Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study

Abstract

Background: Low preoperative haemoglobin is frequently observed in heart surgery patients and is associated with a significant decrease in haemoglobin between post-operative days 2 and 3, known as haemoglobin drift. Overall, these patients tend to receive many RBC transfusions. Since iron homeostasis is often impaired in these patients, restoration of iron availability might override iron-restricted erythropoiesis. However, reduced tolerance to oral iron salts has limited this strategy to intravenous iron administration. Study Design and Methods: The purpose of this study was to assess whether preoperative supplementation with oral sucrosomial iron, a new iron-delivery technology with improved tolerance and bioavailability, might be an effective strategy for this patient population. One thousand consecutive patients were randomized and received either a one-month course of sucrosomial iron (60 mg/day) or no treatment prior to elective heart surgery at a single high-volume centre (ClinicalTrials.gov NCT03560687). Primary end-points were haemoglobin concentration on the day of hospital admittance and number of blood transfusions. Secondary end-points were haemoglobin drift, tolerance of treatment and cost-effectiveness of sucrosomial iron administration. Results: Baseline haemoglobin in the treatment group was higher (by 0.67 g/dL; p<0.001) than that in the control group. The percentage of patients in the treatment group who required transfusion (35.4%) was half that in the control group (64.6%). The average number of transfused units per operation was 0.95 vs. 2.03 in the treatment and control groups, respectively. Haemoglobin drift was substantially similar in the two groups, and the tolerability of treatment was excellent (98%). The overall cost of treatment was 156 Euros less in the treatment group, expressed as a raw cost of transfusion. Conclusion: In elective heart surgery, routine preoperative sucrosomial iron administration seems to be a safe, well-tolerated and cost-effective strategy to increase preoperative haemoglobin and reduce the need for allogeneic blood transfusions.

Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period

“…As mentioned above, Sucrosomial® iron absorption is mostly hepcidin-independent, as it is taken up to the lymphatic circulation through transcellular and M cell-mediated endocytosis routes [9]. This confers Sucrosomial® iron the ability to increase Hb, even in the presence of in ammation, as has been shown in cardiac surgery [25,26] and in patients with chronic kidney disease [27], cancer [28] or in ammatory bowel disease [29,30]. Remarkably, e cacy of Sucrosomial® iron is observed at much lower dose and with fewer gastrointestinal adverse events, compared to oral iron sulfate.…”

Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period

“…As mentioned erlier, Sucrosomial® iron absorption is mostly hepcidin-independent, as it is taken up to the lymphatic circulation through transcellular and M cell-mediated endocytosis routes [ 9 ]. This gives Sucrosomial® iron the ability to increase Hb levels, even in the presence of inflammation, as demonstrated in cardiac surgery [ 25 , 26 ] and in patients with chronic kidney disease [ 27 ], cancer [ 28 ] or inflammatory bowel disease [ 29 , 30 ]. Notably, the efficacy of Sucrosomial® iron is observed at much lower dose and with fewer gastrointestinal adverse events compared to oral iron sulfate.…”

Sucrosomial® Iron: An Updated Review of Its Clinical Efficacy for the Treatment of Iron Deficiency

“…Patients were randomly assigned to receive a one-month course of Sucrosomial ® iron (60 mg/day, treatment group; n = 500) or no treatment (control group, n = 500) prior to elective heart surgery. Primary endpoints were the Hb concentration on the day of hospital admittance and blood transfusions (ClincalTrials.gov NCT03560687) [ 130 ]. Admission hemoglobin was higher by 0.67 g/dL in the treatment group ( p < 0.001).…”

“…Of note, the observed Hb increment with SI was similar to that previously observed with the pre-operative administration of IV ferric carboxymaltose (+0.84 g/dL) [ 131 ] or IV ferric derisomaltoside (+0.95 g/dL) [ 132 ] in anemic subjects scheduled for CS. The transfusion rate was lower in the treated group compared to the control group (35.4% vs. 64.6%, respectively; p < 0.001), as was the average number of transfused units (0.95 U/patient vs. 2.03 U/patient, respectively; p < 0.01) [ 130 ] ( Table 4 ).…”