ISHLT Response to OPTN Update Criteria for Post-Transplant Graft Survival Metrics

Published 29 October 2024

• Advanced Heart Failure & Transplantation
• Advanced Lung Failure & Transplantation
• Cardiothoracic Surgery
• OPTN Comment

The International Society for Heart and Lung Transplantation (ISHLT) appreciates the opportunity to provide feedback on the “Update Criteria for Post-Transplant Graft Survival Metrics” OPTN special public comment.

Because it has the potential to reduce administrative burden on heart and lung transplant programs, ISHLT strongly supports the proposal. ISHLT offers the following general comments:

1. Although achieving the “bold aim” of 60,000 transplants in 2026 is welcomed, it would behelpful if the OPTN would provide more granularity about what is needed to achieve thatgoal (e.g. increased utilization of difficult to place donors, decreased non-utilization oforgans, increased access to transplants for underserved populations, increased resourcesfor transplant programs and OPOs to accommodate increased volume) and the how thisproposal fits into the broader set of steps the Expeditious project is undertaking. Inaddition, breaking down the aim in terms of anticipated increases by organ would behelpful for entities such as ISHLT.
2. The term “complex donor organ” is not clearly defined in the public comment document.We presume this means traditionally difficult to place donors or donors with a highlikelihood of non-utilization, but it would be helpful to the community for a clearer definitionto be provided.
3. ISHLT is interested in whether the MPSC has considered other strategies or incentives toincrease institutional support of programs that might balance the potential loss of thisperceived benefit of MPSC program review.
4. The document makes the important point that other entities’ actions (including SRTR publicreporting and insurance provider Center of Excellence programs) may limit the potentialbenefit of the proposed change. What steps will the MPSC, the OPTN or HRSA take tomitigate this concern?
5. The OPTN encourages process improvement by defining a “performance improvementzone” in addition to the requirements of official MPSC review. With the current hazard ratiothreshold of 1.75, the performance improvement zone applies to those programs withhazard ratio greater than 1.5 but not greater than 1.75. If the MPSC continues to offer process improvement support to those programs withHR>1.5, we believe that raising the threshold for official review to 2.25 will maintain theimportance of continuous process improvement while reducing the impact official MPSCreview may have on acceptance of organs and transplant candidates.
6. ISHLT remains concerned about the use of “special” public comment periods for issues that fall outside of the framework provided by the OPTN Bylaws. In our opinion, issues raised by this proposal are not sufficiently urgent to exclude the benefit in person / virtual presentation and discussion occurring during regional meetings provides to the process. ISHLT recommends that the OPTN Executive Committee develop a proposal to amend the OPTN Bylaws to include a framework for future proposals that don’t meet existing criteria for off cycle public comment requests. At a minimum such a proposal should include criteria to justify off cycle timing, criteria for determining the length of the public comment period and a mechanism to allow members to request that the OPTN Board provide an opportunity for regional discussion of the proposal, either through regularly scheduled regional meetings or comparable events.

ISHLT Responses to the “Considerations for the Community”

Would a change to a threshold of 2.25 from 1.75 for 90-day and 1-year conditional on 90-day graft survival increase your willingness to accept more complex donor organs and perform more complex transplants?

Unlikely. As noted in the proposal and above there are many factors (both internal and external) that impact risk tolerance of transplant programs, including maintaining center of excellence status from third party payers. Moreover, we believe that most programs are mindful of their post-transplant survival while striving to achieve the common goal of getting the most possible patients transplanted with acceptable outcomes. In addition, smaller programs, where a single poor outcome has a disproportionately larger effect on performance metrics, may be less willing to adjust their practice based on this change. Thus, it is unlikely that this proposal alone will lead to a significant increase in utilization of difficult to place donors or donors with a high likelihood of non-utilization without addressing transplant center resource limitations and the oversight/impact of entities beyond the OPTN.

Do you support a change to the alternative threshold of 2.0 considered by the MPSC rather than the proposed 2.25 threshold?

Any reduction in the likelihood of being flagged for MPSC review would be welcomed by ISHLT and its members. ISHLT would welcome comment from the OPTN and HRSA regarding progress toward implementing NASEM report recommendation 13 (“Embed continuous quality improvement efforts across the fabric of the U.S. organ transplantation system”) as an alternative to the current OPTN member quality program and recommendation 14 (“Align reimbursement and programs with desired behaviors and outcomes”) which would have the potential to address the resource limitation issues noted above. We believe efforts toward adoption of the NASEM goals would support the 60,000 transplants goal as or more effectively than this proposal.

Would you support an increase in the threshold for the offer acceptance rate ratio to identify more programs and incentivize programs to accept more organs?

ISHLT supports the MPSC decision in the current proposal to leave the offer acceptance rate ratio threshold unchanged. ISHLT will strongly oppose increasing the threshold in the future unless multi-criteria offer filters for all organs are in place and data is available to support the assertion that increasing the threshold will improve utilization.

Should the change in threshold be applied to pediatric transplants in addition to adult transplants?

The rationale provided in the document for excluding pediatric programs from this change is incomplete. It would have been helpful for the MPSC to provide similar data about the number of programs flagged and their outcomes as well as the impact of raising the current thresholds on the number of programs flagged.

Given that the impact of flagging programs is no different (and may be more significant for typically smaller pediatric programs with limited resources), in the absence of such data, there is inadequate justification for excluding pediatric programs.

Are patients supportive of the change in threshold which aims to increase access to more complex organs?

ISHLT does not have a mechanism to directly answer this question.