Xiaolong Wei1, Tonglei Han1, Yudong Sun2, Xiuli Sun3, Yani Wu4, Shiying Wang1, Jian Zhou5, Zhiqing Zhao6, Zaiping Jing7. 1. Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. 2. Department of General Surgery, Nanjing General Hospital of Eastern Theater Command, Nanjing, China. 3. Department of ophthalmology, Jinan Aier Eye hospital, Jinan, China. 4. Department of Breast and Thyroid Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. 5. Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: zhoujian1-2@163.com. 6. Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: zhaozqxueguan@126.com. 7. Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: jingzaiping_endo@126.com.
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 site-related 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 = 50), but in the EVCD group, it was ≤2 min, 87.9% (n = 107); 2-5 min, 7.5% (n = 107); and ≥10 min, 4.7% (n = 107). The EVCD group had several major complications, while the MC group had none. Two patients (1.9%, n = 107) required vascular repair, one patient (0.6%, n = 107) required blood transfusion, and 1 patient (0.6%, n = 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 = 0.030). The incidence of ecchymosis was 8 (7.5%) in the EVCD group when compared with 13 (26.0%) in the MC group, which showed statistically significant difference (P = 0.001). Other major and minor complications showed no significant differences between these 2 groups. CONCLUSIONS: After invasive procedures by 6F percutaneous access via the brachial artery in preprocedurally fully anticoagulated patients, TTH was significantly reduced in patients who underwent EVCD when compared with patients who underwent MC. MC is a safer and more convenient way to achieve hemostasis but has higher incidence of minor complications.
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 site-related 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 = 50), but in the EVCD group, it was ≤2 min, 87.9% (n = 107); 2-5 min, 7.5% (n = 107); and ≥10 min, 4.7% (n = 107). The EVCD group had several major complications, while the MC group had none. Two patients (1.9%, n = 107) required vascular repair, one patient (0.6%, n = 107) required blood transfusion, and 1 patient (0.6%, n = 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 = 0.030). The incidence of ecchymosis was 8 (7.5%) in the EVCD group when compared with 13 (26.0%) in the MC group, which showed statistically significant difference (P = 0.001). Other major and minor complications showed no significant differences between these 2 groups. CONCLUSIONS: After invasive procedures by 6F percutaneous access via the brachial artery in preprocedurally fully anticoagulated patients, TTH was significantly reduced in patients who underwent EVCD when compared with patients who underwent MC. MC is a safer and more convenient way to achieve hemostasis but has higher incidence of minor complications.