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Effectiveness of a Mobile Health System on Compliance With 2-Year Living Kidney Donor Follow-Up in the United States
Thomas, Alvin G; Hussain, Sarah; Klitenic, Samantha B; Sidoti, Carolyn N; Waldram, Madeleine M; Chang, Amy; Motter, Jennifer D; Terlizzi, Kelly; Massie, Allan B; Schofield, Mary; Barstow, Karol; Bingaman, Adam; Segev, Dorry L; Levan, Macey L
BACKGROUND:Organ Procurement and Transplantation Network (OPTN) policy requires 2 years of follow-up for living kidney donors (LKDs); however, many transplant hospitals struggle to meet this requirement. We developed and tested a mobile health (mHealth) system for LKD follow-up in a pilot randomized-controlled trial (RCT). METHODS:LKDs were randomly assigned to either the intervention (mHealth + standard of care) or control arm (standard of care). We assessed OPTN policy-defined completeness and timeliness of 6-month, 1-year, and 2-year follow-ups. Four hundred LKDs were enrolled in the study (June 2018 to February 2021). RESULTS:At 6-month follow-up, a higher proportion of the intervention arm participants completed composite visits (97.5% vs. 91.5%, p = 0.01). Both arms had similar compliance rates at 1- and 2-year follow-up (92.0% vs. 89.5%, p = 0.49, and 66.5% vs. 65.0%, p = 0.83). Intervention arm participants completed 6-month follow-up 11 days earlier than their counterparts (p = 0.009). CONCLUSION/CONCLUSIONS:mHealth technologies improved 6-month follow-up, but did not impact 1- and 2-year LKD follow-up in this single-center RCT. Other strategies, such as providing services beyond data collection, may be necessary to improve donor engagement and support LDK's long-term follow-up.
PMID: 40145946
ISSN: 1399-0012
CID: 5816602
Association of Functional, Academic, Motor, and Cognitive Deficits in Graft Failure in Pediatric Liver Transplantation
Donnelly, Conor; Patel, Suhani S; Jaffe, Ian S; Akizhanov, Daniyar; Chiang, Teresa Po-Yu; Long, Jane J; Liyanage, Luckmini; Griesemer, Adam; Segev, Dorry L; Massie, Allan B
INTRODUCTION/BACKGROUND:Predicting graft failure risk in pediatric liver transplantation (LT) recipients could identify areas for improving management. Persistent cognitive, motor, academic, and functional deficits are common in recipients and their impact on graft survival following LT helps inform risk prediction. METHODS:Using SRTR data 2008-2023, we evaluated the cognitive, motor, academic, and functional deficits of LT recipients at time of transplant to 14 years post-LT. We compared all cause graft failure (ACGF) among patients with versus without pre-LT and 1-year post-LT deficits using Cox regression, adjusting for recipient characteristics. We calculated an individual risk score for ACGF. RESULTS:In 8062 pediatric LT recipients median age 3 (IQR: 1, 10), 28.0%, 29.5%, 35.0%, and 79.8% of recipients had pre-LT deficits in cognition, motor, academic activity, and functional status respectively. This decreased to 23.0%, 18.1%, 14.2%, and 38.7% 1-year post-LT. Increased hazard of ACGF was noted in recipients with pre-LT decreased functional status (aHR = 1.13 (per 10% decrease), 95% CI: 1.10-1.15, p < 0.001), definite motor delay (aHR = 1.60, 95% CI: 1.21-2.10, p < 0.001), and inability to participate in academics (aHR = 1.49, 95% CI: 1.08-1.89, p = 0.01), but not delays in cognition (aHR = 0.91, 95% CI: 0.69-1.21, p = 0.19). Our risk score predicting ACGF demonstrated improved predictive performance compared to clinical parameters alone (C-statistic = 0.70 (0.67, 0.72) vs. 0.66 (0.64, 0.69), p < 0.001). CONCLUSIONS:Pediatric LT recipients with pre- or post-LT motor, academic, and functional deficits are at higher risk for ACGF. Care should be taken to assess deficits to identify patients who may benefit from functional intervention to potentially reduce ACGF risk.
PMID: 40152814
ISSN: 1399-0012
CID: 5817472
Landscape of US Waitlist Registrants who Received Transplantation Abroad
Terlizzi, Kelly; Jaffe, Ian S; Bisen, Shivani S; Lonze, Bonnie E; Orandi, Babak J; Levan, Macey L; Segev, Dorry L; Massie, Allan B
BACKGROUND:Transplant waitlist registrants in the United States may be delisted because of receipt of a transplant abroad. Although not universally unethical, "travel for transplantation" poses risks to posttransplant care. To better understand this phenomenon, this study identifies temporal trends, geographic patterns, and demographic factors associated with cross-border transplantation. METHODS:Using Scientific Registry of Transplant Recipients data, we identified 818 US waitlist candidates who were removed because of transplantation abroad between 2010 and 2023. We described recipient characteristics overall, by organ, and by top transplant destinations. We used a Cox regression framework to identify characteristics associated with waitlist removal due to transplantation abroad. RESULTS:Transplants abroad averaged 58.4 per year. Incidence peaked at 80 transplants in 2017, with an upward trend after 2021. Kidney transplants made up 92.1% of cases. The most common destinations were the Philippines (19.8%), India (16.5%), Mexico (9.4%), China (8.4%), and Iran (4.4%). India and Mexico experienced the smallest drop-off during the height of the COVID-19 pandemic 2020-2021. Most recipients were US citizens (65.0%) or residents (23.5%). Female (adjusted hazard ratio [aHR], 0.520.610.71; P < 0.001) and Black candidates (aHR, 0.120.180.26; P < 0.001) were less likely to travel abroad compared with Asian candidates (aHR, 5.927.108.52; P < 0.001). Nonresidents (aHR, 6.708.6911.26; P < 0.001) and, among registrations in 2012 or later, nonresidents who traveled to the United States for transplantation (aHR, 27.2738.9155.50; P < 0.001) had a greater chance of undergoing transplantation abroad. CONCLUSIONS:Understanding patterns of international travel for transplantation is key not only for preventing resource drains from destination countries but also for providing adequate posttransplant care for recipients.
PMCID:12262169
PMID: 40653618
ISSN: 1534-6080
CID: 5896832
Bariatric surgery vs. GLP-1 receptor agonists among primarily medicare and medicaid patients with diabetes: a 3-year analysis
Brown, Avery; Patel, Suhani S; Li, Elizabeth; Vu, Alexander Hien; Somoza, Eduardo; Chen, Jialin; Zhang, Donglan; Massie, Allan B; Orandi, Babak J; Segev, Dorry; Parikh, Manish; Chhabra, Karan
BACKGROUND:Bariatric surgery has long been established as an effective treatment option for obesity and diabetes [Kalainov et al. in J Am Acad Orthop Surg [32(10):427-438, 2025] and Ogden et al. in JAMA 311(8):806-806, 2025. 10.1001/jama.2014.732]. Recently, GLP-1 Receptor Agonists' (GLP-1RAs) use has expanded as an alternative therapy for weight loss and diabetes management. While GLP1RAs are known to be safe and effective, few have compared long term outcomes of GLP-1RAs versus the "gold standard" of bariatric surgery among Medicare/Medicaid patients, who make up the largest payer group in the U.S. [Kalainov et al. in J Am Acad Orthop Surg [32(10):427-438, 2025]. METHODS:This was a retrospective, multicenter study of obese, type-2 diabetic patients (T2D) ≥ 18 years old, who initiated weekly injectable semaglutide or tirzepatide or underwent bariatric surgery between January 1st, 2018 to July 31st, 2024. Patients with a baseline BMI ≤ 35, those with prior GLP1-RA use, or any prior bariatric procedure were excluded from analysis. The primary outcome of interest was % total body weight loss 3 months to 3 years post intervention among bariatrics surgery patients vs. GLP1-RA patients (any GLP1-RA prescription and 12 months continuous GLP1-RA prescription). RESULTS:7667 patients were included for analysis (7200 GLP1-RA, 467 bariatric surgery). Bariatric surgery patients were younger (median (IQR): 43 (34, 53) vs. 65 (54, 72); p < 0.001) and more likely to be female (67.5% vs. 60.8%; p < 0.01) and Hispanic (58.7% vs. 19.4%; p < 0.001) while GLP1-RA users were more likely to be white (58.5% vs. 10.7%; p < 0.001). In models adjusting for demographic and clinical characteristics, bariatric surgery was associated with a 22.9% total weight loss 3 years following surgery compared to 2.3% for patients with any GLP1-RA use, and 15.9% vs 2.4% for patients with 12 months consecutive GLP1-RA use (22.9 [21.0-24.8] vs 2.3 [0.5-4.1], 15.9 [6.9-24.9] vs. 2.4 [6.7-11.5]. CONCLUSIONS:Among obese, T2D, publicly insured patients, bariatric surgery was associated with greater weight loss than GLP1-RAs at all measured periods from 3 months to 3 years post op.
PMID: 41326727
ISSN: 1432-2218
CID: 5974752
A Two-Center Randomized Controlled Trial to Assess Financial Incentives for Compliance With Living Kidney Donor Follow-Up in the United States
Bisen, Shivani S; Ishaque, Tanveen; Thomas, Alvin G; Waldram, Madeleine M; Warren, Daniel S; Bannon, Jaclyn; Scalea, Joseph R; Segev, Dorry L; Garonzik-Wang, Jacqueline M; Massie, Allan B; Levan, Macey L
INTRODUCTION/BACKGROUND:The United States Organ Procurement and Transplantation Network mandates collection of 6-month, 1-year, and 2-year post-donation follow-up data on living kidney donors (LKDs), but many centers struggle to meet these requirements. This study investigated whether providing a financial incentive (mailed gift card) could increase patient compliance with LKD follow-up. METHODS:A parallel, non-blinded, 1:1 superiority randomized control trial of LKDs was conducted at two centers from March 2017 to February 2021. The control arm received standard of care (SOC): instructions to complete the mandated LKD follow-up consisting of a health questionnaire and laboratory measurements at 6 months, 1 year, and 2 years post-donation. The intervention arm received SOC and was mailed a $25 gift card for each timely completed follow-up. Compliance rates were compared at each timepoint using Poisson regression. RESULTS:at 2 years). Similarly, no differences were observed in compliance with clinical follow-up, laboratory follow-up, or individual questions or lab values. CONCLUSION/CONCLUSIONS:Mailed gift cards did not improve patient compliance with LKD follow-up requirements; such interventions may be counterproductive among LKDs. Further research is needed to investigate and address barriers to completing LKD follow-up. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov identifier: NCT03090646.
PMID: 41395879
ISSN: 1399-0012
CID: 5979082
Outcomes After Bariatric Surgery in Older Adults With Obesity and End-Stage Kidney Disease
Ishaque, Tanveen; Massie, Allan B; Stewart, Darren; Li, Yiting; Chen, Yusi; Menon, Gayathri; Ghildayal, Nidhi; Montgomery, John R; Seckin, Timur; Chhabra, Karan R; Jenkins, Megan E; Ren-Fielding, Christine J; McAdams-DeMarco, Mara A; Segev, Dorry L; Orandi, Babak J
OBJECTIVE:Given frailty and comorbidities that occur with both aging and end-stage kidney disease (ESKD), it is unclear if older patients with ESKD derive the improved survival and kidney transplant (KT) access associated with Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). METHODS:Using 2006-2021 USRDS data, we identified 876 patients with RYGB and 1508 patients with SG and compared 5-year mortality by age-group (18-29/30-39/40-49/50-59/60-69/≥ 70 years) to nonsurgical matched controls using 1:3 Mahalanobis distance matching, Kaplan-Meier, and Cox regression. We also compared age-stratified KT incidence between waitlisted patients and controls. RESULTS:) for patients with SG versus controls. CONCLUSIONS:RYGB in older patients with ESKD is associated with increased mortality and lower KT likelihood, whereas SG is associated with decreased mortality and higher KT likelihood compared to nonsurgical matched controls. Choice of bariatric surgery type may play a role in improving survival for older patients with ESKD.
PMCID:12643172
PMID: 41266080
ISSN: 1432-2323
CID: 5976062
Environmental and social injustices impact dementia risk among older adults with end-stage kidney disease: a national registry study
Li, Yiting; Menon, Gayathri; Long, Jane J; Wilson, Malika; Kim, Byoungjun; Bae, Sunjae; DeMarco, Mario P; Wu, Wenbo; Orandi, Babak J; Gordon, Terry; Thurston, George D; Purnell, Tanjala S; Thorpe, Roland J; Szanton, Sarah L; Segev, Dorry L; McAdams-DeMarco, Mara A
BACKGROUND/UNASSIGNED:; environmental injustice) by racial/ethnic segregation (social injustice) on dementia diagnosis in ESKD. METHODS/UNASSIGNED:concentrations (annualized and matched to older adults' residential ZIP code at dialysis initiation) and by segregation scores (Theil's H method). FINDINGS/UNASSIGNED:and segregation. INTERPRETATION/UNASSIGNED:experienced an increased risk of dementia; this risk was particularly pronounced among individuals in high segregation and predominantly minority neighborhoods. Environmental and social injustices likely drive racial and ethnic disparities in dementia for older adults with ESKD, underscoring the need for interventions and policies to mitigate these injustices. FUNDING/UNASSIGNED:National Institutes of Health.
PMCID:12550583
PMID: 41141567
ISSN: 2667-193x
CID: 5960892
Physiology and immunology of pig-to-human decedent kidney xenotransplant
Montgomery, Robert A; Stern, Jeffrey M; Fathi, Farshid; Suek, Nathan; Kim, Jacqueline I; Khalil, Karen; Vermette, Benjamin; Tatapudi, Vasishta S; Mattoo, Aprajita; Skolnik, Edward Y; Jaffe, Ian S; Aljabban, Imad; Eitan, Tal; Bisen, Shivani; Weldon, Elaina P; Goutaudier, Valentin; Morgand, Erwan; Mezine, Fariza; Giarraputo, Alessia; Boudhabhay, Idris; Bruneval, Patrick; Sannier, Aurelie; Breen, Kevin; Saad, Yasmeen S; Muntnich, Constanza Bay; Williams, Simon H; Zhang, Weimin; Kagermazova, Larisa; Schmauch, Eloi; Goparaju, Chandra; Dieter, Rebecca; Lawson, Nikki; Dandro, Amy; Fazio-Kroll, Ana Laura; Burdorf, Lars; Ayares, David; Lorber, Marc; Segev, Dorry; Ali, Nicole; Goldfarb, David S; Costa, Victoria; Hilbert, Timothy; Mehta, Sapna A; Herati, Ramin S; Pass, Harvey I; Wu, Ming; Boeke, Jef D; Keating, Brendan; Mangiola, Massimo; Sommer, Philip M; Loupy, Alexandre; Griesemer, Adam; Sykes, Megan
Xenotransplantation of genetically-modified pig kidneys offers a solution to the scarcity of organs for end-stage renal disease patients.1 We performed a 61-day alpha-Gal knock-out pig kidney and thymic autograft transplant into a nephrectomized brain-dead human using clinically approved immunosuppression, without CD40 blockade or additional genetic modification. Hemodynamic and electrolyte stability and dialysis independence were achieved. Post-operative day (POD) 10 biopsies revealed glomerular IgM and IgA deposition, activation of early complement components and mesangiolysis with stable renal function without proteinuria, a phenotype not seen in allotransplantation. On POD 33, an abrupt increase in serum creatinine was associated with antibody-mediated rejection and increased donor-specific IgG. Plasma exchange, C3/C3b inhibition and rabbit anti-thymocyte globulin (rATG), completely reversed xenograft rejection. Pre-existing donor-reactive T cell clones expanded progressively in the circulation post-transplant, acquired an effector transcriptional profile and were detected in the POD 33 rejecting xenograft prior to rATG treatment. This study provides the first long-term physiologic, immunologic, and infectious disease monitoring of a pig-to-human kidney xenotransplant and indicates that pre-existing xenoreactive T cells and induced antibodies to unknown epitope(s) present a major challenge, despite significant immunosuppression. It also demonstrates that a minimally gene-edited pig kidney can support long-term life-sustaining physiologic functions in a human.
PMID: 41233546
ISSN: 1476-4687
CID: 5967072
Risk for Scrotal Surgery After Laparoscopic Donor Nephrectomy : A Population-Based Cohort Study
Garg, Amit X; McArthur, Eric; Sontrop, Jessica M; Boudville, Neil; Connaughton, Dervla M; Cuerden, Meaghan S; Feldman, Liane S; Lam, Ngan N; Lentine, Krista L; Nguan, Christopher; Parikh, Chirag R; Segev, Dorry L; Sener, Alp; Smith, Graham; Wang, Carol; Weir, Matthew A; Yohanna, Seychelle; Young, Ann; Naylor, Kyla L
BACKGROUND/UNASSIGNED:A potential long-term complication of living kidney donation in male donors is scrotal swelling on the same side as the nephrectomy, and some undergo surgery to relieve discomfort from the fluid collection. The long-term risk for this outcome attributable to donation is unknown. OBJECTIVE/UNASSIGNED:To evaluate long-term scrotal surgery rates after laparoscopic nephrectomy in male living kidney donors compared with nondonors. DESIGN/UNASSIGNED:Population-based cohort study (2002 to 2024). (ClinicalTrials.gov: NCT06716723). SETTING/UNASSIGNED:Linked administrative health care databases in Ontario, Canada. PARTICIPANTS/UNASSIGNED:898 male living kidney donors who had a laparoscopic nephrectomy were matched in a 1:10 ratio with 8980 male nondonors from the general population. The matching characteristics were age, date of cohort entry, rural residence, income, prior vasectomy, and prior inguinal hernia repair. Participants were followed for a median of 9 years, up to 22 years. MEASUREMENTS/UNASSIGNED:The primary outcome was hospitalization for surgery to address a unilateral scrotal fluid collection. RESULTS/UNASSIGNED:< 0.001). The median time from donation to scrotal surgery was 5.2 years (IQR, 3.3 to 8.4 years); more than 90% of the surgeries were hydrocelectomies and were performed under general anesthesia. Over 20 years, the cumulative incidence was 13.8% in donors versus 0.7% in nondonors. LIMITATION/UNASSIGNED:The precise causal mechanism remains unknown. CONCLUSION/UNASSIGNED:Laparoscopic nephrectomy is associated with a higher risk for subsequent scrotal surgery in male living kidney donors. PRIMARY FUNDING SOURCE/UNASSIGNED:Canadian Institutes of Health Research.
PMID: 41213151
ISSN: 1539-3704
CID: 5966532
The Rapidly Shifting Calibration between KDRI, KDPI, and Graft Survival: Is it Time to Stop Moving the Goalposts?
Po-Yu Chiang, Teresa; Patel, Shreeja; Bradbrook, Keighly; Booker, Sarah; Ali, Nicole; Orandi, Babak J; Massie, Allan B; Segev, Dorry L; Lonze, Bonnie E; Stewart, Darren E
We sought to understand the potential impacts of a rapidly evolving donor pool on the annual recalibration of the kidney donor profile index (KDPI). Using OPTN data, we examined the kidney donor risk index (KDRI) among deceased kidney donors recovered 2011-2024. We mimicked the OPTN's annual re-mapping process to measure the KDRI-to-KDPI calibration drift and used Cox regression to translate this drift into all-cause graft failure rate differences. The 50th/75th/95th KDRI percentile among recovered donors rose from 1.19/1.47/2.0 in 2011 to 1.40/1.77/2.36 in 2024. For donors with the same KDRI, the KDPI assigned in 2024 was as much as 13 points lower than the KDPI assigned in 2012. Holding other factors constant, the KDRI-KDPI calibration shift equated to 7 years of increased age (65 vs. 58) for KDPI 86% donors. Five-year graft failure risk was 9% higher (RR: 1.0871.0931.097) for a kidney assigned a KDPI of 86% in 2024 versus 2012. Organ recovery practices have changed. The relationship between KDPI and organ quality has become a moving target, complicating shared decision-making and altering the meaning of allocation policy thresholds. Alternative solutions to annually remapping KDPI, such as establishing a fixed reference cohort or migrating away from KDPI, could be considered.
PMID: 41183750
ISSN: 1600-6143
CID: 5959532