Perioperative Hydroxyethyl Starch: A Potential Threat to Patient Safety

Pagel et al1 surprisingly do not report that the 2013 restrictive rules for hydroxyethyl starch (HES) prescription by the US and European regulatory agencies (Food and Drug Administration and European Medical Agency) are being violated to such an extent that in October 17, 2017, the European Medical Agency began an ongoing scrutiny of HES use.2 New data provided by Pagel et al1 were collected in patients at “low risk” for acute kidney injury and do not rule out toxic effects of HES on renal function. They can only say that the effect, if present, was not sufficient to require postoperative renal replacement therapy. In addition, their data provide strong and alarming evidence that the use of HES in the perioperative setting is associated with a significant increase in blood loss, red blood cell transfusion, intraoperative noradrenaline administration, and length of hospital stay. All of these conditions raise substantial concerns for patient safety. Although HES’s effects on coagulation function have been previously described, the data from Pagel et al1 are particularly concerning: in the studied population, blood loss dramatically increased from a mean of 406 mL in patients who only received Ringer’s lactate to 867 mL in patients who received Ringer’s-HES solutions. This increase in blood loss is statistically significant (P < .001), offers new and strong clinical evidence of the impact of HES on clinical management, and is alarming. The authors also report, with little comment, that the length of hospital stay was longer in patients who received HES (12 vs 14 days; P = .002): this is a well-known risk factor for substantial increase in perioperative morbidity, mortality, and costs. HES is far from “ideal” for fluid therapy in the perioperative setting. In the slippery field of HES use, it is important to focus primarily on patient care, and a thoughtful discussion of the data should be provided. Patient safety needs to be appropriately acknowledged by clinicians and researchers active in perioperative care, and safety concerns should be widely shared with health care professionals and patient representatives and should be addressed by dedicated rules from regulatory agencies that prioritize patient safety.