A randomized, controlled trial of Veriset™ hemostatic patch in halting cardiovascular bleeding

Abstract

David Glineur,1 Marc Hendrikx,2 Dainis Krievins,3 Peteris Stradins,3 Bernhard Voss,4 Thomas Waldow,5 Luc Haenen,6 Martin Oberhoffer,7 Caroline M Ritchie8 1Saint Luc Cliniques Universitaires, Brussels, Belgium; 2Faculty of Medicine and Life Sciences, Jessa Hospital, Hasselt University, Hasselt, Belgium; 3Pauls Stradins Clinical University Hospital, Riga, Latvia; 4German Heart Center Munich, Department of Cardiovascular Surgery, Technische Universität München, Munich, Germany; 5Heart Center Dresden GmbH, University Hospital Dresden, Dresden, Germany; 6Imelda Hospital, Bonheiden, Belgium; 7Asklepios Klinik St. Georg, Herzchirurgische Abteilung, Hamburg, Germany; 8Covidien, Medical Affairs, Bedford, MA, USA Background: Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding.Methods: Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil® (control). After application of the hemostat, according to manufacturer instructions for use, time to hemostasis was monitored. Follow-up occurred up to 90 days post-surgery. Results: Median time to hemostasis was 1.5 min with Veriset™ hemostatic patch, compared to 3.0 min with TachoSil® (p<0.0001). Serious adverse events within 30 days post-surgery were experienced by 12/44 (27.3%) patients treated with Veriset™ hemostatic patch and 10/45 (22.2%) in the TachoSil® group (p=0.6295). None of these adverse events were device-related, and no reoperations for bleeding were required within 5 days post-surgery in either treatment group. Conclusion: This study reinforces the difference in minimum recommended application time between Veriset™ hemostatic patch and TachoSil® (30 s versus 3 min respectively). When compared directly at 3 min, Veriset™ displayed no significant difference, showing similar hemostasis and safety profiles on the cardiovascular bleeding sites included in this study. Keywords: surgical bleeding, cardiac surgery, aortic valve replacement, CABG

Keywords

• surgical bleeding
• cardiac surgery
• aortic valve replacement
• CABG