1. Improving Allocation of En Bloc Kidneys
Kidney Transplantation Committee
Next, I will be presenting the Kidney Committee’s current public comment proposal, “Improving Allocation of En Bloc Kidneys.” This is the proposal’s second round of public comment after being voted down at the Board of Directors’ meeting in June. I’ll briefly reintroduce the proposal before I go into the changes the Committee has made in response to feedback from the Board and community.

2. What problem will the proposal solve?
No OPTN policy on allocating en bloc kidneys
DonorNet® overestimates KDPI score for en bloc kidneys, potentially screening medically suitable candidates off the match run
DonorNet ® has communication limitations
Demand for kidneys far exceeds supply. One strategy to increase the donor pool is to utilize kidneys from small pediatric donors. To mitigate the potential complications and challenges associated with transplanting very small single kidneys , both kidneys, including major vasculature, can be transplanted en bloc into a single recipient.
However, there are currently several challenges to allocating kidneys en bloc. First, OPTN policy does not specify how an OPO should allocate these kidneys, or which kidneys qualify for en bloc allocation. As a result, kidneys are often offered as en blocs late, or not recovered at all. Although only about two percent of all kidney transplants are en bloc transplants, members frequently contact UNOS regarding how to allocate these kidneys. With improved allocation, there is the potential for better utilization of these kidneys.
DonorNet also overestimates the KDPI score for en bloc kidneys. The current KDPI scoring does not reflect graft failure risk for kidneys transplanted en bloc, since the KDPI score assumes each kidney will be transplanted as a single kidney and does not account for the survival advantage associated with en bloc use. This has the potential to screen medically suitable candidates off the match run.
In addition, DonorNet currently does not enable an OPO to indicate when it is offering en bloc kidneys, nor does it require transplant centers to indicate that they accept and transplant kidneys en bloc.

3. What are the proposed solutions?
Mandatory en bloc allocation based on donor weight
Allocate en bloc kidneys based on KDPI 0-20% (Sequence A)
Mask KDPI score in en bloc kidney allocation
Centers must report to UNOS that they are willing to accept en bloc kidneys in order to receive en bloc offers
Kidneys allocated en bloc can be split at surgeon’s discretion
There are five key provisions that make up this proposed policy to address these challenges.
First, allocation of en bloc kidneys will be based on donor weight. This donor characteristic is readily available prior to organ recovery and is a significant predictor of organ recovery from small pediatric donors. Donor kidney size was among many other donor characteristics considered; this is information available only post-recovery, however, which could delay offers.*
Second, en bloc kidneys will be allocated based on a deceased donor KDPI of less than or equal to 20%. Recent studies have found that en bloc kidneys have graft survival outcomes comparable to an ideal deceased or living donor. This will ensure all potentially eligible candidates have a chance to receive en bloc kidney offers.
Third, the Committee opted to mask the KDPI value in DonorNet. Masking the KDPI will prevent candidates from being screened off the match run for high KDPI kidneys.
Fourth, this proposal requires transplant centers to report to UNOS that they are willing to accept en bloc kidneys offers. Although this preference is already a part of the minimum acceptance criteria that centers are asked to submit annually, many centers do not update their acceptance criteria on an annual basis or leave the en bloc kidney question unanswered. Furthermore, these criteria are only applied when allocation is facilitated by the Organ Center.
Finally, it will be permissible for surgeons to split en bloc kidneys if they determine they can be single transplants into two recipients.
The Committee heard concerns over provisions 1 and 5 from the Board and during the spring public comment cycle. Next, I’ll share a quick overview of the options we considered in response to this feedback, as well as how we amended the proposal.
*IF ASKED: Yes, some programs can do ultrasounds to determine kidney size pre-recovery, but many programs cannot/do not perform them.

4. Mandatory Weight for En Bloc Allocation
<15 kg donor: mandatory en bloc
15-25 kg donor: OPO option to allocate en bloc or single
Original Proposal
<20 kg donor: mandatory en bloc
Eliminated optional allocation threshold
Board Proposal
(June 2017)
<18 kg donor: mandatory en bloc
Current Proposal
The first provision that received a substantial amount of feedback surrounded the Committee’s selected weight threshold. The original proposal required kidneys from donors less than 15 kg to be allocated as en bloc. For donors kg, the proposed policy allowed the option of allocating en bloc or as singles.
In response to feedback from the first round of public comment, the Committee voted to remove the so-called “tweener” weight range provision from the original proposal which allowed the OPO to decide whether to offer kidneys en bloc or as singles. This decision was made in response to early feedback asking for more concrete direction for OPOs in allocating en bloc kidneys. The Committee requested more data to assist in choosing a weight threshold that would not disadvantage centers currently using en bloc kidneys or centers that use single kidneys from small donors. In June, the Committee proposed a donor weight less than 20 kg for mandatory en bloc allocation to the Board. Some members of the Board of Directors, however, were concerned that 20kg was too high.
Finally, based on the Board’s feedback and available data, the Committee voted to reduce the threshold to 18kg.

5. Supporting Evidence:
This chart shows the number of en bloc and single transplants based on donor weight in each region. En bloc transplants are represented in blue and single kidney transplants are represented in green. The donor weight ranges are listed on the right hand side in dark blue.
As I mentioned, some members of the Board of Directors felt that 20 kg was too high. The Committee reviewed the data and considered the Board’s feedback before settling on 18 kg for the second round of public comment. The data shows that kidneys from donors 19 kg or more are predominantly single transplants rather than en bloc. Lowering the weight range further would disadvantage centers that transplant these kidneys en bloc.
IF ASKED:
Region 1 had no single or en bloc transplants for that donor weight range during the time period.

6. Releasing Split En Blocs & OPTN Policy 5.9
Kidneys allocated en bloc can be split at surgeon’s discretion
Feedback: Some wanted to keep both kidneys if pair was split
Concerns over releasing the second kidney per current OPTN Policy 5.9
Second, the Committee received the most substantial feedback surrounding the proposal’s provision requiring surgeons to release the second kidney in a split pair according to OPTN Policy 5.9. There is currently no consensus regarding when en bloc kidneys should be split for transplantation into two recipients to maximize utility without compromising graft outcomes; rather it is typically based on the surgeon’s discretion.
Both the original proposal and the current proposal allow surgeons to split en bloc pairs should the surgeon decide they are appropriate for single transplant. The receiving transplant program must either transplant one kidney into the originally designated recipient and release the other kidney according to Policy 5.9 or release both kidneys according to Policy 5.9
Many members of the community and the Board of Directors expressed concern about transporting the second kidney and risking discard with added cold ischemia, and stated a preference for this policy to allow surgeons to automatically keep the second kidney in a split pair at their center. The Committee appreciated this feedback and discussed these concerns at length.

7. Donors <18kg with at Least One Match Acceptance of Both (En Bloc or Dual) Kidneys, 2010-2015
87.4% transplanted at accepting center
4.4% (56 of 1282) were split, and 10 of 56 left the accepting center
1.6% (21 of 1282) at least one kidney transplanted at different center
11% (of 1282) both kidneys discarded/not recovered
(N=1282)
As you can see here, splitting en blocs in the first place is exceedingly rare; over the course of 6 years, 56 kidney pairs from donors under 18kg were split. Additionally, only 21 offers had at least one kidney travel to a new center for transplant. As I mentioned, this situation is similar to allocation of a kidney to a high CPRA candidate, or any other transport at high risk for reallocation – the match run must be followed in all of these cases. As this is current practice, the Committee found that alignment with current OPTN Policy 5.9 is the most transparent and patient-centered method to managing released kidneys, especially since splitting is rare.
To improve efficiency, however, the Committee is also recommending adding IT functionality in DonorNet such that all en bloc match runs automatically include both en bloc and single allocation – one after the other – so a match run generated by KDPI for single kidneys is ready should the surgeon decide to split the pair.
NOTES ON COLD ISCHEMIA: None of the transplanted kidneys from the 21 donors who had at least 1 kidney transplanted outside the accepting center left the accepting candidate’s DSA. For split kidneys, the mean CIT for the first kidney was 22 hours, and the second was 28 hours, for a difference of 6 hours for split units.
REMINDER TO PRESENTER: This is donor data!

8. How will members implement the final proposal?
Transplant Programs
Must report to UNOS that they are willing to accept en bloc kidneys to receive en bloc offers
Must document the reason for not transplanting the kidneys en bloc if the surgeon determined the kidneys could be split and transplanted into two recipients
OPOs
Allocate kidneys from donors < 18 kg as en bloc
This proposal impacts transplant centers and OPOs.
Transplant centers:
This proposal requires transplant centers to indicate to UNOS that they are willing to accept en bloc kidneys if they want to receive offers for those organs. This proposal will allow transplant centers to manage acceptance of en bloc kidneys at the candidate or center level using listing defaults. This option should mitigate administrative burden and more effectively ensure that only those candidates and centers willing to consider accepting an en bloc kidney offer appear on the match run.
Current practice of charging one acquisition fee for en bloc kidneys is not expected to change in light of this proposal.
OPOs
Policy does not currently list donor weight as a required data element for kidney offers. It will now be required.
OPOs will allocate kidneys from donors < 18 kg as en bloc to those centers indicating they will implant as en bloc.
If a surgeon opts to split en bloc kidneys, the OPO may be asked to allocate a single kidney.

9. How will the OPTN implement this proposal?
Dec. 2017
Board of Directors
Requires programming in UNetSM IT
Policy notices, system notices
Communications
Requires an education program
Education
Reviewed at 6 months, 1 year, and 2 years
Evaluation
Monitoring will not change
Compliance monitoring
This proposal will require programming in Unet. Changes are required in both WaitList and DonorNet.
The OPTN will follow established protocols to inform members and educate them on any policy changes through policy and system notices posted on the OPTN website and in Transplant Pro.
This proposal will require an instructional program and will be monitored for specific needs throughout implementation to determine the appropriate modality for educating members.
Any data entered in UNet may be subject to OPTN review. Members are required to provide documentation as requested. UNOS will continue to review deceased donor match runs that result in a transplanted organ to ensure that allocation was carried out according to OPTN requirements.

10. Questions? Nicole Turgeon, MD Kidney Committee Chair nturgeo@emory.edu
Chelsea Rock Haynes, MPA
Kidney Committee Liaison
I’d be happy to take any questions you have on the en bloc proposal before I move on to the Dual Kidney proposal.

11. Extra Dual/En Bloc Slides

12. What does it mean to “release” per 5.9?
Releasing organs is current practice. The risk of accepting an organ that can’t be transplanted into the originally intended recipient is always present. 
In these scenarios, the organ is “released” to the OPO to determine whether and how the organ can be reallocated. It rarely means physically shipping it back to the host OPO.
If implemented, new functionality in DonorNet will streamline this process for en bloc kidneys.
OPTN Policy 5.9 states programs must:
“…Release the…organs back to and notify the host OPO…for further distribution. The host OPO must then allocate the organ to other candidates...”
It is important to note that this proposal does not require any changes to current practice regarding Policy 5.9. As with any allocation, the risk of accepting an organ that can’t be transplanted into the originally intended recipient is always present.  Per Policy 5.9 those organs must be released back to the OPO for reallocation.  Reallocation typically follows the original match run for local offers and requires a back-up run for import offers.  The same practice will apply for en bloc allocation.
As I mentioned earlier, the Committee is also recommending adding IT functionality in DonorNet such that all en bloc match runs automatically include both en bloc and single allocation – one after the other – so a match run generated by KDPI for single kidneys is ready should the surgeon decide to split the pair.
IF ASKED:
Q: What if the en blocs are imported to another DSA? The original match run will no longer apply since it was run for the originating OPO.
A: The host OPO must first grant local backup. If granted, the importing OPO will need to run a local backup match run, which is standard practice for most OPO’s. Should the surgeon decide to split after the import has taken place, the local backup match run would have already been generated.

13. Policy 5.9 Released Organs
The transplant surgeon or physician responsible for the care of a candidate will make the final decision whether to transplant the organ.
The transplant program must transplant all accepted, deceased donor organs into the originally designated recipient or release the deceased donor organs back to and notify the host OPO or the OPTN Contractor for further distribution. If a transplant program released an organ, it must explain to the OPTN Contractor the reason for refusing the organ for that candidate. The host OPO must then allocate the organ to other candidates according to the organ-specific policies. The host OPO may delegate this responsibility to the OPTN Contractor or to the OPO serving the candidate transplant program’s DSA.
If deceased donor organs cannot be transplanted into the originally intended recipient, Policy 5.9: Released Organs requires the transplant program to release the organs back to the host OPO and notify the host OPO or the OPTN Contractor for further allocation. The host OPO must allocate the organ to other candidates according to the organ-specific policies (i.e., according to a match run), or can opt to let the OPTN Contractor or the OPO serving the candidate transplant program’s designated service area (i.e. the “importing OPO”) allocate the organ instead. This policy applies to all organ allocation
Reallocation of the kidney to other candidates would still be according to the kidney allocation policies whether it was allocated by the host OPO, the importing OPO, or the Organ Center.

14. Deceased Donor Kidney Transplants 12/4/2014-11/30/2016 by OPTN Region and Kidney Transplant Type
Kidney Procedure Type
Total
LEFT KIDNEY
RIGHT KIDNEY
EN-BLOC
Sequential Kidney N %
OPTN Region
459
50.44
446
49.01 5
0.55
910
100.00 1 2
1585
48.77
1611
49.57 41
1.26 13
0.40
3250 3
1683
47.09
1798
50.31 83
2.32 10
0.28
3574 4
1161
46.59
1261
50.60 57
2.29
0.52
2492
2130
47.36
2235
49.70 95
2.11 37
0.82
4497 6
48.32
463
50.16 14
1.52
923 7
873
48.31
905
50.08 21
1.16 8
0.44
1807
783
49.28
767
48.27 35
2.20
0.25
1589 9
797
46.39
870
50.64
1.22 30
1.75
1718
899
46.77
983
51.14 33
1.72
0.36
1922 11
1250
47.26
1353
51.15
1.32
0.26
2645
12066
47.64
12692
50.11
440
1.74
129
0.51
25327
Sequential = Dual Kidneys

15. KDPI and risk adjustment
The PSRs currently include “procedure type” as a factor:
Left kidney
Right kidney
Double kidney
En bloc kidney
There is no extra risk (or reduction of risk) associated with procedure type
The risk-adjustment model will not harm or reward programs for completing en bloc transplants
For questions surrounding center PSRs (primarily in Region 3)
The Committee did not receive many comments regarding their proposal to mask the KDPI score in DonorNet to mitigate the artificially high KDPI scores of en bloc kidneys. A single commenter felt omitting the KDPI takes away predictive information from coordinators and surgeons to consider when evaluating offers, but others from that region agreed that masking the KDPI is an appropriate compromise, as en bloc KDPI scores are too skewed to serve as a meaningful data point. There were two commenters that suggested a risk adjustment for en bloc kidney transplants in the same way that high KDPI kidney transplants will be excluded from outcomes monitoring.
Committee leadership discussed this feedback with SRTR. SRTR advised that in their PSRs, the KDPI equation is used exactly how it is programmed in UNet to estimate the risk of graft failure, i.e. without the en bloc coefficient. Currently, small donor en bloc kidneys reflect a relatively high KDPI score. The higher the KDPI of an organ, the higher its estimated risk of graft failure. However, this may not be an accurate reflection of the true risk for en bloc transplants. Furthermore, the PSRs include “procedure type” as a factor: for example, left kidney, right kidney, double kidney, or en bloc kidney. In the 1-year deceased donor graft survival models as of April 2017, there is no extra risk (or reduction of risk) associated with procedure type, aside from a very small protective effect for using the left kidney. The risk-adjustment model (i.e., outcomes calculations) will not harm or reward programs for completing en bloc transplants because both KDRI and en bloc are included in the model and can capture the potential effect of en bloc on one-year post-transplant outcomes. Committee leadership were satisfied with this explanation and did not have any concerns.

16. Extra En Bloc Slides

17. One Year Graft Survival of Single versus En Bloc Kidney Transplants by Donor Weight (Maluf et al 2013)
Maluf, D. G., Carrico, R. J., Rosendale, J. D., Perez, R. V., & Feng, S. (2013). Optimizing recovery, utilization and transplantation outcomes for kidneys from small, ≤ 20 kg, pediatric donors. American Journal of Transplantation, 13(10),
This graph from Maluf’s 2013 paper indicates that consideration certainly should be given to en bloc over single transplants as donor weight decreases given differences in post transplant survival. The smaller the donor weight, the greater the hazard ratio for graft survival.
Maluf, D. G., Carrico, R. J., Rosendale, J. D., Perez, R. V., & Feng, S. (2013). Optimizing recovery, utilization and transplantation outcomes for kidneys from small,≤ 20 kg, pediatric donors. American Journal of Transplantation, 13(10),

18. One Year Graft Survival of Single versus En Bloc Kidney Transplants by Donor Weight and Center Volume (Maluf et al 2013)
These graphs from Maluf et al’s 2013 paper show that center experience with transplantation of kidneys from small pediatric donors exerts a profound impact on 1-year graft survival, particularly for single kidney transplants at low donor weights. These data strongly suggest that superior technical expertise at so called ‘‘high volume’’ centers, rather than donor and/or recipient selection or post transplant management protocols, mitigates the risk of 1-year graft loss for both single and en bloc transplant.
Maluf, D. G., Carrico, R. J., Rosendale, J. D., Perez, R. V., & Feng, S. (2013). Optimizing recovery, utilization and transplantation outcomes for kidneys from small,≤ 20 kg, pediatric donors. American Journal of Transplantation, 13(10),

19. *Not utilized means either not recovered or recovered but discarded.
Deceased Kidney Donors Recovered from by Donor Weight and Kidney Disposition
*Not utilized means either not recovered or recovered but discarded.

20. Pre-KAS data
Region 1 had no single or en bloc transplants for that donor weight range during the time period.

21. Monitoring Plan
Evaluated approximately 6 months, 1 year, and 2 years post-implementation
The following questions will guide the evaluation of the proposal after implementation:
Has the number of en-bloc kidney transplants increased?
Has the number of patients transplanted from very small pediatric donors (single and en-bloc) increased?
Has efficiency of en-bloc transplants improved given there is now policy in place regarding these transplants?
Has there been a decrease in kidney discards?
Has the number of programs performing en-bloc kidney transplants increased? 
These metrics, and any others subsequently requested by the Committee, will be evaluated as data become available to compare performance before and after the implementation of this policy. This policy will be formally evaluated approximately 6 months, 1 year, and 2 years post-implementation. If over time it looks like something should be modified, the Committee will have data to support those changes.