The Association of Center Performance Evaluations and Kidney Transplant Volume in the United States

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

A novel patient‐centered “intention‐to‐treat” metric of U.S. lung transplant center performance

Despite the importance of pretransplantation outcomes, 1‐year posttransplantation survival is typically considered the primary metric of lung transplant center performance in the United States. We designed a novel lung transplant center performance metric that incorporates both pre‐ and posttransplantation survival time. We performed an ecologic study of 12 187 lung transplant candidates listed at 56 U.S. lung transplant centers between 2006 and 2012. We calculated an “intention‐to‐treat” survival (ITTS) metric as the percentage of waiting list candidates surviving at least 1 year after transplantation. The median center‐level 1‐year posttransplantation survival rate was 84.1%, and the median center‐level ITTS was 66.9% (mean absolute difference 19.6%, 95% limits of agreement 4.3 to 35.1%). All but 10 centers had ITTS values that were significantly lower than 1‐year posttransplantation survival rates. Observed ITTS was significantly lower than expected ITTS for 7 centers. These data show that one third of lung transplant candidates do not survive 1 year after transplantation, and that 12% of centers have lower than expected ITTS. An “intention‐to‐treat” survival metric may provide a more realistic expectation of patient outcomes at transplant centers and may be of value to transplant centers and policymakers.     

Survival After Adult Liver Transplantation Does Not Correlate with Transplant Center Case Volume in the MELD Era

It has been demonstrated that low-volume orthotopic liver transplant centers have poorer outcomes compared to high-volume centers. In light of the recent significant changes in liver transplantation, we performed an analysis of transplant center procedure volume and mortality with data from the Model for End-stage Liver Disease (MELD) era. We analyzed 9909 adult liver transplants performed in the United States since the beginning of the MELD allocation system. Transplant centers were categorized by volume of transplants performed per year. Multivariate survival models were constructed with raw survival as the primary endpoint for both high- and low-volume centers. Thirty percent of centers were categorized as low volume (< or =20 liver transplants per year) and 8.2% of all transplants were performed at low-volume centers. The unadjusted raw mortality rate at 1-year post-transplant at high-volume centers (9.5%, 95% CI 9.4-9.5) was significantly lower than the rate at low-volume centers (10.9%, 95% CI 10.4-11.4), p < 0.001. However, after adjusting for disease severity and multiple donor and recipient factors, transplant center volume was no longer a significant predictor of post-transplant survival (HR 0.99, 95% CI 0.99-1.00, p = 0.22). We conclude that transplant center case volume is no longer a significant predictor of post-transplant survival in the MELD era and factors which are currently unaccounted for in present survival models should be investigated.     

In Situ Normothermic Regional Perfusion for Controlled Donation After Circulatory Death—The United Kingdom Experience

Organs recovered from donors after circulatory death (DCD) suffer warm ischemia before cold storage which may prejudice graft survival and result in a greater risk of complications after transplant. A period of normothermic regional perfusion (NRP) in the donor may reverse these effects and improve organ function. Twenty‐one NRP retrievals from Maastricht category III DCD donors were performed at three UK centers. NRP was established postasystole via aortic and caval cannulation and maintained for 2 h. Blood gases and biochemistry were monitored to assess organ function. Sixty‐three organs were recovered. Forty‐nine patients were transplanted. The median time from asystole to NRP was 16 min (range 10–23 min). Thirty‐two patients received a kidney transplant. The median cold ischemia time was 12 h 30 min (range 5 h 25 min–18 h 22 min). The median creatinine at 3 and 12 months was 107 µmol/L (range 72–222) and 121 µmol/L (range 63–157), respectively. Thirteen (40%) recipients had delayed graft function and four lost the grafts. Eleven patients received a liver transplant. The first week median peak ALT was 389 IU/L (range 58–3043). One patient had primary nonfunction. Two combined pancreas–kidney transplants, one islet transplant and three double lung transplants were performed with primary function. NRP in DCD donation facilitates organ recovery and may improve short‐term outcomes.     

Does Lung Donation by Heart Donors Have an Impact on Survival in Heart Transplant Recipients?

Lung procurement is increasing during multiorgan recovery and substantially alters the explant process. This study evaluated whether lung donation by a heart donor affects survival in heart transplant recipients. Retrospective analysis of United Network for Organ Sharing (UNOS) adult heart transplantation data from 1998 to 2012 was performed. Lung donors (LDs) were defined as those having at least one lung procured and transplanted. Non‐LDs had neither lung transplanted. Heart transplant recipients who had previous transplants, who had heterotopic transplants, who were waitlisted for other organs or who were temporarily delisted were excluded from the analysis. Kaplan–Meier survival analysis and Cox proportional hazards regression were performed. Of 23 590 heart transplant recipients meeting criteria during the study period, 8638 (36.6%) transplants were from LDs. Donors in the LD group had less history of cigarette use (15.5% vs. 29.5%, p < 0.001). On univariate analysis, LDs were associated with improved patient survival (p < 0.001). On multivariate analysis, LDs were not significantly associated with patient survival (adjusted hazard ratio 0.98, 95% confidence interval 0.94–1.03). Analysis of the UNOS registry suggested that donor pulmonary status and lung procurement had no detrimental effect on survival in heart transplant recipients, supporting the present practice of using donor lungs whenever possible.     

Pediatric heart transplantation at adult‐specialty centers in the United States: A multicenter registry analysis

Recent Organ Procurement and Transplantation Network bylaw revisions mandate that US transplant programs have an “approved pediatric component” in order to perform heart transplantation (HT) in patients <18 years old. The impact of this change on adolescents, a group known to be at high risk for graft loss and nonadherence, is unknown. We studied all US primary pediatric (age <18 years) HT from 2000 to 2015 to compare graft survival between centers organized mainly for adult versus pediatric care. Centers were designated as pediatric‐ or adult‐specialty care according to the ratio of pediatric:adult HT performed and minimum age of HT (pediatric‐specialty defined as ratio>0.7; adult‐specialty ratio<0.05 and minimum age >8 years). In propensity score‐matched cohorts, we observed no difference in graft loss by center type (median survival: adult 12.4 years vs pediatric 9.2 years, P = .174). Compared to the matched pediatric cohort, adult‐specialty center recipients lived closer to their transplant center (31 vs 45 miles, P = .012), and trended toward fewer out‐of‐state transplants (15 vs 25%, P = .082). Our data suggest that select adolescents can achieve similar midterm graft survival at centers organized primarily for adult HT care. Regardless of post‐HT setting, the development of care models that demonstrably improve adherence may be of greatest benefit to improving survival of this high‐risk population.     

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

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

The Impact of Anastomosis Time During Kidney Transplantation on Graft Loss: A Eurotransplant Cohort Study

Recent studies raised the concern that warm ischemia during completion of vascular anastomoses in kidney implantation harms the transplant, but its precise impact on outcome and its interaction with other risk factors remain to be established. We investigated the relationship between anastomosis time and graft survival at 5 years after transplantation in 13 964 recipients of deceased donor solitary kidney transplants in the Eurotransplant region. Anastomosis time was independently associated with graft loss after adjusting for other risk factors (adjusted hazard ratio [HR] 1.10 for every 10‐min increase, 95% confidence interval [CI] 1.06–1.14; p < 0.0001), whereas it did not influence recipient survival (HR 1.00, 95% CI 0.97–1.02). Kidneys from donation after circulatory death (DCD) were less tolerant of prolonged anastomosis time than kidneys from donation after brain death (p = 0.02 for interaction). The additive effect of anastomosis time with donor warm ischemia time (WIT) explains this observation because DCD status was no longer associated with graft survival when adjusted for this summed WIT, and there was no interaction between DCD status and summed WIT. Time to create the vascular anastomoses in kidney transplantation is associated with inferior transplant outcome, especially in recipients of DCD kidneys.     

Local Expansion of Donation After Circulatory Death Kidney Transplant Activity Improves Waitlisted Outcomes and Addresses Inequities of Access to Transplantation

In the United Kingdom, donation after circulatory death (DCD) kidney transplant activity has increased rapidly, but marked regional variation persists. We report how increased DCD kidney transplant activity influenced waitlisted outcomes for a single center. Between 2002–2003 and 2011–2012, 430 (54%) DCD and 361 (46%) donation after brain death (DBD) kidney‐only transplants were performed at the Cambridge Transplant Centre, with a higher proportion of DCD donors fulfilling expanded criteria status (41% DCD vs. 32% DBD; p = 0.01). Compared with U.K. outcomes, for which the proportion of DCD:DBD kidney transplants performed is lower (25%; p < 0.0001), listed patients at our center waited less time for transplantation (645 vs. 1045 days; p < 0.0001), and our center had higher transplantation rates and lower numbers of waiting list deaths. This was most apparent for older patients (aged >65 years; waiting time 730 vs. 1357 days nationally; p < 0.001), who received predominantly DCD kidneys from older donors (mean donor age 64 years), whereas younger recipients received equal proportions of living donor, DBD and DCD kidney transplants. Death‐censored kidney graft survival was nevertheless comparable for younger and older recipients, although transplantation conferred a survival benefit from listing for only younger recipients. Local expansion in DCD kidney transplant activity improves survival outcomes for younger patients and addresses inequity of access to transplantation for older recipients.     

Optimal donation of kidney transplants after controlled circulatory death

Controlled donation after circulatory death (cDCD) is used for “extended criteria” donors with poorer kidney transplant outcomes. The French cDCD program started in 2015 and is characterized by normothermic regional perfusion, hypothermic machine perfusion, and short cold ischemia time. We compared the outcomes of kidney transplantation from cDCD and brain-dead (DBD) donors, matching cDCD and DBD kidney transplants by propensity scoring for donor and recipient characteristics. The matching process retained 442 of 499 cDCD and 809 of 6185 DBD transplantations. The DGF rate was 20% in cDCD recipients compared with 28% in DBD recipients (adjusted relative risk [aRR], 1.43; 95% confidence interval [CI] 1.12–1.82). When DBD transplants were ranked by cold ischemia time and machine perfusion use and compared with cDCD transplants, the aRR of DGF was higher for DBD transplants without machine perfusion, regardless of the cold ischemia time (aRR with cold ischemia time <18 h, 1.57; 95% CI 1.20–2.03, vs aRR with cold ischemia time ≥18 h, 1.79; 95% CI 1.31–2.44). The 1-year graft survival rate was similar in both groups. Early outcome was better for kidney transplants from cDCD than from matched DBD transplants with this French protocol.     

Predictors of Lung Transplant Survival in Eurotransplant

This study was undertaken to assess the influence of patient/donor and center factors on lung transplantation outcome. Outcomes of all consecutive first cadaveric lung transplants performed at 21 Eurotransplant centers in 1997-99 were analyzed. The risk-adjusted center effect on mortality was estimated. A Cox model was built including donor and recipient age and gender, primary disease, HLA mismatches, patient's residence, cold ischemic time, donor's cause of death, serum creatinine, type of lung transplant, respiratory support status, clinical condition and percentage predicted FEV1. The center effect was calculated (expressed as the standardized difference between the observed and expected survival rates), and empirical and full Bayes methods were applied to evaluate between-center differences. A total of 590 adults underwent lung transplantation. The primary disease (p=0.01), HLA-mismatches (p = 0.02), clinical condition(p < 0.0001) and the patient's respiratory support status (p = 0.05) were significantly associated with survival. After adjusting for case-mix, no between-center differences could be found. An in-depth empirical Bayes analysis showed the between-center variation to be zero. Similar results were obtained from the full Bayes analysis. Based on these data, there is no scientific basis to support a hypothesis of possible association between center volume and lung survival rates.     

Does DCD Donor Time‐to‐Death Affect Recipient Outcomes? Implications of Time‐to‐Death at a High‐Volume Center in the United States

For donation after circulatory death (DCD), many centers allow 1 h after treatment withdrawal to donor death for kidneys. Our center has consistently allowed 2 h. We hypothesized that waiting longer would be associated with worse outcome. A single‐center, retrospective analysis of DCD kidneys transplanted between 2008 and 2013 as well as a nationwide survey of organ procurement organization DCD practices were conducted. We identified 296 DCD kidneys, of which 247 (83.4%) were transplanted and 49 (16.6%) were discarded. Of the 247 recipients, 225 (group 1; 91.1%) received kidneys with a time to death (TTD) of 0–1 h; 22 (group 2; 8.9%) received grafts with a TTD of 1–2 h. Five‐year patient survival was 88.8% for group 1, and 83.9% for group 2 (p = 0.667); Graft survival was also similar, with 5‐year survival of 74.1% for group 1, and 83.9% for group 2 (p = 0.507). The delayed graft function rate was the same in both groups (50.2% vs. 50.0%, p = 0.984). TTD was not predictive of graft failure. Nationally, the average maximum wait‐time for DCD kidneys was 77.2 min. By waiting 2 h for DCD kidneys, we performed 9.8% more transplants without worse outcomes. Nationally, this practice would allow for hundreds of additional kidney transplants, annually.     

Accepting multiple simultaneous liver offers does not negatively impact transplant outcomes

Impact of performing multiple liver transplants (LT) in a short period of time is unknown. Consecutively performed LT potentially increase complication rates through team fatigue and overutilization of resources and increase ischemia time. We analyzed the impact of undertaking consecutive LT (Consecutive liver transplant, CLT; LT preceded by another transplant performed not more than 12 h before, both transplants grouped together) on outcomes. Of 1702 LT performed, 314 (18.4%) were CLT. Outcome data was compared with solitary LT (SLT; not more than one LT in 12‐h period). Recipient, donor, and graft characteristics were evenly matched between SLT and CLT; second LT of CLT group utilized younger donors grafts with longer cold ischemic times (P = 0.015). Implantation and operative time were significantly lower in CLT recipients on intergroup analysis (P = 0.0001 and 0.002, respectively). Early hepatic artery thrombosis (E‐HAT) was higher in CLT versus SLT (P = 0.038), despite absolute number of E‐HAT being low in all groups. Intragroup analysis demonstrated a trend toward more frequent E‐HAT in first LT, compared to subsequent transplants; however, difference did not reach statistical significance (P = 0.135). In era of organ scarcity, CLT performed at high‐volume center is safe and allows pragmatic utilization of organs, potentially reducing number of discarded grafts and reducing waiting list mortality.     

Association of Center Volume with Outcome After Liver and Kidney Transplantation

Outcomes for certain surgical procedures have been linked with volume: hospitals performing a high number of procedures demonstrate better outcomes than do low-volume centers. This study examines the effect of volume on hepatic and renal transplant outcomes. Data from the Scientific Registry of Transplant Recipients were analyzed for transplants performed from 1996-2000. Transplant centers were assigned to volume quartiles (kidney) or terciles (liver). Logistic regression models, adjusted for clinical characteristics and transplant center clustering, demonstrate the effect of transplant center volume quantile on 1-year post-transplant patient mortality (liver) and graft loss (kidney). The unadjusted rate of renal graft loss within 1 year was significantly lower at high volume centers (8.6%) compared with very low (9.6%), low (9.9%) and medium (9.7%) volume centers (p = 0.0014). After adjustment, kidney transplant at very low [adjusted odds ratio (AOR) 1.22; p = 0.043) and low volume (AOR 1.22 p = 0.041) centers was associated with a higher incidence of graft loss when compared with high volume centers. Unadjusted 1-year mortality rates for liver transplant were significantly different at high (15.9%) vs. low (16.9%) or medium (14.7%) volume centers. After adjustment, low volume centers were associated with a significantly higher risk of death (AOR 1.30; p = 0.0036). There is considerable variability in the range of failure between quantiles after kidney and liver transplant. Transplant outcomes are better at high volume centers; however, there is no clear minimal threshold volume.     

Differential Rates of Ischemic Cholangiopathy and Graft Survival Associated With Induction Therapy in DCD Liver Transplantation

Transplantation utilizing donation after circulatory death (DCD) donors is associated with ischemic cholangiopathy (IC) and graft loss. The University of Washington (UW) DCD experience totals 89 DCD liver transplants performed between 2003 and 2011. Overall outcome after DCD liver transplantation at UW demonstrates Kaplan–Meier estimated 5‐year patient and graft survival rates of 81.6% and 75.6%, respectively, with the great majority of patient and graft losses occurring in the first‐year posttransplant from IC. Our program has almost exclusively utilized either anti‐thymocyte globulin (ATG) or basiliximab induction (86/89) for DCD liver transplantations. Analysis of the differential effect of induction agent on graft survival demonstrated graft survival of 96.9% at 1 year for ATG versus 75.9% for basiliximab (p = 0.013). The improved survival did not appear to be from a lower rate of rejection (21.9% vs. 22.2%) but rather a differential rate of IC, 35.2% for basiliximab versus 12.5% for ATG (p = 0.011). Multivariable analysis demonstrated induction agent to be independently associated with graft survival and IC free graft survival when analyzed against variables including donor age, fWIT, donor cold ischemia time and transplant era.     

Inferior Outcomes on the Waiting List in Low‐Volume Pediatric Heart Transplant Centers

Low case volume has been associated with poor outcomes in a wide spectrum of procedures. Our objective was to study the association of low case volume and worse outcomes in pediatric heart transplant centers, taking the novel approach of including waitlist outcomes in the analysis. We studied a cohort of 6482 candidates listed in the Organ Procurement and Transplantation Network for pediatric heart transplantation between 2002 and 2014; 4665 (72%) of the candidates underwent transplantation. Candidates were divided into groups according to the average annual transplantation volume of the listing center during the study period: more than 10, six to 10, three to five, or fewer than three transplantations. We used multivariate Cox regression analysis to identify independent risk factors for waitlist and posttransplantation mortality. Of the 6482 candidates, 24% were listed in low‐volume centers (fewer than three annual transplantations). Of these listed candidates in low‐volume centers, only 36% received a transplant versus 89% in high‐volume centers (more than 10 annual transplantations) (p < 0.001). Listing at a low‐volume center was the most significant risk factor for waitlist death (hazard ratio [HR] 4.5, 95% confidence interval [CI] 3.5–5.7 in multivariate Cox regression and HR 5.6, CI 4.4–7.3 in multivariate competing risk regression) and was significant for posttransplantation death (HR 1.27, 95% CI 1.0–1.6 in multivariate Cox regression). During the study period, one‐fourth of pediatric transplant candidates were listed in low‐volume transplant centers. These children had a limited transplantation rate and a much greater risk of dying while on the waitlist.     

Time for reform in transplant program–specific reporting: AST/ASTS transplant metrics taskforce

In accordance with the National Organ Transplant Act and Department of Health and Human Services’ Final Rule, the Scientific Registry of Transplant Recipients (SRTR) publicly releases biannual program‐specific reports that include analyses of transplant centers’ risk‐adjusted waitlist mortality, organ acceptance ratios, transplant rates, and graft and patient survival . Since the inception of these center metrics, 1‐year posttransplant graft and patient survival have improved, and center variation has decreased, casting uncertainty on their clinical relevance. The SRTR has recently modified center evaluations by ranking centers into 5 tiers rather than 3 tiers in an attempt to discriminate between programs performing within a tight range, further exacerbating this uncertainty. The American Society of Transplantation/American Society of Transplant Surgeons convened an expert taskforce to examine both the utility and unintended consequences of transplant center metrics. Estimates of center variation in outcomes in adjacent tiers are imprecise and fleeting, but can result in consequential changes in clinician and center behavior. The taskforce has concerns that current metrics, based principally on 1‐year graft and patient survival, provide minimal if any benefit in informing patient choice and access to transplantation, with the untoward effect of decreased utilization of organs and restriction of research and innovation.     

The effect of center volume on pancreas transplant outcomes

BACKGROUND: Caseload often correlates with improved outcomes for several surgical procedures, including solid organ transplantation. Given the unique nature of pancreas transplantation and large variation in transplant center volumes, this study aims to determine whether center volume affects patient and graft survival after pancreas transplantation. METHODS: Registry data on all forms of whole organ pancreas transplants performed between 1995 and 2000 were obtained from the United Network for Organ Sharing. Patient and graft survival rates were followed until 2002. Center volume then was categorized as: low (< 10/year), medium (10-20/year), high (21-50/year), and very high (< 50/year). Cox proportional hazard regression models were developed to evaluate factors affecting pancreas transplant outcomes. RESULTS: Very-high-volume centers were more likely to do pancreas after kidney transplant, pancreas transplant alone, pancreas with kidney transplant, and repeat transplants, while other centers more frequently performed simultaneous pancreas-kidney transplants (P < .001). Very-high-volume centers were more likely to transplant older recipients and less likely to transplant minority or Medicaid patients. Low-volume centers tended to accept pancreatic allografts from younger donors and had the longest waiting times. In models adjusting for differences in patient population, there were no differences in patient survival. However, low-volume centers had a slightly increased risk of graft loss compared to other centers. Early graft loss was similar among all centers, but medium-volume centers were at increased risk for late graft loss. CONCLUSIONS: Low center volume is not associated with increased mortality after pancreas transplantation. Other factors appear to be more important than center volume in determining pancreas transplant outcomes.     

Simulated Regionalization of Heart and Lung Transplantation in the United States

We simulated the impact of regionalization of isolated heart and lung transplantation within United Network for Organ Sharing (UNOS) regions. Overall, 12 594 orthotopic heart transplantation (OHT) patients across 135 centers and 12 300 orthotopic lung transplantation (OLT) patients across 67 centers were included in the study. An algorithm was constructed that “closed” the lowest volume center in a region and referred its patients to the highest volume center. In the unadjusted analysis, referred patients were assigned the highest volume center's 1‐year mortality rate, and the difference in deaths per region before and after closure was computed. An adjusted analysis was performed using multivariable logistic regression using recipient and donor variables. The primary outcome was the potential number of lives saved at 1 year after transplant. In adjusted OHT analysis, 10 lives were saved (95% confidence interval [CI] 9–11) after one center closure and 240 lives were saved (95% CI 209–272) after up to five center closures per region, with the latter resulting in 1624 total patient referrals (13.2% of OHT patients). For OLT, lives saved ranged from 29 (95% CI 26–32) after one center closure per region to 240 (95% CI 224–256) after up to five regional closures, but the latter resulted in 2999 referrals (24.4% of OLT patients). Increased referral distances would severely limit access to care for rural and resource‐limited populations.     

Remote Ischemic Conditioning on Recipients of Deceased Renal Transplants Does Not Improve Early Graft Function: A Multicenter Randomized,Controlled Clinical Trial

Delayed graft function is a frequent complication following deceased donor renal transplantation, and is closely related to ischemia–reperfusion injury. Experimental and clinical studies have shown protection by remote ischemic conditioning (RIC). We hypothesized that recipient RIC before kidney graft reperfusion reduces the time to graft recovery. This multicenter, blinded, randomized, controlled clinical trial included 225 adult recipients of renal transplants from deceased donors at four transplantation centers in Denmark, Sweden, and the Netherlands. Participants were randomized 1:1 to RIC or sham‐RIC. RIC consisted of 4 × 5‐min thigh occlusion by an inflatable tourniquet each followed by 5‐min deflation, performed during surgery prior to graft reperfusion. The tourniquet remained deflated for sham‐RIC. The primary endpoint was the estimated time to a 50% decrease in baseline plasma creatinine (tCr50) calculated from plasma creatinine measurements 30 days posttransplant or 30 days after the last, posttransplant dialysis. No significant differences were observed between RIC and sham‐RIC‐treated patients in the primary outcome median tCr50 (122 h [95% confidence interval [CI] 98–151] vs. 112 h [95% CI 91–139], p = 0.58), or the number of patients receiving dialysis in the first posttransplant week (33% vs. 35%, p = 0.71). Recipient RIC does not reduce the time to graft recovery in kidney transplantation from deceased donors. ClinicalTrials.gov: NCT01395719.