Organ donation has reached extraordinary levels in Spain, with sustained rates of 32–36 donors per million inhabitants in recent years.1 These results are the consequence of a highly effective system capable of identifying donation opportunities and of transforming possible donors into effective donors. The system is centered on the transplant coordinator (TC) and on close cooperation between the TC and the professionals in the Intensive Care Unit (ICU).2

However, the need to continue progressing with the aim of achieving self-sufficiency in transplantation3,4 is confronted by a gradual decrease in the incidence of brain death (BD) in this country.5 On the other hand, we are witnessing substantial changes in end-of-life care, including the consideration of limitation or withdrawal of life-sustaining treatment (WLST) once a situation of therapeutic futility has been reached.6

The development of new strategies capable of increasing organ availability requires very precise knowledge of the donation process. Such knowledge must also refer to the initial phases, including clinical decision making by the professionals attending patients with devastating brain injury in the end-of-life stage, since such decisions serve to either maintain or discard the donation options. This information is essential in order to identify possibilities for improvement from a dual perspective: that of the transplant coordination system, which must adapt its activity to the new circumstances; and that of the critical care professionals, who must integrate donation options with end-of-life care in variable clinical scenarios.3

ACCORD-España,7 an extension of the ACCORD joint initiative,8 is a project led by the Spanish National Organization of Transplants (NOT) with the support of the Transplants Commission of the Inter-territorial Health Council. The project aims to determine the relevant end-of-life clinical practices referred to organ donation in patients with devastating brain injury in Spain, and to offer hospitals tools for change. The present article focuses on the description of these practices and on the opportunities for improvement in the donation process identified at national level.

A prospective multicenter study of a retrospective cohort was carried out.

The hospitals authorized for organ harvesting in Spain through their corresponding Autonomous and Hospital Coordination of Transplant Systems were invited to participate in the study. The hospitals that were interested reported their participation to the National Organization of Transplants and assigned a professional belonging to Hospital Coordination of Transplants as the person in charge of the study. Specific approval was obtained from the management board of each center, with a positive opinion from the Clinical Research Ethics Committee or Reference Committee.

A total of 68 of the 189 hospitals authorized for organ harvesting (36%) participated in the study. These centers contributed 66% of the effective donors in Spain during the year 2013. Of the participating hospitals (all public centers), 38 (56%) had a Department of Neurosurgery, and 25 (37%) performed some type of organ transplantation. This hospital distribution is similar to that recorded for the global hospitals authorized for organ harvesting in Spain.

Demographic and clinical data of the possible donors

During the study period, we identified 1970 possible donors that met the specified inclusion criteria. Their characteristics are shown in Table 1. In relation to the cause of death, intracranial hemorrhage (I61), stroke (I63), postanoxic encephalopathy (G931) and diffuse brain injury (S062) accounted for the death of 70% of the possible donors.

Table 1.

Demographic and clinical characteristics of the possible donors.

n=1970	n	%
Age
<18 years	28	1.4
18–59 years	472	23.9
60–69 years	371	18.8
70–79 years	618	31.4
≥80 years	481	24.4
Sex
Male	1112	56.4
Main cause of death (ICD-10)
Stroke	1257	63.8
Trauma	290	14.7
Other brain damage	299	15.2
Central nervous system infection	42	2.1
Brain tumor	78	4.0
Other	4	0.2
Time of devastating brain injury
Before hospital admission	1634	83.0
During hospital stay	336	17.0
Time from devastating brain injury to death
0 days	326	16.5
1 day	460	23.4
2 days	268	13.6
3 days	181	9.2
4 to 9 days	496	25.1
≥10 days	241	12.2
Absolute or relative medical contraindications to donation	640	32.5

Although devastating brain injury was the reason for admission to hospital in most cases, 17% of the patients developed devastating brain injury during admission to hospital. The time elapsed from brain damage to death was ≤3 days in 63% of the patients. In one-third of the cases, it was considered that there were absolute or relative medical contraindications to donation—the most frequent being current or past antecedents of malignant disease (49%), vascular disease and multi-disease processes (21%) and sepsis or active infectious diseases (11%).

Fig. 1 shows the Units in which the possible donors died. A total of 41% were seen to have died outside an ICU—fundamentally in a hospital ward.

Figure 1.

Units where death of the possible donors took place. ICU: Intensive Care Unit. *Resuscitation unit and coronary unit.

(0.13MB).

Scenario best describing end-of-life care

The distribution of possible donors according to the scenario is detailed below:

• •

  A (active treatment in ICU until BD): 539 (27%)

• •

  B (active treatment in ICU until unexpected CA): 92 (5%)

• •

  C (admission to ICU for donation): 200 (10%)

• •

  D (active treatment in ICU until WLST decision): 370 (19%)

• •

  E (no admission to ICU): 769 (39%)

The characteristics of the possible donors varied according to the scenario involved. Fig. 2 shows these variations for age and time from brain damage to death.

Figure 2.

Age (mean) and distribution (n and percentage) of days from devastating brain injury to death; overall and according to scenario. BD: brain death; WLST: withdrawal of life-sustaining treatment; CA: cardiac arrest; ICU: Intensive Care Unit.

(0.24MB).

Dead brain donation process

Fig. 3 shows the distribution of the patients that evolved to BD. Of the 695 patients that reached this clinical situation, 569 (29% of the possible donors and 82% of the patients in BD) had no medical contraindications to organ donation, and thus represented the potential sample for dead brain donation.

Figure 3.

Graphic representation of the transition from possible donors to potential and effective donors, under conditions of brain death and controlled asystole. Possible donor: death secondary to devastating brain injury. Potential brain dead donor: death in clinical situation consistent with BD and without absolute or relative medical contraindications to organ donation. Potential non-heart beating donor: death following WLST, without absolute or relative medical contraindications to organ donation, and aged under 70 years. Effective donor: death with surgical incision made for organ harvesting for transplantation. Scenario B: includes possible donors actively treated in an Intensive Care Unit until unexpected cardiac arrest occurs from which the patient cannot be recovered. WLST: withdrawal of life-sustaining treatment; BD: brain death.

(0.14MB).

The reasons why dead brain patients did not progress to effective donation were medical contraindication (41%) followed by family refusal (36%), the impossibility of confirming the diagnosis of BD (9%), CA or hemodynamic instability (6%) and other reasons (8%).

A total of 446 possible donors resulted in effective donation under conditions of BD (23% of the total possible donors and 64% of the cases in BD).

To our knowledge, this is the first study to offer a detailed evaluation of the decision-making process in end-of-life care from the organ donation perspective in Spain.

In concordance with the profile of the effective brain dead donors in this country, a high percentage of possible donors are very elderly (≥80 years). This reflects the increasingly imperative need to use organs from elderly donors—a practice that has already been implanted in Spain, with adequate post-transplantation outcomes.11–14

The study shows that the donation process in cases of BD is optimized in this country from the moment in which the patient suffers BD, and thus in the different phases of the process that take place in an ICU. These Units are the great strength of our system.2,15

Despite the above, the study has identified opportunities for improvement that are evidenced in the description of the end-of-life care scenarios: 40% of the possible donors never enter the ICU (scenario E)—often without admission for possible organ donation having been considered. On the other hand, almost 20% of the possible donors die following WLST (scenario D). Only recently has donation under these circumstances of death become possible in our country.

The possibilities for donation among patients who currently die outside an ICU require some consideration referred to the notification of possible donors to the TC, admission to intensive care for donation and VENT, derived from this study.

Routine and early notification (before death occurs) of possible donors to the TC is considered good practice at international level.16–18 However, 36% of the possible donors in Spain are not notified to the TC at any time during their evolution—mainly because the professionals in charge do not identify the patient as a possible donor, or because they consider that there are contraindications—without having discussed them with the TC. In Spain, it is recommended that the professionals attending neurocritical patients should systematically consider the option of donation when brain damage is devastating and any ulterior treatment is regarded as futile.19 This consideration requires a training effort targeted particularly to the professionals of Units outside the intensive care setting, since these are professionals who, according to the results of our study, generated fewer notifications to the TC. On the other hand, we also observed that the existence of written notification criteria increased the probability of notification by 46%. In establishing these criteria, it is essential to emphasize the need to discuss apparent contraindications with the TC, since the absolute contraindications to organ donation are currently very limited. In fact, external audits of Spanish hospitals have found that the existence of contraindications was established inadequately in over 10% of the potential donors not notified due to medical reasons.5

If the notification of possible donors were to be systematically implemented from Units outside the intensive care setting, it would be necessary to consider a policy of admission to the ICU for donation and VENT. Our study shows that this strategy could very significantly increase the opportunities for donation. Non-therapeutic elective ventilation (VENT) is warranted by our ethical-legal and deontological guidelines.20 At international level, it is also increasingly accepted that health professionals must work in the best interest of the patient—such interest being understood not only from the clinical perspective but also as a holistic concept including the beliefs and moral values of the person.21–23 If the patient wished to serve as a donor, raising the option of donation and facilitating it should be viewed as an ethical imperative and a standard of professional practice. In this context, and without breaching the principle of nonmaleficence, the current international literature is mostly favorable to VENT,24–29 and several countries now describe this practice.8

Our experience shows that admission to intensive care for donation and VENT has become a reality in Spain30,31 and makes a key contribution to donation activity—making it possible to underscore the challenges that face this practice:

• •

  Although the time to death is under three days in most of the possible donors admitted to the ICU for donation (scenarioC), one out of every four patients does not evolve toward BD. It is therefore crucial to ensure strict selection of those cases with a high probability of evolution to BD and to introduce WLST protocols—this being a factor independently correlated to the intubation/ventilation of possible donors. In some cases, and following patient admission to the ICU, contraindications to donation are established that were not previously detected. It is important to inform the family about this possibility.

• •

  Communication with the family to consider admission to the ICU for donation and VENT is complex, with a lesser probability of obtaining consent than when the interview is made with the patient already admitted to intensive care. The participation of the TC in these interviews is therefore particularly important, and has been identified as an independent predictor of increased probability of consent.

• •

  Lastly, and despite the policy of maximum transparency, it is not always possible to conduct an interview prior to admission because of the emotional situation of the family, the absence of relatives with decision making capacity or the clinical severity of the patient at risk of immediate respiratory arrest.

In consideration of all the above, admission to the ICU for donation and VENT requires institutional support, training of the professionals attending neurocritical patients and of the TCs, as well as protocols for intervention and for informing the families.

Lastly, our study corroborates the existence of sup-optimized CNHBD in Spain32: in effect, CNHBD is not considered in 79% of the patients that die following WLST (most with terminal extubation), mainly due to the lack of the required program in the hospital involved. Although CNHBD has increased exponentially in recent years,33 the introduction of new programs seems to be necessary. It is also essential for this type of donation not to have a negative impact upon dead brain donation—an issue that remains a source of concern at international level.34,35 The fact that in our series the time elapsed from brain damage to death was longer in the WLST setting (scenario D) than in other scenarios probably reflects the current practice of waiting some time due to the possibility of evolution toward BD before suspending life support measures that have already become futile. On the other hand, as experience is progressively gained with CNHBD in Spain, it will become necessary to reconsider the maximum age of the potential donors—currently defined in most centers as 65–70years.36

The present study has several limitations. Those in charge of data collection belonged to Hospital Coordination of Transplants, and in many aspects conducted a review of their own activities—a fact that may have exerted some influence upon data recruitment. On the other hand, we did not collect information on non-deceased patients with devastating brain injury—a fact that limits some aspects of understanding of the donation process. Lastly, although data collection was conducted on a prospective basis, it was inevitably fundamented upon a retrospective cohort, which required interpretation by the study supervisor of the information contained in the case history—though due contrasting and completion was attempted with the team in charge of the patient.

In conclusion, dead brain donation has been optimized in our system once the patients have evolved to BD. Admission to the ICU for donation and VENT is an established practice contributing 24% of all the effective donations. The opportunities for improvement are represented by the introduction of a systematic policy of possible donor notification to the TC, together with an expanded practice of admission to the ICU in order to facilitate organ donation. Lastly, CNHBD is confirmed to be a great opportunity for ensuring that donation forms an integral part of end-of-life care, independently of the circumstances of death of our patients.

BDG, EC, TP, ML, EM and RM conceived of and designed the study, and participated in the interpretation of the data. BDG and EC performed the data analysis. All the authors participated in the preparation of the article, its critical review and in definitive approval of the manuscript version submitted for publication. The authors of the hospital centers represented in the study participated in the identification of possible donors and facilitated acquisition of the data required for the study.

The authors declare that they have no conflicts of interest.