Utility of Ecological Risk Factors for Evaluation of Transplant Center Performance.

There is substantial evidence across different healthcare contexts that social determinants of health are strongly associated with morbidity and mortality in the United States. These factors, including socioeconomic status, behavior and environmental risks, education, social support, healthy food, and access to healthcare also vary widely by region and individual communities. One of the implications of heterogeneity in these risks is the potential impact on measured quality of healthcare providers. In particular, there is concern that providers treating disproportionally vulnerable communities may be disadvantaged by lack of risk adjustment for these factors that affect health but not indicators of quality of care. Recently, the National Quality Forum has endorsed risk adjustment for sociodemographic characteristics based on these concerns. These issues are salient to transplant programs since social determinants of health impact transplant patient outcomes and vary by region. In this viewpoint, we argue that integration of ecological (area-level) factors in risk adjustment models used to assess transplant center quality should be strongly considered. We believe this reform could be accomplished rapidly, would attenuate disparities in access to care by reducing disincentives to treat patients from vulnerable communities, and improve risk adjustment and calibration of models used for center evaluations.

Association of Candidate Removals From the Kidney Transplant Waiting List and Center Performance Oversight.

Approximately 59 000 kidney transplant candidates have been removed from the waiting list since 2000 for reasons other than transplantation, death, or transfers. Prior studies indicate that low-performance (LP) center evaluations by the Scientific Registry of Transplant Recipients (SRTR) are associated with reductions in transplant volume. There is limited information to determine whether performance oversight impacts waitlist management. We used national SRTR data to evaluate outcomes of 315 796 candidates on the kidney transplant waiting list (2007-2014). Compared to centers without LP, rates of waitlist removal (WLR) were higher at centers with LP evaluations (44.6/1000 follow-up years, 95% confidence interval [CI] 44.0, 45.1 versus 68.0/1000 follow-up years, 95% CI 66.6, 69.4), respectively, which was consistent after risk adjustment (adjusted hazard ratio [AHR] = 1.59, 95% CI 1.55, 1.63). Candidate mortality following waitlist removal was lower at LP centers (AHR = 0.90, 95% CI 0.87, 0.94). Analyses limited to LP centers indicated a significant increase in WLR (+28.6 removals/1000 follow-up years, p < 0.001), a decrease in transplant rates (-11.9/1000 follow-up years, p < 0.001) and a decrease in mortality after removal (-67.5 deaths/1000 follow-up years, p < 0.001) following LP evaluation. There is a significant association between LP evaluations and transplant center processes of care for waitlisted candidates. Further understanding is needed to determine the impact of performance oversight on transplant center quality of care and patient outcomes.

Comparing Normothermic Machine Perfusion Preservation With Different Perfusates on Porcine Livers From Donors After Circulatory Death.

The utilization of normothermic machine perfusion (NMP) may be an effective strategy to resuscitate livers from donation after circulatory death (DCD). There is no consensus regarding the efficacy of different perfusates on graft and bile duct viability. The aim of this study was to compare, in an NMP porcine DCD model, the preservation potential of three different perfusates. Twenty porcine livers with 60 min of warm ischemia were separated into four preservation groups: cold storage (CS), NMP with Steen solution (Steen; XVIVO Perfusion Inc., Denver, CO), Steen plus red blood cells (RBCs), or whole blood (WB). All livers were preserved for 10 h and reperfused to simulate transplantation for 24 h. During preservation, the NMP with Steen group presented the highest hepatocellular injury. At reperfusion, the CS group had the lowest bile production and the worst hepatocellular injury compared with all other groups, followed by NMP with Steen; the Steen plus RBC and WB groups presented the best functional and hepatocellular injury outcomes, with WB livers showing lower aspartate aminotransferase release and a trend toward better results for most parameters. Based on our results, a perfusate that contains an oxygen carrier is most effective in a model of NMP porcine DCD livers compared with Steen solution. Specifically, WB-perfused livers showed a trend toward better outcomes compared with Steen plus RBCs.

Critical Factors Associated With Missing Follow-Up Data for Living Kidney Donors in the United States.

Follow-up care for living kidney donors is an important responsibility of the transplant community. Prior reports indicate incomplete donor follow-up information, which may reflect both donor and transplant center factors. New UNOS regulations require reporting of donor follow-up information by centers for 2 years. We utilized national SRTR data to evaluate donor and center-level factors associated with completed follow-up for donors 2008-2012 (n = 30 026) using multivariable hierarchical logistic models. We compared center follow-up compliance based on current UNOS standards using adjusted and unadjusted models. Complete follow-up at 6, 12, and 24 months was 67%, 60%, and 50% for clinical and 51%, 40%, and 30% for laboratory data, respectively, but have improved over time. Donor risk factors for missing laboratory data included younger age 18-34 (adjusted odds ratio [AOR] = 2.03, 1.58-2.60), black race (AOR = 1.17, 1.05-1.30), lack of insurance (AOR = 1.25, 1.15-1.36), lower educational attainment (AOR = 1.19, 1.06-1.34), >500 miles to center (AOR = 1.78, 1.60-1.98), and centers performing >40 living donor transplants/year (AOR = 2.20, 1.21-3.98). Risk-adjustment moderately shifted classification of center compliance with UNOS standards. There is substantial missing donor follow-up with marked variation by donor characteristics and centers. Although follow-up has improved over time, targeted efforts are needed for donors with selected characteristics and at centers with higher living donor volume. Adding adjustment for donor factors to policies regulating follow-up may function to provide more balanced evaluation of center efforts.

Liver, pancreas and kidney transplantation for the treatment of Wolcott-Rallison syndrome.

We present the case of a child who underwent a combined liver, pancreas and double kidney transplant following complications of Wolcott-Rallison syndrome (WRS) a rare genetic disorder that causes infantile insulin-dependent diabetes mellitus (IDDM) and often death in childhood from fulminant liver and concomitant kidney failure. WRS is characterized clinically through infantile IDDM, propensity for liver failure following viral infections, bone dysplasia and growth failure and developmental delay. Fewer than 60 cases with WRS are reported in the literature, mostly from consanguineous parents. Future episodes of liver failure, the main contributor to the increased mortality in WRS, may be prevented through timely liver transplantation. To the best of our knowledge, transplantation has not been utilized to manage complications of WRS prior to this report.

Association between liver transplant center performance evaluations and transplant volume.

There has been increased oversight of transplant centers and stagnation in liver transplantation nationally in recent years. We hypothesized that centers that received low performance (LP) evaluations were more likely to alter protocols, resulting in reduced rates of transplants and patients placed on the waiting list. We evaluated the association of LP evaluations and transplant activity among liver transplant centers in the United States using national Scientific Registry of Transplant Recipients data (January 2007 to July 2012). We compared the average change in recipient and candidate volume and donor and patient characteristics based on whether the centers received LP evaluations. Of 92 eligible centers, 27 (29%) received at least one LP evaluation. Centers without an LP evaluation (n = 65) had an average increase of 9.3 transplants and 14.9 candidates while LP centers had an average decrease of 39.9 transplants (p < 0.01) and 67.3 candidates (p < 0.01). LP centers reduced the use of older donors, donations with longer cold ischemia, and donations after cardiac death (p-values < 0.01). There was no association between the change in transplant volume and measured performance (R(2) = 0.002, p = 0.91). Findings indicate a strong association between performance evaluations and changes in candidate listings and transplants among liver transplant centers, with no measurable improvement in outcomes associated with reduction in transplant volume.

Effect of dialysis initiation for preemptively listed candidates in the revised kidney allocation policy.

The new allocation policy for deceased donor kidneys in the United States is expected to begin in late 2014. As part of this policy, prioritization to the highest quality deceased donor kidneys is dependent on candidate's estimated posttransplant survival (EPTS) score. In particular, candidates with low (≤20%) EPTS (indicating better estimated survival) will have greater access to donor offers. We evaluated the effect of dialysis initiation on preemptively listed candidates' EPTS score. Using current estimates, approximately 10% (n = 19,406) of candidates placed on the waiting list between 2008 and 2013 were listed preemptively and would have qualified for top 20% status. These patients were more likely younger, female, Caucasian and nondiabetic compared to other candidates. Among nondiabetic preemptively listed candidates, dialysis initiation decreases EPTS score (indicating better estimated survival and higher allocation priority) for approximately 5 months. In contrast, diabetic patients' EPTS score significantly increases (approximately 6%) immediately upon dialysis initiation. Our results reveal a counterintuitive aberration in the EPTS formula, which is important for decision making regarding organ selection and timing of dialysis initiation in the new allocation system. Revision of the EPTS formula should be considered to address these findings and further understanding of the impact of the new allocation system on candidates' prognosis is important.

Prominent impact of community risk factors on kidney transplant candidate processes and outcomes.

Numerous factors impact patients' health beyond traditional clinical characteristics. We evaluated the association of risk factors in kidney transplant patients' communities with outcomes prior to transplantation. The primary exposure variable was a community risk score (range 0-40) derived from multiple databases and defined by factors including prevalence of comorbidities, access and quality of healthcare, self-reported physical and mental health and socioeconomic status for each U.S. county. We merged data with the Scientific Registry of Transplant Recipients (SRTR) and utilized risk-adjusted models to evaluate effects of community risk for adult candidates listed 2004-2010 (n = 209 198). Patients in highest risk communities were associated with increased mortality (adjusted hazard ratio [AHR] = 1.22, 1.16-1.28), decreased likelihood of living donor transplantation (adjusted odds ratio [AOR] = 0.90, 0.85-0.94), increased waitlist removal for health deterioration (AHR = 1.36, 1.22-1.51), decreased likelihood of preemptive listing (AOR = 0.85, 0.81-0.88), increased likelihood of inactive listing (AOR = 1.49, 1.43-1.55) and increased likelihood of listing for expanded criteria donor kidneys (AHR = 1.19, 1.15-1.24). Associations persisted with adjustment for rural-urban location; furthermore the independent effects of rural-urban location were largely eliminated with adjustment for community risk. Average community risk varied widely by region and transplant center (median = 21, range 5-37). Community risks are powerful factors associated with processes of care and outcomes for transplant candidates and may be important considerations for developing effective interventions and measuring quality of care of transplant centers.

The prognostic value of kidney transplant center report cards.

SRTR report cards provide the basis for quality measurement of US transplant centers. There is limited data evaluating the prognostic value of report cards, informing whether they are predictive of prospective patient outcomes. Using national SRTR data, we simulated report cards and calculated standardized mortality ratios (SMR) for kidney transplant centers over five distinct eras. We ranked centers based on SMR and evaluated outcomes for patients transplanted the year following reports. Recipients transplanted at the 50th, 100th and 200th ranked centers had 18% (AHR = 1.18, 1.13-1.22), 38% (AHR = 1.38, 1.28-1.49) and 91% (AHR = 1.91, 1.64-2.21) increased hazard for 1-year mortality relative to recipients at the top-ranked center. Risks were attenuated but remained significant for long-term outcomes. Patients transplanted at centers meeting low-performance criteria in the prior period had 40% (AHR = 1.40, 1.22-1.68) elevated hazard for 1-year mortality in the prospective period. Centers' SMR from the report card was highly predictive (c-statistics > 0.77) for prospective center SMRs and there was significant correlation between centers' SMR from the report card period and the year following (ρ = 0.57, p < 0.001). Although results do not mitigate potential biases of report cards for measuring quality, they do indicate strong prognostic value for future outcomes. Findings also highlight that outcomes are associated with center ranking across a continuum rather than solely at performance margins.

The impact of deceased donor kidney risk significantly varies by recipient characteristics.

As of May 2012, over 92 000 patients were awaiting a solitary kidney transplant in the United States and new waitlist registrations have been rising for over a decade. The decreasing availability of donor organs makes it imperative that organ allocation be as efficient and effective as possible. We performed a retrospective cohort study of adult recipients in the United States (n=109 392) using Scientific Registry of Transplant Recipients data. The primary aim was to evaluate the interaction of donor risk with recipient characteristics on posttransplant outcomes. Donor quality (based on kidney donor risk index [KDRI]) had significant interactions by race, primary diagnosis and age. The hazard of KDRI on overall graft loss in non-African Americans was 2.16 (95%CI 2.08-2.25) versus 1.85 (95%CI 1.75-1.95) in African Americans (p<0.0001), 2.16 (95%CI 2.08-2.24) in nondiabetics versus 1.84 (95%CI 1.74-1.94) in diabetics (p<0.0001), and 2.22 (95%CI 2.13-2.32) in recipients<60 years versus 1.83 (95%CI 1.74-1.92) in recipients≥60 (p<0.0001). The relative hazard for diabetics at KDRI=0.5 was 1.49 but at KDRI=2.0 the hazard was significantly attenuated to 1.17; among African Americans the respective risks were 1.50 and 1.17 and among recipients 60 and over, it was between 1.64 and 1.22. These findings are critical considerations for informed decision-making for transplant candidates.

The association of center performance evaluations and kidney transplant volume in the United States.

Report cards evaluating transplant center performance have received significant attention in recent years corresponding with the Centers for Medicare and Medicaid Services issue of the 2007 Conditions of Participation. Our primary aim was to evaluate the association of report card evaluations with transplant center volume. We utilized data from the Scientific Registry of Transplant Recipients (SRTR) along with six consecutive program-specific reports from January 2007 to July 2009 for adult kidney transplant centers. Among 203 centers, 46 (23%) were low performing (LP) with statistically significantly lower than expected 1-year graft or patient survival at least once during the study period. Among LP centers, there was a mean decline in transplant volume of 22.4 cases compared to a mean increase of 7.8 transplants among other centers (p = 0.001). Changes in volume between LP and other centers were significant for living, standard and expanded criteria deceased donor (ECD) transplants. LPs had a reduction in use of donors with extended cold ischemia time (p = 0.04) and private pay recipients (p = 0.03). Centers without low performance evaluations were more likely to increase the proportion of overall transplants that were ECDs relative to other centers (p = 0.04). Findings indicate a significant association between reduced kidney transplant volume and low performance report card evaluations.