing our experience with ICOD by describing the practice as a stepwise process in a manner that allows to understand the reality of its associated challenges: predicting the likelihood of BD, assessing donor/organ suitability with limited information available, informing relatives, and using scarce ICU resources for the care of a dying patient.32 To our knowledge, this is the first report on ICOD that focuses on all patients whose families were approached to pose this option and with a commonly applied protocol. Key elements of this protocol are detailed below.
Strict Criteria for the Selection of Patients With a DBI as Possible Organ Donors
ICOD is only considered if prognosis is deemed ominous and the decision has been made not to treat by a multidisciplinary team independent from the DC. The severity of the brain injury was extreme in our study, as made evident by the prognostic scores at the moment of the early interview. Although ischemic stroke is more frequent than hemorrhagic stroke in our setting, the assessment of prognosis is more accurate in the latest. This likely justifies that the majority of patients included in our protocol had been diagnosed with a hemorrhagic stroke. The assessment of prognosis was quite precise in our experience: all patients subject to ICOD died during their ICU stay and 81% evolved to BD within a short time, as predicted. Other studies support that evolution to BD in patients with a DBI occurs shortly.22,32,39 Importantly, no case was reported of improvement, and no patient evolved to an unfavorable neurological state.
Only patients with no apparent medical contraindications to donate were included in the protocol. The assessment of medical suitability of these patients as possible organ donors is complex given their advanced age—as a mean, 75 years in our series. The selection performed was appropriate, because only rarely were medical contraindications identified after having initiated ICOD.
Comprehensive and Transparent Information to the Family
The early interview should pursue that decisions by the family are made after receiving complete information. It should focus in understanding whether organ donation was consistent with the patient’s wishes and values. Information must also include prognostic and other uncertainties—that BD may take longer than 24 to 72 hours or may not occur, and that medical contraindications may arise later in the process. It is critical to agree on an observation period and inform of the way to proceed if BD does not occur. The family must be informed of the measures required to enable organ donation. According to the Spanish legislation, the family must grant authorization for specific interventions if patients lack capacity.12,13 Hence, specific authorization is required for ICOD. Family care during the entire process is paramount.
Despite the difficulty of the early interview, authorization for ICOD was extraordinarily high in our experience (95%), especially considering the high percentage of nonintubated patients (50%), and that 87% of the interviews took place outside of the ICU shortly after hospital admission. This consent rate is higher than that described in Spain for conventional donation interviews, once the patient has developed a BD condition (80%–85%).39 We are convinced that the training and experience of professionals involved in this difficult type of interview have been critical to this impressive result.
Specific Management of the Possible Donor Within the ICU
The key aspect during the admission of possible donors in the ICU is ensuring the comfort of the patient. Only those interventions required for the preservation of transplantable organs should be undertaken, disregarding any other futile measures.
The use of ICU resources for patients who would not be admitted in the ICU under other circumstances is a major concern when considering the implementation of an ICOD protocol. The proper selection of cases is fundamental. The resulting short ICU stay in our series seems appropriate given the benefits of transplantation and the cost-effectiveness of kidney transplants. A recent Australian study estimated that admitting patients in the ICU for palliative care and organ donation confers the community with 7.3 quality adjusted life year per ICU bed day.40
In our series, 79% of patients subject to ICOD transitioned to actual donation. During the study period, 33% of actual donors at both hospitals derived from ICOD, making them reach levels of donation per million population over 50 to 60, compared with national values below 40 for those years. Differences in the contribution of ICOD to actual donation at both hospitals likely relate to the type of center (only one a reference neurosurgical center) and the specific clinical pathway applied to the treatment of neurocritical patients.
Organs recovered were not always suitable for transplantation, which must be interpreted based on the very advanced age of possible donors in our series. Candidates to ICOD were in their 70s/80s. In Spain, the recovery of these organs is routine practice with the assumption that organ utilization is not as good as for young donors.41 However, and in total, the practice derived on 1.2 organs transplanted per actual donor and 1.5 per utilized donor. In implementing ICOD, it is essential that transplant centers are actively using organs from this advanced age donor groups.
Results of this ICOD protocol are encouraging; the prediction of BD was accurate, the practice was well accepted by families, the ICU stay was short, and the impact on donation rates high. This experience invites to revisit ICOD where this is not a reality yet. This will require overcoming the barriers generated by outdated legislations, uncertainties in the selection of possible donors, the limited capacity of our ICUs, the complexity in the communication with the family, and the difficulty to accept donation as an option that respects the autonomy of patients.
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