ferric-oxide--saccharated and Heart-Valve-Diseases

To compare the efficacy of intravenous iron versus placebo to correct postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery.. A prospective, single-blinded, randomized controlled study.. National Center for Cardiovascular Diseases and a university hospital.. The study comprised 150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery.. The patients were randomly assigned (1:1) to either the treatment (intravenous iron) group or the control (placebo) group.. The hemoglobin and ferritin concentrations and postoperative adverse events were collected and compared between the 2 groups. The hemoglobin concentration and the proportion of patients who had their anemia corrected or achieved hemoglobin increments of >20 g/L in the intravenous iron group were significantly higher than that in the placebo group at postoperative day 14 (p = 0.023, p = 0.037, and p = 0.001), whereas there was no statistical difference at postoperative day 7. The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001). There were no significant differences in rates of death, blood tranfusion, antibiotic upgrade, ventilator time >24 hours, postoperative hospital stay >10 days, poor wound healing, and perivalvular leakage between the 2 groups.. Intravenous iron could significantly increase the hemoglobin level in patients with postoperative functional iron deficiency anemia at postoperative day 14. However, there is no difference in blood transfusion requirements or postoperative adverse outcomes between the 2 groups.

Topics: Administration, Intravenous; Adult; Aged; Anemia, Iron-Deficiency; Biomarkers; Female; Ferric Oxide, Saccharated; Follow-Up Studies; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Single-Blind Method; Treatment Outcome; Young Adult

Preoperative anemia is a risk factor for postoperative morbidity and in-hospital mortality in cardiac surgery. However, it is not known whether treatment of anemia before cardiac surgery by administering recombinant human erythropoietin (rhEPO) plus iron improves postoperative outcomes and decreases red blood cell transfusions in these patients. In 1998 a collection of consecutive data for patients who underwent valve replacement was initiated and the inclusion criterion was anemia. Treatment with rhEPO was given at a dose of 500 IU/kg/day every week for 4 weeks and the fifth dose 48 hours before valve replacement. During each rhEPO session, patients received intravenous iron sucrose supplementation. The intervention cohort (2006 to 2011) included 75 patients and the observation cohort was composed of 59 patients who did not receive any treatment (1998 to 2005). Multivariable logistic regression analysis showed that administration of combined therapy was independently associated with decreased postoperative morbidity (odds ratio [OR] 0.13, 95% confidence interval [CI] 0.03 to 0.59 p = 0.008) and in-hospital mortality (OR 0.16, 95% CI 0.28 to 0.95 p = 0.04) after adjusting for logistic European System for Cardiac Operative Risk Evaluation score, type of intervention, time of cardiopulmonary bypass, and year of surgery. Individually, this treatment also decreased postoperative renal failure (OR 0.23, 95% CI 0.06 to 0.88, p = 0.03). Rate of red blood cell transfusion decreased from 93% in the observation cohort to 67% in the intervention cohort as did days of hospitalization (median, 15 days, 10 to 27, versus 10 days, 8 to 14, respectively, p = 0.01 for all comparisons). In conclusion, administration of intravenous rhEPO plus iron in anemic patients before valve replacement improves postoperative survival, decreases blood transfusions, and shortens hospitalization.

Topics: Aged; Anemia; Dose-Response Relationship, Drug; Drug Therapy, Combination; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Hematinics; Hospital Mortality; Humans; Infusions, Intravenous; Male; Postoperative Period; Preoperative Care; Prospective Studies; Recombinant Proteins; Risk Factors; Spain; Sucrose; Survival Rate; Treatment Outcome