kidney transplantation committee update john j. friedewald, md committee chair meetings

Kidney Transplantation Committee Update

John J. Friedewald, MDCommittee Chair

Meetings

Progress to develop a new national kidney allocation system

Recommendations regarding variances Kidney Paired Donation

Ongoing Projects

NATIONAL KIDNEY ALLOCATION SYSTEM

Simulation modeling completed and results reviewed by Committee

Objectives for a new system were met (limitations of current system addressed)

Committee voted to send out a policy proposal in the fall

Progress Update

Top 20 % KDPIto

Top 20 % EPTS

Allocation under “current rules”(All Candidates)

Opt in system of highest 15% KDPI

kidneys“Think improved ECD”

Patients rank ordered by•Waiting /ESRD time•DR matching•Sliding scale CPRA System features•A2 -> B•Broader sharing CPRA>=98%

Patients rank ordered by• Waiting/ESRD timeSystem features• Regional sharing• A2 -> B•Broader sharing CPRA>=98%

Current Working Model

0--------------------------------20-------------------------------------------------85------------------------100KDPI Scale

Addressing System LimitationsStated Limitation of the Current System Applicable Concepts

Mismatch between potential survival of the kidney and the recipient

Longevity matching

Variability in access to transplantation by blood group and geographic location

A2/A2B, broader sharing

High discard rates of kidneys that could benefit candidates on the waiting list

KDPI, expedited placement

Reduce differences in transplant access for populations described in NOTA (e.g., candidates from racial/ethnic minority groups, pediatric candidates, and sensitized candidates).

ESRD time, broader sharing, CPRA sliding scale, maintain peds priority

SIMULATION MODELING RESULTS

Summary Table

Average for 10 iterations N1 N4

Number of candidates (on waitlist at start or joining during run)

122,669 122,669

Average number of primary transplant recipients (KI+KP)

11,531 (11,463-11,586)

11,365 (11,324-11,409)

Average median lifespan post-transplant (min, max of runs)

11.82(11.75 - 11.85)

12.73 (12.65-12.79)

Average median graft years of life (min, max of runs)8.82

(8.80-8.84)9.10

(9.08-9.12)

Average median extra life-years for tx recipient versus waitlist candidate (min, max of runs)

5.01(4.99-5.03)

5.27 (5.24-5.29)

Average median LYFT per transplant (min, max of runs)

5.70 (5.68-5.72)

5.97 (5.95-6.0)

0

5

10

15

20

25

30

35

40

45

50

A AB B O

Perc

ent

2010 N1 N4

-8.0

-6.0

-4.0

-2.0

0.0

2.0

4.0

6.0

8.0

10.0

A AB B O

Diff

eren

ce in

Per

cent

from

N1

N4

Kidney Transplants by Recipient Blood Type

0

5

10

15

20

25

30

35

40

45

<18 18-34 35-49 50-64 65+

Perc

ent

2010 N1 N4

-10.0

-8.0

-6.0

-4.0

-2.0

0.0

2.0

4.0

6.0

8.0

10.0

<18 18-34 35-49 50-64 65+

Diff

eren

ce in

Per

cent

from

N1

N4

Kidney Transplants by Recipient Age

To Table

05

101520253035404550

Perc

ent

2010 N1 N4

-10-8-6-4-202468

10

Diff

eren

ce in

Per

cent

from

N1

N4

Kidney Transplants by Recipient Race

0

1

2

3

4

5

6

7

8

9

10

0 Total HLA mismatches

Perc

ent

2010 N1 N4

-10

-8

-6

-4

-2

0

2

4

6

8

10

0 Total HLA mismatches

Diff

eren

ce in

Per

cent

from

N1

N4

Kidney Transplants by 0 HLA mismatches

0

10

20

30

40

50

60

70

80

90

100

2010 N1 N4

Perc

ent

Local

Shared

Kidney Transplants by Organ Sharing

0

10

20

30

40

50

60

Perc

ent

Waitlist 2010 N1 N4

Kidney Transplants by Recipient CPRA, with waitlist prevalence

To Table

N3 versus N4

N3 N4

• Local CPRA 98-100• Regional CPRA 98-100• National CPRA 98-100

first priority for all kidneys

• Local CPRA 100• Regional CPRA 100• National CPRA 100• Local CPRA 99• Regional CPRA 99• Local CPRA 98

first priority for all kidneys

Kidney Transplants by Recipient cPRA, 95-100

0

1

2

3

4

5

6

95 96 97 98 99 100

Perc

ent o

f tot

al K

IA tr

ansp

lant

s

Waitlist 2010 N1 N3 N4

To Table

Kidney Transplants by Recipient CPRA

-10

-8

-6

-4

-2

0

2

4

Diff

eren

ce in

Per

cent

fro

m N

1

N4

To Table

Projected median patient years of life per transplant: average, minimum, maximum of runs

Projected median graft years per transplant: average, minimum, maximum of runs

Projected LYFT per transplant:average, minimum, maximum of runs

VARIANCE REVIEW PROCESS

Variances

The Committee received rationales from the above OPOs wishing to keep existing variances in the new allocation system

PADVPATF

TXSBTXGC

OKOP VATB

Reg 1

Discontinuation of all variances except for Dialysis waiting time study A2/A2B

Align changes to take place at the time a new kidney allocation system is implemented

Allow applications for transition

Recommendations will be circulated for public comment in the fall

Variance Recommendations

Estimated Date Action

June 25, 2012 OPTN/UNOS Board of Directors reviews recommendations for discontinuation(no action at this time)

Fall 2012 Public Comment for new national kidney allocation system and transition plans approved by the Committee

June 2013 Board of Directors considers proposal and transition plans

Fall 2013 Approved transition plans implementedTBD (likely 2014) New kidney allocation system implemented and

transition plans ended

Timeline for KAS and Variance Proposals

Kidney Paired Donation Pilot Program Update

Overall Match Run Results

Match Run Date Candidates Donors Candidates Matched

Candidates Transplanted

November 15, 2011 134 146 8 2December 12, 2011 144 158 10 0January 25, 2012 104 117 7 0February 23, 2012 128 142 13 0March 21, 2012 145 163 27 0April 4, 2012 135 150 5 0April 19, 2012 151 169 24 2 scheduledMay 2, 2012 150 167 16 0May 16, 2012 151 167 5 2 pendingJune 12, 2012 154 170 16 7 pendingJune 19, 2012 148 163 16 7 pending

TOTAL 19, 16 pending

Centers refusing matches based on combinations of low-level antibodies Donor Pre-Select Tool

Frequency of match runs Now running matches twice a month Will increase frequency as resources allow but

ultimate flexibility depends on automation of the match run

Barriers and Potential Solutions

Sizes of exchanges Testing a smaller exchange size (chain cap of 4)

in June match runs

Barriers and Potential Solutions

June 12, 2012 Match Run Results (#22)

Participants included in the match154 candidates (88 highly sensitized)

170 total donors5 NDDs (2 A, 1 AB, 2 B)

48 centers from 11 regions had at least one eligible pair

Results16 matched candidates (including waiting list candidates)

One 4-chain exchange, Two 3-chain exchanges, Two 3-ways 6 candidates have a CPRA>= 80%

3 NDDs who matched (1A, 2B)

KPD Work Group Activities

Two proposals completing public comment: KPD Policy to replace Operational Guidelines

Comments focused on histocompatibility section and whether the program is ready for policy language

Bridge Donor Proposal Public comment supportive of including bridge

donors

Both proposals likely to be forwarded to the Board in November 2012

KPD Policy

KPD Automated Solution Update

Released on December 12, 2011

Included the ability to: Enter KPD application from UNet℠ Add and maintain donors and candidates Search for donors and candidates Verify ABO Print records

Pre-Match Data Entry Screens

Released on May 24, 2012:

Allows users to view whether candidates and donors are eligible for the next match run in real time

Includes warning messages for potential data entry errors

Eligibility Processing

“I really like the app and think it's user interface should set the standard for other programs. It's a great first step.”

“The addition of eligibility status to the UNet KPD module is a HUGE benefit! I love it that it now tells what is still missing, so we don't have to go hunting for it. Will try to get some more pairs ready for next week's match run. "

Feedback from Users

Donor pre-select tool

Automation of the match run

Display of match results

Tracking of match responses

Future Functionality

Questions?

BACKUP SLIDES

Counts of Kidney Transplants by Recipient CPRA

CPRA Group

Run 0 vs N1

1-19 vs N1

20-49

vs N1

50-79

vs N1

80-89

vs N1

90-94

vs N1

95+ vs N1

N16609 759 - 1001 - 805 - 748 394 478 -

N26922 +313 775 +16 987 -14 766 -39 753 +5 +368 -27 424 -54

N35555 -1054 578 -181 1236 +235 1255 +450 584 -164 +310 -84 1251 +772

N45895 -714 607 -152 1291 +289 1311 +506 623 -126 +338 -57 681 +203

Back To Figure

Counts of Kidney Transplants by Recipient CPRA, 95+

CPRA Group

Run 95 vs N1 96 vs N1 97 vs

N1 98 vs N1 99 vs

N1 100 vs N1

N1 81 - 101 - 94 - 61 - 71 - 71 -

N2 67 -14 87 -14 85 -9 54 -7 64 -7 67 -4

N3 59 -22 70 -31 74 -20 383 +322 398 +327 267 +196

N4 65 -16 75 -26 81 -13 68 +7 108 +37 284 +213

Back To Figure

Counts of Kidney Transplants, by Recipient Age

Age Group

Run <18 vs N1 18-34 vs N1 35-49 vs N1 50-64 vs N1 65+ vs N1

N1529 1120 - 2719 - 4437 - 1991 -

N2475 -54 1178 +58 2765 +46 4540 +103 2036 +45

N3474 -55 1648 +528 3048 +329 3985 -451 1613 -378

N4491 -38 1668 +548 3012 +294 3948 -488 1625 -366

Back To Figure

Sharing by cPRA 98+

0

50

100

150

200

250

300

350

400

450

98 99 100 98 99 100 98 99 100 98 99 100

N1 N2 N3 N4

Tran

spla

nt C

ount

s

Local Regional National

Sharing by 0mm

Pediatric and Adult Transplants by Sharing

Adult and Pediatric Transplants by Top 20/Bottom 80

Top 20 recipients by HLA-mismatch

Sharing by run

• N2 projects a similar amount of sharing as N1• N3 projects fewer local transplants than N1

Sharing by run, continued

• N4 projects fewer local transplants than N1• N4 projects more local transplants than N3