Case 1: Old vs. New Scheme - med-iq.com

Case 1: Old vs. New Scheme

A 24-year-old man is declared brain dead following an MVA, previously was in perfect healthMVA, previously was in perfect health

• 74-year-old man, blood group B in NC, DM and CAD s/p CABG, 3 years listing and HD, DR matched, PRA = 10% (5 points)

• 30-year-old woman, blood group AB in CA, IgA, 3 years listing and HD, PRA = 79%, 4 antigen match (2A, 1B 1DR); listed elsewhere (4 points)1B, 1DR); listed elsewhere (4 points)

• 50-year-old man, blood group O in NY, PKD, 4 years listing, PRA = 0%, 4 antigen match (2A, 2B, 0DR) (4 points)

Kidney Waiting List: How One Would Get Priority Points in 2013

Time

• Longest wait = 1 point (fractions of a point given for each candidate in order)

• 1 year = 1 point

Match

• Sharing a single HLA-DR mismatch with the donor = 1 point

• Sharing a zero HLA-DR mismatch with the donor = 2 points

Sensitization

PRA ≥ 80% = 4 points

Good Samaritan

• Prior kidney donation = 4 points

UNOS Policy 3.5. http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_7.pdf.

• Few objective medical criteria

Waiting time

Rationale for Change

– Waiting time…

• No outcomes matching

– Survival of kidney & recipient are not always matched

ABO

ABO Frequency and Median Wait Time for Kidney Transplantation in the US

Frequency1 O A B AB

US Black 49% 27% 20% 4%

US White 45% 40% 11% 4%

*1,851 days 1,207 1,935 853Median Wait , y

(5.1 years)

,

(3.3)

,

(5.3) (2.3)

1Racial & Ethnic Distribution of ABO Blood Types. www.bloodbook.com/world-abo.html;2OPTN. http://optn.transplant.hrsa.gov/latestData/step2.asp.

Median Wait Times2

Unadjusted Median Wait Times (Years) for Adults Transplanted in 2011, by State of Transplant Center

Patients age 18 years and older receiving a first-time, deceased-donordeceased donor, kidney-only transplant in 2011

US Renal Data System. Chapter 7. Transplantation. www.usrds.org/2013/view/v2_07.aspx.

Old vs. New Scheme

SCD KDPI ≤ 20%OLD NEW

DCD & ECD

Kidney Becomes Available

ECD

KDPI ≥ 35% but ≤ 85%

Kidney Becomes Available

KDPI > 20% but < 35%

All allocation sequences based on KDPI

Friedewald JJ, et al. Surg Clin North Am. 2013;93:1395-406;OPTN. Proposal to Substantially Revise The National Kidney Allocation System.

http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_311.pdf.

DCD & SCD KDPI > 85%

New Kidney Allocation Policy: KDPI and EPTS

KDPI≤0.20 KDPI≤0.21-0.34 KDPI≤0.35-0.85 KDPI>0.85

Local CPRA 100% Local CPRA 100% Local CPRA 100% Local CPRA 100%

Regional CPRA 100% Regional CPRA 100% Regional CPRA 100% Regional CPRA 100%Regional CPRA 100% Regional CPRA 100% Regional CPRA 100% Regional CPRA 100%

National CPRA 100% National CPRA 100% National CPRA 100% National CPRA 100%


Regional CPRA 99% Regional CPRA 99% Regional CPRA 99% Regional CPRA 99%


0 HLA mm top 20 0 HLA mm 0 HLA mm 0 HLA mm

Prior living donors Prior living donors Prior living donors Local, regional adult

Local pediatric Local pediatric Local National adult

Local top 20 Local adult Regional

0 HLA mm bottom 80 Regional pediatric National

Israni AK, et al. J Am Soc Nephrol. 2014. [Epub ahead of print]

g p

Local bottom 80 Regional adult

Regional pediatric National pediatric

Regional top 20 National adult

Regional bottom 80

National pediatric

National top 20

National bottom 80

Estimated Graft Survival Rates by KDPI

KDPI Variables

1. Donor age100%94 0%

2. Donor height

3. Donor weight

4. Donor ethnicity

5. h/o HTN

6. h/o DM

7. Cause of death

8. SCr

Gra

ft S

urv

ival

Rat

e

1-Year

75%

70%

85%

80%

95%

90%

73.6%76.3%

79.4%81.5%

83.2%84.6%

86.0%87.3%

88.4%89.4%

90.1%

90.8%

78.7%

82.1%84.0%

86.2%87.7%

88.8%89.8%90.7%91.6%92.4%93.1%93.5%

94.0%

9. HCV status

10.DCD status

Friedewald JJ, et al. Surg Clin North Am. 2013;93:1395-406.

G

KDPI

1-Year2-Year65%

60%0% 10% 20% 30% 40% 50% 60% 70% 80% 90%100%

69.0%

Patient Survival Curves by EPTS

Kaplan-Meier Patient Survival Curves by EPTS ScoreDecreased donor, adult, solitary kidney transplants from 2003-2010

based on OPTN data as of Feb 7, 2014

Dis

trib

uti

on

Fu

nct

ion

EPTS 0%-20%

0.50

0.75

1.00“Raw EPTS” =

0.047 * Max (Age – 25, 0) +

-0.015 * Diabetes * Max (Age – 25, 0) +

0.398 * Prior Solid Organ Transplant +

-0.237 * Diabetes * Prior Organ Transplant +

0.315 * Log (Years on Dialysis + 1) +

-0.099 * Diabetes * Log (Years on Dialysis + 1) +

0.130 * (Years on Dialysis = 0) +

OPTN. http://optn.transplant.hrsa.gov/ContentDocuments/Guide_to_Calculating_Interpreting_EPTS.pdf.

Su

rviv

al

Years After Transplant

21%-40%41%-60%61%-80%81%-100%

0.00

0.25

0 1 2 3 4 5 6 7 8

-0.348 * Diabetes * (Years on Dialysis = 0) +

1.262 * Diabetes

Old vs. New: Case 1 (continued)

24-year-old man, brain dead following an MVA, previously in perfect health (0.63, 6%)

74 ld 5 i t 98%74-year-old manDM and CAD s/p CABG3 years listing and HD PRA = 10%, DR matched

5 points 98%5 points

30-year-old womanIgA3 years listing and HDPRA = 79%, 4 antigen match (2A, 1B, 1DR)Li t d l h

4 points 5%~6 points

Listed elsewhere

55-year-old manPKD4 years listingPRA = 0%, 4 antigen match (2A, 2B, 0DR)

4 points 23%4 points

58 year old from NC, blood type O, DM II, eGFR 20 mL/min/1.73m2 presents to the nephrologists office

Case #2: When to Refer a Patient

mL/min/1.73m2 presents to the nephrologists office to discuss options for renal replacement therapy.

• When should he be referred?

• Should he take a kidney with a KDPI > 85%?

Proposed Point Changes: When Does Wait Time Begin?

Current Policy:y

• Time begins at listing (eligible for listing with eGFR< 20 mL/min, including on RRT)

New Scheme:

• Time begins at listing with eGFR < 20 mL/min or with initiation of dialysis (if listed after start of RRT)

Friedewald JJ, et al. Surg Clin North Am. 2013;93:1395-406;Israni AK, et al. J Am Soc Neprol. 2014. [Epub ahead of print].

Preemptive listing still advantageous for 0 ABDR mismatch offers and ability to accrue

Weighing the Risk vs. Benefit of KDPI > 85%

Do Not Use Kidney Use Kidney

• Risk– Death on dialysis

• Benefit– Hope for better kidney

• Risk– Early graft failure

– Early mortality

• Benefit– Improved survival

Friedewald JJ, et al. Surg Clin North Am. 2013;93:1395-406;Israni AK, et al. J Am Soc Neprol. 2014. [Epub ahead of print].

Outcomes among recipients of first deceased-donor transplant,

Projected Life-Years Remaining for Patients on Wait List vs. With Transplant

Age Range

DM Status

Projected Life-YearsWithout Transplant

(n = 46,164)

Projected Life-Years With Transplant

(n = 23,275)

20-39 - 20 31

+ 8 25

40-59 - 12 19

for dialysis patients placed on the wait list 1991-1997

Wolfe RA, et al. N Engl J Med. 1999;341:1725-30.

40-59 - 12 19

+ 8 22

60-74 - 7 12

+ 5 8

Projected Life-Years Remaining for Patients on Wait List vs. With Transplant

80Expected Remaining Life-Years

Ad

dit

ion

al Y

ears

US PopulationDialysis PatientsTransplant Recipients

20

40

30

60

50

80

70

OPTN. http://optn.transplant.hrsa.gov/ContentDocuments/KDPI_Guide_Clinicians.pdf.

A

Individual Age Category

20

010

KDPI Selection (New) vs. ECD (Old)

• Patients with high morbidity/mortality on dialysis:– Elderly DM– Elderly, DM

• Patients with expected long duration on dialysis: – OPOs with long wait times, highly sensitized, long time

already on dialysis

• Caution: – High peri-operative mortality, high BMI, highly sensitized,

retransplant frailty

OPTN. http://optn.transplant.hrsa.gov/ContentDocuments/Guide_to_Calculating_Interpreting_KDPI.pdf.

retransplant, frailty

A 55 year old with diabetes x25 years ESRD on

Case #3: ABO Blood Type–Incompatible Kidney Transplantation and Access to Organs

A 55 year old with diabetes x25 years, ESRD, on dialysis 2 years, presents for a kidney transplant evaluation.

• He is from North Carolina, is blood group B, has a BMI of 29, and has a history of blood transfusion, with a cPRA of 90%.

How do you counsel this patient with regards to an• How do you counsel this patient with regards to an ABO incompatible organ in the new system (i.e. taking an A2 organ)?

Pre-Transplant Wait Times by Blood Type and PRA, Listed 2003-2004

Median Wait Time O A B AB PRA PRA PRAMedian Wait Time

Days (Years)

O A B AB PRA

0%-9%

PRA

10%-79%

PRA

> 80%

Nationwide 1,851

(5.1)

1,207

(3.3)

1,935

(5.3)

853

(2.3)

1,381

(3.8)

1,884

(5.2)

NR

Region 11

VA, NC, SC, KY, TN

1,795

(4.9)

1,027

(2.8)

1,758

(4.8)

754

(2.1)

1,476

(4.0)

2,005

(5.5)

2,581

(7.1)

OPTN. 2014 Data. http://optn.transplant.hrsa.gov/latestData/rptStrat.asp.

TN

New Policy: Sensitization Points

Currency Priority Points for Sensitization

4

5

ori

ty

If candidate’s CPRA score is…

…then candidate receives…

CPRA, % Points

0 19 0

Candidate Sensitization Level, CPRA

100%

0

1

2

4

Ad

dit

ion

al P

riP

oin

ts

95%

90%

85%

80%

75% 5% 0%70%

65%

60%

55%

50%

45%

40%

35%

30%

25%

20%

15%

10%

Current 0-19 0

20-29 0.08

30-39 0.21

40-49 0.34

50-59 0.48

60-69 0.81

70-74 1.09

75-79 1.58

80-84 2.46

85-89 4.05

90-94 6.71

95 10.82

96 12.17

Current PolicyPRA > 80% = 4 pointsPRA < 80% = 0 points

New PolicySliding Scale = Improve Access,

Outcomes?!OPTN. Proposal to Substantially Revise The National Kidney Allocation System.


96 12.17

97 17.3

98 24.4

99 50.09

100 202.1

Recipient/Donor O A B AB

Historic ABO Compatibility

New Policy: ABO Compatibility

O ✔

A ✔ ✔

B ✔ ✔

AB ✔ ✔ ✔ ✔

Recipient/ Recipient/D O A A B A B A B

Allocation Within ABO1 Allocation in New System2

Donor O A B AB

O ✔

A ✔

B ✔

AB ✔

Donor O A1 A2 B A1B A2B

O ✔

A ✔ ✔ ✔

B ✔ ✔ ✔

AB ✔ ✔

1OPTN Policies. http://optn.transplant.hrsa.gov/ContentDocuments/OPTN_Policies.pdf#nameddest=Policy_08;2Friedewald JJ, et al. Surg Clin North Am. 2013;93:1395-406.

Graft Survival of B Recipients: A2 or A2B Donor Kidneys Compared With B or O Kidneys

Examination of A2/A2B donors to B recipients between Jan 1994 and Dec 2000 (n = 41) performed at a single Midwestern OPO vs. O/B to B (n = 80)

Graft Survival (Years)

ABO CombinationDWFGa

Censored 1 2 3 4 5 P Value

A2/A2B → B(n = 41)

Yes 91%(28)b

91%(20)

85%(14)

85%(5)

85%(4)

0.48

B, O → B(n = 80)

Yes 91%(60)

86%(50)

84%(37)

80%(23)

80%(16)

0.55

Nelson PW, et al. Am J Transplant. 2002;2:94-9.

95.1% (39/41) of the B patients transplanted with A2 kidneys consistently had low anti-A titers (≤ 4)

A2/A2B →B(n = 41)

No 84%(28)

77%(20)

72%(14)

72%(5)

72%(4)

0.78

B, O → B(n = 80)

No 84%(60)

77%(50)

73%(37)

68%(23)

64%(16)

0.75

aPatient died with a functioning graft.bThe number in parentheses at each time-point represents the number of patients at risk through the end of each respective year.

Changes Expected in the New System

Projected percentage of kidney-alone recipients by age for the baseline and

proposed systems50ien

ts

Overall benefit by age group, depicted as total post-transplant lifespan for recipients

per 1,000 years

0

4540

3025

35

15

5

20

Baseline(2009 + extras)Proposed(top 20%, then within 15%)

5 510

enta

ge

Kid

ney

-Alo

ne

Rec

ip

11

18

2731

41

35

16

11

0

50

30

40

20

10

BaselineProposed

To

tal P

ost

-Tra

nsp

lan

t

Lif

esp

an/1

,000

yea

rs

1414

21

37

107

3732

37

44

• > 8,000 additional life-years annually

• Slight increase in transplants to AA, blood group B, high PRA

• Changes in age distributionOPTN. Proposal to Substantially Revise The National Kidney Allocation System.

http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_311.pdf;OPTN. Concepts for Kidney Allocation.

http://optn.transplant.hrsa.gov/SharedContentDocuments/KidneyConceptDocument.pdf.

0< 18

Per

ce

Recipient Age, years18-3435-49 50-64 > 65

0

Recipient Age, years< 18 18-34 > 6550-6435-49

Preparations for the New Allocation System

For Physicians:

Educate Patients

N t h ill h• Not much will change

• Living donation remains the best option

• Early referral and early listing remain advantageous

• Patients with B-blood type and low-A2 titers should consider A2 organs

• Patients with high mortality rates on dialysis (either on dialysis or near starting dialysis) should consider organs with KDPI > 85%

For Transplant Center: Ed t P ti t d P I f t tEducate Patients and Prepare Infrastructure

• Double check dialysis start dates and EPTS variables

• Educate and consent patients for KDPI organs > 85%

• Educate and consent patients with B-blood type for A2 organs

• Review HLA data for all highly sensitized patients

Friedewald JJ, et al. Surg Clin North Am. 2013;93:1395-406; Israni AK, et al. J Am Soc Neprol. 2014. [Epub ahead of print]; OPTN. Proposal to Substantially Revise The National Kidney Allocation System.


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