BJA Advance Access published online on May 1, 2008
British Journal of Anaesthesia, doi:10.1093/bja/aen106
Experiences in the development of non-heart beating organ donation scheme in a regional neurosciences intensive care unit
The Intensive Care Unit, Frenchay Hospital, Frenchay Park Road, Bristol BS16 1LE, UK
* Corresponding author. E-mail: alex.manara{at}nbt.nhs.uk
Accepted for publication February 21, 2008.
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Abstract |
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 Top Abstract IntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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Background: In the UK demand for organ transplantation continues to outstrip supply and one strategy aimed at reversing this trend is the introduction of non-heart beating donor (NHBD) schemes. In this paper we describe our experience after the introduction of the NHBD scheme at a regional neuroscience intensive care unit (ICU) that also provides general intensive care.
Methods: We describe the steps taken to establish the scheme and present our results from the time of its implementation in July 2002 until March 2007.
Results: Of the 100 patients whom we referred to the transplant co-ordinators, 71 were identified as potential NHBDs and of these 29 went on to become actual donors (conversion rate of 40.8%). Fifty-six kidneys were retrieved and 53 successfully transplanted. In addition, two livers were retrieved but subsequently found to be unsuitable for transplantation, while eight pancreas were retrieved and used for islet cell research. The serum creatinine at 1 yr demonstrates that there is no significant difference between transplanted kidney function from NHBDs and heart-beating donors (HBDs).
Conclusions: We believe that by establishing the NHBD organ donation scheme we are able to fulfil the wishes of more patients who have indicated that they would like to donate their organs while increasing the availability of solid organs for transplantation. With careful preparation, audit, and communication our experience demonstrates that the NHBD scheme can be successfully introduced in an ICU and expanded to other ICUs in a region.
Keywords: donors, organ transplantation; organ donation, non heart-beating organ donation; transplantation
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Introduction |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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Organ transplantation offers patients with end-stage organ failure a cost-effective treatment that improves quality of life and increases life expectancy. In the UK, demand for organ transplantation continues to outstrip supply with a record 7234 people listed as waiting for an organ transplant in March 2007.1 The number of transplants performed since 2001 increased by 16% while the number of patients waiting for a transplant increased by 30%.1 Factors contributing to this disparity include an ageing population, an increase in the prevalence of renal failure, and advances in transplant technology. As demand for organ transplantation increases, the actual number of organs available from heart-beating donors (HBDs) is decreasing.1 This pattern may continue for two reasons: fewer young people are dying as a result of severe injury or catastrophic cerebrovascular events2 while an improvement in the management and outcome of severe traumatic brain injuries3 4 means that fewer patients are confirmed dead by neurological criteria. Furthermore, the 41% refusal rate by relatives approached with a request for organ donation5 means that not all potential donors become actual donors. Strategies to reduce the gap between organ supply and demand include introducing in-house transplant co-ordinators, increasing the number of people who register on the organ donor register, increasing the live donation programme and introducing non-heart beating organ donor (NHBD) programmes.
In NHBD programmes, organs are retrieved from the donor after the confirmation of death following cardiorespiratory arrest. This is not a new concept. In 1968, the Harvard Medical Committee6 described the concept of brain death and this was followed in 1976 by the introduction of bedside, neurological tests to confirm when death has occurred;7 a new concept that allowed organs to be retrieved at optimal viability without the process itself being considered the cause of death. Previously, organs for transplantation had been routinely retrieved from NHBDs, but after the introduction of this concept the practice of NHBD declined. However, as kidneys retrieved from NHBDs have the same long-term outcome as those from donors confirmed dead by neurological criteria,8 transplant centres in the UK are now implementing NHBD schemes in an attempt to redress the imbalance between organ supply and demand. Thus, while the number of HBDs has decreased by 10% since 2001, the number of NHBDs has increased by 280%.1
Patients suitable for NHBD are similar in terms of their underlying pathology to donors confirmed dead by neurological criteria. Typically, these patients have catastrophic brain injuries but fail to fulfil the criteria for death by neurological criteria. Continuation of life-sustaining medical treatment has been deemed not to be in the patient's best interests and a decision to withdraw active support has been made. Currently, about 10% of all patients admitted to adult intensive care units (ICU) have active support withdrawn before their death; a figure accounting for 30–60% of all deaths within an ICU.9 10 Some of this cohort have the potential to become NHBDs. Figures from UK Transplant's (UKT) potential donor audit show that 23 234 patients died in ICU in 2005 of whom 947 were considered potential NHBDs and yet only 85 (9%) went on to become actual NHBDs (UKT, personal communication). Even allowing for relatives' refusal and contraindications to a patient becoming an organ donor, these figures suggest the potential for NHBD is much larger than that currently being achieved.
The ICU at Frenchay Hospital, Bristol is a 15-bedded facility providing a regional neuro-intensive care service for a population of approximately 2.5 million, and general intensive care for the local population. The nearest transplant centre is 5 miles away at Southmead Hospital, which, in combination with Frenchay Hospital, forms North Bristol NHS Trust. In this paper, we present our experience in introducing an NHBD scheme in July 2002, and the results of the first 5 yr of the scheme.
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Introducing the non-heart beating donor scheme |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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Our approach to setting up an NHBD programme was broadly similar to the approach recommended by the Intensive Care Society's Working Group on Organ and Tissue Donation.11 The steps involved were as follows:
Decide which patients would be suitable as potential non-heart beating donors
Potential NHBDs can be classified according to the modified Maastricht classification which identifies five categories of potential NHBDs (Table 1) with categories I, II and V described as uncontrolled and categories III and IV as controlled.12 We chose to consider only patients in Maastricht categories III and IV. These are patients in whom continuation of life-sustaining medical treatment is not considered to be in the patient's best interests and in whom cardiorespiratory arrest is anticipated within 2 h after the withdrawal of active support. The majority of patients suitable as potential NHBDs were expected to be within the ICU with a minority in the Emergency Department (ED).
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Audit the potential number of non-heart beating donors
Before introducing the NHBD programme, we undertook a retrospective audit of all deaths in our ICU and ED in 2 yr (1999–2000) to determine the total number of patients who would have been suitable for NHBD. We identified 73 patients aged 16–60 yr who had died after a catastrophic brain injury. All had normal renal function and no contraindication to organ donation. Death was confirmed using neurological criteria in 22 of these patients with 10 proceeding to become heart-beating organ donors. Of the remaining 51 patients, 26 were extubated as part of the withdrawal of active support. Of these 26 patients, 13 died within 2 h and would have been suitable as NHBDs. The other 25 patients were not extubated as part of the withdrawal process, did not die within 2 h of withdrawal of active support, or did not have active support withdrawn. A further prospective 6-month audit of all deaths in the ICU confirmed that approximately six patients per annum might be expected to become NHBDs. At the time the ICU admitted approximately 550 patients per annum, with active support being withdrawn in 12.6% of all admissions.10 The figure of six patients per annum who may be expected to become NHBDs therefore represented approximately 1% of all patients admitted to our ICU and 9% of all patients who had active support withdrawn. These audits were helpful in assessing workload implications and resource requirements (e.g. theatre time, local retrieval arrangements, etc.) during the planning and drawing up of a local protocol.
Discuss the practical, moral, and ethical issues
We met staff members likely to be involved in the NHBD process including ICU staff, theatre staff, ED staff, and representatives from medical specialties to present why we planned to introduce the NHBD scheme, to outline the projected impact on resources and workload, and to address the practical issues associated with organ retrieval from an NHBD. We also addressed the ethical issues that NHBD raises including the potential for a conflict of interest for ICU staff, the process of withdrawing active support in the context of NHBD, and the confirmation of death using cardiorespiratory criteria. These issues have been widely discussed previously, including how many aspects of NHBD can be accommodated within the principles of patient autonomy, non-maleficence, and a broader interpretation of the dying patient's best interests,13 and will not be discussed further in this paper. The internal discussions we undertook allowed all parties the opportunity to voice concerns about practical, legal, and ethical issues surrounding NHBD, and once resolved led to the development of our local protocol.
Design a protocol for local implementation
Once the consultation process had been completed, our protocol was formalized taking into account local factors and opinions as opposed to simply importing a protocol developed by others. After approval of the protocol by the Trust Board all patients in our region awaiting a renal transplant were informed that they might receive a kidney from an NHBD. No patient on the waiting list expressed a preference not to receive a kidney from an NHBD. Our protocol involves the following key steps:
- The decision to withdraw active support follows usual ICU practice. It is only made after consultation with the patient's relatives and the referring medical team when continuing life-sustaining medical treatment is no longer considered being in the patient's best interests. The decision is made entirely separately from any consideration for potential organ donation and without involving any member of the transplant team, including the in-house co-ordinators.
- The patient is discussed with the donor transplant co-ordinator, and if necessary the coroner, before any approach to the family to avoid the situation where a family may have agreed to organ donation only to then find that the patient is not suitable. All potential donors are referred even if we have concerns about possible contraindications, leaving the decision about suitability with the transplant team.
- The family are only approached with a request for organ donation after they have accepted the reasons for the withdrawal of active support. The approach is made by a senior member of the ICU team with or without a transplant coordinator present. All the practicalities of NHBD are explained in detail.
- We do not escalate current treatment, administer new drugs such as heparin, or carry out interventions such as vascular catheterization ante-mortem if their sole purpose is to improve organ viability and are of no benefit to the dying patient.
- Withdrawal of active support follows our usual ICU practice irrespective of whether organ donation is to take place or not. This may involve extubating the patient, discontinuing vasoactive drug infusions, or both. The timing of withdrawal of active support is decided in consultation with the patient's relatives and the availability of retrieval teams. It may be delayed to allow mobilization of the retrieval team with the family's consent. Opioid or sedative infusions are commenced as appropriate. Withdrawal of active support takes place within the ICU, thus ensuring that ICU nursing expertise in providing care to the dying patient is maintained.
- Once active support is withdrawn, the transplant team are informed of periods of hypotension, hypoxia, or anuria allowing them to consider whether organ donation remains a viable option. For NHBD to proceed, death should occur within 2 h after the withdrawal of active support to limit the warm ischaemia time.11 We did not use a scoring system such as the University of Wisconsin Evaluation Tool14 to predict if the patient would die within 2 h after withdrawing active support.
- A member of the ICU team confirms death after observing 5 min of continuous asystole combined with the absence of an arterial waveform, apnoea, and unconsciousness. Any return of cardiac or respiratory activity during this period prompts a further 5 min of observation from that point. At 5 min, a lack of response to supra-orbital pressure and the absence of pupillary and corneal reflexes are confirmed. This practice meets the recommendations of the Ethics Committee of the Society of Critical Care Medicine15 and of the Intensive Care Society's Working Group on Organ and Tissue Donation.11 Relatives are then offered a further period of up to 5 min with the patient before transferring the deceased to the operation theatre for organ retrieval. If the relatives require further time with the patient at this point, then the feasibility of the donation process is reviewed and if necessary the process abandoned.
- Theatre availability is coordinated with the planned withdrawal of active support and 2 h allowed for organ retrieval. The transplant coordinator ensures that the retrieval team are prepared in the theatre at the time of withdrawal of active support.
- After organ retrieval, relatives are given the opportunity to spend further time with the donor. Anonymized information on the recipients who benefited is provided to the family at a later date.
Regular review of patients
After the introduction of our NHBD programme, the learning curve proved to be minimal. Each of the first few NHBD retrievals was reviewed to allow any issues that had arisen to be discussed and resolved.
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Outcome of kidneys transplanted from non-heart beating donors |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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We compared the creatinine values of recipients of a kidney from our NHBDs to recipients of a kidney from our HBDs on days 5, 14 and at 3, 6, and 12 months after transplantation. Overall statistical significance between heart-beating and non-heart beating creatinine concentrations was determined using a repeated measure two-way ANOVA and at the individual time points by t-tests with Bonferroni corrections.
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Results |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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Between July 2002 and March 2007, 100 patients (96 in the ICU, four in the ED) were considered as potential NHBDs. Of these, 29 (27 in ICU, two in ED) went on to become successful NHBDs (Table 2). This represents approximately six NHBDs per year or 1% of our annual ICU admissions and is in keeping with the numbers predicted by the audit carried out before the introduction of our scheme. Of the 100 patients considered as potential NHBDs, the families of 29 patients were not approached to request organ donation (24 medical contraindications, one coroner refusal, and four other reasons). Of the 71 families who were approached to request organ donation, the refusal rate was 29.6% (21 of 71 families approached). This contrasts with our family refusal rate of 44% for HBDs. Overall, 71 (71%) of the patients considered for NHBD did not become donors. The reasons for this are shown in Table 3. If the patients where no approach to the family to request organ donation was made are excluded, then the conversion rate of potential donors into actual donors (29 out of 71 patients) for our NHBD programme is 40.8%. This compares with a conversion rate of 57% for our HBDs. A total of 56 kidneys were retrieved from 29 donors (two donors had a single kidney), and 53 transplanted (one kidney damaged during retrieval and two kidneys rejected as the donor was potentially infectious). The retrieved livers were unsuitable for transplantation and the pancreas were used for islet cell research.
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Of the 50 patients for whom the process of NHBD was set in motion, 21 patients (42%) did not donate because of either a prolonged time between withdrawal of active support and asystole or because they died before retrieval could be organized (Table 3). As a result, the retrieval team for our NHBD programme was deployed more often than the actual number of NHBDs suggest. There were no instances of having to abandon the NHBD process because the relatives needed more time with the patient after the confirmation of death.
The annual number of potential organ donors (HBDs and NHBDs) referred to the transplant coordinators from our ICU and the number of actual donors following the implementation of the NHBD scheme are shown in Figure 1. The increase in referrals represents a substantial increase in the workload for the transplant coordinators and is clearly an important factor to consider when setting-up an NHBD scheme.
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All the transplanted kidneys functioned well; there were no primary graft failures. As reported previously by others,8 the function of the kidneys retrieved from NHBDs was delayed with serum creatinine concentrations being significantly higher on the fifth (P<0.002) and 14th (P=0.002) postoperative days when compared with recipients of a kidney from a HBD. There was no significant difference in the serum creatinine at 3 months, 6 months or 1 yr after operation (Fig. 2). The overall significance across all the time points using the two-way ANOVA was P<0.0001. All recipients of the kidneys from NHBDs became dialysis-free, and all grafts continued to function. Two recipients have since died from other causes, the renal transplant continuing to function until death.
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Discussion |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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More than 14 million individuals, around 23% of the population of the UK have expressed a wish to donate organs after death by registering on the UKT's Organ Donor Register. Few however go on to become actual organ donors as few actually die in an ICU, and of those who do, only 6% will be confirmed dead using neurological criteria.5 NHBD offers individuals and their relatives another option to meet their wish to donate organs after death, an important option in bereavement care.16 It also has the potential to increase the number of organs available for transplantation. It is clear that none of the organs retrieved from our NHBDs would have been available for transplantation had our NHBD programme not been in place. Our conversion rate of 40.8% (potential donors into actual donors) demonstrates that NHBD programmes can compare favourably with the national conversion rate of 45% being achieved in HBDs.5 Our experience was initially limited to the retrieval and transplantation of kidneys from NHBDs. The long-term outcome of transplanted kidneys retrieved from NHBDs has been shown previously to be comparable with that of kidneys retrieved from HBDs,8 a finding confirmed by our data (Fig. 2). Since implementing our NHBD programme, the 3 yr survival of recipients of livers from NHBDs and HBDs has been shown to be comparable at 63% and 72% respectively, although the rate of primary graft failure is increased from 6 to 12% in recipients of liver from an NHBD.17 Our programme was later expanded to include the retrieval of livers and pancreas; two livers have been successfully retrieved although neither were considered suitable for transplantation and eight pancreas have been retrieved and used for islet cell research.
The majority of patients who became NHBDs had suffered a catastrophic brain injury (96.5% of patients). Neuroscience ICUs have a central role to play in introducing NHBD schemes and subsequently acting as a central coordinating point as schemes are expanded to other ICUs in a region. As experience with the NHBD scheme in our ICU increased, similar schemes were introduced in other hospitals within the region, so that by 2006 every hospital in the region had undertaken at least one NHBD. Although difficult to prove, we believe that the knock-on effect of introducing a successful HHBD scheme in one ICU in the region on donor referrals and successful organ donation should not be underestimated. Since 2002, the number of NHBDs in our region has increased in terms of actual numbers and as a percentage of the total number of organ donors, such that by 2006 NHBD accounted for 15 out of 35 (43%) organ donors in our region (Fig. 3).
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In the UK, numbers of NHBDs have increased annually since 2000. In 2006, NHBDs made up 19% of the total number of organ donors in the UK having increased from 5% in 2000 (data from UKT). Our experience suggests that the introduction of NHBD programmes may help lessen the impact of reduced numbers of HBDs. Any increase in the number of NHBD schemes will depend on individual clinicians and institutions addressing the practical issues and ethical concerns that have been raised about the practice of NHBD.18 While the law remains ambiguous regarding what can and cannot be done to a dying patient to facilitate successful organ retrieval, it should be stressed that the outcomes we report were achieved without any escalation of treatment or the introduction of any new therapies or interventions. This means that NHBD schemes can be introduced if clinicians feel comfortable in delaying the withdrawal of active support to allow the arrival of the retrieval team in the same way that they would to allow the arrival of relatives from afar. This should be possible if clinicians accept that the best interests of patients who wish to donate their organs after death can be translated into an authority to enable a successful retrieval to take place. It could also be argued that clinicians who have ethical objections to NHBD should be prepared to transfer the care of a dying patient who had expressed a desire to donate organs after death, to a clinician prepared to meet these wishes. This would avoid accusations of paternalism directed at those unwilling to meet the expressed wishes of their patients, and is similar to other areas of practice, such as the termination of pregnancy.13 While NHBD may remain problematic for some clinicians, we found no evidence that NHBD presents any specific issues for donor families. A relatives' refusal rate of 29.6% for NHBD compares favourably with a relatives' refusal rate of 44% for HBD on our ICU suggesting that NHBD is acceptable to families. Indeed, NHBD meets the need of families to witness the observable ending of life as represented by the cessation of the heart beat.19
To maximize the number of patients who become NHBDs, we attempt to refer all patients in whom the withdrawal of active support is proposed to the transplant coordinator, leaving the decision regarding suitability for donation with the transplant team. The majority of patients who were considered for NHBD but who did not become successful donors were those who had a contraindication to donation. Among these were patients who had suffered a hypoxic brain injury following resuscitation after a cardiac arrest. Recent interest in this group of patients as potential NHBDs has proved disappointing primarily because of the presence of contraindications to transplantation including age, medical history, and an excessive time to asystole after the withdrawal of active support.20 This should not dissuade medical staff from considering all patients in whom active support is withdrawn on an ICU as being potential NHBDs. It is also worth noting that out of every five patients suitable for NHBD in whom agreement for donation has been obtained from the relatives, two patients will either die before retrieval can be organized or alternatively will have a prolonged dying process resulting in the donation process being terminated. This means that retrieval teams involved in NHBD programmes are deployed more often than the actual number of NHBDs may suggest.
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Conclusion |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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Our experience suggests that an NHBD scheme can run smoothly and effectively and achieve good results. This was the result of careful preparation, audit, and communication and we would recommend a similar approach to any institution developing their own NHBD scheme. NHBD allows families the option to meet the wishes of a dying relative who previously has expressed a wish to become an organ donor but does not meet the criteria for brainstem death. We believe that consideration of organ donation should be a routine part of end-of-life care in ICU's with HBD considered in patients who have undergone confirmation of death by neurological criteria and NHBD considered in patients after the withdrawal of active support. Expansion of NHBD schemes has the potential to increase the number of transplantable organs donated by patients dying in ICU's—none of the organs retrieved from our NHBDs would otherwise have been transplanted. Whether the number of organs retrieved from NHBDs will make up for the reducing number of organs retrieved from HBDs or actually increases the overall number of organs transplanted remains to be seen.
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Funding |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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The intensive care unit at Frenchay Hospital has in the past received a sessional funding for a Consultant Lead and a Donor Liaison Nurse. A.R.M. is an unpaid member of UK Transplant's Donation Advisory Group.
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Acknowledgements |
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TopAbstractIntroductionIntroducing the non-heart...Outcome of kidneys transplanted...ResultsDiscussionConclusionFundingAcknowledgementsReferences |
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We acknowledge the contribution made to the development and audit of our NHBD scheme by Lyn Murphy, previously Donor Liaison Sister for the ICU and to Matthew Laugharne and Phil Pocock for the statistical analysis.
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References |
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