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Assessment of Kidneys Procured From Expanded Criteria Donors Before Transplantation
Abstract
Using expanded criteria donor (ECD) organs is 1 strategy to make more organs available for transplant. To reduce the number of posttransplant complications and failures, there is a need to create a comprehensive system of evaluation before transplantation, especially for kidneys harvested from ECD. The aim of this study was to assess the results of kidneys procured from ECD seeking to discover the most useful factors for kidney evaluation before transplantation.
One hundred seventy-two patients received cadaveric renal transplants between January 1, 2006, and August 31, 2008. We collected data on donors, recipients, and perfusion parameters. We analyzed patient and graft survivals, as well as immediate, delayed, and slow graft function. Kidney recipient function was assessed by serum creatinine concentrations and by creatinine clearance calculated according to the Cockroft-Gault formula. Renal biopsy specimens were obtained in the perioperative periods 147 cases.
The overall 1-year graft survival was 86.9%. More than 25% of transplanted kidneys were harvested from ECD. There were no significant differences in patient survival between recipients of standard criteria donor kidneys (RSCDK) versus of expanded criteria donor kidneys (RECDK). One-year graft survival was higher among the RSCDK group than the RECDK group, namely, 94.4% versus 62.5%, (P = .004). There were no differences in the incidence of primary nonfunction or in delayed graft function between the groups. RECDK were more likely to show slow graft function (69.2% vs 37.8%; P = .033). A lower graft survival at 6 months after transplantation was observed among organs harvested from ECD compared with standard criteria donor (SCD) kidneys who showed histologic lesions or a flow at the fourth hour of machine perfusion below 0.4 mL/g. Using a logistic regression model, chronic histologic changes were shown to influence kidney survival at 6 months after transplantation.
There was no significant difference in patient survival between recipients of kidneys harvested from expanded versus standard criteria donors. ECD kidneys displayed lower graft survival rates. There was no significant difference in the incidence of delayed graft function between recipients of kidneys harvested from expanded versus standard criteria donors. Pretransplant evaluation of ECD kidneys should include 3 variables: donor parameters, histologic findings, and machine perfusion parameters.
... To assess the organ quality with respect to the outcome, several scoring systems considering a varying number of clinical, laboratory and histological parameters have been developed during the last 15 years [4,[8][9][10][11]. Based on these scores, most studies reported a substantial poorer graft survival [4,7,10,15] and function [7,9,14,16,17] of ECD kidneys. Depending on the score applied and the populations studied, differences in one-year kidney graft survival between ECD and standard criteria donor (SCD) recipients remarkably varied between 1.8% and 31.9% ...
... Depending on the score applied and the populations studied, differences in one-year kidney graft survival between ECD and standard criteria donor (SCD) recipients remarkably varied between 1.8% and 31.9% [4,7,13,14,16,[18][19][20]. In previous studies, however, immunological factors such as sensitisation of the recipient, type of immunosuppression and episodes of rejection, which are still regarded as the most important determinants of long-term outcome in kidney transplantation, were poorly controlled [21]. ...
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.
... La MP facilita el almacenamiento durante periodos más largos 19 aunque es nuestro estudio este aspecto no fue valorable puesto que los tiempos de isquemia fría fueron semejantes. También permite la evaluación de la extensión del daño isquémico del órgano e incluso mejora la evaluación de la calidad de los riñones antes del trasplante que, junto con parámetros de los donantes, aporta una predicción de la función renal postrasplante 20 . La preservación renal de injertos de DCE mediante MP además de aportar información adicional sobre la viabilidad del injerto, reduce la incidencia de rechazo crónico y de NTA 21 , enfoques que parecen reflejarse en el presente estudio. ...
Objetivo:
Estudios recientes han demostrado que el mantenimiento de la viabilidad de riñones con criterios expandidos durante su preservación sea un reto. La máquina de perfusión hipotérmica pretende mitigar el efecto del almacenamiento en frío sobre la calidad del órgano cuando el tiempo de isquemia fría es prolongada o el donante subóptimo.
Objetivo:
Evaluar las complicaciones que presentan los pacientes trasplantados renales con preservación estática fría o perfusión hipotérmica pulsátil.
Material y Método:
Estudio observacional retrospectivo durante 2010-2012 donde se incluyeron todos los trasplantes renales realizados en un hospital de tercer nivel. Las variables de estudio: estancia hospitalaria, horas de isquemia, necesidad de diálisis y número de sesiones post trasplante y el dispositivo de almacenamiento, edad y patologías asociadas al donante.
Resultados:
Se realizaron 175 trasplantes donde 70 procedieron de donantes ≥65 años. Se perfundieron en máquina 30 riñones y en 40 se utilizó la preservación estática. Nuestros hallazgos respecto al uso de la máquina de perfusión conllevan un descenso en la estancia media hospitalaria y una menor necesidad de hemodiálisis postrasplante.
Conclusiones:
Debido al alto porcentaje de órganos procedentes de donantes de edad avanzada y difíciles de preservar, resulta fundamental buscar técnicas de perfusión intravascular continua para una preservación más efectiva del órgano.
... Because of its improved graft and receptor survival rates, it represents a better alternative to dialysis. 1 The increase in renal transplants has contributed to the shortage of ideal donors. 2 This has motivated the use of donors with extended criteria. 3 These donors are more vulnerable to the development of ischemiareperfusion injury (IRI), an inevitable consequence in organ transplantation 4 and other vascular procedures, such as coronary revascularization and aortic surgeries. ...
Aim:
Remote ischemic preconditioning (RIPC) has been used as a strategy to reduce acute renal injury and ischemia-reperfusion injury (IRI) in renal transplantation (RT) with controversial results.
Objective:
To determine if RIPC modifies IRI in cadaveric RT recipients through inflammatory mediators and graft function.
Methods:
Twenty-nine RT recipients were studied, 12 in the control group (CG) and 17 in the RIPC group. RIPC which was performed on donors using a pneumatic tourniquet placed on both thighs for 10 min followed by the determination of IL-1, IL-6, TNF-α, VEGF, and ICAM-1, and hematological and biochemical parameters in different phases of RT.
Results:
Serum creatinine levels were significantly lower in the RIPC group versus the CG at 15 and 30 days; however, the estimated glomerular filtration rate (eGFR) showed no significant difference in any phase between either group, only TNF-α showed significantly higher values in the RIPC group versus the CG in almost all phases of the study, meanwhile IL6 was increased at 72 hours (hr) and 30 days, IL1 at 72 hr and 15 days and ICAM-1 post reperfusion, contrary to this VEGF showed a decrease at 7 and 15 days.
Conclusion:
RIPC did not improve eGFR or serum creatinine; however, it modifies the inflammatory response in RT recipients.
... Los criterios extendidos son: tener más de 60 años o más de 50 con dos de los criterios anteriores. 25 Se ha observado que los riñones provenientes de DCD tienen mayor riesgo de falla cuando los niveles de anticuerpos reactivos del panel son mayores de 50%, cuando se presenta algún episodio de rechazo resistente a corticosteroides, cuando el órgano se haya utilizado para trasplantes múltiples, que el donador haya muerto de causas atraumáticas y cuando la edad del donador supera los 35 años. 26,27 Hepático En los casos de trasplante hepático se presenta un problema un poco más notorio, ya que en general este órgano se ve más afectado que otros por los tiempos de isquemia. ...
The use of organs procured from non-heart beating donors can
substantially increase the organ pool for transplants. Other
countries have had promising results. The general guidelines
for these patients, as well as the fact that the Lazarus phenomenon
and the dead donor rule exist with their respective wait
times and consequences, are different, including ethical and
legal aspects. All of the above must be respected and strictly
followed with objective decision making and without any bias.
It’s extremely important to respect ischemic time limits set for
every organ, the time from the life support withdrawal and to
try and minimize ischemia time as well as using perfusion machines
and drugs that can minimize damage to the organ to be
transplanted
... To reduce the number of patients waiting for a kidney transplant, many transplant centres over the world started to accept suboptimal organ donors, referred to as expanded criteria donors (ECD) or marginal donors [5]. Results of these ECD kidney transplantations differ across studies in different regions: some studies reveal no differences in outcome between ECD and non-ECD kidney transplants [6][7][8][9][10], whereas other studies, including a systematic review and a meta-analysis, tend to show higher rates of graft failure and mortality in ECD kidney transplantations, especially in recipients with diabetes or recipients younger than 40 years of age [11][12][13]. In the Eurotransplant (ET) kidney exchange program, facilitating cross-border organ exchange from both ECD and non-ECD donors in eight European countries including the Netherlands, graft and patient survival according to ECD status have not been investigated. ...
Survival of Expanded Criteria Donor (ECD) kidneys and their recipients has not been thoroughly evaluated in Europe. Therefore, we compared outcome of ECD and non-ECD kidney transplantations in a Dutch cohort, stratifying by age and diabetes. In all first Dutch kidney transplants in recipients ? 18 years between 1995 and 2005, both relative risks (hazard ratios, HR) and adjusted absolute risk differences (RD) for ECD kidney transplantation were analyzed. In 3062 transplantations (recipient age 49.0 (12.8) years; 20% ECD), ECD kidney transplantation was associated with graft failure including death (HR 1.62 [1.44 - 1.82]). The adjusted HR was lower in recipients ? 60 years of age (1.32 [1.07 - 1.63] than in recipients 40-59 years (1.71 [1.44 - 2.02] P = 0.12 for comparison with ? 60 years) and recipients 18-39 years (1.92 [1.42 - 2.62] P = 0.03 for comparison with ? 60 years). RDs showed a similar pattern. In diabetics, the risks for graft failure and death were higher than in the non-diabetics. ECD kidney grafts have a poorer prognosis than non-ECD grafts, especially in younger recipients (< 60 years), and diabetic recipients. Further studies and ethical discussions should reveal whether ECD kidneys should preferentially be allocated to specific subgroups, such as elderly and non-diabetic individuals. This article is protected by copyright. All rights reserved.
... Organs from extended criteria donors are associated with a higher incidence of DGF, lower graft survival and suboptimal kidney function [13,14]. Recipients of kidneys procured from extended criteria donors show a 1.7-fold greater risk of graft lost compared to recipients with a kidney from an 'ideal donor' (10-39 years old without hypertension or stroke as a cause of death and a serum creatinine concentration <1.5 mg/dL) [15]. ...
Kidney transplantation is the treatment of choice in patients with end stage renal disease. During kidney transplantation ischemia reperfusion injury (IRI) occurs, which is a risk factor for acute kidney injury, delayed graft function and acute and chronic rejection. Kidneys from living donors show a superior short- and long-term graft survival compared with deceased donors. However, the shortage of donor kidneys has resulted in expansion of the donor pool by using not only living- and brain death donors but also kidneys from donation after circulatory death and from extended criteria donors. These grafts are associated with an increased sensitivity to IRI and decreased graft outcome due to prolonged ischemia and donor comorbidity. Therefore, preventing or ameliorating IRI may improve graft survival. Animal experiments focus on understanding the mechanism behind IRI and try to find methods to minimize IRI either before, during or after ischemia. This review evaluates the different experimental strategies that have been investigated to prevent or ameliorate renal IRI. In addition, we review the current state of translation to the clinical setting. Experimental research has contributed to the development of strategies to prevent or ameliorate IRI, but promising results in animal studies have not yet been successfully translated to clinical use.
... Some tools are used to help the transplant physician better evaluate the viability of ECD organs, such as preimplantion renal biopsy (performed at the time of extractions), parameters of the machine perfusion, (11) and the risk scores which include clinical and morphological variables of the donor related to the quality of the organ and to the renal prognosis. (12,13) Regarding the histological findings of the preimplant biopsy, those that are associated with the worst renal prognosis are interstitial fibrosis/tubular atrophy, glomerulosclerosis, vascular intimal thickening, and arteriolar hyalinosis. ...
Given the shortage of organs transplantation, some strategies have been adopted by the transplant community to increase the supply of organs. One strategy is the use of expanded criteria for donors, that is, donors aged >60 years or 50 and 59 years, and meeting two or more of the following criteria: history of hypertension, terminal serum creatinine >1.5mg/dL, and stroke as the donor´s cause of death. In this review, emphasis was placed on the use of donors with acute renal failure, a condition considered by many as a contraindication for organ acceptance and therefore one of the main causes for kidney discard. Since these are well-selected donors and with no chronic diseases, such as hypertension, renal disease, or diabetes, many studies showed that the use of donors with acute renal failure should be encouraged, because, in general, acute renal dysfunction is reversible. Although most studies demonstrated these grafts have more delayed function, the results of graft and patient survival after transplant are very similar to those with the use of standard donors. Clinical and morphological findings of donors, the use of machine perfusion, and analysis of its parameters, especially intrarenal resistance, are important tools to support decision-making when considering the supply of organs with renal dysfunction.
... Most data indicate the success of transplantation is decreased for ECD organs, however other findings have also been reported, such as Forni et al. (2010Forni et al. ( , 2011 who found that the use of extended donor acceptance criteria did not compromise clinical outcome after heart transplantation (Forni et al. 2010(Forni et al. , 2011. Some studies note a more subtle effect, where ECD appear to affect the allograft survival, but not patient/recipient survival (Bacchella et al. 2008;Domagala et al. 2009). Because ECD organ transplantation may carry more risks than transplantation of a 'standard' organ, it is generally recommended to obtain an informed consent of the patient receiving an ECD organ. ...
The successful transplantation of human materials such as organs, tissues and cells into patients does not only depend on the benefits, but also on the mitigation of risks. To gain insight into recent publications on risks associated with the process of transferring human materials from donor to recipient we performed a horizon scan by reviewing scientific literature and news websites of 2011 on this subject. We found there is ample information on how extended donor criteria, such as donor age, affect the survival rates of organs or patients. Interestingly, gender mismatch does not appear to be a major risk factor in organ rejection. Data on risks of donor tumor transmission was very scarce; however, risk categories for various tumor types have been suggested. In order to avoid rejection, a lot of research is directed towards engineering tissues from a patient's own tissues and cells. Some but not all of these developments have reached the clinic. Developments in the field of stem cell therapy are rapid. However, many hurdles are yet to be overcome before these cells can be applied on a large scale in the clinic. The processes leading to genetic abnormalities in cells differentiated from stem cells need to be identified in order to avoid transplantation of aberrant cells. New insights have been obtained on storage and preservation of human materials, a critical step for success of their clinical use. Likewise, quality management systems have been shown to improve the quality and safety of human materials used for transplantation.
... 11 Fatores referentes à manutenção hemodinâmica e hidroeletrolítica anteriormente à extração multiorgânica, além de características demográficas, associam-se a maior risco para o desenvolvimento de FTE e FRI. 9,[12][13][14][15] No Brasil, a incidência de FTE é significativamente superior à incidência norte-americana (57,3% vs. 23,5%), 2,16 e há menor sobrevida do enxerto após um ano de transplante. 1 12,18,19 Idade, creatinina sérica e presença de hipertensão arterial no doador falecido são características que compõem a definição de doador de critério expandido. 12 Quando a idade do doador é superior a 50 anos e combinada a outros fatores de risco, como hipertensão arterial, creatinina sérica superior a 1,5 mg/dl e etiologia vascular para morte encefálica, ou, isoladamente, quando superior a 60 anos, classifica o doador falecido como expandido. ...
The incidence of delayed graft function (DGF) and unsatisfactory creatinine clearance (UCC) after renal transplantation is significantly higher in Brazil, when compared with that observed in United States or Europe. Deceased donor (DD) characteristics should directly influence the occurrence of these two outcomes.
This study aim to evaluate the influence of DD characteristics on DGF and UCC incidence in Brazil.
DD clinical and laboratory variables were correlated with outcome's incidence.
We evaluated 787 DD whose organs were transplanted in 1298 patients. We noted a high prevalence of vasoactive drugs use (90.2%), hypernatremia (66.6%) and renal dysfunction (34.8%). The incidence of DGF and UCC was 60.6% and 55.2%, respectively. We observed a progressive increase in DGF risk for age groups over 30 years and for cold ischemia time (CIT) greater than 24 hours. DGF risk was two times higher in recipients of donor kidney final serum creatinine (Cr) over than 1.5 mg/dl. Hypertension and CIT over 36 hours was associated with an increasing of 82% and 99% in UCC risk, respectively. Donor age above 40 years was associated with a progressive increase in UCC risk.
DD age, renal function, hypertension and prolonged CIT were associated with increased risk DGF and UCC.
Although kidney transplantation is the standard of care for patients with end‐stage renal disease, there is a worldwide shortage of organs available for kidney transplantation. The quality of the deceased donor kidney has been shown to influence both patient and graft survival for the recipient, and as such must be considered during the selection of both kidney transplant recipients and donors. Brain death is diagnosed as lack of responsiveness or coma accompanied by apnea and an absence of brain stem reflexes, despite standardized conditions. Donation after cardiac death donors are typically those who do not meet brain death criteria, but for whom further medical intervention is deemed futile. Following Human Immunodeficiency Virus+ (HIV+) to HIV+ kidney transplantation, there have been concerns for infectious risks, particularly secondary to immunosuppression. This chapter presents a summary of findings: patient and graft survival for deceased donor kidney transplantation, stratified by deceased donor classification.
Introduction
The approach towards transplanting kidneys from ECDs in Poland is largely site-dependant. The KDRI allows for obtaining a more precise characteristic of ECDs and further stratification into “better” and “worse” quality grafts.
Methods
Comparison of the incidence of DGF and BPAR, median of hospitalisation time and median of eGFR at 1 year after transplantation among kidney graft recipients (n=468), divided by donor status (ECD/SCD) and KDRI value (I: 0.67-1.2, II: 1.21-1.6, III: 1.61-2.0, IV: 2.01-3.48).
Results
ECD kidneys have been transplanted to 32.47% of recipients. There were no ECD recipients in KDRI compartment I, 16.55% in II, 79.22% in III and 100% in IV. In KDRI compartment II DGF was diagnosed in 34.9 and 56% of SCDs and ECDs, respectively (p=0.003), BPAR in 7.8 and 16% (p=0.073), median hospital stay was 12 and 12 days (p=1), eGFR: 50.7 and 49.4 ml/min (p=0.734). In KDRI compartment III DGF was diagnosed in 43.8 and 49.2% of SCDs and ECDs, respectively (p=0.139), BPAR in 6.3 and 31.7% (p=0.001), median hospital stay was 10 and 12 days (p=0.634), eGFR: 49.5 and 45.2 ml/min (p=0.382). 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=0.776), BPAR in 16, 31.7 and 23.1% (p=0.273), median hospital stay was 12, 12 and 12.5 days (p=1), eGFR: 49.5, 45.4 and 36.1 ml/min (p=0.002).
Conclusion
Assessment using both the ECD and KDRI systems allows for a more precise evaluation of prognosis and predicting complications among recipients.
Introduction:
The use of transplants from extended criteria donors increases the number of urological complications after renal transplantation. Two different anastomosis techniques used to restore urinary continuity are compared in this study.
Patients and methods:
Retrospective study, bi-center over a period of 5 years. One hundred and seventy six patients operated at Hospices Civils de Lyon benefited from ureteroneocystostomy according to De Campos-Freire (group 1) and 167 patients operated at the Necker Hospital in Paris had a pyelo-ureterostomy (group 2). The various urological complications (fistulas, strictures, seromas, haematomas and vesico-ureteric reflux) and their care were compared. Risk factors were sought.
Results:
The waiting time before transplantation was longer in group 2 than in group 1 (51 and 33.84 months) as the percentage of anuric patients (52.9 % against 32.9 %) (P<0.001). The cold ischemic time was shorter in group 1 (939.3minutes on average against 1325.3minutes for group 2) (P<0.001). A double J stent was put in place in 97.6 % of cases in group 2 against 84.2 % for group 1 (P<0.001). We did not find any significant difference in the occurrence of stenosis and fistulas (major complications) between the 2 groups. There were more minor complications (hematoma, seroma and vesico-ureteric reflux) in group 1 (P=0.033). There was a difference in the treatment of these complications, especially stenosis (P=0.024) with a significantly more conservative approach in group 2. Multivariate analysis found anuria, sex of recipients and donor age as independent risk factors in the onset of complications and the double J stent as a protective factor.
Conclusion:
This study does not demonstrate the superiority of a urinary anastomosis technique. The establishment of a double J stent reduces the risk of complications. Analysis of risk factors allows to propose a decision tree to guide the surgical strategy, particularly in the population of anuric recipients.
Level of evidence:
5.
The increased discrepancy between the number of patients on the waiting list and the kidney graft availability has prompted most of the transplant centers to expand their suitability criteria for deceased donor kidneys. However, these grafts have a potential lower graft functionality and must be properly allocated to ensure the best outcome. Histopathological pre-transplant evaluation has progressively assumed as the best prognostic factor for graft function in kidney transplantation from older donors. However, there is not consensus about the best strategy of scoring the bioptic samples and there are no clinical trials comparing the best allocation strategy of these kidneys. In this chapter will be reviewed the recent acquisition on pre-transplant histopathologic examination with a brief overview on the role of kidney biopsy in living kidney donors.All rights reserved-
There is an ongoing shortfall of organs for donation in the UK and worldwide. Strategies including donation after circulatory death (DCD), living donation and better identification of potential donors are attempting to increase the number of donors and donated organs. The number of DCD donors in the UK increased by 808% from 37 to 336 between 2001 and 2010 and this is continuing to increase. The most common organs donated from DCD donors are the kidneys, but there is increasing experience of liver, lung and pancreas transplantation. The process of DCD varies between different countries and institutions. The outcome of DCD transplantation has been largely encouraging, particularly for kidneys. The increase in DCD has led to an appraisal of issues that may arise during the donation process; these include the Lazarus phenomenon, the dead donor rule, perimortem interventions, public opinion and conflict of interest for clinicians.
Few reports describing the use of organs donated by transplant recipients have been published. In this case report, kidneys procured from a brain-dead liver recipient were transplanted successfully. A 21-year-old man was referred for liver transplant after an overdose of acetaminophen. The patient's kidney function was initially normal, with proper urine production and normal kidney laboratory parameters. On the third day after admission, the patient's kidney laboratory parameters became elevated and hepatic encephalopathy requiring mechanical ventilation developed. An orthotopic liver transplant was performed the next day. The patient did not recover consciousness, and brain death was diagnosed on the third day after the liver transplant surgery. The maximum serum concentration of creatinine was 5.8 mg/dL (513 μmol/L) before kidney recovery, and urine production was normal. The kidneys were recovered with organ-perfusion support and were preserved by using machine perfusion. The kidneys were transplanted into 2 male recipients. Twelve months after transplant, the recipients remained in good health with satisfactory kidney function. This case demonstrates that transplanting kidneys recovered from liver transplant recipients is possible and beneficial, thus expanding the pool of potential donors.
Due to an impressive reduction in traffic mortalities in recent years, stroke has replaced trauma as the main cause of brain death, and the mean age of donors has increased gradually. As an immediate consequence, donations are growing increasingly more complex and less effective in terms of the number of recipients transplanted, particularly with organs affected negatively by age. The huge regional variability in donation activity observed suggests that there is room for improvement. Generally, liver transplantation extended criteria donors (ECD) are divided by donor-specific characteristics: age ＞65 years, steatosis ＞30% of graft volume, long interval between brain death and procurement or graft infected by hepatitis B or C, cold ischemia ＞12 hours, living donor grafts, split liver grafts, and liver grafts from donors after cardiac death. Deceased donor kidneys are classified as ECD if they meet either of the following conditions: (1) Donor age more than or equal to 60-years or (2) donor age 50 to 59 years, with at least two of the following criteria: serum creatinine more than 1.5 mg/dL, death due to cerebrovascular accident, or history of hypertension. No guidelines exist for allocating an ECD organ. Accurate assessment of the relative risk of graft failure associated with various combinations of donor characteristics is an essential prerequisite for counseling patients, making the decision to accept a transplant offer, evaluating programs, and developing allocation policy.
The shortage of deceased donor kidneys for transplantation continues to restrict the full application of this lifesaving procedure to all who might benefit. Increasing reliance on donors with characteristics previously thought to be unsuitable for use in transplantation has led to questions about graft outcomes for recipients of such organs. Careful definition of the expanded criteria donor (ECD) for kidney has facilitated modifications of national organ allocation policy that are designed to increase procurement, improve use, decrease cold ischemia time, and lead to improved outcome. The effects of these policy changes in the United States have been studied recently and are reviewed here. In addition, the impact of ECD kidney transplantation on mortality risk among candidates awaiting deceased donor renal transplantation is examined. Further studies of ECD organs and their recipients are needed to optimize the use of these scarce resources.
We previously proposed a quantitative approach to assess donor organs for cadaver renal transplantation. To improve on our original scoring system, we studied 34 324 patients who received cadaver renal transplants from adult donors between 1994 and 1999 and were reported to the UNOS Scientific Renal Transplant Registry. A scoring system was developed from five donor variables (age, 0-25 points; history of hypertension, 0-4; creatinine clearance before procurement, 0-4; cause of death, 0-3; HLA mismatch, 0-3) that showed a significant correlation with renal function and long-term graft survival. Cadaver kidneys were stratified by cumulative donor score: grade A, 0-9 points; grade B, 10-19; grade C, 20-29; and grade D, 30-39. The influence of donor score on renal function and graft survival was most severe above 20 points, designated 'marginal' kidneys. In summary, a donor scoring system developed from a large population database was useful in predicting outcome after cadaver renal transplantation. The improved system provides a quantitative approach to evaluation of marginal kidneys and may improve allocation of these organs in cadaver renal transplantation.
The organ shortage has led to extend the procurement to kidneys from 'marginal' donors. As a result, an increasing number of kidneys are discarded, but an extended analysis of the validity of the clinical decision to accept or decline a marginal graft remains to be determined. We have retrospectively analyzed the outcome of 170 kidney transplantations, performed in eight renal transplantation centers between 1992 and 1998. Study group included transplantation from donors accepted after refusal for poor donor or graft quality by at least two centers. Control group included 170 paired recipients from kidneys unanimously accepted by all centers. Main causes of kidney refusal included impaired donor hemodynamics (28%), abnormal pre-harvesting serum creatinine (22%), advanced age in donors (15%), and donor atheroma (14%). The 5-year patient survival (88.2% in the study group and 88.9% in controls) and graft survival (70.4% in the study group and 76.7% in controls, P=0.129) were not significantly different. Delayed graft function occurred significantly more often in the study group patients than in controls patients (63 vs 32%, P<0.0001). Primary non-functioning kidneys were significantly more frequently observed in study patients than in controls (7.7 vs 1.8%, P=0.01). Mean creatinine clearance was significantly lower in the study group patients compared with controls during the post-transplant course. Our results suggest that these initially discarded kidneys provide satisfactory survival rates despite their impaired early functional recovery and poorer long-term renal function, and therefore might be considered acceptable for transplantation in the context of organ shortage.
Expanded criteria donors (ECDs) and donation after cardiac death (DCD) provide more kidneys in the donor pool. However, the financial impact and the long-term benefits of these kidneys have been questioned. From 1998 to 2005, we performed 271 deceased donor kidney transplants into adult recipients. There were 163 (60.1%) SCDs, 44 (16.2%) ECDs, 53 (19.6%) DCDs and 11 (4.1%) ECD/DCDs. The mean follow-up was 50 months. ECD and DCD kidneys had a significantly higher incidence of delayed graft function, longer time to reach serum creatinine below 3 (mg/dL), longer length of stay and more readmissions compared to SCDs. The hospital charge was also higher for ECD, ECD/DCD and DCD kidneys compared to SCDs, primarily due to the longer length of stay and increased requirement for dialysis (70,030 dollars, 72,438 dollars, 72,789 dollars and 47,462 dollars, respectively, p < 0.001). Early graft survival rates were comparable among all groups. However, after a mean follow-up of 50 months, graft survival was significantly less in the ECD group compared to other groups. Although our observations support the utilization of ECD and DCD kidneys, these transplants are associated with increased costs and resource utilization. Revised reimbursement guidelines will be required for centers that utilize these organs.
Background:
The critical shortage of organs for transplantation has resulted in a controversial expansion of the criteria used to define a suitable cadaveric organ donor. The shortage of kidneys has a particularly hard impact on those patients on the waiting list who have uncommon major histocompatibility antigens or who are highly immunized.
Methods:
To determine outcomes between patients receiving grafts from expanded criteria donors (ECDs) and others, a retrospective review of 105 consecutive kidney transplantations performed at a single institution during a 3 1/2 year period was conducted. A total of 44 (41.9%) patients received kidneys from ECDs, 45 (42.9%) from conventional cadaveric donors, and 16 (15.2%) from live donors. All patients were treated by the same physicians and received either triple or quadruple sequential immunosuppressive therapy. In general, high risk recipients did not receive kidneys from ECDs.
Results:
Actuarial graft survival, incidence of delayed function, length of stay, and hospital charges were not significantly different between the ECD and conventional cadaveric donor groups of recipients. A higher incidence of urinary complications occurred in the ECD group (p=0.03). This incidence was noted primarily in the recipients of kidneys from donors 5 years of age or younger. However, no allografts were lost as a result of urinary complications. ECD kidneys that were imported from outside the local catchment area accounted for approximately 25% of all cadaveric transplantations performed.
Conclusions:
With appropriate selection of organs from ECDs, acceptable results can be obtained. ECD organs can serve to partially alleviate the extreme organ shortage. These organs should be procured and made available to those centers willing to use them.
Despite the need to expand the donor pool, it is unclear what parameters should be used. The value of donor renal pathology and calculated creatinine clearance (CrCl) in determining recipient outcome was assessed in 57 kidney transplants from 34 donors in whom pretransplant renal biopsies were performed because of age > or =60, hypertension, and/or vascular disease. We retrospectively compared clinical outcomes in these recipients and 57 control recipients selected to have the same baseline demographics but receiving transplants from low risk donors who were significantly younger (32+/-13.9 vs. 61+/-7.3 years) and lighter weight (71+/-18.1 vs. 84+/-20.2 kg) than the high-risk donors (P<.001 for both).
Recipients of high-risk kidneys had a higher incidence of delayed graft function, defined by a <10% fall in serum creatinine (Cr) in the first 24 hr, (56% vs. 30%, P<.01), a higher incidence of rejection (60% vs. 37%, P = .02) and a higher Cr level (197+/-64 vs. 144+/-54 micromol/L at 18 months, P<.005). Graft and patient survival were similar; 12% and 5% vs. 91% and 9% in high-risk vs. control groups, respectively (P = NS). Donor renal pathology was scored 0-3 (none to severe disease) in four areas: glomerulosclerosis, interstitial fibrosis, tubular atrophy, and vascular disease. A donor vessel score of 3/3 was associated with a 100% incidence of delayed graft function and a mean 1-year Cr level of 275+106 micromol/L (compared with 43% and 192+54 micromol/L in those with lower vessel scores, P<.05). Calculated donor CrCl <100 ml/min was associated with higher recipient Cr levels at 1 year, 240+/-95 micromol/L vs. 180+/-54 micromol/L in recipients of kidneys from donors with CrCl levels >100 ml/min (P<.05). The mean 1-year Cr level was 320+/-102 micromol/L in recipients with both a vascular score of 3/3 and a donor CrCl <100 ml/min and 184+/-63 micromol/L in those with neither factor (P = .001).
Calculated donor CrCl and donor vascular pathology predict recipient graft function and may be helpful in selecting high-risk donors for single kidney transplantation.
To compare outcomes in recipients of expanded criteria donor (ECD) versus standard criteria donor (SCD) kidneys at a single center using a standardized approach with similar immunosuppression.
Expanded criteria deceased organ donors (ECD) are a source of kidneys that permit more patients to benefit from transplantation. ECD is defined as all deceased donors older than 60 years and donors older than 50 years with 2 of the following: hypertension, stroke as the cause of death, or pre-retrieval serum creatinine (SCr) greater than 1.5 mg/dl.
We retrospectively studied 90 recipients of adult deceased donor kidneys transplanted from October 1, 2001 to February 17, 2003, including 37 (41%) from ECDs and 53 (59%) from SCDs. ECD kidneys were used by matching estimated renal functional mass to recipient need, including the use of dual kidney transplants (n = 7). ECD kidney recipients were further selected on the basis of older age, HLA-matching, low allosensitization, and low body mass index. All patients received a similar immunosuppressive regimen. Minimum follow up was 9 months.
There were significant differences in donor and recipient characteristics between ECD and SCD transplants. Patient (99%) and kidney graft survival (88%) rates and morbidity were similar between the 2 groups, with a mean follow-up of 16 months. Initial graft function and the mean 1-week and 1-, 3-, 6-, 12-, and 18-month SCr levels were similar among groups.
The use of ECD kidneys at our center effectively doubled our transplant volume within 1 year. A systematic approach to ECD kidneys based on nephron mass matching and nephron sparing measures may provide optimal utilization with short-term outcomes and renal function comparable to SCD kidneys.
Expanded-criteria donor (ECD) kidneys are associated with a higher risk of posttransplant failure, but they remain a favorable alternative to dialysis. Now that a uniform definition of "expanded criteria" exists, it is more appropriate than ever to evaluate their utility compared with that seen with non-ECD kidneys.
The authors analyzed 202 cadaveric kidney-only recipients that underwent transplantation from January 1999 to September 2001, including 45 (22%) recipients whose donors met current ECD criteria.
ECD and non-ECD kidney recipients had similar pretransplant characteristics except for older age and increased duration of renal failure in the ECD group. Patient, graft, and death-censored graft survival in both groups were similar in primary recipients but significantly worse in retransplant recipients of ECD kidneys. The relative risk of death-censored graft loss was 1.58 in the ECD group (P = 0.45). Overall inpatient charges (minus organ acquisition charge) for 1 year posttransplant were 76,962 US dollars (ECD) versus 71,026 US dollars (non-ECD) (P = 0.53); the same charges in retransplant recipients were 136,596 US dollars (ECD) versus 91,296 US dollars (non-ECD) (P = 0.25). ECD recipients, especially retransplant recipients, had consistently higher creatinine concentrations, although the average current value of all functioning ECD grafts remains less than 2 mg/dL. ECD recipients had a higher incidence of ureteral stricture (4.4% vs. 0%), but this never resulted in graft loss.
Considering the widening disparity between renal allograft availability and need and the fact that ECD kidneys provide superior outcomes compared with dialysis, the authors' data encourage the continued use of ECD kidneys in primary recipients but justify caution in the retransplant setting.
The United Network for Organ Sharing (UNOS) Expanded Criteria Donor (ECD) system utilizes pre-transplant variables to identify deceased donor kidneys with an increased risk of graft loss. The aim of this study was to compare the ECD system with a quantitative approach, the deceased donor score (DDS), in predicting outcome after kidney transplantation. We retrospectively reviewed 49 111 deceased donor renal transplants from the UNOS database between 1984 and 2002. DDS: 0-39 points; >or=20 points defined as marginal. Recipient outcome variables were analyzed by ANOVA or Kaplan-Meier method. There was a 90% agreement between the DDS and ECD systems as predictors of renal function and graft survival. However, DDS identified ECD- kidneys (10.7%) with a significantly poorer outcome than expected (DDS 20-29 points, n = 5,252). Stratification of ECD+ kidneys identified a group with the poorest outcome (DDS >or=30 points). Predictability of early post-transplant events (i.e. need for hemodialysis, decline of serum creatinine and length of hospital stay) was also improved by DDS. DDS predicted outcome of deceased donor renal transplantation better than the ECD system. Knowledge obtained by stratification of deceased donor kidneys can allow for improved utilization of marginal kidneys which is not achieved by the UNOS ECD definition alone.
To compare intermediate-term outcomes in adult recipients of expanded criteria (ECD) versus concurrent standard criteria (SCD) deceased donor kidney transplants at a single center using a standardized approach.
Expanded criteria donors (ECDs) are a source of kidneys that increase the donor organ pool, but the value of transplanting these kidneys has been questioned because of concerns regarding diminished survival and predicted poorer intermediate-term outcomes.
Over a 47-month period, we performed 244 deceased donor kidney transplants into adult recipients, including 143 from SCDs and 101 from ECDs. Management algorithms were implemented to preserve nephron function, and recipient selection for an ECD kidney transplant was based on low immunologic risk. All patients received depleting antibody induction in combination with tacrolimus and mycophenolate mofetil. A total of 188 patients (77%) had at least a 1-year follow-up.
ECDs were older, had a higher BMI, had an increased incidence of cerebrovascular brain death and preexisting donor hypertension, and had a lower estimated creatinine clearance (CrCl, all P < 0.01) compared with SCDs. Cold ischemic times were similar between groups, but more ECD kidneys were preserved with pulsatile perfusion (P < 0.01). ECD kidney recipients were older, less sensitized, had a lower BMI, had fewer 0-antigen mismatches, and had a shorter waiting time (all P < 0.01) compared with SCD kidney recipients. Actual patient (93%) and kidney graft (83%) survival rates were similar between groups with a mean follow-up of 24 months. The rates of delayed graft function (DGF), acute rejection, readmissions, operative complications, major infections, and resource utilization were comparable between groups. Renal function followed longitudinally was consistently better in SCD patients (P < 0.05). Black recipients had higher rates of DGF, acute rejection, and graft loss (P < 0.05), but the effects were less pronounced in the ECD group.
By appropriate donor and recipient profiling and the use of management algorithms to project and protect renal function, excellent intermediate-term outcomes can be achieved with ECD kidney transplants that are comparable to SCD kidney transplants.
Long-term survival of kidneys from suboptimal donors is known to be not as good as that from optimal ones. However, the shortage of donors has led many transplant centers to consider accepting older donors with comorbidities. We analyzed 238 patients who received deceased donor renal transplants in the period 2000-2005. The recipients were matched to be no more than 15 years older or younger than the corresponding donors. Among them 125 received a single and 18 a double transplantation from donors considered marginal, according to UNOS criteria for expanded criteria donor (ECD). Most kidneys were evaluated with a pretransplant biopsy, using the scoring system introduced by Karpinski in 1999. The analysis indicated clearly better results in the non-ECD group: both patients and graft survival rates were 10% higher at 1, 2, and 3 years. However, the ECD group showed satisfactory outcomes, confirming the utility of this procedure. The long-term survival rates of single or double grafts from marginal donors are satisfactory, confirming the practice of allocating kidneys after a preimplantation histological evaluation, allowing expansion of the donor pool and providing older patients access to the waiting lists.
Kidney biopsies are being used to evaluate marginal deceased donor organs, but, the literature on the utility of this practice remains conflicting. We re-examined this issue by performing a multivariate analysis of 597 kidney transplant recipients. The presence of moderate arteriosclerosis and/or moderate arteriolosclerosis (MA), defined as >or=25% luminal compromise, was a significant predictor of graft outcome in standard criteria donors (multivariate, P=0.01) and in expanded criteria donors (ECD) as defined by UNOS criteria (univariate P=0.02). One-, 3-, and 5-year overall allograft survival with MA was 71%, 58%, and 40%, respectively. Increasing degrees of glomerulosclerosis (GS) were associated with earlier graft failure on univariate (P=0.03) but not multivariate analysis (P=0.36). GS>20% and interstitial fibrosis>25% had a low frequency in the material reviewed, likely reflecting our organ utilization practices, and did not have a demonstrable effect on graft outcome. Clinical parameters independently associated with worse graft function were ECD status (P<0.05), retransplantation (P=0.004), recipient age (P<0.05), and delayed graft function (P<0.0001). Donor vascular disease is an independent risk factor for suboptimal graft survival. Great caution should be exercised in the decision to transplant kidneys with moderate arterial and/or arteriolar luminal narrowing.
Expanded criteria donors for kidney transplantation Outcome of kidney transplantation from high-risk donors is determined by both struc-ture and function
- Metzger Ra
- Delmonico Fl
- S Feng
Metzger RA, Delmonico FL, Feng S, et al: Expanded criteria donors for kidney transplantation. Am J Transplant 3(suppl 4):114, 10. Karpinski J, Lajoie G, Cattran D, et al: Outcome of kidney transplantation from high-risk donors is determined by both struc-ture and function. Transplantation 67:1162, 1999