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Plasma non-transferrin-bound iron (NTBI) comprises multiple subspecies, classified by their composition, chemical reactivity, and susceptibility to chelation. The redox-active and chelatable fraction of NTBI is referred to as labile plasma iron (LPI). The pathophysiological significance of NTBI and LPI lies in their ability to enter cells via alternative transport pathways that are not regulated by the transferrin receptor system or by cellular iron levels. Several mechanisms have been proposed for their cellular entry, including the hijacking of divalent metal transporters and passive diffusion. This unregulated uptake can lead to iron accumulation in vulnerable tissues such as the liver and the heart. NTBI and LPI bypassing normal cellular control mechanisms can rapidly exceed the cell’s capacity to safely store excess iron, leading to toxicity. Both NTBI and LPI contribute to oxidative stress by participating in free-radical-generating reactions. However, LPI concentration in the bloodstream may be differentially affected by the mode and extent of iron overload, the presence of residual serum iron-binding activity, and the antioxidant capacity of individual sera. In summary, both NTBI and LPI contribute to iron-mediated toxicity but differ in terms of reactivity, availability, and pathogenic potential depending on the pathophysiological conditions that influence the degree of toxicity.

Replacement iron is the main treatment for iron deficiency, but the relationship between initial intravenous (IV) dose and need for additional treatment is unclear. This study explored patterns of IV iron dosing in US clinical practice. Patient records were obtained for adults who received IV iron for anemia between 2015 and 2017. Patients were classified into four groups: those who received <1500 mg and ≥1500 mg IV iron and those received ≤1000 mg and >1000 mg within 3 weeks of their first dose. The proportion of patients requiring additional IV iron after 30 days of the initial dose was evaluated. Data were obtained for 2959 patients receiving iron sucrose (44.2%), ferric carboxymaltose injection (FCM) (25.8%), and ferumoxytol (FM) (14.3%). Overall, 567 patients (19%) received ≥1500 mg of IV iron and 942 (32%) received >1000 mg of IV iron within the first 21 days. Mean (SD) baseline iron deficit was 1001 mg (312). Patients who received ≥1500 mg had a 32% lower probability of receiving additional IV iron than those who received <1500 mg (adjusted hazard ratio [HR]: 0.68 [95% confidence interval (CI); 0.58, 0.81]) and incurred significantly fewer outpatient visits for all causes (p < 0.001) and IV iron treatment (p < 0.001). Patients who received an initial dose of >1000 mg had a 41% lower probability of receiving additional IV iron than those who received ≤1000 mg (adjusted HR: 0.59 [95% CI; 0.52, 0.67]) and had significantly fewer outpatient visits for all causes (p < 0.001) and IV iron treatment (p < 0.001). Patients receiving FCM required fewer outpatient visits than those receiving FM and other treatments, including a subgroup of patients who initially received >1000 mg IV iron. Higher doses of IV iron within 3 weeks of first dose may reduce further IV iron treatment needs and outpatient visits.

Background: Iron deficiency (ID) is a frequent comorbidity in heart failure (HF), associated with reduced functional capacity and poor prognosis. Although the European Society of Cardiology (ESC) guidelines recommend systematic screening and intravenous iron supplementation (IS), adherence in clinical practice remains limited. This observational study aimed to evaluate how these recommendations are implemented into practice. Methods: We performed a retrospective study including 4348 patients hospitalized with HF (NYHA II-IV) in a tertiary internal medicine clinic in Eastern Europe between January 2018 and September 2022. Demographic data, comorbidities, laboratory parameters, echocardiographic findings were collected from electronic medical records. IS was defined as serum ferritin < 100 ng/mL. Results: Among HF patients, 2547 (58.7%) were screened for ID, and 1091 (42.8%) had absolute deficiency. Only 278 patients (25.5%) received intravenous ferric carbodymaltose. Treated patients were predominantly elderly (70.1% ≥ 70 years), female (60.4%), and often had ischemic or valvular disease. Patients receiving intravenous IS showed higher NT-proBNP and troponin levels. A progressive increase in IS use was observed during the study period, with a temporary decline during the COVID-19 pandemic. Conclusions: Despite relatively high screening rates, only one-quarter of HF patients with confirmed ID received intravenous IS. These findings highlight persistent gaps between guidelines and clinical practice, emphasizing the need for improved awareness and implementation of ESC recommendations to optimize outcomes in HF patients with ID.

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.

Background: Ferric carboxymaltose (FCM) is an intravenous (IV) high-dose iron that is effective in the treatment of iron deficiency anemia. This study was performed to determine whether postoperative FCM infusion is effective at improving hemoglobin (Hb) responders, Hb and iron profiles, and the patient’s quality of life (QOL). Methods: A total of 110 patients with postoperative anemia, defined by a Hb < 10 g/dL within 3 days of unilateral primary TKA, between June 2018 and February 2020 were randomized into either the FCM or Control group. On postoperative day 3, the FCM group (55 patients) received IV FCM while the Control group (55 patients) did not. The Hb responders (Hb increase ≥ 2 g/dL compared to baseline), Hb level, iron profiles (ferritin, total iron-binding capacity (TIBC), transferrin saturation (TSAT)), and EQ-5D scores were compared at weeks 2, 4, and 8. Results: The FCM group demonstrated a significantly greater number of Hb responders (p < 0.001) and a higher Hb level (p = 0.008) at 2 weeks postoperative than did the Control group. The FCM group recovered its preoperative Hb level between 4 and 8 weeks. In contrast, the Control group did not recover its preoperative level until 8 weeks. The FCM infusion group also had higher serum ferritin, iron and TSAT, and lower TIBC levels than those of the Control group between 2 and 8 weeks (all p < 0.001). However, there was no significant difference in the postoperative transfusion rate (p = 0.741) or EQ-5D score between the two groups (all p > 0.05). Discussion: In postoperative anemia following TKA, IV FCM increases the Hb response and improves Hb and iron metabolism variables, however, it does not affect the transfusion rate or QOL.

Background: Iron supplementation is administered orally or intravenously to treat iron-deficiency anemia (IDA). Ferric Carboxymaltose (FCM) \"Ferinject[R]\" is an intravenous (IV) iron preparation that has emerged as a safe therapeutic option for treating IDA in the past decade. Aim: This study aimed to evaluate safety and efficacy of carboxymaltose in a cohort of patients with IDA not responding to oral therapy. Methods: This 12-month retrospective study included 106 patients with IDA, with-or without bariatric surgery, who received (single or multiple doses) of Carboxymaltose 500mg/10mL. Data points included patients' demographics, baseline data for Hb, platelet, ferritin, and MCV pre-and at 1, 2, and 3 months following different doses of IV-Carboxymaltose. Changes in Hb, MCV, platelets, and ferritin levels were recorded in response to Carboxymaltose to assess the optimal dose, risk of hyperferritinemia, and hypophosphatemia. Results: At three months (95 days) follow-up, the median change pre-and post-therapy in hemoglobin was from 9.5 to 11.9g/dL (p < 0.01), MCV 73.6-80.5fL (p < 0.01), and ferritin 5.3-93.8ng/mL. A significant difference was observed between platelet count of patients who underwent bariatric surgery and those who did not. An optimal ferritin response (>30ng/mL) was observed in 87.8% of patients who received first dose, and none of the full three doses showed no response. 37% of patients who received two doses developed hyperferritinemia. Serum phosphate levels were assessed in 28 cases, and hypophosphatemia was observed in 25% of these patients. Conclusion: Carboxymaltose is a reliable option for IDA. IV-FCM therapy helps achieve significant improvement in hemoglobin concentration and MCV from the first dose carrying a low reversible risk of hyperferritinemia following multiple doses. An interesting finding of this study is the discovery of a population of IDA patients requiring periodic assessment for iron reinfusion to sustain normal levels, mostly post-bariatric surgery. Changes in serum phosphate levels reported to occur consecutively with FCM treatment should be further studied. Keywords: iron deficiency, anemia, ferrous carboxymaltose, hypophosphatemia

IntroductionRecent evidence has shown that iron deficiency is a significant co-morbidity in heart failure patients independent of their anaemia status. Iron deficiency is present in about 55% of chronic and 80% of acute heart failure patients and has been associated with reduced exercise capacity, recurrent heart failure hospitalisations, and high cardiovascular and all-cause mortality. A quality improvement project was therefore designed to improve the diagnosis and treatment of iron deficiency in heart failure patients in our tertiary care centre.MethodsAn initial baseline dataset was collected, followed by two cycles examining a cross section of heart failure patients admitted to our hospital over a two-month period. The Plan-Do-Study-Act (PDSA) cycle approach was applied, with the first intervention involving raising awareness of the importance and need to assess iron status of heart failure patients through education provided to doctors, nurses, and patients. Furthermore, informational leaflets were produced and disseminated across the medical wards through social media forums such as WhatsApp™. The post-intervention datasets were collected and compared to the baseline outcomes.ResultsBaseline data collected over a month period showed that 20% (4) of the heart failure patients had their iron status checked and 75% (3) of them were iron depleted (see table 1). Following the first intervention, the compliance improved from 20% to 55% (11). It was observed that nine of the eleven patients assessed for iron status had iron deficiency while appropriate iron replacement was done for 5 (55%) of them. This increased further following PDSA cycle 2 as 80% of patients were assessed for iron status and 85% of those identified to have iron deficiency had iron replacement intravenously using ferric carboxymaltose.Abstract 129 Table 1Results Male (n) Female(n) Total (20) Baseline Iron deficiency present 2 1 1 Iron deficiency absent 0 0 0 IV Iron given 2 0 2 IV Iron not given 15 3 18 PDSA Cycle 1 Iron deficiency present 9 0 9 Iron deficiency absent 1 1 2 IV Iron given 1 0 1 IV Iron not given 16 3 19 PDSA Cycle 2 Iron deficiency present 8 5 13 Iron deficiency absent 2 1 3 IV Iron given 8 3 11 IV Iron not given 0 2 2 ConclusionWe have shown that simple intervention through a QIP can improve the assessment of iron deficiency in patients with heart failure, enable timely replacement and therefore lead to better outcome for these patients.Conflict of InterestNone

Intravenous ferric carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of ferric carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure. AFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin <100 μg/L, or 100–299 μg/L with transferrin saturation <20%), and had a left ventricular ejection fraction of less than 50%. Before hospital discharge, participants were randomly assigned (1:1) to receive intravenous ferric carboxymaltose or placebo for up to 24 weeks, dosed according to the extent of iron deficiency. To maintain masking of patients and study personnel, treatments were administered in black syringes by personnel not involved in any study assessments. The primary outcome was a composite of total hospitalisations for heart failure and cardiovascular death up to 52 weeks after randomisation, analysed in all patients who received at least one dose of study treatment and had at least one post-randomisation data point. Secondary outcomes were the composite of total cardiovascular hospitalisations and cardiovascular death; cardiovascular death; total heart failure hospitalisations; time to first heart failure hospitalisation or cardiovascular death; and days lost due to heart failure hospitalisations or cardiovascular death, all evaluated up to 52 weeks after randomisation. Safety was assessed in all patients for whom study treatment was started. A pre-COVID-19 sensitivity analysis on the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT02937454, and has now been completed. Between March 21, 2017, and July 30, 2019, 1525 patients were screened, of whom 1132 patients were randomly assigned to study groups. Study treatment was started in 1110 patients, and 1108 (558 in the carboxymaltose group and 550 in the placebo group) had at least one post-randomisation value. 293 primary events (57·2 per 100 patient-years) occurred in the ferric carboxymaltose group and 372 (72·5 per 100 patient-years) occurred in the placebo group (rate ratio [RR] 0·79, 95% CI 0·62–1·01, p=0·059). 370 total cardiovascular hospitalisations and cardiovascular deaths occurred in the ferric carboxymaltose group and 451 occurred in the placebo group (RR 0·80, 95% CI 0·64–1·00, p=0·050). There was no difference in cardiovascular death between the two groups (77 [14%] of 558 in the ferric carboxymaltose group vs 78 [14%] in the placebo group; hazard ratio [HR] 0·96, 95% CI 0·70–1·32, p=0·81). 217 total heart failure hospitalisations occurred in the ferric carboxymaltose group and 294 occurred in the placebo group (RR 0·74; 95% CI 0·58–0·94, p=0·013). The composite of first heart failure hospitalisation or cardiovascular death occurred in 181 (32%) patients in the ferric carboxymaltose group and 209 (38%) in the placebo group (HR 0·80, 95% CI 0·66–0·98, p=0·030). Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to ferric carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47–0·97, p=0·035). Serious adverse events occurred in 250 (45%) of 559 patients in the ferric carboxymaltose group and 282 (51%) of 551 patients in the placebo group. In patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with ferric carboxymaltose was safe and reduced the risk of heart failure hospitalisations, with no apparent effect on the risk of cardiovascular death. Vifor Pharma.

Serum ferritin testing is the most commonly used method for screening for iron deficiency. However, iron deficiency screening is not routinely done in low-middle-income countries, including Nigeria, often due to the cost of laboratory evaluation. This study determined the diagnostic value of red blood cell indices, which are cheaper and quicker to conduct, compared to serum ferritin to diagnose iron deficiency during pregnancy. A cross-sectional study of 857 pregnant women at 36 weeks gestation in Nigeria. Standard laboratory techniques assayed mean corpuscular volume (MCV), mean cell haemoglobin (MCH), mean cell haemoglobin concentration (MCHC), red cell distribution width (RDW) and serum ferritin. Spearman's rank correlation coefficient of each of the complete blood count parameters (MCV, MCH, MCHC and RDW) with serum ferritin were assessed and their diagnostic accuracy relative to iron deficiency (defined as ferritin <30ng/mL) was evaluated. Mean age of the pregnant women was 27.7 ± 5.8 years. Median (IQR) was 10.3 (IQR: 9.6-11.0) g/dL for haemoglobin, and 84.0 (IQR: 47.0-157.9) ng/mL for ferritin. Serum ferritin levels have significant correlation with RDW, r = -0.12, p < 0.001 and MCH, r = 0.10, p = 0.003; but not with MCV, r = 0.06, p = 0.083 and MCHC, r = 0.04, p = 0.293. RDW was found to be the best discriminator for iron deficiency based on area under curve (AUC) 59.9% (95%CI: 56.6% - 63.2%), sensitivity 65.6% and specificity 53.8% at best cut-off 14.7fL. On restricting analysis to those with anaemia, the findings did not change materially. The diagnostic value of red blood cell indices, compared to serum ferritin, in detecting iron deficiency and iron deficiency anaemia is poor and should not play a role in diagnosing iron deficiency in pregnancy in a low-resource setting.