Real efficacy of factor VIIa in the treatment of the postpartum hemorrhage

Abstract

Dear Sir, I have read with interest the article of Drs Tanchev; Platikanov, and Karadimov (1) about the usefulness of factor VIIa in the treatment of postpartum hemorrhage. However, the casuistic analysis presented does not provide objective elements that can give value to the conclusions or that can document the efficacy of factor VIIa. From a clinical point of view, assessment of a new hemostatic agent should include at least (i) temporal variation of hemostatic parameters, (ii) type and series of hematological restitution performed, and (iii) assessment of the changes induced by the new agent. None of these has been presented in this work; therefore, and from a scientific point of view, the article only allows making guesses of factor VIIa's efficacy, as it lacks feasible elements for external assessment. The general description written in Patients and methods turns out to be insufficient to obtain conclusions about the usefulness of factor VIIa. The personal clinical assessment is little tenable, as it has not been related to hematological and therapeutic variables, prior to and after the use of factor VIIa. The analysis of patients 1 and 3 makes it possible to notice that, after moderate losses, signs of shock worsening were observed, despite the measures taken. Nevertheless, it is not clear why the shock worsened, when the loss was moderate and simultaneously treated with solutions, blood, and plasma. This discord might be the consequence of a hurried clinical assessment, in which factor VIIa was used prematurely, before completing a pre-established and controlled therapeutic sequence. The complex interaction of factors and hemostatic changes in a pregnant woman make the mere description of clinical cases insufficient to determine the efficacy of factor VIIa. Its high cost and lack of conclusive controlled studies make it impossible to recommend its use as a universal hemostatic agent. However, there are promising studies (2) that allow establishing its huge potential in the treatment of severe obstetric hemorrhages. It is almost obvious, then, to say that casuistic contributions should include a serious frame of scientific investigation, with comparable data, which makes it possible to define its accurate therapeutic indication.