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John O. Colonna, II, MD
Surgical Director
Kidney Transplantation
SNGH & CHKD
April 28, 2018
KIDNEY TRANSPLANT UPDATE
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Changes in Deceased Donor Kidney AllocationDecember 2014
• June 24-25, 2013 – OPTN/UNOS Directors approved substantial amendments to Policy for allocation of deceased donor kidneys
• Goals of changes
Maintain access to transplantation
Enhance post-transplant survival benefit
Increase utilization of donated kidneys
Increase transplant access for biologically disadvantaged candidates
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WHY WAS CHANGE NEEDED ?
• Variability in access to transplantation by candidate blood type and geographic location
• Higher than necessary discard rates of kidneys that could benefit some candidates
• Many kidneys with long potential longevity being allocated to recipients with shorter potential longevity and vice-versa leading to increased need for retransplants
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WHAT IS NEW IN ALLOCATION SYSTEM
• Expanded definition of waiting time
• Sliding scale for sensitization points
• Broader sharing for extremely high PRA
• Expanded access for blood type B
• Longevity matching of some kidneys
• Regional sharing of kidneys with highest discard rates
8,380 additional life years achieved annually
Improved access for highly sensitized and minority candidates
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WAITING TIME DEFINITION
• OLD SYSTEM
Waiting time starts day of listing (GFR < 20)
• NEW SYSTEM
Waiting time starts day patient began dialysis or day GFR < or = to 20, regardless of date of listing
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LONGEVITY MATCHING
• KDPI – Kidney Donor Profile Index
Clinical formula, based on KDRI, incorporating 10 donor factors effecting estimated graft survival
• EPTS – Estimated Post Transplant Survival
Simplified version of Life Years from Transplant (LYFT)
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KDPI COMPONENTS• AGE – < 18 lowers KDPI, > 50 raises KDPI
• HEIGHT – (height – 170) / 10
• WEIGHT – < 80 kg, (weight – 80) /5
• ETHNICITY – increased KDPI for AA
• HTN – increases KDPI
• DIABETES – increases KDPI
• CAUSE OF DEATH – CVA increases KDPI
• CREATININE – rising creatinine increases KDPI
• HCV – increases KDPI for HCV+
• DCD – increases KDPI for DCD donor
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KDPI
• KDRI based on multivariable Cox proportional hazards regression model using graft outcomes from nearly 70,000 adult, solitary, first time deceased donor kidney recipients in U.S. 1995 – 2005.
• KDPI is simply a mapping of the KDRI from a relative risk scale to a cumulative percentage scale
• e.g. Kidney from a donor with a KDPI of 85% has a higher risk of graft failure than 85% of kidneys recovered from donors the previous year
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KIDNEY DONOR PROFILE INDEX
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E P T S
• LYFT felt to have too many variables
• EPTS – four variables, objective* and easily obtained
Candidate age
Diabetes status
Length of time of dialysis
Previous transplant
• Higher EPTS associated with lower expected patient survival
* Cardiovascular health lacked objective metric
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LONGEVITY MATCHING
• Incorporating EPTS allows for better matching of candidates and donated grafts so that individuals with very long EPTS do not receive kidneys with very short survival, thus reducing need for re-transplant
• To start, the use of EPTS in allocation was limited to only the 20% of donated kidneys with the lowest KDPI being offered first to the 20% of candidates with the longest EPTS before other candidates
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IMPROVING ACCESS FOR B CANDIDATES
• Kidneys from donors who are A2 or A2B will be offered first to B candidates
• To be eligible, candidates must have two consecutive quarterly anti-A titers of less than 1:8
• 9 OPO’s had trialed this with comparable survival rates and shortened waiting times for B recipients
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EFFECT OF CPRA ON TRANSPLANT RATEPRIOR TO NEW ALLOCATION SYSTEM
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CPRA SLIDING SCALE
CPRA Points CPRA Points
20 - 29 0.08 85 – 89 4.05
30 – 39 0.21 90 – 94 6.71
40 – 49 0.34 95 10.82
50 – 59 0.48 96 12.17
60 – 69 0.81 97 17.30
70 – 74 1.09 98 24.40
75 – 79 1.58 99 50.09
80 – 84 2.46 100 202.10
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BROADER SHARING FOR HIGHLY SENSITIZED CANDIDATES
• Local CPRA – 100
• Regional CPRA – 100
• National CPRA – 100
• Local CPRA – 99
• Regional CPRA – 99
• Local CPRA – 98
• Zero mismatch classifications
• Prior living donor
Transplant MD and HLA Director must approve unacceptable antigens listed for the candidate
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ALLOCATION SEQUENCESDoc, where am I on the waiting list?
• A – KDPI </= to 20%
• B – KDPI > 20, < 35%
• C – KDPI > 35, </= 85%
• D – KDPI > 85%
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PHS INCREASED RISK DONORS“ A BIRD IN HAND”
• 20+% of deceased donors now classified as IRD
• Am J Transplant. 2018:617-624. Bowring MG, et al
104,998 candidates offered IRD kidney which was ultimately accepted by someone – 12/25/09 to 1/6/15 SRTR data
After 5 yrs, patients who declined IRD offer
• 31% non-IRD DDKT, 6% IRD DDKT, 8% LDKT
• 20% died, 18% removed wait list, 15% still on wait list
• KDPI declined IRD – 21 vs. KDPI of accepted non-IRD – 52
• 5 year post-decision crude mortality was 14% for those who accepted IRD kidney, vs. 22.5% for those who declined
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RISK OF DISEASE TRANSMISSIONRISK BEHAVIOR HIV RISK %HIV RISK HCV RISK %HCV RISK
IV drug use 1:2000 0.05% risk 1:313 0.3% risk
Men having sex
with men1:2500 0.04% risk 1:333 0.03% risk
Commercial sex
worker1:3333 0.03% risk 1:833 0.12% risk
Incarcerated 1:10,000 0.01% risk 1:12,500 0.008% risk
Blood
transfusion1:20,000 0.005% risk 1:25,000 0.004% risk
Additional risk categories: hemodilution, poor historian, STD, sex with
someone with risk factors
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NATIONAL KIDNEY REGISTRY
• Incompatible pairs
• Non-directed donors
• Voluntary system
• Priority for matches which result in the longest chain
• Center of origin of non-directed donors gets additional points for their patients and receives end of chain kidney for allocation to center’s wait listed patients
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IMPACT OF KAS CHANGES & PROGRAM INITIATIVES
ON VOLUMES
0
2
4
6
4
0
7
11
6
18
4
2
0
4
2
0
2
4
6
8
10
12
14
16
18
20
NKR SPK CPRA>98 A2 to B PHS - IRD
2016 2017 2018 Q1
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PROGRAM VOLUMESSNGH + CHKD
2
2936
65 67
7
30
75
105112
2
1216
29 31
0
20
40
60
80
100
120
PANCREAS LIVING DONOR DECEASEDDONOR
TOTALKIDNEYS
TOTALORGANS
2016 2017 2018 Q1
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97.6% 97.2% 97.0% 97.0% 97.2%
99.2%
96.9%97.9% 98.0%
94.7%
70%
75%
80%
85%
90%
95%
100%
SNGH MCV UVA VIDANT INOVA
Scientific Registry of Transplant Recipients Kidney Transplants 7/1/14 - 12/31/16
One-Year Patient Survival
PREDICTED ACTUAL Observed Nationally (97.4%)
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95.4%94.6% 94.3% 93.8%
95.4%
97.4%
94.5%95.3%
96.0%94.8%
70%
75%
80%
85%
90%
95%
100%
SNGH MCV UVA VIDANT INOVA
Scientific Registry of Transplant Recipients Kidney Transplants 7/1/14 - 12/31/16
One-Year Graft Survival
PREDICTED ACTUAL Observed Nationally (95.2%)
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93.8% 94.2% 93.7%93.0%
91.3% 91.9%
95.9%
93.1%
90.0%
94.7%93.5%
89.5%
70%
75%
80%
85%
90%
95%
100%
SNGH MCV HD UVA Vidant Inova
Scientific Registry of Transplant Recipients Kidney Transplants 1/1/12 - 6/30/14
Three-Year Patient Survival
PREDICTED ACTUAL Observed Nationally (93.8%)
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88.2% 88.3% 88.5%87.0%
83.0%
86.7%
93.5%
87.8% 87.8%
89.9%
86.7%
84.2%
70%
75%
80%
85%
90%
95%
100%
SNGH MCV HD UVA Vidant Inova
Scientific Registry of Transplant Recipients Kidney Transplants 1/1/12 - 6/30/14
Three-Year Graft Survival
PREDICTED ACTUAL Observed Nationally (88.7%)
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100.0%
97.6%
100.0% 100.0% 100.0%98.6%
97.4%
94.5%
100.0%
95.3% 96.0% 94.8%
70%
75%
80%
85%
90%
95%
100%
SNGH MCV CHKD UVA VIDANT INOVA
Scientific Registry of Transplant Recipients Living vs. Deceased Donor Kidney Transplants 7/1/14 - 12/31/16
One-Year Graft Survival
LD ACTUAL DD ACTUAL LD Observed Nationally (97.8%) DD Observed Nationally (95.2%)
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100.0%
95.2%
92.7%
97.3%
93.3%92.2%
93.5%
87.8% 87.8%
89.9%
86.7%
84.2%
70%
75%
80%
85%
90%
95%
100%
SNGH MCV HD UVA VIDANT INOVA
Scientific Registry of Transplant Recipients Living Donor vs. Deceased Donor Kidney Transplants 1/1/12 - 6/30/14
Three-Year Graft Survival
LD ACTUAL DD ACTUAL LD Observed Nationally (96.5%) DD Observed Nationally (88.7%)
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SUMMARY
• Changes in the Kidney Allocation System and Program Initiatives have dramatically increased kidney and pancreas transplant volumes at Sentara Norfolk General Hospital
• Clinical outcomes exceed our predicted results
• Patient and graft survivals are superior to those of our in-state and nearby centers as well as national averages
