Liver and Intestine Distribution Using Distance from Donor Hospital Liver and Intestine Transplantation Committee 1
What problem will the proposal solve? DSA and region as allocation units are not aligned with Final Rule requirements and OPTN principles of geography 2
What solutions did the committee consider? The committee modeled two allocation frameworks: Acuity circle and Broader 2 Circles (B2C) Both models follow the geography committee s proposed framework of fixed distances from the donor hospital and use 150, 250 and 500 nautical miles from the donor hospital as units of allocation 3
Acuity Circle Adult Donor Allocation Sequence Classification Candidates that are within this proximity of the donor hospital: And are: 1 500nm Adult or pediatric status 1A 2 500nm Pediatric status 1B 3 150nm MELD or PELD of at least 37 4 250nm MELD or PELD of at least 37 5 500nm MELD or PELD of at least 37 6 150nm MELD or PELD of at least 33 7 250nm MELD or PELD of at least 33 8 500nm MELD or PELD of at least 33 9 150nm MELD or PELD of at least 29 10 250nm MELD or PELD of at least 29 11 500nm MELD or PELD of at least 29 12 150nm MELD or PELD of at least 15 13 250nm MELD or PELD of at least 15 14 500nm MELD or PELD of at least 15 15 National Adult or Pediatric Status 1A 16 National Pediatric Status 1B 17 National MELD or PELD of at least 15 18 150nm MELD or PELD less than 15 19 250nm MELD or PELD less than 15 20 500nm MELD or PELD less than 15 21 National MELD or PELD less than 15 4
Acuity DCD/>70 Donor Allocation Sequence Classification Candidates that are within this proximity of the donor hospital: And are: 1 500nm Adult or Pediatric status 1A 2 500nm Pediatric status 1B 3 150nm MELD or PELD of at least 15 4 250nm MELD or PELD of at least 15 5 500nm MELD or PELD of at least 15 6 Nation Adult or Pediatric status 1A 7 Nation Pediatric status 1B 8 Nation MELD or PELD of at least 15 9 150nm MELD or PELD less than 15 10 250nm MELD or PELD less than 15 11 500nm MELD or PELD less than 15 12 Nation MELD or PELD less than 15 5
B2C Adult Donor Allocation Sequence Classification Candidates that are within this proximity of the donor hospital: And are: 1 500nm Adult or pediatric status 1A 2 500nm Pediatric status 1B 3 250nm MELD or PELD of at least 32 4 150nm MELD or PELD of at least 15 5 250nm MELD or PELD of at least 15 6 500nm MELD or PELD of at least 15 7 National Adult or Pediatric Status 1A 8 National Pediatric Status 1B 9 National MELD or PELD of at least 15 10 150nm MELD or PELD less than 15 11 250nm MELD or PELD less than 15 12 500nm MELD or PELD less than 15 13 National MELD or PELD less than 15 6
B2C DCD/>70 Donor Allocation Sequence Classification Candidates that are within this proximity of the donor hospital: And are: 1 500nm Adult or Pediatric status 1A 2 500nm Pediatric status 1B 3 150nm MELD or PELD of at least 15 4 500nm MELD or PELD of at least 15 5 Nation Adult or Pediatric status 1A 6 Nation Pediatric status 1B 7 Nation MELD or PELD of at least 15 8 150nm MELD or PELD less than 15 9 500nm MELD or PELD less than 15 10 Nation MELD or PELD less than 15 7
Adolescent Donor Allocation Sequence Classification Candidates that are within this proximity of the donor hospital: And are: 1 500nm Pediatric status 1A 2 500nm Adult status 1A 3 500nm Pediatric status 1B 4 500nm Any PELD 5 500nm MELD of at least 15 and 12 to 17 years old 6 500nm MELD less than 15 and 12 to 17 years old 7 Nation Pediatric status 1A 8 Nation Adult status 1A 9 Nation Pediatric status 1B 10 Nation Any PELD 11 Nation Any MELD and 12 to 17 years old 12 500nm MELD of at least 15 and at least 18 years old 13 500nm MELD less than 15 and at least 18 years old 14 Nation Any MELD and at least 18 years old 8
Donor <12 Years Old Allocation Sequence Classification Candidates that are within this proximity of the donor hospital: 1 500nm Pediatric status 1A And are: 2 Nation Pediatric status 1A and 0 to 11 years old 3 500nm Adult status 1A 4 500nm Pediatric status 1B 5 500nm Any PELD 6 500nm MELD of at least 15 and 12 to 17 years old 7 500nm MELD less than 15 and 12 to 17 years old 8 Nation Pediatric status 1A and 12 to 17 years old 9 Nation Adult status 1A 10 Nation Pediatric status 1B and 0 to 17 years old 11 Nation Any PELD 12 Nation Any MELD and 12 to 17 years old 13 500nm MELD of at least 15 and at least 18 years old 14 500nm MELD less than 15 and at least 18 years old 15 Nation Any MELD and at least 18 years old 9
What is the proposed solution? Liver allocation: B2C with a sharing threshold of 32 1. Status 1A and 1B within 500 nautical miles 2. MELD/PELD at least 32 within 250nm 3. MELD/PELD 15-31 within 150nm, then 250nm, then 500nm 4. Status 1A and 1B and MELD or PELD scores of at least 15 across the nation 10
Supporting Evidence Scenario Variance in Median Allocation MELD/PELD at Transplant Median Transport Time (hours) Median Transport Distance (miles) Percent of Organs Flown Waitlist Mortality Count/Rate Current 9.97 1.7 88.5 50.7 1455/.097 2017 Board 7.41 1.7 100.4 54.4 1386/.091 Approved Acuity 250+500 4.33 1.9 183.5 71.4 1341/.087 Acuity 300+600 4.07 2 211.3 74 1318/.085 B2C MELD 35 6.74 1.8 107.7 58.4 1433/.095 B2C MELD 32 6.54 1.8 117.1 60.8 1423/.094 11
Supporting Evidence 12
Supporting Evidence Scenario Variance in Median Allocation MELD/PELD at Transplant Median Transport Time (hours) Median Transport Distance (miles) Percent of Organs Flown Waitlist Mortality Count/Rate Current 9.97 1.7 88.5 50.7 1455/.097 2017 Board 7.41 1.7 100.4 54.4 1386/.091 Approved Acuity 250+500 4.33 1.9 183.5 71.4 1341/.087 Acuity 300+600 4.07 2 211.3 74 1318/.085 Broader 2-Circle MELD 35 Broader 2-Circle MELD 32 6.74 1.8 107.7 58.4 1433/.095 6.54 1.8 117.1 60.8 1423/.094 13
Supporting Evidence Scenario Variance in Median Allocation MELD/PELD at Transplant Median Transport Time (hours) Median Transport Distance (miles) Percent of Organs Flown Waitlist Mortality Count/Rate Current 9.97 1.7 88.5 50.7 1455/.097 2017 Board 7.41 1.7 100.4 54.4 1386/.091 Approved Acuity 250+500 4.33 1.9 183.5 71.4 1341/.087 Acuity 300+600 4.07 2 211.3 74 1318/.085 Broader 2-Circle MELD 35 Broader 2-Circle MELD 32 6.74 1.8 107.7 58.4 1433/.095 6.54 1.8 117.1 60.8 1423/.094 14
Supporting Evidence 15
Supporting Evidence Scenario Variance in Median Allocation MELD/PELD at Transplant Median Transport Time (hours) Median Transport Distance (miles) Percent of Organs Flown Waitlist Mortality Count/Rate Current 9.97 1.7 88.5 50.7 1455/.097 2017 Board 7.41 1.7 100.4 54.4 1386/.091 Approved Acuity 250+500 4.33 1.9 183.5 71.4 1341/.087 Acuity 300+600 4.07 2 211.3 74 1318/.085 Broader 2-Circle MELD 35 Broader 2-Circle MELD 32 6.74 1.8 107.7 58.4 1433/.095 6.54 1.8 117.1 60.8 1423/.094 16
Supporting Evidence Scenario Variance in Median Allocation MELD/PELD at Transplant Median Transport Time (hours) Median Transport Distance (miles) Percent of Organs Flown Waitlist Mortality Count/Rate Current 9.97 1.7 88.5 50.7 1455/.097 2017 Board 7.41 1.7 100.4 54.4 1386/.091 Approved Acuity 250+500 4.33 1.9 183.5 71.4 1341/.087 Acuity 300+600 4.07 2 211.3 74 1318/.085 Broader 2-Circle MELD 35 Broader 2-Circle MELD 32 6.74 1.8 107.7 58.4 1433/.095 6.54 1.8 117.1 60.8 1423/.094 17
% 90-Day Mortality Risk Supporting Evidence 100 90 Mortality Difference Between Scores Estimated % Mortality Risk 80 70 60 50 40 30 20 10 0 0 0 0 0 0 0 1 1 1 1 1 1 1 2 2 2 3 3 3 4 4 5 5 6 6 6 6 6 6 5 5 4 3 2 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 MELD Score 18
Supporting Evidence Liver candidates on the waiting list as of October 4 th 2018 Liver Medical Urgency Status N Percent Status 1A 13 0.1% Status 1B 40 0.3% MELD/PELD < 15 5,716 41.5% MELD/PELD 15 19 2,275 16.5% MELD/PELD 20 24 1,307 9.5% MELD/PELD 25 28 741 5.4% MELD/PELD 29 31 347 2.5% MELD/PELD 32 34 183 1.3% MELD/PELD 35+ 116 0.8% Temporarily Inactive (Status 7) 3,020 22.0% Total 13,758 100% A lower sharing threshold: Includes more candidates in broader distribution. Modeling suggests a lower threshold (35 to 32) results in: More flying Decrease in variance in MMaT Positive impact on waitlist mortality 19
Supporting Evidence Overall, demographic subgroups (Age, sex, and race/ethnicity) were similar between the modeled scenarios and the total population. Except pediatric subgroup saw reductions in MMaT and increases in transplant rate that were better than the improvements for the overall population Trends for the socio-economic status characteristics (education, insurance type, cumulative community risk score, and urbanicity) subgroups were similar between the modeled scenarios and the total population. 20
What are the proposed solutions? National Liver Review Board (NLRB) exception scores: Previously planned: based on the median MELD at transplant (MMaT) in the DSA Proposed: candidates at least 12 years old based on MMaT with 250 nautical miles of the transplant hospital Proposed: candidates under 12 based on median PELD at transplant (MPaT) in the nation 21
What are the proposed solutions? Intestine allocation using 500nm from donor hospital Maintains liver-intestine priority Ends Region 9 variance (New York replacing DSA with state) Continues national split liver variance 22
What are the proposed solutions? Continues Hawaii blood type O donor variance that allows O donors to be offered to any blood type candidates with a MELD/PELD of at least 15 before national offers. Without variance, only B and O candidates would get offers before national. Question: Should Hawaii variance be extended to Puerto Rico as well? 23
What are the proposed solutions- specific language clarifications: Allocates O livers to all B candidates before A and AB candidates Simplifies allocation of livers for other methods of hepatic support and MELD <6 Clarifies other references to local, DSA, and region Makes some clarifications to exception criteria 24
What are the proposed solutions for simultaneous liver-kidney priority Currently: Through MELD 35 within the region All within the DSA Proposed: Through MELD 15 within 150nm Through MELD 32 within 250 nm 25
How will members implement this proposal? NLRB (liver programs) Programs will continue to nominate members for the review board Review board members will need to complete online training prior to beginning to review cases Programs may need to review guidance and criteria for exceptions Allocation (transplant hospitals and OPOs) Prepare for a potential shift in offer patterns Build relationships with programs/opos they may be working with more frequently Prepare for any expected changes in frequency and types of travel for organ recovery Allocation (transplant hospitals) Evaluate whether staffing levels, listing practices, acceptance criteria or recovery practices may need to be adjusted or monitored 26
How will the OPTN implement this proposal? Programming NLRB will take effect before allocation changes Implementation: NLRB expected first quarter of 2019 Allocation expected after NLRB 27
Specific Feedback Requested What is your opinion of this proposal of broader 2-circle sharing at 32 threshold? Do you prefer one of the other models, such as the acuity based model? What is your opinion of the MELD/PELD sharing threshold? Is 32 appropriate, or would you prefer 29? Or 35? What is your opinion of the fixed-distance circles? Are they the right size? Do you support expanding Policy 9.11.B: Closed Variance for Allocation of Blood Type O Deceased Donor Livers in Hawaii to apply to Puerto Rico as well? 28
Questions? 29
Additional Slides 30
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