Abstract
Background: Given regulatory and reimbursement changes in anemia management, we examined hemoglobin variability in a contemporary cohort of maintenance hemodialysis patients. Materials and methods: The study population included > 200,000 hemodialysis patients with Medicare parts A and B as primary payer on October 1, 2012. Based on 25th and 75th percentiles, monthly hemoglobin values were categorized as low, intermediate, or high. Six variability categories were created by patterns during the 6-month observation period. Stable categories were: always-low, always-intermediate, always-high; variable patterns were: varying between low and intermediate, intermediate and high, low and high (most-variable). Cox proportional hazard models were used to assess the association between hemoglobin variability and all-cause mortality or major adverse cardiac events (MACE). Results: The 25th and 75th hemoglobin percentiles were 10.2 and 11.5 g/dL, respectively, in 2012, vs. 11 and 12.5 g/dL in 2004. ESA doses were lower in all categories in 2012 and transfusion rates higher, particularly for always-low patients. Hemoglobin variability decreased modestly: in 2004, 6.0% were always-intermediate, vs. 9.5% in 2012. In 2012, more patients were always-high and fewer were most-variable. Mortality hazard ratios (HRs) were higher for patients with any low hemoglobin: always-low (HR, 95% CI: 2.07, 1.84 – 2.31), varying between low and intermediate (1.37, 1.29 – 1.45), and most-variable (1.23, 1.16 – 1.31); the pattern was similar for MACE. Conclusions: In 2012 vs. 2004, hemoglobin levels decreased, the range of levels narrowed, and variability decreased modestly; transfusions increased. The highest risk of mortality and MACE appeared to occur in patients with persistently low, rather than highly variable, hemoglobin levels.
Highlights
The hypothesis that hemoglobin variability, or within-patient changes in hemoglobin levels over time, is associated with adverse outcomes in patients receiving maintenance dialysis was posited over a decade ago
Given regulatory and reimbursement changes in anemia management, we examined hemoglobin variability in a contemporary cohort of maintenance hemodialysis patients
We sought to ascertain the degree of hemoglobin variability in contemporary hemodialysis patients, and whether hemoglobin variability has changed since the introduction of the revised Prospective Payment System (PPS), implementation of the Quality Improvement Program by Centers for Medicare & Medicaid Services (CMS) [25], and the erythropoiesis-stimulating agents (ESAs) label change by the US Food and Drug Administration
Summary
The hypothesis that hemoglobin variability, or within-patient changes in hemoglobin levels over time, is associated with adverse outcomes in patients receiving maintenance dialysis was posited over a decade ago. Many studies followed [2, 3, 4, 5, 6, 7, 8, 9] characterizing hemoglobin variability in different ways while relating it to patient characteristics and to outcomes in maintenance hemodialysis patients, nondialysis chronic kidney disease patients, and kidney transplant recipients. These studies showed that variability was ubiquitous and generally associated with a higher comorbidity burden and more frequent hospitalizations. The highest risk of mortality and MACE appeared to occur in patients with persistently low, rather than highly variable, hemoglobin levels
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