case 1: old vs. new scheme - med-iq.com
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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%
Local CPRA 99% Local CPRA 99% Local CPRA 99% Local CPRA 99%
Regional CPRA 99% Regional CPRA 99% Regional CPRA 99% Regional CPRA 99%
Local CPRA 98% Local CPRA 98% Local CPRA 98% Local CPRA 98%
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.
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_311.pdf.
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.
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_311.pdf.
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