why waiting time and hla no longer fulfill the ethical tests of utility and justice and dpi-epts is...
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![Page 1: Why Waiting Time and HLA No Longer Fulfill the Ethical Tests of Utility and Justice and DPI-EPTS is a Step in the Right Direction Thomas Mone, MS CEO,](https://reader036.vdocuments.mx/reader036/viewer/2022070306/551700c4550346f5558b4fb3/html5/thumbnails/1.jpg)
Why Waiting Time and HLA No Longer Fulfill the Ethical Tests
of Utility and Justice and DPI-EPTS is a Step in the Right Direction
Thomas Mone, MSCEO, OneLegacy
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US Kidney Allocation: A Fundamental Problem
Remarkable waste of kidneys from older donors
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Why Do We Discard So Many More Kidneys Than Europe?
• EuroTrans Old-for-Old System (65+ Donors to 65+ Recipients) prompts older recipients and their MDs to accept older donor kidneys.
• In the US, waiting time is the primary allocation determinant. A 65+ Recipient who is offered a kidney from a 65+ Donor will wait for an offer of a younger kidney within the next several weeks.
• Older kidneys are too frequently discarded or sometimes not even recovered.
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How Did We Let This Waste Happen?
• When kidney allocation was first debated, efforts to identify predictors of graft survival were without adequate experiential data.
• Community opted for the predictive power of HLA matching to maximize graft survival to address the ethical concept of maximizing Utility.
• To ensure Justice, waiting time was chosen to ensure offers were fair across age, gender, race, and economic differences
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What’s Wrong with HLA?
• Nothing really, except HLA is no longer the powerful predictor of graft survival nor patient survival it once was:– HLA was never all that powerful a predictor of graft survival, as it always
had limited value at 1-5 antigen matches and it was never paired with age factors so it allowed young donor kidneys to go to older recipients
– Advances in immunosuppression have made all HLA essentially non-predictive of graft and patient survival in all but zero-mismatch cases
– Adding DPI-EPTS supplements HLA and provides tremendous predictive power to maximize graft life (not as much as LYFT would have, but a dramatic improvement)
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What’s Wrong with Waiting Time?
• Waiting Time may ensure equality of access within a region or a DSA, but
• Waiting Time can vary by 4-5 times and 5-10 years longer between regions and DSAs due to:– Widely disproportionate list sizes – Widely varied donor potential due to varying death and disease
rates – Moderate variation in donation consent rates
• This disparity is not addressed in this concept, but can be reduced if more older kidneys are transplanted
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How Does DPI-EPTS Help?
• Maximizes graft survival– Reduces rejection, sensitization, re-transplant of
better-matched donors and recipients• Reduces CIT and resulting DGF– Less reliance on time-consuming subjective
assessment of donor-recipient compatibility– Less time wasted offering older organs to younger
patients
• Increase Organ Utilization– Older donor organs less likely to be bypassed
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How Will DPI-EPTS Affect the Older Recipient Population?
• UNOS Data is inadequate to model due to high older donor discard and non-utilization rates
• German/EuroTransplant Data demonstrates the benefits: – First Year Study: “86% 1-Year Graft Survival vs 79% control; reduced
CIT”– Five Year Study: “Since initiation of the ESP (1999), availability of
elderly donors doubled and waiting time for ESP patients decreased. Local allocation led to shorter cold ischemia time (11.9 vs. >17.0 h, p < 0.001) and less delayed graft function (DGF, ESP 29.7% vs. O/A 36.2%, p = 0.047) but 5-10% higher rejection rates. Graft and patient survival were not negatively affected by the ESP allocation when compared to the standard allocation.”
– Ten Year Study: waiting time for the recipient in the ESP program was shortened significantly by more than 1 year. Also the shipping time was to > 6 h significantly shorter.
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EuroTrans Predicted Benefits of DPI-EPTS
• Increased Organ Availability +• More Transplants +• Decreased Waiting Times for old and young +• Decreased CIT +• Equivalent 1 year graft survival +• Decreased Younger Recipient Graft Loss +• Decreased Recipient Sensitization +• Increased Older Recipient 3-5 year Graft Failure –
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Translating from the German Experience
• While the German Old-for-Old system is more extreme than DPI-EPTS, it reasonably predicts that we will see decreased discards, more transplants, increased overall graft survival, while DPI-EPTS broader age bands will limit the graft loss associated with the use of dramatically older organs
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Ethical Implications of DPI-EPTS
• Utility Benefits – Increased utilization of older donor kidneys– Reduced CIT– Reduced waiting time– Improved prediction of graft function– Increased life years from transplant
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Ethical Implications of DPI-EPTS
• Justice Benefits– Reduced graft loss, sensitization, and re-transplant
benefit younger recipients harmed by current system– Increased transplants and reduced waiting time for
older recipients offset the loss of access to younger donor organs
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What Do Donor Families Have to Say?
• The question of DPI-EPTS hasn’t been asked of them, but when asked what they hope for when they choose to donate they offer:– Save as many lives as possible, for as long as possible– Keep my loved one’s organ functioning as long as possible
• DPI-EPTS fulfills these two goals– Transplants MORE organs– Reduces overall graft loss– Increases lives saved and years of organ function
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Is DPI-EPTS the Ideal Solution?
• Will DPI-EPTS reduce discard rates as much as the German Old-for-Old? No, not as much but it can be predicted to decrease waiting time, reduce CIT, and lower discard rates.
• Will DPI-EPTS save as many lives, shorten waiting time, and maximize graft life as much as LYFT would, No, but…for a community that has an appropriate history of caution when fiddling with human lives, it is a meaningful incremental step that will extend graft life and save lives.
• Will DPI-EPTS end the demographic and geographic inequality? No, that will have to be another days work.
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What’s the Bottom Line of this Debate?
… If the primary goals of the balancing of utility and justice in organ allocation are – (1) ending deaths on the waitlist– (2) increasing overall graft survival, and – (3) fulfilling and honoring the wishes of the donors and
donor families who make donation possible
… DPI-EPTS is a significant step forward and it is time to move it from concept to policy.
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