1. Ethical Implications of Multi-Organ Transplants (MOT)
Ethics Committee
Introduce yourself (name, organization and role on committee)
Please note that the multi-organ transplant will be referred to in the presentation as “MOT”

2. What problem will this resource solve?
Current MOT allocation systems are not standardized across organ type
Generates confusion in the community
Lack of consistency has potential to create/perpetuate inequity
Equity in access to transplant is #2 OPTN strategic goal
At the same time…
Amount of MOT have increased over the past two decades
Excluding KP and heart/lung, has doubled in the past six years, from 625 in 2012 to 1,035 in 2017
Need for guidance/clarity
The problem highlighted on this slide is that current MOT allocation is not standardized. This generates confusion in the community, and the lack of consistency could create inequity.
At the same time, the number of MOTs have increased dramatically in the past 2 decades, actually doubling from the period of 2012 to 2017.
This emphasizes the need to provide guidance regarding the ethical implications of MOT allocation as it currently stands

3. How was this resource developed?
Throughout 2018, the Committee identified potential ethical dilemmas for current MOT policies
Solicited feedback from all 21 OPTN committees
Received feedback from members of the following committees:
Pediatric, Patient Affairs, Pancreas, Ops & Safety, Minority Affairs, Thoracic
The ethical issues related to MOT have been a focus of the Ethics committee for several years. This slide details the effort of the committee to develop the white paper which is currently out for public comment.
As part of the effort to develop the white paper and identify ethical dilemmas in relation to MOT, the Ethics Committee solicited feedback from all committees and received feedback from the pediatric, patient affairs, pancreas, ops and safety, minority affairs, and thoracic committees. This feedback was extremely helpful in development of the white paper and addressing ethical issues for MOT.

4. What are the proposed solutions?
Develop a white paper with recommendations for the OPTN/UNOS Board to consider in addressing MOT allocation
The proposed solutions are to develop a white paper to provide recommendations for the OPTN/UNOS Board to consider in addressing MOT allocation

5. Ethical dilemmas addressed
Degree of need
Monitoring MOT in transplant programs
Waitlists and the “pulling of organs”
Fairness to patients awaiting SOT
Organ quality
Standardized Criteria for MOT
Treatment options other than transplantation
Relative Futility
Prioritization of MOT over SOT (single organ transplant)
Impact of adult MOT on pediatric SOT
Regionalization
Protected Subgroups
This is a list of all the ethical dilemmas discussed in the White Paper. The paper explores the details of each ethical dilemma, the conflict between ethical principles and the recommendations of the Ethics Committee. For the sake of time, we will only cover two of the ethical dilemmas that illustrate the impact of MOT on the transplant community. For a full discussion of the ethical implications, please read the ethics MOT paper.
Organ Quality & MOT –
One ethical dilemma identified by the Committee is the impact of organ quality and MOT.
Organ quality used for MOT is commonly better than it is for SOT. For example, the average KDPI in various MOT combinations is 18% to 36% versus an average KDPI of 46% in isolated kidney transplantation (UNOS data).
By pulling high-quality organs away from SOT candidates for use in MOT candidates, SOT candidates become disadvantaged because fewer high-quality organs remain available to them.
SOT candidates may become doubly disadvantaged by MOT if fewer organs of lower quality are available to SOT candidates
Relative futility
Another ethical dilemma identified as significant by the committee relates to relative futility.
The risks of MOT are typically higher than the risks of SOT because the MOT recipient is more ill with multi-organ failure, the combined operations are longer and require more technical skill, and complications with either organ can be life-threatening. However, MOT can be life-saving to someone who is critically ill with multi-organ failure.
Since more donated organs are lost when a MOT recipient dies than when a SOT recipient dies, it is more imperative that MOT candidates be healthy enough to survive post-transplant.
For MOT candidates where the expected rate of survival is significantly lower than that for SOT candidates, “relative futility” exists in which the expected outcomes of the several candidates who could receive the individual organs would far exceed the expected outcome of the single MOT candidate. In the context of relative futility, proceeding with MOT when a poor outcome is likely does not maximize lives saved or life-years added, and caution should be exercised before proceeding.
These are two ethical dilemmas the committee discusses, however, as the slide shows there are other ethical dilemmas the paper reviews and the ethics considers important

6. Recommendations Include:
Establish data reporting for MOT outcomes
Improve transparency and create standards
Consider establishing minimum requirements for MOT
Medical urgency important qualifier
Consider additional “safety net” policies for other MOT combinations
Don’t disadvantage patients who undergo SOT instead of MOT
Minimize added harm to subgroups already disadvantaged in access to transplants
Children, minority populations, highly sensitized patients
These are some of the recommendations provided in the white paper. Overall, the white paper recommends bringing more consistency and transparency to MOT allocation. These 4 recommendations reflect the need for greater transparency and accountability:
1. Establish data reporting for MOT. Because of the lack of MOT reporting, programs may avoid accountability by transplanting high-risk SOT candidates as MOT, effectively manipulating their outcomes data. Consistent standards will help patients evaluate their transplant options and help ensure accountability for program outcomes.
2. Consider establishing minimum requirements for MOT which could differentiate those candidates whose potential benefit from MOT could be considered medically urgent. Priority of non-medically urgent MOT candidates should be avoided.
3. Add “safety net” policies for MOT allocation to ensure that patients who may retain/recover function of their secondary organ are incentivized to first undergo SOT without being disadvantaged to MOT candidates. This could avoid MOT being used when it is not necessary.
4. Ensure that consideration is given to the impact on subgroups already potentially disadvantaged by current allocation – specifically children, minority populations and highly sensitized candidates. These groups may face significant challenges to access to transplant, and MOT policies should be carefully considered regarding whether vulnerable populations are additionally impacted.

7. How will members implement this resource?
Does not require any member action
Will be available as a reference on the OPTN website pending approval by the Board of Directors
This white paper does not require any member action
It will be available as a reference on the OPTN website pending approval by the Board of Directors in June.

8. How will the OPTN implement this resource?
Will be available through the OPTN website
If approved, could serve as reference for the Board of Directors and committees considering future policy changes to MOT
Since this is a White Paper and not a proposal there will be no implementation. If approved, it is likely that White Paper will be an essential reference for future policy projects related to MOT

9. Questions?

10. Extra Slides

11. Pediatric candidates
Focus of paper on adult candidates because the challenges with pediatric candidates may be substantively different for MOT
However, Committee solicited and received feedback from Pediatric Committee, which asked for more discussion on pediatrics
In response to Pediatric Committee, Ethics Committee added language to “Protected Subgroups” section discussing the impact on pediatric candidates
Focus of paper on adult candidates because the challenges with pediatric candidates may be substantively different for MOT
However, Committee solicited and received feedback from Pediatric Committee, which asked for more discussion on pediatrics
In response to Pediatric Committee, Ethics Committee added language to “Protected Subgroups” section discussing the impact on pediatric candidates

12. MOT Increase
Excluding KP and heart/lung, MOT has doubled in the past six years, from 625 in 2012 to 1,035 in 2017
The reason for this increase is not readily apparent
The Committee considered investigating the reason for this increase, but after discussion, agreed the most relevant and important takeaway for the ethical implications of MOT is the fact of the increase, not the reason for it
Excluding KP and heart/lung, MOT has doubled in the past six years, from 625 in 2012 to 1,035 in 2017
The reason for this increase is not readily apparent
The Committee considered investigating the reason for this increase, but after discussion, agreed the most relevant and important takeaway for the ethical implications of MOT is the fact of the increase, not the reason for it