The National Kidney Foundation (NKF) appreciates the opportunity to comment on the concept paper regarding the allocation of deceased donor kidneys for transplantation. We are responding on behalf of the transplant candidates who are members of the NKF Patient and Family Council, transplant recipients belonging to the NKF transAction Council, as well as the National Donor Family Council, representing thousands of family members who have donated the organs of loved ones for transplantation. We believe that a well-designed system of allocation that affords the longest life (longest life for the donated kidney or longest life for the transplant recipient) will serve everyone best. We support the concept paper since its principles provide the opportunity for far-reaching, positive impact.
We note that the goals of the Kidney Allocation Concept Paper align with those of the NKF’s campaign to “End the Wait!” for kidney transplantation, in particular the goal to:
- Increase the percentage of recovered deceased donor kidneys that are utilized
- Reduce the need for re-transplant
- Reduce the number of transplant recipients that die with a functioning graft within the first two years following transplantation.
[One “End the Wait!” priority that is not considered in the concept paper, and should be the subject of a future policy proposal from the Organ Procurement and Transplant Network, is the disparity in access to deceased donor transplantation in different regions of the United States.]
On the other hand, the National Kidney Foundation is concerned that the allocation changes discussed in the concept paper may not succeed in substantially reducing the continued high rate of organ discard that now constitutes 19% of all kidneys recovered. While the system envisioned in the concept paper may affect some organ acceptance decisions, it does not address the largest (and growing) reason for discard, i.e. biopsy findings. Biopsy findings accounted for 42.8% of kidney discards during the period 2005-2009, up from 37.2% in 1995-1999. Furthermore, 46.6% of kidneys from donors between the ages of 35 and 49 are biopsied. In addition, data from the OPTN show that more than 250 kidneys are discarded each year, even though suitable for transplantation, because of inefficiencies in the system, e.g. no recipient located, too old on ice, recipient unsuitable for transplant, too old on pump. Changes in the allocation system alone will probably not reduce such discards. Third, the shamefully high discard rate cannot be reduced without exploring and resolving the disparity in acceptance of organs/turndowns by transplant centers and a comparison of waitlist mortality at those centers. Finally, unless there is a change in the regulatory disincentive for transplant centers to utilize organs with lower estimated graft survival, we fear that kidney discards will continue at an unacceptably high rate.
Kidney Donor Profile Index
The National Kidney Foundation heartily endorses the development and utilization of a kidney donor profile index (KDPI) to better characterize donor kidneys and to provide additional clinical information to inform decision making by surgeons and candidates in responding to organ offers. To illustrate the problem this would address, an analysis of kidney discard rate by KDRI indicates that organs with acceptable estimated graft survival rates are being discarded while organs with the same index are being utilized.
Allocating organs to candidates within 15 years (+/-) of donor age addresses the problem of extreme mismatch in kidney and recipient survival that is possible under the current allocation system. (Kidney with estimated 20 years of survival allocated to candidate with estimated survival of 3 years; or kidney with estimated 3 years of survival being allocated to candidate with estimated survival of 20 years). In addition:
- Under the existing kidney allocation system, the majority of kidney recipients are already within the same age range (within 15 years of the donor’s age) as discussed in the concept document.
- For most candidates, there would be no functional difference in which organs they may be offered first between a system based upon the concept paper and the current system.
Allocating Organs By Expected Survival of Graft/Recipient
Allocating the highest quality kidneys to the candidates with the greatest estimated post-transplant survival means that many will never need to wait for a transplant again. Conversely, placement of older kidneys into older patients can result in very good outcomes. Most such recipients go on to gain normal or near-normal kidney function, live longer free of dialysis, and expire due to some unrelated cause. Although the figure on page 36 of the concept paper depicts a decline in access to transplantation for candidates in the 50-64 and 65+ age groups if the principles were to be implemented, this projection does not take into account the likelihood that more organs with higher KDPI will be accepted and that may mitigate the impact on older transplant candidates.
We are pleased to note that the concept paper addresses concerns expressed by NKF’s constituents with regard to the allocation considerations in LYFT and KAS, namely, the principles in the current concept paper are less likely to impair access for repeat transplants and the concept paper acknowledges the benefit of pre-emptive transplantation. Additionally, implementation of the concept paper may increase the total number of organs available for transplantation in this country in that older Americans who have not considered participating in an organ donor registry, since they believed that their organs would not be transplanted, would be more likely to be organ donors if the likelihood that their organs could save lives were increased because of implementation of the principles in the concept paper. Finally, we suggest that any formal policy proposal should specify how kidneys will be allocated in medical emergency cases (failure of dialysis access, etc.).