Efficacy and safety of 6% hydroxyethyl starch 130/0.4 (Voluven) for perioperative volume replacement in children undergoing cardiac surgery: a propensity-matched analysis

Abstract

Introduction: Six percent hydroxyethyl starch (HES) 130/0.4 is considered an alternative to human albumin (HA) and crystalloids for volume replacement in children undergoing cardiac surgery. In this large propensity-matched analysis, we aimed to assess the efficacy and safety of replacing HA with HES for intraoperative volume therapy in children undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Methods: We retrospectively reviewed our database, including children who underwent cardiac surgery between January 2002 and December 2010. Four percent HA was used until 2005; it was replaced by HES thereafter. Demographic data, intra- and postoperative blood loss and blood component transfusions were recorded, together with the incidence of postoperative complications and mortality. We performed a propensity-matched analysis using 13 possible confounding factors to compare children who received either HES or HA intraoperatively. The primary objectives included the effects of both fluids on intraoperative fluid balance (difference between fluids in and fluids out (efficacy)) and blood loss and exposure to allogeneic blood products (safety). Secondary safety outcomes were mortality and the incidence of postoperative renal dysfunction.

Results: Of 1,832 children reviewed, 1,495 were included in the analysis. Intraoperative use of HES was associated with a less positive fluid balance. Perioperative blood loss, volume of red blood cells and fresh frozen plasma administered, as well as the number of children who received transfusions, were also significantly lower in the HES group. No difference was observed regarding the incidence of postoperative renal failure requiring renal replacement therapy or of morbidity and mortality.

Conclusions: These results confirm that the use of HES for volume replacement in children during cardiac surgery with CPB is as safe as HA. In addition, its use might be associated with less fluid accumulation. Further large studies are needed to assess whether the reduction in fluid accumulation could have a significant impact on postoperative morbidity and mortality.

Figures

Figure 1

Flowchart of the study. ASA, American Society of Anesthesiologists physical status; CPB, Cardiopulmonary bypass; FFP, Fresh frozen plasma; HA, Human albumin; HES, Hydroxyethyl starch; RCT, Randomized controlled trial.

Figure 2

Difference in fluid balance between groups. Red bars represent the human albumin group, and blue bars represent the hydroxyethyl starch group. Data are mean ± standard deviation. #P <0.001. IN, Total fluid volume administered intraoperatively, including cardiopulmonary bypass prime volume, cardioplegia volume and all fluid administered with drugs and flushes of invasive pressure lines; OUT, Total fluid output, including blood loss, urine output and amount of ultrafiltration.

Figure 3

Comparison of perioperative blood loss between groups. Total blood loss includes the amount of blood lost intraoperatively and the blood collected in the chest tubes. Calculated blood loss was determined according to a formula adapted from a previous publication [17] (see Materials and methods section). Red bars represent the human albumin group, and blue bars represent the hydroxyethyl starch group. Data are mean ± standard deviation. #P <0.001.

Figure 4

Difference in amount of blood products transfused between groups intraoperatively and during the first 3 postoperative days. FFP, Fresh frozen plasma; PLT, Platelet concentrates; RBCs, Packed red blood cells. Red bars represent the human albumin group, and blue bars represent the hydroxyethyl starch group. Data are mean ± standard deviation. #P <0.001.