Eric D. Weinhandl

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

Propensity-Matched Mortality Comparison of Incident Hemodialysis and Peritoneal Dialysis Patients

35.3 billion, with

United States Renal Data System 2008 Annual Data Report Abstract

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.

Survival of dialysis patients after cardiac arrest and the impact of implantable cardioverter defibrillators

Contemporary comparisons of mortality in matched hemodialysis and peritoneal dialysis patients are lacking. We aimed to compare survival of incident hemodialysis and peritoneal dialysis patients by intention-to-treat analysis in a matched-pair cohort and in subsets defined by age, cardiovascular disease, and diabetes. We matched 6337 patient pairs from a retrospective cohort of 98,875 adults who initiated dialysis in 2003 in the United States. In the primary intention-to-treat analysis of survival from day 0, cumulative survival was higher for peritoneal dialysis patients than for hemodialysis patients (hazard ratio 0.92; 95% CI 0.86 to 1.00, P = 0.04). Cumulative survival probabilities for peritoneal dialysis versus hemodialysis were 85.8% versus 80.7% (P < 0.01), 71.1% versus 68.0% (P < 0.01), 58.1% versus 56.7% (P = 0.25), and 48.4% versus 47.3% (P = 0.50) at 12, 24, 36, and 48 months, respectively. Peritoneal dialysis was associated with improved survival compared with hemodialysis among subgroups with age <65 years, no cardiovascular disease, and no diabetes. In a sensitivity analysis of survival from 90 days after initiation, we did not detect a difference in survival between modalities overall (hazard ratio 1.05; 95% CI 0.96 to 1.16), but hemodialysis was associated with improved survival among subgroups with cardiovascular disease and diabetes. In conclusion, despite hazard ratio heterogeneity across patient subgroups and nonconstant hazard ratios during the follow-up period, the overall intention-to-treat mortality risk after dialysis initiation was 8% lower for peritoneal dialysis than for matched hemodialysis patients. These data suggest that increased use of peritoneal dialysis may benefit incident ESRD patients.

Hemoglobin Level Variability: Associations with Mortality

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A Comparison of Sevelamer and Calcium-Based Phosphate Binders on Mortality, Hospitalization, and Morbidity in Hemodialysis: A Secondary Analysis of the Dialysis Clinical Outcomes Revisited (DCOR) Randomized Trial Using Claims Data

BACKGROUND Sudden cardiac death is the single largest cause of mortality in dialysis patients. There are no published data on the use or survival impact of implantable cardioverter defibrillators (ICDs) in dialysis patients. The objective of this retrospective cohort study was to determine ICD use in dialysis patients and impact on survival. METHODS Dialysis patients hospitalized from 1996 to 2001 for ventricular fibrillation/cardiac arrest, having ICD implantation within 30 days of admission, discharged alive, and surviving at least 30 days from admission were identified from the 100% end-stage renal disease (ESRD) sample of the Medicare database. Long-term survival was estimated by life-table method. Impact of independent predictors on survival was examined in a comorbidity-adjusted Cox model and a propensity model. RESULTS There were 460 patients (7.6%) with ICD and 5582 patients (92.4%) without ICD. Estimated 1-, 2-, 3-, 4-, and 5-year survivals after day 30 of admission in the ICD group were 71%, 53%, 36%, 25%, and 22%, respectively; in the no-ICD group, 49%, 33%, 23%, 16%, and 12% (P < 0.0001). ICD implantation was independently associated with a 42% reduction in death risk [relative risk 0.58 (95% CI 0.50, 0.66)]. In the propensity model, the relative risks of death for the lower, middle, and upper third propensity groups were 0.45 (0.26, 0.81), 0.61 (0.45, 0.84), and 0.65 (0.55, 0.76), respectively. The C statistic for the propensity model equaled 0.81. CONCLUSION In dialysis patients, ICD therapy is apparently underused. ICD implantation in cardiac arrest survivors on dialysis is associated with greater survival.

Survival in Daily Home Hemodialysis and Matched Thrice-Weekly In-Center Hemodialysis Patients

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.

Predicting Coronary Heart Disease after Kidney Transplantation: Patient Outcomes in Renal Transplantation (PORT) Study

BACKGROUND The Dialysis Clinical Outcomes Revisited (DCOR) trial, a large, randomized, multicenter, open-label study, compared effects of sevelamer with calcium-based phosphate binders on mortality and hospitalization in hemodialysis patients. Many patients were lost to follow-up, precluding intent-to-treat analysis by using prospective data collection. STUDY DESIGN Preplanned secondary analysis, intent-to-treat design for all outcomes, using Centers for Medicare & Medicaid Services (CMS) data. SETTING & PARTICIPANTS Participants were 18 years or older and on hemodialysis therapy for more than 3 months, with Medicare as primary payor. The trial was completed at the end of 2004. INTERVENTION Sevelamer, calcium-based phosphate binders. OUTCOMES Mortality, morbidity, and hospitalization end points. MEASUREMENTS DCOR subjects were linked to the CMS End-Stage Renal Disease database. Outcomes were evaluated through the CMS End-Stage Renal Disease enrollment and claims database; baseline characteristics and comorbid conditions were evaluated using CMS and case-report data. RESULTS Groups were well balanced except for a greater percentage of calcium-group patients with atherosclerotic heart disease. Analyses were adjusted by using 10 baseline characteristics. All-cause (17.7 versus 17.4 deaths/100 patient-years; P = 0.8 unadjusted; P = 0.9 adjusted) and cardiovascular mortality (9.0 versus 8.2 deaths/100 patient-years; P = 0.3 unadjusted; P = 0.4 adjusted) did not differ significantly between treatment groups. First hospitalization, cause-specific multiple hospitalizations, first morbidity, and multiple morbidity rates also did not differ significantly. Multiple all-cause hospitalization rate (1.7 versus 1.9 admissions/patient-year; P = 0.03 unadjusted; P = 0.02 adjusted) and hospital days (12.3 versus 13.9 days/patient-year; P = 0.05 unadjusted; P = 0.03 adjusted) were lower in the sevelamer group. LIMITATIONS Outcome parameters and cardiovascular comorbidity assessments were derived from Medicare claims data; only subjects with Medicare-as-primary-payor status were included in hospitalization and morbidity analyses. CONCLUSIONS In this secondary analysis, treatment with sevelamer versus calcium-based binders did not affect overall mortality (primary outcome), cause-specific mortality, morbidity, or first or cause-specific hospitalization (secondary outcomes), but there was evidence for a beneficial effect on multiple all-cause hospitalizations and hospital days (secondary outcomes).

Estimated number of prevalent cases of metastatic bone disease in the US adult population.

Frequent hemodialysis improves cardiovascular surrogates and quality-of-life indicators, but its effect on survival remains unclear. We used a matched-cohort design to assess relative mortality in daily home hemodialysis and thrice-weekly in-center hemodialysis patients between 2005 and 2008. We matched 1873 home hemodialysis patients with 9365 in-center patients (i.e., 1:5 ratio) selected from the prevalent population in the US Renal Data System database. Matching variables included first date of follow-up, demographic characteristics, and measures of disease severity. The cumulative incidence of death was 19.2% and 21.7% in the home hemodialysis and in-center patients, respectively. In the intention-to-treat analysis, home hemodialysis associated with a 13% lower risk for all-cause mortality than in-center hemodialysis (hazard ratio [HR], 0.87; 95% confidence interval [95% CI], 0.78-0.97). Cause-specific mortality HRs were 0.92 (95% CI, 0.78-1.09) for cardiovascular disease, 1.13 (95% CI, 0.84-1.53) for infection, 0.63 (95% CI, 0.41-0.95) for cachexia/dialysis withdrawal, 1.06 (95% CI, 0.81-1.37) for other specified cause, and 0.59 (95% CI, 0.44-0.79) for unknown cause. Findings were similar using as-treated analyses. We did not detect statistically significant evidence of heterogeneity of treatment effects in subgroup analyses. In summary, these data suggest that relative to thrice-weekly in-center hemodialysis, daily home hemodialysis associates with modest improvements in survival. Continued surveillance should strengthen inference about causes of mortality and determine whether treatment effects are homogeneous throughout the dialysis population.

Effect of Comorbidity Adjustment on CMS Criteria for Kidney Transplant Center Performance

Traditional risk factors do not adequately explain coronary heart disease (CHD) risk after kidney transplantation. We used a large, multicenter database to compare traditional and nontraditional CHD risk factors, and to develop risk‐prediction equations for kidney transplant patients in standard clinical practice. We retrospectively assessed risk factors for CHD (acute myocardial infarction, coronary artery revascularization or sudden death) in 23 575 adult kidney transplant patients from 14 transplant centers worldwide. The CHD cumulative incidence was 3.1%, 5.2% and 7.6%, at 1, 3 and 5 years posttransplant, respectively. In separate Cox proportional hazards analyses of CHD in the first posttransplant year (predicted at time of transplant), and predicted within 3 years after a clinic visit occurring in posttransplant years 1–5, important risk factors included pretransplant diabetes, new onset posttransplant diabetes, prior pre‐ and posttransplant cardiovascular disease events, estimated glomerular filtration rate, delayed graft function, acute rejection, age, sex, race and duration of pretransplant end‐stage kidney disease. The risk‐prediction equations performed well, with the time‐dependent c‐statistic greater than 0.75. Traditional risk factors (e.g. hypertension, dyslipidemia and cigarette smoking) added little additional predictive value. Thus, transplant‐related risk factors, particularly those linked to graft function, explain much of the variation in CHD after kidney transplantation.