Impact of donor kidney biopsy on kidney yield and posttransplant outcomes.

Procurement biopsy is performed to determine kidney quality, but evidence supporting such association is poor. We investigated the impact of glomerulosclerosis percentage (GS%) on kidney yield and patient outcomes. Information on deceased kidney donors from July 1, 2017, to June 30, 2019, was collected. Association between GS% and kidney yield (number of kidneys procured per donor) and posttransplant graft and patient outcomes were studied. Maximal GS% and minimal GS% were calculated to determine the relationship between GS% and kidney yield; minimal GS% only for correlation with posttransplant outcomes. Multinomial logistic regression and Cox models with least absolute shrinkage and selection operator were used to analyze the association of GS% with kidney yield and posttransplant outcomes, respectively. The kidney yield was 1.63 when maximal GS% and minimal GS% were <5%, but was 0.88 when both GS% were >20%. The hazard ratio for graft failure 1 year after transplant was 1.05 when minimal GS% was 16% to 20%, but was 1.3 for GS% of >20%. The hazard ratio for mortality increased from 1 to 1.2 when minimal GS% reached >20%. In summary, higher GS% was associated with lower kidney yield and inferior posttransplant outcomes. Incorporation of GS% into Scientific Registry of Transplant Recipients models may reassure organ procurement organizations and transplant centers pursuing kidneys with relatively high GS% levels, thereby reducing kidney discard rates.

Impact of Donor Liver Macrovesicular Steatosis on Deceased Donor Yield and Posttransplant Outcome.

BACKGROUND: The Scientific Registry of Transplant Recipients (SRTR) had not traditionally considered biopsy results in risk-adjustment models, yet biopsy results may influence outcomes and thus decisions regarding organ acceptance. METHODS: Using SRTR data, which includes data on all donors, waitlisted candidates, and transplant recipients in the United States, we assessed (1) the impact of macrovesicular steatosis on deceased donor yield (defined as number of livers transplanted per donor) and 1-y posttransplant graft failure and (2) the effect of incorporating this variable into existing SRTR risk-adjustment models. RESULTS: There were 21 559 donors with any recovered organ and 17 801 liver transplant recipients included for analysis. Increasing levels of macrovesicular steatosis on donor liver biopsy predicted lower organ yield: ≥31% macrovesicular steatosis on liver biopsy was associated with 87% to 95% lower odds of utilization, with 55% of these livers being discarded. The hazard ratio for graft failure with these livers was 1.53, compared with those with no pretransplant liver biopsy and 0% to 10% steatosis. There was minimal change on organ procurement organization-specific deceased donor yield or program-specific posttransplant outcome assessments when macrovesicular steatosis was added to the risk-adjustment models. CONCLUSIONS: Donor livers with macrovesicular steatosis are disproportionately not transplanted relative to their risk for graft failure. To avoid undue risk aversion, SRTR now accounts for macrovesicular steatosis in the SRTR risk-adjustment models to help facilitate use of these higher-risk organs. Increased recognition of this variable may also encourage further efforts to standardize the reporting of liver biopsy results.

Expected effect of the lung Composite Allocation Score system on US lung transplantation.

Efforts are underway to transition the current lung allocation system to a continuous distribution framework whereby multiple factors are simultaneously combined into a Composite Allocation Score (CAS) to prioritize candidates for lung transplant. The purpose of this study was to compare discrete CAS scenarios with the current concentric circle-based allocation system to assess their potential effects on the US lung transplantation system using the Scientific Registry of Transplant Recipients' thoracic simulated allocation model. Six alternative CAS scenarios were compared over 10 simulation runs using data from individuals on the lung transplant waiting list from January 1, 2018, through December 31, 2019. Outcome measures were transplant rate, count, waitlist deaths, posttransplant deaths within 2 years, donor-to-recipient distance, and percentage of organs predicted to have flown. Across scenarios, waitlist deaths decreased by 36% to 47%, with larger decreases in deaths at lower placement efficiency weight and higher weighting of the waitlist outcomes. When waitlist outcomes were equally weighted to posttransplant outcomes, more transplants occurred in individuals with the highest expected posttransplant survival. All CAS scenarios led to improved overall measures of equity compared with the current Lung Allocation Score system, including reduced waitlist deaths, and resulted in similar posttransplant survival.

Impact of incorporating long-term survival for calculating transplant benefit in the US lung transplant allocation system.

BACKGROUND: The lung allocation score prioritizes candidates for a lung transplant in the United States. As the country adopts the continuous distribution framework for organ allocation, we must reevaluate lung allocation score assumptions to maximize transplant benefit. METHODS: We used Scientific Registry of Transplant Recipients data to study the impact of these changes: (1) updating cohorts; (2) transitioning from 1- to 5-year posttransplant survival; (3) using time-varying effects for non-proportional hazards; and (4) weighting waitlist and posttransplant area under the curve differently. Models were compared using Spearman correlations and C-statistics. The thoracic simulation allocation model characterized transplant rates and proportions of recipient subgroups under the current and new systems. RESULTS: Posttransplant areas under the curve models were estimated with recipients aged ≥12 from January 1, 2014, to December 31, 2018. All models had similar C-statistics and Spearman correlations, indicating similar predictive performance and posttransplant area under the curve rankings. Five-year posttransplant area under the curve across age and diagnosis groups varied more than 1-year groups. Using the thoracic simulation allocation model, 1- and 5-year posttransplant model under the curve models showed similar transplant rates and recipient characteristics under the current system, but under continuous distribution, 5-year posttransplant area under the curve resulted in increased transplant rates with more recipients younger and in diagnosis groups B and C. CONCLUSION: Incorporating equally weighted waitlist and posttransplant models using 5-year posttransplant survival detected the largest variability in survival under the continuous distribution system, which could improve long-term survival in the United States.

Impact of COVID-19 pandemic on the size of US transplant waiting lists.

BACKGROUND: More patients are waitlisted for solid organs than transplants are performed each year. The COVID-19 pandemic immediately increased waitlist mortality and decreased transplants and listings. METHODS: To calculate the number of candidate listings after the pandemic began and short-term changes that may affect waiting time, we conducted a Scientific Registry of Transplant Recipients surveillance study from January 1, 2012 to February 28, 2021. RESULTS: The number of candidates on the liver waitlist continued a steady decline that began before the pandemic. Numbers of candidates on the kidney, heart, and lung waitlists decreased dramatically. More than 3000 fewer candidates were awaiting a kidney transplant on March 7, 2021, than on March 8, 2020. Listings and removals decreased for each solid organ beginning in March 2020. The number of heart and lung listings returned to equal or above that of removals. Listings for kidney transplant, which is often less urgent than heart and lung transplant, remain below numbers of removals. Removals due to transplant decreased for all organs, while removals due to death increased for only kidneys. CONCLUSIONS: We found no evidence of the predicted surge in listings for solid organ transplant with a plateau or control of the pandemic.

The Effect of Acuity Circles on Deceased Donor Transplant and Offer Rates Across Model for End-Stage Liver Disease Scores and Exception Statuses.

Acuity circles (AC), the new liver allocation system, was implemented on February 4, 2020. Difference-in-differences analyses estimated the effect of AC on adjusted deceased donor transplant and offer rates across Pediatric End-Stage Liver Disease (PELD) and Model for End-Stage Liver Disease (MELD) categories and types of exception statuses. The offer rates were the number of first offers, top 5 offers, and top 10 offers on the match run per person-year. Each analysis adjusted for candidate characteristics and only used active candidate time on the waiting list. The before-AC period was February 4, 2019, to February 3, 2020, and the after-AC period was February 4, 2020, to February 3, 2021. Candidates with PELD/MELD scores 29 to 32 and PELD/MELD scores 33 to 36 had higher transplant rates than candidates with PELD/MELD scores 15 to 28 after AC compared with before AC (transplant rate ratios: PELD/MELD scores 29-32, 2.34 3.324.71 ; PELD/MELD scores 33-36, 1.70 2.513.71 ). Candidates with PELD/MELD scores 29 or higher had higher offer rates than candidates with PELD/MELD scores 15 to 28, and candidates with PELD/MELD scores 29 to 32 had the largest difference (offer rate ratios [ORR]: first offers, 2.77 3.955.63 ; top 5 offers, 3.90 4.394.95 ; top 10 offers, 4.85 5.305.80 ). Candidates with exceptions had lower offer rates than candidates without exceptions for offers in the top 5 (ORR: hepatocellular carcinoma [HCC], 0.68 0.770.88 ; non-HCC, 0.73 0.810.89 ) and top 10 (ORR: HCC, 0.59 0.650.71 ; non-HCC, 0.69 0.750.81 ). Recipients with PELD/MELD scores 15 to 28 and an HCC exception received a larger proportion of donation after circulatory death (DCD) donors after AC than before AC, although the differences in the liver donor risk index were comparatively small. Thus, candidates with PELD/MELD scores 29 to 34 and no exceptions had better access to transplant after AC, and donor quality did not notably change beyond the proportion of DCD donors.

Mortality among solid organ waitlist candidates during COVID-19 in the United States.

We examined the effects of COVID-19 on solid organ waiting list mortality in the United States and compared effects across patient demographics (e.g., race, age, and sex) and donation service areas. Three separate piecewise exponential survival models estimated for each solid organ the overall, demographic-specific, and donation service area-specific differences in the hazard of waitlist mortality before and after the national emergency declaration on March 13, 2020. Kidney waiting list mortality was higher after than before the national emergency (adjusted hazard ratio [aHR], 1.37; 95% CI, 1.23-1.52). The hazard of waitlist mortality was not significantly different before and after COVID-19 for liver (aHR, 0.94), pancreas (aHR, 1.01), lung (aHR, 1.00), and heart (aHR, 0.94). Kidney candidates had notable variability in differences across donation service areas (aHRs, New York City, 2.52; New Jersey, 1.84; and Michigan, 1.56). The only demographic group with increased waiting list mortality were Blacks versus Whites (aHR, 1.41; 95% CI, 1.07-1.86) for kidney candidates. The first 10 weeks after the declaration of a national emergency had a heterogeneous effect on waitlist mortality rate, varying by geography and ethnicity. This heterogeneity will complicate comparisons of transplant program performance during COVID-19.

Improving the predictive ability of the pediatric end-stage liver disease score for young children awaiting liver transplant.

The current pediatric end-stage liver disease (PELD) score underestimates pediatric waitlist mortality. Children frequently require PELD exception points to achieve appropriate priority ranking. We developed a new PELD score using serum sodium, creatinine, and updated original PELD components to more accurately rank children and equalize children's mortality risk with the age-standardized mortality rate of adults. We included children aged younger than 12 years with chronic liver disease, listed for deceased donor livers January 1, 2005-December 31, 2017. Pediatric candidates (n = 5111) were followed from listing to the earliest of waitlist mortality (death or removal from the list due to being too sick to undergo transplant, n = 339) or 180 days. We incorporated linear splines for the current components of PELD and added sodium and creatinine to the equation. The updated PELD-Na-Cr had a cross-validated AUC ROC of 0.854, vs 0.799 for the original PELD. PELD-Na-Cr required 9.44 additional points to equalize children's mortality risk with the age-standardized mortality rate of adults. PELD-Na-Cr better ordered the sickest children and should better prioritize children relative to adults. As a result, PELD-Na-Cr could increase pediatric transplant rates and reduce pediatric liver transplant waitlist mortality.

Posttransplant outcome assessments at listing: Long-term outcomes are more important than short-term outcomes.

Posttransplant outcome assessments are publicly reported for patient and regulatory use. However, the currently reported 1-year posttransplant graft survival assessments are commonly criticized for not identifying clinically meaningful differences between programs, and not providing information about longer-term posttransplant outcomes. We investigated the association of different posttransplant outcome assessments available to patients at the time of listing with subsequent posttransplant graft survival. The posttransplant assessments were from period prevalent, rather than incident, cohorts with more timely 1-, 3-, and 5-year follow-up and 6-, 12-, 18-, 24-, and 30-month cohort windows. The association of these assessments at listing with subsequent posttransplant graft survival included candidates listed between July 12, 2011, and December 15, 2015, who subsequently underwent transplant before December 31, 2018. The assessments with 1-year follow-up had uniformly weaker associations than the assessments with 3- and 5-year follow-up. The assessments with 5-year follow-up had the strongest association in kidney and liver transplantation. For kidney, liver, and lung transplantation, assessment windows of at least 18 months typically had the strongest associations with subsequent graft survival. Posttransplant assessments with 5-year follow-up and 18-30-month cohort windows are better than the current posttransplant assessment with 1-year follow-up, particularly at the time of listing.

Association between changes in Membership and Professional Standards Committee review criteria and use of higher-risk kidneys for transplant.

The Organ Procurement and Transplantation Network's Membership and Professional Standards Committee implemented an operational rule on March 1, 2017, intended to increase the number of kidneys transplanted from donors with kidney donor profile index (KDPI) ≥ 85% into recipients with poor estimated posttransplant survival (≥ 80%). Using data from the Scientific Registry of Transplant Recipients, ordinal and logistic regressions estimated, respectively, differences in kidney yield (number of transplanted kidneys per recovered donor) and offer acceptance practices before and after implementation. We included donors recovered January 1, 2016-February 28, 2018. The odds of higher kidney yield for donors with KDPI ≥ 85% were 27% higher after implementation (odds ratio, 1.06 1.271.53 ), but odds were also 20% higher for donors with KDPI < 85% (1.04 1.201.38 ). Thus, kidney yield was higher for all donors, with a slightly larger difference for donors with KDPI ≥ 85%. Additionally, the difference in offer acceptance before and after implementation was similar regardless of KDPI (KDPI < 85%, 0.97 1.021.07 ; KDPI ≥ 85%, 0.95 1.041.14 ). In the first year after implementation, kidney yield increased for donors with KDPI < and ≥ 85%. Thus, kidney yield from higher KDPI donors may have increased without the operational rule.

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.

Comparing Pretransplant and Posttransplant Outcomes When Choosing a Transplant Center: Focus Groups and a Randomized Survey.

BACKGROUND: In response to calls for an increased focus on pretransplant outcomes and other patient-centered metrics in public reports of center outcomes, a mixed methods study evaluated how the content and presentation style of new information influences decision-making. The mixed methods design utilized qualitative and quantitative phases where the strengths of one method help address limitations of the other, and multiple methods facilitate comparing results. METHODS: First, a series of organ-specific focus groups of kidney, liver, heart, and lung patients helped to develop and refine potential displays of center outcomes and understand patient perceptions. A subsequent randomized survey included adult internet users who viewed a single, randomly-selected variation of 6 potential online information displays. Multinomial regression evaluated the effects of graphical presentations of information on decision-making. RESULTS: One hundred twenty-seven candidates and recipients joined 23 focus groups. Survey responses were analyzed from 975 adults. Qualitative feedback identified patient perceptions of uncertainty in outcome metrics, in particular pretransplant metrics, and suggested a need for clear guidance to interpret the most important metric for organ-specific patient mortality. In the randomized survey, only respondents who viewed a note indicating that transplant rate had the largest impact on survival chose the hospital with the best transplant rate over the hospital with the best posttransplant outcomes (marginal relative risk and 95% confidence interval, 1.161.501.95). CONCLUSIONS: The presentation of public reports influenced decision-making behavior. The combination of qualitative and quantitative research helped to guide and enhance understanding of the impacts of proposed changes in reported metrics.

The Collaborative Innovation and Improvement Network (COIIN): Effect on donor yield, waitlist mortality, transplant rates, and offer acceptance.

The Organ Procurement and Transplantation Network implemented the Collaborative Improvement and Innovation Network (COIIN) to improve the use of donors with kidney donor profile index >50%. COIIN recruited 2 separate cohorts of kidney transplant programs. Cohort A included 19 programs of 44 applicants (January 1, 2017, to September 30, 2017), and cohort B included 39 programs of 47 applicants (October 1, 2017, to June 30, 2018). We investigated the effect of COIIN on kidney yield (number of kidneys transplanted from donors from whom any organ was recovered), offer acceptance, deceased donor transplant rates, and waitlist mortality rates for January 1, 2016, to March 31, 2019. COIIN did not notably affect kidney yield or waitlist mortality rates. Cohort A, but not cohort B, had significantly higher deceased donor transplant and offer acceptance rates during its intervention period than programs not in COIIN (adjusted transplant rate ratio: cohort A, 1.08 1.171.27 , cohort B, 0.94 1.011.08 ; adjusted offer acceptance ratio: cohort A, 1.08 1.181.29 , cohort B, 0.93 1.001.08 ). Thus, COIIN improved the use of kidneys at programs in cohort A but not at those in cohort B. Further research is necessary to understand the different effects for cohorts A and B, and further monitoring of posttransplant outcomes is required.

The association between loss of Medicare, immunosuppressive medication use, and kidney transplant outcomes.

Kidney transplant recipients aged <65 years qualify for Medicare coverage, but coverage ends 3 years posttransplant. We determined the association between timing of Medicare loss and immunosuppressive medication fills and kidney allograft loss. Using data from the Scientific Registry of Transplant Recipients (SRTR), US Renal Data System, and Symphony pharmacy fill database, we analyzed 78 861 Medicare-covered, kidney-alone recipients aged <65 years, and assessed the timing of Medicare loss posttransplant: early (<3 years), on-time (at 3 years), or late (>3 years). Immunosuppressant use was measured as medication possession ratio (MPR). Allograft loss was assessed using SRTR data. MPR was lower for recipients with early or late Medicare loss compared with no coverage loss for all immunosuppressive medication types. For calcineurin inhibitors, early Medicare loss was associated with a 53% to 86% lower MPR. On-time Medicare loss was not associated with a lower MPR. When recipients were matched by age, posttransplant timing of Medicare loss, and donor risk, the hazard of allograft loss was 990% to 1630% higher after early Medicare loss, and 140% to 740% higher after late Medicare loss, with no difference in the hazard for on-time Medicare loss. Ensuring ongoing Medicare access before and after 3 years posttransplant could affect graft survival.

Increasing dental health-care utilisation for all: understanding individual factors and place factors in Hawaii.

INTRODUCTION: Dental service utilisation is an important global health problem. Studies report that when people are able to access oral health care, they are more likely to receive basic preventive services than emergency care. Previous studies also report that dental-care utilisation varies according to individual patient and place factors. However, studies on the interplay of individual and place factors are limited. This study investigated the associations of dental-care utilisation according to urban/rural setting and individual patient factors, such as demographic, health care, health behaviour and financial autonomy. METHODS: The association of dental-care utilisation according to individual factors and place was investigated by analysing information obtained from the Hawaii Behavioral Risk Factor Surveillance Survey (BRFSS). The BRFSS is a health-related telephone survey system that collects state data on US residents regarding their health-related risk behaviours, chronic health conditions and use of preventive services. RESULTS: We found that health care, behaviours and financial autonomy were not substantially different between urban sites and rural sites in terms of the odds of dental-service utilisation. Our results showed that individual factors, such as financial autonomy, were more consistently associated with dental-service utilisation. DISCUSSION: Financial autonomy, as well as socio-economic factors, need to be considered to improve dental-service utilisation in Hawaii.