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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
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
The limits of generalizing from six OPOs: Response [Letter]
Levan, Macey L; Segev, Dorry L; Massie, Allan B
PMID: 40602462
ISSN: 1600-6143
CID: 5888082
Consequences of Patient Denial at First Exemption Request for Cardiac Transplantation [Letter]
Alam, A; Golob, S; Patel, S; Fatma, N; Segev, D; Massie, A; Moussa, M; Flattery, E; Phillips, K; Wayda, B; Katz, J N; Stewart, D; Gentry, S; Goldberg, R I; Rao, S; Reyentovich, A; Moazami, N
PMID: 40691956
ISSN: 1557-3117
CID: 5901342
The early impacts of an attempt to standardize kidney procurement biopsy practices
Po-Yu Chiang, Teresa; Jaffe, Ian S; Zeiser, Laura B; Lonze, Bonnie E; Segev, Dorry L; Massie, Allan B; Stewart, Darren E
Procurement biopsies are routinely obtained in the United States to evaluate kidneys considered for transplantation, but some argue that they may contribute to kidney nonutilization. Historically, biopsy decisions have been left solely to the discretion of organ procurement organizations (OPOs) and transplant centers. In September 2022, an organ procurement and transplantation network (OPTN) policy designating donors meeting specific clinical criteria as "biopsy-required" went into effect. Using OPTN data from 1 year before and after policy implementation, we used causal inference methods to estimate the policy's impacts on biopsy practices and kidney utilization. The overall biopsy rate remained stable at 62%, rising from 90.6% to 95.8% (P < .001) among biopsy-required kidneys while falling from 49.1% to 43.4% (P < .001) among biopsy-optional kidneys. After adjusting for changing donor characteristics, the policy was associated with a 5% decline in the biopsy rate (adjusted risk ratio = 0.95; P = .007). The overall kidney nonuse rate rose from 27.2% to 28.7%. After accounting for changes in donor characteristics, the policy was not associated with elevated nonuse (adjusted risk ratio = 0.96, P = .06). Although most OPOs are now biopsying nearly all required kidneys, practices still vary widely regarding biopsy-optional kidneys. No correlation was found between OPO-level changes in adjusted biopsy and nonuse rates (ρ = 0.05, P = .70). The OPTN policy has partially standardized biopsy practices without harming kidney utilization.
PMCID:12259276
PMID: 40545004
ISSN: 1600-6143
CID: 5906232
Potential Pool of Cardiothoracic Organs from Donors with HIV
Bowring, Mary G; Ruck, Jessica M; Nauroz, Zeba; Saeed, Omar; Farr, Maryjane; Hall, Shelley; Hashmi, Zubair; Aslam, Saima; Habal, Marlena; Tobian, Aaron A R; Massie, Allan B; Hemmige, Vagish; Segev, Dorry L; Durand, Christine M
BACKGROUND:Under the HOPE Act, transplants from donors with HIV to recipients with HIV (HIV D+/R+) have been largely limited to kidney and liver. However, recent modifications to HOPE research guidelines allow broader participation of cardiothoracic programs. METHODS:To quantify potential cardiothoracic HOPE donors, we used SRTR data (3/2016-12/2024) to identify 101,200 donors without HIV and 273 HOPE donors (with true and false positive HIV tests). Using logistic regression, we predicted the probability of having a heart or lung(s) used for transplant among donors without HIV that had a kidney or liver used. We then applied model parameters to HOPE donors that had a kidney or liver used to estimate the number of HOPE donors that might have been cardiothoracic donors if the practice were expanded. RESULTS:Among donors without HIV, cardiothoracic donation was associated with age, cause of death, hepatitis C, hypertension, diabetes, smoking, cardiovascular disease, blood gas, and circulatory death. Applying our model, an estimated 41.0% (N=111), 18.7% (N=51), and 15.2% (N=41) of HOPE donors were potential heart, any lung (single or double), or double-lung donors, as compared to 32.3%, 21.8%, and 18.2% of abdominal organ donors without HIV, respectively. This translated to an annual 13-18 potential heart and 5-8 potential lung transplants (of which 4-6 would be double-lung transplants) from HOPE donors. CONCLUSIONS:If HIV D+/R+ is more widely expanded to cardiothoracic transplantation, 41% of HOPE kidney and liver donors have potential to donate a heart and almost 20% to donate a lung to candidates with HIV.
PMID: 41115672
ISSN: 1557-3117
CID: 5956682
Beyond Theory and Into Practice: A Qualitative Study of the Experiences of Xenotransplant Recipients
Levan, Macey L; Ahuja, Harsimar Kaur; Reed, Rhiannon D; Locke, Jayme; Sidoti, Carolyn N; Looney, Towana; Andrews, Timothy; Stewart, William; Segev, Dorry; Weldon, Elaina; Parent, Brendan; Stern, Jeffery; Khalil, Karen; Griesemer, Adam; Aprajita Mattoo,; Massie, Allan B; Tapapudi, Vasishta; Kawai, Tatsuo; Montgomery, Robert A; Riella, Leonardo; Williams, Winfred W
With U.S. Food and Drug Administration (FDA) clearance of clinical trials of kidney xenotransplantation (XTx) in living humans, understanding the recipient experience is critical. Semi-structured interviews with the three living XTx recipients identified core domains of the recipient experience, including quality of life (QoL), fears about XTx, and healthcare team communication and support. Transcribed interviews were analyzed by two qualitative researchers using an inductive thematic approach and were mapped onto the Warwick Patient Experience Model, a validated framework to assess key aspects of patient satisfaction with the healthcare experience. All three recipients (53-year-old female; 66-year-old male; 54-year old male) described a restoration of hope, contrasted with their poor quality of life on dialysis. They emphasized that access to XTx and graft survival requires mutual confidence and commitment between recipients and healthcare teams. XTx recipients use dialysis as a point of reference when describing changes in their post-transplant QoL and seemed well-situated to handle the possibility of graft failure. These insights may aid in the creation of decision aids and educational materials tailored to the specific needs of XTx recipients.
PMID: 41101596
ISSN: 1600-6143
CID: 5955132
Association of Payment Model Changes With the Rate of Total Joint Arthroplasty in Patients Undergoing Kidney Replacement Therapy
Motter, Jennifer D; Bae, Sunjae; Paredes-Barbeito, Amanda; Chen, Antonia F; McAdams-DeMarco, Mara; Segev, Dorry L; Massie, Allan B; Humbyrd, Casey Jo
BACKGROUND:To encourage high-quality, reduced-cost care for total joint arthroplasty (TJA), the Centers of Medicare & Medicaid Services mandated a pay-for-performance model, the Comprehensive Care for Joint Replacement (CJR), as part of the Patient Protection and Affordable Care Act (PPACA). The CJR incentivizes cost containment, and it was anticipated that its implementation would reduce access to TJA for high-cost populations. Patients with end-stage kidney disease (ESKD) undergoing kidney replacement therapy (dialysis and kidney transplant) are costly compared with healthier patients, but it was unknown whether this population lost access to hip and knee replacement because of CJR implementation. This population allows study of whether TJA is accessible for medically complex patients whose risk of surgical complications has been mitigated, as kidney transplantation improves outcomes compared with dialysis, allowing evaluation as to whether access improved when patients crossed over from dialysis to transplantation. Because all patients with ESKD are included in a mandated national registry, we can quantify whether access changed for patients who underwent dialysis and transplantation. QUESTIONS/PURPOSES/OBJECTIVE:(1) How did the rate of TJA change amid the shift to bundled payments for patients with ESKD receiving dialysis? (2) How did the rate of TJA change amid the shift to bundled payments for patients with ESKD after kidney transplant? METHODS:This was an observational cohort study from 2008 to 2018 using the United States Renal Data System, a mandatory national registry that allows for the opportunity to study all individuals with ESKD. During the study period, we identified 1,324,614 adults undergoing routine dialysis and 187,212 adult kidney transplant recipients; after exclusion for non-Medicare primary insurance (n = 785,224 for dialysis and 78,011 for transplant), patients who were 100 years or older (n = 79 and 0, respectively), those who resided outside of 50 US states and Puerto Rico (n = 781 and 87, respectively), missing dialysis status for the dialysis cohort (n = 8658), and multiorgan transplant recipients for the transplant cohort (n = 2442), our study population was 40% (529,872) of patients who underwent routine dialysis and 57% (106,672) of adult kidney transplant recipients, respectively. TJA was ascertained using Medicare Severity Diagnosis Related Groups and ICD-9 and ICD-10 codes. We divided the study period by PPACA (January 1, 2014, to March 31, 2016) and CJR (April 1, 2016, to December 31, 2018) implementation and compared the incidence of TJA by era using mixed-effects Poisson regression adjusting for calendar time and clinical and demographic variables. RESULTS:After adjustment for linear temporal trend and patient case mix, there was no evidence of association between policy implementation and the incidence of TJA. In the dialysis cohort, the adjusted incidence rate ratio (IRR) for TJA was 1.06 (95% confidence interval [CI] 0.98 to 1.14; p = 0.2) comparing PPACA with the previous period and 1.02 (95% CI 0.96 to 1.08; p = 0.6) comparing CJR with the previous periods. Similarly, in the transplant cohort, the adjusted IRR for TJA was 0.82 (95% CI 0.67 to 1.02; p = 0.07) comparing PPACA with the previous period and 1.10 (95% CI 0.94 to 1.28; p = 0.9) comparing CJR with the previous periods. CONCLUSION/CONCLUSIONS:There was no loss in access to TJA for medically complex patients receiving kidney replacement therapy. The increase in TJA incidence for patients after kidney transplant and decrease for patients receiving dialysis suggest that surgeons continued to provide care for higher risk patients whose risk of morbidity or mortality with total joint replacement has been maximally improved after transplantation. LEVEL OF EVIDENCE/METHODS:Level III, prognostic study.
PMID: 40271981
ISSN: 1528-1132
CID: 5830482
Graft Survival in Single versus Bilateral Lung Transplantation for Emphysema
Stewart, Darren E; Ruck, Jessica M; Massie, Allan B; Segev, Dorry L; Lesko, Melissa B; Chan, Justin C; Chang, Stephanie H; Geraci, Travis C; Rudym, Darya; Sonnick, Mark A; Barmaimon, Guido; Angel, Luis F; Natalini, Jake G
The benefits of bilateral lung transplantation (BLT) versus single lung transplantation (SLT) are still debated. One impediment to clinical recommendations is that BLT vs. SLT advantages may vary based on underlying disease. Since both options are clinically tenable in patients with emphysema, we conducted a comprehensive assessment of lung allograft survival in this population. Using U.S. registry data, we studied time to all-cause allograft failure in 8,092 patients 12 years or older transplanted from 2006 to 2022, adjusting for recipient, donor, and transplant factors by inverse propensity weighting. Median allograft survival was 6.6 years in BLT compared to 5.3 years in SLT, a 25% risk-adjusted survival advantage of 0.81.31.8 years. Risk-adjusted bilateral survival advantages varied between 0.9 and 2.4 years across eleven subgroups. Median allograft survival in BLT was 1.2 years greater than right SLT and 2.0 years greater than left SLT. During the 16-year study period, allograft survival steadily improved for BLT but not for SLT. Although the 25% BLT survival advantage pre-dated the pandemic, COVID-19 may have contributed to an apparent SLT survival decline. Recognizing the possible influence of residual confounding due to selection biases, these findings may aid offer decision-making when both donor lungs are available.
PMID: 40419023
ISSN: 1600-6143
CID: 5855112