OPTN/SRTR 2022 Annual Data Report: Deceased Organ Donation.

The Scientific Registry of Transplant Recipients uses data collected by the Organ Procurement and Transplantation Network to calculate metrics such as organs recovered per donor, organs transplanted per donor, and organs recovered for transplant but not transplanted (ie, nonuse). In 2022, there were 14,905 deceased donors, a 7.5% increase from 13,863 in 2021, and this number has been increasing since 2010. The number of deceased donor organs used for transplant increased to 37,334 in 2022, a 4.6% increase from 35,687 in 2021; this number has been increasing since 2012. The increase may be due in part to the rising number of deaths of young people amid the ongoing opioid epidemic. The number of organs transplanted included 10,130 left kidneys, 10,039 right kidneys, 298 en bloc kidneys, 922 pancreata, 8,847 livers, 83 intestines, 4,169 hearts, and 2,633 lungs. Compared with 2021, transplants of all organs except pancreata and intestines increased in 2022. In 2022, 3,563 left kidneys, 3,673 right kidneys, 156 en bloc kidneys, 366 pancreata, 965 livers, 4 intestines, 54 hearts, and 219 lungs were not used. These data suggest an opportunity to increase the number of transplants by reducing the number of unused organs. Despite the COVID-19 pandemic, there was no dramatic increase in the number of unused organs and there was an increase in the total numbers of donors and transplants.

Adjusting for race in metrics of organ procurement organization performance.

The Scientific Registry of Transplant Recipients has previously reported the effects of adjusting for demographic variables, including race, in the Centers for Medicare & Medicaid Services (CMS) organ procurement organization (OPO) performance metrics: donation rate and transplant rate. CMS chose not to adjust for most demographic variables other than age (for the transplant rate), arguing that there is no biological reason that these variables would affect the organ donation/utilization decision. However, organ donation is a process based on altruism and trust, not a simple biological phenomenon. Focusing only on biological impacts on health ignores other pathways through which demographic factors can influence OPO outcomes. In this study, we update analyses of demographic adjustment on the OPO metrics for 2020 with a specific focus on adjusting for race. We find that adjusting for race would lead to 8 OPOs changing their CMS tier rankings, including 2 OPOs that actually overperform the national rate among non-White donors improving from a tier 3 ranking (facing decertification without possibility of recompeting) to a tier 2 ranking (allowing the possibility of recompeting). Incorporation of stratified and risk-adjusted metrics in public reporting of OPO performance could help OPOs identify areas for improvement within specific demographic categories.

OPTN/SRTR 2021 Annual Data Report: Deceased Organ Donation.

The Scientific Registry of Transplant Recipients uses data collected by the Organ Procurement and Transplantation Network to calculate metrics such as donation rate, organ yield, and rate of organs recovered for transplant but not transplanted (ie, nonuse). In 2021, there were 13,862 deceased donors, a 10.1% increase from 12,588 in 2020, and an increase from 11,870 in 2019; this number has been increasing since 2010. The number of deceased donor transplants increased to 41,346 transplants in 2021, a 5.9% increase from 39,028 in 2020; this number has been increasing since 2012. The increase may be due in part to the rising number of deaths of young people amid the ongoing opioid epidemic. The number of organs transplanted included 9,702 left kidneys, 9,509 right kidneys, 551 en bloc kidneys, 964 pancreata, 8,595 livers, 96 intestines, 3,861 hearts, and 2,443 lungs. Compared with 2019, transplants of all organs except lungs increased in 2021, which is remarkable as this occurred despite the COVID-19 pandemic. In 2021, 2,951 left kidneys, 3,149 right kidneys, 184 en bloc kidneys, 343 pancreata, 945 liver, 1 intestine, 39 hearts, and 188 lungs were not used. These numbers suggest an opportunity to increase numbers of transplants by reducing nonused organs. Despite the pandemic, there was no dramatic increase in number of nonused organs and there was an increase in total numbers of donors and transplants. The new Centers for Medicare & Medicaid Services metrics for donation rate and transplant rate have also been described and vary across organ procurement organizations; the donation rate metric varied from 5.82 to 19.14 and the transplant rate metric varied from 18.7 to 60.0.

Transplant program evaluations in the middle of the COVID-19 pandemic.

Potential regional variations in effects of COVID-19 on federally mandated, program-specific evaluations by the Scientific Registry of Transplant Recipients (SRTR) have been controversial. SRTR January 2022 program evaluations ended transplant follow-up on March 12, 2020, and excluded transplants performed from March 13, 2020 to June 12, 2020 (the "carve-out"). This study examined the carve-out's impact, and the effect of additionally censoring COVID-19 deaths, on first-year posttransplant outcomes for transplants from July 2018 through December 2020. Program-specific hazard ratios (HRs) for graft failure and death estimated under two alternative scenarios were compared with published HRs: (1) the carve-out was removed; (2) the carve-out was retained, but deaths due to COVID-19 were additionally censored. The HRs estimated by censoring COVID-19 deaths were highly correlated with those estimated with the carve-out alone (r2  = .96). Removal of the carve-out resulted in greater variation in HRs while remaining highly correlated (r2  = .82); however, little geographic impact of the carve-out was observed. The carve-out increased average HR in the Northwest by 0.049; carve-out plus censoring reduced average HR in the Midwest by 0.009. Other regions of the country were not significantly affected. Thus, the current COVID-19 carve-out does not appear to impart substantial bias based on the region of the country.

The Centers for Medicare and Medicaid Services' proposed metrics for recertification of organ procurement organizations: Evaluation by the Scientific Registry of Transplant Recipients.

On December 23, 2019, the US Centers for Medicare and Medicaid Services proposed 2 new standards that organ procurement organizations (OPOs) must meet for recertification. An OPO's organ donation rate (deceased donors/potential donors) and organ transplant rate (organs transplanted/potential donors) must not fall significantly below the 75th percentile for rates among all OPOs. We examined how OPOs would have fared under the proposed performance standards in 2016-2017. Data on donors and transplants were from the Organ Procurement and Transplantation Network; donor potential was estimated from Detailed Multiple Cause of Death data collected by the Centers for Disease Control and Prevention. In 2017, 31 (53%) OPOs failed to meet the proposed donation rate standard, 36 (62%) failed to meet the proposed organ transplant rate standard, and 37 (64%) failed at least 1 standard. We found that adjusting for age, race, and Hispanic ethnicity altered the evaluation: 8 OPOs changed their pass/fail status for the donation rate and 5 for the proposed organ transplant rate standard. We conclude that the proposed new standards may result in over half of OPOs facing decertification, and risk adjustment suggests that underlying characteristics of deaths vary regionally such that decertification decisions may be affected.

Seeking new answers to old questions about public reporting of transplant program performance in the United States.

The Scientific Registry of Transplant Recipients (SRTR) is mandated by the National Organ Transplant Act, the Final Rule, and the SRTR contract with the Health Resources and Services Administration to report program-specific information on the performance of transplant programs. Following a consensus conference in 2012, SRTR developed a new version of the public website to improve public reporting of often complex metrics, including changing from a 3-tier to a 5-tier summary metric for first-year posttransplant survival. After its release in December 2016, the new presentation was moved to a "beta" website to allow collection of additional feedback. SRTR made further improvements and released a new beta website in May 2018. In response to feedback, SRTR added 5-tier summaries for standardized waitlist mortality and deceased donor transplant rate ratios, along with an indicator of which metric most affects survival after listing. Presentation of results was made more understandable with input from patients and families from surveys and focus groups. Room for improvement remains, including continuing to make the data more useful to patients, deciding what additional data elements should be collected to improve risk adjustment, and developing new metrics that better reflect outcomes most relevant to patients.

Liver sharing and organ procurement organization performance.

Whether the liver allocation system shifts organs from better performing organ procurement organizations (OPOs) to poorer performing OPOs has been debated for many years. Models of OPO performance from the Scientific Registry of Transplant Recipients make it possible to study this question in a data-driven manner. We investigated whether each OPO's net liver import was correlated with 2 performance metrics [observed to expected (O:E) liver yield and liver donor conversion ratio] as well as 2 alternative explanations [eligible deaths and incident listings above a Model for End-Stage Liver Disease (MELD) score of 15]. We found no evidence to support the hypothesis that the allocation system transfers livers from better performing OPOs to centers with poorer performing OPOs. Also, having fewer eligible deaths was not associated with a net import. However, having more incident listings was strongly correlated with the net import, both before and after Share 35. Most importantly, the magnitude of the variation in OPO performance was much lower than the variation in demand: although the poorest performing OPOs differed from the best ones by less than 2-fold in the O:E liver yield, incident listings above a MELD score of 15 varied nearly 14-fold. Although it is imperative that all OPOs achieve the best possible results, the flow of livers is not explained by OPO performance metrics, and instead, it appears to be strongly related to differences in demand.

Liver sharing and organ procurement organization performance under redistricted allocation.

Concerns have been raised that optimized redistricting of liver allocation areas might have the unintended result of shifting livers from better-performing to poorer-performing organ procurement organizations (OPOs). We used liver simulated allocation modeling to simulate a 5-year period of liver sharing within either 4 or 8 optimized districts. We investigated whether each OPO's net liver import under redistricting would be correlated with 2 OPO performance metrics (observed to expected liver yield and liver donor conversion ratio), along with 2 other potential correlates (eligible deaths and incident listings above a Model for End-Stage Liver Disease score of 15). We found no evidence that livers would flow from better-performing OPOs to poorer-performing OPOs in either redistricting scenario. Instead, under these optimized redistricting plans, our simulations suggest that livers would flow from OPOs with more-than-expected eligible deaths toward those with fewer-than-expected eligible deaths and that livers would flow from OPOs with fewer-than-expected incident listings to those with more-than-expected incident listings; the latter is a pattern that is already established in the current allocation system. Redistricting liver distribution to reduce geographic inequity is expected to align liver allocation across the country with the distribution of supply and demand rather than transferring livers from better-performing OPOs to poorer-performing OPOs.

Impact of Centers for Medicare and Medicaid Services Final Rule on Organ Procurement Organization Metrics and Procedural Trends in the Procurement of Pancreata for Research.

OBJECTIVE: Pancreata recovered for research are included as a success (or positive) in the Centers for Medicare and Medicaid Services' (CMS) donation and organ transplantation rate metrics for recertification of organ procurement organizations (OPOs). MATERIALS AND METHODS: Given these metrics directly incentivize recovery of pancreata for research, this study tracks trends in recovery of pancreata for research across the implementation of the CMS metrics. RESULTS: In the 26 months before the December 2, 2020, publication of the CMS metrics, research pancreata as a percent of organs transplanted, including research pancreata, was 1.7% nationally, including as much as 10.8% of organs transplanted within any OPO. In the 26 months after the CMS metrics were published, research pancreata increased to 5.1% of organs counted as transplants nationally, including as much as 20.3% within any OPO. If research pancreata were excluded from the CMS metrics, 6 OPOs would change their CMS evaluation status for recertification purposes: 2 would move up a tier and 4 would move down a tier. CONCLUSIONS: Procurement of research pancreata has increased since the publication of the CMS performance metrics, OPOs vary in their recovery of pancreata for research, and recovery of pancreata for research can affect recertification of OPOs.

Evaluating real-world use of cinacalcet and biochemical response to therapy in US hemodialysis patients.

BACKGROUND/AIMS: Data describing real-world use and effectiveness of cinacalcet are limited. We aimed to characterize predictors of treatment and changes in secondary hyperparathyroidism (SHPT) biochemistry after cinacalcet initiation. METHODS: We studied 25,250 in-center hemodialysis patients from a large dialysis provider, alive through November 2004, with no prior cinacalcet prescription. Patients were followed until initiation of cinacalcet, censoring, death, or July 31, 2007. Initiators were further followed for dose titration and discontinuation. Predictors of these events were evaluated using Cox proportional hazards modeling. Biochemical parameters and other SHPT medication use were compared between baseline, pre-initiation, and post-initiation time points. RESULTS: Over an average of 1.25 years of follow-up, 30% of patients initiated cinacalcet therapy. Between baseline and initiation (mean of 386 days), parathyroid hormone (PTH) and phosphorus levels increased 78 and 7%, respectively, in these patients. After adjustment, cinacalcet initiation was associated with higher SHPT severity, younger age, African-American race, higher phosphorus levels, and more comorbidity. Within 1 month of initiation, median PTH was reduced by 15-30% and phosphorus by 3-5%. Reductions were sustained or increased over 12 months, depending on initiating PTH level and whether dose up-titration occurred. Discontinuation was common, although many patients reinitiated. CONCLUSIONS: A substantial proportion of patients experienced SHPT progression and initiated cinacalcet treatment. Reductions in biochemistry varied by disease severity and whether doses were titrated.

Racial differences in clinical use of cinacalcet in a large population of hemodialysis patients.

BACKGROUND/AIMS: African-Americans with end-stage renal disease receiving dialysis have more severe secondary hyperparathyroidism than Whites. We aimed to assess racial differences in clinical use of cinacalcet. METHODS: This retrospective cohort study used data from DaVita, Inc., for 45,589 prevalent hemodialysis patients, August 2004, linked to Centers for Medicare & Medicaid Services data, with follow-up through July 2007. Patients with Medicare as primary payer, intravenous vitamin D use, or weighted mean parathyroid hormone (PTH) level >150 pg/ml at baseline (August 1-October 31, 2004) were included. Cox proportional hazard modeling was used to evaluate race and other demographic and clinical characteristics as predictors of cinacalcet initiation, titration, and discontinuation. RESULTS: Of 16,897 included patients, 7,674 (45.4%) were African-American and 9,223 (54.6%) were white; 53.2% of cinacalcet users were African-American. Cinacalcet was prescribed for 47.7% of African-Americans and 34.5% of Whites, and for a greater percentage of African-Americans at higher doses at each PTH strata. After covariate adjustment, African-Americans were more likely than Whites to receive cinacalcet prescriptions (hazard ratio 1.17, p < 0.001). The direction and magnitude of this effect appeared to vary by age, baseline PTH, and calcium, and by elemental calcium use. African-Americans were less likely than Whites to have prescriptions discontinued and slightly more likely to undergo uptitration (hazard ratio 1.09, 95% confidence interval 0.995-1.188), but this relationship lacked statistical significance. CONCLUSION: Cinacalcet is prescribed more commonly and at higher initial doses for African-Americans than for Whites to manage secondary hyperparathyroidism.

Use of exception status listing and related outcomes during two heart allocation policy periods.

BACKGROUND: The October 2018 update to the heart allocation policy was intended to decrease exception status requests, whereby candidates are listed at a specific status due to perceived need despite not meeting prespecified criteria of illness severity. We assessed the use of exception status and waitlist outcomes before and after the 2018 policy. METHODS: We used data from the Scientific Registry of Transplant Recipients on adult heart transplant candidates listed from 2015 to 2021. We assessed (1) the use of exception status across patient characteristics between the two periods and (2) transplant rate and waitlist mortality or delisting due to deterioration in each period. Patients listed by exception versus standard criteria were compared with multivariable logistic regression, and waitlist outcomes were assessed using Cox proportional hazard models with medical urgency and exception status as time-dependent covariates. RESULTS: During the study period (n = 19,213), heart transplants under exception status increased postpolicy from 10.0% to 32.3%, with 20.6% of transplants performed for patients at status 2 exception. Exception status candidates postpolicy were more frequently Black or Hispanic/Latino and less likely to have hypertrophic or restrictive cardiomyopathy and had worse hemodynamics. Exception status listing was associated with higher transplant rates in both periods. Postpolicy, candidates listed status 1 exception had a lower likelihood for waitlist mortality or delisting (hazard ratio, 0.60; 95% CI, 0.37-0.99; and p = 0.05). CONCLUSIONS: Under the 2018 policy, exception status listings dramatically increased. The policy change shifted the population of patients listed by exception status and affected waitlist mortality, which suggests a need to further evaluate the policy's impact.

Cognitive impairment in peritoneal dialysis patients.

BACKGROUND: The prevalence of moderate to severe cognitive impairment in hemodialysis patients is more than double the prevalence in the general population. This study describes cognitive impairment occurrence in a peritoneal dialysis cohort compared with a cohort without chronic kidney disease (CKD). STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: 51 English-speaking peritoneal dialysis patients from 2 urban dialysis units compared with 338 hemodialysis patients from 16 urban dialysis units and 101 voluntary controls without CKD from urban general medicine clinics. PREDICTOR: 45-minute battery of 9 validated neuropsychological tests (cognitive domains memory, executive function, and language). OUTCOMES: Mild, moderate, or severe cognitive impairment, classified according to a previously designed algorithm. RESULTS: Of the peritoneal dialysis cohort, 33.3% had no or mild, 35.3% had moderate, and 31.4% had severe cognitive impairment; corresponding values were 60.4%, 26.7%, and 12.9% of the non-CKD cohort and 26.6%, 36.4%, and 37.0% of the hemodialysis cohort. A logistic regression model including age, sex, race, education, hemoglobin level, diabetes, and stroke showed that only nonwhite race (P = 0.002) and low education (P = 0.002) were associated with moderate to severe cognitive impairment in the peritoneal dialysis cohort. Compared with hemodialysis patients, more peritoneal dialysis patients had moderate to severe memory impairment (58% vs 51%), but fewer had impaired executive function (one-third vs one-half). Peritoneal dialysis was associated with a more than 2.5-fold increased risk of moderate to severe global cognitive impairment compared with no CKD (OR, 2.58; 95% CI, 1.02-6.53), as was hemodialysis (OR, 3.16; 95% CI, 1.91-5.24), in an adjusted logistic regression model. LIMITATIONS: Small sample size, participation rate somewhat low. CONCLUSIONS: Similar to hemodialysis patients, two-thirds of peritoneal dialysis patients had moderate to severe cognitive impairment, enough to interfere with safely self-administering dialysis and adhering to complex medication regimens. These patients could benefit from cognitive assessment before and periodically after dialysis therapy initiation.

Cost, healthcare utilization, and outcomes of antibody-mediated rejection in kidney transplant recipients in the US.

BACKGROUND: Antibody-mediated rejection (AMR) is one of the leading causes of graft loss in kidney transplant recipients but little is known about the associated cost and healthcare burden of AMR. METHODS: We developed an algorithm to detect AMR using the 2006-2011 Centers for Medicare & Medicaid Services (CMS) using ICD-10 and billing codes as there is no specific ICD-10 or procedure code for AMR. We then compared healthcare utilization, cost, and risk of graft failure or death in AMR. patients versus matched controls. RESULTS: The algorithm had a 39.4% true-positive rate (69/175) and a 4.1% false-positive rate (110/2,655). We identified 5,679/101,554 (5.6%) with AMR, who had a nearly 3-fold higher risk of graft failure (hazard ratio [HR], 2.75, 95% confidence interval [CI], 2.50 to 3.03; p < .0001) and death (HR, 2.59; 95% CI, 2.35 to 2.86; p < .0001) at 2 years, nearly 5 times the hospitalizations in the 60 d before AMR diagnosis, and increased nephrology and emergency department visits. Mean AMR attributable healthcare costs were 4 times higher than matched controls, at $13,066 more per patient in the 60 d before AMR diagnosis and $35,740 per patient per year higher in the 2 years after AMR diagnosis. CONCLUSIONS: US kidney transplant recipients with AMR have substantially greater healthcare utilization and higher costs and risk of graft loss and mortality.

Cinacalcet hydrochloride treatment significantly improves all-cause and cardiovascular survival in a large cohort of hemodialysis patients.

Secondary hyperparathyroidism (SHPT) affects a significant number of hemodialysis patients, and metabolic disturbances associated with it may contribute to their high mortality rate. As patients with lower serum calcium, phosphorus, and parathyroid hormone are reported to have improved survival, we tested whether prescription of the calcimimetic cinacalcet to hemodialysis patients with SHPT improved their survival. We prospectively collected data on hemodialysis patients from a large provider beginning in 2004, a time coincident with the commercial availability of cinacalcet hydrochloride. This information was merged with data in the United States Renal Data System to determine all-cause and cardiovascular mortality. Patients included in the study received intravenous (i.v.) vitamin D therapy (a surrogate for the diagnosis of SHPT). Of 19,186 patients, 5976 received cinacalcet and all were followed from November 2004 for up to 26 months. Unadjusted and adjusted time-dependent Cox proportional hazards modeling found that all-cause and cardiovascular mortality rates were significantly lower for those treated with cinacalcet than for those without calcimimetic. Hence, this observational study found a significant survival benefit associated with cinacalcet prescription in patients receiving i.v. vitamin D. Definitive proof, however, of a survival advantage awaits the performance of randomized clinical trials.

Acute variation in cognitive function in hemodialysis patients: a cohort study with repeated measures.

BACKGROUND: Although cognitive function in hemodialysis patients is believed to be best 24 hours after the dialysis session, the extent of variation during the dialysis cycle is unknown. STUDY DESIGN: Cohort study with repeated measures. SETTING & PARTICIPANTS: Hemodialysis centers; patients aged 55 years or older. PREDICTOR: Time of assessment related to the dialysis session. Time 1 (T1) occurred approximately 1 hour before the dialysis session; T2, 1 hour into the session; T3, 1 hour after; and T4, the next day. OUTCOMES: Measures of cognitive function using a 45-minute cognitive battery. An average composite score was calculated to measure global cognitive function, equal to the average of subjects' standardized scores on all tests given at each test time. Times were classified as best and worst according to composite scores. MEASUREMENTS: Testing was conducted on average over 2 dialysis sessions to avoid test fatigue. The cognitive battery included tests of verbal fluency, immediate and delayed verbal and visual memory, and executive function, administered at 4 times. RESULTS: In the 28 subjects who completed testing at 3 or 4 testing times, mean age was 66.7 +/- 9.5 years and mean dialysis vintage was 44.7 +/- 33.3 months. Using a general linear model for correlated data, the composite score was significantly lower (poorer) during dialysis (T2) than shortly before the session (T1) or on the next day (T4; P < 0.001 for both). LIMITATIONS: Relatively small sample size, testing delays, results may not be generalizable. CONCLUSION: Global cognitive function varies significantly during the dialysis cycle, being worst during dialysis and best shortly before the session or on the day after. Clinician visits may be most effective at these times.