Intravenous iron does not effectively correct preoperative anaemia in cardiac surgery: a pilot randomized controlled trial

Padmanabhan, Hari; Siau, Keith; Nevill, Alan M.; Morgan, I; Cotton, James; Ng, Alex; Brookes, Matthew; Luckraz, Heyman

doi:10.1093/icvts/ivy226

Cited by 32 publications

(59 citation statements)

References 30 publications

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“…Upon statistical analysis, there was yet no significant impact of ID on mortality. This finding is supported by a similar report by Miles et al 15 and also these results are in line with two previous intervention studies with perioperative iron application that both failed to prevent severe adverse events 17,18 …”

Section: Discussionsupporting

confidence: 91%

“…In contrast, another recent study by Rheude et al 16 showed no differences in the postoperative outcomes of anemic patients with ID compared with anemic patients without ID undergoing transcatheter aortic valve implantation (TAVI). Most of the studies about ID in cardiac surgery are by now focusing on the effects of ID‐associated anemia on perioperative blood transfusion regimes 17,18 . Nonetheless, current European guidelines for patient blood management in cardiac surgery are still unclear with respect to the question of whether pre‐existing ID should be treated before cardiac surgery 19 .…”

Section: Introductionmentioning

confidence: 99%

“…Most of the studies about ID in cardiac surgery are by now focusing on the effects of ID-associated anemia on perioperative blood transfusion regimes. 17,18 Nonetheless, current European guidelines for patient blood management in cardiac surgery are still unclear with respect to the question of whether pre-existing ID should be treated before cardiac surgery. 19 As there is only little and conflicting data available, profound data are still obviously missing about the impact of ID on the outcome after major cardiac surgery.…”

Section: Introductionmentioning

confidence: 99%

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Iron deficiency does not impair the outcome after elective coronary artery bypass and aortic valve procedures

et al. 2020

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Background and Aim of the Study: Iron deficiency (ID), a common malnutrition, has been linked to impaired prognosis in patients with congestive heart failure. It remains unclear whether ID also affects the outcome after elective cardiac surgery. Methods: A total of 378 consecutive patients undergoing either coronary artery bypass grafting (CABG) or surgical aortic valve replacement (SAVR) were prospectively enrolled, and blood samples were taken before surgery for analysis of iron metabolism. Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) was defined as the primary endpoint of the study. Results: ID (ferritin < 100 ng/ml or ferritin = 100-299 ng/ml and transferrin saturation < 20%) was common in cardiac surgery patients (ID, n = 265, 70%) and related to significant decreased preoperative hemoglobin values (ID: 13.6 ± 1.6 g/dl, Non-ID: 14.3 ± 1.5 g/dl, p < 0.01). We did not observe any differences in the postoperative outcome of the two groups. The incidence of MACCE was 4.9% in patients with ID and 8.8% in Non-ID (p = 0.16). In-hospital mortality (ID: 1.9%, Non-ID: 4.4%, p = 0.17) and stroke (ID: 1.1%, Non-ID: 1.8%, p = 0.64) were also not altered by ID. In addition, intensive care unit and hospital stay, perioperative blood transfusions as well as perioperative morbidities, such as acute kidney injury, low cardiac output syndrome, major bleeding complication, and sternal wound infections were comparable in patients with and without ID. Conclusions: The majority of patients undergoing elective CABG or SAVR suffer from ID; however, we found no significant differences in regard to MACCE and postoperative morbidity between ID and non-ID patients.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Iron deficiency does not impair the outcome after elective coronary artery bypass and aortic valve procedures

et al. 2020

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“…Tables 1, 2, and 4). In cardiac surgery, conflicting results have been found depending on whether intravenous iron was given with or without concomitant rHuEPO [31, 32]. Most guidelines from professional associations and international consensus documents recommend the administration of intravenous iron for the management of perioperative anemia [5, 14, 33-35].…”

Section: Treatment Options For Iron Deficiencymentioning

confidence: 99%

“…In surgical patients, RBCT is associated with increased risk of infection, circulatory overload, thromboembolic events, prolonged hospitalization, impaired quality of life, cancer recurrence, and mortality, and should be minimized or avoided [52-57]. A restrictive RBCT policy and transfusing 1 RBC unit at a time, with post-RBCT reassessment, are strongly recommended by most guidelines [5, 14, 18, 32-35, 58]. …”

Section: Treatment Options For Iron Deficiencymentioning

confidence: 99%

Management of Perioperative Iron Deficiency Anemia

et al. 2019

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Preoperative anemia affects 30–40% of patients undergoing major surgery and is an independent risk factor for perioperative blood transfusion, morbidity, and mortality. Absolute or functional iron deficiency is its leading cause. Nonanemic hematinic deficiencies are also prevalent and may hamper preoperative hemoglobin optimization and/or recovery from postoperative anemia. As modifiable risk factors, anemia and hematinic deficiencies should be detected and corrected prior to major surgical procedures. Postoperative anemia is even more common (up to 80–90%) due to surgery-associated blood loss, inflammation-induced blunted erythropoiesis, and/or preexisting anemia. Preoperative oral iron may have a role in mild-to-moderate anemia, provided there is sufficient time (6–8 weeks) and adequate tolerance of oral preparations. Postoperative oral iron is of little value and rife with gastrointestinal adverse events. Intravenous iron should preferentially be used in cases of moderate-to-severe iron deficiency anemia, concomitant use of erythropoiesis-stimulating agents, short time to surgery or nonelective procedures, and for postoperative anemia management. Minor infusion reactions to intravenous iron are rare, the incidence of severe anaphylactic reactions is extremely low, and there is no increase in infections with intravenous iron. Currently available intravenous iron formulations allowing administration of large single doses are preferred.

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Risk of Infection Associated With Administration of Intravenous Iron

et al. 2021

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IMPORTANCEIntravenous iron is recommended by many clinical guidelines based largely on its effectiveness in reducing anemia. However, the association with important safety outcomes, such as infection, remains uncertain. OBJECTIVE To examine the risk of infection associated with intravenous iron compared with oral iron or no iron. DATA SOURCES Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials (RCTs) from 1966 to January 31, 2021. Ongoing trials were sought from ClinicalTrials.gov, CENTRAL, and the World Health Organization International Clinical Trials Search Registry Platform. STUDY SELECTION Pairs of reviewers identified RCTs that compared intravenous iron with oral iron or no iron across all patient populations, excluding healthy volunteers. Nonrandomized studies published since January 1, 2007, were also included. A total of 312 full-text articles were assessed for eligibility. DATA EXTRACTION AND SYNTHESIS Data extraction and risk of bias assessments were performed according to the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) and Cochrane recommendations, and the quality of evidence was assessed using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach. Two reviewers extracted data independently. A random-effects model was used to synthesize data from RCTs. A narrative synthesis was performed to characterize the reporting of infection. MAIN OUTCOMES AND MEASURESThe primary outcome was risk of infection. Secondary outcomes included mortality, hospital length of stay, and changes in hemoglobin and red blood cell transfusion requirements. Measures of association were reported as risk ratios (RRs) or mean differences.RESULTS A total of 154 RCTs (32 920 participants) were included in the main analysis. Intravenous iron was associated with an increased risk of infection when compared with oral iron or no iron (RR, 1.17; 95% CI, 1.04-1.31; I 2 = 37%; moderate certainty of evidence). Intravenous iron also was associated with an increase in hemoglobin (mean difference, 0.57 g/dL; 95% CI, 0.50-0.64 g/dL; I 2 = 94%) and a reduction in the risk of requiring a red blood cell transfusion (RR, 0.93; 95% CI, 0.76-0.89; I 2 = 15%) when compared with oral iron or no iron. There was no evidence of an effect on mortality or hospital length of stay. (continued) Key Points Question In patients who require treatment with intravenous iron, what is the evidence that this intervention increases the risk of developing a new infection? Findings In this systematic review and meta-analysis of 154 randomized clinical trials that included 32 920 participants, intravenous iron was associated with an increased risk of infection. Meaning The results of this study suggest that, despite broad advocacy in clinical guidelines, intravenous iron may increase the risk of infection, which must be balanced with the potential benefits of treating anemia and reducing blood transfusion requirements.

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Intravenous iron does not effectively correct preoperative anaemia in cardiac surgery: a pilot randomized controlled trial

Abstract: ISRCTN22158788.

Cited by 32 publications

References 30 publications

Iron deficiency does not impair the outcome after elective coronary artery bypass and aortic valve procedures

Iron deficiency does not impair the outcome after elective coronary artery bypass and aortic valve procedures

Management of Perioperative Iron Deficiency Anemia

Risk of Infection Associated With Administration of Intravenous Iron

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