At a glance Current policy Uterus is the most sought-after Vascularized Composite Allograft (VCA) transplant, with 44 candidates added to the waiting list since 2016. The majority of uterus transplants performed to date (20 out of the 32) were made possible through living donation. Currently, uterus transplant programs are subject to the general VCA membership requirements that apply to several types of VCA. Since uterus transplantation is expected to continue increasing, specific requirements for programs performing uterus transplants and living donor uterus recoveries are proposed. Supporting media Presentation View presentation Watch the Sept. 22 webinar presentation by members of the VCA Committee for a more detailed overview of the proposal, along with an overview of OPTN VCA projects as well as uterus transplantation in the U.S. Proposed changes Establishes uterus as a type of VCA separate from other genitourinary organs. Establishes primary surgeon and primary obstetrician-gynecologist requirements specific to uterus transplant programs. Adds requirements for uterus transplant programs that recover uteri from living donors. Anticipated impact What it's expected to do Promote living donor and transplant recipient safety by establishing more tailored membership requirements for uterus transplant programs that reflect the expertise needed to safely perform these transplants What it won't do This proposal does not include any changes to membership requirements for VCA types that are subject to the membership requirements for “other VCA” transplant programs Themes Uterus transplantation Membership requirements Living donors 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. Living donor: A living individual from whom at least one organ is recovered for transplant. Click here to search the OPTN glossary Comments NCBC, CMA, NCPD, NACN-USA | 09/30/2021 See comment, attached. Attachment Living Donor Committee | 09/30/2021 The OPTN Living Donor Committee appreciates the opportunity to provide feedback on this proposal and overall supports the proposed changes. The Committee suggested that those involved in living donor uterus transplants should be the ones to determine the acceptable number of living donor uterus recoveries and radical hysterectomies. The Committee stated that living donors would want to be aware whether their surgeon had performed a low number of living donor surgeries prior and have the ability to consent to that. The Committee supported the addition of radical hysterectomies as a way for surgeons to gain experience for living donor uterus transplantation. The Committee emphasized the importance of a timeline related to completing the needed requirements. The Committee suggested that a measure of competence to be certified by another primary surgeon before allowing independent uterus transplant surgery. Region 11 | 09/30/2021 Region 11 sentiment: 3 strongly support, 9 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment, and one attendee commented that they supported further development for requirements for this type of transplant program to keep our potential recipients as safe as possible. Hospital of the University of Pennsylvania | 09/30/2021 As one of the leading VCA Uterus programs, PAUP strongly suggests to build and maintain alignment with the two core roles in other designated transplant programs rather than adding a tertiary role as the Ob/Gyn role - which can be embodied within the structure of the primary surgeon or primary physician. Given the specialty of clinical expertise required for a complex procedure such as Uterus transplant, PAUP recommends the following adjustments to the proposed membership requirements to meet the intended rationale of the proposal and maintain alignment with other transplant programs: Primary Surgeon: recommend a transplant surgeon or surgeon with expertise in surgical Ob/Gyn and/or radical hysterectomy/pelvic surgery (if the primary surgeon is not a transplant surgeon with expertise in immunosuppression management, such an individual must be specified in the program application). Primary Physician: recommend Ob/Gyn. Given primary disorder is gynecologic, primary physician should be a specialist in this area. This mirrors the role of the primary physician in other solid organ transplants (i.e. kidney transplant primary physician is nephrologist, liver transplant primary physician is hepatologist, etc). NATCO | 09/29/2021 NATCO supports the VCA Committee’s recommendation to establish separate criteria for uterus transplant from other VCA transplants. Since uterus transplant has proven to be successful and there is increasing demand, establishing specific requirements for uterus transplant programs seems necessary in order to ensure safety and equitable access of transplants for potential recipients. American Society of Transplant Surgeons | 09/29/2021 The American Society of Transplant Surgeons (ASTS) strongly supports the OPTN’s Vascularized Composite Allograft (VCA) Transplantation Committee’s proposed membership requirements for uterus transplant programs with the following change. 1. Do the proposed changes to the list of covered body parts that are considered VCAs under the OPTN Final Rule definition appropriately represent the types of genitourinary organs that might be transplanted together under current clinical practice? See: Uterus: includes uterus, cervix, vagina, External male genitalia: Includes penis and scrotum, Other genitourinary organ: Includes internal male genitalia; external and internal female genitalia other than uterus, cervix, and vagina; and urinary bladder. Currently, the genitourinary organ category of covered VCAs as defined includes “uterus, internal and external male and female genitalia, and urinary bladder.” The new proposal separates the “genitourinary organ” into three categories of VCA: 1. uterus, 2. external male genitalia, and 3. other genitourinary organs. ASTS supports the division into only two separate categories. Specifically, “external and internal female genitalia” and “external and internal male genitalia and bladder” with the elimination of the “other genitourinary organs.” The expertise and infrastructure required to performed vascularized transplant female related genitalia is similar, thus, requirements integrating all these under the same category is beneficial for patient safety, for new and existing transplant teams, for infrastructure, for resources, for data collection, and for innovation. Similar reasoning applies for vascularized transplant male related genitalia adding bladder. As such, removing the “other” category altogether [i.e. in the current and in the proposed list of covered body parts that includes both female and male GU organs under one category]. 2. Do the proposed membership requirements for uterus transplant programs provide adequate flexibility to account for variation in the uterus transplant field in how hospitals develop multidisciplinary teams? The current membership requirements do not include any requirements specific to uterus transplantation and do not reflect the expertise required. Currently, the uterus transplant programs are subject to the same requirements as programs performing transplants of other genitourinary organs like the penis. The new proposal suggests a division and more tailored membership requirements specific for uterus transplant programs. The role of primary obstetrician-gynecologist is added to the roles of primary surgeon and primary physician. The same individual can be named for >1 role. ASTS supports the proposed membership requirements and agrees that they provide flexibility for uterus transplant programs to ensure qualified staff to safely perform uterus transplants. 3. Will the proposed membership requirements ensure that approved uterus transplant programs have the expertise needed to safely perform uterus transplants, and, as applicable living donor uterus recovery? The proposed requirements for living donor uterus transplant programs and living donor uterus surgeon align with the recently approved proposal by the OPTN Board of Directors to update Policy 14 (Living Donation) to include all living donors, including living uterus donors and the current requirements for the living donor liver surgeon. ASTS supports the proposed requirement without changes. 4. Are there any requirements that should be removed or relaxed, or any additional requirements that should be included? ASTS recommends revision of the requirement for living donor uterus surgeon requirements (J.5.D.) to the following, “At least 2 living donor uterus recoveries must be directly observed or participated as primary surgeon or co-surgeon.” The VCA committee does not believe it feasible for a potential living donor surgeon to receive credentialing at one of the very few institutions that perform living donor uterus recoveries to be primary or co-surgeon, and that observation by an experienced surgeon should be adequate exposure. 5. Do members understand which procedures qualify as "radical hysterectomies”? The proposal defines radical hysterectomy as removal of the uterus, cervix, the upper part of the vagina, and tissues next to the uterus (the parametria and the uterosacral ligaments). ASTS agrees with this definition. Attachment American Society of Transplantation | 09/29/2021 The American Society of Transplantation is generally supportive of this proposal. We believe that it brings needed structure and defines the minimum areas of expertise required to conduct uterus transplantation. A concern was raised regarding the definition of organs covered. Clearly, uterus, cervix and vagina, would cover the organs transplanted as part of a uterus transplant to accomplish the goal of carrying a fetus and delivering a live baby. A strong recommendation is that the definition be inclusive of all female genital organs. The rationale for this change is to avoid a program considering performing any form of female genital tissue transplantation that would not fall under this policy but that requires the similar infrastructure and expertise already covered by a uterus transplant program. We believe that the OPTN committee made great progress with defining the needed areas of expertise that would build a team that is able to care for female or transgender patients undergoing any form of genital tissue transplantation and it would be applicable to allow this policy to cover all female genital tissue (and another one for all male genital tissue in the list of body covered parts), so that any program that would offer any such transplant, would have in place an OPTN policy that would guarantee the safety of patients and donors without the need to formulate new policies with the delay in development and implementation given the needed timeline for policy creation. On the same lines, it would also avoid an “other GU” category. Another concern was raised about the proposed required observations for the primary surgeon to complete at another institution to be approved to perform living donation. Some in the AST pointed out that this should not be necessary. The rationale is that that the expertise needed to perform a safe uterus procurement is most definitely obtained by performing hysterectomies with the added need to obtain long vascular pedicles, though we appreciate the important technical differences in hysterectomy versus recovery for transplantation here. A high-volume gynecology practice with a reasonable number of hysterectomies may be more important with caveats on transplant training, noted below. A gynecology surgeon can observe a multi-organ deceased donor procurement to be acquainted to the donor procurement environment. We are concerned that observing transplants or procurements for transplants at another institution may become increasingly difficult as the numbers of uterus transplants are declining and the number of active programs is low. In addition, this could be an unreasonable financial burden once initial financial support from institutions ceases and it becomes a commercial practice, with no third-party payers currently supporting or offering uterus transplantation. This is unlikely to change with the limited national coverage for fertility therapy in general. Finally, the credentialing process and/or visitor process for a visiting surgeon vary per institution and it will add logistical challenges (e.g., at the hosting institution and/or leaving a clinical practice). Unlike other solid organ transplantations where the transplant is most often lifesaving, the goal of a uterus transplant is to enable women or transgender individuals to grow a fetus in the transplanted organ, with the aim of a live birth. Accordingly, we would like to emphasize a few points that in our mind are critical for any uterus transplant program: 1. The primary surgeon or OBGYN should undergo training in immunology/ transplant medicine or be in collaboration with the local transplant team– to enable them to provide adequate counseling, appropriate immunosuppression coverage, and treatment of its side effects to enable a healthy pregnancy and good long-term outcomes for the mother. 2. The ethical principles of living donation programs of separation between the medical teams dealing with the donor and the recipient should be adopted, including a specific and separate living donor coordinator and advocate. 3. We believe it is important to clarify that the existing OPTN Bylaws outlining “Other Transplant Program Personnel” including Clinical Transplant Pharmacist apply to Uterus Transplant Program requirements, as this detail was not explicitly outlined/mentioned. Since all hospitals must have other solid organ transplant programs in order to establish a designated VCA transplant program, including uterus. As such, the support personnel requirements described in Appendix D of the OPTN Bylaws (including Clinical Transplant Pharmacist, Clinical Transplant Coordinator, Financial Coordinator, Mental Health and Social Support, and Medical Expert Support) should align with the membership requirements for Uterus Transplant Programs. This is important to ensure quality patient care, as these patients are on maintenance immunosuppressants like other transplant recipients and require close pharmacologic, multidisciplinary management. 4. The recipient team should include a social worker/psychologist who is expert in female and transgender reproductive issues and can provide the necessary support system to the donor. Especially as not all transplants end with a live birth. There should also be a discussion of alternatives to uterus transplant, i.e., adoption and surrogacy, once again as not all transplants end with a live birth. 5. This proposal mentions the psychological evaluation and requires centers to have clinical resources to perform a psychosocial evaluation of the living donor, makes comments to the effect of psychosocial evaluation of the candidate but no clear comment on evaluation of the candidate, which we believe may be very impactful as well. 6. Very minor wording clarification is needed: J5.B. Living Donor Psychological Evaluation – this should be changed to “Living Donor Psychosocial Evaluation. As currently written (i.e., Psychological), this would require all programs to have a clinical or counseling psychologist as there are state law requirements about who can conduct a “psychological evaluation.” Use of the term “psychosocial” is much broader and includes psychologists, social workers, psychiatrists, etc., which I believe is the intention of the committee. Region 10 | 09/28/2021 Region 10 sentiment: 7 Strongly Support; 8 Support; 5 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose Comments: None Region 1 | 09/24/2021 Region 1 sentiment: 3 Strongly Support, 2 Support, 3 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: A member commented that it will be important to consider how to support new programs, as their volumes for all will be low initially. Region 6 | 09/23/2021 Region 6 sentiment: 2 Strongly Support; 6 Support; 2 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments. Region 8 | 09/22/2021 Region 8 sentiment: 4 strongly support, 10 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Region 8 supports this proposal. OPTN Membership and Professional Standards Committee (MPSC) | 09/17/2021 The MPSC thanks the VCA Committee for presenting its proposal “Establish Membership Requirements for Uterus Transplant Programs.” The MPSC offers the following comments: The medical expert support requirements should specify what qualifies individuals for those roles, such as board certification in a certain discipline, for example. It would be helpful for the VCA Committee to define “demonstrates collaboration” in the medical expert support requirements so the MPSC knows what sort of evidence or documentation a member should provide to prove they have met the requirement. Region 7 | 09/15/2021 Region 7 sentiment: 5 strongly support, 9 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. No comments. Region 9 | 09/14/2021 Region 9 sentiment: 1 Strongly Support; 4 Support; 4 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose. No Comments. Region 3 | 09/10/2021 Region 3 sentiment: 2 strongly support, 8 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose Region 2 | 09/10/2021 • Region 2 sentiment: 7 Strongly Support, 15 Support, 5 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose • Comments: None Region 5 | 08/30/2021 Region 5 sentiment: 8 strongly support, 13 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose. Region 5 supported the proposal to Establish Membership Requirements for Uterus Transplant Programs. Region 4 | 08/27/2021 3 strongly support, 5 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. Region 4 supported this proposal. Adam Frank | 08/14/2021 My comment is not a reflection of my transplant program and is based on my individual opinion. I have great concern about uterus transplant procedure(s), and in that regard I do have a desire to distance the OPTN from them. The surgical and medical risks associated with uterus transplantation for both the potential mother and for living donors are too high in my opinion in comparison to the benefit. The purpose/benefit of these procedures is to have the recipient experience of pregnancy and childbirth. I understand that there will be some who disagree with me on this, but I am troubled by the number of procedures involved and the risks. In most cases, the uterus is procured from a living donor. (If that donor, develops renal failure later in life will they not be highly advantaged towards getting a deceased donor kidney transplant?) The procured uterus is then transplanted into the mother and an embryo is implanted. This is hopefully followed by the pregnancy and childbirth which are the benefits of this transplant. Following this, the transplanted uterus usually must be removed with another surgery. Of course, during the time the uterus is in place, immunosuppression must given to the recipient with its associated potential problems. Considering the unique risk benefit equation associated with uterus transplantation, I do not think the OPTN should be overly engaged. Uterus transplantation requires a lot infrastructure and expertise and thus engaged institutions likely enjoy having guidance and thus seek help from the OPTN. It is my opinion though that uterus transplantation is different than the majority of OPTN work were prolonging life or making a person whole with the minimum number of surgeries is the more typical goal. In this regard, I feel another body should be charged with its development and promulgation.