I’m Rose D’Acquisto, a past chair of the National Kidney Foundation’s (NKF) National Donor Family Council, one of three NKF constituent councils, which has over 11,000 members. (The total membership of the National Kidney Foundation exceeds 80,000, including physicians, dietitians, social workers, and nurses, as well as dialysis patients, living donors, transplant candidates, and transplant recipients.)
NKF appreciates the time and effort that the OPTN/UNOS has devoted to investigating the possibility of changing kidney allocation policy. NKF also recognizes the success that the OPTN/UNOS has had in beneficially altering allocation policies for other forms of organ transplantation. We thank OPTN/UNOS for the opportunity to participate in today’s forum.
Balancing the need for equity and efficiency in organ donation/transplantation is a formidable challenge. We realize that OPTN/UNOS was required to undertake this responsibility because of a regulation implementing the National Organ Transplant Act of 1984. While OPTN/UNOS has already revised allocation policy affecting liver and lung transplantation, kidney transplantation presents different policy options. Unlike liver and lung transplant candidates, people waiting for a kidney transplant have alternative life-sustaining therapy with dialysis.
Our comments are in the order of support and priority attributed to the concepts in the RFI by the wide variety of constituents who comprise the membership and volunteers of NKF.
Each constituency has been part of the dialogue within NKF related to the issues surrounding kidney allocation.
Donor Profile Index (DPI)
The NKF heartily endorses the concept of the donor profile index. Donor families want to avoid wastage of donated organs. Currently, 20% of all kidneys recovered are not transplanted, and 30-40% of ECD kidneys are discarded. DPI could foster an ECD utilization rate closer to a rate commensurate with the scientific assessment of the usefulness of ECD kidneys for transplantation.
Certainly, some have expressed concern that older transplant recipients may experience poorer outcomes with the ECD kidneys that they will be offered based on LYFT. However, centers using ECD kidneys routinely have demonstrated excellent outcomes. UNOS could develop a message for kidney transplant candidates incorporating the theme: “you will get a kidney that looks like you.” Furthermore, DPI by its very presence could enhance the likelihood that all OPOs provide pump, biopsy, and rapid transport capabilities to enhance assessment of ECD kidneys and decrease wastage of all kidneys. Of course, acceptance of any specific organ must ultimately be determined by the transplant center, the transplant surgeon, and the candidate.
Life Years from Transplant (LYFT)
An allocation system incorporating LYFT concepts would probably make it more difficult for older candidates with diabetes to receive a transplant. This would also be the case for individuals requiring re-transplantation. Should these candidates decry the loss of the opportunity of transplantation, it could negatively affect public perception of the U.S. transplant system. Conversely, a LYFT-based allocation system would probably favor younger transplant candidates who might not be as careful about adherence to anti-rejection medication therapy as older transplant recipients. This also raises the risk of a possible negative impact on overall graft survival from such a new system.
A LYFT-based allocation system, however, does make sense on many other levels.
i) As stated on page 13 of the RFI, it could increase the number of years that donated kidneys function
ii) It would probably lessen the need for re-transplantation in some patients, and
iii) It may reduce the incidence of death with a functioning graft.
Thus, LYFT could foster the most effective use of donated kidneys.
Donor families want organs to go to individuals who will be enabled to enhance their quality of life and to live fulfilling lives. However, that does not necessarily mean that donor families prefer a policy favoring younger recipients. Finally, by focusing attention on maximizing life years from transplant, LYFT could, in general, foster improved medical management for the co-morbidities that transplant candidates experience, to reduce the toll of these co-morbidities post-transplantation.
Dialysis Time (DT)
An allocation system that recognizes dialysis time provides a bridge between utility and equity. On the other hand, using dialysis time to assign priority for kidney transplantation does not promote NKF’s strategic goal of facilitating early transplantation and the improved outcomes derived from early transplantation. For example, if one examined candidates with identical profiles, individuals not yet on dialysis would have a lower Kidney Allocation Score than candidates who have been on dialysis. For this reason, perhaps dialysis time should be phased out of the Kidney Allocation Score in stages.
The implications of a policy that would require candidates who are listed for a pancreas (but are also in need of a kidney) be offered the kidney with the pancreas, have not been widely discussed. While such a policy might increase the number of organs transplanted per donor, this should not be the main thrust of an organ allocation policy, especially if it reduces access for kidney-only transplant candidates or results in poorer outcomes for kidney-only candidates.
Possible Solutions to Limitations
There may be several approaches that could be employed to minimize any potential negative impact of changing the kidney allocation system through the proposed structured components of DPI, LYFT, and dialysis time.
- There could be a “grandfather” provision that awards extra points to individuals who have been waiting for a kidney for a long time. Perhaps this also could be phased out over time.
- UNOS could demonstrate the acceptability and efficacy of LYFT during a trial period, emphasizing the fact that many ECD kidneys are truly excellent for transplantation, thus limiting wastage of donor kidneys.
- The potential components of a Kidney Allocation Score could be introduced sequentially, with DPI and dialysis time implemented before LYFT.
- Allocation for multiorgan recipients could be modified to limit match runs in certain, yet fair ways, so that kidney-only candidates have equal access to the organs available.
- All OPOs should work to implement measures to assess and optimally preserve and transport any and all recovered kidneys.
- Finally, UNOS could develop a message for kidney transplant candidates incorporating the theme: “you will get a kidney that looks like you.”
In conclusion I would like to quote from the NKF statement for the UNOS Forum in Dallas in February 2007. “Whatever the allocation policy becomes, it is imperative to maintain the public’s trust in the organ transplant system in the United States. We believe this means that, before final adoption, there must be a communications plan explaining in clear, easily understood language any proposed change in policy and how it will affect access to transplantation for different candidates and its impact once implemented… The final point we would like to make is that the results of any policy change must be measurable. OPTN/UNOS must have the data necessary to evaluate whether a new kidney allocation policy has achieved its stated goals.”
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