Influence of the sFlt-1/PlGF Ratio on Clinical Decision-Making in Women with Suspected Preeclampsia

Abstract

ObjectiveTo evaluate the influence of the soluble fms-like tyrosine kinase 1/placental growth factor ratio in physicians’ decision making in pregnant women with signs and symptoms of preeclampsia in routine clinical practice.MethodsA multicenter, prospective, open, non-interventional study enrolled pregnant women presenting with preeclampsia signs and symptoms in several European perinatal care centers. Before the soluble fms-like tyrosine kinase 1/placental growth factor ratio result was known, physicians documented intended clinical procedures using an iPad® application (data locked/time stamped). After the result was available, clinical decisions were confirmed or revised and documented. An independent adjudication committee evaluated the appropriateness of decisions based on maternal/fetal outcomes. Clinician decision making with regard to hospitalization was the primary outcome.ResultsIn 16.9% of mothers (20/118) the hospitalization decision was changed after knowledge of the ratio. In 13 women (11.0%), the initial decision to hospitalize was changed to no hospitalization. In seven women (5.9%) the revised decision was hospitalization. All revised decisions were considered appropriate by the panel of adjudicators (McNemar test; p < 0.0001).ConclusionsThe use of the soluble fms-like tyrosine kinase 1/placental growth factor test influenced clinical decision making towards appropriate hospitalization in a considerable proportion of women with suspected preeclampsia. This is the first study to demonstrate the impact of angiogenic biomarkers on decision making in a routine clinical practice.

Individual and Combined Diagnostic Accuracy of Biochemical Markers for Detecting Early On-Set Preeclampsia

“…This finding is consistent with a current prospective observational study which concluded that sFlt-1: PlGF ratio of 38 or lower can be used to predict the short-term absence of preeclampsia in women in whom the syndrome is suspected clinically [21]. Saleh et al, also observed that an elevated ratio is superior to the clinical diagnosis of PE for predicting an adverse pregnancy outcome and a low ratio is inversely correlated with prolongation of pregnancy [22]. …”

sFlt‐1/PlGF ratio test for pre‐eclampsia: an economic assessment for the UK

“…The impact of the sFlt‐1/PlGF ratio test as an aid to diagnosis and clinical decision‐making has been investigated in Austria and Germany in the PreOS study, where the test is in routine clinical use in accordance with their local guidelines. The cut‐off ratio of 85 was considered in PreOS to confirm the diagnosis of pre‐eclampsia and inform management of women with suspected pre‐eclampsia.…”

“…Quantification of the ratio between two angiogenic placental factors involved in the formation of new blood vessels – serum fms‐like tyrosine kinase‐1 (sFlt‐1) and placental growth factor (PlGF) – has provided valuable diagnostic information and forms the basis of the first automated biomarker test for pre‐eclampsia, the Elecsys® sFlt‐1/PlGF immunoassay ratio (Roche Diagnostics GmbH, Mannheim, Germany). PreOS, a multicenter, non‐interventional study evaluating the test for its aid in diagnosis and clinical decision‐making, found that changed decisions due to test results regarding hospitalization were in agreement with the maternal and neonatal outcomes. Recently, PROGNOSIS, a global, multicenter, non‐interventional study derived and validated cut‐off values for the short‐term prediction of pre‐eclampsia.…”

Angiogenic factors: potential to change clinical practice in pre‐eclampsia?

“…Klein et al . conducted a multi‐centre, prospective non‐interventional study (PreOS) of the application of the sFlt‐1/PlGF ratio in decision‐making in women with suspected PE, The results suggested that use of angiogenic markers significantly impacts both the decision to hospitalise patients appropriately and stratifies the risk, and may help to guide the required intensity of patient management …”