Modify Living Donor Exclusion Criteria At a glance Current policy OPTN Policy 14.4.E: Living Donor Exclusion Criteria lists fourteen criteria that excludes individuals from becoming living donors. Most of these criteria remain current and important to protect living organ donors. Supporting media Presentation View presentation Proposed changes The Living Donor Committee reviewed OPTN Policy 14.4.E: Living Donor Exclusion Criteria to ensure these criteria are up-to-date. The Committee found the majority of living donor exclusion criteria remain current and important to protect living organ donors. The Committee recommends four changes that may allow more people to become living donors safely. These changes allow transplant programs more autonomy in evaluating individuals with malignancies and individuals with type 2 diabetes for living donation. Additional proposed modifications address exclusion criteria related to donor coercion, and illegal exchange between donor and recipient, to ensure consistency throughout OPTN policy language. Anticipated impact What it's expected to do Allow transplant hospitals more autonomy in their evaluation of potential living donors with certain medical conditions such as low grade malignancies, and type 2 diabetes. Allow transplant hospitals, potential living donors, transplant candidates, and families to make decisions together regarding living donation. Align policy language to make it consistent with other OPTN policies. What it won't do Create a list of types of cancers that exclude individuals from becoming living donors. Remove restrictions that exclude individuals with type 1 diabetes from donating kidneys. Terms to know Contraindication: Anything that prevents a person from receiving a particular treatment or undergoing a procedure. Diabetes: A disease in which the pancreas does not manufacture an adequate amount of insulin. As a result, the level of sugar in the blood is too high. A leading factor in heart and kidney disease. High Blood Pressure (hypertension, HTN): When the force of the blood pushing against the walls of the blood vessels is higher than normal because the blood vessels have either become less elastic or have gotten smaller. High blood pressure causes the heart to pump harder to move blood through the body. High blood pressure can cause kidney failure and heart disease if not treated. Living Donor (LD): A living person who donates an organ for transplantation, such as a kidney or a segment of the lung, liver, pancreas, or intestine. Living donors may be blood relatives, emotionally related individuals, or altruistic strangers. These may also include domino heart or liver. Malignancy: The presence of cancerous cells that have the ability to spread to other sites in the body or to invade and destroy tissues. Click here to search the OPTN glossary Comments UC San Diego Health Center for Transplantation | 03/23/2022 CASD supports the modifications proposed to the living donor exclusion criteria and agrees that they will allow transplant programs more autonomy in evaluating potential living donors and may result in more lives saved. We also agree that consideration of “lifetime risk “should be individualized and based on clinical judgement, and, should include comprehensive informed consent from the donor. Sharon N. | 03/23/2022 I and three family members have gone through the living donor evaluation process as we attempted to qualify to donate to a close family member, so I understand the process. Allowing transplant centers more autonomy and allowing the transplant team, potential living donors, candidates, and families to make decisions together just makes good sense. I would expect that the candidates would be made aware of any medical situations of the donor (incl. low-grade malignancies, Type II diabetes, etc.) so they may make a full, informed consent about accepting an organ. Thank you for all you do for the transplant community. Ethics Committee | 03/23/2022 The OPTN Ethics Committee thanks the OPTN Living Donor Transplantation Committee for the opportunity to provide comment on their policy proposal. In all, members were supportive of these changes to the living donor exclusion criteria. There was concern that the lifetime risk in the diabetes section was written in a vague manner that could impact member interpretation of the policy. A member inquired about requiring a lifetime risk algorithm for all centers to use. A member noted the potential for transmission to occur after transplant and suggested rephrasing the malignancy section to ‘more than a minimal known risk of transmission.’ Members praised the improvements to the coercion section, and a member suggested rephrasing it to say ‘undue inducement.’ A member noted that while HIV positive donors are only eligible to donate to HIV positive recipients, there is no similar concern for increased risk of kidney disease from Type 2 diabetes donors. A member suggested the Living Donor Committee ought to provide guidance on how transplant programs should provide long-term follow up with living donors. Ad Hoc Disease Transmission Advisory Committee | 03/23/2022 The OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) appreciates the opportunity to comment on this proposal and is highly supportive of the proposed changes. The DTAC considers that the proposal strikes an appropriate balance between donor/recipient safety and increasing the potential donor pool. The DTAC suggests that the Living Donor Committee consider adding that the malignancy risk evaluation for living donors should include both risk of transmission to the recipient as well as risk of longer term treatment for the donor. National Catholic Bioethics Center and National Catholic Partnership on Disability | 03/23/2022 We ask for modifications as contained in the attached two documents, pertaining to those donors with psychiatric and substance abuse conditions, the incarcerated, and the presence of any evidence of coercion or inducement, including the transfer of anything of value. We are supportive of the exclusion of minors and those incapable of making informed decisions. We are opposed to including donors with Diabetes II and also the donation of a uterus, as indicated in our public comment of September 29, 2021 (RE: 2021-2024 OPTN Strategic Plan as it pertains to Public Comment: Proposal Establish Membership Requirements for Uterus Transplant Programs). We ask for an enhancement of the evaluation policy, and the applicability of Living Donation policies to Domino donors. See attached. Attachment Transplant Administrators Committee | 03/23/2022 The Committee thanks the OPTN Living Donor Committee for their proposal Modify Living Donor Exclusion Criteria. The Committee supports the proposal as it increases the possibility of living donation, specifically amongst type II diabetes patients based off of medical judgement. Region 6 | 03/23/2022 Sentiment: 1 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: An attendee suggested policy language state potential living donors with insulin dependence be excluded and only those on oral should be considered for donation. Humana | 03/23/2022 Humana supports efforts to promote consistency of policy and increase of the availability of organs for transplant candidates. American Society of Transplantation | 03/22/2022 The American Society of Transplantation is generally supportive of this proposal. Overall, the spirit of the proposed change is to allow the decision to proceed with living donor transplantation to be based on individualized, thoughtful discussion of the potential donor with their care team. The Society offers the following comments for consideration: #1 Active malignancy, or incompletely treated malignancy that requires treatment, other than surveillance, or more than minimal risk of transmission We agree with the committee’s rationale to allow donor candidates with active or incompletely treated tumors that do not require current or future treatment to donate as long as they carry <0.1-1% risk of transmission to the recipient. While the risk of transmission to recipient is well defined among individuals with low grade prostate cancer and skin cancer, it may be less well defined for other tumors. We recommend transplant hospitals are reminded to include potential malignancy transmission in their recipient informed consent process. #2 The Committee proposes modifying this exclusion criterion with the following language: “High suspicion of donor inducement, coercion, or other undue pressure” The policy changes regarding the language around “high suspicion of donor coercion” and “high suspicion of illegal financial exchange between donor and recipient” as absolute contraindications to living donation are well aligned with the legal standards and longstanding practices of transplant centers. This is essential in assuring donors are able to make decisions to undergo such procedures voluntarily and to reduce the risk of psychosocial harm associated with living donation. #3 The Committee proposes modifying this exclusion criterion with the following language: “High suspicion of knowingly acquiring, receiving, or otherwise transferring anything of value in exchange for any human organ”. We support the proposed modification and want to verify that donating a kidney in a KPD transaction or in exchange for a voucher is excluded from consideration as something “of value” in the transaction. #4 Diabetes Living kidney donation has been stagnant in the United States and we applaud the OPTN efforts to increase living kidney donation by expanding the pool of eligible potential donors. We offer the following recommendations for more precise clinical risk assessment: • Alter terminology to avoid using “type 1” and “type 2” and consider instead “insulin dependent” and “non-insulin dependent” as DM is now understood to exist along a spectrum. We agree with the OPTN committee’s exclusion of type 1 (insulin dependent) diabetics from consideration as living donors. With regards to type 2 diabetes (non-insulin dependent), the committee recommends making an individualized assessment of donor demographics or comorbidities reveals evidence of end organ damage or life-time risk of complications. The recommendations are vague and are compounded by absence of a widely accepted calculator that provides accurate estimates of life-time risk of kidney disease, and mortality in living kidney donors with diabetes. In addition, there are no studies demonstrating long-term medical safety of living kidney donation among diabetics and very few studies on living kidney donors with pre-diabetes. However, “resolved” diabetes i.e., A1c < 6.5 with lifestyle modification may be an appropriate expansion esp. with the addition of an age modifier. Risk of lifetime complication from diabetes is very different in a 40-year-old compared to a 60-year-old donor. We believe this could be appropriate in select populations with shared decision making contributing to donor informed consent and careful post-donation monitoring. #5 “Uncontrolled diagnosable psychiatric conditions requiring treatment before donation, including any evidence of suicidality” We agree that no additional changes to the wording around “uncontrolled diagnosable psychiatric conditions requiring treatment before donation, including any evidence of suicidality” does not need to be changed to include substance abuse. Substance use disorders are considered psychiatric conditions and are thus captured in the current definition. Attachment Anonymous | 03/22/2022 I am a 71-year-old patient with Primary Sclerosing Cholangitis. Because I'm fairly healthy, I am not yet a candidate for transplant, and I hope I stay that way. But I'm very concerned that the transplant process be fair and efficient. The proposed changes head in that direction, and I support them. Transplant Coordinators Committee | 03/22/2022 The Transplant Coordinators Committee thanks the OPTN Living Donor Committee for their work on the proposal Modify Living Donor Exclusion Criteria and the opportunity to provide feedback. The Committee has two comments. First, consideration should be given to a required number of years of diabetes prior to donation for type II diabetic donors; this would prevent young diabetic donors with a high likelihood of developing end stage renal disease from donating early on in their diagnosis. Second, a comprehensive monitoring plan should be developed to ensure that this policy change does not put living donors at unacceptable risk. Region 2 | 03/22/2022 4 strongly support, 16 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose - A member noted that the proposal should provide clear definitions for type 1 versus type 2 diabetes because there can sometimes be confusion in diagnosing patients on age rather than objective criteria. It was also noted that with the liberalization of the diabetes criteria, there should be more direction or requirements for education of potential donors with diabetes. Lastly, a member noted support of the proposal’s less prescriptive approach. Anonymous | 03/22/2022 The effort to decrease the barriers against kidney donation by the committee is laudable and very needed. I have some reservations regarding the removal of diabetes as an exclusion criterion given the following: We do not know what is the additive risk of having diabetes (even perfectly controlled) on kidney function after donation and as such informing donor candidates about that risk is not possible. Please refer to the JAMA paper by Nelson et al in 2019 where a CKD risk calculator was generated from studying 5 million subjects (both article and risk calculators are cited below). In non donors, the 5 years risk of GFR decline from 90 ml/min/1.73m2 to <60 ml/min/1.73 m2 increases from 4% to 11% (in a female patient, BMI of 25, HbA1C of 6, without HTN, without albuminuria) just by having diabetes. In donors, this risk is not known and that baseline is not 90 anymore given single kidney status. Obviously these data have limitations especially the lack of granularity in terms of diabetes duration, the type of treatment, the family history of kidney disease, and etc but removing this exclusion could lead to accepting candidates who have individual risk factors that are not prohibitive on their own but could add up beyond what we would think is acceptable risk wise, especially when the risk is not something quantifiable to discuss with the candidate for informed consent. Thank you, Kassem Safa, MD https://jamanetwork.com/journals/jama/fullarticle/2755299 https://ckdpcrisk.org/ckdrisk/ Anonymous | 03/21/2022 This important update allows families and care providers to adequately weigh the risks and benefits of live donation for their personal circumstances. As a family member of a transplant candidate, I'm most invested in our care team having more autonomy to skillfully evaluate a potential donor. By allowing more individuals to become candidates for live donation, we support our family members in receiving donations before they are critically ill and listed to receive an organ from a deceased donor, in addition to adding more viable organs to the pool. Being less sick at the time of donation better positions recipients for positive outcomes. Region 11 | 03/21/2022 Sentiment: 1 strongly support, 7 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Overall the region supported the proposal. One attendee suggested, and another agreed, the policy include language clarifying that all policy language is subject to change based on the best medical data. The attendee added that it is the responsibility of the physicians caring for living donors to make a determination of whether they are an appropriate candidate for donation or not. NATCO | 03/21/2022 NATCO supports the proposed living donor exclusion modifications which focus on four criteria that may allow more people to become living donors safely. We agree that these changes allow transplant programs more autonomy in evaluating individuals with malignancies and individuals with type 2 diabetes for living donation, and may result in more lives saved. We agree that consideration should be individualized and based on clinical judgement, and, should include comprehensive informed consent. While we recognize that there may be an additional burden to centers who choose to adopt new protocols for evaluation, we believe the benefits outweigh the costs. We also support the additional proposed modifications that address exclusion criteria related to donor coercion, and illegal exchange between donor and recipient, emphasizing the importance of eliminating any illegal transactions. Region 7 | 03/21/2022 Sentiment: 1 strongly support, 11 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose. Comments: Member of the region support the proposal, but had several comments. There was some support for the proposed changes for donor diabetes and malignancy because it allows the transplant program more leeway in the donor selection process and could potentially result in an increase in living donation. One member noted that for potential donors with diabetes programs need to ensure that there will be proper follow up post donation before approving the donor. Another member noted that the diagnosis of diabetes and/or low grade malignancy is very broad and the risk varies on the severity of these conditions as well as the age of the donor and other comorbidities. This may increase the availability of organs, but it can increase the risk to the donor. There also needs to be more feedback from actual living donors and recipients about their thoughts of these changes. Another member opposed allowing evaluation of potential donors with diabetes due to donor safety. There is no way to predict how the donor’s diabetes will be affected after donating a kidney. They also raised concerns about the subjectivity of the proposal, it will result in different selection practices across programs. Lastly, another member expressed caution with expanding the definitions for coercion and financial exchange. Too broad of an interpretation could disqualify potential living donors. OPTN Pediatric Transplantation Committee | 03/20/2022 The Pediatric Committee thanks the OPTN Living Donor Committee for the opportunity to review their public comment proposal. The Committee provides the following feedback: The Committee agreed with the proposal and pointed out that the modifications to the exclusion criteria in this proposal are actually meant to give programs more flexibility when considering whether a specific living donor is appropriate in a specific situation. The exclusion criterion related to age does not seem to be utilized even though there is flexibility in the criterion language. Concerns were raised regarding coercion and it was mentioned that, while coercion would be addressed in the psychosocial exam for living donation, the psychosocial evaluation is not always a full psychological evaluation done by a psychologist or psychiatrist – at some centers it might be a social worker doing the best they can. The Committee encouraged the OPTN Living Donor Committee to discuss specifics about when it might be appropriate to consider a minor as a living donor and to reference the ethics paper from American Academy of Pediatrics (https://publications.aap.org/pediatrics/article/122/2/454/73096/Minors-as-Living-Solid-Organ-Donors). The Committee also agreed that, in cases where minors might be considered living donors, it’s important that age-appropriate informed consent processes and psychosocial evaluations are followed. American Society for Histocompatibility and Immunogenetics | 03/19/2022 The American Society for Histocompatibility (ASHI) and it's National Clinical Affairs Committee (NCAC) appreciate the opportunity to comment on this proposal and are in support of the modification of living donor exclusion criteria. ASHI fully supports transplant hospitals, potential living donors, transplant candidates, and their families. These modifications will allow increased autonomy in the evaluation of living donors and will permit more individuals to qualify for living donations. Region 1 | 03/18/2022 Sentiment: 4 Strongly Support; 6 Support; 2 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: Overall the region supported this proposal. A member expressed concern that more liberal acceptance of donors with overt metabolic disarray may increase the likelihood of donor chronic kidney disease in the decades to come. Another attendee agreed with the proposal and said that so much of this is subjective, but the committee will set a point for the risk each program can take. One individual supported the proposal, but suggested that the phrase “anything of value” is too vague and could result in assistance provided by NLDAC being considered an exchange of something of value. Another member shared concern that the impacts of accepting more medically complicated living donors will not be known for decades, and they encouraged the committee to monitor living donor outcomes as well as how transplant center practices change in response to this proposal. Region 9 | 03/17/2022 Sentiment: 3 strongly support, 7 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: One member commented they were concerned about allowing Type 2 diabetics to donate. They added that it is difficult to predict outcomes and long term risk which is age dependent. They went on to recommend that to protect donors, there should be zero risk outside of the surgical procedure. They added that if there were zero risk, there would likely be less reluctance to have family members donate and would increase living donation. American Society of Transplant Surgeons | 03/17/2022 American Society of Transplant Surgeons supports. Attachment American Nephrology Nurses Association (ANNA) | 03/11/2022 ANNA supports and agrees with concern for safety while allowing more autonomy to transplant hospitals. Attachment Virginia Mason Franciscan Health | 03/08/2022 I have concerns about allowing donors under 18 years old and incarcerated individuals as their independent decision making abilities are compromised. Kidney Transplantation Committee | 03/08/2022 The OPTN Kidney Committee thanks the Living Donor Committee for their efforts on this proposal. The Kidney Committee supports this proposal, and recognizes the Living Donor Committee’s decision to expand transplant program autonomy in implementation of the modified exclusion criteria. Several members of the Committee also recommended expanding living donor data collection and monitoring, to better evaluate living donor safety and recipient outcomes. One member specified Hemoglobin A1c at time of donation, need for insulin vs. oral hypoglycemic agents, and length of time with diabetes diagnosis as potential elements for living donor data collection and evaluation. Region 3 | 03/02/2022 • Sentiment: 1 strongly support, 11 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose • Comments: An attendee questioned if any programs are approving living donors with active malignancy or Type I diabetes mellitus. Hatem Amer | 02/26/2022 I would like to thank the living donor committee for taking this on and reviewing the exclusion criteria for living donors. I agree fully with the proposed modifications to remove type two diabetes and malignancy as elusions to living donation. Although it is ideal that every kidney transplant candidate received a living donor from a healthy individual, that may not be an option for many candidates even if all disincentives to donation were removed. The change in policy will serve the transplant community well. It will open options that can increase access to living donation with careful assessments and informed consent. It may in fact result in improved safety for living donors. For example a spouse in their sixties wishing to donate who has well controlled diabetes with no evidence of renal disease, vs. the 20 your old child being the donor who may go on to develop diabetes later on in life with an unknown propensity for complications. . Milton Mitchell | 02/25/2022 As a liver donor (domino procedure) I strongly support any proposal increasing liver donation. This would greatly assist the Numerous individuals currently on the "Liver Waiting List". I hope this modification is approved, implemented and advanced now, with urgency, not later. Thank you Region 8 | 02/23/2022 1 strongly support, 12 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose - Region 8 generally supported this proposal with some opposition. A member supported the living donor exclusion criteria decision being made at a center level, and commented that this proposal allows aggressive centers more leeway without being pejorative to the less aggressive centers. A member asked for clarification on the language about coercion. The member stated that the recipient is authorized to provide support with donor expenses associated with donation so if there is a broad definition it becomes less clear. A member supported the proposal and inquired, that based on current living donor qualification/disqualification data, what would be the estimated increase in 'qualified' living donors; and are there additional malignancies considered low-grade other than prostate cancer; and how is acceptable risk determined. A member pointed to the donor safety concern and suggested to continue working on the proposal. Another member suggested that long term follow-up for the applicable donors and recipients is important. Region 4 | 02/18/2022 2 strongly support, 18 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose - Region 4 supported this proposal. One attendee commended the committee on great work on the proposal and added they hope it moves forward quickly. Another attendee commented that they were grateful to see the allowance of more clinical judgement and an opportunity to expand the donor pool. One attendee recommended getting written documentation from oncologists to support this proposal because not everyone has a great understanding of the implications of malignancy. Michael F | 02/17/2022 Updating the criteria to be both clearer in its language and individualized in its approach to assessing donors seems like a necessary evolution. Especially as the kidney shortage persists, giving transplant programs autonomy in deciding whether or not to evaluate donors with malignancies and type 2 diabetes could potentially help recipients avoid the waitlist. A healthy kidney that may have previously been deemed unacceptable despite no definitive assessment could get more recipients on their way to living healthier lives quicker. Though current research seems to support these changes, If a living donor is deemed safe despite malignancies or type 2 diabetes, I think it is important that patients be provided with evaluation results. The new criteria may give patients pause, so if a kidney is deemed safe despite the ailments of the living donor, I believe it would be beneficial to both alleviate patient concerns as well as be transparent with them about any potential risks through this process. Erika Sjolander | 02/16/2022 I completely support any change that allows more people to be included in the living donor category. We need to do anything we can to allow more people to qualify as a living donor as there are so many people waiting on the kidney donation list. Region 5 | 02/16/2022 2 Strongly Support, 18 Support, 9 Neutral/Abstain, 3 Oppose, 0 Strongly Oppose - A member pointed out that if the committee expands the donors to include type 2 diabetics he was concerned there is a lack of truly long-term donor registry. He encouraged members to think about their responsibility in taking care of these donors and also pointed out that younger populations are more at risk. There was also a suggestion for long-term follow-up requirements on the living donor registry. A member stated that he agrees with only changing the policy regarding coercion and financial exchange. He disagrees with the malignancy policy change as if it requires surveillance, and believes it is an unacceptable risk to the donor if they do require treatment in the future and risk of transmission to the immunosuppressed recipient, albeit minimal. He also disagree with the policy changes regarding diabetes and believes they are unacceptable donors. A member asked if the recipient should be informed of a potential increased risk compared to an ideal donor. Region 10 | 02/16/2022 3 Strongly Support, 9 Support, 2 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose Christian C | 02/15/2022 It would be extremely beneficial to allow more autonomy in evaluating potential living donors. This would allow more to be evaluated on a case by case basis rather than excluding donors outright based on criteria that may or may not affect the organ in question. Transparency will be extremely important in communicating to organ recipients though to ensure they fully understand any ailments the donor had and why the organ was deemed healthy and feasible for donation. This would avoid conflict from recipients that are not experts on the matter that may have an unnecessary aversion to receiving an organ under updated criteria. One issue i have is with the point regarding allowing families to make decisions regarding living donation. Would this prevent a patient with no chance of survival from donating their organs while living and thus bringing on their death sooner, while saving the lives of others, if their living family simply says no? Josh F | 02/14/2022 I believe it's important to continually review these kind of exclusory policies to make sure they're current. Obviously patient safety is a primary concern but if there is research that supports expanding the criteria it's worth discussing. Hans Gritsch | 02/03/2022 We more long term data if we expand the use of diabetic donors. There are clearly situations where donors have very low grade malignancy that should not preclude living donation. Anonymous | 01/27/2022 Why on earth would you want to give a recipient a kidney from someone with diabetes or cancer? As an immunosuppressed transplant recipient who received a kidney from a living donor I would have been horrified to have been given a substandard organ. I believe it is wrong to do that. Instead, encourage and incentivize more healthy living donors.