1. OPTN/UNOS Kidney Transplantation Committee
Fall 2017
Hello, my name is _______________ and I am the region __ representative to the Kidney Committee and I will be presenting the Kidney Committee Update.

2. Kidney Committee Update
SLK Allocation Policy Implementation
2 Year KAS Data
Allowing Deceased Donor-Initiated KPD Chains Concept Paper
Improving Allocation of En Bloc Kidneys (Voting item)
Improving Allocation of Dual Kidneys (Voting item)
Today, I’ll be updating you on the IT implementation for SLK and providing you with a brief overview of the latest KAS data. I’ll also be presenting on the three Committee projects out for public comment. I’ll pause for questions after completing the update portion of the presentation before I move in to the public comment proposals.

3. Implementation Update
SLK Allocation
Primary Changes: SLK medical eligibility criteria, SLK allocation requirements, safety net for liver recipients registered on kidney waiting list within a year after liver transplant (effective Aug. 10).
New Waitlist fields available since May 31.
Visit for policy and system training resources.
As most of you know by now, the Simultaneous Liver Kidney (SLK) Allocation policy that was approved by the Board in June 2016 was implemented in mid-August of this year. As a reminder, the new policy includes medical eligibility criteria for SLK candidates, SLK allocation rules, and provides a safety net for liver recipients who end up registered on the kidney waiting list within a year after their liver transplant. These changes took effect on August 10th of this year, though the new Waitlist fields have been available in Unet since May 31st. UNOS Connect’s course catalog has policy and system training resources available for you and your centers.

4. Implementation Update
New Waitlist Reports determine candidate eligibility at their center:
“Kidney Priority for Liver Transplant Recipient” report
“Liver-Kidney (SLK) Candidate” report
As a reminder, there are also two new reports available for centers to use to determine patient and candidate eligibility: the Kidney Priority for Liver Transplant report and the “Liver-Kidney (SLK) Candidate” report.

5. The Kidney Allocation System (KAS) The First Two Years
Prepared for OPTN Kidney Transplantation Committee
April 19, 2017
Amber R. Wilk, PhD
John Beck
Anna Y. Kucheryavaya, MS
United Network for Organ Sharing
UNOS Research Department
The next item up is the 2 Year KAS Monitoring Report.

6. Background
Performance initially tracked monthly through June 2015 (“out of the gate” reports)
Six month report completed September 2015
One year report completed April 2016
Two year analysis completed April 2017
Post-KAS years only, comparing Post-KAS Year 1 to Post-KAS Year 2:
Post-KAS Year 1: December 4, December 3, 2015
Post-KAS Year 2: December 4, December 3, 2016
Pre-KAS: December 4, 2013 – December 3, 2014
The analysis periods are 1 year post-KAS and 2 years post-KAS (for most data slides unless otherwise indicated). Any pre-KAS comparison is 1-year pre-KAS. 6

7. Geographic Distribution of Kidney Transplants
3.9%
3.4%
13.0% %
13.5%
14.2%
9.9%
9.7%
3.7%
3.8%
7.4%
6.4%
6.4% %
7.2%
6.7%
7.8%
10.2%
10.9% 0% 5%
10%
15%
20%
17.5% %
25% 1 2 3 4 5 7 8 9 10 11 6
OPTN Region
Post−KAS Year 1 Post−KAS Year 2
Overall, transplants increased 9.1% post−KAS, from 11,392 Post−KAS Year 1 to 12,433 Post−KAS Year 2, though the rise in transplants cannot be entirely attributed to KAS. There were no substantial changes in any region post-KAS Year 2 vs. post-KAS Year 1.
No substantial changes in any region post−KAS Year 2 vs. post−KAS Year 1.

8. Deceased Donor Transplants by Recipient Age
0.7%
0.2%
0.8%
2.3% %
0.5%
12.8% %
8.6%
27.9%
38.8%
37.2%
19.5%
18.2%
26.0%
24.4%
22.4% 0%
10%
20%
30%
40%
0−5
6−10
11−17
35−49
50−64
65+
18−34
Recipient Age
Waitlist (11/30/2016) Post−KAS Year1 Post−KAS Year 2
43.6%
The percent of transplants to younger candidates (18−49) decreased slightly, and transplants to 50+ candidates increased slightly. Pediatric candidates still receive more transplants than their representation on the waiting list, regardless of pediatric age group.
The percent of transplants to younger candidates (18−49) decreased slightly, and
transplants to 50+ candidates increased slightly.

9. Geographic Distribution of Pediatric Kidney Transplants6
OPTN Region
5.9%
2.9%
4.1%
9.9% 9.8%
7.6%
16.8% 15.8% 16.7%
14.7% 15.0%
13.2%
16.0% 15.6%
21.2%
3.4% 3.9%
2.2%
5.6%
7.4%
10.0%
7.1% 7.7%
5.2% 5.0% 5.0%
7.6% 7.7% 6.5%
6.1%
9.5% 9.5% 0%
10%
20%
30%
40%
50% 1 2 3 4 5 7 8 9 10 11
Pre−KAS Post−KAS Year 1 Post−KAS Year 2
Post−KAS, most regions had higher or similar percent of pediatric transplants Year 2 vs. Year 1; regions 7, 10, and 11 had a decrease in pediatric transplants, while regions 1 and 8 saw increases. Region 5 still represents the largest decline compared to pre-KAS data.
Post−KAS, most regions had higher or similar percent of pediatric transplants Year 2 vs. Year 1; regions 7, 10, and 11 had a decrease in pediatric transplants, while regions 1 and 8 saw increases.

10. CPRA 99-100% Recipient “Bolus Effect”
1.8%
1.6%
3.2%
2.3% 2.0%
2.9%
3.5%
2.5% 2.8% 2.4%
17.7%
15.7%
15.4%
13.4%
14.6%
12.6%
11.7%
11.2%
12.2%
11.8%
12.4%
11.9%
10.6% 10.5%
10.2% %
9.7% 9.5% 9.9% 9.6% 9.7% 10.0%
12.3%
10.1%
9.6%
KAS Implementation 5 10 15 20
Percent of Transplants to CPRA 99−100% Recipients
Transplants to CPRA 99−100% patients rose sharply after KAS but have tapered to around 10% for the past year, remaining relatively stable here.
Feb− May− Aug− Nov− Feb− May− Aug− Nov− Feb− May− Aug− Nov− Feb−2017
Transplant Date
Transplants to CPRA 99−100% patients rose sharply after KAS but have tapered to around 10%.

11. High Dialysis Time Recipient “Bolus Effect”
Percent of Transplants to Recipients with 10+ Years of Dialysis
4.3% 4.3%
6.2%
4.8% 4.6% 4.5%
5.2% 5.2% 5.2%
3.3% 3.6%
4.5%
18.6%
17.1%
12.2%
11.1%
12.4%
8.9%
8.3%
9.1%
7.7% 7.6% 7.5%
6.7%
6.0%
6.8%
5.7%
5.6%
7.2% 7.0%
4.1%
KAS Implementation 5 10 15 20
Transplants to candidates with 10+ years of dialysis rose sharply after KAS but have tapered substantially to around 6% for the past year, remaining relatively stable here.
Feb− May− Aug− Nov− Feb− May− Aug− Nov− Feb− May− Aug− Nov− Feb−2017
Transplant Date
Transplants to candidates with 10+ years of dialysis rose sharply after KAS but have tapered substantially to around 6%.

12. Kidney Discard Rate by KDPI
2.7%
2.5%
5.2%
6.7%
6.4%
19.7%
18.5%
17.1%
59.3%
58.9%
54.8% 0%
20%
40%
60%
0−20
21−34
35−85
86−100
KAS Year
Pre−KAS
Post−KAS Year 1
Post−KAS Year 2
1.3% %
3.6% %
6.1% %
6.9% %
10.1% 11.8%
16.2%
14.3%
19.8% 19.8%
28.0% 28.4%
40.2% 41.7%
66.8% 65.0% 0%
20%
40%
60%
0−10
11−20
21−30
31−40
41−50
51−60
61−70
71−80
81−90
91−100
The overall discard rate increased from 19.3% post−KAS Year 1 to 19.9% post−KAS Year 2. Looking at the allocation sequences (top graphic), KDPI 21−34% kidneys saw a decrease in discard rate in the most recent year, while KDPI 35−85% kidneys discard rates increased again. KDPI 0−20% and 86−100% remain fairly stable in the post−KAS era. Looking more granularly (bottom graphic), discard rates for 21−30% and 91−100% KDPI kidneys decreased in the 2nd year post−KAS, but increased for KDPI and Pre−KAS KDPI data presented in the 1−year report were not this granular.
KDPI (%)
The overall discard rate increased from 19.3% post−KAS Year 1 to 19.9% post−KAS Year 2. KDPI 21−34%
kidneys saw a decrease in discard rate in the most recent year, while KDPI 35−85% kidneys discard
rates increased again. KDPI 0−20% and 86−100% remain fairly stable in the post−KAS era. 40

13. Delayed Graft Function (DGF) Rates
30% 29.6%
27.7%
24.4% 0%
10%
20%
Pre−KAS
Post−KAS Year 1 Post−KAS Year 2
KAS Year
Percent Delayed Graft Function (DGF)
It’s been well-documented that delayed graft function, or recipients requiring dialysis within the first week post-transplant, increased under KAS. However, though still higher than one-year pre-KAS, this increase tapered significantly in the second year post-KAS, from just shy of 30% to 28%.
The percentage of recipients requiring dialysis within the first week after transplant decreased from
29.6% post−KAS Year 1 to 27.7% post−KAS Year 2, but remains higher than pre−KAS.
The decrease was significant (p = ).

14. Patient and Graft Survival - Overall
KAS Year
Pre−KAS
Post−KAS
Time Post−Transplant (Days)
360
270
300
330
120 90 60 30
p−value:
80%
85%
90%
95%
100%
Patient Survival (%)
p−value:
80%
85%
90%
95%
100% 30 60 90
120
270
300
330
360
Graft Survival (%)
Overall, one-year patient survival is significantly lower post-KAS versus pre-KAS, at 96.2% post-KAS versus 96.9% pre-KAS. During policy development, simulation modelling for KAS showed a net benefit in survival, but the number of high CPRA , zero mismatch, non-local, and high dialysis time transplants, which present unique challenges, has been higher than predicted.
Similarly, although there was no significant decrease, one-year graft survival is slightly lower post-KAS versus pre-KAS, at 93.6% post-KAS versus 94.1% pre-KAS.
Analyses were stratified by factors including KDPI, CPRA, Dialysis time, recipient age, and CIT. There were no statistical differences pre- vs. post-KAS for KDPI > 85%, CPRA %, and dialysis 10+ years. Pediatric graft survival significantly improved with KAS, and CIT 36+ hours saw a significant decrease in graft survival post-KAS.
In summary, short-term patient and graft survival rates are lower in the post-KAS versus pre-KAS era. However, due to bolus effects, the characteristics of KAS recipients during the first year are not representative of recipients transplanted under KAS’s steady state, as was described previously. These slight declines in early outcomes, if real and not random variability, could be driven by these factors in combination, as well as other unaccounted factors.

15. Highlights: First 2 years of KAS
Many very highly sensitized and high dialysis time patients have been transplanted under KAS
Transplants to these groups have tapered over 2 years
Deceased donor transplant volume has increased
Largest impact on pediatric transplants is still concentrated in Region 5
However, utilization of recovered kidneys has not improved
DGF has increased but is slowly trending downward
Post-KAS, 1-year graft (94.1%) and recipient (96.2%) survival are excellent, though slightly lower than pre-KAS
In summary, many very highly sensitized and high dialysis time patients have been transplanted under KAS, and transplants to these groups have tapered over the past 2 years. Overall, the deceased donor transplant volume has increased 9%, however, utilization of recovered kidneys has not improved. The largest impact on pediatric transplants was observed in Region 5. DGF has increased with KAS but continues to slowly trend downward. Post-KAS, 1y-year graft and recipient survival are excellent, though patient survival is significantly lower than pre-KAS, and graft survival is not significantly different but trending in that direction.
The full 2 Year Report is available now on the OPTN Web site. In the coming year, the Kidney Committee will propose a complete review of KAS as a new project to the Policy Oversight Committee. If there are any specific aspects of KAS you would like the Committee to consider, please do not hesitate to contact our Committee Chair or Liaison with your comments.
IF ASKED WHAT WE’RE SPECIFICALLY LOOKING AT: Pediatric tx rates, priority points

16. Allowing Deceased Donor-Initiated KPD Chains
New Project
Allowing Deceased Donor-Initiated KPD Chains
Concept Paper with three models for allowing deceased donors to initiate KPD chains
Requesting feedback on proposed methods and feasibility
Available for comment on OPTN website
The Kidney Committee is also circulating a concept paper in order to gain early insight on the Deceased Donor-Initiated KPD Chains project. The Deceased Donor Chains Work Group began meeting in October 2016 to identify the potential logistical, operational and ethical concerns associated with these types of exchanges. Before selecting a policy solution, the Committee would like to notify the community that the project is underway and requests early input from all stakeholders.
The Deceased Donor Chains Work Group itself includes representation from several external societies, UNOS Committees, as well as major KPD programs.

17. Concepts Under Consideration
FIRST: Candidate receives increased priority on Waitlist
THEN: Candidate is transplanted
THEN: Paired living donor donates
Candidate-Driven Model
FIRST: Paired living donor donates
THEN: Paired candidate receives priority on Waitlist
List Exchange Chains Model
FIRST: Deceased donor organ redirected from Waitlist allocation to a specific KPD program and their matching priorities
THEN: KPD Candidate matched and transplanted
Donor-Driven Model
I will briefly summarize the three concepts for you here before concluding the update portion of this presentation.
We’re asking the community to comment specifically on which of the three models presented in the paper is preferred, and any concerns the Committee should take into consideration.
In a candidate-driven system, a candidate enrolled in KPD is given predetermined priority on the deceased donor waitlist in exchange for their paired donor donating.
In a list exchange chain system, a donor/candidate pair enters the KPD program together. The paired living donor is matched to a paired candidate to begin a chain, similar to a non-directed donor chain. The chain continues with a bridge donor or donates to the waitlist. After the living donor donates, their paired candidate receives elevated priority on the deceased donor waitlist.
In a donor-driven system, a deceased donor kidney is redirected from the waitlist allocation for placement with a KPD program.
The Committee also welcomes suggestions for other models not yet considered. Following the fall public comment cycle, the Committee will consider feedback received and begin developing policy language.

18. Questions? Amber Wilk, PhD Nicole Turgeon, MD
Kidney Committee Research Liaison
Gena Boyle, MPA
SLK Liaison
Nicole Turgeon, MD
Kidney Committee Chair
Chelsea Rock Haynes, MPA
Kidney Committee Liaison
I’m happy to take any final questions you have on the SLK, KAS or Deceased Donor Chains updates before moving on to the Dual and En Bloc public comment proposals.