1. Donor Allocation Policy in the US
W. Ray Kim
Professor and Chief
Gastroenterology and Hepatology
Stanford University School of Medicine

2. Terminology Organ Distribution (Grouping)
Geographic organization for organ sharing
Consideration of logistics (i.e., cold ischemic time)
Regions and Donor Service Areas
Organ Allocation (Ordering)
Determination of priority among transplant candidates
Within/across distribution boundaries

3. Terminology Organ Distribution (Grouping)
Geographic organization for organ sharing
Consideration of logistics (i.e., cold ischemic time)
Regions and Donor Service Areas
Organ Allocation (Ordering)
Determination of priority among transplant candidates
Within/across distribution boundaries

4. Unit of Distribution for the severely ill
11 UNOS Regions
Unit of Distribution for the severely ill

5. 58 Donor Service Areas

6. Terminology Organ Distribution
Geographic organization for organ sharing
Consideration of logistics (i.e., cold ischemic time)
Regions and Donor Service Areas
Organ Allocation (Ordering)
Determination of priority among transplant candidates
Within/across distribution boundaries

7. Two cases Case #1 47-year old accountant with diabetes x 5 years
Refractory ascites requiring TIPS procedure in 2015
Disabling encephalopathy, requires frequent hospitalization
Lab: Bilirubin (3.0 mg/dl), INR (1.4), Creatinine (1.4 mg/dl)
Case #2
69-year old grandmother of 5 with HCV (transfusion in the 1970s)
Increasing ascites and encephalopathy
Admitted with SBP
Lab: Bilirubin (14.6 mg/dl), INR (1.8), Creatinine (1.9 mg/dl)

8. Who to Transplant?
If there is one liver to transplant, to which of the two cases should it be given?
49-year old accountant with refractory encephalopathy
MELD=18
9% 90-day mortality
97% expected 5-year survival with LTx
68-year old grandmother with SBP-induced hepatic decompensation
MELD=29
35% 90-day mortality
82% expected 5-year survival with LTx
To whom is LTx more life-saving?
In whom will the LTx deliver more meaningful life?

9. Philosophy in Liver Allocation
Use liver transplantation to save lives of dying patients
Share donated livers to derive maximum benefit
‘Efficiency’
principle
‘Urgency’

10. Philosophy in Liver Allocation
Sickest first
Rescue from certain death in desperately ill patients
Chance for post-LTx survival may be low.
Maximize benefits of LTx
Largest number of patients living with best quality of life
Severely ill patients may not be offered Tx.
‘Efficiency’
principle
‘Urgency’

11. Regulatory Mandates
Final rule (DHHS) on Organ Procurement and Transplantation Network (OPTN), 1998
Principles of organ allocation policies and procedures
Allocate organs in the order of medical urgency
Sound medical judgment
Avoid futile transplantation
Institute of Medicine (IOM) Report, 1999
Waiting time: not an appropriate measure of the fairness of the organ allocation system
Equitable allocation of organs based on medical characteristics and disease prognosis
42 CFR Part 121: available

12. Better Off Without LTx? ‘Share 15 National’ Policy Tx Harmful
Tx Better
Merion Am J Transpl 2005;307

13. More Cases Case #3 53-year old musician with long history of drinking
Ill with hepatic encephalopathy following a drinking binge
Ascites, muscle emaciation, gynecomastia
Lab: Bilirubin (14.6 mg/dl), INR (1.8), Creatinine (1.9 mg/dl)
Case #4
19-year old college student with acute hepatitis A
Encephalopathic
Case #5
59-year old businessman with HBV cirrhosis and HCC
Undetectable HBV DNA x 5 years on entecavir
Ultrasound: 6-cm mass in seg 7
Lab: Bilirubin (3.0 mg/dl), INR (1.4), Creatinine (1.4 mg/dl)

14. Who to Transplant?
If there is one liver to transplant, which patient should receive it?
49-year old accountant with refractory encephalopathy (MELD=18)
68-year old grandmother with HCV, hepatic decompensation, and SBP (MELD=29)
53-year old musician with alcoholic hepatitis (MELD=29)
19-year old college student with acute fulminant hepatitis A (MELD=29)
59-year old businessman with HBV and liver cancer (MELD=18)
What if there were two livers?

15. History of Liver Allocation in the US
1980
1990
2000
2010 No
Competition
Allocation
Increasing Demand
Organ
Shortage
Liver transplant as an experimental, last resort procedure
First-come-first-served
Urgency status
MELD Score
Share 15 National
Share 35 Regional
MELD-Na
2002

16. Impact of MELD-based Allocation on Waitlist Outcome
Decreased waitlist registration
Drop in median waiting time
Increased transplant rate
Decrease in mortality
Mortality per 100 patient-yeas

17. MELD Exception
MELD score in HCC patients does not take into account adverse oncological outcomes in patients waiting for LTx.
ESLD Patients
Other ‘Exception’ Patients
HPS, CF, PoPH, FAP,
Oxaluria
HCC Patients
Tumor progression beyond the Milan criteria
Disease progression to disqualify for LTx
MELD score effectively captures risk of death from liver failure

18. MELD Exception for HCC Initial implementation (2002):
MELD exception score = 29
2003 Revision:
Exception = 24
2005 revision:
Exception = 22
Upgrade scores: by 10% point increase in mortality every 3 months
Time 3 6 9 12 15 18 21
Exception 22 25 28 29 31 34 36 39

19. Challenges to the MELD System
HCC versus non-HCC Balance
% Drop Out
Days after registration
Washburn. AJT 2010; 10: 1652–1657

20. MELD Exception for HCC Initial implementation (2002):
MELD exception score = 29
2003 Revision:
Exception = 24
2005 revision:
Exception = 22
Upgrade scores: by 10% point increase in mortality every 3 months
As of 2016, HCC exception MELD score has been capped at 34.
Time 3 6 9 12 15 18 21
Exception 22 25 28 29 31 34
Time 3 6 9 12 15 18 21
Exception 22 25 28 29 31 34 36 39

21. Policing HCC Exception Policy
Specification of imaging equipment/procedure
Scanner, detector/coil type, contrast injection speed, etc.
Specification of eligible imaging characteristics
OPTN HCC Class (5A, 5B and 5T)
Compliance monitoring
Documentation of imaging records subject to audits by UNOS
Submission of explant pathology form
Within 60 days
If no HCC in explant, must submit imaging report in support
Committee review if >10% has no HCC on pathology report per year

22. UNOS HCC Imaging Criteria
OPTN Class 5B: must meet all of the following
Single nodule diameter 2-5cm
Contrast enhancement in late hepatic arterial phase
One of the following:
Washout on portal venous/delayed phase,
Late capsule or pseudocapsule enhancement,
Growth by 50% or more documented on serial MRI or CT obtained < 6 month apart OR
Biopsy
OPTN Class 5A nodules: tumors 1-2 cm
OPTN Class 5T nodules: OPTN Class 5B lesions treated loco-regionally.

23. Current Challenges Donor Shortage
Scientific Registry of Transplant Recipients (SRTR:

24. Summary
Tension between urgency and efficiency:
Urgency first
Avoid futile LTx
Progresses:
MELD improved waitlist outcome
Exception scores
Challenges:
Donor shortage
Better predictor of mortality (MELD-Na)
Truly broader geographic sharing
Equity among candidates with different indications

25. Current US Liver Allocation#3
49-year old accountant with refractory encephalopathy (MELD=18)
68-year old grandmother with SBP-induced hepatic decompensation (MELD=29)
53-year old musician with alcoholic hepatitis (MELD=29)
19-year old college student with acute fulminant hepatitis A (MELD=29)
59-year old businessman with HBV and liver cancer (MELD=18) #2 No #1 #3

26. 감사합니다.