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Modify Graft Failure Definition for VCA

eye iconAt a glance

Current policy

The current OPTN definition of graft failure does not appropriately characterize graft failure for all VCAs. The Committee proposes modifying the OPTN definition of graft failure to include a definition that is more specific to covered VCAs and acknowledges the possibility of planned graft removal. For example, for certain types of VCAs, most notably uterus, the transplanted graft may be removed intentionally when the transplant is still functioning, but has fulfilled its intended goal (i.e. following a successful birth). This proposal will update data collection on VCA graft failure and graft removal for accuracy.

Supporting media

Presentation

View presentation


Watch the February 24th webinar presentation by the Vice Chair of the VCA Committee to learn more about the proposal and how it complements VCA projects that are pending implementation.

Proposed changes

  • Exclude the planned removal of a VCA graft, when the graft is no longer needed to achieve the transplant’s goal, from the definition of graft failure
  • Add a policy definition for planned removal of a VCA graft
  • Modify the policy definition of graft failure to indicate that graft failure has occurred if a candidate requires a re-transplant for a covered VCA
  • Modify data collection on graft failure for covered VCAs to improve data quality
  • Modify data collection on hysterectomies performed for uterus transplants to improve data quality
  • Modify data collection on causes of VCA graft failure to reduce redundancy
  • Modify policy to reflect the ability to accrue waiting time for the three types of genitourinary organ VCAs (uterus, external male genitalia, and other genitourinary organ)

Anticipated impact

  • What it's expected to do
    • This proposal will revise policy and update relevant data collection to more accurately reflect VCA graft outcomes for all covered VCA types
    • This proposal will revise policy related to waiting time accrual to reflect the most recently approved covered VCA types.
  • What it won't do
    • This proposal does not include any changes to graft failure definitions for other transplants outside of VCA.
    • This proposal will not impact transplant hospitals that do not perform VCA transplants.
    • This proposal will not change current routine monitoring of OPTN members.

Terms to know

  • Vascularized Composite Allograft (VCA): Transplant of multiple structures, which may include connective tissue, skin, bone, muscles, blood vessels, and nerves. For example, face and hand transplants are two of the most well-known types of VCA transplants.
  • Graft: A transplanted organ or tissue.
  • Transplant Recipient Registration (TRR): The form completed and submitted by the transplant center when a patient is transplanted. The form contains patient status, pretransplant clinical measures, transplant procedure, post-transplant clinical measures, graft status, treatment and immunosuppression.
  • Transplant Recipient Follow-up (TRF): The form completed and submitted by the transplant center containing recipient information at six months posttransplant and annually thereafter. The form contains patient status, clinical measures at follow-up, graft status, viral detection, treatment and immunosuppression.

Click here to search the OPTN glossary

eye iconComments

Transplant Administrators Committee | 03/23/2022

The Transplant Administrators Committee thanks the OPTN Vascularized Composite Allograft Committee for the opportunity to comment on their proposal Modify Graft Failure Definition for VCA. The Committee supports this proposal because it clarifies the definition of graft failure to ensure successful uterus transplants are not counted as failed grafts.

Region 6 | 03/23/2022

0 strongly support, 6 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Chauvet Steering Committee | 03/22/2022

We agree with adding criteria for graft failure related to the patient’s request for graft removal due to the graft not meeting their goals. We believe that patients may request graft removal if they have unsatisfactory quality of life and that monitoring for quality of life and utilizing patient reported outcomes would be helpful to decrease the potential for patients to make this request. We also note that patients need support if the transplant team advises them to have graft removal and that additional support should be provided to these recipients especially if they are opposed to the removal of the graft.

American Society of Transplantation | 03/22/2022

The American Society of Transplantation supports the clarifications and improved data collection introduced with this policy proposal; however, we do have some concerns that we believe warrant consideration. Background: The goal of VCA transplants varies by VCA type and among recipients of a particular VCA type. Unlike solid organ transplants, they are not expected to prolong life and for several VCA organ types there may be other options that the recipient would have considered and opted for a VCA understanding a certain outcome and treatment burden. The brunt of this proposal is to change the definition of graft failure in VCA. It seeks to introduce “Planned Removal” as an exception to graft failure. The authors of the proposal stipulate that such intention must be declared pre-transplant or at the time of transplant. Planned Graft Removal as an Exception to Graft Failure in VCA: Of the currently performed VCA transplants, the only one that the transplant community would generally agree is a temporary transplant, is a uterus. The intent is to allow for one or more live births for a patient with uterine factor infertility. It is not intended to be a lifelong transplant necessitating ongoing immunosuppression. As such, this is currently the only exception to the goal of one transplant for life which all solid organ transplants strive to achieve. So, an allograft hysterectomy post live birth should not be counted as a graft failure and the proposed policy is fully supported in that regard. The converse would be true, if after the uterus transplant there is no live birth then even if that uterus was menstruating at the time of removal this would be a failure of the VCA transplant. This later situation raises an interesting question, how long should a recipient be attempting pregnancy and a live birth before this transplant would be considered a failure. There could be significant underreporting of VCA graft failures if no hysterectomy is performed and no live birth occurs. The other two examples given for a possible planned graft removal (abdominal wall grafts and musculoskeletal composite graft segments when transplanted for purposes of temporary coverage or to allow for the regrowth of the original tissue) do not appear to be reasonable assumptions that necessitate having this exception apply to all VCA graft types. The latter at this stage is purely theoretical, and the goal of VCA graft is to replace like with like body components as per the definition of a VCA adopted by the OPTN. The former is usually performed due to loss of abdominal wall domain and as a last resort. Expanding intended removal to all VCA organs can result in a situation where a program will be fully compliant and avoid any form of graft failure if they list all patients with a planned removal of the organ after X years/months or even with no end date documented. Simply that the intention is to remove it. If there is an end date and the graft is functionating, there is nothing in the policy that would flag the program as of concern. Why not list an upper extremity transplant with the intention to have it for only one year? Relisting for Same VCA: The addition of this as an indicator of graft failure is reasonable. It should be defined that it is the same VCA organ and same laterality. One can conceivably have a unilateral upper extremity transplant and require a contralateral transplant. Thus, it should be worded more precisely. To avoid under reporting of graft failures, it will be important to include definitions of, and mechanisms of determining at what point decreased or limited function is no longer acceptable. Graft Function: VCA transplants need graft specific functional expectations to be included in the definition of graft failure. The closest example is in pancreas transplantation where insulin requirements in addition to graft removal or patient survival are included in the definition. As noted above, the different VCA transplants have different goals. Among patients receiving the same transplant, the goals can vary. For uterus it may be the easiest, to specify, live birth of a healthy infant as a possible requirement. For upper extremity and face, individualized goals and expectations should be set before the transplant and followed post-transplant to determine graft success or failure. Would a patient with perfusing upper extremity grafts or face allograft that has no nerve regeneration be deemed a functioning graft or a graft failure? These are challenges and opportunities that will impact the acceptance of VCA transplantation into mainstream clinical practice. Suggestions: 1. Restrict planned removal of VCA graft as exclusion from graft failure to only uterus and expand to other temporary organs as they are performed and there is acceptance from the transplant community that they are truly temporary. 2. Live birth following a uterus transplant can be considered as a defined success. 3. Include some form of minimum function for each organ to allow that organ to count as functioning. 4. Suggest that future proposals allow for individualized goals to be set before the transplant that can allow future assessment of whether the VCA graft met the individual patient’s goals. These should be in addition to standardized outcomes as currently in place. Proposed Changes to data collection: Appendix 1 in the proposal appear to be limited to uterus transplantation. We are unclear if this was the intent. Under proposed options for primary cause of death “Maternal and obstetric mortality: other specify”. If this was intended for uterus alone, then this is very appropriate. If the intent is for all VCA grafts, then it would be strongly recommended to include a wider array of causes of death such as cancer, cardiovascular, and infectious death.

Attachment

Transplant Coordinators Committee | 03/22/2022

The Transplant Coordinators Committee thanks the OPTN Vascularized Composite Allograft Transplantation Committee for the opportunity to provide feedback on their proposal Modify Graft Failure Definitions for VCA. The Committee supports this proposal as it clarifies the nature of graft failure and allows programs to more accurately collect data on graft removals and failures.

Region 2 | 03/22/2022

1 strongly support, 16 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Region 11 | 03/21/2022

Sentiment: 3 strongly support, 3 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose. No additional comments.

NATCO | 03/21/2022

NATCO recognizes that the current OPTN definition of graft failure does not appropriately characterize graft failure for all VCAs. We support the proposed modifications to the OPTN definition of graft failure to include a definition that is more specific to covered VCAs and acknowledges the possibility of planned graft removal. We believe that the proposed definition appropriately distinguishes between graft failure and planned removal of a VCA graft, and we agree that the proposed modifications to data collection regarding uterus transplant outcomes are sufficient to capture data on various circumstances.

Region 7 | 03/21/2022

Sentiment: 2 strongly support, 8 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose. No comments.

Region 1 | 03/18/2022

Sentiment: 4 Strongly Support; 4 Support; 4 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No additional comments.

Region 9 | 03/17/2022

Sentiment: 1 strongly support, 8 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. No comments.

American Society of Transplant Surgeons | 03/17/2022

American Society of Transplant Surgeons opposes.

Attachment

Membership and Professional Standards Committee | 03/16/2022

The MPSC thanks the VCA Committee for presenting its proposal and shares the following feedback from its discussion: The proposed definitions clearly distinguish between graft failure and planned removal. According to the proposed graft failure definition, a VCA recipient could be registered for a second VCA of the same type, which is not intended to replace a failed transplant, and it would be considered a graft failure.

Region 3 | 03/02/2022

• Sentiment: 2 strongly support, 7 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

Jennifer Gobrecht | 02/24/2022

planned graft removal does not equate to failure when referring to the removal of a life enhancing transplant like a uterus transplant. Planned graft removal at the time of a successful birth is really the success of the grafts full function. I support redefining graft failures.

Region 8 | 02/23/2022

2 strongly support, 7 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose - Region 8 supported this proposal. A member commented that the failure definition needs to be updated in order to have accurate failure data. Another member thought this proposal was accurate and consistent.

Region 4 | 02/18/2022

0 strongly support, 16 support, 10 neutral/abstain, 0 oppose, 0 strongly oppose - Region 4 supported this proposal with one attendee commenting that this proposal is needed for guidance and clear definitions.

Region 5 | 02/16/2022

6 Strongly Support, 17 Support, 10 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Region 10 | 02/16/2022

3 Strongly Support, 8 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose