Evaluation of the use of Floseal®, a topical hemostatic agent, in cardiothoracic surgery

Introduction: Achieving haemostasis is critical in surgical procedures. Surgical bleeding is associated with an increased risk of mortality and morbidity with consequences at both clinical and organizational level, and with significant economic implications. In addition to conventional methods for controlling intraoperative bleeding, many topical adjunctive hemostatic products are available; among them Floseal® (Baxter Healthcare Corporation), a gelatin-based hemostatic matrix. The aim of this study is to provide an updated systematic literature review of Floseal® in cardiac surgery and estimate its associated economic impact in an Italian hospital. Methods: A literature search was conducted in MEDLINE and the Cochrane Library over the period 2013-2016 to identify new publications related to Floseal® in cardiac surgery, in addition to those already included in the systematic review of Echave et al. Furthermore, we investigated the economic impact of the use of Floseal® adapting the model elaborated by Tackett et al. to the Italian NHS. Four new studies were selected. Results: High variability in surgical procedures, choice of hemostatic products compared to Floseal® and outcome definition is confirmed. Clinical, organizational, and economics endpoints were investigated. A cost-consequence analysis estimated relevant savings. A scenario analysis, despite showing a high variability in patient level savings (€ 441-2.831), confirmed economic advantages associated with Floseal®. Discussion: Results support prior research both in terms of heterogeneity of evidence on the effectiveness of Floseal® in cardiac surgery and cost implications. The use of Floseal® achieves substantial cost savings in a hypothetical Italian hospital with a cardiac surgery unit.