Vascularized Composite Allograft (VCA) Transplantation Committee Fall 2014

Recent Board Approval VCA & organ definitions VCA donor authorization VCA allocation Membership approval On July 3, 2014, amendments to the OPTN Final Rule took effect that included VCAs under the definition of a “covered human organ”. As such, oversight of VCA recovery and transplant came under the OPTN. The OPTN Board of Directors unanimously approved several policy and bylaw changes during their June 2014 meeting. Since the public comment period could not be complete before the federal regulation took effect, the Board acted in advance of public comment. The Board also approved a sunset provision for these changes. This will require the Board to revisit these policy and bylaw changes after public comment is received. The changes listed on this slide are currently out for public comment and will be presented separately during an OPTN public comment webinar hosted by Regional Administration. To give you a broad overview, the changes include: VCA and organ definitions – VCAs (for example: upper limbs, faces, or abdominal wall grafts) are now considered organs. Future advancements in transplantation will expand this list. VCA donor authorization – Authorization for VCA donation cannot be assumed in the presence of a general donor registry. Authorization for organ donation should occur first, then authorization for VCA donation, if appropriate. This is to not dissuade a potential donor’s family from life-saving organ donation. Additionally, a separate authorization form for VCA donation should be used. VCA allocation – VCA Allocation must be based of the OPTN VCA Candidate list, much like a match run list for a heart or liver. Allocation starts regionally, then proceeds to the national level. VCA transplant program membership criteria – Basic membership criteria were broadly written to avoid burdensome impact on those VCA transplant programs operating when the regulatory change occurred. These membership criteria are being examined by the VCA Committee currently. In addition, providing the Board approved exemptions from certain policies that will not apply to VCA in this interim stage.

Educational Resources VCA Donor Authorization Guidance Document Memo: VCA Grafts in Reconstructing Abdominal Wall VCA Membership Application Help Document We are working on a number of educational resources to help transplant programs and OPOs comply with the new policies and bylaws: The VCA Committee developed a Donor Authorization Guidance Document. This document was approved at the November 2014 board meeting and the OPTN website. In this document, OPOs with experience in VCA recoveries shared best practices. Another resource includes a memo that clarifies the use VCA grafts when reconstructing the abdominal wall. The VCA Committee recognized the potential for surgeons in the United States to need tissue that meet the nine criteria of a VCA in abdominal procedures for both transplant and non-transplant patients. Furthermore, the Committee was concerned that surgeons may be unaware of the regulatory change and the processes that required before they engage in this clinical practice. Finally, if you are considering adding a VCA program to your transplant hospital, help documentation to walk you through the application process will be available. You will be able to access all of these resources on the OPTN website in the coming months.

Ongoing Committee Initiatives VCA Program Membership VCA Graft Failure We are also working on the following additional policy and bylaws changes. Refining VCA Membership Criteria – The committee drafted the current VCA Program Membership requirements to put minimum membership standards into place for VCA program approval beginning July 3, 2014. Our Membership Subcommittee is working on future public comment proposal for specific criteria for upper limb, lower limb, face, abdominal wall, and “other VCA” transplant programs. These will be similar to the primary surgeon and primary physician requirements of other organ specific requirements to the extent possible. The Subcommittee is considering challenges faced by other organs and restrictive membership requirements. The intent is to be inclusive as possible to surgeons and physicians interested in VCA transplantation. We anticipate these proposed requirements will be shared for Public Comment in 2015. VCA Graft Failure Definition – The current OPTN definition of “graft failure” is very broad and the committee is concerned that this definition does not fit VCA graft failure well. The Data Subcommittee will work on a VCA-specific definition of graft failure in the future. If you have specific feedback concerning the development of these two elements, please contact your Regional Administrator.

New Committee Initiatives VCA Allocation The VCA Committee’s initial allocation algorithm was intended to allow broader access to VCA grafts from donors. Yet, in the future, the committee hopes to move away from the “regional, then national” algorithm to a more advanced model. This future model may resemble the algorithm currently used for hearts; concentric distances from the donor hospital. Data is central to this VCA allocation enhancement. The Committee wants to better understand the role of cold ischemic time as it relates to graft and patient outcomes. This may impact future allocation modeling for VCAs. Donor Hospital Regional National

Questions? Sue V. McDiarmid, M.D. Committee Chair smcdiarmid@mednet.ucla.edu Insert presenter here Christopher L. Wholley, M.S.A., NRP, CPTC Committee Liaison christopher.wholley@unos.org

VCA Criteria That is vascularized and requires blood flow by surgical connection of blood vessels to function after transplantation. Containing multiple tissue types. Recovered from a human donor as an anatomical/structural unit. Transplanted into a human recipient as an anatomical/structural unit. Minimally manipulated (i.e., processing that does not alter the original relevant characteristics of the organ relating to the organ's utility for reconstruction, repair, or replacement).

VCA Criteria For homologous use (the replacement or supplementation of a recipient's organ with an organ that performs the same basic function or functions in the recipient as in the donor). Not combined with another article such as a device. Susceptible to ischemia and, therefore, only stored temporarily and not cryopreserved. Susceptible to allograft rejection, generally requiring immunosuppression that may increase infectious disease risk to the recipient.