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The transplant center regulations recently published by the Centers for Medicare and Medicaid (CMS) mandate that observed program-specific survival outcomes to fall within expected risk-adjusted outcomes. Meeting these outcomes is essential to continued participation in the Medicare program. Both donor and recipient variables not considered in current risk adjustment models can result in inferior outcomes and therefore may cause an overestimation of transplant center expected performance, precluding participation in the federally funded Medicare program. We reviewed the most recent four reporting periods published by the Scientific Registry for Transplant Recipients on their public website. We identified kidney, liver and heart transplant programs that were flagged for having outcomes statistically lower than expected as well as those that failed to meet CMS criteria. We also analyzed whether center volumes correlated with outcomes in these centers. We highlight the need for mitigating factors that could justify inferior outcomes under specific circumstances. Failure to reach consensus on such a mechanism for appeal may result in risk-averse behavior by transplant centers with respect to innovation and therefore hamper the ability to advance the field of transplantation. We propose a methodology that may address this emerging dilemma.

Continuous quality improvement efforts have become a central focus of leading health care organizations. The transplant community has been a pioneer in periodic review of clinical outcomes to ensure the optimal use of limited donor organs. Through data collected from the Organ Procurement and Transplantation Network (OPTN) and analyzed by the Scientific Registry of Transplant Recipients (SRTR), transplantation professionals have intermittent access to specific, accurate and clinically relevant data that provides information to improve transplantation. Statistical process control techniques, including cumulative sum charts (CUSUM), are designed to provide continuous, real-time assessment of clinical outcomes. Through the use of currently collected data, CUSUMs can be constructed that provide risk-adjusted program-specific data to inform quality improvement programs. When retrospectively compared to currently available data reporting, the CUSUM method was found to detect clinically significant changes in center performance more rapidly, which has the potential to inform center leadership and enhance quality improvement efforts.

Currently, patients awaiting deceased-donor liver transplantation are prioritized by medical urgency. Specifically, wait-listed chronic liver failure patients are sequenced in decreasing order of Model for End-stage Liver Disease (MELD) score. To maximize lifetime gained through liver transplantation, posttransplant survival should be considered in prioritizing liver waiting list candidates. We evaluate a survival benefit based system for allocating deceased-donor livers to chronic liver failure patients. Under the proposed system, at the time of offer, the transplant survival benefit score would be computed for each patient active on the waiting list. The proposed score is based on the difference in 5-year mean lifetime (with vs. without a liver transplant) and accounts for patient and donor characteristics. The rank correlation between benefit score and MELD score is 0.67. There is great overlap in the distribution of benefit scores across MELD categories, since waiting list mortality is significantly affected by several factors. Simulation results indicate that over 2000 life-years would be saved per year if benefit-based allocation was implemented. The shortage of donor livers increases the need to maximize the life-saving capacity of procured livers. Allocation of deceased-donor livers to chronic liver failure patients would be improved by prioritizing patients by transplant survival benefit.

Antifungal prophylaxis for liver transplant recipients (LTRs) is common among patients considered at high risk of infection, but optimal prophylaxis duration and drug has not been defined. This study aimed to assess the effects of 14 days of antifungal therapy prophylaxis in reducing proven invasive fungal infections (IFI) in high-risk subjects. Eligible subjects who met 2 or more risk criteria were randomized 1:1 to the treatment arms (liposomal amphotericin B or fluconazole) and were followed for 100 days post transplantation for evidence of IFI. The study was designed to enroll 300 subjects, but was closed early for insufficient enrollment. A total of 71 subjects were enrolled and randomized. Two-thirds of subjects completed 14 days of study therapy. Ten subjects developed proven or probable IFI with Candida species (9 subjects) and Cryptococcus neoformans (1 subject); rates were similar in the 2 treatment arms. Eleven subjects died, but no death was attributed to study drug or IFI. In summary, high-risk LTRs tolerated antifungal prophylaxis well, and rates of IFI were lower than previously reported in untreated high-risk LTRs.

Living donor liver transplantation (LDLT) may have better immunological outcomes compared to deceased donor liver transplantation (DDLT). The aim of this study was to analyze the incidence of acute cellular rejection (ACR) after LDLT and DDLT. Data from the adult-to-adult living donor liver transplantation (A2ALL) retrospective cohort study on 593 liver transplants done between May 1998 and March 2004 were studied (380 LDLT; 213 DDLT). Median LDLT and DDLT follow-up was 778 and 713 days, respectively. Rates of clinically treated and biopsy-proven ACR were compared. There were 174 (46%) LDLT and 80 (38%) DDLT recipients with >/=1 clinically treated episodes of ACR, whereas 103 (27%) LDLT and 58 (27%) DDLT recipients had >/=1 biopsy-proven ACR episode. A higher proportion of LDLT recipients had clinically treated ACR (p = 0.052), but this difference was largely attributable to one center. There were similar proportions of biopsy-proven rejection (p = 0.97) and graft loss due to rejection (p = 0.16). Longer cold ischemia time was associated with a higher rate of ACR in both groups despite much shorter median cold ischemia time in LDLT. These data do not show an immunological advantage for LDLT, and therefore do not support the application of unique posttransplant immunosuppression protocols for LDLT recipients.

The Centers for Medicare and Medicaid Services (CMS) has developed a set of regulations that spell out the Conditions of Participation (CoPs) for provider hospitals that wish to be certified (and thus eligible for reimbursement) by Medicare for transplant services. The American Society of Transplant Surgeons (ASTS) Council has played a major role in providing CMS with advice and guidance in the development and ongoing implementation of these conditions through a process of fruitful dialogue. In this report, we highlight the events that led to the development of the regulations and describe the process to date in implementing the CoPs. We have raised some important questions regarding the effectiveness of the regulations for improving safety, and we have highlighted the cost associated with their implementation. This report has been vetted by and represents the opinions of the Council of the ASTS.

Background & Aims: Liver transplant candidates with mild hepatic synthetic dysfunction and marked renal insufficiency may have higher Model for End-Stage Liver Disease (MELD) scores than candidates with severe liver disease and normal renal function. We re-estimated MELD coefficients and evaluated the effect of updated MELD on the liver transplant waiting list ranking., Methods: Scientific Registry of Transplant Recipients data was analyzed for 38,899 adults wait-listed between September, 2001 and December, 2006. A time-dependent Cox regression waiting list mortality model estimated updated MELD component coefficients. Rank correlation between existing and updated MELD scores was computed., Results: Existing MELD component coefficient (log(e) creatinine, 0.957 vs 1.266 [95% confidence interval (CI), 1.21-1.32]; log(e) bilirubin, 0.378 vs 0.939 [95% CI, 0.91-0.97]; log(e) international normalized ratio, 1.120 vs 1.658 [95% CI, 1.58-1.74]) was significantly different than updated counterpart. Index of concordance was higher for updated MELD than existing MELD for predicting overall (0.68 vs. 0.64) and 90-day waiting list mortality (0.77 vs. 0.75). Rank correlation between existing and updated MELD scores was 0.95 for all candidates and 0.72 for candidates with existing MELD >or=20. Among candidates with equal existing MELD, those with lower creatinine and higher bilirubin had significantly higher waiting list mortality., Conclusions: Existing MELD coefficient components are significantly different than those calculated from national waiting list data. Updated MELD assigns lower weight to creatinine and international normalized ratio and higher weight to bilirubin. Updated MELD better predicts waiting list mortality. Using updated MELD for liver allocation would alter waiting list candidate ranking.

Objective: To investigate whether intensity of surgical training influences type of vascular access placed and fistula survival., Summary Background Data: Wide variations in fistula placement and survival occur internationally. Underlying explanations are not well understood., Methods: Prospective data from 12 countries in the Dialysis Outcomes and Practice Patterns Study were analyzed; outcomes of interest were type of vascular access in use (fistula vs. graft) in hemodialysis patients at study entry and time from placement until primary and secondary access failures, as predicted by surgical training. Logistic and Cox regression models were adjusted for patient characteristics and time on hemodialysis., Results: During training, US surgeons created fewer fistulae (US mean = 16 vs. 39-426 in other countries) and noted less emphasis on vascular access placement compared with surgeons elsewhere. Significant predictors of fistula versus graft placement in hemodialysis patients included number of fistulae placed during training (adjusted odds ratio [AOR] = 2.2 for fistula placement, per 2 times greater number of fistulae placed during training, P < 0.0001) and degree of emphasis on vascular access creation during training (AOR = 2.4 for fistula placement, for much-to-extreme emphasis vs. no emphasis, P = 0.0008). Risk of primary fistula failure was 34% lower (relative risk = 0.66, P = 0.002) when placed by surgeons who created > or = 25 (vs. < 25) fistulae during training., Conclusions: Surgical training is key to both fistula placement and survival, yet US surgical programs seem to place less emphasis on fistula creation than those in other countries. Enhancing surgical training in fistula creation would help meet targets of the Fistula First Initiative.

Liver transplantation in 2006 generally resembled previous years, with fewer candidates waiting for deceased donor liver transplants (DDLT), continuing a trend initiated with the implementation of the model for end-stage liver disease (MELD). Candidate age distribution continued to skew toward older ages with fewer children listed in 2006 than in any prior year. Total transplants increased due to more DDLT with slightly fewer living donor liver transplants (LDLT). Waiting list deaths and time to transplant continued to improve. In 2006, there also were fewer DDLT for patients with MELD <15, fewer pediatric Status 1A/B transplants and more transplants from donation after cardiac death (DCD) donors. Adjusted patient and graft survival rates were similar for LDLT and DDLT. This article also contains in-depth analyses of transplantation for hepatocellular carcinoma (HCC). Recipients with HCC had lower adjusted 3-year posttransplant survival than recipients without HCC. HCC recipients who received pretransplant ablative treatments had superior adjusted 3-year posttransplant survival compared to HCC recipients who did not. Intestinal transplantation continued to slowly increase with the largest number of candidates on the waiting list since 1997. Survival rates have increased over time. Small children waiting for intestine grafts continue to have the highest waiting list mortality.

Transplant tourism, where patients travel to foreign countries specifically to receive a transplant, is poorly characterized. This study examined national data to determine the minimum scope of this practice. US national waiting list removal data were analyzed. Waiting list removals for transplant without a corresponding US transplant in the database were reviewed via a data validation query to transplant centers to identify foreign transplants. Additionally, waiting list removal records with text field entries indicating a transplant abroad were identified. We identified 373 foreign transplants (173 directly noted; 200 from data validation); most (89.3%) were kidney transplants. Between 2001 and 2006, the annual number of waiting list removals for transplant abroad increased. Male sex, Asian race, resident and nonresident alien status and college education were significantly and independently associated with foreign transplant. Recipients from 34 states, plus the District of Columbia, received foreign transplants in 35 countries, led by China, the Philippines and India. Transplants in foreign countries among waitlisted candidates in the US are increasingly performed. The data reported here represent the minimum number of cases and the full extent of this practice cannot be determined using existing data. Additional reporting requirements are needed.

The survival benefit of liver transplantation depends on candidate disease severity, as measured by MELD score. However, donor liver quality may also affect survival benefit. Using US data from the SRTR on 28 165 adult liver transplant candidates wait-listed between 2001 and 2005, we estimated survival benefit according to cross-classifications of candidate MELD score and deceased donor risk index (DRI) using sequential stratification. Covariate-adjusted hazard ratios (HR) were calculated for each liver transplant recipient at a given MELD with an organ of a given DRI, comparing posttransplant mortality to continued wait-listing with possible later transplantation using a lower-DRI organ. High-DRI organs were more often transplanted into lower-MELD recipients and vice versa. Compared to waiting for a lower-DRI organ, the lowest-MELD category recipients (MELD 6-8) who received high-DRI organs experienced significantly higher mortality (HR = 3.70; p < 0.0005). All recipients with MELD > or =20 had a significant survival benefit from transplantation, regardless of DRI. Transplantation of high-DRI organs is effective for high but not low-MELD candidates. Pairing of high-DRI livers with lower-MELD candidates fails to maximize survival benefit and may deny lifesaving organs to high-MELD candidates who are at high risk of death without transplantation.

Context: Disparities in access to organ transplantation exist for racial minorities, women, and patients with lower socioeconomic status or inadequate insurance. Rural residents represent another group that may have impaired access to transplant services., Objective: To assess the association of rural residence with waiting list registration for heart, liver, and kidney transplant and rates of transplantation among wait-listed candidates., Design, Setting, and Patients: Five-year US cohort of 174,630 patients who were wait-listed and who underwent heart, liver, or kidney transplantation between 1999 and 2004., Main Outcome Measures: Rates of new waiting list registrations and transplants per million population for residents of 3 residential classifications (rural/small town population, <10,000; micropolitan, 10,000-50,000; and metropolitan >50,000 or suburb of major city)., Results: Compared with urban residents, waiting list registration rates for rural/small town residents were significantly lower for heart (covariate-adjusted rate ratio [RR] = 0.91; 95% confidence interval [CI], 0.86-0.96; P<.002), liver (RR = 0.86; 95% CI, 0.83-0.89; P<.001), and kidney transplants (RR = 0.92; 95% CI, 0.90-0.95; P<.001). Compared with residents in urban areas, rural/small town residents had lower relative transplant rates for heart (RR = 0.88; 95% CI, 0.81-0.94; P = .004), liver (RR = 0.80; 95% CI, 0.77-0.84; P<.001), and kidney transplantation (covariate-adjusted RR = 0.90; 95% CI, 0.88-0.93; P<.001). These disparities were consistent across national organ allocation regions. Significantly longer waiting times among rural patients wait-listed for heart transplantation were observed but not for liver and kidney transplantation. There were no significant differences in posttransplantation outcomes between groups., Conclusions: Patients living in rural areas had a lower rate of wait-lisiting and transplant of solid organs, but did not experience significantly different outcomes following transplant. Differences in rates of wait-listing and transplant may be due to variations in the burden of disease between different patient groups or barriers to evaluation and waiting list entry for rural residents with organ failure.

Background: Mortality among patients with chronic liver failure is significantly reduced upon liver transplantation. However, decreases in mortality may not be accompanied by decreases in morbidity metrics, such as hospitalization rates. We compared pre- and posttransplant hospitalization rates for liver transplant recipients., Methods: Statewide hospitalization data were analyzed among 215 adult chronic liver failure patients in Pennsylvania who received a deceased donor transplant from September 2001 to December 2002. Generalized estimating equation (GEE) models were fitted to compare covariate-adjusted pre- and posttransplant hospital admission rates and mean length of stay per admission. The study minimized biases by calculating pre- and posttransplant morbidity in a cohort restricted to patients who received a transplant and were compared to themselves., Results: Liver transplant recipients experienced a significant 70% reduction in hospitalization rates (P<0.0001) posttransplant versus pretransplant. The decline, which occurred for all Model for End-Stage Liver Disease (MELD) subgroups, was significant for patients transplanted at all MELD scores except 6-9. However, even patients with MELD 6-9 experienced a significant decrease in mean length of stay, post versus pretransplant. Higher MELD scores at transplant were generally associated with a greater reduction in hospitalization rates. Also, patients transplanted with lower MELD scores appeared to receive lower quality livers., Conclusions: Our results indicate that the benefit of transplantation extends beyond patient survival and that an important reduction in hospitalization rates is experienced by transplanted patients. Further study is required to determine whether these results are generalizable to the entire United States and to evaluate the donor liver quality used for recipients of different MELD scores.

Obese patients are at higher risk for morbidity and mortality after liver transplantation (LT) than nonobese recipients. However, there are no reports assessing the survival benefit of LT according to recipient body mass index (BMI). A retrospective cohort of liver transplant candidates who were initially wait-listed between September 2001 and December 2004 was identified in the Scientific Registry of Transplant Recipients database. Adjusted Cox regression models were fitted to assess the association between BMI and liver transplant survival benefit (posttransplantation vs. waiting list mortality). During the study period, 25,647 patients were placed on the waiting list. Of these, 4,488 (17%) underwent LT by December 31, 2004. At wait-listing and transplantation, similar proportions were morbidly obese (BMI>or=40; 3.8% vs. 3.4%, respectively) and underweight (BMI<20; 4.5% vs. 4.0%, respectively). Underweight patients experienced a significantly higher covariate-adjusted risk of death on the waiting list (hazard ratio [HR]=1.61; P<0.0001) compared to normal weight candidates (BMI 20 to <25), but underweight recipients had a similar risk of posttransplantation death (HR=1.28; P=0.15) compared to recipients of normal weight. In conclusion, compared to patients on the waiting list with a similar BMI, all subgroups of liver transplant recipients demonstrated a significant (P<0.0001) survival benefit, including morbidly obese and underweight recipients. Our results suggest that high or low recipient BMI should not be a contraindication for LT., (Copyright (c) 2007 AASLD.)

Background & Aims: More than 2000 adult-to-adult living donor liver transplantations (LDLT) have been performed in the United States, yet the potential benefit to liver transplant candidates of undergoing LDLT compared with waiting for deceased donor liver transplantation (DDLT) is unknown. The aim of this study was to determine whether there is a survival benefit of adult LDLT., Methods: Adults with chronic liver disease who had a potential living donor evaluated from January 1998 to February 2003 at 9 university-based hospitals were analyzed. Starting at the time of a potential donor's evaluation, we compared mortality after LDLT to mortality among those who remained on the waiting list or received DDLT. Median follow-up was 4.4 years. Comparisons were made by hazard ratios (HR) adjusted for LDLT candidate characteristics at the time of donor evaluation., Results: Among 807 potential living donor recipients, 389 underwent LDLT, 249 underwent DDLT, 99 died without transplantation, and 70 were awaiting transplantation at last follow-up. Receipt of LDLT was associated with an adjusted mortality HR of 0.56 (95% confidence interval [CI]: 0.42-0.74; P < .001) relative to candidates who did not undergo LDLT. As centers gained greater experience (>20 LDLT), LDLT benefit was magnified, with a mortality HR of 0.35 (95% CI: 0.23-0.53; P < .001)., Conclusions: Adult LDLT was associated with lower mortality than the alternative of waiting for DDLT. This reduction in mortality was magnified as centers gained experience with LDLT. This reduction in transplant candidate mortality must be balanced against the risks undertaken by the living donors themselves.

Background: A national policy to allocate kidneys from expanded criteria donors (ECD) took effect October 31, 2002., Methods: To assess its impact, we analyzed data from the Scientific Registry of Transplant Recipients for ECD kidney candidates and recipients between November 1999 and October 2005., Results: The likelihood of being listed for ECD transplant, of receiving any transplant, and of receiving an ECD transplant were assessed using logistic regression models. As of October 31, 2005, 42.6% of candidates were listed with an ECD designation (range by donation service area [DSA], 1.9% to 94.9%). ECD-listed candidates were likely to be older, diabetic, and sensitized. By October 31, 2005, candidates listed for ECD as of November 1, 2002 were 41% more likely to receive any kidney transplant than those not ECD-listed. Among ECD-listed recipients, 30.1% received an ECD transplant and 69.9% a non-ECD transplant. Recipients more likely to receive an ECD transplant were significantly older and in DSAs where a high percentage of ECD transplants were performed and/or a low percentage of candidates were ECD-listed., Conclusions: A large, regionally variable fraction of candidates are opting to receive ECD offers. Listing with an ECD designation increases the likelihood of transplantation in selected populations. Selective listing of ECD candidates is associated with a higher likelihood of receiving an ECD transplant.

Unlabelled: The purpose of donor evaluation for adult-to-adult living donor liver transplantation (LDLT) is to discover medical conditions that could increase the donor postoperative risk of complications and to determine whether the donor can yield a suitable graft for the recipient. We report the outcomes of LDLT donor candidates evaluated in a large multicenter study of LDLT. The records of all donor candidates and their respective recipients between 1998 and 2003 were reviewed as part of the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL). The outcomes of the evaluation were recorded along with demographic data on the donors and recipients. Of the 1011 donor candidates evaluated, 405 (40%) were accepted for donation. The donor characteristics associated with acceptance (P < 0.05) were younger age, lower body mass index, and biological or spousal relationship to the recipient. Recipient characteristics associated with donor acceptance were younger age, lower Model for End-stage Liver Disease score, and shorter time from listing to first donor evaluation. Other predictors of donor acceptance included earlier year of evaluation and transplant center., Conclusion: Both donor and recipient features appear to affect acceptance for LDLT. These findings may aid the donor evaluation process and allow an objective assessment of the likelihood of donor candidate acceptance.

Urinary complications are common following renal transplantation. The aim of this study is to evaluate the risk factors associated with renal transplant urinary complications. We collected data on 1698 consecutive renal transplants patients. The association of donor, transplant and recipient characteristics with urinary complications was assessed by univariable and multivariable Cox proportional hazards models, fitted to analyze time-to-event outcomes of urinary complications and graft failure. Urinary complications were observed in 105 (6.2%) recipients, with a 2.8% ureteral stricture rate, a 1.7% rate of leak and stricture, and a 1.6% rate of urine leaks. Seventy percent of these complications were definitively managed with a percutaneous intervention. Independent risk factors for a urinary complication included: male recipient, African American recipient, and the "U"-stitch technique. Ureteral stricture was an independent risk factor for graft loss, while urinary leak was not. Laparoscopic donor technique (compared to open living donor nephrectomy) was not associated with more urinary complications. Our data suggest that several patient characteristics are associated with an increased risk of a urinary complication. The U-stitch technique should not be used for the ureteral anastomosis.

Status 1 is the listing category reserved for patients awaiting liver transplantation who are at risk of imminent death. This high allocation priority was intended to benefit patients with acute liver failure and children with severe chronic liver failure. However, the status 1 criteria were not well defined. The aims of this study, which used the Organ Procurement and Transplantation Network/Scientific Registry of Transplant Recipients database for patients wait-listed between February 27, 2002, and September 30, 2003, were to determine the indication and numbers of children and adults at status 1 (including regional variations); examine death rates on the waiting list for children at vs. not at status 1; and examine time to death, transplant, or removal from the waiting list for both pediatric and adult status 1 candidates. During the study period, 40.3% of children and 6.1% of adults were transplanted at status 1. The indication was acute liver failure in 52.1% of adults and 31% of children. Among status 1 transplants, Regional Review Board exceptions were granted for 16.7% of children and 10.1% of adults. Death rates for children listed at status 1 by exception per patient-year at risk were substantially lower (0.51) than those of children with acute liver failure (4.06) or with chronic liver disease and Pediatric End-Stage Liver Disease score > or =25 (4.63). The percentage of adults who died while on the waiting list within 90 days of listing was more than twice that of children, whereas the percentages transplanted were similar. Patients listed and transplanted at status 1 were a heterogeneous population with an overrepresentation of children with varying degrees of chronic liver disease and other exceptions, and an associated wide variation in waiting list mortality. Recent changes in status 1 criteria provide stricter definitions, particularly for children, including the removal of the "by exception" category, with the intent that all candidates listed at status 1 share a similar mortality risk.

Background: Elderly patients (ages 70 yr and older) are among the fastest-growing group starting renal-replacement therapy in the United States. The outcomes of elderly patients who receive a kidney transplant have not been well studied compared with those of their peers on the waiting list., Methods: Using the Scientific Registry of Transplant Recipients, we analyzed data from 5667 elderly renal transplant candidates who initially were wait-listed from January 1, 1990 to December 31, 2004. Of these candidates, 2078 received a deceased donor transplant, and 360 received a living donor transplant by 31 December 2005. Time-to-death was studied using Cox regression models with transplant as a time-dependent covariate. Mortality hazard ratios (RRs) of transplant versus waiting list were adjusted for recipient age, sex, race, ethnicity, blood type, panel reactive antibody, year of placement on the waiting list, dialysis modality, comorbidities, donation service area, and time from first dialysis to first placement on the waiting list., Results: Elderly transplant recipients had a 41% lower overall risk of death compared with wait-listed candidates (RR=0.59; P<0.0001). Recipients of nonstandard, that is, expanded criteria donor, kidneys also had a significantly lower mortality risk (RR=0.75; P<0.0001). Elderly patients with diabetes and those with hypertension as a cause of end-stage renal disease also experienced a large benefit., Conclusions: Transplantation offers a significant reduction in mortality compared with dialysis in the wait-listed elderly population with end-stage renal disease.

The Pediatric end-stage liver disease (PELD) score was developed as a measure of the severity of chronic liver disease that would predict mortality or children awaiting liver transplant. From multivariate analyses a model was derived that included five objective factors which together comprise the PELD score. The factors are growth failure, age less than 1 year, international normalized ratio (INR), serum albumin and total bilirubin.

The number of liver transplants performed yearly has slowly and steadily increased over the last 10 years, reaching 6441 procedures in 2005. The number of living donor liver transplants performed rose steadily from 1996 to 2001, when it peaked at 519; since 2003 there have been approximately 320 such procedures performed each year. The continual increase in the size of the waiting list for a liver transplant, which peaked in 2001 at 14 897 patients, was interrupted in 2002 by the implementation of the allocation system based on the model for end-stage liver disease and pediatric end-stage liver disease (MELD/PELD). Activity in all areas of intestinal transplantation continues to increase. One-year patient and graft survival following intestine-alone transplantation now seem to be superior to outcomes following liver-intestine transplantation. Other topics covered here include the recent 'Share 15' component of the MELD allocation system; liver transplantation following donation after cardiac death; simultaneous liver-kidney transplantation and waiting list and post-transplant outcomes for both liver and intestine transplantation, broken out by a variety of clinical and demographic factors.

A sample of 490 high school students from 81 schools in Michigan participated in an experiment in which they were randomly assigned to either a control or an experimental Web site. The experimental Web site provided exposure to educational material about the process of organ donation and organ transplantation. The control Web site provided educational material on methods to avoid the common cold. The pre-and posttests of knowledge of issues related to organ donation and of attitude toward donation demonstrated statistically significant increases for the experimental group compared with the control group. A structural equation path model suggested that these increases in knowledge and prodonation attitude mediated the effects of the experiment on contacting the Michigan donor registry. The increase in knowledge and in prodonation attitude increased the likelihood of contacting the registry. The potential for this and similar other Web interventions to enhance students' health education is discussed.

Objective: This study examines donation after cardiac death (DCD) practices and outcomes in liver transplantation., Summary Background Data: Livers procured from DCD donors have recently been used to increase the number of deceased donors and bridge the gap between limited organ supply and the pool of waiting list candidates. Comprehensive evaluation of this practice and its outcomes has not been previously reported., Methods: A national cohort of all DCD and donation after brain-death (DBD) liver transplants between January 1, 2000 and December 31, 2004 was identified in the Scientific Registry of Transplant Recipients. Time to graft failure (including death) was modeled by Cox regression, adjusted for relevant donor and recipient characteristics., Results: DCD livers were used for 472 (2%) of 24,070 transplants. Annual DCD liver activity increased from 39 in 2000 to 176 in 2004. The adjusted relative risk of DCD graft failure was 85% higher than for DBD grafts (relative risk, 1.85; 95% confidence interval, 1.51-2.26; P < 0.001), corresponding to 3-month, 1-year, and 3-year graft survival rates of 83.0%, 70.1%, and 60.5%, respectively (vs. 89.2%, 83.0%, and 75.0% for DBD recipients). There was no significant association between transplant program DCD liver transplant volume and graft outcome., Conclusions: The annual number of DCD livers used for transplant has increased rapidly. However, DCD livers are associated with a significantly increased risk of graft failure unrelated to modifiable donor or recipient factors. Appropriate recipients for DCD livers have not been fully characterized and recipient informed consent should be obtained before use of these organs.

The ability of the model for end-stage liver disease (MELD) score to accurately predict death among liver transplant candidates allows for evaluation of geographic differences in transplant access for patients with similar death risk. Adjusted models of time to transplant and death for adult liver transplant candidates listed between 2002 and 2003 were developed to test for differences in MELD score among Organ Procurement and Transplantation Network (OPTN) regions and Donation Service Areas (DSA). The average MELD and relative risk (RR) of death varied somewhat by region (from 0.82 to 1.28), with only two regions having significant differences in RRs. Greater variability existed in adjusted transplant rates by region; 7 of 11 regions differed significantly from the national average. Simulation results indicate that an allocation system providing regional priority to candidates at MELD scores > or = 15 would increase the median MELD score at transplant and reduce the total number of deaths across DSA quintiles. Simulation results also indicate that increasing priority to higher MELD candidates would reduce the percentage variation among DSAs of transplants to patients with MELD scores > or = 15. The variation decrease was due to increasing the MELD score at time of transplantation in the DSAs with the lowest MELD scores at transplant.

The optimal use of kidneys from small pediatric deceased donors remains undetermined. Using data from the Scientific Registry of Transplant Recipients, 2886 small (< 21 kg) pediatric donors between 1993 and 2002 were identified. Donor factors predictive of kidney recovery and transplantation (1343 en bloc; 1600 single) were identified by logistic regression. Multivariable Cox regression was used to assess the risk of graft loss. The rate of kidney recovery from small pediatric donors was significantly higher with increasing age, weight and height. The odds of transplant of recovered small donor kidneys were significantly higher with increasing age, weight, height and en bloc recovery (adjusted odds ratio = 65.8 vs. single; p < 0.0001), and significantly lower with increasing creatinine. Compared to en bloc, solitary transplants had a 78% higher risk of graft loss (p < 0.0001). En bloc transplants had a similar graft survival to ideal donors (p = 0.45) while solitary transplants had an increased risk of graft loss (p < 0.0001). En bloc recovery of kidneys from small pediatric donors may result in the highest probability of transplantation. Although limited by the retrospective nature of the study, kidneys transplanted en bloc had a similar graft survival to ideal donors but may not maximize the number of successfully transplanted recipients.

Transplant physicians and candidates have become increasingly aware that donor characteristics significantly impact liver transplantation outcomes. Although the qualitative effect of individual donor variables are understood, the quantitative risk associated with combinations of characteristics are unclear. Using national data from 1998 to 2002, we developed a quantitative donor risk index. Cox regression models identified seven donor characteristics that independently predicted significantly increased risk of graft failure. Donor age over 40 years (and particularly over 60 years), donation after cardiac death (DCD), and split/partial grafts were strongly associated with graft failure, while African-American race, less height, cerebrovascular accident and 'other' causes of brain death were more modestly but still significantly associated with graft failure. Grafts with an increased donor risk index have been preferentially transplanted into older candidates (>50 years of age) with moderate disease severity (nonstatus 1 with lower model for end-stage liver disease (MELD) scores) and without hepatitis C. Quantitative assessment of the risk of donor liver graft failure using a donor risk index is useful to inform the process of organ acceptance.

Prevention of invasive fungal infections (IFIs) in orthotopic liver transplant (OLT) recipients utilizing postoperative systemic antifungal prophylaxis, typically with fluconazole, is justified among those at high risk for IFI. Use of postoperative antifungal prophylaxis for low-risk OLT recipients is widely practiced but not universally accepted nor supported by data. We conducted a prospective observational study among 200 OLT recipients who were at low risk for IFI and did not receive postoperative antifungal prophylaxis. Patients were considered low risk if they had /=units of 40 blood products or return to the operating room for intra-abdominal bleeding; return to the operating room for anastomotic leak or vascular insufficiency; preoperative serum creatinine of >/=2 mg/dL; and perioperative Candida colonization. Patients were followed 100 d post-transplantation for evidence of IFI. Of 193 eligible patients, 7 (4%) developed an IFI. Three (2%) IFIs were due to Candida spp. and potentially preventable by standard fluconazole prophylaxis. Three patients developed invasive aspergillosis; one developed late onset disseminated cryptococcosis. Liver transplant recipients at low risk for IFI can be identified utilizing pre-determined criteria, and post-transplantation antifungal prophylaxis can be routinely withheld in these patients.

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.

Context: Transplantation using kidneys from deceased donors who meet the expanded criteria donor (ECD) definition (age > or =60 years or 50 to 59 years with at least 2 of the following: history of hypertension, serum creatinine level >1.5 mg/dL [132.6 micromol/L], and cerebrovascular cause of death) is associated with 70% higher risk of graft failure compared with non-ECD transplants. However, if ECD transplants offer improved overall patient survival, inferior graft outcome may represent an acceptable trade-off., Objective: To compare mortality after ECD kidney transplantation vs that in a combined standard-therapy group of non-ECD recipients and those still receiving dialysis., Design, Setting, and Patients: Retrospective cohort study using data from a US national registry of mortality and graft outcomes among kidney transplant candidates and recipients. The cohort included 109,127 patients receiving dialysis and added to the kidney waiting list between January 1, 1995, and December 31, 2002, and followed up through July 31, 2004., Main Outcome Measure: Long-term (3-year) relative risk of mortality for ECD kidney recipients vs those receiving standard therapy, estimated using time-dependent Cox regression models., Results: By end of follow-up, 7790 ECD kidney transplants were performed. Because of excess ECD recipient mortality in the perioperative period, cumulative survival did not equal that of standard-therapy patients until 3.5 years posttransplantation. Long-term relative mortality risk was 17% lower for ECD recipients (relative risk, 0.83; 95% confidence interval, 0.77-0.90; P<.001). Subgroups with significant ECD survival benefit included patients older than 40 years, both sexes, non-Hispanics, all races, unsensitized patients, and those with diabetes or hypertension. In organ procurement organizations (OPOs) with long median waiting times (>1350 days), ECD recipients had a 27% lower risk of death (relative risk, 0.73; 95% confidence interval, 0.64-0.83; P<.001). In areas with shorter waiting times, only recipients with diabetes demonstrated an ECD survival benefit., Conclusions: ECD kidney transplants should be offered principally to candidates older than 40 years in OPOs with long waiting times. In OPOs with shorter waiting times, in which non-ECD kidney transplant availability is higher, candidates should be counseled that ECD survival benefit is observed only for patients with diabetes.

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.

Objective: The objective of this study was to characterize the patient population with respect to patient selection, assess surgical morbidity and graft failures, and analyze the contribution of perioperative clinical factors to recipient outcome in adult living donor liver transplantation (ALDLT)., Summary Background Data: Previous reports have been center-specific or from large databases lacking detailed variables. The Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) represents the first detailed North American multicenter report of recipient risk and outcome aiming to characterize variables predictive of graft failure., Methods: Three hundred eighty-five ALDLT recipients transplanted at 9 centers were studied with analysis of over 35 donor, recipient, intraoperative, and postoperative variables. Cox regression models were used to examine the relationship of variables to the risk of graft failure., Results: Ninety-day and 1-year graft survival were 87% and 81%, respectively. Fifty-one (13.2%) grafts failed in the first 90 days. The most common causes of graft failure were vascular thrombosis, primary nonfunction, and sepsis. Biliary complications were common (30% early, 11% late). Older recipient age and length of cold ischemia were significant predictors of graft failure. Center experience greater than 20 ALDLT was associated with a significantly lower risk of graft failure. Recipient Model for End-stage Liver Disease score and graft size were not significant predictors., Conclusions: This multicenter A2ALL experience provides evidence that ALDLT is a viable option for liver replacement. Older recipient age and prolonged cold ischemia time increase the risk of graft failure. Outcomes improve with increasing center experience.

Background: The international Dialysis Outcomes and Practice Patterns Study (DOPPS I and II) allows description of variations in kidney transplantation and wait-listing from nationally representative samples of 18- to 65-year-old hemodialysis patients. The present study examines the health status and socioeconomic characteristics of United States patients, the role of for-profit versus not-for-profit status of dialysis facilities, and the likelihood of transplant wait-listing and transplantation rates., Methods: Analyses of transplantation rates were based on 5267 randomly selected DOPPS I patients in dialysis units in the United States, Europe, and Japan who received chronic hemodialysis therapy for at least 90 days in 2000. Left-truncated Cox regression was used to assess time to kidney transplantation. Logistic regression determined the odds of being transplant wait-listed for a cross-section of 1323 hemodialysis patients in the United States in 2000. Furthermore, kidney transplant wait-listing was determined in 12 countries from cross-sectional samples of DOPPS II hemodialysis patients in 2002 to 2003 (N= 4274)., Results: Transplantation rates varied widely, from very low in Japan to 25-fold higher in the United States and 75-fold higher in Spain (both P values <0.0001). Factors associated with higher rates of transplantation included younger age, nonblack race, less comorbidity, fewer years on dialysis, higher income, and higher education levels. The likelihood of being wait-listed showed wide variation internationally and by United States region but not by for-profit dialysis unit status within the United States., Conclusion: DOPPS I and II confirmed large variations in kidney transplantation rates by country, even after adjusting for differences in case mix. Facility size and, in the United States, profit status, were not associated with varying transplantation rates. International results consistently showed higher transplantation rates for younger, healthier, better-educated, and higher income patients.

Background: We sought to evaluate the effect on short-term outcomes of normothermic, extracorporeal perfusion (ECMO) for donation of abdominal organs for transplantation after cardiac death (DCD). Study parameters included increase in number of donors and organs, types of organs procured, and viability of kidneys transplanted., Methods: We retrospectively reviewed medical record data for all patients enrolled in our ECMO-supported DCD donor protocol between 10/1/2000 to 2/01/2004. We also reviewed the records for all patients undergoing organ donation after brain-death (DBD) during the study period at our institution. Recipient data were obtained and analyzed for all kidneys procured from both groups., Results: Twenty patients were enrolled in our DCD protocol and underwent attempted organ donation. Fifteen patients completed the protocol; 3 maintained cardiac function throughout the prescribed 60 minutes after withdrawal of life support, and two patients' organs were deemed unsuitable for transplantation. Fourteen (70%) of the DCD donor patients originated on the trauma service and six (30%) were from other clinical services. The DCD program increased the potential donor pool by 33% (61 versus 81 patients) and the number of kidneys transplanted by 24% (100 versus 124). A total of 24 kidney, 5 liver, and 1 pancreas transplants were performed with these organs. Two of 24 (8.3%) DCD kidneys had delayed graft function. There were no perioperative rejection episodes or deaths., Conclusion: The implementation of a DCD protocol using extracorporeal perfusion increased the potential organ donor pool at our institution by 33%. This was accomplished without short term adverse effect on organ function compared with kidneys transplanted from DBD donors.

Background: The U.S. Organ Procurement and Transplantation Network recently implemented a policy allocating expanded criteria donor (ECD) kidneys by waiting time alone. ECD kidneys were defined as having a risk of graft failure > or = 1.7 times that of ideal donors. ECDs include any donor > or = 60 years old and donors 50 to 59 years old with at least two of the following: terminal creatinine >1.5 mg/dL, history of hypertension, or death by cerebrovascular accident. The impact of this policy on use of ECD kidneys is assessed., Methods: The authors compared use of ECD kidneys recovered in the 18 months immediately before and after policy implementation. Differences were tested using t test and chi2 analyses., Results: There was an 18.3% increase in ECD kidney recoveries and a 15.0% increase in ECD kidney transplants in the first 18 months after policy implementation. ECD kidneys made up 22.1% of all recovered kidneys and 16.8% of all transplants, compared with 18.8% (P<0.001) and 14.5% (P<0.001), respectively, in the prior period. The discard rate was unchanged. The median relative risk (RR) for graft failure for transplanted ECD kidneys was 2.07 versus 1.99 in the prepolicy period (P=not significant); the median RR for procured ECD kidneys was unchanged at 2.16. The percentage of transplanted ECD kidneys with cold ischemia times (CIT) <12 hr increased significantly; the corresponding percentage for CIT > or = 24 hr decreased significantly., Conclusions: The recent increase in ECD kidney recoveries and transplants appears to be related to implementation of the ECD allocation system.

Using OPTN/SRTR data, this article reviews the state of thoracic organ transplantation in 2003 and the previous decade. Time spent on the heart waiting list has increased significantly over the last decade. The percentage of patients awaiting heart transplantation for >2 years increased from 23% in 1994 to 49% by 2003. However, there has been a general decline in heart waiting list death rates over the decade. In 2003, the lung transplant waiting list reached a record high of 3,836 registrants, up slightly from 2002 and more than threefold since 1994. One-year patient survival for those receiving lungs in 2002 was 82%, a statistically significant improvement from 2001 (78%). The number of patients awaiting a heart-lung transplant, declining since 1998, reached 189 in 2003. Adjusted patient survival for heart-lung recipients is consistently worse than the corresponding rate for isolated lung recipients, primarily due to worse outcomes for heart-lung recipients with congenital heart disease. A new lung allocation system, approved in June 2004, derives from the survival benefit of transplantation with consideration of urgency based on waiting list survival, instead of being based solely on waiting time. A goal of the policy is to minimize deaths on the waiting list.

Retransplantation for liver allograft failure associated with hepatitis C virus (HCV) has been increasing due to nearly universal posttransplant HCV recurrence and has been demonstrated to be associated with poor outcomes. We report on the risk factors for death after retransplantation among liver recipients with HCV. A retrospective cohort of liver transplant recipients who underwent retransplantation between January 1997 and December 2002 was identified in the Scientific Registry of Transplant Recipients database. Cox regression was used to assess the relative effect of HCV diagnosis on mortality risk after retransplantation and was adjusted for multiple covariates. Of 1,718 liver retransplantations during the study period, 464 (27%) were associated with a diagnosis of HCV infection. Based on Cox regression, retransplant recipients with HCV had a 30% higher covariate-adjusted mortality risk than those without HCV diagnosis (hazard ratio [HR], 1.30; 95% confidence interval [CI], 1.10-1.54; P = 0.002). Other covariates associated with significant relative risk of death after retransplantation included older recipient age, presence in an intensive care unit (ICU), serum creatinine, and donor age. Additional regression analysis revealed that the increase in mortality risk associated with HCV was concentrated between 3 and 24 months postretransplantation, among patients age 18 to 39 at retransplant, and in patients retransplanted during the years 2000 to 2002. In conclusion, HCV liver recipients account for a considerable proportion of all retransplantations performed. Surprisingly, younger age predicted a higher mortality for recipients with HCV undergoing liver retransplantation. This may reflect a willingness to retransplant younger patients with an increased severity of illness or a more virulent HCV infection in this population. Although HCV was predictive of an increased risk of death, consideration of other characteristics of HCV patients, including donor and recipient age and need for preoperative ICU care may identify those at significantly higher risk.

Demand for liver transplantation continues to exceed donor organ supply. Comparing recipient survival to that of comparable candidates without a transplant can improve understanding of transplant survival benefit. Waiting list and post-transplant mortality was studied among a cohort of 12 996 adult patients placed on the waiting list between 2001 and 2003. Time-dependent Cox regression models were fitted to determine relative mortality rates for candidates and recipients. Overall, deceased donor transplant recipients had a 79% lower mortality risk than candidates (HR = 0.21; p < 0.001). At Model for End-stage Liver Disease (MELD) 18-20, mortality risk was 38% lower (p < 0.01) among recipients compared to candidates. Survival benefit increased with increasing MELD score; at the maximum score of 40, recipient mortality risk was 96% lower than that for candidates (p < 0.001). In contrast, at lower MELD scores, recipient mortality risk during the first post-transplant year was much higher than for candidates (HR = 3.64 at MELD 6-11, HR = 2.35 at MELD 12-14; both p < 0.001). Liver transplant survival benefit at 1 year is concentrated among patients at higher risk of pre-transplant death. Futile transplants among severely ill patients are not identified under current practice. With 1 year post-transplant follow-up, patients at lower risk of pre-transplant death do not have a demonstrable survival benefit from liver transplant.

The worsening shortage of donor kidneys for transplant and the aging of both the donor and candidate populations have contributed to the increasing importance of ECD kidney transplantation. While ECD transplants have an increased risk of graft failure, for most candidates patient survival is still improved over remaining on dialysis. Because of this risk, however, ECD kidneys have a high likelihood of discard; significant geographic variation in discard and transplant rates impedes maximum utilization of these kidneys. The ECD allocation system was implemented to help facilitate expeditious placement of ECD kidneys to pre-consented candidates by a simplified allocation algorithm. Under this system, recovery and transplantation of ECD kidneys have increased at rates not seen with non-ECD kidneys and not predicted by preexisting trends. More disappointing has been the lack of effect on the percentage of discards and DGF, despite significant reductions in CIT. The disadvantage in graft survival for ECD kidneys extends equally across the spectrum of recipient characteristics, such that no one group of candidates has a proportionately smaller increase in risk. However, benefit analyses comparing the risk of accepting an ECD kidney versus waiting for a non-ECD kidney demonstrate a significant ECD benefit for older and diabetic candidates in regions with prolonged waiting times. The potential value of an ECD kidney to an individual candidate hinges upon the ability to receive it substantially earlier than a non-ECD kidney. Thus, future allocation efforts may focus on ensuring that is the case. In allocation driven by net benefit, ECD kidneys may become an alternative for those who might not otherwise receive a kidney transplant.