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

Abstract

Background: This study aimed to assess the safety and efficacy of EXOSEAL vascular closure device (EVCD) insertion by comparing its performance with manual compression (MC) in achieving hemostasis at the brachial artery puncture site. 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 siteerelated complications was the primary safety end point. TTH and major and minor complications associated with treatment of these 2 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 insertion and 50 patients underwent MC. The baseline characteristics of the 2 groups were similar. TTH was significantly shorter for EVCD over MC (P < 0.05). The TTH 10 min in the MC group was 100.0% (n ¼ 50), but in the EVCD group, it was 2 min, 87.9% (n ¼ 107); 2e5 min, 7.5% (n ¼ 107); and 10 min, 4.7% (n ¼ 107). The EVCD group had several major complications, while the MC group had none. Two patients (1.9%, n ¼ 107) required vascular repair, one patient (0.6%, n ¼ 107) required blood transfusion, and 1 patient (0.6%, n ¼ 107) developed upper limb numbness and weakness after EVCD deployment. Minor complication such as the occurrence of hematoma (5 cm) in the MC group was 4 (8.0%) but was also 4 (3.7%) in the EVCD group, showing statistically significant difference (P ¼ 0.030). The incidence of ecchymosis was Xiaolong Wei, Tonglei Han and Yudong Sun contributed equally to this work.

Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures

“…In order to lower the UEA cutdown morbidity rates, in recent years a percutaneous approach with VCDs has been proposed. Percutaneous brachial access with commercially available VCDs was investigated in a recent study with disappointing results 33 while a percutaneous AXA access has been proposed by different authors. 10,14,15,19e23 (Table 5).…”

Vascular Closure Devices versus Manual Compression in Cardiac Interventional Procedures: Systematic Review and Meta-Analysis

“…After removing 462 duplicate studies, step by step screening was performed based on inclusion and exclusion criteria. Eventually, 32 studies comprising 12 RCTs [28][29][30][31][32][33][34][35][36][37][38][39], 17 observational studies [40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55], and 3 propensity-score matched studies [56][57][58] were included in this meta-analysis. Figure 1 shows the flowchart of inclusions and exclusions.…”