Persistent regional and racial disparities in nondirected living kidney donation

Nondirected living donors (NDLDs) are an important and growing source of kidneys to help reduce the organ shortage. In its infancy, NDLD transplantation was clustered at a few transplant centers and rarely benefited African American (AA) recipients. However, NDLDs have increased 9.4‐fold since 2000, and now are often used to initiate kidney paired donation chains. Therefore, we hypothesized that the initial geographic clustering and racial disparities may have improved. We used Scientific Registry of Transplant Recipients data to compare NDLDs and their recipients between 2008‐2015 and 2000‐2007. We found that NDLD increased an average of 12% per year, from 20 in 2000 to 188 in 2015 (IRR: 1.12, 95% CI: 1.11‐1.13, P < .001). In 2000‐2007, 18.3% of recipients of NDLD kidneys were AA; this decreased in 2008‐2015 to 15.7%. NDLD transplants initially became more evenly distributed across centers (Gini 0.91 in 2000 to Gini 0.69 in 2011), but then became more clustered at fewer transplant centers (Gini 0.75 in 2015). Despite the increased number of NDLDs, racial disparities have worsened and the center‐level distribution of NDLD transplants has narrowed in recent years.     

CMS oversight,OPOs and transplant centers and the law of unintended consequences

Abstract: The Health Resources and Services Administration launched collaboratives with the goals of increasing donation rates, increasing the number of organs transplanted, eliminating deaths on the waiting list and improving outcomes. The Center for Medicare and Medicaid Services (CMS) recently published requirements for organ procurement organizations (OPOs) and transplant centers. Failure to meet CMS performance measures could result in OPOs losing their service area or transplant centers losing their CMS certification. CMS uses analyses by the Scientific Registry of Transplant Recipients (SRTR) to evaluate a transplant center’s performance based on risk‐adjusted outcomes. However, CMS also uses a more liberal (one‐sided) statistical test rendering more centers likely to qualify as low performing. Furthermore, the SRTR model does not incorporate some important patient variables in its statistical model which may result in biased determinations of quality of care. Cumulatively, there is much unexplained variation for transplant outcomes as suggested by the low predictive ability of survival models compared to other disease contexts. OPOs and transplant centers are unlikely to quietly accept their elimination. They may take certain steps that can result in exclusion of candidates who might otherwise benefit from transplantation and/or result in fewer transplants through restricted use of organs thought to carry higher risk of failure. CMS should join with transplant organizations to ensure that the goals of the collaborative are not inhibited by their performance measures.     

Center‐Level Utilization of Kidney Paired Donation

With many multicenter consortia and a United Network for Organ Sharing program, participation in kidney paired donation (KPD) has become mainstream in the United States and should be feasible for any center that performs live donor kidney transplantation (LDKT). Lack of participation in KPD may significantly disadvantage patients with incompatible donors. To explore utilization of this modality, we analyzed adjusted center‐specific KPD rates based on casemix of adult LDKT‐eligible patients at 207 centers between 2006 and 2011 using SRTR data. From 2006 to 2008, KPD transplants became more evenly distributed across centers, but from 2008 to 2011 the distribution remained unchanged (Gini coefficient = 0.91 for 2006, 0.76 for 2008 and 0.77 for 2011), showing an unfortunate stall in dissemination. At the 10% of centers with the highest KPD rates, 9.9–38.5% of LDKTs occurred through KPD during 2009–2011; if all centers adopted KPD at rates observed in the very high‐KPD centers, the number of KPD transplants per year would increase by a factor of 3.2 (from 494 to 1593). Broader implementation of KPD across a wide number of centers is crucial to properly serve transplant candidates with healthy but incompatible live donors.     

Liver transplantation: waiting list dynamics in the state of São Paulo, Brazil

S?o Paulo is the first Brazilian state to perform liver transplantation in 1968. Since then the recipient waiting list has increased; now approximately 150 new cases per month are referred to the single list at the central organ procurement organization. Official data have shown 37.3 monthly deaths on the waiting list in the state of S?o Paulo. The number of liver transplants has increased after the creation of S?o Paulo transplant notification centers but are insufficient to deal with the increasing waiting list. The aim of this study was to demonstrate the performance of our state liver transplantation program and analyze when the number of liver transplantations will meet our waiting list demand.     

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.     

Measuring and monitoring equity in access to deceased donor kidney transplantation

The Organ Procurement and Transplantation Network monitors progress toward strategic goals such as increasing the number of transplants and improving waitlisted patient, living donor, and transplant recipient outcomes. However, a methodology for assessing system performance in providing equity in access to transplants was lacking. We present a novel approach for quantifying the degree of disparity in access to deceased donor kidney transplants among waitlisted patients and determine which factors are most associated with disparities. A Poisson rate regression model was built for each of 29 quarterly, period‐prevalent cohorts (January 1, 2010‐March 31, 2017; 5 years pre–kidney allocation system [KAS], 2 years post‐KAS) of active kidney waiting list registrations. Inequity was quantified as the outlier‐robust standard deviation (SD_w) of predicted transplant rates (log scale) among registrations, after “discounting” for intentional, policy‐induced disparities (eg, pediatric priority) by holding such factors constant. The overall SD_w declined by 40% after KAS implementation, suggesting substantially increased equity. Risk‐adjusted, factor‐specific disparities were measured with the SD_w after holding all other factors constant. Disparities associated with calculated panel‐reactive antibodies decreased sharply. Donor service area was the factor most associated with access disparities post‐KAS. This methodology will help the transplant community evaluate tradeoffs between equity and utility‐centric goals when considering new policies and help monitor equity in access as policies change.     

Risks,benefits, and ethical questions associated with transplanting kidneys from hepatitis C virus‐infected donors into hepatitis C virus‐negative patients

Utilization of kidneys from hepatitis C virus (HCV)‐infected deceased donors has the potential to increase the number of kidney transplants by 500‐1000 (or more) each year. This increase in the number of kidney transplants offers major opportunities to extend survival and improve quality of life for patients infected with HCV, as well as uninfected recipients. However, due to a lack of prospective safety and efficacy data on a sufficient number of HCV‐negative recipients who received a kidney from a HCV‐infected donor, as well as key logistical barriers, the practice of transplanting HCV‐infected organs into uninfected recipients is not yet ready to be considered as standard of care. Ongoing research coupled with a collaboration between insurers and transplant centers might bring positive‐into‐negative transplant into the realm of standard of care in well‐informed transplant candidates, regardless of HCV status.     

OPTN/SRTR 2018 Annual Data Report: Intestine

Despite medical and surgical advances in treatment of intestinal failure, intestine transplant still plays an important role. However, the number of new patients added to the intestine transplant waiting list has decreased over the past decade, reaching a low of 135 in 2018. The number of intestine donors also decreased, reaching a low of 106 in 2018, and the number of intestine transplants performed declined to its lowest level, 104, of which 59% were intestine‐liver transplants. Graft failure has plateaued over the past decade. Patient survival for transplants in 2011‐2013 varied by age and transplant type. Patient survival was lowest for adult intestine‐liver recipients (1‐and 5‐year survival 66.7% and 49.1%, respectively) and highest for pediatric intestine recipients (1‐and 5‐year survival 89.1% and 76.4%, respectively).     

Transplant Center Quality Assessment Using a Continuously Updatable, Risk-Adjusted Technique (CUSUM)

Access to timely, risk-adjusted measures of transplant center outcomes is crucial for program quality improvement. The cumulative summation technique (CUSUM) has been proposed as a sensitive tool to detect persistent, clinically relevant changes in transplant center performance over time. Scientific Registry of Transplant Recipients data for adult kidney and liver transplants (1/97 to 12/01) were examined using logistic regression models to predict risk of graft failure (kidney) and death (liver) at 1 year. Risk-adjusted CUSUM charts were constructed for each center and compared with results from the semi-annual method of the Organ Procurement and Transplantation Network (OPTN). Transplant centers (N = 258) performed 59 650 kidney transplants, with a 9.2% 1-year graft failure rate. The CUSUM method identified centers with a period of significantly improving (N = 92) or declining (N = 52) performance. Transplant centers (N = 114) performed 18 277 liver transplants, with a 13.9% 1-year mortality rate. The CUSUM method demonstrated improving performance at 48 centers and declining performance at 24 centers. The CUSUM technique also identified the majority of centers flagged by the current OPTN method (20/22 kidney and 8/11 liver). CUSUM monitoring may be a useful technique for quality improvement, allowing center directors to identify clinically important, risk-adjusted changes in transplant center outcome.     

Consummation of the Legislative Map of Transplantation in Latin America: Law on Donation and Transplantation Nicaragua–The Last Piece of the Puzzle

Latin America started its transplant activity early—as soon as the first transplants in the world took place. Its member states have created their laws of donation and transplantation also. The first laws for transplants in the region were created in Brazil in 1963. Subsequently, all states approved its regulatory framework for transplants. Until 2012, Nicaragua was the only country in the region that did not have a transplants law. In October 2013, Nicaragua adopted the “Law on Donation and Transplantation of Organs, Tissues and Cells for Human Beings,” which consummates the process that creates the legal framework for donation and transplantation in Latin America, a journey of 50 years' duration, from Brazil's law to Nicaragua's law. This achievement is the fundament for searching an exercise of transplantation in a ground of accessibility, equity, ethics, and transparency as part of comprehensive health care services in the region.     

Incidence of delayed graft function in cadaveric kidney transplants in Brazil: a multicenter analysis

To evaluate the frequency of delayed graft function (DGF) in kidney transplant centers in Brazil, we sent a questionnaire requesting information on the number of cadaveric donor kidney transplants performed during the years 2000, 2001, and 2002, the number of early nonfunctioning grafts, and the number of patients on dialysis during the first posttransplant week with subsequent recovery. Among all centers performing more than 50 kidney transplants during the last year of evaluation, 6, performing 612 cadaveric kidney transplants during the study period, replied to the questionnaire. Sixty procedures (9.7%) resulted in nonfunctioning grafts, while 312 (55.6%) patients required dialysis during the first Ptx week: 216 (53.9%) in 2000, 189 (62.3%) in 2001, and 216 (51.6%) in 2002. The frequency of DGF during the study period was higher than that noted by several previous foreign studies. To better evaluate the possible causes of this finding, a more extensive and focused study is warranted.     

A National Survey Assessing the Current Workforce of Transplant Pharmacists Across Accredited U.S. Solid Organ Transplant Programs

Integration of pharmacists into multidisciplinary transplant patient care has advanced in recent years, with limited data available to evaluate the current status of the profession. This was a national survey developed as an AST Pharmacy COP initiative. Responses were solicited from pharmacists practicing at U.S. transplant programs based on UNOS listing; 176 participants from 113 centers (41%) responded, with 79% practicing ≤10 years. There is a median of 1.4 pharmacist full‐time equivalents (FTEs) (range 0.1–7.1) for every 100 transplants. The predominant activities performed by pharmacists during the transplant phase include medication review (95%), lab review (92%), allergy review (88%), medication therapy management (92%), bedside rounds (87%), medication education (79%), documentation (71%), and coordinating discharge medications (58%). Similar activities were reported during the other phases, but participation was less common. The involvement of dedicated transplant pharmacists within multidisciplinary care has become standard at a large number of centers, although expansion is still needed to ensure core pharmaceutical care components are provided to all transplant recipients across all centers. These results inform on the typical responsibilities of pharmacists practicing within the field of transplantation and illustrate that the level of pharmacist involvement significantly varies across transplant centers and the phases of transplantation.     

There Are 33,784 Functioning Kidney Grafts in Spain: Who Monitors Them and How?

BackgroundAs of December 31, 2018, Spain's National Transplant Organization estimated that there were 61,764 people under renal replacement therapy across the country. Of this population, 33,784 (54.7%) had a functioning kidney graft.MethodsThrough the use of a survey to all Spanish hospitals involved in kidney transplantations, we studied the distribution of these recipients nationally, along with who was monitoring them and how. Data collected include the ratio of recipients to transplant nephrologists, median number of recipients followed in each center, and median number of transplant nephrologists per hospital. Of the 806 centers in the Spanish hospital network, 43 (5.3%) were involved in kidney transplants, including 39 transplant hospitals and 4 associated hospitals. The median number of transplants per center was 800 (interquartile range [IQR] = 510-1200). There were 3 nephrologists (IQR 2-5), and the ratio of recipients to transplant nephrologists was 270 (IQR = 190-323).ResultsThere were no significant differences in these data between autonomous communities, except in the case of the Canary Islands, which had a significantly lower ratio of recipients to transplant nephrologists (146; IQR = 100-185) compared with the rest of the country (ratio 277; IQR = 207-329; P < .001). Of the 39 hospitals, 29 (74.4%) referred patients to centers that did not perform transplants.ConclusionsAll in all, few Spanish hospitals perform kidney transplants. The ratio of recipients to transplant nephrologists is very high, compelling most hospitals to refer patients to nontransplant hospitals for follow-up. There are important differences in the distribution of recipients in hospitals in the Canary Islands vs the rest of the country, a difference that is undoubtedly attributable to its geographic peculiarities.     

OPTN/SRTR 2018 Annual Data Report: Kidney

Despite the ongoing severe mismatch between organ need and supply, data from 2018 revealed some promising trends. For the fourth year in a row, the number of patients waiting for a kidney transplant in the US declined and numbers of both deceased and living donor kidney transplants increased. These encouraging trends are tempered by ongoing challenges, such as a large proportion of listed patients with dialysis time longer than 5 years. The proportion of candidates aged 65 years or older continued to rise, and the proportion undergoing transplant within 5 years of listing continued to vary dramatically nationwide, from 10% to nearly 80% across donation service areas. Increasing trends in the recovery of organs from hepatitis C positive donors and donors with anoxic brain injury warrant ongoing monitoring, as does the ongoing discard of nearly 20% of recovered organs. While the number of living donor transplants increased, racial disparities persisted in the proportion of living versus deceased donors. Strikingly, the total number of kidney transplant recipients alive with a functioning graft is on track to pass 250,000 in the next 1‐2 years. The total number of pediatric kidney transplants remained steady at 756 in 2018. Deeply concerning to the pediatric community is the persistently low level of living donor kidney transplants, representing only 36.2% in 2018.     

Bi‐organ paired exchange—Sentinel case of a liver‐kidney swap

Organ transplantation is the optimal treatment for patients with end stage liver disease and end stage renal disease. However, due to the imbalance in the demand and supply of deceased organs, most transplant centers worldwide have consciously pursued a strategy for living donation. Paired exchanges were introduced as a means to bypass various biologic incompatibilities (blood‐ and tissue‐typing), while expanding the living donor pool. This shift in paradigm has introduced new ethical concerns that have hitherto been unaddressed, especially with nondirected, altruistic living donors. So far, transplant communities have focused efforts on separate liver‐ and kidney‐paired exchanges, whereas the concept of a transorgan paired exchange has been theorized and could potentially facilitate a greater number of transplants. We describe the performance of the first successful liver‐kidney swap.     

Potential to Mitigate Disparities in Access to Kidney Transplant in the Hispanic/Latino Population With a Specialized Clinic: Single Center Study Representing Single State Data

BackgroundWe sought to evaluate potential disparities in kidney transplant rates in a single state in the United States. We studied the potential to mitigate disparities with a specialized clinic using it as a model presentation.MethodsBased on data from the United States Renal Data System and Organ Procurement and Transplantation Network, we estimated the yearly end-stage renal disease and waitlist addition, stratified by race/ethnicity from 2000 to 2018. Institution rates were analyzed similarly, and the implementation of a focused Latino clinic was evaluated.ResultsThe number of patients added to the national transplant waitlist has increased by 40% in non-Latino whites and by 160% in Latinos from 2000 to 2017. Comparing the period from 2000 to 2004 to 2015 to 2018 in North Carolina, the waitlist increased for Latino patients by 482% and non-Latino whites by 23%. One year after a designated Latino transplant clinic at our institution, there was a 125% increase in the number of Latino referrals for kidney transplant evaluation, a 142% increase in the number of waitlisted Latino patients, and an increase in kidney transplants of 145%.ConclusionWith the increasing number of patients in the Latino community who are diagnosed with end-stage renal disease, there is a direct benefit for a culturally competent program that addresses access to transplants.     

Expanding clarity or confusion? Volatility of the 5‐tier ratings assessing quality of transplant centers in the United States

Outcomes of patients receiving solid organ transplants in the United States are systematically aggregated into bi‐annual Program‐Specific Reports (PSRs) detailing risk‐adjusted survival by transplant center. Recently, the Scientific Registry of Transplant Recipients (SRTR) issued 5‐tier ratings evaluating centers based on risk‐adjusted 1‐year graft survival. Our primary aim was to examine the reliability of 5‐tier ratings over time. Using 10 consecutive PSRs for adult kidney transplant centers from June 2012 to December 2016 (n = 208), we applied 5‐tier ratings to center outcomes and evaluated ratings over time. From the baseline period (June 2012), 47% of centers had at least a 1‐unit tier change within 6 months, 66% by 1 year, and 94% by 3 years. Similarly, 46% of centers had at least a 2‐unit tier change by 3 years. In comparison, 15% of centers had a change in the traditional 3‐tier rating at 3 years. The 5‐tier ratings at 4 years had minimal association with baseline rating (Kappa 0.07, 95% confidence interval [CI] ‐0.002 to 0.158). Centers had a median of 3 different 5‐tier ratings over the period (q1 = 2, q3 = 4). Findings were consistent for center volume, transplant rate, and baseline 5‐tier rating. Cumulatively, results suggest that 5‐tier ratings are highly volatile, limiting their utility for informing potential stakeholders, particularly transplant candidates given expected waiting times between wait listing and transplantation.     

OPTN/SRTR 2017 Annual Data Report: Heart

In 2017, 3273 heart transplants were performed in the United States. New listings continued to increase, and 3769 new adults were listed for heart transplant in 2017. Over the past decade, posttransplant mortality has declined. The number of new pediatric listings increased over the past decade, as did the number of pediatric heart transplants, although some fluctuation has occurred more recently. New listings for pediatric heart transplants increased from 481 in 2007 to 623 in 2017. The number of pediatric heart transplants performed each year increased from 330 in 2007 to 432 in 2017, slightly fewer than in 2016. Short‐term and long‐term mortality improved. Among pediatric patients who underwent transplant between 2015‐2016, 4.8% had died by 6 months and 6.2% by 1 year.     

Lung Transplant Center Volume Ameliorates Adverse Influence of Prolonged Ischemic Time on Mortality

The influence of prolonged ischemic time on outcomes after lung transplant is controversial, but no research has investigated ischemic time in the context of center volume. We used data from the United Network for Organ Sharing to estimate the influence of ischemic time on patient survival conditional on center volume in the post–lung allocation score era (2005–2015). The analytic sample included 14 877 adult lung transplant recipients, of whom 12 447 were included in multivariable survival analysis. Patient survival was improved in high‐volume centers compared with low‐volume centers (log‐rank test p = 0.001), although mean ischemic times were longer at high‐volume centers (5.16 ± 1.70 h vs. 4.83 ± 1.63 h, p < 0.001). Multivariable Cox proportional hazards regression stratified by transplant center found an adverse influence of longer ischemic time at low‐volume centers but not at high‐volume centers. At centers performing 50 transplants in the period 2005–2015, for example, 8 versus 6 h of ischemia were associated with an 18.9% (95% confidence interval 6.5–32.7%; p < 0.001) greater mortality hazard, whereas at centers performing 350 transplants in this period, no differences in survival by ischemic time were predicted. Despite longer mean ischemic time at high‐volume transplant centers, these centers had favorable patient outcomes and no adverse survival implications of prolonged ischemia.     

Disruptions in the Supply of Medications Used in Transplantation: Implications and Management Strategies for the Transplant Clinician

Drug shortages are a threat to patient care and public health, and the number of drugs on shortage is growing at an exponential rate. The major therapy areas affected by these shortages are oncology, anti‐infective, cardiovascular and central nervous system. However, drugs utilized in the transplant patient population have not been exempt, and can have significant influence on posttransplant outcomes. The purpose of this review is to discuss the current and historical solid organ transplant‐related disruptions in the supply of medications and implications on patient care and safety. Transplant centers should be armed with an implementation plan when imperative transplant‐related drugs such as tacrolimus, mycophenolate, or antithymocyte globulin go on shortage. This plan should provide steps to manage the shortage, and provide effective therapeutic alternatives.