Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network.

There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device-related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle.

Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy Devices.

Background: Recent innovations have the potential to disrupt the current paradigm for kidney failure treatment. The US Food and Drug Administration is committed to incorporating valid scientific evidence about how patients weigh the benefits and risks of new devices into their decision making, but to date, premarket submission of patient preference information (PPI) has been limited for kidney devices. With input from stakeholders, we developed a survey intended to yield valid PPI, capturing how patients trade off the potential benefits and risks of wearable dialysis devices and in-center hemodialysis. Methods: We conducted concept elicitation interviews with individuals receiving dialysis to inform instrument content. After instrument drafting, we conducted two rounds of pretest interviews to evaluate survey face validity, comprehensibility, and perceived relevance. We pilot tested the survey with in-center hemodialysis patients to assess comprehensibility and usability further. Throughout, we used participant input to guide survey refinements. Results: Thirty-six individuals receiving in-center or home dialysis participated in concept elicitation (N=20) and pretest (N=16) interviews. Participants identified reduced fatigue, lower treatment burden, and enhanced freedom as important benefits of a wearable device, and many expressed concerns about risks related to device disconnection-specifically bleeding and infection. We drafted a survey that included descriptions of the risks of serious bleeding and serious infection and an assessment of respondent willingness to wait for a safer device. Input from pretest interviewees led to various instrument modifications, including treatment descriptions, item wording, and risk-level explanations. Pilot testing of the updated survey among 24 in-center hemodialysis patients demonstrated acceptable survey comprehensibility and usability, although 50% of patients required some assistance. Conclusions: The final survey is a 54-item web-based instrument that will yield estimates of the maximal acceptable risk for the described wearable device and willingness to wait for wearable devices with lower risk.

Toward Patient-Centered Innovation: A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement Devices.

Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.

A Technology Roadmap for Innovative Approaches to Kidney Replacement Therapies: A Catalyst for Change.

The number of patients dialyzed for ESKD exceeds 500,000 in the United States and more than 2.6 million people worldwide, with the expectation that the worldwide number will double by 2030. The human cost of health and societal financial cost of ESKD is substantial. Dialytic therapy is associated with an unacceptably high morbidity and mortality rate and poor quality of life. Although innovation in many areas of science has been transformative, there has been little innovation in dialysis or alternatives for kidney replacement therapy (KRT) since its introduction approximately 70 years ago. Advances in kidney biology, stem cells and kidney cell differentiation protocols, biomaterials, sensors, nano/microtechnology, sorbents and engineering, and interdisciplinary approaches and collaborations can lead to disruptive innovation. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the US Food and Drug Administration, has convened a multidisciplinary group to create a technology roadmap for innovative approaches to KRT to address patients' needs. The Roadmap is a living document. It identifies the design criteria that must be considered to replace the myriad functions of the kidney, as well as scientific, technical, regulatory, and payor milestones required to commercialize and provide patient access to KRT alternatives. Various embodiments of potential solutions are discussed, but the Roadmap is agnostic to any particular solution set. System enablers are identified, including vascular access, biomaterial development, biologic and immunologic modulation, function, and safety monitoring. Important Roadmap supporting activities include regulatory alignment and innovative financial incentives and payment pathways. The Roadmap provides estimated timelines for replacement of specific kidney functions so that approaches can be conceptualized in ways that are actionable and attract talented innovators from multiple disciplines. The Roadmap has been used to guide the selection of KidneyX prizes for innovation in KRT.

FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access.

In an effort to foster innovation and new product development, the American Society of Nephrology and the US Food and Drug Administration partnered to form the Kidney Health Initiative in 2012. Part of the Kidney Health Initiative's mission is to foster development of therapies by creating a collaborative environment where the US Food and Drug Administration and the greater nephrology community can interact to optimize product evaluation. This particular Kidney Health Initiative project focused on products related to hemodialysis vascular access, with the goal of clarifying appropriate trial end points that could subsequently inform clinical, regulatory, and coverage decisions. Both the lack of common definitions and the lack of consensus on trial end points have been viewed as barriers to innovation in this area. Toward this end, the Kidney Health Initiative convened teams of expert stakeholders to address these issues for each major vascular access category (arteriovenous grafts, arteriovenous fistulas, and central venous catheters), and each team provided recommendations. This commentary provides an overview of the US Food and Drug Administration centers that regulate hemodialysis vascular access and certain laws and regulations that affect these products as well as our perspectives on some of the issues raised and end points proposed by the Kidney Health Initiative teams. The standardized definitions and clinical trial end points proposed by the teams represent an important step forward to improve innovation in this area.

Impact of poverty and race on pre-end-stage renal disease care among dialysis patients in the United States.

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 from 1 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.

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas.

Impact of Poverty and Health Care Insurance on Arteriovenous Fistula Use among Incident Hemodialysis Patients.

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.

Racial differences and income disparities are associated with poor outcomes in kidney transplant recipients with lupus nephritis.

BACKGROUND: An analysis of income and racial/ethnic disparities on renal transplant outcomes in recipients with lupus nephritis (LN) has not been reported. We analyzed the United States Renal Data System database to assess the impact of these disparities on graft loss and death in the LN and non-LN cohorts. METHODS: We identified 4214 patients with LN as the cause of end-stage renal disease in a retrospective cohort of 150,118 patients first transplanted from January 1, 1995 to July 1, 2006. We merged data on median household income from the United States Census based on the ZIP code. RESULTS: In multivariate Cox regression analyses, African-Americans (AF) recipients with LN (vs. non-AF) had an increased risk of graft loss (adjusted hazard ratio [AHR], 1.39; 95% confidence interval [CI], 1.21-1.60) and death (AHR, 1.33; 95% CI, 1.09-1.63). Furthermore, there were significant associations of lower-income quintiles with higher risk for graft loss and death among AF with LN. In comparison, among non-AF recipients with LN, income levels did not predict risk for transplant outcomes. The racial disparity for both graft loss and death outcomes among AF with LN was greater than among AF without LN (AHR, 1.32; 95% CI, 1.29-1.36 for graft loss and AHR, 1.02; 95% CI, 0.99-1.05 for death). CONCLUSIONS: AF kidney transplant recipients with LN were at increased risk for graft loss and death compared with non-AF. Income levels were associated with the risk of graft loss and death in AF but not in non-AF recipients with LN.

Impact of isometric handgrip exercises on cephalic vein diameter in non-AVF candidates, a pilot study.

PURPOSE: Incident arteriovenous fistula (AVF) rates remain low. AVF placement is often not attempted because of small cephalic vein (CV) diameter. We postulated that isometric handgrip exercises would increase forearm CV diameter and allow successful AVF creation in non-AVF candidates. METHODS: Adult subjects without prior vascular access (eGFR<25 mL/min/1.73 m²; CV<2.5 mm) were prospectively enrolled. They performed daily handgrip exercises in the preferred access arm (EA), with the nonexercised arm (NEA) as control. Adherence was assessed by exercise logs and grip strength. CV diameter was measured at baseline, four and eight weeks by ultrasound. The primary endpoint was the mean increase in CV diameter. Secondary endpoints were mean CV diameter increase from baseline, increased proportion of potential AVF sites and successful AVF placement. RESULTS: A total of 17 subjects were enrolled and 15 completed the study. EA grip strength increased significantly. Mean CV diameter increased in both the EA and NEA by 0.48-0.59 and 0.71-0.81 mm (P=NS), respectively. Compared to baseline, all CV diameters increased significantly (P<.05) after four weeks. In the EA, mean distal and proximal CV increased from 1.66 to 2.13 mm and from 2.22 to 2.81 mm, respectively. Similar changes were noted in the NEA. There were also significant increases in the number of sites and subjects eligible for AVF creation. Five subjects had successful AVF placement. CONCLUSIONS: Isometric handgrip exercises resulted in significant CV diameter increases after four weeks, in both the EA and the NEA and potentially allows for AVF creation in those not previously deemed candidates.

Practice patterns in evaluation of living kidney donors in United Network for Organ Sharing-approved kidney transplant centers.

INTRODUCTION: The current pattern of evaluation for living kidney donors was investigated. METHODS: We designed a 37-question electronic survey to collect information about living kidney donor evaluation. Of the 181 United Network for Organ Sharing (UNOS)-approved centers, 72 responded. Survey responses were coded and downloaded into SPSS. Data was expressed as means and standard deviations or the percentage of centers with specific responses. RESULTS: 66% of the centers used a cut-off of <80 ml/min for exclusion of living kidney donors. 24-hour urine measuring creatinine clearance (CrCl) was the most common screening method for glomerular filtration rate (GFR) assessment in potential living donors. 56% of the centers excluded donors with blood pressure (BP) >140/90, whereas 22.7 and 7.1% excluded patients with pre-hypertension with a cut-off BP of 130/85 and 120/80, respectively. 66% of the centers used 24-hour urine creatinine to assess for proteinuria. 20% of the centers accepted living kidney donors with microalbuminuria and 84% accepted patients with a history of nephrolithiasis. 24% of the centers reported use of formal cognitive testing of potential living donors. DISCUSSION: There were significant variations in exclusion criteria based on GFR, history of kidney stones, body mass index, BP and donors with urinary abnormalities. The definitions for hematuria and proteinuria were variable. There is a need for uniformity in selection and for a living donor registry. We also recommend raising the cut-off for estimated GFR to 90 ml/min to account for 10-15% overestimation when CrCl is used.

Poor outcomes in elderly kidney transplant recipients receiving alemtuzumab induction.

INTRODUCTION: Alemtuzumab and rabbit antithymocyte globulin (rATG) are being used with increasing frequency as induction agents in kidney transplantation. Using the US Renal Data Base System, we analyzed the safety profile of these agents in the elderly. METHODS: In a cohort of patients transplanted from January 2000 to July 2009 and followed through 2009, we assessed the effect of induction on allograft loss and death among elderly recipients. Recipients were censored at dates of allograft loss, death or the end of study. Independent associations between induction agents and allograft loss or death were examined using multivariate analysis with forward stepwise Cox regression. RESULTS: Among 130,402 patients with first transplants, 14,907 were age 65 years or older. 4,466 (30%), 3,049 (20.5%), 1,501 (10.1%), and 999 (6.7%) were induced with thymoglobulin, basiliximab, daclizumab, and alemtuzumab, respectively. After adjusting for baseline differences, induction with alemtuzumab was associated with an increased risk of graft loss and death, with an adjusted hazard ratio (AHR) of 1.26 (95% CI 1.08-1.48). Risk was also present at other age cutoffs [age >60 (AHR 1.16; 95% CI 1.03-1.31; p = 0.014), age >70 (AHR 1.43; 95% CI 1.13-1.81; p = 0.003) and age >75 (AHR 1.68; 95% CI 1.07-2.63; p = 0.024)]. CONCLUSIONS: In the elderly, alemtuzumab is associated with an escalating risk of death and graft loss in recipients of kidney transplantations.

Effect of smoking on kidney transplant outcomes: analysis of the United States Renal Data System.

BACKGROUND: We investigated the effect of smoking on postkidney transplant outcomes in the United States Renal Data System. METHODS: In a retrospective cohort of 41,705 adult Medicare primary renal transplant recipients in the United States Renal Data System database transplanted from January 1, 2000, to June 30, 2006, and followed through October 31, 2006, we assessed Medicare claims for smoking. The association between renal allograft loss and death and smoking as a time-dependent variable was assessed with Cox nonproportional hazards regression. RESULTS: Of 41,705 Medicare primary adult renal transplant patients, there were 9.9% patients who had evidence of prior smoking and 4.6% patients with new claims for smoking after transplant. Incident smoking (new onset smokers) occurred at a mean of 1.29±0.88 years after transplant. In the adjusted analysis, factors associated with new smoking included male gender, history of drug or alcohol use, history of chronic obstructive pulmonary disease, and later year of transplant. Compared with never smokers, incident smoking after transplant was associated with increased risk of death-censored allograft loss (adjusted hazard ratio [AHR] 1.46 [95% confidence interval {CI}: 1.19-1.79]; P<0.001) and death (AHR 2.32 [95% CI: 1.98-2.72]; P<0.001). In a sensitivity analysis excluding patients with history of chronic obstructive pulmonary disease, similar results were obtained with increased risk of death-censored allograft loss (AHR 1.43 [95% CI: 1.16-1.76]; P=0.001) and death (AHR 2.26 [95% CI: 1.91-2.66]; P<0.001). DISCUSSION: Incident smoking was detrimental to graft and patient survival. Transplant programs should screen those at risk during transplant follow-up and have smoking cessation programs.

Racial variation in the development of posttransplant lymphoproliferative disorders after renal transplantation.

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.

Incidence, predictors and associated outcomes of renal cell carcinoma in long-term dialysis patients.

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.

Poor outcomes associated with neutropenia after kidney transplantation: analysis of United States Renal Data System.

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.

Outcomes associated with influenza vaccination in the first year after kidney transplantation.

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.

Trends in renal transplantation in patients with human immunodeficiency virus infection: an analysis of the United States renal data system.

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.

Arteriovenous fistulas among incident hemodialysis patients in Department of Defense and Veterans Affairs facilities.

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.