Kidney Transplantation Committee

Spring 2015

Implemented Dec. 4, 2014

6 month data will be shared at Aug-Oct regional meetings

Monitoring community feedback to determine where clarification and tweaks may be needed in policy and UNet℠

Revised Kidney Allocation System

17+ data analyses, including:

Longevity matching: are fewer age or longevity-mismatched transplants occurring?

Access: are high CPRA and blood type B patients getting more offers and transplants? What is the distribution of transplants by recipient age?

Utilization: have kidney discard rates decreased, in particular for high KDPI kidneys?

How will KAS be monitored?

Geography: are more kidneys being allocated outside of the local DSA?

Unintended consequences:

are fewer kidney patients being listed?

has the number of transplants for any demographic or clinically specific groups changed unexpectedly?

how often are shipped kidneys for CPRA 99 & 100 patients discarded or redirected?

How will KAS be monitored?

Analysis schedule: 6 months, 1 year, annually

The problem:

OPTN Final Rule requires allocation policies be: based on sound medical judgment and standardized criteria seek to achieve the best use of organs avoid futile transplants

No standard rules or medical criteria specified in OPTN policy for SLK allocation

Current policy requires kidney to be allocated with liver if donor and candidate are in same DSA but does not specify rules for regional or national allocation

KAS and elimination of kidney payback system erased incentive for OPOs to share kidney with liver regionally

Simultaneous Liver Kidney (SLK) Allocation Project

2006-2007—Societies hold consensus conference on the issue

2009— Kidney and Liver Committees sponsor public comment proposal Majority of regions, individual commenters, and other

committees supported proposed changes Varying concerns expressed from national groups (ASTS,

NKF, AUA)

2010—Committees decided not to move forward due to complex IT programming associated with proposal (mostly due to kidney allocation variances) and development of the new KAS

2014—KAS is implemented, removing all variances

Important Historical Background

OPO community perspective: No consistent rules beyond local distribution means the OPO is left to make the decision

Liver community perspective: This inconsistency is counter to goal the regional ‘Share 35’ liver policy seeks to achieve

Kidney community perspective: Some medical criteria should be required to ensure that kidney is not allocated to a candidate who may regain kidney function after liver-alone transplant because this diverts access from a kidney alone candidate

Different Perspectives on the Problem

The Impact of the Problem by #’s

2015 SLK Working Group Recommendations

Transplant nephrologist must confirm candidate has one of the following:

And tx hospital must document one of the following in the medical record:

1. Chronic kidney disease 1. Dialysis for ESRD2. eGFR/CrCl at or below 35 mL/min

2. Sustained acute kidney non-function

1. Dialysis for six consecutive weeks2. eGFR/CrCl at or below 25 mL/min for at

least six consecutive weeks3. Any combination of #1 and #2 above for six

consecutive weeks

3. Metabolic disease Diagnosis of:1.Hyperoxaluria2.Atypical HUS from mutations in factor H and possibly factor I3.Familial non-neuropathic systemic amyloid4.Methylmalonic aciduria

Recommended SLK Eligibility Criteria

If candidate meets the eligibility criteria, the OPO must allocate the kidney with the liver if allocation is local or regional before offering the kidney to a kidney-alone candidate

Recommended SLK Allocation Policy

Data Reviewed for Safety Net Recommendations

If, 2-12 months after a liver transplant, a liver recipient is registered for a kidney and: has begun dialysis for ESRD or has an eGFR at or below 20 mL/min

The candidate will receive additional priority on the kidney waiting list

Once the candidate meets this criteria, the candidate will continue to be eligible for additional priority.

Recommended ‘Safety Net’ Policy

Sequence AKDPI <=20%

Sequence BKDPI >20% but

<35%

Sequence CKDPI >=35% but

<=85%

Sequence DKDPI>85%

Highly Sensitized0-ABDRmm Prior living donorLocal pediatricsLocal top 20% EPTS0-ABDRmm (all)Local (all)Regional pediatricsRegional (top 20%)Regional (all)National pediatricsNational (top 20%)National (all)

Highly Sensitized0-ABDRmmPrior living donorLocal pediatricsSLK safety netLocal adultsRegional pediatricsRegional adultsNational pediatricsNational adults

Highly Sensitized0-ABDRmmPrior living donorSLK safety netLocal RegionalNational

Highly Sensitized0-ABDRmmSLK safety netLocal + Regional National

Seeking feedback from: Regions Professional transplant societies and national groups Other Committees

Committees will reconvene in Spring to review feedback/finalize a public comment proposal for Fall 2015

Explore and discuss application of these changes to heart/kidney and lung/kidney allocation

Next Steps

Richard Formica, MD Committee Chair richard.formica@yale.edu

Regional Rep name (RA will complete) Region X Representative email address

Gena Boyle, MPA Committee Liaison

gena.boyle@unos.org

Comments/Questions?

Extras

Survival advantage of receiving a KI

Purpose: Provide evidence supporting SLK eligibility criteria

Crude survival advantage of receiving a kidney vs. liver aloneR

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Cohort: recipients Mar 31, 2002 – Dec 21, 2012

p-value=0.0007LI Alone SLK

White 70% 62%

Diabetes 27% 41%

MELD* 36 27

KDPI% 50 40

Age* 55 56

LI CIT* 6.9 6.4

LI Alone SLK

White 73% 65%

Diabetes 23% 38%

MELD* 17 28

KDPI% 50 40

Age* 55 57

LI CIT* 6.7 6.5

* Medians are shown

KI graft survival for SLK vs. KI alone… and Heart-Kidney

Purpose: Assess degree of decrease in kidney graft survival in multi-organ

transplants

Kidney graft survival

Cohort: recipients Mar 31, 2002 – Dec 21, 2012

Recipient survival

SLK (ren. failure)SLK (no ren.

failure)KI

White 62% 65% 45%

Age (median) 56 57 54

Kidney graft survival

Cohort: recipients Mar 31, 2002 – Dec 21, 2012

The effect of a previous LI tx on KI waiting list and recipient survival

Purpose: provide evidence supporting the use of the safety net

Kidney patient survival: with vs. without prior liver tx

Waiting list survival Recipient survival

Time period: Mar 31, 2002 – Dec 21, 2012

With LI (<=1)

With LI (>1)

W/t LI

White 75% 74% 45%

Age (median) 57 59 53

With LI (<=3)

With LI (>3)

W/t LI

White 70% 78% 45%

Age (median) 57 60 54

Summary

Predicting ESRD* after LI txIsrani, at al Am J Transplant 2013; 13: 1782–1792

Hazard function for ESRD (post MELD) Incidence of ESRD

* Initiation of maintenance dialysis therapy, KI tx or listing for KI tx

Kidney Transplantation Committee

Liver and Intestinal Organ Transplantation Committee

OPO Committee

Ethics Committee

Minority Affairs Committee

Operations and Safety Committee

SLK Working Group

Achieving a Balance

Access

Utility