Changes in liver acceptance patterns after implementation of Share 35.

The Share 35 policy was implemented June 2013. We sought to evaluate liver offer acceptance patterns of centers under this policy. We compared three 1-year eras (1, 2, and 3) before and 1 era (4) after the implementation date of the Share 35 policy (June 18, 2013). We evaluated all offers for liver-only recipients including only those offers for livers that were ultimately transplanted. Logistic regression was used to develop a liver acceptance model. In era 3, there were 4809 offers for Model for End-Stage Liver Disease (MELD) score ≥ 35 patients with 1071 acceptances (22.3%) and 10,141 offers and 1652 acceptances (16.3%) in era 4 (P < 0.001). In era 3, there were 42,954 offers for MELD score < 35 patients with 4181 acceptances (9.7%) and 44,137 offers and 3882 acceptances (8.8%) in era 4 (P < 0.001). The lower acceptance rate persisted across all United Network for Organ Sharing regions and was significantly less in regions 2, 3, 4, 5, and 7. Mean donor risk index was the same (1.3) for all eras for MELD scores ≥ 35 acceptances and the same (1.4) for MELD score < 35 acceptances. Refusal reasons did not vary throughout the eras. The adjusted odds ratio of accepting a liver for a MELD score of 35 + compared to a MELD score < 35 patient was 1.289 before the policy and 0.960 after policy implementation. In conclusion, the Share 35 policy has resulted in more offers to patients with MELD scores ≥ 35. Overall acceptance rates were significantly less compared to the same patient group before the policy implementation. Centers are less likely to accept a liver for a patient with a MELD score of 35 + after the policy change. Decreased donor acceptance rates could reflect more programmatic selectivity and ongoing donor and recipient matching.

Region 11 MELD Na exception prospective study.

INTRODUCTION: Hyponatremia complicates cirrhosis and predicts short term mortality, including adverse outcomes before and after liver transplantation. MATERIAL AND METHODS: From April 1, 2008, through April 2, 2010, all adult candidates for primary liver transplantation with cirrhosis, listed in Region 11 with hyponatremia, were eligible for sodium (Na) exception. RESULTS: Patients with serum sodium (SNa) less than 130 mg/dL, measured two weeks apart and within 30 days of Model for End Stage Liver Disease (MELD) exception request, were given preapproved Na exception. MELD Na was calculated [MELD + 1.59 (135-SNa/30 days)]. MELD Na was capped at 22, and subject to standard adult recertification schedule. On data end of follow-up, December 28, 2010, 15,285 potential U.S. liver recipients met the inclusion criteria of true MELD between 6 and 22. In Region 11, 1,198 of total eligible liver recipients were listed. Sixty-two (5.2%) patients were eligible for Na exception (MELD Na); 823 patients (68.7%) were listed with standard MELD (SMELD); and 313 patients (26.1%) received HCC MELD exception. Ninety percent of MELD Na patients and 97% of HCC MELD patients were transplanted at end of follow up, compared to 49% of Region 11 standard MELD and 40% of U.S.A. standard MELD (USA MELD) patients (p < 0.001); with comparable dropout rates (6.5, 1.6, 6.9, 9% respectively; p = 0.2). MELD Na, HCC MELD, Region 11 SMELD, and USA MELD post-transplant six-month actual patient survivals were similar (92.9, 92.8, 92.2, and 93.9 %, respectively). CONCLUSION: The Region 11 MELD Na exception prospective trial improved hyponatremic cirrhotic patient access to transplant equitably, and without compromising transplant efficacy.

Report of a national conference on liver allocation in patients with hepatocellular carcinoma in the United States.

A national conference was held to better characterize the long-term outcomes of liver transplantation (LT) for patients with hepatocellular carcinoma (HCC) and to assess whether it is justified to continue the policy of assigning increased priority for candidates with early-stage HCC on the transplant waiting list in the United States. The objectives of the conference were to address specific HCC issues as they relate to liver allocation, develop a standardized pathology report form for the assessment of the explanted liver, develop more specific imaging criteria for HCC designed to qualify LT candidates for automatic Model for End-Stage Liver Disease (MELD) exception points without the need for biopsy, and develop a standardized pretransplant imaging report form for the assessment of patients with liver lesions. At the completion of the meeting, there was agreement that the allocation policy should result in similar risks of removal from the waiting list and similar transplant rates for HCC and non-HCC candidates. In addition, the allocation policy should select HCC candidates so that there are similar posttransplant outcomes for HCC and non-HCC recipients. There was a general consensus for the development of a calculated continuous HCC priority score for ranking HCC candidates on the list that would incorporate the calculated MELD score, alpha-fetoprotein, tumor size, and rate of tumor growth. Only candidates with at least stage T2 tumors would receive additional HCC priority points.

Use of a pediatric end-stage liver disease score for deceased donor allocation: the United States experience.

The Pediatric end-stage liver disease (PELD) score was developed as a measure of the severity of chronic liver disease that would predict mortality or children awaiting liver transplant. From multivariate analyses a model was derived that included five objective factors which together comprise the PELD score. The factors are growth failure, age less than 1 year, international normalized ratio (INR), serum albumin and total bilirubin.

Regional sharing for adult status 1 candidates: reduction in waitlist mortality.

The intent of regional sharing for status 1 candidates is to promote timely access to donor livers. Presumably this decreases waitlist mortality. Little published data exists that supports this policy. Organ Procurement and Transplantation Network data was used to calculate region 4 and national adult waitlist death and transplant rates 4 yr prior to (period A) and after (period B) implementation of the sharing agreement in July 1999. Death and transplant rates were calculated using a competing risk analysis. Regional sharing resulted in a reduction in adult status 1 waitlist death rate and an increase in transplant rate for region 4 candidates at 7 and 14 days (P > 0.05) without a change in the death rate at 90 days for the non-status 1 candidates. National data showed a significant increase in transplant rate at 7 days and reduction in waitlist death rate at 14 days after listing (P < 0.05). Status 1 waiting time was decreased from 10 to 3 days (P < 0.05). Adult patient survival was not significantly different between the periods. In conclusion, regional sharing for status 1 candidates results in an increased transplant rate and a reduction in waitlist mortality. Sharing did not impact waitlist mortality for non-status 1 candidates.

Results of the first year of the new liver allocation plan.

Liver allocation policy in the U.S. was recently changed to a continuous disease severity scale with minimal weight given to time waiting in an effort to better prioritize deceased donor liver transplant candidates. We compared rates of waiting list registrations, removals, transplants, and deaths during the year prior to implementation of the new liver allocation policy (2/27/01-2/26/02, Era 1) with the first year's experience (2/27/02-2/26/03, Era 2) under this new policy. Rates were adjusted for 1,000 patient years on the waiting list and compared using z-tests. A 1-sided test was used to compare death rates; 2-sided tests were used to compare transplant rates. Overall and subgroup analyses were performed for demographic, geographic, and medical strata. In Era 2, we observed a 12% reduction in new liver transplant waiting list registrations, with the largest reductions seen in new registrants with low MELD/PELD scores. In Era 2, there was a 3.5% reduction in waiting list death rate (P =.076) and a 10.2% increase in cadaveric transplants (P <.001). The reduction in waiting list mortality and increase in transplantation rates were evenly distributed across all demographic and medical strata, with some variation across geographic variables. Early patient and graft survival after deceased donor liver transplantation remains unchanged. In conclusion, by eliminating the categorical waiting list prioritization system that emphasized time waiting, the new system has been associated with reduced registrations and improved transplantation rates without increased mortality rates for individual groups of waiting candidates or changes in early transplant survival rates.

Liver transplantation for hepatocellular carcinoma: the MELD impact.

The new allocation policy of the United Network of Organ Sharing (UNOS) based on the model for end-stage liver disease (MELD) gives candidates with stage T1 or stage T2 hepatocellular carcinoma (HCC) a priority MELD score beyond their degree of hepatic decompensation. The aim of this study was to determine the impact of the new allocation policy on HCC candidates before and after the institution of MELD. The UNOS database was reviewed for all HCC candidates listed between July 1999 and July 2002. The candidates were grouped by two time periods, based on the date of implementation of new allocation policy of February 27, 2002. Pre-MELD candidates were listed for deceased donor liver transplantation (DDLT) before February 27,2002, and post-MELD candidates were listed after February 27, 2002. Candidates were compared by incidence of DDLT, time to DDLT, and dropout rate from the waiting list because of clinical deterioration or death, and survival while waiting and after DDLT. Incidence rates calculated for pre-MELD and post-MELD periods were expressed in person years. During the study, 2,074 HCC candidates were listed for DDLT in the UNOS database. The DDLT incidence rate was 0.439 transplant/person years pre-MELD and 1.454 transplant/person years post-MELD (P < 0.001). The time to DDLT was 2.28 years pre-MELD and 0.69 years post-MELD (P < 0.001). The 5-month dropout rate was 16.5% pre-MELD and 8.5% post-MELD (P < 0.001). The 5-month waiting-list survival was 90.3% pre-MELD and 95.7% post-MELD (P < 0.001). The 5-month survival after DDLT was similar for both time periods. The new allocation policy has led to an increased incidence rate of DDLT in HCC candidates. Furthermore, the 5-month dropout rate has decreased significantly. In addition, 5-month survival while waiting has increased in the post-MELD period. Thus, the new MELD-based allocation policy has benefited HCC candidates.

The sickest first? Disparities with model for end-stage liver disease-based organ allocation: one region's experience.

February 27, 2002, allocation of cadaver livers for transplantation changed from a waiting-time-based system to an evidence-based system referred to as the Model for End-Stage Liver Disease (MELD). We reviewed data from 1 of the 11 United Network for Organ Sharing regions to determine the impact of the MELD on the allocation of cadaver livers for transplantation in that region. The region of interest (study region) consists of three distinct geographic areas (referred to as Transplant Service Areas [TSAs]). Based on information obtained from the Organ Procurement and Transplantation Network for the United States and for the study region, the following observations were made: (1) study region patients who received a cadaver liver had higher mean and median MELD scores than cadaver liver recipients in the United States (study region mean score, 25.1; median, 26.0; US mean score, 23.9; median, 24.0); (2) within the study region, TSAs with competing liver transplant programs performed transplantation on patients at a significantly higher mean MELD score than TSAs dominated by a single center (TSA-1 mean score, 27.3; TSA-2 mean score, 26.6; TSA-3 mean score, 21.3); this disparity persisted when transplantations for hepatocellular carcinoma (HCC) were excluded; and (3) study region patients removed from the waiting list because of death or being too sick for transplantation have higher MELD scores than the national average (study region mean score, 25.4; US mean score, 23.8). Overall, implementation of the MELD resulted in a substantial increase in the number of transplantations performed for HCC, and MELD exceptions for all reasons were more common in TSAs that have multiple centers. Despite the MELD, there remains disparity in organ allocation within the study region. The MELD may accurately predict pretransplantation mortality, but it does not ensure equitable organ distribution. We propose that intraregional sharing of cadaver livers based on the MELD may help limit disparities in organ allocation.

Model for end-stage liver disease (MELD) and allocation of donor livers.

BACKGROUND & AIMS: A consensus has been reached that liver donor allocation should be based primarily on liver disease severity and that waiting time should not be a major determining factor. Our aim was to assess the capability of the Model for End-Stage Liver Disease (MELD) score to correctly rank potential liver recipients according to their severity of liver disease and mortality risk on the OPTN liver waiting list. METHODS: The MELD model predicts liver disease severity based on serum creatinine, serum total bilirubin, and INR and has been shown to be useful in predicting mortality in patients with compensated and decompensated cirrhosis. In this study, we prospectively applied the MELD score to estimate 3-month mortality to 3437 adult liver transplant candidates with chronic liver disease who were added to the OPTN waiting list at 2A or 2B status between November, 1999, and December, 2001. RESULTS: In this study cohort with chronic liver disease, 412 (12%) died during the 3-month follow-up period. Waiting list mortality increased directly in proportion to the listing MELD score. Patients having a MELD score <9 experienced a 1.9% mortality, whereas patients having a MELD score > or =40 had a mortality rate of 71.3%. Using the c-statistic with 3-month mortality as the end point, the area under the receiver operating characteristic (ROC) curve for the MELD score was 0.83 compared with 0.76 for the Child-Turcotte-Pugh (CTP) score (P < 0.001). CONCLUSIONS: These data suggest that the MELD score is able to accurately predict 3-month mortality among patients with chronic liver disease on the liver waiting list and can be applied for allocation of donor livers.

The OPTN waiting list, 1988-2002.

1. Additions to the OPTN waiting list decreased in 2002 for all organs except kidney and pancreas islets. 2. On November 30, 2003, there were 89,361 registrations on the combined UNOS waiting list. Of these, 67% were awaiting kidney transplantation, and 20% were awaiting liver transplantation. 3. The majority of patients on the UNOS waiting list on October 31, 2000 were of blood type O (52%), White (51%) and male (57%), and awaiting their first transplant (87%). 4. Despite lengthy waiting times, the percentage transplanted within one year following listing has increased over the past 2 years for all organs except kidney. A tremendous increase in the percentage of liver candidates transplanted within one year was observed in 2002. 5. Blood type and medical urgency have a significant impact upon the percent transplanted within one year of listing for most organ types. Patients awaiting heart, liver, pancreas, and intestinal transplants experience the highest probability of receiving a transplant within one year. 6. Death rates per patients waiting at risk have declined since 1988 for most patients awaiting life-saving organs and have remained relatively low for those awaiting a kidney, pancreas, or kidney-pancreas transplant.

The new liver allocation system: moving toward evidence-based transplantation policy.

In 1999, the Institute of Medicine suggested that instituting a continuous disease severity score that de-emphasizes waiting time could improve the allocation of cadaveric livers for transplantation. This report describes the development and initial implementation of this new plan. The goal was to develop a continuous disease severity scale that uses objective, readily available variables to predict mortality risk in patients with end-stage liver disease and reduce the emphasis on waiting time. Mechanisms were also developed for inclusion of good transplant candidates who do not have high risk of death but for whom transplantation may be urgent. The Model for End-Stage Liver Disease (MELD) and Pediatric End-Stage Liver Disease (PELD) scores were selected as the basis for the new allocation policy because of their high degree of accuracy for predicting death in patients having a variety of liver disease etiologies and across a broad spectrum of liver disease severity. Except for the most urgent patients, all patients will be ranked continuously under the new policy by their MELD/PELD score. Waiting time is used only to prioritize patients with identical MELD/PELD scores. Patients who are not well served by the MELD/PELD scores can be prioritized through a regionalized peer review system. This new liver allocation plan is based on more objective, verifiable measures of disease severity with minimal emphasis on waiting time. Application of such risk models provides an evidenced-based approach on which to base further refinements and improve the model.

The impact of MELD on OPTN liver allocation: preliminary results.

The OPTN implemented a revised system (MELD/ PELD) for the allocation of cadaveric livers on February 27, 2002. When compared with an earlier era, preliminary results indicate that transplant rates remain similar by gender, ethnicity, age group (adult and pediatric) and for most principal diagnoses. Both the actual number of pretransplant deaths and the pretransplant death rate has dropped under the new system. While some regional variation exists in the average MELD scores at listing, death and transplant, it accounts for only a small percentage of the total variation observed. In a multivariate analysis, MELD scores above 20 had the strongest effect and were associated with a significantly increased mortality risk on the waiting list. More data are need to analyze the impact of MELD on posttransplant outcomes.