Expanded Criteria Donor Recipients Research Articles

Impact of Donation After Circulatory Death on Outcomes of Expanded Criteria Donor Kidney Transplants

Expanded criteria donor (ECD) kidneys experience suboptimal outcomes compared with standard criteria donor kidneys. To examine the additional impact of deceased organ category, donation after circulatory death (DCD), and neurologic determination of death (NDD) on ECD outcomes, we examined 1- and 3-year patient and graft survival in all ECD kidney recipients in our institution between January 2008 and December 2017. Of 166 ECD recipients, 49 (29.5%) were DCD and 117 (70.5%) were NDD. Delayed graft function was higher in the DCD/ECD group 61.2 % vs 32.0 % among NDD/ECD recipients. Graft loss was significantly increased among DCD/ECD (hazard ratio for graft loss 4.81 [95% CI1.78-13.01], P = .002 at 1 year and 2.03 [95% CI 1.03-4.0], P = .042 at 3 years). Death-censored graft loss was higher among DCD/ECD (hazard ratio was 10.12 [95% CI, 2.14, 47.92], P = .004 at 1 year and 2.83 [95% CI, 1.24, 6.46], P = .014 at 3 years). There was no statistically significant difference in all-cause mortality. Our study demonstrated that DCD/ECD kidneys have lower graft survival compared with NDD/ECD kidneys. Time on dialysis, waiting time, and panel reactive antibody should be taken into account when offering these organs to patients.

A kidney discard decision strategy based on zero-time histology analysis could lead to an unjustified increase in the organ turndown rate among ECD.

The utility of zero-time kidney biopsies (KB) in deciding to accept expanded criteria donor (ECD) kidneys remains controversial. However, zero-time histology is one of the main causes for discarding kidneys in the United States. In a single-centre study, we examined the utility and impact on outcome of the use of frozen section zero-time KB among ECD. Ninety-two zero-time KB were analysed for accept/discard decision between 2005 and 2015 among ECD. 53% of kidneys were rejected after zero-time KB analysis; there was no difference in individual clinical and biological data between accepted/rejected groups. However, histology of rejected kidneys showed more sclerotic glomeruli (20% vs. 8%; P<0.001), increased interstitial fibrosis (1.25±0.12 vs. 0.47±0.09; P<0.0001), more arteriosclerosis (2.14±0.17 vs. 1.71±0.11; P=0.0032) and arteriolar hyalinosis (2.15±0.12 vs. 1.55±0.11; P=0.0006). Using propensity score matching, we generated a group of 42 kidney allograft recipients who received a transplant matched for donor zero-time histology and clinical characteristics with donors whose kidneys were rejected. Interestingly, their 1- and 5-year graft survival and function were similar to the global cohort of ECD recipients. In conclusion, when performed, zero-time KB was a decisive element for kidney discard decision. However, adverse zero-time histology was not associated with poorer graft survival and kidney function among ECD.

Impact of pre-transplant biopsy on 5-year outcomes of expanded criteria donor kidney transplantation.

Compared to Standard Criteria Donors (SCD), Expanded Criteria Donor (ECD) kidneys are associated with poorer outcomes, although pre-transplant biopsy may mitigate risks. This study assessed 5-year outcomes of deceased-donor kidney transplant recipients, comparing recipients of ECD allografts evaluated histologically to recipients of SCD and ECD kidneys assessed clinically. This is a single-centre retrospective study. From November 2005 to December 2009 (Era 1), donors were assessed clinically for suitability for kidney donation. From December 2009 to October 2017 (Era 2), kidneys from ECDs and diabetics underwent pre-transplant biopsy and were allocated based on Remuzzi score. Outcomes of Era 1 and 2 recipients were compared. ECD kidney transplantation increased from 30.4% to 40.0% from Era 1 to 2. Univariable Cox regression, stratified by transplant era, found that 5-year graft loss was highest with Era 1 ECD (HR 2.5, 95% CI 1.1-5.5, P = .027) while graft loss for Era 2 ECD recipients was similar to SCD recipients. There was no difference in 5-year recipient survival. Amongst Era 1 ECD recipients, 51.2% experienced rejection compared to 30.8-41.5% for other subgroups. Five-year eGFR was higher with Era 2 ECD at 48.4 (33.3-60.7) ml/min/1.73 m2 compared to 42.2 (35.8-57.3) ml/min/1.73 m2 for Era 1 ECD. However, these differences were not statistically significant. Introduction of pre-transplant biopsy assessment may be associated with improved outcomes of ECD kidney recipients such that they are now comparable to SCD kidney recipients, with benefits persisting over 5 years.

Multicenter registry analysis comparing survival on home hemodialysis and kidney transplant recipients in Australia and New Zealand.

In the era of organ shortage, home hemodialysis (HHD) has been identified as the possible preferential bridge to kidney transplantation. Data are conflicting regarding the comparability of HHD and transplantation outcomes. This study aimed to compare patient and treatment survival between HHD patients and kidney transplant recipients. The Australia and New Zealand Dialysis and Transplant Registry was used to include incident HHD patients on Day 90 after initiation of kidney replacement therapy and first kidney-only transplant recipients in Australia and New Zealand from 1997 to 2017. Survival times were analyzed using the Kaplan-Meier product-limit method comparing HHD patients with subtypes of kidney transplant recipients using the log-rank test. Adjusted analyses were performed with multivariable Cox proportional hazards regression models for time to all-cause mortality. Time-to-treatment failure or death was assessed as a composite secondary outcome. The study compared 1411 HHD patients with 4960 living donor (LD) recipients, 6019 standard criteria donor (SCD) recipients and 2427 expanded criteria donor (ECD) recipients. While LD and SCD recipients had reduced risks of mortality compared with HHD patients [LD adjusted hazard ratio (HR) = 0.57, 95% confidence interval (CI) 0.46-0.71; SCD HR = 0.65 95% CI 0.52-0.79], the risk of mortality was comparable between ECD recipients and HHD patients (HR = 0.90, 95% CI 0.73-1.12). LD, SCD and ECD kidney recipients each experienced superior time-to-treatment failure or death compared with HHD patients. This large registry study showed that kidney transplant offers a survival benefit compared with HHD but that this advantage is not significant for ECD recipients.

Use of expanded-criteria donors and>85 KDPI kidneys for pediatric kidney transplantation in the United States.

Pediatric kidney transplant outcomes associated with expanded-criteria donors (ECD) and high Kidney Donor Profile Index (KDPI) kidneys are unknown. We reviewed the Scientific Registry of Transplant Recipients data from 1987-2017 to identify 96 ECD and 92>85 KDPI kidney recipients (<18years). Using propensity scores, we created comparison groups of 375 non-ECD and 357≤85 KDPI recipients for comparisons with ECD and>85 KDPI transplants, respectively. We used Cox regression for patient/graft survival and sequential Cox approach for survival benefit of ECD and>85 KDPI transplantationvs remaining on the waitlist. After adjustment, ECD recipients were at significantly increased risk of graft failure (adjusted hazard ratio [aHR]=1.6; P=.001) but not of mortality (aHR=1.33; P=.15) compared with non-ECD recipients. We observed no survival benefit of ECD transplants vs remaining on the waitlist (aHR=1.05; P=.83). We found no significant difference in graft failure (aHR=1.27; P=.12) and mortality (aHR=1.41; P=.13) risks between>85 KDPI and≤85 KDPI recipients. However, > 85 KDPI transplants were associated with a survival benefit vs remaining on the waitlist (aHR=0.41; P=.01). ECD transplantation in children is associated with a high graft loss risk and no survival benefit, whereas>85 KDPI transplantation is associated with a survival benefit for children vs remaining on the waitlist.

P1431MULTI-CENTER REGISTRY ANALYSIS COMPARING SURVIVAL ON HOME HEMODIALYSIS AND KIDNEY TRANSPLANT RECIPIENTS IN AUSTRALIA AND NEW ZEALAND

Abstract Background and Aims In the era of organ shortage, home hemodialysis (HHD) has been identified as the possible preferential bridge to kidney transplantation. Data are conflicting regarding the comparability of HHD and transplantation outcomes. This study aimed to compare patient and treatment survival between HHD patients and kidney transplant recipients. Method The Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry was used to include incident HHD patients on day 90 after initiation of kidney replacement therapy and first kidney-only transplant recipients in Australia and New Zealand from 1997 to 2017. Survival times were analyzed using the Kaplan-Meier product limit method comparing HHD patients to subtypes of kidney transplant recipients using the log-rank test. Adjusted analyses were performed with multivariable Cox proportional hazards regression models for time to all-cause mortality. Time-to-treatment failure or death was assessed as a composite secondary outcome. Results The study compared 1411 HHD patients to 4960 living donor (LD) recipients, 6019 standard criteria donor (SCD) recipients and 2427 expanded criteria donor (ECD) recipients. While LD and SCD recipients had reduced risks of mortality compared to HHD patients (LD adjusted hazard ratio [HR] 0.57, 95%CI 0.46-0.71; SCD HR 0.65 95%CI 0.52-0.79), the risk of mortality was comparable between ECD recipients and HHD patients (HR 0.90, 95%CI 0.73-1.12). LD, SCD and ECD kidney recipients each experienced superior time-to-treatment failure or death compared to HHD patients. Conclusion This large registry study showed that kidney transplant offers a survival benefit compared to HHD but that this advantage is not significant for ECD recipients.

Variable Benefits of Antibody Induction by Kidney Allograft Type

BackgroundKidneys from acute renal failure (ARF), expanded criteria donors (ECD), and donation after cardiac death (DCD) donors are often discarded due to concerns for delayed graft function (DGF) and graft failure. Induction immunosuppression may be used to minimize these risks, but practices vary widely. Furthermore, little is known regarding national outcomes of transplant recipients receiving induction immunosuppression for receipt of high-risk kidneys. Materials and methodsUsing a center-level retrospective study, deceased donor transplants (115,485) from the Scientific Registry of Transplant Recipients from January 2003 to June 2016 were evaluated. Patients who received induction immunosuppression, including lymphocyte immune globulin, muromonab CD-3, IL-1 receptor antagonist, anti-thymocyte globulin, daclizumab, basiliximab, alemtuzumab, and rituximab, were included. Associations of center-level induction use with acute rejection in the first post-transplant year, graft failure, and patient mortality were evaluated using multivariable Cox and logistic regression. ResultsAmong all kidneys, increasing percentage of center-level induction was associated with lower risk of graft failure, acute rejection, and patient mortality. In recipients of ARF kidneys, the beneficial association of induction on graft failure and acute rejection was greater than in those that received non-ARF kidneys. Marginally greater benefit of induction was seen for acute rejection in ECD compared to standard criteria donor (SCD) recipients and for graft failure in DCD compared to donors after brain death (DBD). No benefit of induction was detected for patient and graft survival in ECD recipients, acute rejection in DCD recipients, and patient survival in DGF recipients. No difference in the benefit of induction was detected in any other comparisons. ConclusionsWhile seemingly beneficial for recipients of all kidneys, induction has more robust associations with lower graft failure and acute rejection probability for recipients of ARF kidneys. Given the lack of observed benefit for ECD recipients, induction policies should be carefully considered in these patients.

Analysis of Distribution of Expanded- and Standard-Criteria Donors and Complications Among Polish Recipients by Kidney Donor Risk Index Value

IntroductionThe approach toward transplanting kidneys from expanded-criteria donors (ECDs) in Poland is largely site-dependent. The Kidney Donor Risk Index (KDRI) allows for obtaining a more precise characteristic of ECDs and further stratification into “better” and “worse” quality grafts. MethodsComparison of the incidence of delayed graft function (DGF) and biopsy-proven acute rejection (BPAR), median of hospitalization time and median of estimated glomerular filtration rate (eGFR) at 1 year after transplantation among kidney graft recipients (n = 468), divided by donor status (ECD/standard-criteria donor [SCD]) and KDRI value (I: 0.67–1.2, II: 1.21–1.6, III: 1.61–2.0, IV: 2.01–3.48). ResultsECD kidneys have been transplanted to 32.47% of recipients. There were no ECD recipients in KDRI compartment I, 16.55% in compartment II, 79.22% in compartment III, and 100% in IV. In KDRI compartment II, DGF was diagnosed in 34.9% of SCDs and 56% of ECDs (P = .003), BPAR occurred in 7.8% of SCDs and 16% of ECDs (P = .073), median hospital stay was 12 days for SCDs and ECDs (P = 1), and eGFR was 50.7 mL/min for SCDs and 49.4 mL/min for ECDs (P = .734). In KDRI compartment III, DGF was diagnosed in 43.8% of SCDs and 49.2% of ECDs (P = .139), BPAR occurred in 6.3% of SCDs and 31.7% of ECDs (P = .001), median hospital stay was 10 days for SCDs and 12 days for ECDs (P = .634), and eGFR was 49.5 mL/min for SCDs and 45.2 mL/min for ECDs (P = .382). Among ECD recipients, DGF was diagnosed in 56.0%, 49.2%, and 47.7% of patients for KDRI compartments II, III, and IV respectively (P = .776); BPAR occurred in 16% (compartment II), 31.7% (compartment III), and 23.1% (compartment IV) (P = .273); the median hospital stay was 12 days (compartment II), 12 days (compartment III), and 12.5 days (compartment IV) (P = 1); and eGFR was 49.5 mL/min (compartment II), 45.4 mL/min (compartment III), and 36.1 mL/min (compartment IV) (P = .002). ConclusionAssessment using both the ECD and KDRI systems allows for a more precise evaluation of prognosis and predicting complications among recipients.

Preimplantation Kidney Biopsies of Extended Criteria Donors Have a Heavier Inflammatory Burden Than Kidneys From Standard Criteria Donors.

BackgroundDonors after brain death develop a systemic proinflammatory state that may predispose the kidneys to injury after transplantation. Because it is not known whether this inflammatory environment similarly affects the kidneys from expanded criteria donor (ECD) and standard criteria donors (SCD), we sought to evaluate differences in the gene expression of inflammatory cytokines in preimplantation biopsies (PIBx) from ECD and SCD kidneys.MethodsCytokines gene expression was measured in 80 PIBx (SCD, 52; ECD, 28) and associated with donor variables.ResultsNormal histology and chronic histological lesions were not different between both types of kidneys. ECD kidneys showed significant increase in the transcripts of MCP-1, RANTES, TGF-β1, and IL-10 when compared with SCD. Kidneys presenting normal histology had similar inflammatory profile except by a higher expression of RANTES observed in ECD (P = 0.04). Interstitial fibrosis and tubular atrophy (interstitial fibrosis and tubular atrophy ≥ 1) were associated with higher expression of TGF-β1, RANTES, and IL-10 in ECD compared with SCD kidneys. Cold ischemia time of 24 hours or longer was significantly associated with upregulation of FOXP3, MCP-1, RANTES, and IL10, whereas longer duration of donor hospitalization significantly increased gene expression of all markers. High FOXP3 expression was also associated with lower level of serum creatinine at 1 year. Donor age was not associated with any of the transcripts studied.ConclusionsPIBx of ECD exhibit a higher gene expression of inflammatory cytokines when compared with SCD kidneys. This molecular profile may be a specific ECD kidney response to brain death and may help to predict the posttransplant outcomes of ECD recipients.

Long-Term Outcomes of Kidney Transplantation From Expanded-Criteria Deceased Donors: A Single-Center Experience

BackgroundOrgan shortage has prompted the use of expanded-criteria donors (ECDs). Our objective was to compare long-term outcomes of kidney transplants from ECDs with those from concurrent standard-criteria donors (SCDs). In addition, we evaluated variables associated with graft survival in both groups. MethodsWe retrospectively reviewed all 617 deceased-donor kidney transplantations performed from 2005 to 2009 in our department. The population was divided according to donor status into ECD or SCD. Patients were followed until 5 years after transplantation, death, graft failure, or loss to follow-up. ResultsWe transplanted 150 deceased-donor kidneys from ECDs and 467 from SCDs. ECD were older, more frequently women, had a lower pre-retrieval glomerular filtration rate, and more frequently died due to cerebrovascular accident. ECD recipients were older, presented a lower proportion of black race, more frequently were on hemodialysis, and presented a higher rate of first kidney transplants. Mean glomerular filtration rate was consistently lower in the ECD group. Patient and graft survivals were lower in the ECD group, but statistical significance was present only in graft survival censored for death with a functioning graft at 3 years and graft survival noncensored for death with a functioning graft at 5 years. Younger recipient ages, longer time on dialysis, acute rejection episodes, and glomerular filtration rate at 1 year after transplantation were independent risk factors for lower graft survival. ConclusionsTransplantation with the use of ECD kidneys provide quite satisfactory patient and graft survival rates despite their poorer long-term outcomes.

Trends in Usage and Outcomes for Expanded Criteria Donor Kidney Transplantation in the United States Characterized by Kidney Donor Profile Index.

There has been increasing concern in the kidney transplant community about the declining use of expanded criteria donors (ECD) despite improvement in survival and quality of life. The recent introduction of the Kidney Donor Profile Index (KDPI), which provides a more granular characterization of donor quality, was expected to increase utilization of marginal kidneys and decrease the discard rates. However, trends and practice patterns of ECD kidney utilization on a national level based on donor organ quality as per KDPI are not well known. We, therefore, performed a trend analysis of all ECD recipients in the United Network for Organ Sharing (UNOS) registry between 2002 and 2012, after calculating the corresponding KDPI, to enable understanding the trends of usage and outcomes based on the KDPI characterization. High-risk recipient characteristics (diabetes, body mass index ≥30 kg/m2, hypertension, and age ≥60 years) increased over the period of the study (trend test p<0.001 for all). The proportion of ECD transplants increased from 18% in 2003 to a peak of 20.4% in 2008 and then declined thereafter to 17.3% in 2012. Using the KDPI >85% definition, the proportion increased from 9.4% in 2003 to a peak of 12.1% in 2008 and declined to 9.7% in 2012. Overall, although this represents a significant utilization of kidneys with KDPI >85% over time (p<0.001), recent years have seen a decline in usage, probably related to regulations imposed by Centers for Medicare & Medicaid Services (CMS).When comparing the hazards of graft failure by KDPI, ECD kidneys with KDPI >85% have a slightly lower risk of graft failure compared to standard criteria donor (SCD) kidneys with KDPI >85%, with a hazard ratio (HR) of 0.95, a confidence interval (CI) of 0.94-0.96, and statistical significance of p<0.001. This indicates that some SCD kidneys may actually have a lower estimated quality, with a higher Kidney Donor Risk Index (KDRI), than some ECDs. The incidence of delayed graft function (DGF) in ECD recipients has significantly decreased over time from 35.2% in 2003 to 29.6% in 2011 (p=0.007), probably related to better understanding of the donor risk profile along with increased use of hypothermic machine perfusion and pretransplant biopsy to aid in optimal allograft selection.The recent decline in transplantation of KDPI >85% kidneys probably reflects risk-averse transplant center behavior. Whether discard of discordant SCD kidneys with KDPI >85% has contributed to this decline remains to be studied.

Does Thymoglobulin Induction Increase Susceptibility to Carbapenem-Resistant Acinetobacter baumannii Sepsis-related Death in Expanded Criteria Donors?

Solid organ transplant recipients are susceptible to antibiotic-resistant infections and carbapenem-resistant Acinetobacter baumannii (CRAB) has recently been recognized as a serious complication in solid organ recipients. High mortality rates have been described. We retrospectively analyzed 807 transplantations and detected 10 patients who died 24 hours after the diagnosis of septicemia, all with CRAB-positive blood cultures. Recipients were followed up for at least 1 year and were stratified into the following groups: Group 1, patients alive; Group 2, patients that died due to other causes except Acinetobacter infection; and Group 3, patients who died within 24 hours of CRAB diagnosis. CRAB-positive patients died a median of 3.17 (range, 1.81-18.7) months after transplantation. In these patients, expanded criteria donors (ECDs) were more frequent (P< .001), as were the use of anti-thymocyte globulin (ATG) induction (P= .02) and delayed graft function (P= .01). For ECD recipients, death rate from any cause, whether induced with ATG or not, was 25% and 20.6%, respectively (odds ratio [OR], 1.28; confidence interval [CI] 95%, 0.56-2.91; P= .68). The death rate from CRAB-related sepsis was 10.3% and 0% whether receiving ATG or not, respectively (OR, 15.49; CI 95%, 0.87-277.16; P= .014). There was a 25.75-fold increase in the death rate in ECD kidney recipients induced with thymoglobulin and with CRAB-related sepsis. Transplants from ECDs and induced with thymoglobulin may be at increased risk of CRAB death in 24 hours when compared with patients with standard donors and induced with thymoglobulin.

Comparison of survival outcomes between Expanded Criteria Donor and Standard Criteria Donor kidney transplant recipients: a systematic review and meta-analysis

In 2002, the United Network for Organ Sharing proposed increasing the pool of donor kidneys to include Expanded Criteria Donor (ECD). Outside the USA, the ECD definition remains the one used without questioning whether such a graft allocation criterion is valid worldwide. We performed a meta-analysis to quantify the differences between ECD and Standard Criteria Donor (SCD) transplants. We paid particular attention to select studies in which the methodology was appropriate and we took into consideration the geographical area. Thirty-two publications were included. Only five studies, all from the USA, reported confounder-adjusted hazard ratios comparing the survival outcomes between ECD and SCD kidney transplant recipients. These five studies confirmed that ECD recipients seemed to have poorer prognosis. From 29 studies reporting appropriate survival curves, we estimated the 5-year pooled nonadjusted survivals for ECD and SCD recipients. The relative differences between the two groups were lower in Europe than in North America, particularly for death-censored graft failure. It is of primary importance to propose appropriate studies for external validation of the ECD criteria in non-US kidney transplant recipients.

A Lifetime of Allograft Function with Kidneys from Older Donors.

Strategies to increase expanded criteria donor (ECD) transplantation are needed. We quantified the extent to which ECD kidneys provide recipients with a lifetime of allograft function by determining the difference between patient survival and death-censored allograft survival (graft survival). Initial analyses compared 5-year outcomes in the Eurotransplant Senior Program (European) and the United States Renal Data System. Among European recipients ≥65 years, patient survival exceeded graft survival, and ECD recipients returned to dialysis for an average of 5.2 months after transplant failure. Among United States recipients ≥60 years, graft survival exceeded patient survival. Although patient survival in elderly recipients in the United States was low (49% at 5 years), the average difference in patient survival at 10 years in elderly recipients in the United States with an ECD versus non-ECD transplant was only 7 months. The probability of patient survival with a functioning allograft at 5 years was higher with ECD transplantation within 1 year after activation to the waiting list than with delayed non-ECD transplantation ≥3 years after activation to the waiting list. Subsequent analyses demonstrated that ECD transplants do not provide a lifetime of allograft function in recipients <50 years in the United States. These findings should encourage ECD transplantation in patients ≥60 years, demonstrate that rapid ECD transplantation is superior to delayed non-ECD transplantation, and challenge the policy in the United States of allowing patients <50 years to receive an ECD transplant.

Outcomes in kidney transplant recipients from older living donors.

Previous studies demonstrate that graft survival from older living kidney donors (LD; age>60 years) is worse than younger LD but similar to deceased standard criteria donors (SCD). Limited sample size has precluded more detailed analyses of transplants from older LD. Using the United Network for Organ Sharing database from 1994 to 2012, recipients were categorized by donor status: SCD, expanded criteria donor (ECD), or LD (by donor age: <60, 60-64, 65-69, ≥70 years). Adjusted models, controlling for donor and recipient risk factors, evaluated graft and recipient survivals. Of 250,827 kidney transplants during the study period, 92,646 were LD kidneys, with 4.5% of these recipients (n=4,186) transplanted with older LD kidneys. The use of LD donors 60 years or older increased significantly from 3.6% in 1994 to 7.4% in 2011. Transplant recipients with older LD kidneys had significantly lower graft and overall survival compared to younger LD recipients. Compared to SCD recipients, graft survival was decreased in recipients with LD 70 years or older, but overall survival was similar. Older LD kidney recipients had better graft and overall survival than ECD recipients. As use of older kidney donors increases, overall survival among kidney transplant recipients from older living donors was similar to or better than SCD recipients, better than ECD recipients, but worse than younger LD recipients. With increasing kidney donation from older adults to alleviate profound organ shortages, the use of older kidney donors appears to be an equivalent or beneficial alternative to awaiting deceased donor kidneys.

Risk factors and outcome of expanded-criteria donor kidney transplants in patients with low immunological risk

The aim of this study was to evaluate risk factors and outcome of expanded-criteria donor (ECD) kidney transplants in patients with low immunological risk. We evaluated graft survival and graft function in 265 recipients with low immunological risk defined as the absence of pretransplant donor-specific HLA antibodies. A total of 112 (42%) kidneys derived from ECD and 153 (58%) from standard-criteria donors (SCDs). Overall, in a multivariate Cox regression, ECD status was the only significant risk factor for graft failure (hazard ratio [HR] 2.31, 95% confidence interval [CI] 1.22-4.37; p = 0.01). In the SCD group there was an increased risk for graft failure with increasing recipient age (HR 1.06 per year, CI 1.01-1.10; p = 0.02) and in the ECD group a trend for risk reduction for recipients treated with tacrolimus (Tac) (HR 0.46, CI 0.20‒1.06; p = 0.07). One, three and five-year graft survival of ECD kidneys was significantly better when recipients were treated with Tac (95%, 88% and 72%, respectively) than when they were treated without Tac (73%, 65% and 50%, respectively) (p = 0.008). At three years, ECD kidneys had a lower median estimated creatinine clearance (eCrCl) than SCD kidneys (37 vs 58 ml/min, p <0.001). Within the ECD group, recipients treated with Tac had a higher median eCrCl than those treated without Tac (41 ml/min vs 33 ml/min, p = 0.004). Graft function from one to three years was preserved in ECD recipients treated with Tac (median change 0.0 ml/min, p = 0.4) compared with those treated without Tac (median change -3.2 ml/min, p = 0.005). Tac-based immunosuppression seems to improve graft survival and to preserve graft function in ECD kidneys with low immunological risk.

ECD kidneys and re-transplantation

Dear Editor,We congratulate Ortiz and associates on this very informative paper that discusses the role of expand-ed criteria donor (ECD) kidneys in recipients with prior transplants [1]. Based on their graft and pa-tient survival data, they recommend an aggressive attitude towards utilization of these kidneys in re-transplant (RT) patients. We have a few comments about the study, but importantly, we question why RT patients are treated differently at the time of kidney allocation and discuss the risks posed by re-transplantation.The authors found RT recipients to be younger than their rst-time ECD recipients, probably be-cause of their younger age at the time of their rst transplant when they received a standard criteria donor (SCD) kidney. They found a signi cant dif-ference in delayed graft function (DGF) between ECDRT and SCDRT (42% vs. 27%), suggesting that perhaps it is the kidney quality and not the RT that is responsible for this difference in DGF. With com-parable graft and patient survival in the short term, Ortiz et al. have shown that ECD kidneys can be a useful resource even in the RT group.Ortiz et al. found that ECDRT and ECD recipients had similar outcomes. This is not surprising, be-cause both groups received ECD kidneys. More im-portantly, however, this shows that the RT status did not have a negative impact on the outcome, and that perhaps the high risk attributed to RT may be an exaggeration. The main factor that determines

Current Profiles of Kidney Transplant Recipients and their Donors in Spain

Objective: To define the anthropometric, demographic and clinical characteristics and specific profiles of kidney transplant (KT) recipients in Spain, as well as their donor characteristics. Methods: Observational, cross-sectional, multicenter study conducted as retrospective clinical records review in KT units nationwide. The last 23 adult KT recipients of 2010 were consecutively reviewed in each center. Multiorgan transplants were excluded. Results: 11 hospitals included 253 KT recipients (mean age 53.9±14.5 y, 68.0% men) and their donors (mean age 54.7±14.8 y, 55.3% men). Mean cold ischemia time was 17.4±5.9 h in cadaveric donors (84.8%) and 1.5±1.1 h in living donors (15%). Donor mean serum creatinine level was 1.2 mg/dl (CI95%: 0.7-1.7), being >1.5 in 5.9%. Main causes of donor death were cerebrovascular accident (60%) and cranioencephalic trauma (14.1%). Most common causes for transplant were: glomerulonephritis (26.1%), polycystic disease (18.2%) and DM (16%). 95.3% were simple KT (first transplant in 84.2% of cases). 14.6% of recipients received a pre-emptive KT. Recipients mean BMI was 25.6±3.8 Kg/m2 (41.5% normal BMI, 39.9% overweighed, 13.4% obese). 22.5% of recipients had pre-transplant DM and the investigators considered that 30% of the non-diabetic at transplant were at risk of NODM. 11.1% had ischemic heart disease history, 8.7% peripheral vascular disease, and 42.3% moderate/ severe atheromatosis. Regarding the specific patient profiles: 5.5% were high immunological risk recipients, 15% were living donor recipients (13.2%of donors were >60y), 36.8% were recipients with cardiovascualr risk and/or DM, 45.5% were expanded criteria donor recipients (>60 y, or >55 y with at least one of the following: hypertension, SCr>1.5 mg/dl or death from cerebrovascular accident) and 54.5% were at risk of delayed graft function. Conclusions: The Spanish KT recipients are a middle-aged and overweighed population with a considerable rate of cardiovascular disease history and posttransplant NODM risk, that receive in almost 50% an extended criteria donor kidney. This population is far from the one included in clinical trials, and will require a specific tailored immunosuppression to try to avoid DGF, preserve renal function on the long term, and minimize posttransplant cardiovascular events.

Use of 12-Month Renal Function and Baseline Clinical Factors to Predict Long-Term Graft Survival

Innovation in renal transplant management would benefit from identification of early markers that accurately predict long-term graft survival. Data from the United States Renal Data System for kidney transplant recipients (1995-2004) were analyzed to develop prediction models for all-cause graft survival based on estimated glomerular filtration rate (eGFR), the presence or absence of acute rejection within 1 year, and recipient and donor demographic characteristics. The prediction models were applied to participants in the Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial and Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial--EXTended criteria donors trials comparing belatacept with cyclosporine in standard criteria donor (SCD) and expanded criteria donor (ECD) graft recipients, respectively, as an external validation of the model predictions in a diverse population. Compared with eGFR 60 mL/min/1.73 m(2), the relative hazard for all-cause graft loss increased in an accelerating pattern with lower GFR to approximately eight and seven times, respectively, among SCD and ECD recipients with eGFR less than 15 mL/min/1.73 m(2). When applied to the clinical trial samples, the predicted differences in all-cause graft survival of less intensive belatacept versus cyclosporine at the second transplant anniversary (SCD: 3.9%, 95% confidence interval [CI]: 3.6% to 4.2%; ECD: 4.1%, 95% CI: 3.5% to 4.7%) were similar to observed differences (SCD: 4.2%, 97.3% CI: -1.3% to 10.1%; ECD: 1.4%, 97.3% CI: -7.5% to 10.2%). Accurate models of long-term graft survival can be developed using eGFR, donor, and recipient characteristics. Long-term survival prediction models may provide an efficient method for assessing the impact of novel pharmaceutical agents and clinical management protocols.

9 The added value of quality-of-life and other patient-reported outcomes in clinical research of patients with myelodysplastic syndromes

European senior programme (ESP) is well known for acceptable outcomes using expanded criteria donor (ECD) kidneys from donors older than 65 years for recipients older than 65 years. The incidence of end-stage renal disease (ESRD) is 229/million in India with a mean age of 45 years. We performed a retrospective analysis of transplantation of ECD versus standard criteria donor (SCD) kidneys into younger recipients.Forty-three ECD transplantations among 158 deceased donor organ transplantation (DDOT) were performed between January 2006 and December 2009. Among 43 transplantation from 30 donors, 14 were dual kidney transplantations (DKT) performed based upon biopsy evaluation. All recipients received thymoglobulin (rATG) induction followed by immunosuppression with a steroid, mycophenolate mofetil (MMF), and a calcineurin inhibitor. Statistical analysis used chi-square test and unpaired Student t test. Kaplan-Meier curves were used for survival analysis.For ECD the mean donor age was 64 ± 11 years. Cerebrovascular accidents (CVA) were the cause of death among 60% of donors, 73.13% of whom were hypertensive and 23.13% diabetic.Mean DKT donor age was 75 ± 9.17 years versus 60 ± 8.0 years for single kidney transplantation (SKT). Mean recipient age of DKT versus SKT was 44 ± 12.4 years versus 43 ± 14 years. Mean serum creatinine (SCr; mg/dL) of SKT patients was 1.64 ± 0.75 versus 1.68 ± 0.46 in DKT. Mean follow-up was 455 ± 352 days. Mean SCr of 43 ECD recipients of mean age, 43.4 ± 14.2 years was 1.61 ± 0.61 mg/dL. Among 43 recipients, 23.25% were diabetic, 41.86% displayed delayed graft function (DGF), and 23.25% experienced biopsy-proven acute rejection (BPAR). Patient survival rate was 72.09% and graft survival rate was 67.44%. For SCD transplantations (n = 115), the mean donor age was 36 ± 14 years and recipient mean age was 32.8 ± 14.07 years. Mean SCr was 1.32 ± 0.46 mg/dL with 26.95% recipients displaying DGF, whereas 20.86% had BPAR. In the SCD group the patient survival rate was 79.13% and the graft survival rate was 72.17%. Thus, although the ECD group showed poor graft function (P = .042), they had acceptable patient and graft survivals (P = .34 and P = .56, respectively).Because of the organ shortage, DDOT using ECD transplants for younger recipients is a feasible option with acceptable outcomes.