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Background and Objectives: Anemia management changed substantially among dialysis patients in the United States around the time of implementation of the new Centers for Medicare & Medicaid Services bundled payment system and erythropoiesis-stimulating agent (ESA) label change in 2011. Among these, average ferritin levels increased dramatically and have remained high since; this study sought to gain understanding of this sustained rise in ferritin levels., Design, Setting, Participants, & Measurements: Trends in mean ferritin, hemoglobin, IV iron dose, and ESA dose from 2009 to 2013 were examined in 9735 patients from 91 United States Dialysis Outcomes and Practice Patterns Study facilities. Linear mixed models were used to assess the extent to which intravenous (IV) iron and ESA dose accounted for patients' changes in ferritin over time., Results: Mean ESA dose and hemoglobin levels declined throughout the study. Mean IV iron dose increased from 210 mg/mo in 2009-2010 to a peak of 280 mg/mo in 2011, then declined back to 200 mg/mo and remained stable from 2012 to 2013. Mean ferritin increased from 601 ng/ml in the third quarter of 2009 to 887 ng/ml in the first quarter of 2012; models suggest that higher IV iron dosing was a primary determinant during 2011, but lower ESA doses contributed to the sustained high ferritin levels thereafter. In a subset of 17 facilities that decreased IV iron dose in 2011, mean ferritin rose by 120 ng/ml to 764 ng/ml, which appeared to be primarily due to ESA reduction. Together, changes in IV iron and ESA doses accounted for 46% of the increase in ferritin over the study period., Conclusions: In contrast to expectations, the rise in average IV iron dose did not persist beyond 2011. The sustained rise in ferritin levels in United States dialysis patients after policy changes in 2011, to average levels well in excess of 800 ng/ml, appeared to be partly due to reductions in ESA dosing and not solely IV iron dosing practices. The effect of these changes in ferritin on health outcomes requires further investigation., (Copyright © 2015 by the American Society of Nephrology.)

A previous commentary pointed out that the renal community has led American healthcare in the development and continuous improvement of quality outcomes. However, survival, hospitalization, and quality of life for US dialysis patients is still not optimal. This follow-up commentary examines the obstacles, gaps, and metrics that characterize this unfortunate state of affairs. It posits that current paradigms are essential contributors to quality outcomes but are no longer sufficient to improve quality. New strategies are needed that arise from a preponderance of evidence, in addition to beyond a reasonable doubt standard. This work offers an action plan that consists of new pathways of care that will lead to improved survival, fewer hospitalizations and rehospitalizations, and better quality of life for patients undergoing dialysis therapy. Nephrologists in collaboration with large and small dialysis organizations and other stakeholders, including the Centers for Medicare and Medicaid Services, can implement these proposed new pathways of care and closely monitor their effectiveness. We suggest that our patients deserve nothing less and must receive even more.

Background and Objectives: Approximately one million Americans initiated chronic dialysis over the past decade; the first-year mortality rate reported by the U.S. Renal Data System was 19.6% in 2007. This estimate has historically excluded the first 90 days of chronic dialysis., Design, Setting, Participants, & Measurements: To characterize the mortality and hospitalization risks for patients starting chronic renal replacement therapy, we followed all patients initiating dialysis in 1733 facilities throughout the United States (n = 303,289). Mortality and hospitalizations within the first 90 days were compared with outcomes after this period, and the results were analyzed. Standard time-series analyses were used to depict the weekly risk estimates for each outcome., Results: Between 1997 and 2009, >300,000 patients initiated chronic dialysis and were followed for >35 million dialysis treatments; the highest risk for morbidity and mortality occurred in the first 2 weeks of treatment. The initial 2-week risk of death for a typical dialysis patient was 2.72-fold higher, and the risk of hospitalization was 1.95-fold higher when compared to a patient who survived the first year of chronic dialysis (week 53 after initiation). Similarly, over the first 90 days, the risk of mortality and hospitalization remained elevated. Thereafter, between days 91 and 365, these risks decreased considerably by more than half. Surviving these first weeks of dialysis was most associated with the type of vascular access. Initiating dialysis with a fistula was associated with a decreased early death risk by 61%, whereas peritoneal dialysis decreased the risk by 87%., Conclusions: The first 2 weeks of chronic dialysis are associated with heightened mortality and hospitalization risks, which remain elevated over the ensuing 90 days.

Background and Objectives: Referring hemodialysis patients for elective access angiography and percutaneous transluminal angioplasty (PTA) is commonly done to prevent access failure, yet the effectiveness of this procedure remains unclear. DESIGN, SETTING, PARTICIPANTS, & MEASURES: An observational matched cohort analysis among 40,132 Medicare beneficiaries receiving hemodialysis with a fistula or graft was performed. Cox regression was used to determine whether access intervention was associated with improved 1-year access survival., Results: Nonsurgical access intervention was found to be frequent at a rate of 20.9 procedures per 100 access years. In the 1-year period after intervention using angiography and PTA, the overall access failure rate was 53.7 per 100 access years in the intervention group and 49.6 in the nonintervention group (HR = 1.02; 95% CI, 0.96 to 1.08). Similar findings were also seen when the analysis was repeated in only fistulas (HR = 1.06; 95% CI, 0.98 to 1.15) and grafts (HR = 0.95; 95% CI, 0.86 to 1.05). In patients with a low intra-access flow rate (HR = 0.86; 95% CI, 0.75 to 0.99) or a new access (HR = 0.79; 95% CI, 0.71 to 0.89), angiography and PTA significantly increased access survival when compared with nonintervention (P for interaction was <0.0001). Angiography-PTA-related upper-extremity hematoma, vessel injury, or embolism-thrombosis occurred in 1.1% of all patients., Conclusions: Access characteristics significantly modify the survival benefits of angiography and PTA intervention where the benefits of these interventions are most seen in newer accesses or accesses with insufficient flow.

The ability to offer repetitive hemodialysis for treatment of chronic kidney failure has now reached its half-century anniversary. Although millions of patients have benefited from this life-extending procedure, current results in the United States have now stagnated with only small annual improvements in survival and continued high hospitalization rates. Recognition that this stagnation may be, at least in part, the result of inadequacies of current and prior paths utilized in dialysis treatment has led to the concept that dialysis therapy is at a crossroads and that new paths need to be articulated, explored, and applied. This article proposes some of these new paths and their rationale. Two elements of the new paths are emphasized: avoidance of indwelling catheters for vascular access and meticulous attention to control of extracellular volume and mitigation of left ventricular hypertrophy and fibrosis. It is postulated that progress in these two areas, along with continued attention to other elements embodied in the new and old paths, will unlock the stagnation in outcomes of dialysis therapy of end-stage kidney failure and allow it to realize its full potential of prolonging life and alleviating disability.

Background and Objectives: Higher mortality risk reported with reuse versus single use of dialyzers is potentially related to reuse reagents that modify membrane surface characteristics and the blood-membrane interface. A key mechanism may involve stimulation of an inflammatory response., Design, Setting, Participants, & Measurements: In a prospective crossover design, laboratory markers and mortality from 23 hemodialysis facilities abandoning reuse with peracetic acid mixture were tracked. C-reactive protein (CRP), white blood cell (WBC) count, albumin, and prealbumin were measured for 2 consecutive months before abandoning reuse and subsequently within 3 and 6 months on single use. Survival models were utilized to compare the 6-month period before abandoning reuse (baseline) and the 6-month period on single use of dialyzers after a 3-month "washout period.", Results: Patients from baseline and single-use periods had a mean age of approximately 63 years; 44% were female, 54% were diabetic, 60% were white, and the mean vintage was approximately 3.2 years. The unadjusted hazard ratio for death was 0.70 and after case-mix adjustment was 0.74 for single use compared with reuse. Patients with CRP≥5 mg/L during reuse (mean CRP=26.6 mg/ml in April) declined on single use to 20.2 mg/L by August and 20.4 mg/L by November. WBC count declined slightly during single use, but nutritional markers were unchanged., Conclusions: Abandonment of peracetic-acid-based reuse was associated with improved survival and lower levels of inflammatory but not nutritional markers. Further study is needed to evaluate a potential link between dialyzer reuse, inflammation, and mortality.

Background and Objectives: Conversion from central venous catheters to a graft or a fistula is associated with lower mortality risk in long-term hemodialysis (HD) patients; however, a similar association with hospitalization risk remains to be elucidated., Design, Setting, Participants, & Measurements: We conducted a prospective observational study all maintenance in-center HD patients who were treated in Fresenius Medical Care, North America legacy facilities; were alive on January 1, 2007; and had baseline laboratory data from December 2006. Access conversion (particularly from a catheter to a fistula or a graft) during the 4-month period from January 1 through April 30, 2007, was linked using Cox models to hospitalization risk during the succeeding 1-year follow-up period (until April 30, 2008)., Results: The cohort (N = 79,545) on January 1, 2007 had 43% fistulas, 29% catheters, and 27% grafts. By April 30, 2007, 70,852 patients were still on HD, and among 19,792 catheters initially, only 10.3% (2045 patients) converted to either a graft or a fistula. With catheters as reference, patients who converted to grafts/fistulas had similar adjusted hazard ratios (0.69) as patients on fistulas (0.71), while patients with fistulas/grafts who converted to catheters did worse (1.22), all P < 0.0001., Conclusions: Catheters remain associated with the greatest hospitalization risk. Conversion from a catheter to either graft or fistula had significantly lower hospitalization risk relative to keeping the catheter. Prospective studies are needed to determine whether programs that reduce catheters will decrease hospitalization risk in HD patients.

Background and Objectives: The benefits and risks of aggressive glycemic control in diabetes mellitus complicated by end-stage kidney failure remain uncertain but have importance because of the large patient population with inferior overall prognosis. Recent large observational studies with differing methodologies reached somewhat contrasting conclusions regarding the association of hemoglobin A1c with survival in diabetic chronic hemodialysis patients., Design, Setting, Participants, & Measurements: This study supplements the authors' previous analysis (which found no correlation) by extending the follow-up period to 3 years and using time-dependent survival models with repeated measures. Among 24,875 nationally distributed study patients, 94.5% had type 2 diabetes, allowing additional analysis in the subset with type 1 diabetes. Data were collected at baseline and every quarter to a maximum of 3 years' follow-up., Results: Adjusted standard and time-dependent Cox models indicated that only extremes of glycemia were associated with inferior survival. There was no effect modification by serum albumin levels, a marker of protein nutrition status, and no trend associated with random glucose measurements in a post hoc analysis. In type 1 diabetic patients, upper extreme hemoglobin A1c values indicated lower survival risk., Conclusions: Sustained extremes of glycemia were only variably and weakly associated with decreased survival in this population. In the absence of randomized, controlled trials, these results suggest that aggressive glycemic control cannot be routinely recommended for all diabetic hemodialysis patients on the basis of reducing mortality risk. Physicians are encouraged to individualize glycemic targets based on potential risks and benefits in diabetic ESRD patients.

Background and Objectives: Randomized, controlled trials (RCTs) are the gold standard for defining causal inferences but are sometimes not feasible because of cost, ethical, or time considerations. We explored the accuracy and potential use of a "simulated trial" through the modeling of a previously published RCT, Die Deutsche Diabetes Dialyse Studie (4D Study), a landmark study that investigated the cardiovascular benefit of atorvastatin use in 1255 patients with ESRD., Design, Setting, Participants, & Measurements: Using a large historical database of interventions and outcomes in dialysis patients, we conducted an observational model of the 4D Study in dialysis patients who had type 2 diabetes and were prescribed a statin (5144 patients) and matched to a non-statin user (5144 control subjects) before multivariate modeling. Inclusion, exclusion, and outcome parameters of the study, as prespecified by the 4D Study, were strictly modeled in this analysis., Results: In covariate- and propensity-adjusted Cox regression, statin use (versus nonuse) was associated with a decrease in the composite primary outcome of cardiac death, nonfatal myocardial infarction, and stroke. Statin use was also associated with a decrease in cardiovascular mortality and all cardiac events combined. The hazard ratios in this observational model were numerically comparable to the hazard ratios reported in the 4D Study; however, because of the larger number of patients "enrolled," results in this simulated study achieved statistical significance., Conclusions: Statin use was associated with some cardiovascular benefit in a simulated trial of patients with ESRD; however, the size of benefit was considerably smaller than that seen in the general population. Such simulated trials may represent an exploratory, cost-effective option when RCTs are not immediately feasible.

Background and Objectives: The Short Form 12 (SF-12) has not been validated for long-term dialysis patients. The study compared physical and mental component summary (PCS/MCS) scores from the SF-36 with those from the embedded SF-12 in a national cohort of dialysis patients., Design, Setting, Participants, & Measurements: All 44,395 patients who had scorable SF-36 and SF-12 from January 1, 2006, to December 31, 2006, and were treated at Fresenius Medical Care, North America facilities were included. Death and first hospitalization were followed for up to 1 year from the date of survey. Correlation and agreement were obtained between PCS-36 and PCS-12 and MCS-36 and MCS-12; then Cox models were constructed to compare associated hazard ratios (HRs) between them., Results: Physical and mental dimensions both exhibited excellent intraclass correlation coefficients of 0.94. Each incremental point for both PCS-12 and PCS-36 was associated with a 2.4% lower adjusted HR of death and 0.4% decline in HR for first hospitalization (both P < 0.0001). Corresponding improvement in HR of death for each MCS point was 1.2% for MCS-12 and 1.3% for MCS-36, whereas both had similar 0.6% lower HR for hospitalization per point (all P < 0.0001)., Conclusions: The use of the SF-12 alone or as part of a larger survey is valid in dialysis patients. Composite scores from the SF-12 and SF-36 have similar prognostic association with death and hospitalization risk. Prospective longitudinal studies of SF-12 surveys that consider responsiveness to specific clinical, situational, and interventional changes are needed in this population.

Background and Objectives: The objective of this study was to evaluate epidemiology and outcomes of a large in-center nocturnal hemodialysis (INHD) program., Design, Setting, Participants, & Measurements: This case-control study compared patients who were on thrice-weekly INHD from 56 Fresenius Medical Care, North America facilities with conventional hemodialysis patients from 244 facilities within the surrounding geographic area. All INHD cases and conventional hemodialysis control subjects who were active as of January 1, 2007, were followed until December 31, 2007, for evaluation of mortality and hospitalization., Results: As of January 1, 2007, 655 patients had been on INHD for 51 +/- 73 d. Patients were younger, there were more male and black patients, and vintage was longer, but they had less diabetes compared with 15,334 control subjects. Unadjusted hazard ratio was 0.59 for mortality and 0.76 for hospitalization. After adjustment for case mix and access type, only hospitalization remained significant. Fewer INHD patients were hospitalized (48 versus 59%) with a normalized rate of 9.6 versus 13.5 hospital days per patient-year. INHD patients had greater interdialytic weight gains but lower BP. At baseline, hemoglobin values were similar, whereas albumin and phosphorus values favored INHD. Mean equilibrated Kt/V was higher in INHD patients related to longer treatment time, despite lower blood and dialysate flow rates., Conclusions: Patients who were on INHD exhibited excellent quality indicators, with better survival and lower hospitalization rates. The relative contributions of patient selection versus effect of therapy on outcomes remain to be elucidated in prospective clinical trials.

Mortality risk for dialysis patients is highest in the first year. We previously showed a 41% mortality benefit associated with a pilot case management program for incident hemodialysis patients (n = 918). The RightStart Program (RSP) provided prompt medical management and self-management education and was recently expanded to more facilities. We conducted a matched cohort analysis to validate the expanded program's continued effectiveness. Death risk was reduced for RS patients (n = 4308) versus matched controls (C; n = 4308) by 34% (hazard ratio = 0.66, P < 0.0001) at 120 d and 22% at 1 yr (hazard ratio = 0.78, P < 0.0001). RS patients had lower hospitalization during the first year (RS = 15.5 days per patient year versus C = 16.9, P < 0.01). At 120 d, more RS patients achieved hemoglobin 11 to 12 g/dl (RS = 22.4% versus C = 19.7%, P < 0.01), eKt/V > or = 1.2 (RS = 66% versus C = 53.5%, P < 0.01), albumin > or = 4.0 g/dl (RS = 26% versus C = 22%, P < 0.01), and phosphorus 3.5 to 5.5 mg/dl (RS = 52.4% versus C = 45.4%). At 120 d, RS patients had a greater reduction in catheter use (RS = 32% versus C = 25%, P < 0.01) and more vitamin D orders (RS = 60% versus C = 55%, P < 0.01). Expansion of RS to a larger incident patient population results in significant reduction of morbidity and mortality associated with improvement of intermediate outcomes.

Background and Objectives: Patient knowledge about chronic hemodialysis (CHD) is important for effective self-management behaviors, but little is known about its association with vascular access use., Design, Setting, Participants, & Measurements: Prospective cohort of adult incident CHD patients from May 2002 until November 2005 and followed for 6 mo after initiation of hemodialysis (HD). Patient knowledge was measured using the Chronic Hemodialysis Knowledge Survey (CHeKS). The primary outcome was dialysis access type at: baseline, 3 mo, and 6 mo after HD initiation. Secondary outcomes included anemia, nutritional, and mineral laboratory measures., Results: In 490 patients, the median (interquartile range) CHeKS score (0 to 100%) was 65%[52% to 78%]. Lower scores were associated with older age, fewer years of education, and nonwhite race. Patients with CHeKS scores 20 percentage points higher were more likely to use an arteriovenous fistula or graft compared with a catheter at HD initiation and 6 mo after adjustment for age, sex, race, education, and diabetes mellitus. No statistically significant associations were found between knowledge and laboratory outcome measures, except for a moderate association with serum albumin. Potential limitations include residual confounding and an underpowered study to determine associations with some clinical measures., Conclusions: Patients with less dialysis knowledge may be less likely to use an arteriovenous access for dialysis at initiation and after starting hemodialysis. Additional studies are needed to explore the impact of patient dialysis knowledge, and its improvement after educational interventions, on vascular access in hemodialysis.

Background and Objectives: Annualized mortality rates of chronic hemodialysis (CHD) patients in their first 90 d of treatment range from 24 to 50%. Limited studies also show high hospitalization rates. It was hypothesized that a structured quality improvement program (RightStart), focused on medical needs and patient education and support, would improve outcomes for incident CHD patients., Design, Setting, Participants, & Measurements: A total of 918 CHD incident patients were prospectively enrolled in a multicenter RightStart Program, and compared with a time-concurrent group of 1020 control patients from non-RightStart clinics. RightStart patients received 3 mo of intervention in management of anemia, dosage of dialysis, nutrition, and dialysis access and a comprehensive educational program. Outcomes were tracked for up to 12 mo., Results: At 3 mo, RightStart patients had higher albumin and hematocrit values. Dose of dialysis and permanent access placement were not statistically significantly different from control subjects. Compared with baseline, Mental Composite Score for RightStart patients improved significantly. Mean hospitalization days per patient year were reduced with RightStart versus control subjects. Mortality rates at 3, 6, and 12 mo were 20, 18, and 17 for RightStart patients versus 39, 33, and 30 deaths per 100 patient-years for control subjects, respectively., Conclusions: A structured program of prompt medical and educational strategies in incident CHD patients results in improved morbidity and mortality that last up to 1 yr.