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

Abstract

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

Supplementary materials

Table S1 Subgroup analysis effectiveness by treatment application site (per protocol population)

Table S2 Rescue therapy (as-treated population)

Table S3 Independent ethics committees and their associated clinical trial sites

Acknowledgments

This work was sponsored and funded by Covidien (Mansfield, MA, USA), which contributed to the study design, data collection, and data analysis, and assisted with manuscript writing. Covidien LP is an indirect wholly owned subsidiary of Medtronic plc.

The authors would like to thank the other principal investigators who participated in the study: Professor Parla Astarci (Saint Luc Cliniques Universitaires), Professor Michael Schmoeckel (Asklepios Klinik St. Georg, Herzchirurgische Abteilung), Professor Martin Misfeld (Herzzentrum Leipzig), Professor Francis Wellens (UZ Brussels), Professor Filip Rega (UZ Leuven), and Michael Sudkamp, MD, PhD (Universitätsklinikum Freiburg). Additionally, they thank all the co-investigators and study personnel who assisted in the surgical procedures, follow-up assessments, and data collection. Statistical support was provided by Biostatistical Consulting, Inc. (Burlington, MA, USA). Editorial support was provided by John Hauschild and Nicholas Paquette (Medtronic).

Disclosure

All authors or their institutions received support from Covidien (the manufacturer of Veriset™) to conduct this study. The authors report no other conflicts of interest in this work.

Author contributions

Authors made substantial contributions to the study conduct and manuscript development beginning with the initial study conception, including study design (DG, MH, DK, PS, BV, TW, LH, MO), data acquisition (DG, MH, DK, PS, BV, TW, LH, MO), data analysis (DG, MH, DK, PS, BV, TW, LH, MO, CMR), data interpretation (DG, MH, DK, PS, BV, TW, LH, MO, CMR), manuscript writing (DG, CMR), critical revisions (DG, MH, DK, PS, BV, TW, LH, MO, CMR), final approval of the manuscript for submission (DG, MH, DK, PS, BV, TW, LH, MO, CMR); and agree to be accountable for the accuracy and integrity of the work (DG, MH, DK, PS, BV, TW, LH, MO, CMR).