Increased recombinant activated factor VII use and need for surgical reexploration following a switch from aprotinin to epsilon-aminocaproic acid in infant cardiac surgery.

The authors sought to evaluate whether conversion from aprotinin to epsilon-aminocaproic acid (EACA) during infant cardiac surgery was associated with increased perioperative bleeding. They compared a cohort of 68 infants operated in 2006 who received aprotinin to a cohort of 77 infants operated in 2008 who received EACA. EACA-treated infants bled more, received more blood products and required re-exploration more frequently. Importantly, recombinant activated factor VII (rFVIIa) was administered more frequently in the EACA cohort.

As for all retrospective cohort studies, patients were not randomised to antifibrinolytic treatment and observer or other biases cannot be excluded. Nevertheless, whether we accept the authors’ findings or not, their conclusions are very relevant to the ongoing discussions on blood-sparing strategies in paediatric cardiac surgery. First, we definitely need randomised controlled studies comparing different antifibrinolytics in paediatric cardiac surgery. Second, the “routine” use of rFVIIa cannot be recommended in the absence of studies examining its safety and efficacy in paediatric cardiac surgery. For the time being, the administration of rFVIIa in such patients is definitely “off-label”, is not supported by any solid evidence and, consequently, should remain exceptional.

– Jean-François Hardy

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