A Retrospective Study Comparing the Effectiveness and Safety of EXOSEAL Vascular Closure Device to Manual Compression in Patients Undergoing Percutaneous Transbrachial Procedures

Abstract Introduction This study aimed to assess the safety and efficacy of EXOSEAL vascular closure device (EVCD) by comparing its performance with manual compressions(MC) in achieving hemostasis at the brachial artery puncture site. Material and methods A retrospective study of brachial artery access by using either MC or EVCD for achieving hemostasis from March 2016 to October 2017 was conducted. Patients with Stanford type B aortic dissection(TBAD) undergoing percutaneous transbrachial procedures were included. Time to hemostasis (TTH) was the primary efficacy end point. Seven-day incidence of major access site related complications was the primary safety end point. TTH, major and minor complications associated with treatment of these two groups were also evaluated. Results A total of 157 patients with TBAD undergoing percutaneous transbrachial procedures entered the analysis. Of these, 107 patients underwent EVCD and 50 patients underwent MC. The baseline characteristics of the two groups were similar. TTH was significantly shorter for EVCD over MC (P Conclusion After 6-F percutaneous access via the brachial artery invasive procedures in preprocedurally fully anticoagulated patients, TTH was significantly reduced in patients who underwent EVCD when compared to patients who underwent MC. MC is a safer and more convenient way to achieve hemostasis, while has higher incidence of minor complications.