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  • HCV Positive Allografts: A Solution for… Most?

    Dr. Ryan HelmickRyan A. Helmick, MD
    University of Tennessee Health Science Center
    Methodist University Hospital

     

    As the transplant community continues to search for a solution to the available organ shortfall, xenotransplantation remains a far-off promise and tissue engineered organs are in the earliest stages of research. Despite these challenges, the number of deceased donors has been increasing in recent years, due in large part to the opioid crisis. Between the years of 2010 and 2016, the number of deceased donors has increased overall by about 26%, while the number of donors who have died of a drug overdose has increased by 277%.1 Often these donors are classified as PHS increased risk, and many have recent or long term infection from Hepatitis B virus (HBV) or Hepatitis C virus (HCV).

    Utilization of organs from donors that are seropositive for HBV core antibody has long been considered acceptable at many centers, given the available therapies including Hepatitis B immunoglobulin as well as the antiretrovirals with a long history of successful HBV prevention. The lack of effective therapies for HCV has long limited organs from these donors only to patients who already have HCV. Some have reported positive results by utilizing the narrow subset of donors that are HCV antibody positive and RNA negative.2 Yet in the current age of highly effective direct acting antiviral therapy, this way of thinking needs to be re-evaluated. The utilization of HCV positive organs for negative patients necessitates many ethical, financial, and medical questions be addressed in a thorough fashion, ideally by the entire transplant community.

    The biggest hurdle in the utilization of HCV mismatch organs may relate to the ethical questions that arise from such transplants. Our medical school oath to “do no harm,” and the thought of knowingly “giving” someone HCV causes great hesitation; however, the transmission of cytomegalovirus (CMV) or Epstein Barr virus (EBV) in a seronegative recipient is rarely given a second thought. Treatment of CMV tissue invasive disease can be a significant though manageable challenge with severe cases causing morbidity and prolonged hospitalizations. Less frequently, EBV causes lymphomas necessitating chemotherapy and reductions in immunosuppression that can place the transplanted organs at risk of rejection. With the current state of treatment for HCV, patients receive a 12- to 24-week course of oral therapy that is often well tolerated with minimal side effects. De novo HCV infection almost never causes severe liver dysfunction, and with treatment response rates reported at 99-100% depending on the chosen direct acting antiviral regimen, post-transplant HCV should be a rather benign and easily treatable issue, especially when compared to PTLD or aggressive CMV. Given the treatability of HCV in the current era, use of these organs should flow from the basic tenets of medical ethics; with adequate informed consent, autonomous patients should have the option to proceed with these transplants.

    The next tenet of medical ethics, beneficence, may be a trickier ethical question to address. The framing of the question should not merely revolve around “should this patient get an HCV+ allograft or not?” Rather, the issue is “should this recipient get an HCV+ kidney or remain on dialysis for another year or two?” or “should this low MELD recipient take an HCV+ liver or not get transplanted at all?” Bowring et al recently described the risks to kidney recipients who decline kidneys labeled as “PHS Increased Risk” in terms of delays in transplantation.3 What further gains might patients be able to realize in terms of decreases in dialysis time by opting for a HCV mismatched organ and going through treatment after transplant?

    Once a program, surgeon, and patient are comfortable with the ethical issues regarding HCV mismatch, there are financial considerations to consider. While the early direct acting antiviral (DAA) therapies were reported to cost as much as $100,000, newer regimens are coming down in cost with estimates in the $25,000-35,000 range. When we compare these costs to the yearly costs associated with dialysis, earlier transplantation of kidney recipients might result in overall cost savings compared to waiting on dialysis for an HCV negative organ. Patients who are willing to accept HCV+ kidneys may be able to avoid dialysis altogether and realize the benefits of pre-emptive kidney transplant. As newer and more effective HCV therapies come to market and innovation and competition drive drug prices down, this will continue to be a more financially competitive option compared to years on dialysis.

    Utilization of HCV mismatch organs is not likely to be a one-size-fits-all solution as it relates to medical suitability, including long wait times and donor shortages. Does it make sense to give a 30-year-old who has not yet started dialysis an HCV+ kidney? Would it make sense if the average wait time in that recipient’s region was eight years and he was not expected to do well on dialysis? What if instead he had steatosis and grade 2 fibrosis? There are certainly patients where HCV mismatch makes a great deal of sense; older diabetic patients without living donors in regions with long waiting times are prime candidates to use HCV+ kidneys. Similarly, patients with persistently low MELD scores can benefit from liver transplant with HCV mismatch livers and DAA therapy afterwards.  

    The great efficacy that new DAA therapies for HCV have demonstrated has ushered in new opportunities for organ utilization. Given the rapidly increasing numbers of donors who are dying of drug overdose and who have HCV exposures, the transplant community has the opportunity and responsibility to utilize these organs for patients in dire need of lifesaving transplantation.

    References

    1. Chute DF, Sise ME. Effect of the Opioid Crisis on the Donor Pool for Kidney Transplantation: An Analysis of National Kidney Deceased Donor Trends from 2010-2016. Am J Nephrol. 2018;47(2):84-93. doi:10.1159/000486516
    2. Nowak KM, Witzke O, Sotiropoulos GC, et al. Transplantation of Renal Allografts From Organ Donors Reactive for HCV Antibodies to HCV-Negative Recipients: Safety and Clinical Outcome. Kidney Int Rep. 2017;2(1):53-59. doi:10.1016/j.ekir.2016.09.058
    3. Bowring Mary G., Holscher Courtenay M., Zhou Sheng, et al. Turn down for what? Patient outcomes associated with declining increased infectious risk kidneys. Am J Transplant. 2017;18(3):617-624. doi:10.1111/ajt.14577

     

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  • The National Living Donor Assistance Center: A Valuable Tool for Living Donors and Transplant Programs

    Dr. Amith MathurAmit K. Mathur, MD, MS
    Consultant, Division of Transplant Surgery, Mayo Clinic in Arizona
    Assistant Professor of Surgery, Mayo Clinic School of Medicine
    Program Evaluation Specialist, National Living Donor Assistance Center

    As transplant professionals engaged in living donor transplantation, we come across the same story every day. We evaluate and list a transplant candidate, who begins the long wait on the deceased donor waiting list because they do not have a living donor. We are all too familiar with the risk of waitlist mortality – to our patients and our programs. Even more frustrating than the lack of a living donor is watching a perfectly good living donor be ruled out, or maybe never even come forward. Many of these individuals are fit enough to donate, want to donate, but are unable to do so because they lack the resources to be evaluated, to subsist after surgery, and struggle with even getting to the transplant center. The associated costs are often uncovered by recipient insurance. Without financial assistance to support living donors, we are often caught offering patients a less optimal therapy than they could have availed through a living donor transplant.

    One of the most helpful resources to help potential living donors is The National Living Donor Assistance Center (NLDAC). NLDAC provides financial support for travel and subsistence costs to support living donor evaluation, surgery, and after care for up to two years. NLDAC has been continuously supported by federal funds awarded by the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA). The program is cooperatively administered by the ASTS and the University of Arizona, owing to the tireless efforts of our dedicated program staff working with potential donors. The program is also supported through the efforts of individuals from a consortium of institutions including Arbor Research Collaborative for Health, Washington University in Saint Louis, and the Mayo Clinic.

    NLDAC celebrated its 10th anniversary in 2017. Since its inception (as of November 2017), NLDAC has received nearly 8,000 applications, has provided more than $14.3 million dollars, which has culminated in 4,156 living donor transplants.

    NLDAC now supports nearly 10% of all living donors in the United States.

    Based on surveys of donors who have used NLDAC, 75% state that they could not have donated without financial assistance from NLDAC. This is quite astounding, given that the average amount spent per application received is $1,737.

    96% of transplant centers have filed applications on behalf of living donors, but there is tremendous variation in the use of the program among centers. Here is an outline of the NLDAC program, how it works, and how your program can access these resources for living donors.

    What is the legal basis for NLDAC?

    The funds issued by NLDAC do not constitute payment for profit. The National Organ Transplant Act of 1984 (NOTA) and the Organ Donation and Recovery Improvement Act of 2004 (ODRIA) are the federal legal precedents that have established many of the regulations surrounding transplant and organ donation activity in the United States. NOTA specifically prohibits individuals from receiving “valuable consideration” for donating organs, i.e. people cannot profit specifically for donating an organ. However, expenses incurred related to travel, subsistence, and other non-medical expenses can be provided. This is specifically authorized in ODRIA, and is the basis for the NLDAC program and funds provided to a potential living donor through NLDAC do not constitute a profit for that individual. More information on this is available at http://www.livingdonorassistance.org.

    Who is eligible for financial support from NLDAC?

    NLDAC categoriesThe program is designed to be a payer of last resort. If other public or private programs (or funds from the recipients) are accessible to potential donors to help support travel and subsistence costs, those should be used.

    If no other funds exist, NLDAC has specific eligibility guidelines based primarily on recipient income relative to the federal poverty guidelines (Figure 1). Donor and recipient income verification is performed as a part of the application process. Since funds are limited for the program on an annual basis, the priority for funding follows Preference Categories. These Preference Categories are centered on where donor and recipient household income (not personal income) fall relative to the 300% threshold of the federal poverty line. The Preference Categories are shown in the Figure. NLDAC is not currently accepting Preference Category 2 applications.

    Based on these eligibility guidelines, NLDAC has found that both recipient and donor household average approximately $27,000 - $35,000 per year.

    What if the donor and recipient live above the 300% federal poverty line but would still have considerable financial hardship in the donor evaluation process?

    These applications will be considered in NLDAC Preference Category 4. There is a portion of the application process for providing proof of financial hardship. These applications are reviewed on an individual basis by the HRSA project officer. Historically, this preference category was underutilized, but now constitutes more than 20% of NLDAC applications.

    What expenses qualify for reimbursement? Is there a cap on funds? Is there a cap on donors per recipient?

    Currently, NLDAC reimburses travel, lodging, meals, and incidental expenses incurred by the potential donor and an accompanying person as a part of donor evaluation, hospitalization for the living donor surgical procedure, and followup appointments for up to 2 years. The program will pay for a total of five trips, three for the donor and two for the accompanying person. This can be modified if additional visits are required by the transplant center.

    The cap on NLDAC funds for a particular donor and accompanying individual is $6000.00. Kidney recipients may have one donor evaluated at a time, with a maximum of three donors total. Liver recipients operate similarly, with a maximum of five donors. Lung recipients may have two donors at a time, with a maximum of six donors total.

    Does NLDAC work with paired exchange donors?

    NLDAC does operate with paired exchange donors, and the eligibility criteria are based on the originally intended recipient. NLDAC is currently exploring options for non-directed donors.

    How quickly are applications processed? How do living donors receive funds from NLDAC?

    NLDAC applications are typically initiated by transplant center personnel and directed to us. Once applications are received by NLDAC, the average time for an application decision and to contact the applicant is 5.7 days.

    NLDAC issues funds prospectively to potential living donors through a Control Value Card (CVC), administered by American Express. This card resembles a credit card that potential donors can use to purchase airline tickets, pay for gas, hotels, food at restaurants or grocery stores, and other vendors. It takes less than a week to receive the CVC from NLDAC.

    How can donors at my center access NLDAC?

    NLDAC application forms are available on our website (http://www.livingdonorassistance.org). Educational videos are also available there to help potential donors understand if they qualify and how to apply. Questions can also be directed to NLDAC@livingdonorassistance.org or by calling 1-888-870-5002. You can also follow NLDAC on social media on Facebook, Twitter (@NLDAC_ASTS), and Instagram (@NLDAC)

    How does NLDAC help my transplant center?

    208 transplant centers have used NLDAC for their potential donors. Utilization of the NLDAC program varies greatly by transplant centers. Transplant center staff may request a report of their activity by completing an electronic request form. Some centers have filed more than 400 applications, and some as few as one application. We would love to see this change, and encourage centers to contact us to help answer questions about eligibility, assistance with applications, or other issues. The NLDAC team holds monthly webinars for transplant professionals to learn about the application process and will provide a webinar for your transplant team on request.

    NLDAC is a relatively untapped tool at many centers, and can help centers evaluate more living donors and potentially see growth in their living donor transplant programs.

    Summary

    NLDAC is valuable resource for potential living donors by providing financial assistance for expenses that go uncovered by recipient insurance. Greater awareness of this program may help transplant candidates receive a timely living donor transplant at even greater rates in the future.

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  • CME/MOC for the Transplant Surgeon – New ABS Requirements for MOC and How to Obtain MOC Credits in Transplantation

    Dr. Matthew LevineMatthew Levine, MD, PhD
    Assistant Professor, Perelman School of Medicine, University of Pennsylvania
    Chair, ASTS CME Committee

    The American Board of Surgery (ABS) has specific criteria for a 10-year cycle of maintenance of certification (MOC) for board certified general surgeons. This 10-year cycle until recently involved three-year cycles of MOC, which repeat three times and then are followed by a recertification exam every 10 years. The ABS MOC program consists of four parts: 1) Professional Standing (licensure and hospital privileges), 2) Lifelong Learning and Self Assessment, which will be the subject of this narrative, 3) Cognitive Expertise (the recertification examination), and 4) Evaluating Performance in Practice (involving participation in local, regional, or national outcomes registries (for which UNOS and SRTR qualify). The major effort involved in this, aside from the recertifying examination, is the MOC requirement. Strategies to gain MOC credits for the ABS within the realm of transplantation will be discussed below.

    In early July 2017, the ABS officially altered the requirements for MOC. These changes will significantly relax the requirements for self-assessment MOC and due to the recent nature of these changes, they will be summarized in detail here.

    For the past decade, Part 2 ABS MOC involved three-year cycles of MOC requiring 90 hours of CME credits, of which 60 involve self-assessment with testing that require 75% correct in order to obtain credit. This amounted to a requirement for 20 hours of annual self-assessment credits to be obtained with tabulation and submission every three years.

    The new Part 2 ABS MOC requirements have reduced this requirement by half. Cycles of submission of MOC credits will be lengthened from three to five years. Therefore, only two such cycles will be required for each 10-year period of exam-based recertification as opposed to three such cycles previously. With each new five-year submission period, 150 CME credits will be required, of which only 50 must include self-assessment. This amounts to a requirement of 10 self-assessment hours per year over the longer 5-year cycle. There will be a requirement for an additional 20 hours of non-self-assessment CME per year. These credits are generally easier to obtain and are satisfied by attendance at Grand Rounds/M&M meetings in most institutions as well as by attendance at conferences that do not grant self-assessment credits. These changes in ABS guidelines are new and may have caveats yet to be determined or disseminated. Information regarding these changes can be monitored at the ABS website.

    MOC must be completed by December 31 of the fifth year of each cycle. Diplomates must provide proof of completion to the ABS via a brief online form and submissions are subject to audit.

    Over the past several years there has been a significant effort by the ASTS via the CME Committee to produce current CME/MOC materials with transplant content so that transplant professionals can maintain certification by studying within their field of practice. Under CME Committee leadership preceding mine, a number of steps were taken to create CME/MOC content within the ASTS Academic Universe. This has continued, and there are currently approximately 30 hours of modules on the ASTS Academic Universe site that will renew over time. These modules cover different topics in transplantation and were largely created by CME Committee members from recent American Journal of Transplantation (AJT) published manuscripts. These modules do have a nominal per-module fee attached for access by ASTS members and nonmembers.

    A second source of MOC credits comes from the AJT directly in the form of a monthly Images in Transplantation feature. This feature, which is available at no cost to AJT subscribers (all ASTS members), allows the accumulation of an hour of MOC credit per AJT issue if the testing is completed. These features are available for 12 months on the AJT website. Thus, at any one time, 12 are available. In each five-year cycle, 60 hours of MOC will be available via this feature, but doing so will require attention throughout the five-year period – only 12 will be available if this is left to the last moment to complete. I strongly suggest that ASTS members utilize this resource longitudinally to maximize impact.

    A third avenue for transplant-specific MOC content is a recent partnership between ASTS and AJT called “ASTS MOC – Education through the AJT.” This feature allows selected high impact manuscripts at AJT to be rapidly tracked for MOC content preparation by the authorship group, assisted by ASTS CME Committee members. Operationally we expect content of 1-2 articles most months in AJT going forward. This MOC content will be housed in the ASTS Academic Universe and does come with a nominal per-module fee for members and non-members of ASTS. Each successfully completed module yields 1 hour of MOC credit. These modules will be available for three years on the ASTS Academic Universe site after creation. Once this program matures, it should yield a renewing source of MOC content that should be more than 30-40 hours of available content at any given time. The first MOC article was published in January of 2017, and there has been one article in each of the subsequent issues of AJT.

    A fourth method of MOC credit in transplantation is obvious but significantly underutilized: MOC credits available from attendance at the ASTS Winter Symposium and the ATC. In the past four years, the planning committees of these meetings along with the CME Committee have initially piloted and then fully developed a program of MOC with self-assessments that has averaged 8-13 hours of credit available at these meetings. Essentially, one could obtain all needed MOC credits in a five-year cycle by attending even one of these meetings and completing the self-assessment modules that are provided to attendees after the meeting. In past years, a small percentage of attendees have taken the self-assessment exams to get credits. This is a resource that has the potential to alleviate much of the burden of MOC accrual and is an added rationale to attend these meetings. These modules are at no added cost for meeting attendees.

    Overall, ASTS leadership has paid careful attention to the needs of the membership and has provided a number of resources for transplant-specific MOC modules that are sufficient to meet the ABS requirements without having to study topics well outside of the practice of the transplant surgeon. The work of prior CME Committee chairs Mike Ishitani and Richard Knight set the stage for the production of this MOC portfolio, and Nerissa Legge, the ASTS liaison for CME and MOC content, has greatly facilitated these efforts. The help of Allan Kirk and Jill White at AJT has been essential in building the partnership with AJT that has facilitated much of this MOC content production. We should acknowledge the efforts of ASTS CME Committee members, who have produced the majority of these modules.

    Strategically, it is worth planning ahead and taking advantage of these modules throughout the five years of the recertification cycle, as 50 hours of credits take a long time to accumulate and some content is available on a rolling basis. It is harder to get 50 credits if one waits until the month prior to the due date. The relaxation of the ABS MOC requirements will allow for a fairly painless process of MOC accumulation for most transplant surgeons as long as it is treated as a process to be completed over a 5-year period and not left to the last moment.

    With these policy changes, the ABS also issued a policy statement stipulating that some specialty-specific approaches to the 10-year cycle of written examination recertification are being considered. This change may apply to transplant surgery in the future, but details are not yet available. It should be noted that while currently only the meeting-related credits are certified for the American Board of Internal Medicine (ABIM) for non-surgeon members of ASTS, we are exploring the feasibility of extending ABIM certification to a greater part of the MOC portfolio available to ASTS members.

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