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Update to VCA Transplant Outcomes Data Collection

Proposal Overview

Status: Implemented

Sponsoring Committee: Vascularized Composite Allograft (VCA) Transplantation

Strategic Goal: Improve waitlisted patient, living donor, and transplant recipient outcomes

Read the proposal (PDF; 01/2020)

View the Board Briefing Paper (PDF; 06/2020)

View the notice of OPTN data collection changes (PDF; 7/2020)

Contact: Tina Rhoades

eye iconAt a glance

What is current policy and why change it?

OPTN data submission requirements for Vascular Composite Allograft transplant (VCA) recipients were implemented September 2015. A review of data reported to the OPTN since that time noted opportunities to refine the data collection to further capture recipient outcomes. This proposal will modify data reported to the OPTN on VCA transplants.

What’s the proposal?

  • Modify existing Transplant Recipient Registration (TRR) and Transplant Recipient Follow-up (TRF) instruments used to collect data on head and neck, and upper limb transplant recipients.
  • Add new data elements for uterus on TRR and TRF instruments.
  • Request feedback on the data elements to collect for VCA types such as larynx, abdominal wall and penis.

What’s the anticipated impact of this change?

  • What it’s expected to do
    • Create consistent data elements across VCA types that are developed by consensus in the field.
    • Develop VCA outcomes data that can be used for future policy decision making.
  • What it won’t do
    • Change data reporting policy requirements, e.g., when forms are due, for OPTN members.

Themes to consider

  • Additional data submitted on uterus transplant recipients.
  • What data elements should be collected for other VCA types, including abdominal wall, larynx, musculoskeletal graft segments and penis? The feedback received from the transplant community will inform a future data collection proposal requiring data collection on the above VCA types other than upper limb, head and neck and uterus.
  • Which is the most appropriate psychosocial assessment to be included on the Transplant Recipient Follow-up (TRF) instrument for all VCA types?

Terms you need to know

  • Transplant Recipient Registration (TRR): The form completed and submitted by the transplant center when a patient is transplanted. The form contains patient status, pre-transplant 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 post-transplant (all but thoracic) 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.


Hatem Amer | 03/24/2020

First, I would like to thank the VCA committee and the OPTN for moving to update the data collection for VCA. I think the proposal is timely and needed. I do have some questions, suggestions, and requests for clarification: 1. In regard to hemoglobin A1C. I agree fully that it be collected at the time of recipient registration. As noted, it will provide an important baseline given the risk of post-transplant new onset diabetes. It is unclear to me why then it will be removed from the TRF forms (page 17 &21). What is the purpose of obtaining a baseline and then not having a follow-up? This would be an opportunity to objectively capture NODAT (new onset diabetes after transplant). 2. In head and neck, the action items to assess function such as smile restoration, ability to open and close eyelids, etc. are excellent. Is there any consideration for including other deficits that facial transplantation may restore such as nasal breathing, smell, oral competence, ability to swim, and mastication? 3. In appendix 3 (page 26) it would be helpful to the community to clarify, and aid in standardization, how to report differences in findings over the graft. For the hot and cold discrimination (it does specify upper and lower lip) what about a case where the lips were not part of the graft? Should this be for the least or most sensate part of the graft? Two-point discrimination is nicely described from S0 to S4. As we know, sensation improves over time and is from proximal to distal. What should programs report? The best achieved area, the most distal area, the least sensate or the range noted on the graft? If we take the range noted, this could help with future analyses as it will show the best and worst achieved and can, be trended over time. 4. On the same page in the appendix is also discusses the ability to open and close the eyelids. Two values are provided 0 and 1. 0 is spontaneous and 1 is on command for both eyes. How is this entered if there is no function at all or there is unilateral function? 5. The psychosocial assessment is of extreme importance in VCA given its life enhancing role. The SF36 appears to be the relative gold standard. It is long and has been criticized that it may be affected by factors not directly related to the transplant. The SF-12, as stated, is shorter but may not be as reliable in a small population without the added input of a condition specific instrument. The PGI addresses the deficits posed by the SF12 and SF36 and offers a patient specific, objective, assessment that can be compared over time. I think this can assist in objectively assessing patient specific expectation and outcomes from VCA and help to determine success or failure for the individual for whom this field was developed. 6. Over the past 20 years of clinical VCA, we have seen, heard of, had presented at meetings, subjects who have had VCA transplants with varied outcomes. Some have stopped immunosuppression despite apparent good functional outcomes, some have had objectively limited functional outcome but report excellent quality of life and are appreciative of the transplant. Many are somewhere in between. One of the strategic goals of the OPTN is to ensure safety and to improve outcomes. The current proposal includes ongoing collection of complications (page 15) that list metabolic, infections, malignancy, and others. It might be beneficial to include specific measures for some of these, looking for known complication of immunosuppression, and addressing some of the unique aspects of these recipients. For example, in a bilateral UE transplant recipient who also has bilateral lower extremity amputations with reduced muscle mass, measured renal function (such as 24-hour creatinine clearance) and not estimated from creatinine will be needed. A challenge for comparing programs is the small number of transplants, the significant heterogenicity of injuries, and reasons for proceeding with a VCA. A suggested framework that can extend to novel VCA regardless of numbers: a. Collect patient specific goals that can be measured overtime objectively -an instrument such as the PGI. b. Collect objective measures of function for the VCA unit being transplanted. c. Collect medical and psychological complications of the transplant (malignancy, renal dysfunction, infections, burden of treatment, depression).

Region 7 | 03/24/2020

6 Strongly Support, 6 Support, 3 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Anonymous | 03/24/2020

I do not believe that the SF 36 or SF 12 are an adequate measure of the quality of life in this population. It would be helpful to use a measure that is more specific to the needs of the patients who are the recipients of the graft based on their own values and lifestyle. The PGI appears to provide as strategy for incorporating the patients report of their particular needs in a way that could be measured over time. I would support the use of this measure.

Region 10 | 03/24/2020

5 Strongly Support, 7 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

OPTN Region 9 | 03/24/2020

Strongly support (2), Support (7), Neutral/Abstain (3), Oppose (0), Strongly Oppose (0)

American Society of Transplantation | 03/23/2020

The American Society of Transplantation is supportive of this proposal. VCA transplantation is rapidly evolving. There is a need for the OPTN to be responsive to rapid changes in the field and to ensure that data being captured are meaningful to patients, providers, and policy experts. The removal and addition of data elements to the head and neck, upper limb, and uterus transplant TRR and TRF forms has been thoughtfully considered by the Committee, with critical input from key stakeholder groups. The VCA Committee has identified three QOL assessment tools and asks for comments about which one should be selected for inclusion on the TRF. The three are the SF36, SF12, and PGI. • The PGI, which is a novel patient-centered tool, should be removed from consideration. It requires open-ended responses from the patient, which makes data mining, conversion, validation, and interpretation much more challenging and less likely to be used by researchers or policy experts going forward. Additionally, use of the PGI – considering its format – would place a much larger administrative burden on transplant programs to administer the questionnaire and enter the data onto the TRF. • The SF36 and SF12 are widely used, have been extensively validated in multiple languages, and provide standardized scores reflecting multiple domains of health-related QOL. The SF12 obviously provides less granularity than the SF36, but is less burdensome for patients and programs. If the Committee’s intention to use one of these three measures, We would support use of the SF12. Both, however, will place additional administrative burden on transplant programs. Overall, while the AST agrees with the desire to collect this QOL information in the context of VCA transplantation, we are concerned that compliance will be low – both with patients who do not complete the measure due to time constraints or lack of follow-up and for programs who will have to develop a process for collecting, tracking, and entering the data. Even when done as part of highly resourced, NIH-funded transplant outcome studies, rates of QOL assessment completion are generally less than 70% the further removed from transplant surgery the assessment gets. For this reason, we strongly support additional discussion and consideration of alternative strategies to capture and share health-related QOL through program consortia rather than through a required OPTN data element that may be used as a measure of program performance and place high administrative burden on programs. While the AST constituencies concurred with the proposal in Table 2 without modifications and additionally supported the modifications noted in Tables 3, 4, 7 and 8, there was not support for the removal of the “Skin changes noted with acute rejection” in Tables 5 and 6. Currently, the monitoring for rejection is the skin, thus, data on skin changes should be collected during rejection. Data elements collected for biopsy data are dissimilar to those observed with skin changes. Thus, failure to collect visual changes will impair the ability to comprehensively monitor the graft leading to poorer outcomes.

OPTN Living Donor Committee | 03/23/2020

Strongly support (7), Support (4), Neutral/Abstain (0), Oppose (1), Strongly Oppose (0) The OPTN Living Donor Committee is in support of the proposal.

American Society of Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) appreciates the opportunity to comment and strongly supports this proposal as written. We agree OPTN data submission requirements for Vascular Composite Allograft (VCA) transplants need to be improved to better assess patient outcomes, address limitations and inconsistencies in VCA data collection, and achieve consistency in data reporting. ASTS concurs with the addition of new data elements to the Transplant Recipient Registration (TRR) and Transplant Recipient Follow-up (TRF) forms. However, the ASTS feels strongly that uterine transplant is an abdominal organ that should be considered under its own egis and not as a vascular allograft. Recipients of uterine transplants require unique considerations to address their specific needs including coordination with other medical specialties such as infertility medicine. When uterine transplants are performed, we recommend offspring are observed at the following intervals: birth to record APGAR score, 1 month to record early survivability and growth, 1 year, and 6 years to record physical and intellectual development.

NATCO | 03/23/2020

NATCO supports the proposal to modify and add new data to TRR and TRF for VCA recipients. This field of transplant has evolved since the first policy was created in 2014, and it is important to capture all relevant information so that we can continue improve care and outcomes moving forward. The ability to remove/add data that is specific and measurable is needed, as is the addition of a new data element for uterine transplant to evaluate outcomes of this patient population.

OPTN Region 3 | 03/22/2020

Vote: 6 strongly support, 12 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Region 11 | 03/19/2020

Strongly support (3), Support (8), Neutral/Abstain (6), Oppose (0), Strongly Oppose (0)

Robert Goodman | 03/11/2020

While I am not a formal member of the VCA Committee nor a VCA transplant recipient (heart only for me), as a Board member I have been sitting in on many of the VCA Committee calls because I find this area of transplant fascinating and important. My comment is fundamentally that the transplant community ought to do what is necessary to have VCA transplants managed from a data collection standpoint just as another other transplant type. The outcomes measures for research and future development of new techniques, management protocols, etc. need to be gathered, assessed, measured, distributed and otherwise made available to others in order to further the work being done in the VCA area. On a personal level, I am in favor of the proposal.

Region 1 | 03/10/2020

Strongly support (3), Support (5), Neutral/Abstain (0), Oppose (0), Strongly Oppose (0) No comments or questions

Anonymous | 02/28/2020

5 Strongly Support, 28 Support, 0 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Region 5 | 02/21/2020

Strongly support (13), Support (8), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0)

Region 6 | 02/21/2020

Strongly support (8), Support (9), Neutral/Abstain (0), Oppose (0), Strongly Oppose (0)

Region 8 | 02/20/2020

8 Strongly Support, 10 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Region 4 | 02/20/2020

Strongly support (11), Support (9), Neutral/Abstain (2), Oppose (0), Strongly Oppose (0)

Baylor University Medical Center | 02/03/2020

We appreciate the opportunity to comment on plans to enhance VCA Transplant Outcomes Data Collection. Our center’s experience with uterus transplant for the past several years puts us in a unique position to inform this work. We wholeheartedly agree with removing data fields that are not pertinent to the general VCA and uterus specific instruments. Additions to the Uterus TRF instrument may provide valuable information. It is important to recognize that follow up in this population is challenging. Commercialization of this type of VCA transplantation may impact recipient inclination for long term, intrusive, follow up. In our experience, healthy uterus transplant recipients, after delivery and transplanted organ removed, are prefer to forgo long term follow up with a transplant center to provide information about themselves and their child(ren) in favor of moving with family life. Our research trial includes follow up for 5 years and we have encountered challenges in achieving this long term follow-up. Recipient follow up for 2 years or until the transplanted organ is removed, is realistic. Likewise, follow up of children delivered after uterus transplantation for 2 years, including only information gathered at routine pediatric visits, seems reasonable. We do not support the addition of an assessment of psychosocial status after uterus transplantation. Other type of VCA recipients may benefit from this type of assessment. Uterus transplant candidates are healthy women desiring a healthy baby and have limited willingness to undergo such an evaluation after transplant. In addition, the value of gathering this information from uterine transplant recipients will not outweigh the costs. We recognize the importance of monitoring of this novel type of VCA transplantation and look forwarding to continued collaboration with UNOS/ OPTN and other VCA programs.