James P. Ebben

Projecting the Number of Patients with End-Stage Renal Disease in the United States to the Year 2015

The size of the prevalent ESRD population in the United States increased dramatically during the 1990s, from 196,000 in 1991 to 382,000 in 2000. Incidence also increased considerably during the same period, from 53,000 to 93,000 per year. If previous trends in ESRD incidence and prevalence continue, then current levels of health care resources that are devoted to the care of these patients will eventually be unable to meet the demand. This study discusses a Markov model developed to predict ESRD incidence, prevalence, and mortality to the year 2015 and incorporating expected changes in age/race distributions, diabetes prevalence, ESRD incidence, and probability of death. The model predicted that by 2015 there will be 136,166 incident ESRD patients per year (lower/upper limits 110,989 to 164,550), 712,290 prevalent patients (595,046 to 842,761), and 107,760 ESRD deaths annually (96,068 to 118,220). Incidence and prevalence counts are expected to increase by 44 and 85%, respectively, from 2000 to 2015 and incidence and prevalence rates per million population by 32 and 70%, respectively. The financial and human resources that will be needed to care for these patients in 2015 will be considerably greater than in 2005.

Mortality risks of peritoneal dialysis and hemodialysis

Studies of outcomes associated with dialysis therapies have yielded conflicting results. Bloembergen et al showed that prevalent patients on continuous ambulatory peritoneal dialysis (CAPD) or continuous cycling peritoneal dialysis (CCPD) had a 19% higher mortality risk than hemodialysis patients, and Fenton et al, analyzing Canadian incident patients, found a 27% lower risk. Attempting to reconcile these differences, we evaluated incident Medicare patients (99,048 on hemodialysis, 18,110 on CAPD/CCPD) from 1994 through 1996, following up to June 30, 1997. Patients were followed to transplantation, death, loss to follow-up, 60 days after modality change, or end of the study period. For each 3-month survival period, we used an interval Poisson regression to compare death rates, adjusting for age, gender, race, and primary renal diagnosis. A Cox regression was used to evaluate cause-specific mortality, and proportionality was addressed in both regressions by separating diabetic and nondiabetic patients. The Poisson regressions showed CAPD/CCPD to have outcomes comparable with or significantly better than hemodialysis, although results varied over time. The Cox regression found a lower mortality risk in nondiabetic CAPD/CCPD patients (women younger than 55 years: risk ratio [RR] = 0. 61; Cl, 0.59 to 0.66; women age 55 years or older: RR = 0.87; Cl, 0. 84 to 0.91; men younger than 55 years: RR = 0.72; Cl, 0.67 to 0.77; men age 55 years or older: RR = 0.87; Cl, 0.83 to 0.92) and in diabetic CAPD/CCPD patients younger than 55 (women: RR = 0.88; Cl, 0. 82 to 0.94; men: RR = 0.86; Cl, 0.81 to 0.92). The risk of all-cause death for female diabetics 55 years of age and older, in contrast, was 1.21 (Cl, 1.17 to 1.24) for CAPD/CCPD, and in cause-specific analyses, these patients had a significantly higher risk of infectious death. We conclude that, overall, within the first 2 years of therapy, short-term CAPD/CCPD appears to be associated with superior outcomes compared with hemodialysis. It also appears that patients on the two therapies have different mortality patterns over time, a nonproportionality that makes survival analyses vulnerable to the length of follow-up. Further investigation is needed to evaluate both the potential explanations for these findings and the use of more advanced statistical methods in the analysis of mortality rates associated with these dialytic therapies.

Excerpts From the US Renal Data System 2009 Annual Data Report

This 21st US Renal Data System Annual Data Report covers data through 2007, and again includes a section on chronic kidney disease (CKD) in the United States. Using NHANES and employer group health plan data, we estimate the relationship between kidney disease markers and mortality risk and the likelihood of blood pressure and lipid control by CKD stage; illustrate use of the new ICD-9-CM CKD diagnosis codes; and report on morbidity, mortality, care and costs during the transition to ESRD. New chapters address CKD patient care, the transition to ESRD, and acute kidney injury. In 2007, 111,000 patients started end-stage renal disease (ESRD) therapy, and the prevalent population reached 527,283 (including 368,544 dialysis patients); 17,513 transplants were performed, and 158,739 patients had a functioning graft at year’s end. Program expenditures reached

United States Renal Data System 2008 Annual Data Report Abstract

35.3 billion, with

Hemoglobin Level Variability: Associations with Comorbidity, Intercurrent Events, and Hospitalizations

23.9 billion from Medicare (accounting for 5.8% of total Medicare expenditures). The incident rate fell 2.1%, to 354 per million. Fistula use in prevalent patients declined 2.6 percent; catheter use continues to be a concern. The percentage of patients with hemoglobin levels above 13 g/dl has fallen since 2006, but levels in the incident population frequently exceed 12. First-year mortality and morbidity among hemodialysis patients—particularly the increasing rate of hospitalizations due to infections—continue to be major concerns, and pediatric patient survival has not improved. The public health impact of kidney disease is larger than previously appreciated, and early detection, education, intervention, and risk factor control need to address the heavy burden of cardiovascular disease and adverse events in this vulnerable population.

Hemoglobin Level Variability: Associations with Mortality

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Trends in anemia treatment with erythropoietin usage and patient outcomes

National payment policies target a hemoglobin range of 11 to 12.5 g/dl for patients with ESRD. However, clinical complications and provider practices may contribute to wide fluctuations over time. This study evaluated the frequency with which patients maintain stable hemoglobin levels below, within, and above the Centers for Medicare & Medicaid Services target range and assessed patterns of hemoglobin level change that resulted in large fluctuations across the target range during a 6-mo period. All hemodialysis patients who survived the first 6 mo of 2003, had Medicare as primary payer, and had Medicare outpatient erythropoietin claims in each of the first 6 mo of 2003 (n = 152,846) were studied. Six patient groups were defined on the basis of patterns of hemoglobin level fluctuation: Consistently low (<11 g/dl), consistently target range (11 to 12.5 g/dl), consistently high (> or =12.5 g/dl), low-amplitude fluctuation with low hemoglobin levels, low-amplitude fluctuation with high hemoglobin levels, and high-amplitude fluctuation. Only 10.3% of patients maintained stable hemoglobin levels during the 6 mo and only 6.5% in the target range. The consistently low group had the highest percentage of hospitalizations and the highest number of comorbid conditions. High-amplitude fluctuation was the most common pattern (39.5%), with hemoglobin levels falling below and rising above the target range during the 6-mo period. Hemoglobin levels in almost 90% of patients are in some degree of flux at any point in time, and the fluctuation is highly associated with clinical complications and provider practices.

Hemoglobin Level Variability: Anemia Management among Variability Groups

BACKGROUND/OBJECTIVES Awareness of hemoglobin level variability in dialysis patients is increasing, as is interest in its potential implications. In this retrospective, national study of associations between the degree of hemoglobin level variability in the first 6 mo of 2004 and subsequent mortality rates in the following 6 mo, 159,720 hemodialysis patients receiving epoetin therapy were studied. DESIGN, SETTING, PARTICIPANTS, MEASUREMENTS Monthly hemoglobin values were categorized as low (L; < 11 g/dl), intermediate (I; 11 to 12.5 g/dl), and high (H; >12.5 g/dl). Variability groups were classified on the basis of the lowest and highest hemoglobin categories seen during the 6-mo observation period: low-low (L-L), 1.4%; intermediate-intermediate (I-I), 6.0%; high-high (H-H), 2.3%; low-intermediate (L-I), 18.3%; intermediate-high (I-H), 31.7%, and low-high (L-H), 40.2%. RESULTS On multivariate analysis, adjusted hazards ratios for subsequent mortality events were as follows: I-I, 1.0 (reference category); I-H, 1.02 (95% confidence interval [CI] 0.95 to 1.11); H-H, 1.06 (95% CI 0.93 to 1.21); L-H, 1.19 (95% CI 1.10 to 1.28); L-I, 1.44 (95% CI 1.33 to 1.56), and L-L, 2.18 (95% CI 1.93 to 2.45). Persistently and transiently low hemoglobin levels and highly variable hemoglobin levels were associated with increased risk of death; transiently and persistently high hemoglobin levels were not associated with increased risk of death. Bayesian modeling indicated that > or =3 mo with hemoglobin levels <11 g/dl may be associated with of increased risk of death. CONCLUSIONS Number of months with hemoglobin values below the target range, rather than hemoglobin variability itself, may be the primary driver of increased risk of death. Further research is needed to distinguish cause from effect and to understand the underlying mechanisms.

Agreement of reported vascular access on the medical evidence report and on medicare claims at hemodialysis initiation

Recombinant erythropoietin, first approved for Medicare reimbursement in June 1989, was prescribed at initial doses for dialysis patients of 2,500 to 2,700 U per administration independent of hematocrit level. By 1997, however, patients with hematocrits less than 30% were administered 6,000 U/dose, compared with 4,500 U administered to patients with hematocrits of 33% to 36%. Since 1990, the percentage of patients with hematocrits less than 30% decreased from 60% to 22% in 1997, whereas the percentage of patients with hematocrits of 33% to 36% increased from 10% to 30%. In 1997, Medicare initiated the Hematocrit Measurement Audit (HMA) policy, which was directed at reducing the percentage of claims for hematocrits greater than 36% and increasing the stability of the hematocrit levels. The policy change achieved the initial effect but resulted in a reduction of the mean hematocrit as well. The policy was changed in 1998 in response to patient and provider concerns. Mortality studies show that hematocrits less than 30% (or hemoglobin levels < 110 g/L) are associated with an 18% to 40% increased associated risk for death. Higher hematocrits of 33% to 36% appear to be associated with a 7% reduced risk for death. The risk for hospitalization parallels that of mortality. Patients with sustained hematocrits of 33% to 36% over 1 year appear to have the best outcome compared with patients with hematocrits that decrease. The latter are at greater risk than those patients in whom the hematocrits increase. In conclusion, dramatic improvements in hemodialysis patient hematocrits have occurred since 1989. Mortality and hospitalization studies support the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF DOQI) target hematocrit range of 33% to 36% as providing the best associated outcomes.

Impact of disease severity and hematocrit level on reuse-associated mortality.

Background/Aims: Hemoglobin level variability in hemodialysis patients is common, and has been associated with comorbidity, intercurrent illness, and mortality risk. We aimed to describe the influence of anemia management interventions (erythropoiesis-stimulating agents [ESAs], intravenous iron, and transfusions) on hemoglobin variability. Methods:We studied all Medicare primary payer hemodialysis patients who survived and had ESA claims in the first 6 months of 2004 (n = 159,720). Monthly hemoglobin values were categorized as low (<11 g/dl), intermediate (11–12.5 g/dl), and high (>12.5 g/dl). Variability groups were classified based on lowest and highest hemoglobin categories during a 6-month observation period. ESA, intravenous iron, and transfusion use were characterized by variability group. Results:Patients with consistently low or low and intermediate hemoglobin received the highest ESA doses and the most frequent transfusions, while patients with consistently or intermittently intermediate or high hemoglobin received lower ESA doses and fewer transfusions. Intravenous iron doses were highest initially for patients with consistently high hemoglobin; these doses subsequently declined. Iron doses were lowest for patients with consistently intermediate hemoglobin. Conclusions: Anemia management protocols describing coordinated administration of ESAs and iron may help to increase the number of patients achieving target hemoglobin levels.