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What's New


                                                                                  Liver Transplantation: Version 7.0

What’s New?

1. Updated first year billed charges from Milliman:


See table at the end of this Quick Reference Guide.

2. Treatment of Hepatitis C

Hepatitis C (HepC) is the most common indication for liver transplantation (30% of all liver transplants). This virus is present in almost 1% of all Americans. The natural history of Hepatitis C viral infection is quite morbid with 75% of infected patients going on to develop chronic infection. Furthermore, 10-20% will develop cirrhosis and 1-5% will succumb to either cirrhosis or both cirrhosis and Hepato-Cellular carcinoma. While this is a serious and potentially life threatening disease, the recent introduction of highly effective anti-viral therapies has the potential to dramatically and positively impact the natural history of this disease. It is projected that transplants for conditions arising from HepC will significantly decline over the next decade, including many fewer new cases of HCC.  In the meantime, the medical community is continuing to evolve protocols directed at eliminating the Hepatitis C virus in patients on the liver transplant waiting list and in patients re-infected post transplant. Historically, recurrent Hepatitis C was a leading cause of post-transplant graft and patient loss.


3. Updated UNOS liver allocation policy: [1]

Adult Donor Liver Allocation
 
The disparity between organ availability and clinical need continues to put an enormous strain on those physicians and organizations responsible for the allocation of these life saving organs. UNOS (United Network for Organ Sharing) is the governing body that decides who receives a donor’s organ. All transplant centers must follow UNOS rules. The algorithm determining liver allocation was fundamentally changed in 2002 when the transplant community adopted the MELD (Model for End-stage Liver Disease, PELD for children) system. This approach continues to be modified as the transplant community strives to minimize disparities in organ availability based on geography while simultaneously improving overall outcomes for patients on the liver transplant waiting list.

The most recent significant change to Liver Allocation (Share 35) became effective on June 18, 2013. Historically, livers were allocated locally, then regionally, and only finally nationally. This meant that local patients on the wait list might be transplanted when a more seriously ill patient in another area of the country continued to wait. This translated into potentially preventable deaths on the waiting list for these critically ill patients. Share 35 addresses this concern by mandating that all local and regional patients with a MELD score of 35 or higher be offered the liver before local patients with a lower MELD be considered.

The allocation algorithms have become quite complicated in efforts to achieve better use of organs and more equity for those on the wait list. For a comprehensive description and review of up-to-date (November 10, 2016) liver and other organ allocation policies, visit the Organ Procurement and Transplant Network web site here.

Liver allocation summary

        1) Candidates with MELD/PELD Scores <15 in descending order of mortality
             risk scores (probability of candidate death)
        2) Status 1A candidates in descending point order
        3) Status 1B candidates in descending point order
        4) All other candidates in descending order of mortality risk scores

The organ distribution system has a special pediatric policy that, for all candidates listed as status 1A and B, a liver recovered from a pediatric organ donor shall be allocated to a pediatric liver candidate first, then to an appropriately-sized adult candidate if the pediatric candidate’s transplant program cannot use the liver. Children receive 8 – 9 % of all liver transplants in the US.


Source: 2016 UNOS Transplant Management Forum

Pediatric Donor Liver Allocation Algorithm


Local

    1. Pediatric Status 1A candidates (age 0-17) in descending point order

Regional

    2. Pediatric Status 1A candidates (age 0-17) in descending point order

Local

    3. Adult Status 1A candidates in descending point order

Regional

    4. Adult Status 1A candidates in descending point order

Local

    5. Pediatric Status 1B candidates (age 0-17) in descending point order

Regional

    6. Pediatric Status 1B candidates (age 0-17) in descending point order

    7. Pediatric candidates age 0-11 in descending order of mortality risk scores

Local

    8. Pediatric candidates age 12-17 with MELD scores of 15 or greater, in
        descending order of mortality risk scores

    9. Adult candidates with MELD scores of 15 or greater, in descending order
        of mortality risk scores

Regional

    10. Pediatric candidates age 12-17 with MELD scores of 15 or greater, in
          descending  order of mortality risk scores

    11. Adult candidates with MELD scores of 15 or greater, in descending order
          of mortality risk scores

Local

    12. All other pediatric candidates age 12-17 in descending order of
          mortality risk scores

    13. All other adult candidates in descending order of mortality risk scores

Regional

    14. All other pediatric candidates age 12-17 in descending order of mortality
          risk scores

    15. All other adult candidates in descending order of mortality risk scores

National

    16. Pediatric Status 1A candidates in descending point order

    17. Adult Status 1A candidates in descending point order

    18. Pediatric Status 1B candidates in descending point order

    19. All other pediatric candidates age 0-11 in descending order of mortality risk scores

    20. All remaining pediatric candidates in descending order of mortality risk scores

    21. All remaining adult candidates in descending order of mortality risk scores

4. Updated Definitions of Liver Transplant Status:

1A    A patient greater than or equal to 18 years of age listed as Status 1A has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days.

A pediatric patient listed as Status 1A or 1B is located in the hospital's Intensive Care Unit (ICU) and meets the following criteria:
        •    Fulminant liver failure
        •    Primary non function
        •    Hepatic artery thrombosis
        •    Acute decompensated Wilson’s Disease
        •    Chronic liver disease
Patients meeting criteria (i) (ii), (iii), or (iv) may be listed as a Status 1A; those meeting   criteria (v) may be listed as a Status 1B.

1B    Pediatric patients with chronic liver disease and in the ICU can be listed at Status 1B if the patient has a calculated PELD score of >25 or calculated MELD score of >25 for adolescent candidates (12-17 years) and one of the following criteria is met (candidates listed for a combined liver-intestine transplant may meet these criteria with their adjusted match score as described in Policy 3.6.4.7 (Combined Liver-Intestine Candidates):
        •    On a mechanical ventilator
        •    Gastrointestinal bleeding requiring at least 30 cc/kg of red blood cell
              replacement within the previous 24 hours
        •    Renal failure or renal insufficiency defined as requiring dialysis or continuous
              CVVH or continuous CVVD
        •    Glasgow coma score < 10

7 Not currently listed

5. Changes in MELD/PELD Scoring: [2]

Hepatocellular Carcinoma (HCC)

Liver transplantation for treatment of hepatocellular carcinoma (HCC) is attractive because resection of the malignant tumor can be achieved while also replacing the cirrhotic liver that remains at risk for the development of new lesions. However, early experience with transplantation for patients with unrespectable local HCC was disappointing. Unacceptable 90-day mortality rates, tumor recurrence in up to 80 percent of patients, and long-term survival rates that were well below that of patients transplanted for nonmalignant disease all reflected the advanced nature of the disease. To address these concerns UNOS has adopted the “Milan Criteria” as its standard guide to prioritizing patients with HCC and cirrhosis awaiting transplantation. These Criteria set a limit on primary tumor size and the number of associated tumors before a patient receives additional “tumor exception points” which increases their chance of receiving an organ in a timely manner. But, we are also learning that patients transplanted for hepatocellular carcinoma with a MELD score of less than 14 (before added points are awarded) have a poorer outcome than those with a higher score. This is due to the one year morbidity and mortality associated with the procedure being more harmful to the recipient than living with the modest tumor burden required for transplant consideration. This information has led to further refinement before patients receive tumor exception points. A patient must now be on the waiting list for 6 months and be re-staged before receiving exception points.

Hepatoblastoma

A pediatric patient with non-metastatic hepatoblastoma who is otherwise a suitable candidate for liver transplantation may be assigned a PELD (less than 12 years old) or MELD (12-17 years old) score, of 30.

Pediatric Liver Transplant Candidates with Metabolic Diseases
 
A pediatric liver transplant candidate with an urea cycle disorder or organic acidemia shall be assigned a PELD (less than 12 years old) or MELD (12-17 years old) score of 30.  If the candidate does not receive a transplant within 30 days of being listed with a MELD/PELD of 30, then the candidate may be listed as a Status 1B.
 
As the above demonstrates, the field of liver transplantation is constantly changing as new information becomes available. Watch for changes in hepatocellular carcinoma management and transplantation indications, the growing diversity of conditions for which transplantation may be effective, and allocation policy changes by visiting the OPTN/UNOS websites. Many programs believe that in the coming years, liver disease related to the obesity epidemic may exceed all other indications for liver transplantation.


6. Liver-Kidney Transplantation

Since the institution of the MELD system, which inadvertently increased the proportion of simultaneous liver kidney transplants (SLK), experts have been debating the indications for this operation. In 2014 SLK accounted for 8.2% of all liver transplants performed in the United States compared to 4.3% in 2003 and only 1.7% in 1990. There have been 2 consensus reports on this topic in the last 14 years. It is clear that patients with End Stage Liver Disease and need for dialysis do poorly and that SLK can improve liver graft survival and in selected patients, overall survival. However we are also aware of the profound organ shortage and do not want to transplant a kidney when the patient may recover renal function following a successful liver transplant.  A recent publication  analyzed 2112 adult deceased donor liver transplant recipients who received acute dialysis for less than 90 days before liver transplant. The author concluded that native renal function recovered in the majority of patients within 6 months post-transplant. The cumulative risk of renal non-recovery was 8.9% and factors such as age, longer duration of dialysis, re-transplant, and pre-existing diabetes were significant risk factors of non-recovery. The author concluded that patients without these risk factors should not be listed for SLK.



 

1 Organ Procurement and Transplantation Network. Policy 9.6.E on 11/10/2016. “ Allocation of Livers and Liver-Intestines”.

2 Sharma, Pratima, et al. “Short-Term Pretransplant Renal Replacement Therapy and Renal Nonrecovery after Liver Transplantation Alone.” Clin J Am Soc Nephrol, vol. 8, no. 7, 3 July 2013, p. 1135-1142.