New Kidney Allocation and What it Means to Your Transplant Center and Your Patients

Transcription

1 New Kidney Allocation and What it Means to Your Transplant Center and Your Patients Alexander Wiseman, M.D. Professor, Division of Renal Diseases and Hypertension Medical Director, Kidney and Pancreas Transplant Programs University of Colorado Health Sciences Center

2 The Kidney Transplant Waiting List: How do you get priority points in 2013? Time: Longest wait =1 point, with fractions of a point given for each candidate in order 1 Year=1 point Match: HLA DR match=1 point for each DR locus that is not mismatched (maximum of 2) Sensitization: Panel reactive antibody level>80%=4 points Good Samaritan: Prior kidney donation=4 points UNOS Policy 3.5

3 Case 1 A 24 y/o male is declared brain dead following an MVA and is an organ donor. Perfect health prior to MVA. The match run performed by UNOS identifies a recipient with the highest priority: 74 y/o man with DM, CAD s/p CABG, on dialysis/listed for 3 years, panel reactive antibody= 10% HLA DR matched at both loci=2 points 3 years of wait time=3 points Total=5 points

4 Case continued: #2 on the match run is a 30 yo female with IgA nephropathy on dialysis/waiting list for 3 years with a PRA of 70%, 4 Ag match (2 A, 1 B, 1 DR), listed with a different transplant program in the area HLA DR matched at one loci=1 point 3 years of wait time=3 points Total points=4 #3 on the match run is a 50 y/o with PKD, PRA 0% and no other medical problems on the waiting list for 4 years, potential 4 Ag match (2 A, 2 B) 4 years of wait time=4 points Total points=4

5 Major Rationale for Change The current system Uses few available objective medical criteria Kidneys with long projected post-transplant survival are allocated to candidates with short post-transplant survival (and vice versa)

6 Objectives for the Proposed Kidney Allocation System Improve outcomes of recipients of deceased donor kidneys through improved matching of graft/recipient projected survival Improve access for biologically disadvantaged kidney transplant candidates (highly sensitized, blood group B, minority candidates)

7 Overview of proposed policy Current Proposed All allocation sequences to be based on kidney donor profile index (KDPI)

8 Factors used to determine groups KDPI Donor age Race/ethnicity Hypertension Diabetes Serum creatinine COD CVA Height Weight DCD HCV Candidate Estimated Post-Transplant Survival (EPTS) Candidate Age Candidate Diabetes Prior transplant ESRD time

9 Overview of proposed policy Proposed Allocation to those with longest expected posttransplant survival Allocation first to Pediatric list, then according to waiting time Allocation according to waiting time Allocation to those who consent (similar to today s ECD ) All allocation sequences to be based on kidney donor profile index (KDPI)

10 Kidney Donor Profile Index (KDPI) KDPI Variables Donor age Height Weight Ethnicity History of Hypertension History of Diabetes Cause of Death Serum Creatinine HCV Status DCD Status

11 Case (for the referring nephrologist): Your 55 yo patient with T2DM, not yet on dialysis (but is close, with GFR 13) has consented to a KDPI >85. He gets an offer for a kidney that has KDPI of >85. Do you: A. Advise him to take it B. Advise him to decline it C. Ask about the KDPI

12 Case (for the transplant center): You receive an offer for a 55 yo patient with T2DM, not yet on dialysis (but is close, with GFR 13) who has consented to a KDPI >85. The donor is a 59 yo obese AA with CVA and HTN. The KDPI is 95. Do you: A. Accept the kidney B. Decline the kidney

13 Highly sensitized patients rarely get offers under current allocation policy

14 New Policy: Sensitization Points (Current) (Proposed) Current policy awards 4 points to candidates with PRA>80% Candidates <80% do not receive any points Proposed policy would generate a sliding scale for priority so that highly sensitized candidates get improved access

15 Modeling transplant results by CPRA (95-100%)

16 Projected results >8000 additional life years annually Slight increase in transplants to African Americans, blood type B, and high PRA recipients % of transplants current estimated Changes in age distribution < Recipients, by age

17 Allocation Scheme

18 Scenario 1: 48 yo with FSGS on HD for 7 years, variably adherent, missed transplant evaluations x 2 in past (illness). Still modestly nonadherent. Makes appointment, is ultimately placed on waiting list. Scenario 2: 68 yo with DM on HD for 2 years, very adherent, missed transplant evaluation in past (illness). Still very functional on CCPD, is ultimately placed on waiting list.

19 Proposed Point Changes: Waiting Time Current policy begins waiting time points for adults at registration with: GFR<=20 ml/min Dialysis time Proposed policy would also award waiting time points for dialysis time prior to registration Applies to both pediatric and adult candidates Better recognizes time spent with ESRD as the basis for priority Pre-emptive listing would still be advantageous for 0-ABDR mismatch offers

20 Discussion For the physician: How do you educate patients regarding new allocation policies? For the transplant center: How do you manage the waiting list with the new allocation policies?

21 Conclusions KDPI will permit efficient allocation but does not necessarily increase number of transplants, unless demand for high KDPI increases Sliding scale for sensitization/%pra are components that have gained approval

22 Case A 17 yo patient with Henoch-Schonlein Purpura (HSP) and CKD V not yet on dialysis She has a family member who is interested in donating with compatible blood type. Average waiting time for an adult blood type O candidate is 5 years What is the likelihood that she will get an offer for a kidney within 2 months? 12 months? What do you recommend: A) living donor transplant B) wait for deceased donor transplant

23 Pediatric Kidney Allocation

24 Pediatric kidney transplantation With introduction of Share 35 in November 2005 (in which all deceased donors < 35y are offered first to candidates <18y), waiting time is shorter, rates of living donation have fallen Age at Registration <1 Year Years Years Years Years Is shortening pediatric waiting time by 2-4 months really the best strategy? SRTR Annual Report 2011 Fig 8.13

25 Inferior outcomes with deceased donor vs living donor in pediatric recipients Higher acute rejection rates Worse graft survival Is the shorter waiting time worth the de-emphasis on living donation? SRTR Annual Report 2011 Figs 8.26, 8.27

26 Utility of Share 35 donor kidneys are NOT optimized by use in pediatric population Using Share 35 donors, overall graft survival and deathcensored graft survival is better in adults than those 17 Higher graft loss in younger recipients Higher death rate in older recipients Best utility is in recipients age 31-45, not the pediatric recipients Moudgil A et al, Transplantation 2013; 95:319

27 Pancreas Allocation and Transplantation

28 Patients receiving SPK transplants have the greatest net lifetime benefit * from transplantation *(estimated survival with functioning graft) - (estimated survival on dialysis x 0.8) 4% 32% 64% Wolfe R et al, AJT 2008; 8:

29 Organ Allocation: The kidney follows the pancreas Organ Donor: 2 kidneys, 1 pancreas Pancreas list A (E on kidney list) B C (G on kidney list) D Kidney list A B C D E F G If Pancreas follows kidney : Candidates A and B get kidneys, and B gets panc If Kidney follows pancreas : Candidate A gets kidney, and E gets SPK INCENTIVE TO PUT PATIENTS ON SPK LIST (EVEN T2DM???)

30 Organ Allocation for Diabetes: The kidney follows the pancreas Median waiting time to transplant (days) 2004 SPK A: 323 B: 520 O: 533 AB:214 Kidney A: 815 B: 1655 O: 1568 AB: 602 INCENTIVE TO PUT PATIENTS ON SPK LIST (EVEN T2DM???) SRTR Annual Report 2009

31 Case 46 yo man with T1DM who underwent SPK transplant after only 14 months of waiting tells his buddy with T2DM on dialysis how great it is to be off dialysis and without insulin. His buddy, a 49 yo with BMI 29, has been waiting on the kidney transplant waiting list for 2 years and wonders if he can undergo an SPK transplant What do you advise him? A) He is not a candidate due to T2DM B) SPK is much less successful in T2DM than T1DM C) SPK may be a reasonable option

32 Simultaneous Pancreas Kidney Transplantation: For T2DM? In U.S.-Eligibility for SPK waiting list: 1. DM with c-peptide <2 ng/ml 2. DM, c-peptide >2 ng/ml with BMI <28-30kg/m 2

33 Pancreas transplant outcomes are equivalent in T1DM vs. selected T2DM OPTN/UNOS Data analysis of SPK recipients T2DM recipients vs 6141 T1DM recipients Patient Survival Pancreas Graft Survival Pancreas-related complications T1DM T2DM P One-year kidney and/or pancreas rejection Pancreas complications abscess/local infection anastomosis leak pancreatitis primary nonfunction surgery to convert bladder to enteric drainage Sampiao M et al, CJASN 2011; 6: 1198

34 Does the added pancreas transplant lead to better outcomes for young, thin patients with T2DM? SRTR analysis of patients with T2DM, age 18-59, with BMI kg/m 2 receiving an SPK (n=424), LDKA or DDKA during : Multivariate analysis: HR 0.9 (p=ns) Multivariate analysis: HR 0.5 (p<0.001)) SPK: better patient survival than DDKA, but inferior compared to LDKA SPK: Waiting time much shorter, donor age much younger than DDKA Wiseman AC and Gralla J, CJASN 2012 Apr;7(4):656

35 Summary/Conclusion: SPK as a Transplant Option Avoid dialysis know the waiting time expectations for SPK and advise your patients accordingly For most T1DM: SPK is preferable to deceased donor kidney transplant. LD kidney transplant vs SPK: depends on dialysis/waiting time For most T2DM: LD > DD <10% of T2DM may be eligible for SPK, better than DD but may be inferior to LD