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Background: Previous reports showed an increased early mortality after chronic dialysis initiation among the end-stage renal disease (ESRD) population. We hypothesized that ESRD patients in the Military Health System (MHS) would have greater access to pre-ESRD care and hence better survival rates during this early high-risk period.Methods: In this retrospective cohort study, using the US Renal Data System database, we identified 1,256,640 patients initiated on chronic dialysis from January 2, 2004 through December 31, 2014, from which a bootstrap sample of 3,984 non-MHS incident dialysis patients were compared with 996 MHS patients. We assessed care by a nephrologist and dietitian, erythropoietin administration, and vascular access use at dialysis initiation as well as all-cause mortality as outcome variables.Results: MHS patients were significantly more likely to have had pre-ESRD nephrology care (adjusted OR [aOR] 2.9; 95% CI 2.3-3.7) and arteriovenous fistula used at dialysis initiation (aOR 2.2; 95% CI 1.7-2.7). Crude mortality rates peaked between the 4th and the 8th week for both cohorts but were reduced among MHS patients. The baseline adjusted Cox model showed significantly lower death rates among MHS vs. non-MHS patients at 6, 9, and 12 months. This survival advantage among MHS patients was attenuated after further adjustment for pre-ESRD nephrology care and dialysis vascular access.Conclusions: MHS patients had improved survival within the first 12 months compared to the general ESRD population, which may be explained in part by differences in pre-ESRD nephrology care and vascular access types. [ABSTRACT FROM AUTHOR]

Background: Access to nephrology care prior to end-stage renal disease (ESRD) is significantly associated with lower rates of morbidity and mortality. We assessed the association of area-level and individual-level indicators of poverty and race/ethnicity on pre-ESRD care provided by nephrologists. Methods: In this retrospective cohort study using the US Renal Data System database, we identified 739 537 patients initiated on maintenance dialysis from1 January 2007 through 31 December 2012.We assessed the Medicare-Medicaid dual eligibility status as an indicator of individual-level poverty and ZIP code-level median household income (MHI) data obtained from the 2010 US census. We conducted multivariable logistic regression of pre-ESRD nephrology care as the outcome variable. Results: Among patients in the lowest area-level MHI quintile, 61.28% received pre-ESRD nephrology care versus 67.68% among those in higher quintiles (P < 0.001). Similarly, the proportions of dual-eligible and nondual-eligible patients who had pre-ESRD nephrology care were 61.49 and 69.84%, respectively (P < 0.001). Patients in the lowest area-level MHI quintile were associated with significantly lower likelihood of pre-ESRD nephrology care (adjusted odds ratio [aOR] 0.86 [95% confidence interval (CI) 0.85-0.87]) compared with those in higher quintiles. Both African American (AA) and Hispanic patients were significantly less likely to have received pre-ESRD nephrology care [aOR 0.85 (95% CI 0.84-0.86) and aOR 0.72 (95% CI 0.71-0.74), respectively]. Conclusions: Individual- and area-level measures of poverty, AA race and Hispanic ethnicity were independently associated with a lower likelihood of pre-ESRD nephrology care. Efforts to improve pre-ESRD nephrology care may require focusing on the poor and minority groups. [ABSTRACT FROM AUTHOR]

Background: Serum creatinine (SCr) levels are decreased following traumatic amputation, leading to the overestimation of glomerular filtration rate (GFR). β-Trace protein (BTP) and β2-microglobulin (B2M) strongly correlate with measured GFR and have not been studied following amputation. We hypothesized that BTP and B2M would be unaffected by traumatic amputation.Methods: We used the Department of Defense Serum Repository to compare pre- and post-traumatic amputation serum BTP and B2M levels in 33 male soldiers, via the N Latex BTP and B2M nephelometric assays (Siemens Diagnostics, Tarrytown, N.Y., USA). Osterkamp estimation using DEXA scan measurements was used to establish percent estimated body weight loss (%EBWL). Results were analyzed for small (3-5.9% EBWL), medium (6-13.5%), and large (>13.5%) amputation subgroups; and for a control group matched 1:1 to the 12 large amputation subjects. Paired Student's t test was used for comparisons.Results: Mean serum BTP levels were unchanged in controls, all amputees, and the small and medium amputation subgroups. BTP appeared to decrease following large %EBWL amputation (p = 0.05). Mean serum B2M levels were unchanged in controls, all amputees, and the small and medium amputation subgroups. B2M appeared to increase following large %EBWL amputation (p = 0.05).Conclusions: BTP and B2M levels are less affected than SCr by amputation, and should be considered for future study of GFR estimation. BTP and B2M changes following large %EBWL amputation require validation and may offer insight into non-GFR BTP and B2M determinants as well as increased cardiovascular disease and mortality following amputation. [ABSTRACT FROM AUTHOR]

Background: The impact of socioeconomic factors on arteriovenous fistula (AVF) creation in hemodialysis (HD) patients is not well understood. We assessed the association of area and individual-level indicators of poverty and health care insurance on AVF use among incident end-stage renal disease (ESRD) patients initiated on HD.Methods: In this retrospective cohort study using the United States Renal Data System database, we identified 669,206 patients initiated on maintenance HD from January 1, 2007 through December 31, 2012. We assessed the Medicare-Medicaid dual-eligibility status as an indicator of individual-level poverty and ZIP code-level median household income (MHI) data obtained from the 2010 United States Census. We conducted logistic regression of AVF use at start of dialysis as the outcome variable.Results: The proportions of dual-eligible and non-dual-eligible patients who initiated HD with an AVF were 12.53 and 16.17%, respectively (p<0.001). Dual eligibility was associated with significantly lower likelihood of AVF use upon initiation of HD (adjusted odds ratio (aOR) 0.91; 95% CI 0.90-0.93). Patients in the lowest area-level MHI quintile had an aOR of 0.97 (95% CI 0.95-0.99) compared to those in higher quintile levels. However, dual eligibility and area-level MHI were not significant in patients with Veterans Affairs (VA) coverage.Conclusions: Individual- and area-level measures of poverty were independently associated with a lower likelihood of AVF use at the start of HD, the only exception being patients with VA health care benefits. Efforts to improve incident AVF use may require focusing on pre-ESRD care to be successful. [ABSTRACT FROM AUTHOR]

Background/Aims. We aimed to examine the cost-effectiveness of mycophenolate mofetil (MMF) and azathioprine (AZA) as maintenance therapy for patients with Class III and Class IV lupus nephritis (LN), from a United States (US) perspective. Methods. Using a Markov model, we conducted a cost-utility analysis from a societal perspective over a lifetime horizon. The modeled population comprised patients with proliferative LN who received maintenance therapy with MMF (2 gm/day) versus AZA (150 mg/day) for 3 years. Risk estimates of clinical events were based on a Cochrane meta-analysis while costs and utilities were retrieved from other published sources. Outcome measures included costs, quality-adjusted life-years (QALY), incremental cost-effectiveness ratios (ICER), and net monetary benefit. Results. The base-case model showed that, compared with AZA strategy, the ICER for MMF was $2,630,592/QALY at 3 years. Over the patients’ lifetime, however, the ICER of MMF compared to AZA was $6,454/QALY. Overall, the ICER results from various sensitivity and subgroup analyses did not alter the conclusions of the model simulation. Conclusions. In the short term, an AZA-based regimen confers greater value than MMF for the maintenance therapy of proliferative LN. From a lifelong perspective, however, MMF is cost-effective compared to AZA. [ABSTRACT FROM AUTHOR]

Clinical practice guidelines for management of chronic kidney disease (CKD) have been developed within the Kidney Disease Outcomes Quality Initiative (K/DOQI). Adherence patterns may identify focus areas for quality improvement. We retrospectively studied contemporary CKD care patterns within a private health system in the United States, and systematically reviewed literature of reported practices internationally. Five hundred and nineteen patients with moderate CKD (estimated GFR 30–59 ml/min) using healthcare benefits in 2002–2005 were identified from administrative insurance records. Thirty-three relevant publications in 2000–2006 describing care in 77,588 CKD patients were reviewed. Baseline demographic traits and provider specialty were considered as correlates of delivered care. Testing consistent with K/DOQI guidelines and prevalence of angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB) medication prescriptions were ascertained from billing claims. Care descriptions in the literature sample were based on medical charts, electronic records and/or claims. KDOQI-consistent measurements of parathyroid hormone (7.1 vs. 0.6%, P = 0.0002), phosphorus (38.2 vs. 1.9%, P < 0.0001) and quantified urinary protein (23.8 vs. 9.4%, P = 0.008) were more common among CKD patients with versus without nephrology referral in the administrative data. Nephrology referral correlated with increased likelihood of testing for parathyroid hormone and phosphorus after adjustment for baseline patient factors. Use of ACEi/ARB medications was more common among patients with nephrology contact (50.0 vs. 30.0%; P = 0.008) but appeared largely driven by higher comorbidity burden. The literature review demonstrated similar practice patterns. Delivery of CKD care may be monitored by administrative data. There is opportunity for improvement in CKD guideline adherence in practice. [ABSTRACT FROM AUTHOR]

Single-center studies have reported that HIV-associated nephropathy (HIVAN) can occur in children and may have a clinical course and prognosis similar to that of adults. However, the prevalence and survival has not been reported for a national sample of children with HIVAN and end-stage renal disease (ESRD) on dialysis in the United States. We utilized the United States Renal Data System (USRDS) database to determine the prevalence, demographic information, and survival of children with HIVAN and ESRD in the United States. The Kaplan-Meier method was used to estimate survival of children with HIVAN and the log-rank test was used to compare their survival with children with focal segmental glomerulosclerosis (FSGS) and adults with HIVAN. Cox regression analysis was used to model adjusted hazard ratios (AHR) with HIVAN as a cause of ESRD and its impact on mortality during the study period, adjusted for potential confounders. Of the 7,732 patients identified with HIVAN, only 60 were younger than 21 years and were classified as children; 50% were males and the majority (88.3%) was black. The cumulative percentage survival of children with HIVAN at 12, 24, and 36 months was better than adults with HIVAN (76%, 62%, and 54% vs. 60%, 43%, and 34%). Survival of children with HIVAN who started dialysis after 1996 was significantly better than those who started dialysis in or before 1996 (log rank P value <0.043). However, the major factor associated with better survival on Cox proportional hazard analysis was female gender (male vs. female AHR 2.85, 95% confidence interval 1.04–6.73). We conclude that only a small number of children with HIVAN and ESRD have received dialysis in the United States. The prognosis of these children is better than that of adults with HIVAN and among children with HIVAN females have better survival than males. [ABSTRACT FROM AUTHOR]

Background: The incidence and risk factors for diabetic ketoacidosis (diabetic ketoacidosis) and hyperglycemic hyperosmolar syndrome (hyperglycemic hyperosmolar syndrome, previously called non-ketotic hyperosmolar coma) have not been reported in a national population of renal transplant (renal transplantation) recipients. Methods: We performed a historical cohort study of 39,628 renal transplantation recipients in the United States Renal Data System between 1 July 1994 and 30 June 1998, followed until 31 Dec 1999. Outcomes were hospitalizations for a primary diagnosis of diabetic ketoacidosis (ICD-9 code 250.1x) and hyperglycemic hyperosmolar syndrome (code 250.2x). Cox Regression analysis was used to calculate adjusted hazard ratios for time to hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome. Results: The incidence of diabetic ketoacidosis and hyperglycemic hyperosmolar syndrome were 33.2/1000 person years (PY) and 2.7/1000 PY respectively for recipients with a prior diagnosis of diabetes mellitus (DM), and 2.0/1000 PY and 1.1/1000 PY in patients without DM. In Cox Regression analysis, African Americans (AHR, 2.71, 95 %CI, 1.96-3.75), females, recipients of cadaver kidneys, patients age 33-44 (vs. >55), more recent year of transplant, and patients with maintenance TAC (tacrolimus, vs. cyclosporine) had significantly higher risk of diabetic ketoacidosis. However, the rate of diabetic ketoacidosis decreased more over time in TAC users than overall. Risk factors for hyperglycemic hyperosmolar syndrome were similar except for the significance of positive recipient hepatitis C serology and non-significance of female gender. Both diabetic ketoacidosis (AHR, 2.44, 95% CI, 2.10-2.85, p < 0.0001) and hyperglycemic hyperosmolar syndrome (AHR 1.87, 95% CI, 1.22-2.88, p = 0.004) were independently associated with increased mortality. [ABSTRACT FROM AUTHOR]

Hospitalized avascular necrosis after renal transplantation in the United States. Background. The national incidence of and risk factors for hospitalized avascular necrosis (AVN) in renal transplant recipients has not been reported. Methods. This historical cohort study consisted of 42,096 renal transplant recipients enrolled in the United States Renal Data System (USRDS) between 1 July 1994 and 30 June 1998. The data source was USRDS files through May 2000. Associations with hospitalizations for a primary diagnosis of AVN (ICD-9 codes 733.4x) within three years after renal transplant were assessed in an intention-to-treat design by Cox regression analysis. Results. Recipients had a cumulative incidence of 7.1 episodes/1000 person-years from 1994 to 1998. The two-year incidence of AVN did not change significantly over time. Eighty-nine percent of the cases of AVN were due to AVN of the hip (733.42) and 60.2% of patients with AVN underwent total hip arthroplasty (THA); these percentages did not change significantly over time. In the Cox regression analysis, an earlier year of transplant, African American race [adjusted hazard ratio (AHR), 1.65, 95% confidence interval (CI) 1.33 to 2.03], allograft rejection (AHR 1.67, 95% CI 1.35 to 2.07), peritoneal dialysis (vs. hemodialysis; AHR 1.44, 95% CI 1.15 to 1.81), and diabetes (AHR 0.41, 95% CI 0.27 to 0.64) were the only factors independently associated with hospitalizations for AVN. Conclusions. The incidence of AVN did not decline significantly over time in the renal transplant population. Patients with allograft rejection, African American race, peritoneal dialysis and earlier date of transplant were at the highest risk of AVN, while diabetic recipients were at a decreased risk. [ABSTRACT FROM AUTHOR]

Background: The national incidence of and risk factors for hospitalized poisonings in renal transplant recipients has not been reported. Methods: Historical cohort study of 39,628 renal transplant recipients in the United States Renal Data System between 1 July 1994 and 30 June 1998. Associations with time to hospitalizations for a primary diagnosis of poisonings (ICD-9 codes 960.x-989.x) within three years after renal transplant were assessed by Cox Regression. Results: The incidence of hospitalized poisonings was 2.3 patients per 1000 person years. The most frequent causes of poisonings were immunosuppressive agents (25.3%), analgesics/ antipyretics (14.1%), psychotropic agents (10.0%), and insulin/antidiabetic agents (7.1%). In Cox Regression analysis, low body mass index (BMI, <21.6 vs. >28.3 kg/m2, adjusted hazard ratio (AHR), 3.02, 95% CI, 1.45-6.28, and allograft rejection, AHR 1.83, 95% CI, 1.15-2.89, were the only factors independently associated with hospitalized poisonings. Hospitalized poisonings were independently associated with increased mortality (AHR, 1.54, 95% CI 1.22-1.92, p = 0.002). Conclusions: Hospitalized poisonings were associated with increased mortality after renal transplantation. However, almost all reported poisonings in renal transplant recipients were due to the use of prescribed medications. Allograft rejection and low BMI were the only independent risk factors for poisonings identified in this population. [ABSTRACT FROM AUTHOR]

Background: In the United States, transjugular renal biopsies using the Quickcore™ side cut needle system have previously been described primarily for transjugular renal biopsy in patients with concurrent liver and kidney disease. Methods: We describe transjugular renal biopsy with the Quickcore™ system in 9 patients with nephrotic syndrome and contraindications to percutaneous renal biopsy, who underwent biopsy between 23 October 1996 and 12 April 2001. The most common contraindication was oral anticoagulation with coumadin (40%). Other contraindications included horseshoe kidney, severe renal failure, and spontaneous coagulopathy. A 62 cm straight catheter and 60 cm side-cut Quickcore™ biopsy needle were used to obtain cortical tissue. Packing of the biopsy tract with Gelfoam™ was used for venographically identified capsular perforation. Results: Ten procedures were performed on 9 patients with one requiring re-biopsy (5% of all renal biopsies performed at our institution). There were 9 transjugular renal biopsy and one combined liver-kidney biopsy. A mean of 4 ± 2 passes were made, with a mean of 3 ± 1 cores obtained per procedure. Histologic diagnosis was made in 90% of biopsies and in 100% of patients. Two patients developed transient hydronephrosis associated with gross hematuria; both required transfusion. Capsular perforation occurred in 90%. One patient died of bacterial sepsis, unrelated to the biopsy, several days after the procedure. Conclusions: Transjugular renal biopsy appears to be efficacious in high-risk patients, for whom the percutaneous approach is contraindicated, including patients on oral anticoagulation. The transfusion rate in the present study was similar to other American reports using this technique. [ABSTRACT FROM AUTHOR]

Objective: To examine the recent epidemiology of pediatric urinary stone disease (USD) in the United States.Methods: We utilized the 2004-2016 Optum© Clinformatics® Data Mart database, a de-identified adjudicated administrative health claims database that includes 15-18 million individuals covered annually by commercial insurance in all 50 US states. The analysis included 12,739,125 children aged 0-18 years. We calculated annual rates of USD, ambulatory visits, and procedures, and the prevalence of prescription fills.Results: The 2005-2016 USD rate was 59.5 cases per 100,000 person-years. The annual rate rose gradually from 2005 to a peak of 65.2 cases per 100,000 person-years in 2011. The USD rate increased with increasing age, and was highest among females compared to males, non-Hispanic Whites compared to other race/ethnic groups, and those residing in the South compared to other geographic regions. The overall 2005-2016 rate in the 120 days following a USD episode was 1.9 for ambulatory visits, 0.24 for surgical procedures, and 1.1 for imaging procedures. Ureteroscopy was the most common surgical procedure and CT scan was the most common imaging procedures, although ultrasound utilization increased over time. Medications were filled in 46.9% of cases, and use was lowest among males (43.1%), Asians (34.8%), and in the Northeast (34.3%). Opiate agonists were the most prevalent prescription (39.9%).Conclusion: Our study provides one of the most comprehensive examinations of pediatric USD to date, demonstrating shifting rates and treatment patterns over time, as well as differences by age, gender, race/ethnicity, and geographic region. [ABSTRACT FROM AUTHOR]

The association of race, ethnicity, and socioeconomic factors with survival rates of nursing home (NH) residents with treated end-stage renal disease (ESRD) is unclear. We examined whether race/ethnicity, ZIP code–level, and individual-level indicators of poverty relate to mortality of NH residents on dialysis. Retrospective cohort study. Using the United States Renal Data System database, we identified 56,194 nursing home residents initiated on maintenance dialysis from January 1, 2007 through December 31, 2013, followed until May 31, 2014. We evaluated baseline characteristics of the NH cohort on dialysis, including race and ethnicity. We assessed the Medicare-Medicaid dual eligibility status as an indicator of individual-level poverty and ZIP code–level median household income (MHI) data. We conducted Cox regression analyses with all-cause mortality as the outcome variable, adjusted for clinical and sociodemographic factors including end-of-life preferences. Adjusted Cox analysis showed a significantly lower risk of death among black vs nonblack NH residents [adjusted hazard ratio (AHR) 0.91, 95% confidence interval (CI) 0.89, 0.94]. Dual-eligibility status was significantly associated with lower risk of death compared to those with Medicare alone (AHR 0.80, 95% CI 0.78, 0.82). Compared to those in higher MHI quintile levels, NH ESRD patients in the lowest quintile were significantly associated with higher risk of death (AHR 1.09, 95% CI 1.06, 1.13). Black and Hispanic NH residents on dialysis had an apparent survival advantage. This "survival paradox" occurs despite well-documented racial/ethnic disparities in ESRD and NH care and warrants further exploration that could generate new insights into means of improving survival of all NH residents on dialysis. Area-level indicator of poverty was independently associated with mortality, whereas dual-eligibility status for Medicare and Medicaid was associated with lower risk of death, which could be partly explained by improved access to care. [ABSTRACT FROM AUTHOR]

We carried out an analysis of the United States Renal Data System to determine the incidence, risk factors and prognosis of renal cell carcinoma (RCC) in a national population of patients receiving incident long-term dialysis. In Cox regression, male gender, older age, end-stage renal disease caused by obstruction, tuberous sclerosis, focal segmental glomerulosclerosis, as well as acquired renal cysts, were independently associated with RCC. Most cases of RCC in incident long-term dialysis patients occurred in patients without acquired renal cysts. A diagnosis of RCC was associated with increased risk of subsequent mortality overall and in all high-risk groups. [ABSTRACT FROM AUTHOR]

Experience with delivery of renal replacement therapy (RRT) in support of combat operations by the U.S. military has not been reported since the 1970s. We describe the tri-service military medical experience with RRT in support of Operation Iraqi Freedom. Through December 31, 2006, RRT was provided to 12 individuals inside the theater of operations. Navy medical personnel provided RRT to three patients (two U.S. active duty service members and one host nation individual) aboard the USNS Comfort, a mobile level 4 hospital. Dialysis was performed using conventional single-pass hemodialysis machines equipped with portable reverse osmosis systems. Army and Air Force medical personnel provided RRT to nine patients in theater (eight host nation patients and one U.S. active duty service member), using peritoneal dialysis and continuous renal replacement therapy (CRRT), not requiring trained renal nurses or technicians. Originally, U.S. military personnel with acute kidney injury (AKI) who were evacuated from theater to Landstuhl Regional Medical Center (LRMC), or those who developed AKI at LRMC were transferred to the German civilian medical system, if RRT was required. After creation of a rapid-response dialysis team and, later, positioning of a full-time active duty reserve nephrologist at LRMC, 16 patients received RRT at LRMC. None had required RRT in theater. Renal failure requiring RRT during combat operations remains an unusual but serious event, calling for flexibility in the provision of care. Notably, the Operation Iraqi Freedom experience has highlighted the needs of injured host nation patients with AKI and future military medical planning will need to account for their intratheater renal care. [ABSTRACT FROM AUTHOR]

Renal cell carcinoma as a cause of end-stage renal disease in the United States: Patient characteristics and survival. Background. The patient characteristics and mortality associated with renal cell carcinoma (RCC) as a cause of end-stage renal disease (ESRD) have not been characterized for a national population. Methods. An historical cohort study of renal cell carcinoma (RCC) was conducted from April 1, 1995, to December 31, 1999. Included were 360,651 patients in the United States Renal Data System (USRDS) who were initiated on ESRD therapy with valid causes of ESRD. Results. Of the study population, 1646 patients (0.5%) had RCC. The mean age of patients with RCC was 66.8 ± 14.6 years versus 61.3 ± 16.4 years for patients with other causes of ESRD (P < 0.01 by Student t test). The unadjusted 3-year survival (censored at the date of renal transplantation) of patients with RCC during the study period was 23% versus 36% in all other patients [adjusted hazard ratio (AHR), 1.10, 95% confidence interval (CI) 1.02–1.19, P = 0.019 by Cox regression]. However, patients with RCC who underwent nephrectomy (bilateral or unilateral) had significantly better survival compared to RCC patients who did not (AHR, 0.73, 95% CI, 0.63–0.85, P < 0.01), and their survival was not significantly different in comparison with nondiabetic ESRD patients. Bilateral nephrectomy (vs. unilateral) was not associated with any difference in adjusted mortality. Conclusion. Among patients with ESRD, the demographics of those with RCC were similar to those of patients with RCC in the general population. Overall, patients with RCC had decreased survival compared to patients with other causes of ESRD; those who underwent nephrectomy had significantly better survival than those who did not, with survival comparable to patients with nondiabetic ESRD. [ABSTRACT FROM AUTHOR]

Erythropoietin (EPO) is the primary regulator of bone marrow erythropoiesis. Mouse models have provided evidence that EPO also promotes bone remodeling and that EPO-stimulated erythropoiesis is accompanied by bone loss independent of increased red blood cell production. EPO has been used clinically for three decades to treat anemia in end-stage renal disease, and notably, although the incidence of hip fractures decreased in the United States generally after 1990, it rose among hemodialysis patients coincident with the introduction and subsequent dose escalation of EPO treatment. Given this clinical paradox and findings from studies in mice that elevated EPO affects bone health, we examined EPO treatment as a risk factor for fractures in hemodialysis patients. Relationships between EPO treatment and hip fractures were analyzed using United States Renal Data System (USRDS) datasets from 1997 to 2013 and Consolidated Renal Operations in a Web-enabled Network (CROWNWeb) datasets for 2013. Fracture risks for patients treated with <50 units of EPO/kg/week were compared to those receiving higher doses by multivariable Cox regression. Hip fracture rates for 747,832 patients in USRDS datasets (1997-2013) increased from 12.0 per 1000 patient years in 1997 to 18.9 in 2004, then decreased to 13.1 by 2013. Concomitantly, average EPO doses increased from 11,900 units/week in 1997 to 18,300 in 2004, then decreased to 8,800 by 2013. During this time, adjusted hazard ratios for hip fractures with EPO doses of 50-149, 150-299, and ≥ 300 units/kg/week compared to <50 units/kg/week were 1.08 (95% confidence interval [CI], 1.01-1.15), 1.22 (95% CI, 1.14-1.31), and 1.41 (95% CI, 1.31-1.52), respectively. Multivariable analyses of 128,941 patients in CROWNWeb datasets (2013) replicated these findings. This study implicates EPO treatment as an independent risk factor for hip fractures in hemodialysis patients and supports the conclusion that EPO treatment may have contributed to changing trends in fracture incidence for these patients during recent decades. Published 2021. This article is a U.S. Government work and is in the public domain in the USA. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR)., (Published 2021. This article is a U.S. Government work and is in the public domain in the USA. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).)

Background: Because stroke prevention is a major goal in the management of ESKD hemodialysis patients with atrial fibrillation, investigating racial/ethnic disparities in stroke among such patients is important to those who could benefit from strategies to maximize preventive measures., Methods: We used the United States Renal Data System to identify ESKD patients who initiated hemodialysis from 2006 to 2013 and then identified those with a subsequent atrial fibrillation diagnosis and Medicare Part A/B/D. Patients were followed for 1 year for all-cause stroke, mortality, prescription medications, and cardiovascular disease procedures. The survival mediational g-formula quantified the percentage of excess strokes attributable to lower use of atrial fibrillation treatments by race/ethnicity., Results: The study included 56,587 ESKD hemodialysis patients with atrial fibrillation. Black, white, Hispanic, and Asian patients accounted for 19%, 69%, 8%, and 3% of the population, respectively. Compared with white patients, black, Hispanic, or Asian patients were more likely to experience stroke (13%, 15%, and 16%, respectively) but less likely to fill a warfarin prescription (10%, 17%, and 28%, respectively). Warfarin prescription was associated with decreased stroke rates. Analyses suggested that equalizing the warfarin distribution to that in the white population would prevent 7%, 10%, and 12% of excess strokes among black, Hispanic, and Asian patients, respectively. We found no racial/ethnic disparities in all-cause mortality or use of cardiovascular disease procedures., Conclusions: Racial/ethnic disparities in all-cause stroke among hemodialysis patients with atrial fibrillation are partially mediated by lower use of anticoagulants among black, Hispanic, and Asian patients. The reasons for these disparities are unknown, but strategies to maximize stroke prevention in minority hemodialysis populations should be further investigated., (Copyright © 2020 by the American Society of Nephrology.)

Background: The opioid epidemic is a public health emergency and appropriate medication prescription for pain remains challenging. Physicians have increasingly prescribed gabapentinoids for pain despite limited evidence supporting their use. We determined the prevalence of concomitant gabapentinoid and opioid prescriptions and evaluated their associations with outcomes among dialysis patients., Methods: We used the United States Renal Data System to identify patients treated with dialysis with Part A, B, and D coverage for all of 2010. Patients were grouped into 4 categories of drugs exposure status in 2010: (1) no prescriptions of either an opioid or gabapentinoid, (2) ≥1 prescription of an opioid and no prescriptions of gabapentinoids, (3) no prescriptions of an opioid and ≥1 prescription of gabapenbtinoids, (4) ≥1 prescription of both an opioid and gabapentinoid. Outcomes included 2-year all-cause death, dialysis discontinuation, and hospitalizations assessed in 2011 and 2012., Results: The study population included 153,758 dialysis patients. Concomitant prescription of an opioid and gabapentin (15%) was more common than concomitant prescription of an opioid and pregabalin (4%). In adjusted analyses, concomitant prescription of an opioid and gabapentin compared to no prescription of either was associated with increased risk of death (hazard ratio [HR] 1.16, 95% CI 1.12-1.19), dialysis discontinuation (HR 1.14, 95% CI 1.03-1.27), and hospitalization (HR 1.33, 95% CI 1.31-1.36). Concomitant prescription of an opioid and pregabalin compared to no prescription of either was associated with increased mortality (HR 1.22, 95% CI 1.16-1.28) and hospitalization (HR 1.37, 95% CI 1.33-1.41), but not dialysis discontinuation (HR 1.13, 95% CI 0.95-1.35). Prescription of opioids and gabepentinoids compared to only being prescribed opioids was associated with higher risk of hospitalizations, but not mortality, or dialysis discontinuation., Conclusions: Concomitant prescription of opioids and gabapentinoids among US dialysis patients is common, and both drugs have independent effects on outcomes. Future research should prospectively investigate the potential harms of such drugs and identify safer alternatives for treatment of pain in end-stage renal disease patients., (© 2020 Published by S. Karger AG, Basel.)

We hypothesized that high incidence rates of end-stage renal disease (ESRD) in certain counties of the U.S. are partly due to patients with a type of ESRD resembling chronic kidney disease of uncertain etiology (CKDu), which has been observed in Central America and other countries. Using data on 338,126 incident ESRD patients from the United States Renal Data System (USRDS) (2011 - 2013) and the Behavior Risk Factor Surveillance System (BRFSS) Supplement on county-level variables (2006), we describe both patient-level and county-level characteristics in counties with the highest quartile of ESRD incidence rate standardized for age, sex, and race (> 420 cases/million population/year) compared to the rest of the U.S. and two specific "hotspots" of ESRD: the San Joaquin Valley and the Rio Grande Valley. Logistic regression was used to examine characteristics associated with patients who had either missing cause of ESRD or "unknown" listed as the primary cause of ESRD. High incidence rates of ESRD were observed in southern Texas, the Southeast and parts of California (including the San Joaquin valley area), while low rates were seen in the Northwest and the Mountain Regions. The median crude incidence rate of ESRD was 335 (range 0 - 2,341) new cases per million population per year among counties. Significant predictors of missing/unknown primary cause of ESRD included: older age, white or unknown race, non-Hispanic ethnicity, lack of comorbidities at ESRD onset, lower estimated glomerular filtration rate (eGFR) at initiation, and lack of pre-dialysis care. Large areas of the U.S. have very high rates of ESRD incidence. We cannot confirm that CKDu is present in the U.S. based on this preliminary work. This topic therefore requires further investigation, as many of these patients may well be undocumented aliens working as farm laborers and therefore not registered in the USRDS.
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Seizures have been associated with uremia, but there are few data regarding the prevalence, treatment, and outcomes of patients with end-stage renal disease (ESRD) with epilepsy compared to those with ESRD without epilepsy. Here we conducted a retrospective cohort study using the United States Renal Data System to assess mortality and antiseizure medication prescriptions among patients with ESRD with and without a diagnosis of epilepsy. A modified Poisson regression with a robust variance was used to estimate the association between epilepsy status and mortality, and evaluate effect modification by neurology consultation. Additionally antiseizure medications were assessed in relation to mortality among those with epilepsy. Of 148,294 patients with ESRD in the cohort, 13,094 (8.8%) met a claims-based definition for epilepsy. Among those with epilepsy, 80.9% filled an anticonvulsant or hydantoin prescription in 2013-2014, compared to 33.3% without epilepsy. After adjustment for confounders, the mortality risk among those with epilepsy was 1.11 (95% confidence interval: 1.07, 1.14) times higher than those without. An epilepsy diagnosis was associated with a 15% increase in mortality risk among patients who did not have a neurology consultation (relative risk: 1.15 [95% confidence interval: 1.10, 1.20]), but this risk was attenuated among patients with a neurology consultation (1.07 [1.03, 1.11]). Prescription of gabapentin to patients with an epilepsy diagnosis compared to other antiseizure medications was associated with increased mortality (1.08 [1.01, 1.15]). Thus, patients with ESRD treated with dialysis have a high prevalence of epilepsy, which was associated with increased mortality risk compared to those without epilepsy. Hence, appropriate multidisciplinary care, treatment, and medication selection may reduce mortality among dialysis patients with epilepsy., (Published by Elsevier Inc.)

Background: Data from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established., Methods: To develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients., Results: The trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care., Conclusions: Although a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery., (Copyright © 2019 by the American Society of Nephrology.)

Importance: Cardiovascular disease (CVD) is a leading cause of death among patients with end-stage renal disease (ESRD). Young adult (ages 22-29 years) have risks for ESRD-associated CVD that may vary from other ages., Objective: To test the hypothesis that young adult-onset ESRD is associated with higher cardiovascular (CV) hospitalizations and mortality with different characteristics than childhood-onset disease., Design, Setting, and Participants: This population-based cohort study used the US Renal Data System to categorize patients who initiated ESRD care between 2003 and 2013 by age at ESRD onset (1-11, 12-21, and 22-29 years). Cardiovascular hospitalizations were identified via International Classification of Diseases, Ninth Revision discharge codes and CV mortality from the Centers for Medicare & Medicaid ESRD Death Notification Form. Patients were censored at death from non-CVD events, loss to follow-up, recovery, or survival to December 31, 2014. Adjusted proportional hazard models (95% CI) were fit to determine risk of CV hospitalization and mortality by age group. Data analysis occurred from May 2016 and December 2017., Exposures: Onset of ESRD., Main Outcomes and Measures: Cardiovascular mortality and hospitalization., Results: A total of 33 156 patients aged 1 to 29 years were included in the study population. Young adults (aged 22-29 years) had a 1-year CV hospitalization rate of 138 (95% CI, 121-159) per 1000 patient-years. Young adults had a higher risk for CV hospitalization than children (aged 1-11 years; hazard ratio [HR], 0.41 [95% CI, 0.26-0.64]) and adolescents (aged 12-21 years; HR, 0.86 [95% CI, 0.77-0.97]). Of 4038 deaths in young adults, 1577 (39.1%) were owing to CVD. Five-year cumulative incidence of mortality in this group (7.3%) was higher than in younger patients (adolescents, 4.0%; children, 1.7%). Adjusted HRs for CV mortality were higher for young adults with all causes of ESRD than children (cystic, hereditary, and congenital conditions: HR, 0.22 [95% CI, 0.11-0.46]; P < .001; glomerulonephritis: HR, 0.21 [95% CI, 0.10-0.44]; P < .001; other conditions: HR, 0.33 [95% CI, 0.23-0.49]; P < .001). Adolescents had a lower risk for CV mortality than young adults for all causes of ESRD except glomerulonephritis (cystic, hereditary, and congenital conditions: HR, 0.45 [95% CI, 0.27-0.74]; glomerulonephritis: HR, 0.99 [95% CI, 0.76-1.11]; other: HR, 0.47 [95% CI, 0.40-0.57]). Higher risks for CV hospitalization and mortality were associated with lack of preemptive transplant compared with hemodialysis (hospital: HR, 14.24 [95% CI, 5.92-34.28]; mortality: HR, 13.64 [95% CI, 8.79-21.14]) and peritoneal dialysis [hospital: HR, 8.47 [95% CI, 3.50-20.53]; mortality: HR, 7.86 [95% CI, 4.96-12.45]). Nephrology care before ESRD was associated with lower risk for CV mortality (HR, 0.77 [95% CI, 0.70-0.85])., Conclusions and Relevance: Cardiovascular disease accounted for nearly 40% of deaths in young adults with incident ESRD in this cohort. Identified risk factors may inform development of age-appropriate ESRD strategies to improve the CV health of this population.

Objective: To develop and validate a risk prediction model that would help individualize treatment and improve the shared decision-making process between clinicians and patients., Patients and Methods: We developed a risk prediction tool for mortality during the first year of dialysis based on pre-end-stage renal disease characteristics in a cohort of 35,878 US veterans with incident end-stage renal disease who transitioned to dialysis treatment between October 1, 2007, and March 31, 2014 and then externally validated this tool among 4284 patients in the Kaiser Permanente Southern California (KPSC) health care system who transitioned to dialysis treatment between January 1, 2007, and September 30, 2015., Results: To ensure model goodness of fit, 2 separate models were selected for patients whose last estimated glomerular filtration rate (eGFR) before dialysis initiation was less than 15 mL/min per 1.73 m 2 or 15 mL/min per 1.73 m 2 or higher. Model discrimination in the internal validation cohort of veterans resulted in C statistics of 0.71 (95% CI, 0.70-0.72) and 0.66 (95% CI, 0.65-0.67) among patients with eGFR lower than 15 mL/min per 1.73 m 2 and 15 mL/min per 1.73 m 2 or higher, respectively. In the KPSC external validation cohort, the developed risk score exhibited C statistics of 0.77 (95% CI, 0.74-0.79) in men and 0.74 (95% CI, 0.71-0.76) in women with eGFR lower than 15 mL/min per 1.73 m 2 and 0.71 (95% CI, 0.67-0.74) in men and 0.67 (95% CI, 0.62-0.72) in women with eGFR of 15 mL/min per 1.73 m 2 or higher., Conclusion: A new risk prediction tool for mortality during the first year after transition to dialysis (available at www.DialysisScore.com) was developed in the large national Veterans Affairs cohort and validated with good performance in the racially, ethnically, and gender diverse KPSC cohort. This risk prediction tool will help identify high-risk populations and guide management strategies at the transition to dialysis., (Copyright © 2018 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Background: Centers for Disease Control and Prevention guidelines recommend caution in prescribing opioids for chronic pain. The characteristics of opioid prescription (OpRx) among kidney transplant (KTx) recipients have not been described in a national population., Methods: We assessed OpRx prevalence among prevalent KTx recipients, and associated duration (long-term, defined as ≥90 days in a year) and dosing (in morphine milligram equivalents per day of <50, 50-89, and ≥90) with outcomes, death and graft loss, among incident KTx recipients using 2006-2010 US Renal Data System files, including Medicare Part D for medication ascertainment. Cox models controlled for recipient factors., Results: Of 36,486 KTx recipients in the 2010 prevalent cohort, approximately 14.6% had long-term OpRx. The strongest association with long-term OpRx after KTx was long-term OpRx before KTx (64%; adjusted odds ratio, 95% confidence interval, 95.2, 74.2-122.1). Incident KTx recipients with long-term OpRx had increased risk of mortality and graft loss compared with those without OpRx or short-term OpRx after KTx. This risk was highest among recipients with long-term OpRx doses of ≥90 morphine milligram equivalents or higher per day (adjusted hazard ratio, 95% confidence interval, 1.61, 1.24-2.10 for death, and 1.33, 1.05-1.67 for graft loss, respectively)., Conclusions: In contrast to either no or short-term OpRx, long-term, and especially long-term high-dose OpRx, is associated with increased risk of death and graft loss in US KTx recipients. Causal relationships cannot be inferred, and OpRx may be an illness marker. Nevertheless, efforts to treat pain effectively in KTx recipients with less toxic interventions and decrease OpRx deserve consideration.

Aggressive pain treatment was advocated for ESRD patients, but new Centers for Disease Control and Prevention guidelines recommend cautious opioid prescription. Little is known regarding outcomes associated with ESRD opioid prescription. We assessed opioid prescriptions and associations between opioid prescription and dose and patient outcomes using 2006-2010 US Renal Data System information in patients on maintenance dialysis with Medicare Part A, B, and D coverage in each study year ( n =671,281, of whom 271,285 were unique patients). Opioid prescription was confirmed from Part D prescription claims. In the 2010 prevalent cohort ( n =153,758), we examined associations of opioid prescription with subsequent all-cause death, dialysis discontinuation, and hospitalization controlled for demographics, comorbidity, modality, and residence. Overall, >60% of dialysis patients had at least one opioid prescription every year. Approximately 20% of patients had a chronic (≥90-day supply) opioid prescription each year, in 2010 usually for hydrocodone, oxycodone, or tramadol. In the 2010 cohort, compared with patients without an opioid prescription, patients with short-term (1-89 days) and chronic opioid prescriptions had increased mortality, dialysis discontinuation, and hospitalization. All opioid drugs associated with mortality; most associated with worsened morbidity. Higher opioid doses correlated with death in a monotonically increasing fashion. We conclude that opioid drug prescription is associated with increased risk of death, dialysis discontinuation, and hospitalization in dialysis patients. Causal relationships cannot be inferred, and opioid prescription may be an illness marker. Efforts to treat pain effectively in patients on dialysis yet decrease opioid prescriptions and dose deserve consideration., (Copyright © 2017 by the American Society of Nephrology.)

Background and Objectives: Mortality and CKD risk have not been described in military casualties with post-traumatic AKI requiring RRT suffered in the Iraq and Afghanistan wars., Design, Setting, Participants, & Measurements: This is a retrospective case series of post-traumatic AKI requiring RRT in 51 military health care beneficiaries (October 7, 2001-December 1, 2013), evacuated to the National Capital Region, documenting in-hospital mortality and subsequent CKD. Participants were identified using electronic medical and procedure records., Results: Age at injury was 26±6 years; of the participants, 50 were men, 16% were black, 67% were white, and 88% of injuries were caused by blast or projectiles. Presumed AKI cause was acute tubular necrosis in 98%, with rhabdomyolysis in 72%. Sixty-day all-cause mortality was 22% (95% confidence interval [95% CI], 12% to 35%), significantly less than the 50% predicted historical mortality (P<0.001). The VA/NIH Acute Renal Failure Trial Network AKI integer score predicted 60-day mortality risk was 33% (range, 6%-96%) (n=49). Of these, nine died (mortality, 18%; 95% CI, 10% to 32%), with predicted risks significantly miscalibrated (P<0.001). The area under the receiver operator characteristic curve for the AKI integer score was 0.72 (95% CI, 0.56 to 0.88), not significantly different than the AKI integer score model cohort (P=0.27). Of the 40 survivors, one had ESRD caused by cortical necrosis. Of the remaining 39, median time to last follow-up serum creatinine was 1158 days (range, 99-3316 days), serum creatinine was 0.85±0.24 mg/dl, and eGFR was 118±23 ml/min per 1.73 m(2). No eGFR was <60 ml/min per 1.73 m(2), but it may be overestimated because of large/medium amputations in 54%. Twenty-five percent (n=36) had proteinuria; one was diagnosed with CKD stage 2., Conclusions: Despite severe injuries, participants had better in-hospital survival than predicted historically and by AKI integer score. No patient who recovered renal function had an eGFR<60 ml/min per 1.73 m(2) at last follow-up, but 23% had proteinuria, suggesting CKD burden., (Copyright © 2015 by the American Society of Nephrology.)

Background: A recent study showed an increased risk of death in African Americans compared with whites with end-stage renal disease (ESRD) due to lupus nephritis (LN). We assessed the impact of age stratification, socioeconomic factors, and kidney transplantation on the disparity in patient survival among African American versus non-African American patients with LN-caused ESRD, compared with other causes., Study Design: Retrospective cohort study., Setting & Participants: Using the US Renal Data System database, we identified 12,352 patients with LN-caused ESRD among 1,132,202 patients who initiated maintenance dialysis therapy from January 1, 1995, through December 31, 2006, and were followed up until December 31, 2010., Predictors: Baseline demographics and comorbid conditions, Hispanic ethnicity, socioeconomic factors (employment status, Medicare/Medicaid insurance, and area-level median household income based on zip code as obtained from the 2000 US census), and kidney transplantation as a time-dependent variable., Outcome: All-cause mortality., Measurements: Multivariable Cox and competing-risk regressions., Results: Mean duration of follow-up in the LN-caused ESRD and other-cause ESRD cohorts were 6.24±4.20 (SD) and 4.06±3.61 years, respectively. 6,106 patients with LN-caused ESRD (49.43%) and 853,762 patients with other-cause ESRD (76.24%) died during the study period (P<0.001). Patients with LN-caused ESRD were significantly younger (mean age, 39.92 years) and more likely women (81.65%) and African American (48.13%) than those with other-cause ESRD. In the fully adjusted multivariable Cox regression model, African American (vs non-African American) patients with LN-caused ESRD had significantly increased risk of death at age 18 to 30 years (adjusted HR, 1.43; 95% CI, 1.24-1.65) and at age 31 to 40 years (adjusted HR, 1.17; 95% CI, 1.02-1.34). Among patients with other-cause ESRD, African Americans were at significantly increased risk at age 18 to 30 years (adjusted HR, 1.17; 95% CI, 1.11-1.22)., Limitations: We used zip code-based median household income as a surrogate for patient income. Residual socioeconomic confounders may exist., Conclusions: African Americans are at significantly increased risk of death compared with non-African Americans with LN-caused ESRD at age 18 to 40 years, a racial disparity risk that is 10 years longer than that in the general ESRD population. Accounting for area-level median household income and transplantation significantly attenuated the disparity in mortality of African American versus non-African American patients with LN-caused ESRD., (Published by Elsevier Inc.)

Beginning in the 2014-2015 training year, the US Accreditation Council for Graduate Medical Education (ACGME) required that nephrology Clinical Competency Committees assess fellows' progress toward 23 subcompetency "context nonspecific" internal medicine subspecialty milestones. Fellows' advancement toward the "ready for unsupervised practice" target milestone now is tracked in each of the 6 competencies: Patient Care, Medical Knowledge, Professionalism, Interpersonal Communication Skills, Practice-Based Learning and Improvement, and Systems-Based Practice. Nephrology program directors and subspecialty societies must define nephrology-specific "curricular milestones," mapped to the nonspecific ACGME milestones. Although the ACGME goal is to produce data that can discriminate between successful and underperforming training programs, the approach is at risk to produce biased, inaccurate, and unhelpful information. We map the ACGME internal medicine subspecialty milestones to our previously published nephrology-specific milestone schema and describe entrustable professional activities and other objective assessment tools that inform milestone decisions. Mapping our schema onto the ACGME subspecialty milestone reporting form allows comparison with the ACGME subspecialty milestones and the curricular milestones developed by the American Society of Nephrology Program Directors. Clinical Competency Committees may easily adapt and directly translate milestone decisions reached using our schema onto the ACGME internal medicine subspecialty competency milestone-reporting format., (Published by Elsevier Inc.)

Objective: To describe the development of the Combat Casualty Critical Care Database, a comprehensive database of critically injured combat casualties to identify potentially modifiable risk factors for morbidity and mortality in this population., Methods: The Department of Defense's Joint Theater Trauma Registry was queried for all combat casualties injured from February 1, 2002 through February 1, 2011. The search was limited to patients who required admission to the intensive care unit and survived to be evacuated to Landstuhl Regional Medical Center., Results: The query yielded 6,011 patients. The mean age was 25.7 ± 6.2 years. The majority of patients were male (98.3%), injured in Iraq (80%) and were members of the U. S. Army (72.6%). Most patients (58.0%) had an injury severity score in the lowest severity category (0-15). The mortality rate was 1.8%. The median day of death after injury (interquartile range) was 6 (3-14)., Conclusions: We identified a cohort of critically wounded combat casualties that encompasses the majority of such patients injured in the course of the wars in Iraq and Afghanistan. When this database is fully populated, rigorous epidemiologic analysis will seek to identify factors associated with morbidity and mortality to improve future care., (Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.)

Background: An analysis of intracranial hemorrhage (ICH) in a national sample of autosomal dominant polycystic kidney disease (ADPKD) patients receiving long-term dialysis has not been reported. It is often assumed that patients with ADPKD are not at increased risk of ICH after starting dialysis. We hypothesized that patients with ADPKD would have a higher subsequent risk of ICH even after the start of chronic dialysis., Methods: Retrospective cohort study of Medicare primary patients with and without ADPKD in the United States Renal Data System (USRDS), initiated on chronic dialysis or transplanted between 1 January 1999 and 3 July 2009, and followed until 31 December 2009. Covariates included age, gender, race, prior stroke, diabetes mellitus, dialysis modality, body mass index, serum albumin and other co-morbid conditions from the Medical Evidence Form. Primary outcome was ICH, based on inpatient and outpatient Medicare claims, and all-cause mortality. Kaplan-Meier analysis was used for unadjusted assessment of time to events. Cox regression was used for assessment of factors associated with ICH and mortality. We performed competing risk regression using kidney transplant and death as competing risks. Kidney transplant was also modeled as a time-dependent covariate in Cox regression., Results: Competing risk regression demonstrated that ADPKD had a subhazard ratio 2.97 for ICH (95% CI 2.27-3.89). Adjusted Cox analysis showed that ADPKD patients had an AHR for death of 0.59 vs. non-ADPKD patients (95% CI 0.57-0.61)., Conclusions: ADPKD is a significant risk factor for ICH among patients on maintenance dialysis. Our Medicare primary cohort was older than in previous studies of intracranial aneurysm rupture among ADPKD patients. There are also limitations inherent to using the USRDS database.

Background: Mortality records identify cancer as the leading cause of death among living kidney donors, but information on the burden of cancer outside death records is limited in this population., Methods: We examined a database wherein U.S. Organ Procurement and Transplantation Network identifiers for 4,650 living kidney donors in 1987 to 2007 were linked to administrative data of a U.S. private health insurer (2000-2007 claims) to identify postdonation cancer diagnoses. Skin cancer and non-skin cancer diagnoses were ascertained from International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes on billing claims. Donors were also matched one-to-one with general insurance beneficiaries by sex and age when benefits began. Diagnosis rates within observation windows were compared as rate ratios., Results: The median time from donation to the end of plan insurance enrollment was 7.7 years, with a median observation period of 2.1 years. Skin cancer rates were similar among prior living donors in the observation period and nondonor controls (rate ratio, 0.91; 95% confidence interval [CI], 0.59-1.40). In contrast, the rate of total non-skin cancers was significantly less common among donors than among controls (rate ratio, 0.74; 95% CI, 0.55-0.99), although reduced relative risk was limited to donors captured earlier in relation to donation. Several cases of cancer diagnosis (uterine, melanoma, "other") were identified within the first year after donation. Prostate cancer diagnosis was significantly more common among living donors compared with controls (rate ratio, 3.80; 95% CI, 1.42-10.2)., Conclusions: Continued study of cancer after kidney donation is warranted to ensure that evaluation, selection, and long-term follow-up support overall good health of the donor.

Background: We previously reported that posttransplant lymphoproliferative disorders (PTLD) occurred more frequently in non-African American (AF) kidney transplant recipients. An in-depth analysis of racial differences in the development of PTLD has not been reported., Methods: We assessed Medicare claims for PTLD in a retrospective cohort of 53,719 patients who underwent transplantation from January 2000 to September 2006 and followed up through December 2007., Results: There were 719 (1.3%) patients with claims for PTLD. Non-AF recipient race (including all races analyzed separately, adjusted hazard ratio [AHR] 1.38, 95% confidence interval [CI] 1.13-1.68), recipient Epstein-Barr virus (EBV) immunoglobulin G (IgG) seronegative status (AHR 1.88, 95% CI 1.53-2.34), and de novo sirolimus (AHR 1.22, 95% CI 1.03-1.45) were associated with an increased risk of PTLD. Furthermore, de novo sirolimus showed a significant interaction with EBV IgG; among EBV IgG-negative recipients, sirolimus use was significant (P = 0.003), but among EBV IgG-positive recipients, it was not significant (P = 0.18). EBV IgG-seronegative status was significant in all races except for AFs, and racial differences were a significant effect modifier for EBV IgG status and risk of PTLD. Mortality subsequent to PTLD did not differ by race. CONCLUSIONS.: AF kidney transplant recipients were at lower risk for PTLD, irrespective of the recipient EBV IgG serostatus. On the contrary, recipient EBV IgG-seronegative status was associated with a higher risk of PTLD in the non-AF population. De novo sirolimus therapy was associated with increased risk of PTLD in EBV IgG-negative recipients, regardless of race.

Background: Posttransplant neutropenia (PTN) is relatively common after kidney transplantation, and may result in a reduction of immunosuppression, which may precipitate acute rejection. Granulocyte colony-stimulating factors (GCSF) have been used to treat PTN, although outcomes associated with use of this medication in this population are unknown., Methods: In a retrospective cohort of 41,705 adult Medicare primary patients transplanted from January 2001 to June 2006, we assessed Medicare claims for neutropenia, leukopenia, and GCSF use, respectively. Outcomes included allograft loss and death., Results: There were 6043 (14.5%) patients with claims for PTN. Factors associated with PTN included female gender, Caucasian ethnicity, ischemic heart disease, donor cytomegalovirus positive, deceased donor, expanded donor criteria, delayed graft function, elevated panel reactive antibody, higher human leukocyte antigen mismatch, and later year of transplant. Thymoglobulin induction, tacrolimus, and mycophenolate mofetil were also associated. PTN was less frequent among patients with congestive heart failure, recipient cytomegalovirus positive, and interleukin-2 induction. PTN was associated with increased risk of allograft loss (adjusted hazard ratio, 1.59; 95% confidence interval, 1.43-1.76; P<0.001) and death (adjusted hazard ratio, 1.74; 95% confidence interval, 1.59-1.90; P<0.001). Of the 6043 patients with PTN, 740 (12.2%) received GCSF. Patients who received GCSF had a lower risk of death on unadjusted analysis, but this only trended towards significance after adjustment., Conclusions: Neutropenia after renal transplantation is common and is associated with an increased risk of allograft loss and death. GCSF was used in 12% of cases and did not increase risk of allograft loss. Strategies to avoid PTN and greater use of GCSF may be indicated to prevent graft loss and death.

Background: Limited data are available on the use of potentially cardioprotective medications among U.S. kidney transplant recipients., Methods: We constructed a database wherein Organ Procurement and Transplant Network identifiers for kidney transplant recipients were linked to billing records of a private health insurer (2003-2006 claims). Transplant recipients and general beneficiaries with acute myocardial infarction (AMI) events were identified by diagnosis codes. The healthcare process measures of interest comprised prescription fills for beta-blockers, antiplatelet drugs, angiotensin-converting enzyme inhibitors/angiotensin-2 receptor blockers, and β-hydroxy-β-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors (statins) within 60 days after AMI. Medication use was compared in transplant and general patients by multivariable regression and by one-to-one matching for demographic and clinical factors including comorbidities and revascularization status., Results: We identified 192 kidney transplant recipients and 52,021 general patients who survived with insurance benefits more than or equal to 60 days after AMI diagnosis. In multiple logistic regression, transplant status was independently associated with increased likelihood of beta-blocker (adjusted odds ratio, 2.50; 95% confidence interval, 1.70-3.68; P<0.0001) and statin (adjusted odds ratio, 1.78; 95% confidence interval, 1.28-2.48; P=0.0006) use after AMI. Similarly kidney transplant recipients with AMI more commonly received beta-blockers (83.0% vs. 65.9%; P=0.0001) and statins (72.0% vs. 62.6%; P=0.04) compared with matched controls. Use of antiplatelet agents and angiotensin-converting enzyme inhibitors/angiotensin-2 receptor blockers did not differ significantly by transplant status., Conclusions: Although kidney transplant status does not seem to be a barrier to medication use after AMI, there may be opportunities for improving cardiovascular risk management in high-risk transplant recipients. Administrative records offer a practical tool for monitoring cardiovascular complications and healthcare delivery not tracked in national registries.

Background and Objectives: Influenza vaccination is recommended in all renal transplant recipients. However, immunosuppression in the early period post-transplant may attenuate the immunologic response to the vaccine. Additionally, it has been theorized that vaccination can induce an immune response that could trigger rejection episodes., Design, Setting, Participants, & Measurements: In a retrospective cohort of 51,730 adult Medicare primary patients who were first transplanted from January 2000 to July 2006 and followed through October 2006, we assessed Medicare claims for influenza vaccination and influenza infections, respectively. Outcomes included allograft loss and death., Results: There were 9678 (18.7%) patients with claims for influenza vaccination in the first year post-transplant. Factors associated with vaccination included older age, diabetes, later year of transplant, and tacrolimus or mycophenolate at discharge. Vaccinations were less frequent among men, African Americans, highly sensitized patients, or those receiving induction immunosuppression or expanded criteria donor kidneys. Vaccination in the first year after transplant was associated with lower risk of subsequent allograft loss and death. Claims for influenza infection were reported in 310 (0.6%) patients and were not significantly associated with graft loss, although there was a trend toward death., Conclusions: In the first year after renal transplantation, influenza vaccination was associated with a lower risk of subsequent allograft loss and death. Although this study cannot comment on formation of protective antibodies after vaccination, these data do not support withholding vaccination on the basis of concerns of adversely affecting allograft function., (Copyright © 2011 by the American Society of Nephrology)

Background: We examined the United States Renal Data System registry to analyze trends in renal transplantation in patients with human immunodeficiency virus (HIV) infection., Methods: A retrospective cohort study was performed using the United States Renal Data System, analyzing patients receiving renal transplants from January 1, 1995, to September 29, 2006. Factors independently associated with transplantation in HIV-infected patients with end-stage renal disease were identified., Results: There was a significant increase in renal transplant recipients who were HIV seropositive who received renal transplants from 2001 to 2006 (n=208, 0.26%) versus 1995 to 2000 era (n=43, 0.06%, P<0.001). Before 2001, only 18 states performed renal transplants in HIV-infected patients, whereas most states transplanted HIV-infected patients in the second era. There were more African American recipients with HIV infection from 2001 to 2006 compared with the earlier cohort (n=118 vs. 8, P<0.001). Patients with HIV infection were more likely to have received induction therapy (n=121 vs. 37, P<0.001) and tacrolimus maintenance suppression (n=105 vs. 13, P<0.001) in the latter era. There were also more deceased donor transplants from 2001 to 2006 (n=143 vs. 25, P<0.001). In logistic regression analysis, when adjusted for multiple factors including recipient and donor age, race, gender, and donor type, patients with HIV infection were more likely to have been transplanted after 2001 (adjusted odds ratio, 2.21; 95% confidence interval=1.49-3.28). In analysis adjusted for multiple factors including hepatitis C virus coinfection, HIV infection was not significantly associated with all-cause graft loss., Conclusions: There has been a dramatic increase in the number of transplants among HIV-infected patients. These findings suggest improved access to transplant wait listing and better management of immunosuppression, especially among African American patients., (© 2011 by Lippincott Williams & Wilkins)

Introduction: We carried out an analysis of the United States Renal Data System to determine the incidence, risk factors, prognosis, and costs associated with the diagnosis of renal cell carcinoma (RCC) after kidney transplantation., Methods: This is a retrospective cohort of 40,821 Medicare primary renal transplant recipients transplanted from January 1, 2000, to July 1, 2005, and followed up till December 31, 2005, excluding those with prior RCC or nephrectomy. Kaplan-Meier analysis was performed to determine the time of occurrence of RCC, and Cox regression was used to determine factors associated with RCC., Results: Three hundred sixty-eight patients were diagnosed with RCC within 3 years after transplant (incidence of 3.16 per 1000 person years). The 3-year incidence of RCC posttransplant was 9.29 per 1000 person years (2.3%) for those with pretransplant cysts and 3.08 per 1000 person years (0.7%) without pretransplant cysts. RCC was diagnosed disproportionately early posttransplant in patients with cysts. Cysts were independently associated with increased risk of RCC, as was male gender, older recipient, donor age, African American recipient, increased time on dialysis and acute rejection within first year posttransplant. RCC was associated with increased risk of mortality with a higher risk with pretransplant cysts. Patients who developed RCC had higher cumulative median costs ($55,456 at 2 years) than those who did not develop RCC ($40,369). There was no "clustering" of RCC in individual states or centers more than would be expected by chance., Conclusion: RCC was diagnosed disproportionately early in patients with pretransplant renal cysts and was associated with a worse prognosis and increased costs.

A higher proportion of patients initiate hemodialysis (HD) with an arteriovenous fistula (AVF) in countries with universal health care systems compared with the United States. Because federally sponsored national health care organizations in the United States, such as the Department of Veterans Affairs (DVA) and the Department of Defense (DoD), are similar to a universal health care model, we studied AVF use within these organizations. We used the US Renal Data System database to perform a cross-sectional analysis of patients who initiated HD between 2005 and 2006. Patients who received predialysis nephrology care had 10-fold greater odds of initiating dialysis with an AVF (adjusted odds ratio [aOR] 10.3; 95% confidence interval [CI] 9.6 to 11.1). DVA/DoD insurance also independently associated with initiating HD with an AVF (aOR 1.4; 95% CI 1.2 to 1.5). Fewer patients initiated HD at a DoD facility, but these patients were also approximately twice as likely to use an AVF (aOR 2.3; 95% CI 1.2 to 4.6). In conclusion, patients in DVA/DoD systems are significantly more likely to use an AVF at initiation of HD than patients with other insurance types, including Medicare. Further study of these federal systems may identify practices that could improve processes of care across health care systems to increase the number of patients who initiate HD with an AVF.