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Impact of MELD on Liver Allocation: Review of Positive and Adverse Effects

Impact of MELD on Liver Allocation: Review of Positive and Adverse Effects. Richard B. Freeman, MD Tufts-New England Medical Center EASL-ELTA Berlin Germany, April 14, 2004. OPTN. SRTR. Outline. The MELD /PELD Allocation System Rationale for MELD/PELD Brief description of system

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Impact of MELD on Liver Allocation: Review of Positive and Adverse Effects

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  1. Impact of MELD on Liver Allocation: Review of Positive and Adverse Effects Richard B. Freeman, MD Tufts-New England Medical Center EASL-ELTA Berlin Germany, April 14, 2004 OPTN SRTR

  2. Outline • The MELD /PELD Allocation System • Rationale for MELD/PELD • Brief description of system • What is Good? • 18 month trends • Survival rates • What Could Be Made Better? • Geographic differences • Transplants at low MELD scores • Exceptions • Future

  3. Outline • The MELD /PELD Allocation System • Rationale for MELD/PELD • Brief description of system • What is Good? • 18 month trends • Survival rates • What Could Be Made Better? • Geographic differences • Transplants at low MELD scores • Exceptions • Future

  4. MELD/PELD Rationale • Waiting time does not reflect medical need • Categorical urgency system fails to prioritize large number of waiting patients accurately. • CTP score • Subjective • Never validated for waiting list • Doesn’t distinguish more ill candidates

  5. Relative Risk of Pre-Transplant Mortality As a Function of Median Waiting TimeInitial Status 2

  6. Relative Risk of Pre-Transplant Mortality As a Function of Median Waiting TimeInitial Status 3

  7. Conclusions • There is No Relationship Between Waiting List Mortality and a Center’s Waiting Time When Patients Are Stratified By Initial Entry Status

  8. CTP vs MELD National Wait List 2001 MELD Score CTP Score

  9. MELD/PELD Equations • MELD =(0.957 x LN(creatinine) + 0.378 x LN(bilirubin) +1.12 x LN(INR) +0.643) x 10 Capped at 40 • PELD= (0.436 x Age*)-(0.687 x log(albumin))+(0.480 x log(bilirubin))+ (1.857 x log(INR))+(0.667 X growth failure†) x 10 • * Age < 1 year gets 1, Age >1year gets 0 • † growth failure =1, no growth failure =0

  10. MELD and PELD Three Month Mortality Risks 1,230 Adult and 649 Pediatric Patients Added to Waiting List between 3/1/01 and 8/15/01 • PELD: SPLIT Patients MELD: National Waitlist Freeman Liver Transplantation, 2002, 8:854.

  11. MELD vs. CTP ValidationROC Curve UNOS Waitlist MELD CTP MELD AUC = 0.83 CTP AUC = 0.76 Wiesner, et al, Liver Transplantation, 2001; 7:567-580

  12. n Deaths 3 months 3-Month Mortality (Concordance) 1-Year Mortality (Concordance) Hospitalized Cirrhotics 282 59 0.87 (0.82 – 0.92) 0.85 (0.80 – 0.90) Outpatient Cirrhotics 491 34 0.80 (0.69 – 0.90) 0.78 (0.70 – 0.85) PBC Outpatients 326 5 0.87 (0.71 – 1.00) 0.87 (0.80 – 0.93) Historical Cirrhotics 1179 220 0.78 (0.74 – 0.81) 0.73 (0.69 – 0.76) MELD Validation Wiesner, et al, Liver Transplantation, 2001; 7:567-580

  13. MELD Validation Summary • MELD score consistently predicts 3-month mortality among a variety of patients with liver disease. • Addition of subjective clinical or diagnosis variables does not improve the predictive value of the MELD model.

  14. Outline • The MELD /PELD Allocation System • Rationale for MELD/PELD • Brief description of system • What is Good? • 18 month trends • Survival rates • What Could Be Made Better? • Geographic differences • Transplants at low MELD scores • Exceptions • Future

  15. Sequence of Allocation Local 1. Status 1 patients in descending point order Regional 2. Status 1 patients in descending point order Local 3. All other patients in descending order of mortality risk scores(MELD/PELD) Regional 4. All other patients in descending order of mortality risk scores (MELD/PELD) National 5. Status 1 patients in descending point order 6. All other patients in descending order of mortality risk scores (MELD/PELD)

  16. Exceptions • Recognized that all patients wouldn’t be served by MELD/PELD • HCC • Metabolic disease • Hepatopulmonary Syndrome • Peer Review System • Regional Review Boards

  17. Regional Review Boards(RRB) • Centers apply for increased MELD/PELD score. • RRB reviews application and votes. • Appeals are allowed. • If no resolution in 21 days, patient automatically gets requested score. • Reviewed by OPTN Committee

  18. Hepatocellular CA • Imaging Study (CT or MRI) Showing Stage I or II Tumor (chest CT and bone scan - for mets) AND one of the following • APF >200 • Angiogram • Biopsy • Chemoembolization • Cryoablation • Radiofrequency Ablation • Alcohol Ablation

  19. Hepatocellular CAMELD Prioritization Centers recertify every 3 months. Patients continuing to meet stage I or II definition receive additional 10% mortality risk points (~5 MELD points)

  20. MELD/PELD Logistical Changes • Eliminate justification forms, all listing/data through UNET. • No signatures required • Prospective review by RRBs • Some form of written documentation required to substantiate MELD/PELD data.

  21. 30 Day Outcomes for RemovalsBy MELD Score SRTR

  22. Competing Risks for HCC Exceptions2/27/02-2/26/03 vs. 2/27/03-8/27/03 * *

  23. Other Special Cases • HPS (hepatopulmonary syndrome =PaO2 < 60 on RA, shunt, no COPD or other lung Dx) • RRB will assign MELD points that will give reasonable chance of organ offer within 3 months in that region. • FAP (familial amyloidosis) • RRB review and assign MELD points • Other • RRB review, need experience with MELD/PELD to assess proper placement • Frequent feedback to centers, RRBs, and patients essential to accurate placement

  24. Recertification of MELD/PELD Data • MELD/PELD  25 every 7 days • MELD/PELD  24 but >18 every 30 days • MELD/PELD  18 but  11 every 90 days • MELD/PELD  10 every year • If not met patient reverts to last available MELD/PELD score • If no previous MELD/PELD score, patient assigned 10 MELD/PELD points

  25. MELD/PELD Logistical Changes • Eliminate justification forms, all listing/data through UNET. • No signatures required • Prospective review by RRBs • Some form of written documentation required to substantiate MELD/PELD data.

  26. Outline • The MELD /PELD Allocation System • Rationale for MELD/PELD • Brief description of system • What is Good? • 18 month trends • Survival rates • What Could Be Made Better? • Geographic differences • Transplants at low MELD scores • Exceptions • Future

  27. New Listings by Month02/27/02-08/27/03

  28. Mean MELD/PELD at Listing

  29. Distribution of M/P Scores for New Listings by Month, 02/27/02-08/27/03

  30. End Of Month Liver Waiting List3/31/02 – 8/31/03

  31. Trends In Liver WL Death Rates By Age P=0.134

  32. Trends In Liver Transplant Rates By Age *

  33. Adult Living Donor Transplants02/27/02-08/27/03

  34. Trends In Meld At TransplantAdults, By Gender P < 0.001 * *

  35. Trends In Meld At Transplant:Adults, By ABO * *

  36. Outline • The MELD /PELD Allocation System • Rationale for MELD/PELD • Brief description of system • What is Good? • 18 month trends • Survival rates • What Could Be Better? • Geographic differences • Transplants at low MELD scores • Exceptions • Future

  37. 6-Month Patient Survival2/27/02-12/31/02 M/P Status 1

  38. 6-Month Patient SurvivalCalculated MELD, 2/27/02-12/31/02

  39. 6-Month Patient SurvivalCalculated PELD, 2/27/02-12/31/02

  40. 6-Month Patient Survival02/27/02-12/31/02

  41. Outline • The MELD /PELD Allocation System • Rationale for MELD/PELD • Brief description of system • What is Good? • 18 month trends • Survival rates • What Could Be Made Better? • Geographic differences • Transplants at low MELD scores • Exceptions • Future

  42. PR & US VI OPO Service Areas MA RI DE MD HI

  43. UNOS/OPTN Regions

  44. Why Are Liver Sharing Boundaries Necessary? Adam, et al. Lancet 1992 Levy, et al.ATC 2001 #1714

  45. Why Are Liver Sharing Boundaries Practical? Totsuka, et al. Surg Today 2002

  46. Mean MELD for New Listings by Region and OPO, 02/27/02-08/27/03

  47. Analysis Of Variance:Meld At Death/Too Sick * % of total variation explained by additional factor

  48. Mean MELD Score at Cadaveric TransplantBy Region, by OPO, All Cases 12 Months 18 Months

  49. Analysis Of Variance:MELD At Transplant * % of total variation explained by additional factor

  50. Outline • The MELD /PELD Allocation System • Rationale for MELD/PELD • Brief description of system • What is Good? • 18 month trends • Survival rates • What Could Be Better? • Geographic differences • Transplants at low MELD scores • Exceptions • Future

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