Comments

OPTN Organ Procurement Organization Committee | 09/21/2023

The OPTN Organ Procurement Organization Committee thanks the OPTN Vascularized Composite Allograft Transplantation Committee for their work and for the opportunity to comment on this guidance document.

A member remarked that there are few programs equipped to perform VCA transplants, which poses a challenge to VCA allocation. As a result, many OPOs don’t have the opportunity to work with VCAs. 

A member explained that there is limited general understanding of how VCA allocation works, and that it can be difficult to learn and approach VCA allocation. 

One member remarked that it would be helpful to observe VCA allocation, to better understand how this process works. The member added that it would also be helpful to ensure OPOs have a general understanding of the requirements and for VCA donation; the member noted that this information is not currently easily accessible. 

One member shared that they rarely receive interest in VCA offers. The member explained that their teams have extensive training in VCA, but that there is limited opportunity for VCA transplant, and thus it is difficult for personnel to become proficient in the VCA field.  

A member noted that there may be challenges in finding additional interest from OPOs for VCA transplants, particularly as CMS metrics for transplant programs do not consider VCA transplants.

Region 8 | 09/19/2023

Sentiment: 3 strongly support, 6 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. The region supports this updated guidance document and complimented the committee on the helpful supporting documentation.

Association of Organ Procurements Organizations | 09/19/2023

AOPO applauds the Committee’s work, Update Guidance on Optimizing VCA Recovery. AOPO will focus its response on the following questions posed by the Committee.

• Are there additional effective practices the community should include in these recommendations to the transplant community?

AOPO applauds the Committee on a comprehensive update. Although financial aspects of VCA transplantation are not within the purview of the OPTN, we believe it is important to suggest in the guidance document that both OPOs and transplant centers be aware of financial issues such as costs and the impact of VCA recovery on the OPO CMS cost report prior to partnering in a VCA recovery.

• What barriers and challenges are keeping the transplant community from becoming more involved with VCA recovery and transplant?

Hopefully, any barriers created by a manual on paper allocation process of the past are being eliminated with the programming of VCA allocation in UNet. The VCA community should strive to keep the OPO community well informed of progress and developments. Due to the relative infrequency of a VCA transplant, it is possible for an OPO to screen hundreds of donors for VCA suitability over multiple years without experiencing a single acceptance. Frontline staff may occasionally benefit from motivational educational materials and encouragement that efforts are not in vain.

• What are the experiences of donor families regarding the VCA authorization process?

It has been the experience of AOPO membership that approaching organ donor families for a potential VCA donation should be carefully considered on a case-by-case basis due to the varying potential response of donor families. In the frequent scenario of first-person authorization which is typically documented through donor registries, donor family members can have varying enthusiasm in supporting or in some cases, not supporting the organ donation decisions made of their loved one. OPO staff should use their expertise in evaluating donor family dynamics to ensure that an approach for

VCA donation does not jeopardize the potential for organ donation in any given situation.

• What are experiences of donor families, recipient families, and recipients with media and public relations strategies?

The AOPO community has found media stories covering VCA successes very inspirational and a motivating tool for public education within their communities. Stories that include connecting donor families with VCA recipients are very successful in promoting VCA and donation in general. AOPO has historically embraced the telling of these stories throughout our community and has promoted VCA at national meetings and on the national stage.

Region 9 | 09/19/2023

Sentiment: 2 strongly support, 5 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

NATCO | 09/19/2023

NATCO is in strong agreement with the proposed policy changes regarding VCA. We believe the proposed VCA policy is clear, thorough, and will place VCA transplantation in the same consideration as solid organ transplantation. NATCO emphasizes that while VCA is important, it should never compromise solid organ r

Region 3 | 09/19/2023

Sentiment: 0 strongly support, 7 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that a “Family Considerations” section will be helpful. 

Region 10 | 09/19/2023

Sentiment: 1 strongly support, 8 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee noted that this proposal is necessary to increase the number of VCA transplants.

Region 7 | 09/18/2023

Sentiment: 1 strongly support, 7 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplant Surgeons | 09/18/2023

See attachment.

View attachment from American Society of Transplant Surgeons

Region 1 | 09/15/2023

Sentiment: 0 strongly support, 3 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Gift of Life Michigan | 09/15/2023

We appreciate the Committee’s work to refine guidance around recovery and transplantation of Vascular Composite Allografts (VCA) to patients in need.
The grafts provide life-changing outcomes for many recipients. The patient who receives a face transplant or someone receiving a working human limb can have a chance at a quality of life somewhat comparable to their status before needing such an intervention. A woman who receives a uterus transplant can experience the profound event of giving birth.

We have seen notable examples of the potential good that comes from VCA transplants. It seems we are still identifying and perfecting the procedures, but many have already benefited. We are also aware that some ethical considerations arise when transplant programs must weigh the risks and benefits against limited resources. For example, if someone survives a failed suicide attempt and needs a face transplant, the team will likely have to carefully consider the possibly heavy psychological aspects of both the event leading to the need for transplant, and the ability and willingness for a recipient to comply with sometimes complex post-transplant regimens.

Cost is another key aspect of VCA transplant. Payors are likely somewhat reluctant to support these transplants until they are “proven”. We encourage the Committee to explore potential hurdles in supporting VCA financially and to include payors in their discussions.

It has been our experience as an Organ Procurement Organization that many families of potential VCA donors are very supportive of these gifts. It is our practice to fully disclose to families how the recovery of VCA may affect the appearance of their loved one’s body, and to ensure their comfort. Even in cases of registered donors, we believe it is extremely important to fully inform families. Some of the families of VCA donors have enthusiastically chosen to publicly share their loved one’s VCA donation story and to encourage others to sign up as donors.

Region 6 | 09/15/2023

Sentiment: 1 strongly support, 7 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplantation | 09/15/2023

The American Society of Transplantation (AST) supports the proposal, “Update Guidance on Optimizing VCA Recovery.”

View attachment from American Society of Transplantation

American Society for Histocompatibility and Immunogenetics | 09/14/2023

This proposal is not pertinent to ASHI or its members.

View attachment from American Society for Histocompatibility and Immunogenetics

Region 5 | 09/13/2023

Sentiment: 6 strongly support, 10 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose

Region 11 | 09/12/2023

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

Region 2 | 09/01/2023

Sentiment: 4 strongly support, 11 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Region 4 | 08/30/2023

Sentiment: 3 strongly support, 9 support, 11 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that optimizing VCA recovery should not jeopardize recovery of other organs.

OPTN Transplant Coordinators Committee | 08/28/2023

The OPTN Transplant Coordinators Committee thanks the OPTN Vascular Composite Allograft Committee for their work and for the opportunity to comment on this proposal.

The Committee supported this proposal and agreed it is a great guidance document and can be extremely helpful to increase VCA transplants.