Dataset Information

Use and safety of heparin-free maintenance hemodialysis in the USA.

ABSTRACT:

Background

Although heparin is used to anticoagulate the extracorporeal circuit for most patients on maintenance hemodialysis (HD), some patients undergo heparin-free HD. We describe the determinants of heparin-free HD and its association with adverse outcomes using data from a national dialysis provider merged with Medicare claims.

Methods

We identified patients aged ?67 years with no recent history of warfarin use who initiated maintenance HD from 2007 to 2008. We applied the Cox regression to a propensity score-matched cohort to estimate the hazards of all-cause mortality, bleeding (gastrointestinal hemorrhage, hemorrhagic stroke, other hemorrhage), atherothrombosis (ischemic stroke, myocardial infarction) and venous thromboembolism (VTE) (deep vein thrombosis, pulmonary embolism).

Results

Among 12 468 patients, 836 (6.7%) were dialyzed heparin-free. In multivariable-adjusted analyses, a history of gastrointestinal bleeding, hemorrhagic stroke and lower hemoglobin and platelet counts were associated with higher odds of heparin-free HD. Heparin-free HD use also varied as much as 4-fold by facility region. We found no significant association of heparin-free HD with all-cause mortality [hazard ratio (HR) 1.08; 95% confidence interval (CI): 0.94-1.26], bleeding (HR 1.15; 95% CI: 0.83-1.60), atherothrombosis (HR 1.09, 95% CI: 0.90-1.31) or VTE (HR 1.23, 95% CI: 0.93-1.64) compared with HD with heparin.

Conclusions

Patient markers of increased risk of bleeding and facility region associated with heparin-free HD use. Despite the potential benefits of avoiding heparin use, heparin-free HD was not significantly associated with decreased hazards of death, bleeding or thrombosis, suggesting that it may be no safer than HD with heparin.

SUBMITTER: Shen JI

PROVIDER: S-EPMC3888305 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Publications

Use and safety of heparin-free maintenance hemodialysis in the USA.

Shen Jenny I JI Mitani Aya A AA Chang Tara I TI Winkelmayer Wolfgang C WC

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association 20130405 6

<h4>Background</h4>Although heparin is used to anticoagulate the extracorporeal circuit for most patients on maintenance hemodialysis (HD), some patients undergo heparin-free HD. We describe the determinants of heparin-free HD and its association with adverse outcomes using data from a national dialysis provider merged with Medicare claims.<h4>Methods</h4>We identified patients aged ≥67 years with no recent history of warfarin use who initiated maintenance HD from 2007 to 2008. We applied the Co ...[more]

PMID: 23563280

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Project description:BackgroundLow molecular weight heparins (LMWH) have been extensively studied and became the treatment of choice for several indications including pulmonary embolism. While their efficacy in hemodialysis is considered similar to unfractionated heparin (UFH), their safety remains controversial mainly due to a risk of bioaccumulation in patients with renal impairment. The aim of this systematic review was to evaluate the safety of LMWH when compared to UFH for extracorporeal circuit (ECC) anticoagulation.MethodsWe used Pubmed, Embase, Cochrane central register of controlled trials, Trip database and NICE to retrieve relevant studies with no language restriction. We looked for controlled experimental trials comparing LMWH to UFH for ECC anticoagulation among end-stage renal disease patients undergoing chronic hemodialysis. Studies were kept if they reported at least one of the following outcomes: bleeding, lipid profile, cardiovascular events, osteoporosis or heparin-induced thrombocytopenia. Two independent reviewers conducted studies selection, quality assessment and data extraction with discrepancies solved by a third reviewer. Relative risk and 95% CI was calculated for dichotomous outcomes and mean weighted difference (MWD) with 95% CI was used to pool continuous variables.ResultsSeventeen studies were selected as part of the systematic. The relative risk for total bleeding was 0.76 (95% CI 0.26-2.22). The WMD calculated for total cholesterol was -28.70 mg/dl (95% CI -51.43 to -5.98), a WMD for triglycerides of -55.57 mg/dl (95% CI -94.49 to -16.66) was estimated, and finally LDL-cholesterol had a WMD of -14.88 mg/dl (95% CI -36.27 to 6.51).ConclusionsLMWH showed to be at least as safe as UFH for ECC anticoagulation in chronic hemodialysis. The limited number of studies reporting on osteoporosis and HIT does not allow any conclusion for these outcomes. Larger studies are needed to evaluate properly the safety of LMWH in chronic hemodialysis.

Project description:Recent research has reported that patients receiving bolus (frequent large doses to achieve iron repletion) versus maintenance dosing of iron have an increased short-term risk of infection, but a similar risk of cardiovascular events. We sought to determine whether these findings could be replicated using the same methods and a different data source.Clinical data from 6,605 patients of a small U.S. dialysis provider merged with Medicare claims data were examined. Iron dosing patterns (bolus, maintenance, no iron) were identified during 1-month exposure periods and cardiovascular and infection-related outcomes were assessed during 3-month follow-up periods. The effects of bolus versus maintenance dosing were assessed using Cox proportional hazards regression analyses to estimate hazard ratios and semiparametric additive risk models to estimate hazard rate differences, controlling for demographic and clinical characteristics, laboratory values and medications, and comorbidities.48,050 exposure/follow-up periods were examined. 13.9 percent of the exposure periods were bolus dosing, 49.3 percent were maintenance dosing, and the remainder were no iron use. All of the adjusted hazard ratios were >1.00 for the infection-related outcomes, suggesting that bolus dosing increases the risk of these events. The effects were greatest for hospitalized for infection of any major organ system (hazard ratio 1.13 (1.03, 1.24)) and use of intravenous antibiotics (hazard ratio 1.08 (1.02, 1.15). When examining the subgroup of individuals with catheters, the hazard ratios for the infection-related outcomes were generally greater than in the overall sample. There was little association between type of dosing practice and cardiovascular outcomes.Results of this study provide further evidence of the association between bolus dosing and increased infection risk, particularly in the subgroup of patients with a catheter, and of the lack of an association between dosing practices and cardiovascular outcomes.

Project description:Background and objectivesThe study was conducted to identify a conversion factor for switching from previous erythropoiesis-stimulating agents (ESAs) to continuous erythropoietin receptor activator-methoxy polyethylene glycol-epoetin beta (C.E.R.A.) and to document the efficacy and long-term safety of C.E.R.A. in pediatric patients with anemia of CKD undergoing hemodialysis.Design, setting, participants, & measurementsIn this open-label, multicenter study, patients aged 6-17 years, with stable chronic anemia of CKD, undergoing hemodialysis received C.E.R.A. every 4 weeks, at a starting dose determined by previous weekly epoetin alfa/beta or darbepoetin dosing. After a 16-week dose-titration and a 4-week evaluation period, patients with stable hemoglobin could enter a 1-year optional safety extension.ResultsA total of 64 patients were enrolled. A conversion factor (4 µg every 4 weeks for each weekly dose of 125 IU epoetin alfa/beta or 0.55 µg darbepoetin) was identified that allowed patients to maintain hemoglobin within target levels on switching to C.E.R.A. from another ESA. Using this conversion factor, the adjusted mean change in hemoglobin from baseline to evaluation was -0.09 g/dl (95% confidence interval, -0.45 to 0.26); 81% of patients maintained hemoglobin within 10.0-12.0 g/dl and 75% maintained hemoglobin within 1.0 g/dl of baseline. Results were consistent across age groups (6-11 and 12-17 years) and previous ESA. Thirty-seven patients entered the safety extension period and 17 completed 73 weeks of treatment. Most withdrawals were for kidney transplantation. A total of 70% of patients had hemoglobin within 10.0-12.0 g/dl at last observation, and 62% were within ±1.0 g/dl of baseline. Safety was similar to studies in adult patients, with no new signal detected.ConclusionsUsing a defined conversion factor, 4-weekly C.E.R.A. was efficacious in maintaining hemoglobin levels in pediatric patients with stable anemia of CKD undergoing hemodialysis, switching from maintenance treatment with epoetin alfa/beta or darbepoetin. Safety was consistent with the known C.E.R.A. safety profile in adults.

Dataset Information

Use and safety of heparin-free maintenance hemodialysis in the USA.

Background

Methods

Results

Conclusions

Publications

Use and safety of heparin-free maintenance hemodialysis in the USA.

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