48 results on '"Levan ML"'
Search Results
2. Trials and Tribulations: Responses of ChatGPT to Patient Questions About Kidney Transplantation.
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Xu J, Mankowski M, Vanterpool KB, Strauss AT, Lonze BE, Orandi BJ, Stewart D, Bae S, Ali N, Stern J, Mattoo A, Robalino R, Soomro I, Weldon E, Oermann EK, Aphinyanaphongs Y, Sidoti C, McAdams-DeMarco M, Massie AB, Gentry SE, Segev DL, and Levan ML
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Competing Interests: M.L.L. is the Social Media Editor, and M.M. is the Specialist Editor in Computational Science for the Transplantation. The other authors declare no conflicts of interest.
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- 2024
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3. Data professionals' attitudes on data privacy, sharing, and consent in healthcare and research.
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Kaplow K, Downey M, Stewart D, Massie AB, Motter JD, Taylor L, Massarelli J, Matalon T, Sidoti C, Levan ML, and Parent B
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Objective: Individuals who work on health data systems and services are uniquely positioned to understand the risks of health data collection and use. We designed and conducted a survey assessing the perceptions of those who work with health data around health data consent, sharing, and privacy practices in healthcare and clinical research., Methods: A 43-item online survey was distributed via a market research firm to individuals (18+) who work with health data in the United States from March to April 2023. Descriptive statistics were calculated for all variables. Associations with demographic variables were assessed using Pearson's X
2 tests and ordinal logistic regression., Results: Most of our respondents (61.7%) reported that they would trust people to use their health data across various sectors, but more respondents trusted those working in academic medical research (86.5%) and healthcare offices (89.9%) compared to those working in industry (68.2%). Despite this reported trust, a strong majority believed that individuals should have complete control over their health data (97.3%), specific consent should be obtained for each use of their health data (92.0%), and that there should be higher standards of consent and privacy for health records data than other types of data (93.7%)., Conclusions: Based on our findings, we might infer that people who work with health data generally trust institutions across sectors to protect their health data. However, many would prefer to have complete control over who has access to their health data and how it is used. These insights should be explored further through qualitative studies., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2024.)- Published
- 2024
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4. Thirty-Year Trends in Perioperative Mortality Risk for Living Kidney Donors.
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Massie AB, Motter JD, Snyder JJ, Levan ML, and Segev DL
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- Adult, Female, Humans, Male, Middle Aged, Nephrectomy methods, Nephrectomy mortality, Risk, United States epidemiology, Risk Assessment, Laparoscopy methods, Laparoscopy mortality, Kidney Transplantation methods, Kidney Transplantation statistics & numerical data, Living Donors statistics & numerical data, Perioperative Period mortality, Perioperative Period trends, Tissue and Organ Harvesting methods, Tissue and Organ Harvesting mortality
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- 2024
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5. A Delphi Panel Study for Public Education about Vascularized Composite Allograft Donation in the United States.
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Downey MC, Sidoti CN, Ferzola A, Anderson N, Sung HC, Van Pilsum Rasmussen SE, Vanterpool KB, Segev DL, Cooney CM, Kimberly LL, Warren DS, Johnson ID, Brandacher G, Gordon EJ, and Levan ML
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- Humans, United States, Surveys and Questionnaires, Male, Female, Health Education, Adult, Middle Aged, Composite Tissue Allografts, Delphi Technique, Tissue and Organ Procurement
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Introduction: Improving public awareness about the opportunity to become a vascularized composite allograft (VCA) donor is crucial to increasing access to organs. Prior research identified a need for comprehensive and comprehensible public education materials. A 2-round Delphi panel was conducted to garner US expert consensus on the topics and language to include in public education materials via an organ procurement organization-hosted website. Methods: The round 1 survey assessed the importance of educational topics and statements ( n = 19) using 5-point Likert scales. The round 2 survey asked experts to rate new and repeated educational topics ( n = 27). Open-ended comment boxes elicited experts' feedback and language revisions for educational statements. Responses were analyzed using descriptive statistics and rapid qualitative analysis. Findings: Eighteen experts responded to the round 1 survey and 15 to round 2. After round 2, 20 topics had mean ( M ) importance greater than neutral ( M > 3.00) and were retained in the educational materials. The 5 most important topics by mean Likert ratings were: consent process for donation ( M = 4.73), potential recipients ( M = 4.73), most common vascularized composite organs transplanted ( M = 4.47), purpose ( M = 4.47), and definition ( M = 4.47). Seven themes emerged from experts' open-ended comments about the importance and language of educational statements. Conclusions: Delphi panel findings identified expert-endorsed topics and educational statements for public education about vascularized composite organ donation via an educational website. Future research should assess the website's impact on public knowledge of VCA donation., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dorry L. Segev discloses consulting for AstraZeneca, CareDx, Moderna Therapeutics, Novavax, Regeneron, and Springer Publishing. Dorry L. Segev discloses being a speaker/honorarium for AstraZeneca, CareDx, Houston Methodist, Northwell Health, Optum Health Education, Sanofi, and WebMd. Gerald Brandacher discloses being a medical advisor for X-Therma and for Ossium Health. The other authors declared no potential conflicts of interest with the research, authorship, and/or publication of this article.
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- 2024
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6. A scoping review of the legal and ethical challenges with the use of normothermic regional perfusion in controlled donation after circulatory determination of death from 2005 to 2023.
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da Graca B, Snoddy M, Fischbach C, Ramakrishnan S, Levan ML, Parent B, Testa G, and Wall A
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Use of normothermic regional perfusion (NRP) to enable organ reconditioning and assessment in donation after circulatory determination of death is controversial. We conducted a scoping review of peer-reviewed articles, news media, legal literature, and professional society position statements addressing ethical and/or legal issues in use of NRP in controlled donation after circulatory determination of death from January 1, 2005, to January 5, 2024. Thematic analysis, assessing the 4 principles of bioethics (autonomy, beneficence, nonmaleficence, and justice) and subthemes identified within each, was conducted for the 112 publications meeting inclusion criteria. More than 30 publications addressed the topic in each of 2022 and 2023, vs ≤6 per year previously. Nonmaleficence was the most frequently addressed bioethical principle (111/112 publications), and the most varied, with 14 subthemes. Attitudes toward NRP differed by type of NRP: of 72 publications discussing thoracoabdominal NRP, 22 (30.6%) were "In Favor," 39 (54.2%) were "Neutral," and 11 (15.3%) were "Against"; of 44 discussing abdominal NRP, 23 (52.3%) were "In Favor," 20 (45.5%) were "Neutral," and 1 (2.3%) was "Against." Attitudes differed by authors' country, degree, and affiliation, and by the clinical focus of the publishing journal. Overall, our review shows that the ethical and legal issues raised by NRP remain unresolved, and the debate centered on nonmaleficence., Competing Interests: Declaration of competing interest The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation., (Copyright © 2024 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2024
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7. Research involving the recently deceased: ethics questions that must be answered.
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Parent B, Kates OS, Arap W, Caplan A, Childs B, Dickert NW, Homan M, Kinlaw K, Lang A, Latham S, Levan ML, Truog RD, Webb A, Root Wolpe P, and Pentz RD
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- Humans, Tissue Donors ethics, Death, Ethics, Research, Trust, Brain Death, Tissue and Organ Procurement ethics
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Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria-or 'research involving the recently deceased'-can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor's legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically., Competing Interests: Competing interests: WA is a founder, equity stockholder, and scientific advisor of PhageNova Bio and of MBrace therapeutics. PhageNova Bio and MBrace Therapeutics partially support his academic laboratory through Sponsored Research Agreements. WA has previously out-licensed intellectual property related to findings potentially discovered and/or validated through translational research involving recently deceased human subjects or terminal-wean patients at the end of life. These relationships are currently managed according to established institutional conflict of interest policies of Rutgers, The State University of New Jersey. BP directs transplant ethics and policy research which is in part supported by a gift from United Therapeutics., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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8. Patient Perspectives on Solid Organ Transplantation From Donors With Hepatitis C Viremia to Recipients Without Hepatitis C Viremia.
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Vanterpool KB, Diallo K, Kim E, Van Pilsum Rasmussen SE, Johnson MA, Predmore Z, Brundage J, Barnaba B, Desai N, Levan ML, Sung HC, Kates O, Sugarman J, and Durand CM
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Background: Organ transplantation from donors with hepatitis C viremia (HCV) to recipients without HCV (HCV D+/R-) has excellent medical outcomes. Less is known about the psychosocial impact and experiences of HCV D+/R- recipients, particularly outside of clinical trials., Methods: We conducted in-depth, semistructured interviews with 24 HCV D+/R- recipients (kidney, n = 8; lung, n = 7; liver, n = 5; heart, n = 3; simultaneous heart and kidney, n = 1) who received transplants outside of clinical trials and were treated for HCV after transplant to assess their experiences and perspectives. We used thematic analysis to analyze the interviews., Results: Interviewees' reasons for accepting an HCV D + organ were based on perceived benefits and confidence in the effectiveness of HCV treatment. The majority (62%) received HCV treatment within 1 month after transplant (range, 1 day-2 months). Most interviewees reported positive transplant outcomes, including reduced wait times and improved survival, health, physical activity, and quality of life. Overall, themes and experiences did not differ significantly between different organ transplant types. Generally, interviewees did not perceive stigma from those aware of the HCV D+ transplant; yet, disclosure was selective and a few recipients reported concerns from family members about posttransplant HCV transmission risk. Other common concerns included treatment costs and delays, which were not always anticipated by recipients., Conclusions: Our findings suggest that HCV D+/R- kidney, liver, and heart and lung transplant recipients outside of clinical trials had overall positive experiences. However, HCV transmission risk, treatments costs, and treatment delays were a source of concern that might be mitigated with targeted pretransplant education., Competing Interests: Potential conflicts of interest. J. S. is a member of Merck KGaA's Ethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA's Ethics Advisory Panel; a member of Aspen Neurosciences Clinical Advisory Panel; was a member of a Merck Data Monitoring Committee; and was a consultant to Biogen. None of these activities is related to the material discussed in this manuscript. C. M. D. serves on a grant review committee for Gilead Sciences, a pharmaceutical company that makes antivirals for the treatment of HCV, and she is an investigator on 2 trials of HCV transplantation to which Gilead donates drug. All other authors report no potential conflicts., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2024.)
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- 2024
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9. National Attitudes Toward Living Kidney Donation in the United States: Results of a Public Opinion Survey.
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Kaplow K, Ruck JM, Levan ML, Thomas AG, Stewart D, Massie AB, Sung HC, Pisano SF, Sidoti C, Segev DL, Sinacore J, and Waterman AD
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Rationale & Objective: Understanding national attitudes about living kidney donation will enable us to identify and address existing disincentives to living kidney donation. We performed a national survey to describe living kidney donation perceptions, perceived factors that affect the willingness to donate, and analyzed differences by demographic subgroups., Study Design: The survey items captured living kidney donation awareness, living kidney donation knowledge, willingness to donate, and barriers and facilitators to living kidney donation., Setting & Population: We surveyed 802 US adults (aged 25-65 years) in June 2021, randomly selected from an online platform with diverse representation., Analytical Approach: We developed summed, scaled indices to assess the association between the living kidney donation knowledge (9 items) and the willingness to donate (8 items) to self-reported demographic characteristics and other variables of interest using analysis of variance. All other associations for categorical questions were calculated using Pearson's χ
2 and Fisher exact tests. We inductively evaluated free-text responses to identify additional barriers and facilitators to living kidney donation., Results: Most (86.6%) of the respondents reported that they might or would definitely consider donating a kidney while they were still living. Barriers to living kidney donation included concerns about the risk of the surgery, paying for medical expenses, and potential health effects. Facilitators to living kidney donation included having information on the donation surgery's safety, knowing that the donor would not have to pay for medical expenses related to the donation, and hearing living kidney donation success stories. Awareness of the ability to participate in kidney-paired donation was associated with a higher willingness to donate., Limitations: Potential for selection bias resulting from the use of survey panels and varied incentive amounts, and measurement error related to respondents' attention level., Conclusions: Most people would consider becoming a living kidney donor. Increased rates of living kidney donation may be possible with investment in culturally competent educational interventions that address risks associated with donating, policies that reduce financial disincentives, and communication campaigns that raise awareness of kidney-paired donation and living kidney donation., (© 2024 The Authors.)- Published
- 2023
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10. Using Social Media to Promote Cutting-edge Research in Transplantation: Results of an International Survey.
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Atif M, Kaplow KN, Akhtar JM, Sidoti CN, Li J, Au EHK, Baan CC, and Levan ML
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- Humans, Surveys and Questionnaires, Social Media
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- 2023
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11. The Transplantgram Revolution: Instagram's Influence on the Perception and Promotion of Organ Transplantation.
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Levan ML, Klitenic SB, Patel SS, Akhtar JM, Nemeth DV, Jones D, Massie AB, and Segev DL
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- Humans, Perception, Organ Transplantation adverse effects
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Competing Interests: M.L.L. is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest.
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- 2023
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12. Artificial intelligence-based clinical decision support for liver transplant evaluation and considerations about fairness: A qualitative study.
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Strauss AT, Sidoti CN, Sung HC, Jain VS, Lehmann H, Purnell TS, Jackson JW, Malinsky D, Hamilton JP, Garonzik-Wang J, Gray SH, Levan ML, Hinson JS, Gurses AP, Gurakar A, Segev DL, and Levin S
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- Humans, Artificial Intelligence, Qualitative Research, Liver Transplantation, Decision Support Systems, Clinical
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Background: The use of large-scale data and artificial intelligence (AI) to support complex transplantation decisions is in its infancy. Transplant candidate decision-making, which relies heavily on subjective assessment (ie, high variability), provides a ripe opportunity for AI-based clinical decision support (CDS). However, AI-CDS for transplant applications must consider important concerns regarding fairness (ie, health equity). The objective of this study was to use human-centered design methods to elicit providers' perceptions of AI-CDS for liver transplant listing decisions., Methods: In this multicenter qualitative study conducted from December 2020 to July 2021, we performed semistructured interviews with 53 multidisciplinary liver transplant providers from 2 transplant centers. We used inductive coding and constant comparison analysis of interview data., Results: Analysis yielded 6 themes important for the design of fair AI-CDS for liver transplant listing decisions: (1) transparency in the creators behind the AI-CDS and their motivations; (2) understanding how the AI-CDS uses data to support recommendations (ie, interpretability); (3) acknowledgment that AI-CDS could mitigate emotions and biases; (4) AI-CDS as a member of the transplant team, not a replacement; (5) identifying patient resource needs; and (6) including the patient's role in the AI-CDS., Conclusions: Overall, providers interviewed were cautiously optimistic about the potential for AI-CDS to improve clinical and equitable outcomes for patients. These findings can guide multidisciplinary developers in the design and implementation of AI-CDS that deliberately considers health equity., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Study of Liver Diseases.)
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- 2023
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13. TikTok and Transplantation: A Trending Opportunity.
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Levan ML, Klitenic SB, Patel SS, Akhtar JM, Nemeth DV, Jones DM, Massie AB, and Segev DL
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- Humans, Social Media, Transplantation
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Competing Interests: M.L.L. is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest.
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- 2023
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14. Patient definitions of transplant success in upper extremity vascularized composite allotransplantation: A mixed-methods study.
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Downey MC, Gacki-Smith J, Kuramitsu B, Vanterpool KB, Nordstrom M, Luken M, Langlee W, Riggleman T, Fichter S, Altema W, Jensen SE, Dumanian GA, Cooney CM, Levan ML, Tintle S, Brandacher G, and Gordon EJ
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Objective: Upper extremity vascularized composite allotransplantation is an innovative treatment option for people with upper extremity amputations. Limited patient-relevant long-term outcomes data about transplant success may impede patients' informed treatment decision-making. We assessed perceptions of what constitutes upper extremity vascularized composite allotransplantation success among individuals with upper extremity amputations., Methods: This multisite study entailed interviews and focus groups with individuals with upper extremity amputations and upper extremity vascularized composite allotransplantation candidates, participants, and recipients. We examined perceptions of transplant success and preferences for five upper extremity vascularized composite allotransplantation outcomes. Qualitative data were analyzed using thematic analysis; and quantitative data were analyzed using descriptive statistics., Results: In all, 50 individuals participated in interviews (61.7% participation rate), and 37 participated in nine focus groups (75.5% participation rate). Most were White (72%, 73%), had a mean age of 45 and 48 years, and had a unilateral amputation (84%, 59%), respectively. Participants conceptualized upper extremity vascularized composite allotransplantation success as transplant outcomes: (1) restoring function and sensation to enable new activities; (2) accepting the transplanted limb into one's identity and appearance; (3) not having transplant rejection; (4) attaining greater quality of life compared to prosthetics; and (5) ensuring benefits outweigh risks. Participants rated their most important upper extremity vascularized composite allotransplantation outcomes as follows: not having transplant rejection, not developing health complications, grasping objects, feeling touch and temperature, and accepting the upper extremity vascularized composite allotransplantation into your identity., Conclusion: Individuals with upper extremity amputations maintain several conceptions of vascularized composite allotransplantation success, spanning functional, psychosocial, clinical, and quality of life outcomes. Providers should address patients' conceptions of success to improve informed consent discussions and outcomes reporting for upper extremity vascularized composite allotransplantation., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)
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- 2023
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15. Patient preferences of patient selection criteria for upper extremity vascularized composite allotransplantation: A qualitative study.
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Vanterpool KB, Gacki-Smith J, Downey MC, Nordstrom M, Luken M, Riggleman T, Fichter S, Altema W, Jensen SE, Dumanian GA, Cooney CM, Levan ML, Tintle S, Brandacher G, and Gordon EJ
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Background: Upper extremity vascularized composite allotransplantation is a life-enhancing reconstructive treatment option that aims to improve recipients' quality of life and maximize function. This study assessed upper extremity vascularized composite allotransplantation patient selection criteria perceptions among individuals with upper extremity limb loss. The perceptions of individuals with upper extremity limb loss on patient selection criteria may enable vascularized composite allotransplantation centers to improve criteria to avoid mismatched expectations about the posttransplant vascularized composite allotransplantation experience and outcomes. Realistic patient expectations may increase patient adherence, improve outcomes, and reduce vascularized composite allotransplantation graft loss., Methods: We conducted in-depth interviews with civilian and military service members with upper extremity limb loss and upper extremity vascularized composite allotransplantation candidates, participants, and recipients from three US institutions. Interviews assessed perceptions of patient selection criteria for suitability as a candidate for upper extremity vascularized composite allotransplantation. Thematic analysis was used to analyze qualitative data., Results: A total of 50 individuals participated (66% participation rate). Most participants were male (78%), White (72%), with a unilateral limb loss (84%), and a mean age of 45 years. Six themes emerged regarding upper extremity vascularized composite allotransplantation patient selection criteria, including support for candidates who: (1) are of younger age, (2) are in good physical health, (3) have mental stability, (4) are willing to "put in the work," (5) have specific amputation characteristics, and (6) have sufficient social support. Patients had preferences about selecting candidates with unilateral versus bilateral limb loss., Conclusions: Our findings suggest that numerous factors, including medical, social, and psychological characteristics, inform patients' perceptions of patient selection criteria for upper extremity vascularized composite allotransplantation. Patient perceptions of patient selection criteria should inform the development of validated screening measures that optimize patient outcomes., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)
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- 2023
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16. Factors impacting the medication "Adherence Landscape" for transplant patients.
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Bendersky VA, Saha A, Sidoti CN, Ferzola A, Downey M, Ruck JM, Vanterpool KB, Young L, Shegelman A, Segev DL, and Levan ML
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- Adult, Humans, Medication Adherence, Transplant Recipients, Immunosuppressive Agents therapeutic use, Graft Rejection drug therapy, Graft Rejection etiology, Graft Rejection prevention & control, Kidney Transplantation, Liver Transplantation
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Background: Medication non-adherence contributes to post-transplant graft rejection and failure; however, limited knowledge about the reasons for non-adherence hinders the development of interventions to improve adherence. We conducted focus groups with solid organ transplant recipients regarding overlooked challenges in the process of transplant medication self-management and examined their adherence strategies and perceptions towards the post-transplant medication regimen., Methods: We conducted four focus groups with n = 31 total adult transplant recipients. Participants had received kidney, liver, or combined liver/kidney transplant at Johns Hopkins Hospital between 2014 and 2019. Focus groups were audio-recorded and transcribed. Transcripts were analyzed inductively, using the constant comparative method., Results: Responses generally fell into two major categories: (1) barriers to adherence and (2) "adherence landscape". We define the former as factors directly labeled as barriers to adherence by participants and the latter as factors that heavily influence the post-transplant medication self-management process., Conclusions: We propose a shift in the way healthcare providers and researchers, address the question of medication non-adherence. Rather than asking why patients are non-adherent, we suggest that constructing and understanding patients' "adherence landscape" will provide an optimal way to align the goals of patients and providers and boost health outcomes., (© 2023 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.)
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- 2023
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17. Factors enabling transplant program participation in the Scientific Registry of Transplant Recipients (SRTR) Living Donor Collective: A national survey.
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Lentine KL, Dew MA, Xiao H, Wisniewski A, Levan ML, Al Ammary F, Sharfuddin A, Axelrod DA, Waterman AD, and Kasiske B
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- Humans, United States, Living Donors, Transplant Recipients, Registries, Surveys and Questionnaires, Organ Transplantation, Tissue and Organ Procurement
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Background: The Scientific Registry of Transplant Recipients (SRTR) Living Donor Collective (LDC), the first effort to create a lifetime registry for living donor candidates in the United States, requires transplant programs to register donor candidates while the SRTR conducts follow-up., Methods: To better understand facilitators and barriers to program participation, we conducted a brief electronic survey of U.S. transplant program staff from October 26, 2021 to December 17, 2021., Results: We received 132 responses, with at least one response from 87 living donor programs (46 kidney programs, 33 kidney and liver programs, and eight liver programs alone). We found 86% of program representatives strongly agreed or agreed that funding adequate to cover the cost of data collection would facilitate LDC participation, 92% agreed or strongly agreed with importance of electronic data submission options, and 74% reported that elimination of requirements to submit duplicative pre-operative information to the Organ Procurement and Transplantation Network (OPTN) would be helpful. Other potentially enabling factors include reduction in duration of OPTN postdonation follow-up requirements, ease-of-use, protection from data use for regulation, adequate data security, and equity in data access., Conclusion: This survey identifies potential targets to strengthen participation in the effort to create a national living donor registry in the United States. Collaboration and investment to overcome barriers to LDC participation among transplant programs are vital to generate long-term data on living donation for donor candidates, donors, and patients in need of transplant., (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
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- 2023
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18. 6-month antibody kinetics and durability after four doses of a SARS-CoV-2 vaccine in solid organ transplant recipients.
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Mitchell J, Chiang TP, Alejo JL, Kim JD, Chang A, Abedon AT, Avery RK, Tobian AAR, Levan ML, Warren DS, Garonzik-Wang JM, Segev DL, Massie AB, and Werbel WA
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- Humans, COVID-19 Vaccines, Kinetics, SARS-CoV-2, Antibodies, Transplant Recipients, Antibodies, Viral, COVID-19 epidemiology, COVID-19 prevention & control, Organ Transplantation
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- 2023
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19. Transplantation Amid a Pandemic: The Fall and Rise of Kidney Transplantation in the United States.
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Bisen SS, Zeiser LB, Boyarsky B, Werbel W, Snyder J, Garonzik-Wang J, Levan ML, Segev DL, and Massie AB
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Following the outbreak of coronavirus disease 2019 (COVID-19) in the United States, the number of kidney waitlist additions and living-donor and deceased-donor kidney transplants (LDKT/DDKT) decreased substantially but began recovering within a few months. Since then, there have been several additional waves of infection, most notably, the Delta and Omicron surges beginning in August and December 2021, respectively., Methods: Using SRTR data, we compared observed waitlist registrations, waitlist mortality, waitlist removal due to deteriorating condition, LDKT, and DDKT over 5 distinct pandemic periods to expected events based on calculations from preepidemic data while accounting for seasonality and secular trends., Results: Although the number of daily waitlist additions has been increasing since May 2020, the size of the active waitlist has consistently declined, reaching a minimum of 52 556 on February 27, 2022. The recent Omicron surge knocked LDKT from 25% below baseline (incidence rate ratio [IRR] =
0.69 0.750.81 ) during the Delta wave to 38% below baseline (IRR =0.58 0.620.67 ). DDKT, however, was less affected by the Omicron wave (IRR =0.85 0.890.93 and0.88 0.920.96 during the Delta and Omicron waves, respectively). Waitlist death decreased from 56% above baseline (IRR =1.43 1.561.70 ) during Delta to 41% above baseline during Omicron, whereas waitlist removal due to deteriorating condition remained at baseline/expected levels during the Delta wave (IRR =0.93 1.021.12 ) and the Omicron wave (IRR =0.99 1.071.16 )., Conclusions: Despite exceptionally high COVID-19 incidence during the Omicron wave, the transplant system responded similarly to prior waves that imposed a lesser disease burden, demonstrating the transplant system's growing adaptations and resilience to this now endemic disease., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)- Published
- 2022
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20. Multicenter study of racial and ethnic inequities in liver transplantation evaluation: Understanding mechanisms and identifying solutions.
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Strauss AT, Sidoti CN, Purnell TS, Sung HC, Jackson JW, Levin S, Jain VS, Malinsky D, Segev DL, Hamilton JP, Garonzik-Wang J, Gray SH, Levan ML, Scalea JR, Cameron AM, Gurakar A, and Gurses AP
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- Humans, Racial Groups, Ethnicity, Waiting Lists, Delivery of Health Care, Healthcare Disparities, Liver Transplantation adverse effects
- Abstract
Racial and ethnic disparities persist in access to the liver transplantation (LT) waiting list; however, there is limited knowledge about underlying system-level factors that may be responsible for these disparities. Given the complex nature of LT candidate evaluation, a human factors and systems engineering approach may provide insights. We recruited participants from the LT teams (coordinators, advanced practice providers, physicians, social workers, dieticians, pharmacists, leadership) at two major LT centers. From December 2020 to July 2021, we performed ethnographic observations (participant-patient appointments, committee meetings) and semistructured interviews (N = 54 interviews, 49 observation hours). Based on findings from this multicenter, multimethod qualitative study combined with the Systems Engineering Initiative for Patient Safety 2.0 (a human factors and systems engineering model for health care), we created a conceptual framework describing how transplant work system characteristics and other external factors may improve equity in the LT evaluation process. Participant perceptions about listing disparities described external factors (e.g., structural racism, ambiguous national guidelines, national quality metrics) that permeate the LT evaluation process. Mechanisms identified included minimal transplant team diversity, implicit bias, and interpersonal racism. A lack of resources was a common theme, such as social workers, transportation assistance, non-English-language materials, and time (e.g., more time for education for patients with health literacy concerns). Because of the minimal data collection or center feedback about disparities, participants felt uncomfortable with and unadaptable to unwanted outcomes, which perpetuate disparities. We proposed transplant center-level solutions (i.e., including but not limited to training of staff on health equity) to modifiable barriers in the clinical work system that could help patient navigation, reduce disparities, and improve access to care. Our findings call for an urgent need for transplant centers, national societies, and policy makers to focus efforts on improving equity (tailored, patient-centered resources) using the science of human factors and systems engineering., (© 2022 The Authors. Liver Transplantation published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.)
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- 2022
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21. Maximizing the use of potential donors through increased rates of family approach for authorization.
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Levan ML, Massie AB, Trahan C, Hewlett J, Strout T, Klitenic SB, Vanterpool KB, Segev DL, Adams BL, and Niles P
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- Female, Humans, United States, Referral and Consultation, Tissue Donors, Tissue and Organ Procurement
- Abstract
In the United States, a small proportion of potential deceased organ donor referrals lead to donation and recovery. Understanding variation in the processes involved between organ procurement organizations (OPOs) may help increase deceased donation and reduce the organ shortage. We studied 103 923 referrals from 10 OPOs from 2018 to 2019, of which 14.4% led to approach for authorization, 8.2% led to authorization, 5.1% led to organ recovery, and 4.8% led to transplantation. First-person authorization (FPA) was associated with threefold higher odds of donation (OR =
2.83 3.023.22 , p < .001). Female referrals had 11% lower odds of approach; when approached, Black and Hispanic referrals had 46% and 35% lower odds of authorization, respectively (all p < .001). There was substantial OPO-level variation in rates of approach, authorization, and organ recovery, which persisted after adjusting for age, sex, race, and FPA status. An OPO's relative rate of approach correlated strongly with its relative rate of donation among all referrals (ρ = 0.43). Correlation between an individual OPO's authorization rate among approached families, and overall rate of donation, was negative, suggesting that high authorization rates may be the result of selective approach practices. Therefore, approaching a higher proportion of families for authorization may lead to higher donation rates., (© 2022 The American Society of Transplantation and the American Society of Transplant Surgeons.)- Published
- 2022
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22. Public Perceptions and Information Needs of VCA Transplantation and Donation: A Mixed Methods Study.
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Ferzola A, Uriarte J, Sung HC, Anderson N, Sidoti C, Van Pilsum Rasmussen SE, Downey M, Vanterpool KB, Langlee W, Klitenic S, Young L, Cooney CM, Johnson I, Coleman A, Shores JT, Segev DL, Brandacher G, Gordon EJ, and Levan ML
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- Female, Humans, Adult, Male, Cross-Sectional Studies, Public Opinion, Tissue Donors, Vascularized Composite Allotransplantation, Organ Transplantation
- Abstract
Vascularized Composite Allotransplantation (VCA) involves transplantation of multiple tissues from a donor to a recipient (e.g., skin, muscle, bone). Little is known about the US public's perceptions of and attitudes toward VCA organ donation. This multi-site, cross-sectional, mixed methods study involved focus groups and surveys to assess members of the general public's attitudes about VCA, and willingness and barriers to donate VCA organs. Qualitative data were analyzed by thematic analysis; quantitative data were analyzed by descriptive statistics. In focus groups ( n = 6, 42 participants), most participants were female (57%) and Black (62%) with mean age of 42.6 years. Three main themes emerged: 1) awareness and perceptions of VCA, 2) purpose of VCA donation, 3) and barriers to VCA donation. Participants had heard little about VCA and sought information about VCA donation. Participants perceived VCA as challenging their concepts of "normality" and voiced concerns that VCA would create "Frankenstein[s]." Barriers to VCA donation included disruptions to end-of-life arrangements and information gaps regarding the donation process. Participants reported moderate to high willingness to donate their hands (69%) and face (50%) Public education efforts should address the specific needs and concerns of the public to facilitate VCA donation and family authorization., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Ferzola, Uriarte, Sung, Anderson, Sidoti, Van Pilsum Rasmussen, Downey, Vanterpool, Langlee, Klitenic, Young, Cooney, Johnson, Coleman, Shores, Segev, Brandacher, Gordon and Levan.)
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- 2022
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23. Antibody response to a third dose of SARS-CoV-2 vaccine in heart and lung transplant recipients.
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Alejo JL, Ruck JM, Chiang TPY, Abedon AT, Kim JD, Avery RK, Tobian AAR, Warren DS, Levan ML, Massie AB, Garonzik-Wang JM, Segev DL, and Werbel WA
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- Humans, COVID-19 Vaccines, Antibody Formation, SARS-CoV-2, Transplant Recipients, Antibodies, Viral, COVID-19 epidemiology, COVID-19 prevention & control, Lung Transplantation
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- 2022
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24. Predicting a Positive Antibody Response After 2 SARS-CoV-2 mRNA Vaccines in Transplant Recipients: A Machine Learning Approach With External Validation.
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Alejo JL, Mitchell J, Chiang TP, Chang A, Abedon AT, Werbel WA, Boyarsky BJ, Zeiser LB, Avery RK, Tobian AAR, Levan ML, Warren DS, Massie AB, Moore LW, Guha A, Huang HJ, Knight RJ, Gaber AO, Ghobrial RM, Garonzik-Wang JM, Segev DL, and Bae S
- Subjects
- Antibodies, Viral, Antibody Formation, BNT162 Vaccine, Humans, Immunosuppressive Agents adverse effects, Machine Learning, Mycophenolic Acid, SARS-CoV-2, Vaccines, Vaccines, Synthetic, mRNA Vaccines, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Transplant Recipients
- Abstract
Background: Solid organ transplant recipients (SOTRs) are less likely to mount an antibody response to SARS-CoV-2 mRNA vaccines. Understanding risk factors for impaired vaccine response can guide strategies for antibody testing and additional vaccine dose recommendations., Methods: Using a nationwide observational cohort of 1031 SOTRs, we created a machine learning model to explore, identify, rank, and quantify the association of 19 clinical factors with antibody responses to 2 doses of SARS-CoV-2 mRNA vaccines. External validation of the model was performed using a cohort of 512 SOTRs at Houston Methodist Hospital., Results: Mycophenolate mofetil use, a shorter time since transplant, and older age were the strongest predictors of a negative antibody response, collectively contributing to 76% of the model's prediction performance. Other clinical factors, including transplanted organ, vaccine type (mRNA-1273 versus BNT162b2), sex, race, and other immunosuppressants, showed comparatively weaker associations with an antibody response. This model showed moderate prediction performance, with an area under the receiver operating characteristic curve of 0.79 in our cohort and 0.67 in the external validation cohort. An online calculator based on our prediction model is available at http://transplantmodels.com/covidvaccine/ ., Conclusions: Our machine learning model helps understand which transplant patients need closer follow-up and additional doses of vaccine to achieve protective immunity. The online calculator based on this model can be incorporated into transplant providers' practice to facilitate patient-centric, precision risk stratification and inform vaccination strategies among SOTRs., Competing Interests: D.L.S. has the following financial disclosures: consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, Thermo Fisher Scientific, Regeneron, and AstraZeneca. R.K.A. has grant/research support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, and Takeda/Shire. M.L.L. is the Social Media Editor for Transplantation and is a consultant for Takeda/Shire and Patients Like Me. The other authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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25. Letter to the editor: Six-month antibody kinetics and durability in liver transplant recipients after two doses of SARS-CoV-2 mRNA vaccination.
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Chang A, Strauss AT, Alejo JL, Chiang TP, Hernandez NF, Zeiser LB, Boyarsky BJ, Avery RK, Tobian AAR, Levan ML, Warren DS, Garonzik-Wang JM, Massie AB, Werbel WA, and Segev DL
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- Antibodies, Humans, Kinetics, RNA, Messenger, SARS-CoV-2 genetics, Vaccination, COVID-19 prevention & control, Liver Transplantation
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- 2022
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26. Incidence and Severity of COVID-19 Among Vaccinated Solid Organ Transplant Recipients During the Omicron Wave.
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Alejo JL, Chiang TPY, Bowles Zeiser L, Kim JD, Mitchell J, Avery RK, Tobian AAR, Abedon RR, Levan ML, Warren DS, Garonzik-Wang JM, Massie AB, Segev DL, and Werbel WA
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- Humans, Incidence, Transplant Recipients, COVID-19 epidemiology, COVID-19 prevention & control, Organ Transplantation adverse effects
- Abstract
Competing Interests: D.L.S. has the following financial disclosures: consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, Thermo Fisher Scientific, Regeneron, and AstraZeneca. R.K.A. is an associate editor of Transplantation and has grant/research support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, Regeneron, and Takeda/Shire. M.L.L. is a Social Media Editor for Transplantation and receives consulting honoraria that are not related to her authorship of the article from Takeda/Patients Like Me. The other authors declare no conflicts of interest.
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- 2022
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27. Immunogenicity of Ad26.COV2.S prime and two subsequent doses of mRNA SARS-CoV-2 vaccines in solid organ transplant recipients: A case series.
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Chang A, Mitchell J, Alejo JL, Chiang TPY, Abedon AT, Kim JD, Avery RK, Tobian AAR, Levan ML, Warren DS, Garonzik-Wang JM, Massie AB, Segev DL, and Werbel WA
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- Ad26COVS1, Antibodies, Viral, COVID-19 Vaccines, Humans, RNA, Messenger, SARS-CoV-2 genetics, Transplant Recipients, COVID-19 epidemiology, COVID-19 prevention & control, Organ Transplantation adverse effects
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- 2022
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28. Heterologous Ad.26.COV2.S versus homologous BNT162b2/mRNA-1273 as a third dose in solid organ transplant recipients seronegative after two-dose mRNA vaccination.
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Chiang TP, Alejo JL, Mitchell J, Kim JD, Abedon AT, Karaba AH, Thomas L, Levan ML, Garonzik-Wang JM, Avery RK, Pekosz A, Clarke WA, Warren DS, Tobian AAR, Massie AB, Segev DL, and Werbel WA
- Subjects
- Antibodies, Viral, COVID-19 Vaccines adverse effects, Humans, RNA, Messenger genetics, SARS-CoV-2, Transplant Recipients, Vaccination, 2019-nCoV Vaccine mRNA-1273 adverse effects, BNT162 Vaccine adverse effects, COVID-19 epidemiology, COVID-19 prevention & control, Influenza Vaccines, Organ Transplantation adverse effects
- Abstract
Heterologous vaccination ("mixing platforms") for the third (D3) dose of SARS-CoV-2 vaccine is a potential strategy to improve antibody responses in solid organ transplant recipients (SOTRs), but data are mixed regarding potential differential immunogenicity. We assessed for differences in immunogenicity and tolerability of homologous (BNT162b2 or mRNA-1273; D3-mRNA) versus heterologous (Ad.26.COV2.S; D3-JJ) D3 among 377 SARS-CoV-2-infection naïve SOTRs who remained seronegative after two mRNA vaccines. We measured anti-spike titers and used weighted Poisson regression to evaluate seroconversion and development of high-titers, comparing D3-JJ to D3-mRNA, at 1-, 3-, and 6 month post-D3. 1-month post-D3, seroconversion (63% vs. 52%, p = .3) and development of high-titers (29% vs. 25%, p = .7) were comparable between D3-JJ and D3-mRNA recipients. 3 month post-D3, D3-JJ recipients were 1.4-fold more likely to seroconvert (80% vs. 57%, weighted incidence-rate-ratio: wIRR =
1.10 1.401.77 , p = .006) but not more likely to develop high-titers (27% vs. 22%, wIRR =0.44 0.921.93 , p = .8). 6 month post-D3, D3-JJ recipients were 1.41-fold more likely to seroconvert (88% vs. 59%, wIRR =1.04 1.411.93 , p = .029) and 2.63-fold more likely to develop high-titers (59% vs. 21%, wIRR =1.38 2.635.00 , p = .003). There was no differential signal in alloimmune events or reactogenicity between platforms. SOTRs without antibody response after two mRNA vaccines may derive benefit from heterologous Ad.26.COV2.S D3., (© 2022 The Authors. American Journal of Transplantation published by Wiley Periodicals LLC on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.)- Published
- 2022
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29. Questions of accountability and transparency in the US organ donation and transplantation system.
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Levan ML, Klitenic S, Massie A, Parent B, Caplan A, Gentry S, and Segev D
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- Humans, Social Responsibility, Surveys and Questionnaires, Tissue Donors, Organ Transplantation, Tissue and Organ Procurement
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- 2022
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30. Improved humoral immunogenicity with mRNA-1273 versus BNT162b2 as third vaccine dose among solid organ transplant recipients seronegative after two BNT162b2 doses.
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Chang A, Chiang TP, Kim JD, Mitchell J, Alejo JL, Jefferis AA, Avery RK, Tobian AAR, Levan ML, Warren DS, Garonzik-Wang JM, Massie AB, Segev DL, and Werbel WA
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- 2019-nCoV Vaccine mRNA-1273, Antibodies, Viral, BNT162 Vaccine, Humans, Transplant Recipients, Influenza Vaccines, Organ Transplantation adverse effects
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- 2022
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31. Severe acute respiratory syndrome coronavirus 2 antibody response to a third dose of homologous messenger RNA vaccination in liver transplantation recipients.
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Strauss AT, Chang A, Alejo JL, Chiang TP, Hernandez NF, Zeiser LB, Boyarsky BJ, Avery RK, Tobian AAR, Levan ML, Warren DS, Massie AB, Garonzik-Wang JM, Segev DL, and Werbel WA
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- Antibodies, Viral, Antibody Formation, Humans, RNA, Messenger, SARS-CoV-2 genetics, Transplant Recipients, Vaccination, COVID-19 prevention & control, Liver Transplantation adverse effects
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- 2022
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32. Short Report: Evaluating the Effects of Automated Donor Referral Technology on Deceased Donor Referrals.
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Levan ML, Trahan C, Klitenic SB, Hewlett J, Strout T, Levan MA, Vanterpool KB, Segev DL, Adams BL, Massie AB, and Niles P
- Abstract
Automation of deceased donor referrals with standardized clinical triggers allows organ procurement organizations to be rapidly aware of medically eligible potential donors without the need for manual reporting and subjective decision-making of otherwise very busy hospital staff. In October 2018, 3 Texas hospitals (pilot hospitals) began using an automated referral system; our goal was to evaluate the impact of this system on eligible donor referral., Methods: We studied ventilated referrals (n = 28 034) in a single organ procurement organization from January 2015 to March 2021. We estimated the change in referral rate in the 3 pilot hospitals due to the automated referral system using a difference-in-differences analysis with Poisson regression., Results: Ventilated referrals from the pilot hospitals increased from mean 11.7 per month pre-October 2018 to 26.7 per month post-October 2018. The difference-in-differences analysis estimated that automated referral was associated with a 45% increase in referrals (adjusted incidence rate ratio [aIRR] =
1.30 1.451.62 ), an 83% increase in approaches for authorization (aIRR =1.34 1.832.48 ), a 73% increase in authorizations (aIRR =1.18 1.732.55 ), and a 92% increase in organ donors (aIRR =1.13 1.923.09 )., Conclusions: Following deployment of an automated referral system that did not require any actions by the referring hospital, referrals, authorizations, and organ donors increased substantially in the 3 pilot hospitals. Broader deployment of automated referral systems may lead to increases in the deceased donor pool., Competing Interests: Funding or a product for the study described in this publication was provided by Southwest Transplant Alliance. Spouse of M.A.L. is also a paid consultant to Southwest Transplant Alliance. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. D.L.S. reports consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other authors declare no conflicts of interest., (Copyright © 2022 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)- Published
- 2022
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33. Antibody Response to a Fourth Dose of SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: An Update.
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Mitchell J, Alejo JL, Chiang TPY, Kim J, Chang A, Abedon AT, Avery RK, Tobian AAR, Massie AB, Levan ML, Warren DS, Garonzik-Wang JM, Segev DL, and Werbel WA
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- Antibodies, Viral, Antibody Formation, COVID-19 Vaccines, Humans, SARS-CoV-2, Transplant Recipients, COVID-19 prevention & control, Organ Transplantation adverse effects
- Abstract
Competing Interests: D.L.S. has the following financial disclosures: consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, Thermo Fisher Scientific, Regeneron, and AstraZeneca. R.K.A. has study/grant support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, Regeneron, Takeda/Shire, and Vir/GSK and is an Associate Reviewer for Transplantation. M.L.L. is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest.
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- 2022
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34. Humoral and Cellular Immune Response to a Third Dose of SARS-CoV-2 Vaccine in Kidney Transplant Recipients Taking Belatacept.
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Mitchell J, Kim J, Alejo JL, Chiang TP, Karaba AH, Blankson JN, Aytenfisu TY, Chang A, Abedon AT, Avery RK, Tobian AA, Massie AB, Levan ML, Warren DS, Garonzik-Wang JM, Segev DL, and Werbel WA
- Subjects
- Abatacept therapeutic use, Antibodies, Viral, COVID-19 Vaccines, Humans, Immunity, Cellular, SARS-CoV-2, Transplant Recipients, COVID-19 prevention & control, Kidney Transplantation adverse effects
- Abstract
Competing Interests: D.L.S. has received consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, Thermo Fisher Scientific, Regeneron, and Astra Zeneca. A.H.K. has received consulting fees from Roche. R.K.A. has study/grant support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, Regeneron, Takeda/Shire, and Vir/GSK and is an Associate Reviewer for Transplantation. M.L.L. is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest.
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- 2022
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35. Six-month Antibody Kinetics and Durability After 3 Doses of SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series.
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Abedon AT, Alejo JL, Kim JD, Thomas L, Mitchell J, Chiang TPY, Avery RK, Tobian AAR, Levan ML, Warren DS, Massie AB, Garonzik-Wang JM, Segev DL, and Werbel WA
- Subjects
- Antibodies, Viral, COVID-19 Vaccines, Humans, Kinetics, SARS-CoV-2, Transplant Recipients, COVID-19 prevention & control, Organ Transplantation adverse effects
- Abstract
Competing Interests: D.L.S. has received consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, Thermo Fisher Scientific, Regeneron, and Astra Zeneca. R.K.A. has study/grant support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, Regeneron, Takeda/Shire, and Vir/GSK and is an Associate Reviewer for Transplantation. M.L.L. is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest.
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- 2022
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36. Improved Antibody Response After a Fifth Dose of a SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series.
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Abedon AT, Teles MS, Alejo JL, Kim JD, Mitchell J, Chiang TPY, Avery RK, Tobian AAR, Levan ML, Warren DS, Massie AB, Garonzik-Wang JM, Segev DL, and Werbel WA
- Subjects
- Antibodies, Viral, Antibody Formation, COVID-19 Vaccines, Humans, SARS-CoV-2, Transplant Recipients, COVID-19 prevention & control, Organ Transplantation adverse effects
- Abstract
Competing Interests: D.L.S. received consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, Thermo Fisher Scientific, Regeneron, and AstraZeneca. M.L.L. is the Social Media Editor for Transplantation. R.K.A. has grant/research support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, and Takeda/Shire. The other authors declare no conflicts of interest.
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- 2022
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37. Effect of Mycophenolate Mofetil Dosing on Antibody Response to SARS-CoV-2 Vaccination in Heart and Lung Transplant Recipients.
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Mitchell J, Chiang TP, Alejo JL, Chang A, Abedon AT, Avery RK, Tobian AAR, Massie AB, Levan ML, Warren DS, Garonzik-Wang JM, Segev DL, and Werbel WA
- Subjects
- Antibodies, Viral, Antibody Formation, COVID-19 Vaccines, Humans, Immunosuppressive Agents adverse effects, Lung, Mycophenolic Acid, SARS-CoV-2, Vaccination, COVID-19 prevention & control, Transplant Recipients
- Abstract
Competing Interests: D.L.S. received consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. R.K.A. has study/grant support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, Regeneron, Takeda/Shire, and Vir/GSK, and he is an associate editor for Transplantation. M.L.L. is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest.
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- 2022
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38. Perceived Susceptibility to Chronic Kidney Disease and Hypertension Self-Management among Black and White Live Kidney Donors.
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Gianaris K, Vargas GB, Johnson M, Yu Y, Wilson E, Perkins JA, Jackson A, Boulware LE, Massie A, Levan ML, Segev DL, and Purnell TS
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- Female, Humans, Male, Middle Aged, Tissue Donors, Hypertension, Kidney Transplantation, Renal Insufficiency, Chronic therapy, Self-Management
- Abstract
Background: Despite the societal benefits of live kidney donation, Black donors may be more likely than White donors to develop hypertension (HTN) and chronic kidney disease after donation. Among live kidney donors diagnosed with post-donation HTN, little is known about potential racial/ethnic differences in HTN self-care behaviors and perceived susceptibility to developing kidney disease., Methods: We ascertained electronic medical records and phone survey data from live donors enrolled in the multi-center Wellness and Health Outcomes of LivE Donors (WHOLE-Donor) Hypertension Care Study between May 2013 and April 2020. Using multivariable logistic regression models performed January through June 2021, we examined potential associations of donor race/ethnicity with perceived susceptibility to kidney disease and self-care behaviors (ie, Behavioral Risk Factor Surveillance System measure assessing self-reported actions to control high blood pressure)., Results: The study included 318 US-based live kidney donors who developed post-donation HTN (57.6% female; 78.9% White; 18.6% Black; and mean age 46.7 years at donation). Black donors were equally as likely as White donors to report being moderately or strongly concerned about developing kidney disease (adjusted odds ratio, aOR: 1.27, 95%CI: .66, 2.14, P=.57). Donors with diabetes were more likely than those without diabetes (aOR: 2.43, 95%CI: 1.03, 5.01, P=.04), while donors aged >50 years were less likely than younger donors (aOR: .39, 95%CI: .18, .85, P=.02) to report being moderately or strongly concerned about kidney disease. Overall, 87% of donors reported taking at least one action to help control blood pressure, with no significant differences by sociodemographic factors., Conclusions: We found no substantial differences in perceived susceptibility to kidney disease among Black and White donors, despite published evidence that Black donors may experience greater risk of developing kidney disease than White donors. Behavioral interventions to enhance knowledge about future disease risk, attitudes, and self-care strategies among living kidney donors may be beneficial., Competing Interests: Competing Interests: None declared., (Copyright © 2022, Ethnicity & Disease, Inc.)
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- 2022
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39. Antibody Response to an mRNA SARS-CoV-2 Vaccine Following Initial Vaccination With Ad.26.COV2.S in Solid Organ Transplant Recipients: A Case Series.
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Chang A, Alejo JL, Abedon AT, Mitchell J, Chiang TP, Boyarsky BJ, Avery RK, Tobian AAR, Levan ML, Warren DS, Massie AB, Garonzik-Wang JM, Segev DL, and Werbel WA
- Subjects
- Adult, Aged, Female, Humans, Male, Middle Aged, RNA, Messenger genetics, SARS-CoV-2 genetics, SARS-CoV-2 isolation & purification, Vaccination adverse effects, Antibody Formation, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, Organ Transplantation adverse effects, Transplant Recipients
- Abstract
Competing Interests: Dr Segev has the following financial disclosures: consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. Dr Avery has study/grant support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, Regeneron, Takeda/Shire, and Vir/GSK, and is an associate editor for Transplantation. Dr Levan is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest.
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- 2022
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40. After 20 Years of Advocacy, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Finally Become Law.
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Levan ML, Reich DJ, and Segev DLL
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- Humans, Immunosuppressive Agents adverse effects, Medicare, United States, Kidney Transplantation adverse effects
- Abstract
Competing Interests: The authors declare no funding or conflicts of interest.
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- 2022
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41. Utilizing Social Media to Identify Potential Living Donors: Learning from US Living Donor Programs.
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Nishio-Lucar AG, Hunt HF, Booker SE, Cartwright LA, Larkin L, Gonzalez SA, Spiers JA, Srinivas T, Ahmad MU, Levan ML, Singh P, Wertin H, McAdams C, Lentine KL, and Schaffer R 3rd
- Abstract
Purpose of Review: Living donor transplantation provides the best possible recipient outcomes in solid organ transplantation. Yet, identifying potential living donors can be a laborious and resource intensive task that heavily relies on the recipient's means and social network. Social media has evolved to become a key tool in helping to bring recipients and potential living donors together given its ease of utilization, widespread access, and improved recipient's comfort with public solicitation. However, in the USA, formal guidelines to direct the use of social media in this context are lacking., Recent Findings: To better inform the landscape and opportunities utilizing social media in living donation, the OPTN Living Donor Committee surveyed US transplant programs to explore programs' experiences and challenges when helping patients use social media to identify potential living donors (September 2019). A large majority of survey participants ( N = 125/174, 72%) indicated that their program provided education to use social media to identify potential living donors and most programs tracking referral source confirmed an increase utilization over time. The use of social media was compounded with program and recipient's challenges including concerns about privacy, inadequate technology access, and knowledge gaps. In this review, we discuss the results of this national survey and recent literature, and provide suggestions to inform program practices and guidance provided to patients wishing to use social media to identify potential living donors., Summary: Transplant programs should become competent in the use of social media for potential living donor identification to empower patients interested in using this tool. Social media education should be provided to all patients regardless of voiced interest and, when appropriate, revisited at multiple time points. Programs should consider developing a "team of experts" that can provide focused education and support to patients embarking in social media living donor campaigns. Care should be taken to avoid exacerbating disparities in access to living donor transplantation. Effective and timely guidance to patients in the use of social media could enhance the identification of potential living donors., Supplementary Information: The online version contains supplementary material available at 10.1007/s40472-022-00382-1., Competing Interests: Conflict of InterestSAB, LAC, and LL are UNOS staff members, and the other authors served as volunteer members of the OPTN/UNOS Living Donor Committee. ST is an employee of CareDx. KLL is a Senior Scientist of the SRTR, receives research funding related to living donation from the National Institutes of Health (R01DK120551), and is also supported by the Mid-America Transplant/Jane A. Beckman Endowed Chair in Transplantation. KLL is chair of the American Society of Transplantation Living Donor Community of Practice, a member of the ASN policy and Advocacy Committee, and a member of the National Kidney Foundation Transplant Advisory Committee. Unrelated to this work, KLL receives consulting fees from CareDx and speaker honoraria from Sanofi., (© The Author(s) 2022.)
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- 2022
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42. Six-month Antibody Kinetics and Durability in SARS-CoV-2 mRNA Vaccinated Solid Organ Transplant Recipients.
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Alejo JL, Mitchell J, Chiang TP, Abedon AT, Sidoti CN, Boyarsky BJ, Avery RK, Tobian AAR, Levan ML, Warren DS, Massie AB, Garonzik-Wang JM, Segev DL, and Werbel WA
- Subjects
- Humans, Kinetics, Vaccines, Synthetic immunology, mRNA Vaccines immunology, Antibodies, Viral blood, COVID-19 prevention & control, COVID-19 Vaccines immunology, Organ Transplantation
- Abstract
Competing Interests: D.L.S. received consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. M.L.L. is the Social Media Editor for Transplantation. R.K.A. has grant/research support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, and Takeda/Shire. The other authors declare no conflicts of interest.
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- 2022
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43. Patients Can Make Policy Narratives for Organ Donation and Transplantation.
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Levan ML
- Subjects
- Humans, Policy, Narration, Tissue and Organ Procurement, Organ Transplantation
- Abstract
This commentary discusses 13 unique stories by patients who have received an organ transplant. Their stories are diverse and capture the essence of the highs and lows on the journey to needing, receiving, and living with an organ transplant. The stories speak to immeasurable gratitude, and all provide insight into how we might support more fair and equitable organ transplant system policies in the US and abroad. This commentary suggests that a narrative policy framework in organ transplantation can have a positive influence as we formulate, adopt, and implement transplant policy.
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- 2022
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44. Antibody Response to a Fourth Dose of a SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series.
- Author
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Alejo JL, Mitchell J, Chiang TP, Abedon AT, Boyarsky BJ, Avery RK, Tobian AAR, Levan ML, Massie AB, Garonzik-Wang JM, Segev DL, and Werbel WA
- Subjects
- Humans, Organ Transplantation, Antibody Formation, COVID-19 prevention & control, COVID-19 Vaccines immunology, Transplant Recipients
- Abstract
Competing Interests: D.L.S. has received consulting and speaking honoraria from Sanofi, Novartis, CLS Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. M.L.L. is the Social Media Editor for Transplantation. The other authors declare no conflicts of interest. J.L.A., J.M., T.P.-Y.C., A.T.A., B.J.B., R.K.A., A.A.R.T., M.L.L., A.B.M., J.M.G.-W., D.L.S., and W.A.W. participated in conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; drafting the work of revising it critically for important intellectual content; gave the final approval of the version to be published; and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
- Published
- 2021
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- View/download PDF
45. Outcomes of living liver donor candidate evaluations in the Living Donor Collective pilot registry.
- Author
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Kasiske BL, Ahn YS, Conboy M, Dew MA, Folken C, Levan ML, Humar A, Israni AK, Rudow DL, Trotter JF, Massie AB, and Musgrove D
- Subjects
- Female, Humans, Liver, Registries, SARS-CoV-2, COVID-19, Living Donors
- Abstract
Background: To gather information on long-term outcomes after living donation, the Scientific Registry of Transplant Recipients (SRTR) conducted a pilot on the feasibility of establishing a comprehensive donor candidate registry., Methods: A convenience sample of 6 US living liver donor programs evaluated 398 consecutive donor candidates in 2018, ending with the March 12, 2020, COVID-19 emergency., Results: For 333/398 (83.7%), the donor or program decided whether to donate; 166/333 (49.8%) were approved, and 167/333 (50.2%) were not or opted out. Approval rates varied by program, from 27.0% to 63.3% (median, 46%; intraquartile range, 37.3-51.1%). Of those approved, 90.4% were white, 57.2% were women, 83.1% were < 50 years, and 85.5% had more than a high school education. Of 167 candidates, 131 (78.4%) were not approved or opted out because of: medical risk (10.7%); chronic liver disease risk (11.5%); psychosocial reasons (5.3%); candidate declined (6.1%); anatomical reasons increasing recipient risk (26.0%); recipient-related reasons (33.6%); finances (1.5%); or other (5.3%)., Conclusions: A comprehensive national registry is feasible and necessary to better understand candidate selection and long-term outcomes. As a result, the US Health Resources and Services Administration asked SRTR to expand the pilot to include all US living donor programs., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
- Published
- 2021
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46. Long-term kidney function and survival in recipients of allografts from living kidney donors with hypertension: a national cohort study.
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Al Ammary F, Yu S, Muzaale AD, Segev DL, Liyanage L, Crews DC, Brennan DC, El-Meanawy A, Alqahtani S, Atta MG, Levan ML, Caffo BS, Welling PA, and Massie AB
- Subjects
- Allografts, Cohort Studies, Graft Survival, Humans, Kidney, Living Donors, Middle Aged, Retrospective Studies, Tissue Donors, Treatment Outcome, Hypertension, Kidney Transplantation adverse effects
- Abstract
Allografts from living kidney donors with hypertension may carry subclinical kidney disease from the donor to the recipient and, thus, lead to adverse recipient outcomes. We examined eGFR trajectories and all-cause allograft failure in recipients from donors with versus without hypertension, using mixed-linear and Cox regression models stratified by donor age. We studied a US cohort from 1/1/2005 to 6/30/2017; 49 990 recipients of allografts from younger (<50 years old) donors including 597 with donor hypertension and 21 130 recipients of allografts from older (≥50 years old) donors including 1441 with donor hypertension. Donor hypertension was defined as documented predonation use of antihypertensive therapy. Among recipients from younger donors with versus without hypertension, the annual eGFR decline was -1.03 versus -0.53 ml/min/m
2 (P = 0.002); 13-year allograft survival was 49.7% vs. 59.0% (adjusted allograft failure hazard ratio [aHR] 1.23; 95% CI 1.05-1.43; P = 0.009). Among recipients from older donors with versus without hypertension, the annual eGFR decline was -0.67 versus -0.66 ml/min/m2 (P = 0.9); 13-year allograft survival was 48.6% versus 52.6% (aHR 1.05; 95% CI 0.94-1.17; P = 0.4). In secondary analyses, our inferences remained similar for risk of death-censored allograft failure and mortality. Hypertension in younger, but not older, living kidney donors is associated with worse recipient outcomes., (© 2021 The Authors. Transplant International published by John Wiley & Sons Ltd on behalf of Steunstichting ESOT.)- Published
- 2021
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47. Science Over Stigma: Lessons and Future Direction of HIV-to-HIV Transplantation.
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Klitenic SB, Levan ML, Van Pilsum Rasmussen SE, and Durand CM
- Abstract
Purpose of Review: The HIV Organ Policy Equity (HOPE) Act permits transplantation from donors-with-HIV to recipients-with-HIV (HIV D + /R +). We assess HOPE implementation, summarizing progress and challenges at clinical, legislative, and community levels., Recent Findings: As of July 2021, there have been 300 kidney and 87 liver transplants within HOPE research studies in the USA. Early HIV D + /R + kidney transplant outcomes show excellent patient survival (100%) and graft survival (92%). The number of HOPE donors continues to grow annually but remains lower than projections. State-level policy restrictions are identified in 34 states; however, these do not seem to have impacted practice; 16 states have passed new legislation to facilitate HIV D + /R + transplantation. Stigma related to HIV and low donor registration rates pose additional barriers., Summary: Early outcomes of HOPE Act transplants are encouraging. Progress to reach full implementation and realize the full benefit of this innovation is ongoing., (© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2021.)
- Published
- 2021
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48. Financial incentives versus standard of care to improve patient compliance with live kidney donor follow-up: protocol for a multi-center, parallel-group randomized controlled trial.
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Levan ML, Waldram MM, DiBrito SR, Thomas AG, Al Ammary F, Ottman S, Bannon J, Brennan DC, Massie AB, Scalea J, Barth RN, Segev DL, and Garonzik-Wang JM
- Subjects
- Adult, Humans, Baltimore, Follow-Up Studies, Postoperative Complications diagnosis, Standard of Care, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Aftercare economics, Kidney Transplantation, Living Donors, Motivation, Patient Compliance
- Abstract
Background: Live kidney donors (LKDs) account for nearly a third of kidney transplants in the United States. While donor nephrectomy poses minimal post-surgical risk, LKDs face an elevated adjusted risk of developing chronic diseases such as hypertension, diabetes, and end-stage renal disease. Routine screening presents an opportunity for the early detection and management of chronic conditions. Transplant hospital reporting requirements mandate the submission of laboratory and clinical data at 6-months, 1-year, and 2-years after kidney donation, but less than 50% of hospitals are able to comply. Strategies to increase patient engagement in follow-up efforts while minimizing administrative burden are needed. We seek to evaluate the effectiveness of using small financial incentives to promote patient compliance with LKD follow-up., Methods/design: We are conducting a two-arm randomized controlled trial (RCT) of patients who undergo live donor nephrectomy at The Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) and the University of Maryland Medical Center Transplant Center (MDUM). Eligible donors will be recruited in-person at their first post-surgical clinic visit or over the phone. We will use block randomization to assign LKDs to the intervention ($25 gift card at each follow-up visit) or control arm (current standard of care). Follow-up compliance will be tracked over time. The primary outcome will be complete (all components addressed) and timely (60 days before or after expected visit date), submission of LKD follow-up data at required 6-month, 1-year, and 2-year time points. The secondary outcome will be transplant hospital-level compliance with federal reporting requirements at each visit. Rates will be compared between the two arms following the intention-to-treat principle., Discussion: Small financial incentivization might increase patient compliance in the context of LKD follow-up, without placing undue administrative burden on transplant providers. The findings of this RCT will inform potential center- and national-level initiatives to provide all LKDs with small financial incentives to promote engagement with post-donation monitoring efforts., Trial Registration: ClinicalTrials.gov number: NCT03090646 Date of registration: March 2, 2017 Sponsors: Johns Hopkins University, University of Maryland Medical Center Funding: The Living Legacy Foundation of Maryland.
- Published
- 2020
- Full Text
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