Résumé
Patient Blood Management (PBM) has been encouraged in cardiac surgery to prevent anemia- and transfusion-induced morbidity and mortality.(1) Preoperative anemia has an increasing prevalence due to an ageing population with more chronic diseases, and affects up to 20 to 40% of patients who are scheduled for cardiac surgery.(2) Preoperative anemia by its own is an independent factor of adverse outcome, but it is also an independent factor of allogenic red blood cell (RBC) transfusions, which are associated too with a higher mortality risk.(3) Therefore blood conservation strategy in cardiac surgery is aimed at reducing both risks.
This was a single-center, prospective, comparative, open label randomized trial. All patients signed a written informed consent. This trial protocol was approved by the local ethics committee (Sud Mediterrannée V 19.04.02.61948) and the French National Agency of Security of Drugs (ANSM) and was registered online at ClinicalTrails.gov (NCT04141631). An independent trial safety committee monitored trial benefit/risk ratio and safety for the entire duration of the study.
In the control group, postoperative RBC transfusion was performed if hemoglobin (Hb) <= 8g/dL; if Hb >8g/dL two administrations of oxide ferric sucrose (Venofer®, Viforpharma) were performed. In the STOP group (Optimisation Transfusion Strategy), EPO and CMF were administered if Hb <13g/dL the day before or at ICU admission the day of surgery; postoperative RBC transfusion was performed in case of Hb <8g/dL associated with ScvO2 <65%. The primary endpoint was the proportion of patients transfused with RBC units after surgery, during the ICU stay up to hospital discharge or postoperative day 28, whatever came first
From January 2020 to August 2022, 128 patients were randomized: 63 in the control group and 65 in the STOP group with no statistical difference in demographic, pre- and intraoperative characteristics. The mean preoperative Hb was 12.9 ±1.3 g/dL. Postoperative erythrocyte transfusion incidence was significantly lower in STOP group: 14.52% vs 31.15%, respectively (p < 0.03) with RR 0.466 ([95% CI: 0.2291-0.9479](Figure 1). In STOP group, all transfusions respected the ScVO2 threshold < 65% with a mean of 54.84 ±7.51%. Hb values were significantly higher in STOP group versus control Group from the first postoperative day to hospital discharge and one month after discharge, respectively (p<0.01) (Figure 2). There were no statistically significant differences between the 2 groups for the ICU or the hospital lengths of stay, or mortality. There were no significant difference between the 2 groups for any postoperative complications.
In this study, an optimized and individualized PBM strategy with preoperative EPO and FCM the day associated with ScvO2 to guide postoperative erythrocyte transfusion reduced the incidence of transfusion by 50% and increased postoperative Hb concentrations at short and medium term.