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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
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
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 limits of generalizing from six OPOs: Response [Letter]
Levan, Macey L; Segev, Dorry L; Massie, Allan B
PMID: 40602462
ISSN: 1600-6143
CID: 5888082
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
Advancing Genetic Risk Assessment in Living Kidney Donation: A Comprehensive Approach to Patient Education and Counseling
Akhtar, Jasmine M; Sidoti, Carolyn N; Diallo, Kadiatou; Downey, Max C; Klitenic, Samantha B; Stewart, Darren E; Vanterpool, Karen B; Schiff, Tamar; Snyder, Jon J; Ali, Nicole M; Massie, Allan B; Segev, Dorry L; Levan, Macey L
PMID: 40960879
ISSN: 1555-905x
CID: 5935242
The Survival Benefit of Accepting an Older Donor Lung Transplant Compared With Waiting for a Younger Donor Offer
Zeiser, Laura B; Ruck, Jessica M; Segev, Dorry L; Angel, Luis F; Stewart, Darren E; Massie, Allan B
BACKGROUND:Donor pool expansion is critical as lung candidates suffer high mortality, yet older donor lungs remain underutilized. We evaluated whether accepting an older donor (defined 4 ways: donor age 30-39, 40-49, 50-59, or 60-69 y) lung transplant was associated with a survival benefit over waiting for a younger donor offer. METHODS:Adult candidates who received a lung offer were identified using Scientific Registry of Transplant Recipients data, 2015-2022. Offers were categorized by donor age and candidate lung allocation score (LAS; <40, 40-55, >55). Postoffer mortality was compared between candidates for whom the offer was accepted ("acceptors") versus declined ("decliners") within each age-LAS category using weighted Cox regression. RESULTS:A total of 21 426 candidates received an offer from a donor age ≥30 y; 11 679 accepted. For LAS >55 candidates, a survival benefit was observed for acceptors of donors ages 30-39 y (weighted hazard ratio [wHR] of mortality: 0.450.520.59), 40-49 y (wHR: 0.610.700.79), and 50-59 y (wHR: 0.670.770.88); P < 0.001. For candidates with LAS 40-55, results suggest a survival benefit of accepting lung offers from donors age 30-39 y (wHR: 0.770.870.99) and 40-49 y (wHR: 0.760.870.99); P = 0.03. However, for candidates with LAS <40, a survival benefit was not observed for accepting any older donor transplant, with possible harm in accepting an age 50+ donor offer. CONCLUSIONS:Compared with declining and waiting for a younger donor offer, accepting an older donor lung transplant was associated with a survival advantage in candidates with high LAS in the precontinuous distribution era. Decision makers should consider these findings while recognizing potential changes in waiting time dynamics in the current era.
PMID: 40254736
ISSN: 1534-6080
CID: 5829842
Revisiting racial/ethnic disparities in the deceased organ donor referral process
Levan, Macey L; Terlizzi, Kelly; Rigsby, Matilin; Klitenic, Samantha; Hewlett, Jonathan; Adams, Bradley L; Barnes, Jade; Funk, Geoffrey; Segev, Dorry L; Massie, Allan B
Racial/ethnic disparities in the deceased organ donor referral process may contribute to the organ shortage and place minority communities at a greater disadvantage. Prior literature cites substantial inequalities, though methodological concerns may bias estimates. Using Organ Retrieval and Collection of Health Information for Donation data, we conducted a simulation study and re-analysis of 132,968 referrals 2015-2021 across six organ procurement organizations (OPOs). We excluded brain death declaration and cause/mechanism/circumstances of death from the approach model and conducted Poisson regression with robust standard errors. We found Black patients were approached at a more similar rate relative to White patients, although disparities remained (incidence rate ratio (IRR): 0.910.940.97). Black patients provided authorization at a 31% lower rate than White patients (IRR: 0.670.690.71). Slight disparities were observed at procurement (IRR: 0.940.960.99). Our findings are directionally similar to prior literature but suggest substantially less inequality (vs 23% and 65% higher risk of approach and authorization, for non-Black vs Black referrals). Accurate quantification of racial/ethnic disparities in transplantation impacts public perception of those involved, particularly OPOs, and is paramount to any study. Importantly, continued measures are needed to promote equality among Black and minority patients in our national organ donation and transplant system.
PMID: 40254225
ISSN: 1600-6143
CID: 5829802
Trends over Time in Practice and Outcomes of Lung Transplantation in Recipients with Human Immunodeficiency Virus
Nauroz, Zeba; Ruck, Jessica M; Shah, Pali; Bush, Errol; Werbel, William; Raju, Sarath; Hemmige, Vagish; Haidar, Ghady; Massie, Allan B; Segev, Dorry L; Durand, Christine M; Bowring, Mary G
BACKGROUND:People with human immunodeficiency virus (HIV) are at an increased risk for end-stage lung disease, for which lung transplantation (LT) may be necessary. METHODS:We aimed to characterize the national practice patterns of LT in recipients with HIV (HIV R+) and post-LT outcomes, including rejection in the US over time. Using the Scientific Registry of Transplant Recipients data (from January 1, 2004, to December 1, 2024, for practice patterns and from January 1, 2016, to December 1, 2024, for outcomes), we compared 96 adult HIV R+ to 42 341 LT recipients without HIV (HIV R-). We examined the association between HIV and outcomes using Gini coefficients, Cox regression, and modified Poisson regression before and after 2020. RESULTS:HIV R+ LTs increased from 0.1% in 2004 to 0.4% of LTs in 2024 (p = 0.07). Pre-2020, 18 centers performed 80% of HIV R+ LTs (Gini = 0.78); post-2020, 14 centers performed 80% of HIV R+ LTs (Gini = 0.76), indicating no expansion of the practice across centers. HIV R+ did not have an increased risk of mortality (adjusted hazard ratio pre-2020: 0.91 [95% confidence interval 0.41-1.62], p = 0.7 and post-2020: 1.05 [0.49-3.25], p = 0.8), or increased risk of 1-year rejection rate (adjusted relative risk pre-2020: 0.60 [0.20-1.77], p = 0.3, and post-2020: 0.77 [0.26-2.2], p = 0.6). CONCLUSIONS:Increasing numbers of HIV R+ LTs and comparable outcomes to those without HIV are encouraging, yet few centers perform these transplants.
PMID: 40778480
ISSN: 1399-3062
CID: 5905422