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Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia
Friedman, T., Dann, E. J., Bitton-Worms, K., Makhoul, M., Glam, R., Weis, A., Tam, D. Y., Bolotin, G.
British journal of anaesthesia. 2023
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Editor's Choice
Abstract
BACKGROUND Reducing the need for blood transfusion among patients undergoing cardiac surgery FLA reduce postoperative complications and mortality. Our study aimed to assess the effects of administering preoperative i.v. ferric carboxymaltose on postoperative red cell transfusion requirements in patients without anaemia undergoing on-pump cardiac surgery. METHODS This double-blind, randomised, placebo-controlled trial was conducted between October 2016 and November 2019, with a follow-up period of up to 6 weeks after surgery. Patients without anaemia who underwent on-pump cardiac surgery were included as participants and administered i.v. iron in the form of ferric carboxymaltose or placebo once, 24-72 h before surgery. The primary outcome was the number of red cell units transfused during the first four postoperative days, and the secondary outcome measures were blood haemoglobin concentrations at 4 days and 6 weeks after surgery. RESULTS The 200 patients included were randomly assigned to the ferric carboxymaltose (n=102) and placebo (n=98) groups. By postoperative Day 4, a significantly lower mean number of red cell units were transfused in the ferric carboxymaltose than in the placebo group, 0.3 (0.8) vs 1.6 (4.4), respectively; P=0.007. The mean haemoglobin concentrations on postoperative Day 4 were 9.7 (1) g dl(-1) and 9.3 (1) g dl(-1), respectively (P=0.03). Corresponding values at 6 weeks after surgery were 12.6 (1.4) g dl(-1) and 11.8 (1.5) g dl(-1), respectively (P=0.012). CONCLUSIONS In patients without anaemia undergoing on-pump cardiac surgery, treatment with a single dose of 1000 mg ferric carboxymaltose i.v. 1-3 days before surgery significantly reduced the need for red cell transfusions and increased the postoperative haemoglobin concentration. CLINICAL TRIAL REGISTRATION NCT02939794.
PICO Summary
Population
Patients without anaemia who underwent on-pump cardiac surgery (n= 200).
Intervention
Ferric carboxymaltose (n= 102).
Comparison
Placebo (n= 98).
Outcome
By postoperative day 4, a significantly lower mean number of red cell units were transfused in the ferric carboxymaltose than in the placebo group, 0.3 (0.8) vs. 1.6 (4.4), respectively. The mean haemoglobin concentrations on postoperative day 4 were 9.7 (1) g dl(-1) and 9.3 (1) g dl(-1), respectively. Corresponding values at 6 weeks after surgery were 12.6 (1.4) g dl(-1) and 11.8 (1.5) g dl(-1), respectively.
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Effect of Preoperative Administration of Intravenous Ferric Carboxymaltose in Patients with Iron Deficiency Anemia after Off-Pump Coronary Artery Bypass Grafting: A Randomized Controlled Trial
Kim HH, Park EH, Lee SH, Yoo KJ, Youn YN
Journal of clinical medicine. 2023;12(5)
Abstract
Patients scheduled for cardiac surgery often have anemia and iron deficiency. We investigated the effect of the preoperative administration of intravenous ferric carboxymaltose (IVFC) in patients with iron deficiency anemia (IDA) who were due to undergo off-pump coronary artery bypass grafting (OPCAB). Patients who were due to undergo elective OPCAB between February 2019 and March 2022 who had IDA (n = 86) were included in this single center, randomized, parallel-group controlled study. The participants were randomly assigned (1:1) to receive either IVFC or placebo treatment. Postoperative hematologic parameters [hemoglobin (Hb), hematocrit, serum iron concentration, total iron-binding capacity, transferrin saturation, transferrin concentration, and ferritin concentration] and the changes in these parameters during the follow-up period were the primary and secondary outcomes, respectively. The tertiary endpoints were early clinical outcomes, such as the volume of mediastinal drainage and the need for blood transfusions. IVFC treatment significantly reduced the need for red blood cell (RBC) and platelet transfusions. Despite receiving fewer RBC transfusions, patients in the treatment group had higher levels of Hb, hematocrit, and serum iron and ferritin concentrations during weeks 1 and 12 after surgery. No serious adverse events occurred during the study period. Preoperative IVFC treatment in patients with IDA undergoing OPCAB improved the values of the hematologic parameters and iron bioavailability. Therefore, is a useful strategy for stabilizing patients prior to OPCAB.
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Preoperative anemia and anemia treatment in cardiac surgery: a systematic review and meta-analysis
Lau, Mpxl, Low, C. J. W., Ling, R. R., Liu, N. S. H., Tan, C. S., Ti, L. K., Kofidis, T., MacLaren, G., Ramanathan, K.
Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2023
Abstract
PURPOSE We aimed to conduct a systematic review and meta-analysis to assess the effects of anemia and anemia severity on patient outcomes in cardiac surgery and determine whether preoperative treatments confer postoperative benefit. SOURCE We searched four international databases for observational and randomized studies published until 1 October 2022. Study quality was assessed via Newcastle-Ottawa scores and the Cochrane Risk-of-Bias 2 tool and certainty of evidence was rated with the Grading of Recommendations, Assessment, Development and Evaluations approach. We conducted random-effects meta-analyses for our primary outcome of mortality, for secondary outcomes including length of stay (LOS) in the hospital and intensive care unit, and for postsurgical complications. As part of a secondary analysis, we analyzed short-term preoperative anemia treatments and conducted trial sequential analysis of randomized trials to assess the efficacy of these treatment programs. PRINCIPAL FINDINGS We included 35 studies (159,025 patients) in our primary meta-analysis. Preoperative anemia was associated with increased mortality (odds ratio [OR], 2.5; 95% confidence interval [CI], 2.2 to 2.9; P < 0.001, high certainty). Study-level meta-regression revealed lower hemoglobin levels and studies with lower proportions of male patients to be associated with increased risk of mortality. Preoperative anemia was also associated with an increase in LOS and postsurgical complications. Our secondary analysis (seven studies, 1,012 patients) revealed short-term preoperative anemia treatments did not significantly reduce mortality (OR, 1.1; 95% CI, 0.65 to 1.9; P = 0.69). Trial sequential analysis suggested that there was insufficient evidence to conclude if treatment programs yield any benefit or harm. CONCLUSIONS Preoperative anemia is associated with mortality and morbidity after cardiac surgery. More research is warranted to test the efficacy of current anemia treatment programs. STUDY REGISTRATION PROSPERO (CRD42022319431); first submitted 17 April 2023.
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The efficacy of intravenous iron for treatment of anemia before cardiac surgery: An updated systematic review and meta-analysis with trial sequential analysis
Liu, H. M., Tang, X. S., Yu, H., Yu, H.
Journal of Cardiothoracic Surgery. 2023;18(1):16
Abstract
BACKGROUND Preoperative anemia is common in patients undergoing cardiac surgery with various etiologies, among which iron deficiency is the leading cause. However, the benefit of intravenous (IV) iron for the treatment of anemia before cardiac surgery is uncertain. This updated meta-analysis aimed to evaluate the efficacy of IV iron in adult cardiac surgery patients with preoperative anemia. METHODS This review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched Embase, PubMed and the Cochrane Central Register of Controlled Trials to identify eligible randomized controlled trials (RCTs) and observational studies. Quality was assessed using the Cochrane Collaboration risk of bias tool and Newcastle-Ottawa scale, and the strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria. Trial sequential analysis was performed on the primary outcome (transfusion rate) to confirm whether firm evidence was reached. RESULTS Six RCTs (936 patients) and 5 observational studies (1350 patients) were included in this meta-analysis. The IV iron group and the control group were comparable in terms of transfusion rate [55.1% vs 60.9%, risk ratio (RR) = 0.91, 95% confidence interval (CI) 0.81-1.03, P = 0.13, low quality]. There were no significant differences in units transfused per patient, ICU stay and hospital length of stay between the two groups. And pooled data showed a benefit of IV iron compared to the control group on mortality (2.76% vs 3.75%, RR = 0.58, 95% CI 0.36-0.95, P = 0.03, moderate quality) and no mortality reduction existed when including only RCTs. CONCLUSIONS This meta-analysis suggested that IV iron treatment for patients with anemia before cardiac surgery did not reduce the transfusion requirement (low quality), but it was associated with decreased mortality (moderate quality). More large-scale, high-quality randomized clinical trials are warranted to confirm or refute our findings. PROSPERO registry reference: CRD42022331875.
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Effects of perioperative erythropoietin administration on acute kidney injury and red blood cell transfusion in patients undergoing cardiac surgery: A systematic review and meta-analysis
Shin HJ, Ko E, Jun I, Kim HJ, Lim CH
Medicine. 2022;101(9):e28920
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Editor's Choice
Abstract
BACKGROUND The renoprotective effects of erythropoietin (EPO) are well-known; however, the optimal timing of EPO administration remains controversial. Red blood cell (RBC) transfusion is an independent risk factor for cardiac surgery-associated acute kidney injury (CSA-AKI). We aimed to evaluate the efficacy of EPO on CSA-AKI and RBC transfusion according to the timing of administration. METHODS We searched the Cochrane Library, EMBASE, and MEDLINE databases for randomized controlled trials. The primary outcome was the incidence of CSA-AKI following perioperative EPO administration, and the secondary outcomes were changes in serum creatinine, S-cystatin C, S-neutrophil gelatinase-associated lipocalin, urinary neutrophil gelatinase-associated lipocalin, length of hospital and intensive care unit (ICU) stay, volume of RBC transfusion, and mortality. The subgroup analysis was stratified according to the timing of EPO administration in relation to surgery. RESULTS Eight randomized controlled trials with 610 patients were included in the study. EPO administration significantly decreased the incidence of CSA-AKI (odds ratio: 0.60, 95% confidence interval [CI]: 0.43-0.85, P = .004; I2 = 52%; P for heterogeneity = .04), intra-operative RBC transfusion (standardized mean difference: -0.30, 95% CI: -0.55 to -0.05, P = .02; I2 = 15%, P for heterogeneity = .31), and hospital length of stay (mean difference: -1.54 days, 95% CI: -2.70 to -0.39, P = .009; I2 = 75%, P for heterogeneity = .001) compared with control groups. Subgroup analyses revealed that pre-operative EPO treatment significantly reduced the incidence of CSA-AKI, intra-operative RBC transfusion, serum creatinine, and length of hospital and ICU stay. CONCLUSION Pre-operative administration of EPO may reduce the incidence of CSA-AKI and RBC transfusion, but not in patients administered EPO during the intra-operative or postoperative period. Therefore, pre-operative EPO treatment can be considered to improve postoperative outcomes by decreasing the length of hospital and ICU stay in patients undergoing cardiac surgery.
PICO Summary
Population
Patients undergoing cardiac surgery (8 studies, n= 610).
Intervention
Perioperative erythropoietin (EPO).
Comparison
Placebo.
Outcome
EPO administration significantly decreased the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI), intra-operative red blood cell transfusion (standardized mean difference: -0.30), and hospital length of stay (mean difference: -1.54 days) compared with control groups. Subgroup analyses revealed that pre-operative EPO treatment significantly reduced the incidence of CSA-AKI, intra-operative red blood cell transfusion, serum creatinine, and length of hospital and intensive care unit stay.
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Benefits of pre-operative oral Sucrosomial(®) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender
Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L
Blood transfusion = Trasfusione del sangue. 2022
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Free full text
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Editor's Choice
Abstract
BACKGROUND The prevalence of low pre-operative hemoglobin (Hb) among cardiac surgery patients is high. As iron homeostasis is often impaired in these patients, restoration of iron availability might over-ride iron-restricted erythropoiesis. This post-hoc analysis of a previously published, large, randomized clinical trial (ClincalTrials.gov NCT03560687; n=1,000) assesses which sub-cohort of patients benefits the most from pre-operative Hb optimization with oral Sucrosomial(®) iron. MATERIALS AND METHODS Patients without baseline Hb (n=349) or receiving >5 red blood cell units (n=57) were excluded from the study. Data from the remaining 594 were reanalyzed according to treatment, baseline anemia (Hb <13 g/dL) or gender. Patients (pt) received a one-month course of 60 mg/day Sucrosomial(®) iron (Iron group, n=309) or routine care (Control group, n=285) prior to elective cardiac surgery. Main end-point variables were increase in Hb from randomization to hospital admission, transfusion requirements, and cost-effectiveness of Sucrosomial(®) iron administration. RESULTS At hospital admission, Hb had increased 0.7 g/dL and 0.1 g/dL, for Iron and Control groups, respectively (p<0.001), with no gender-related differences, leading to a decrease in transfusion rate (30 vs 59%, respectively; p<0.001) and transfusion index (0.5 units/patient vs 1.2 units/pt, respectively; p<0.001). Sucrosomial(®) iron administration was well-tolerated, and yielded cost-savings of €92/pt (p<0.001), particularly in those presenting with baseline Hb <13 g/dL. CONCLUSIONS This post-hoc analysis confirms pre-operative Sucrosomial(®) iron administration is a safe and cost-effective strategy to increase preoperative Hb and decrease transfusion requirements in elective cardiac surgery, especially in those anemic at baseline.
PICO Summary
Population
Cardiac surgery patients (n= 594).
Intervention
Sucrosomial® iron prior to elective cardiac surgery (Iron group, n= 309).
Comparison
Routine care (Control group, n= 285).
Outcome
This post-hoc analysis of a large, randomized clinical trial (n= 1,000) reanalyzed data according to treatment, baseline anemia (Hb <13 g/dL) or gender. At hospital admission, haemoglobin (Hb) had increased 0.7 g/dL and 0.1 g/dL, for Iron and Control groups, respectively, with no gender-related differences, leading to a decrease in transfusion rate (30 vs. 59%, respectively) and transfusion index (0.5 units/patient vs. 1.2 units/pt, respectively). Sucrosomial® iron administration was well-tolerated, and yielded cost-savings of €92/pt, particularly in those presenting with baseline Hb <13 g/dL.
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Effects of recombinant erythropoietin on hemoglobin levels and blood transfusion needs in patients with preoperative anemia undergoing cardiac surgery
Totonchi, Z., Noohi, F., Futuhi, F., Azarfarin, R., Radbin, P.
Annals of Cardiac Anaesthesia. 2022;25(4):466-471
Abstract
INTRODUCTION Preoperative anemia is an important and relatively common problem in patients undergoing cardiac surgery, and its treatment is crucial in improving postoperative outcomes. The use of recombinant erythropoietin is one of the suggested methods in this field. Therefore, in the present study, we sought to evaluate the effects of recombinant erythropoietin on hemoglobin (Hb) levels and blood transfusion needs in cardiac surgery in patients with preoperative anemia. METHODS This randomized nonblind clinical trial was performed on patients with mild-to-moderate anemia (Hb <12 g/dL in men and Hb <11 g/dL in women) undergoing cardiac surgery at a referral heart hospital (Tehran, Iran). The patients were randomly divided into two groups of 33 patients. In the intervention group, recombinant erythropoietin was administered at a dose of 500 IU/kg one to three days before surgery. Intra- and postoperative Hb levels and the need for blood transfusion were recorded during surgery and for 3 days afterward. RESULTS The use of packed red blood cells in the operating room was similar in the intervention and control groups (P = 0.156), but it was significantly lower in the intensive care unit in the intervention group (P = 0.030). The mean Hb, which was initially identical in the two groups (P > 0.05), showed a significantly lower decrease in the intervention group (P = 0.001). No significant differences were observed concerning other variables. CONCLUSIONS The use of recombinant erythropoietin (500 IU/kg/day) one to three days before cardiac surgery in our anemic patients blunted a reduction in Hb levels and decreased blood transfusion needs.
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Effects of Iron Sucrose and Erythropoietin on Transfusion Requirements in Patients with Preoperative Iron Deficiency Anemia Undergoing on-Pump Coronary Artery Bypass Graft
Jafari S, Talasaz AH, Salehiomran A, Ariannejad H, Jalali A
The journal of Tehran Heart Center. 2022;17(1):7-14
Abstract
Background: Preoperative anemia is an independent risk factor for higher rates of blood transfusion in cardiac surgery. This study aimed to evaluate the effects of intravenous iron sucrose and erythropoietin on transfusion requirements in patients with preoperative iron deficiency anemia (IDA) undergoing on-pump coronary artery bypass graft (CABG) surgery. Methods: In this open-label, randomized clinical trial, patients with preoperative IDA who were candidates for on-pump CABG were randomized into intervention (iron plus erythropoietin) or control groups. Iron sucrose was administered as a 200 mg intravenous dose and erythropoietin as a 100 IU/kg bolus 1 to 2 days before surgery. The primary outcome was the amount of blood transfusion during the first 4 postoperative days. Results: The study population consisted of 114 patients. The mean age was 64.11±8.18 years in the intervention group and 63.35±8.70 years in the control group. Twenty-seven patients (47.4%) in the intervention group and 25 (43.9%) in the control group were males. The number of red blood cell units transfused per patient exhibited a significant fall in the intervention group compared with the control group (P˂0.001). The ferritin level showed a significant rise in the intervention group on postoperative day 7 (P=0.027). The length of stay in the intensive care unit and the hospital was significantly lower in the intervention arm (P=0.041 and P=0.006, respectively). No adverse events were reported in both groups. Conclusion: The use of erythropoietin and iron sucrose 1 to 2 days before surgery significantly decreased the need for blood transfusion in patients with IDA undergoing CABG without any significant adverse events.
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Effects of ferric carboxymaltose on hemoglobin level after cardiac surgery: A randomized controlled trial
Houry M, Tohme J, Sleilaty G, Jabbour K, Bou Gebrael W, Jebara V, Madi-Jebara S
Anaesthesia, critical care & pain medicine. 2022;:101171
Abstract
BACKGROUND Perioperative anemia is common in cardiac surgery. Few studies investigated the effect of postoperative intravenous (IV) iron supplementation and were mostly inconclusive. METHODS Design: A randomized single-center, double-blind, placebo-controlled, parallel-group trial. PARTICIPANTS 195 non-anemic patients were recruited from December 2018 until December 2020: 97 patients received 1 g of ferric carboxymaltose (FCM) and 98 patients received 100 mL of physiological serum on postoperative day 1. MEASUREMENTS hemoglobin levels, reticulocyte count, serum iron, serum ferritin, and transferrin saturation were measured at induction of anesthesia, postoperative days 1, 5, and 30. Transfusion rate, duration of mechanical ventilation, critical care unit length of stay, and side effects associated with IV iron administration were measured. The primary outcome was hemoglobin level on day 30. Secondary outcomes included iron balance, transfused red cell packs, and critical care unit length of stay. RESULTS At day 30, the hemoglobine level was higher in the FCM group than in the placebo group (mean 12.9 ± 1.2 vs. 12.1 ± 1.3 g/dL, 95%CI 0.41-1.23, p-value <0.001). Patients in the FCM group received fewer blood units (median 1[0-2] unit vs. 2 [0-3] units, p-value = 0.037) and had significant improvement in iron balance compared to the control group. No side effects associated with FCM administration were reported. CONCLUSION In this randomized controlled trial, administration of FCM on postoperative day 1 in non-anemic patients undergoing cardiac surgery increased hemoglobin levels by 0.8 g/dL on postoperative day 30, leading to reduced transfusion rate, and improved iron levels on postoperative day 5 and 30 (NCT03759964). CLINICAL TRIAL REGISTRY NUMBER NCT03759964.
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Intravenous iron supplement for iron deficiency in patients with severe aortic stenosis scheduled for TAVI Results of the IIISAS randomised trial
Kvaslerud AB, Bardan S, Andresen K, Kløve SF, Fagerland MW, Edvardsen T, Gullestad L, Broch K
European journal of heart failure. 2022
Abstract
AIMS: The aim of this trial was to evaluate whether intravenous iron could provide benefit beyond transcatheter aortic valve implantation (TAVI) in iron deficient patients with severe aortic stenosis. METHODS AND RESULTS In this randomised, placebo-controlled, double-blinded, single-centre trial, we enrolled patients with severe aortic stenosis and iron deficiency (defined as ferritin < 100 μg/L, or 100-299 μg/L with a transferrin saturation < 20 %) who were evaluated for TAVI. Patients were randomly assigned (1:1) to receive i.v. ferric derisomaltose or placebo approximately three months before TAVI. The primary endpoint was the between-group, baseline-adjusted six-minute walk distance measured three months after TAVI. Secondary outcomes included quality of life, iron stores, handgrip strength, NYHA class, and safety. Between January 2020 and September 2021, we randomised 74 patients to ferric derisomaltose and 75 patients to placebo. The modified intention-to-treat population comprised the 104 patients who completed the six-minute walk test at baseline and three months after successful TAVI. Iron stores were restored in 76 % of the patients allocated to iron and 13 % of the patients allocated to placebo (p < 0.001). There was no difference in the baseline-adjusted six-minute walk distance between the two treatment arms (p = 0.82). The number of serious adverse events, quality of life, handgrip strength, and NYHA class did not differ between the treatment arms. CONCLUSION Treatment with intravenous iron did not provide clinical benefit beyond TAVI in iron deficient patients with severe aortic stenosis.