Non-standard kidneys for transplants: clinical margins, medical morality, and the law.

Advances in kidney transplantation over the past six decades have been impressive, but have not eliminated the significant variability in outcome related to donor organ quality. Organ shortage means that, in addition to 'standard' deceased donor kidneys (SD), 'non-standard donor' (NSD), 'expanded criteria donor', or 'marginal' kidneys, which fail to meet standard criteria and are often associated with less good outcomes, are now being transplanted into selected recipients as a means of increasing the donor pool. A similar, but less-documented, practice has developed in living donation. This article outlines the clinical rationale and ethical argument underpinning the use of such donor kidneys and examines their legal status in the UK, which we claim remains largely undefined and untested. While it is probable that the general principles governing medico-legal consent and liability also apply to organ donation, the special circumstances of donation, notably the inadequate supply of donors and the emphasis on a 'gift relationship', make it difficult to know how far existing medico-legal precedents can or should apply. The non-standard status of deceased donor organs creates potential problems for the validity of 'appropriate consent' to donation required by statute. It may also be relevant to the use of interventions intended to optimise deceased donor organ quality. Furthermore, the SD/NSD distinction in clinical practice may produce unexpected legal effects. For example, the recent UK Regulations 2012, which bring into force the EU Directive on standards of quality and safety of human organs intended for transplantation, could produce a negative legal restraint on the use of NSD kidneys. There is an urgent need for clarification of the effect of using NSDs in areas such as recipient and donor consent, liability for negligence, and the law of product liability.  Some argue that the need for non-standard organs results from society's failure to compel the retrieval of all suitable standard organs from the deceased as a community resource. However, the Human Tissue Acts of 2004 and 2006 (Scotland), which govern organ donation and transplantation in the UK, expressly require individual consent or authorisation in the decision to donate. This emphasis on individual autonomy appears to chime with prevailing public opinion. However, the sense of medico-legal security gained by uncritical observance of the existing law and of directives published under its authority may be an obstacle to the development of a system which adequately meets the needs of recipients while safeguarding donor autonomy.

Long-term survival after renal transplantation: the influence of pretransplant bilateral nephrectomy.

The long-term survival of first successful renal transplants, along with overall patient survival, was studied retrospectively in 309 recipients at Belfast City Hospital between 1968 and 1986, of whom 155 had undergone prior bilateral nephrectomy (BN) and 154 had not (non-BN). The groups were comparable as regards mean age, gender, primary diagnoses, clinical status, pre-existing hypertension and pre-transplant dialysis and transfusion. There were 34 organs (BN 14, non-BN 20) from living related donors. Donor ages were comparable, as were histocompatibility findings. Recipients more than 60, with diabetic nephropathy, or with other co-morbidity were excluded. All recipients took azathioprine and low-dose steroid as maintenance antirejection, fewer than 3% switching to cyclosporine or other drugs during first graft survival. Mean BN graft survival was 15.9 years (95% CI 14.1-17.7) compared to 12.9 for non-BN (95% CI 11.3-14.5; p < 0.01). Mean BN patient survival was 19.4 years (95% CI 17.6-21.2) and non-BN was 14.9 years (95% CI 13.2-16.6; p < 0.01). Cumulative BN graft survival was 76.8% at 5 years, 61.6% at 10 years, and 37.4% at 20 years, compared to 67.1%, 53.5% and 27.0% for non-BN (p < 0.01). Overall BN patient survival was 84.5% at 5 years, 74.2% at 10 years and 51.6% at 20 years, with non-BN equivalents of 72.3%, 49.0% and 24.5%, respectively (p < 0.01). Long-term BN survivors also had less hypertension than non-BN (22.8% v 54.8% at 20 years; p < 0.05) which may be relevant to their better survival. Overall (BN plus non-BN) median graft (14.4 years) and patient (17.6 years) survival are testimony to the continuing long-term success of the low-dose steroid regime followed in Belfast from 1968 to 1986.

One thousand renal transplants in Belfast (1968-1998).

The first kidney transplant was performed in Belfast in 1968. During the next 30 years 1,000 transplants were undertaken at this unit. Data were analysed on 937 cadaveric transplants, 815 first and 122 regrafts. There were 63 living transplants. Long-term follow-up was achieved for all grafts except one live transplant. All recipients had follow-up of at least 5 years. One- and 5-year graft survival rates were 78.9% and 65.0% for first cadaveric grafts, 83.6% and 66.4% for regrafts and 85.7% and 68.3% for living transplants. Nine of 41 transplants performed more than 30 years ago are still functioning. Multivariate analysis determined risk factors for graft survival as recipient age, donor age, HLA-A mismatching, HLA cytotoxic antibody level and year of transplant. A conservative regime regarding the use of immunosuppression, HLA matching and crossmatching has proved successful in accomplishing good graft survival at this unit.