Fujihara Masahiko, Haramitsu Yuichi, Ohshimo Kenji, Yazu Yuko, Izumi Eri, Higashimori Akihiro, Yokoi Yoshiaki
Department of Cardiology, Kishiwada Tokushukai Hospital, 4-27-1 Kamori-cho, Kishiwada, Osaka, 596-8522, Japan.
Department of Medicine and Biosystemic Science, Faculty of Medicine, Kyushu University, Fukuoka, Japan.
Cardiovasc Interv Ther. 2017 Jul;32(3):233-240. doi: 10.1007/s12928-016-0409-x. Epub 2016 Jul 18.
To assess the safety and efficacy of routine use of ultrasound-guided puncture and the use of vascular closure device (VCD) in patients undergoing endovascular therapy (EVT) through femoral access. This was a single-center, non-randomized clinical study that enrolled 513 patients undergoing EVT via femoral artery access in which hemostasis was achieved using VCDs (406-patient EXOSEAL arm and 107-patient PROGLIDE arm). All cases were performed by routine use of ultrasound-guided access. The primary endpoint was the achievement of hemostasis without periprocedural and 30-day incidence of major or minor access site-related complications. The primary endpoint was achieved in 91.6 % of the cases (470/513) with a higher success rate in the EXOSEAL arm (93.6). Major complications were observed in 5 patients (0.9 %) in total cohort and 3 patients (0.7 %) treated with EXOSEAL arm vs. 2 patients (1.8 %) with PROGLIDE arm (p = 0.32). Combined treatment two VCDs with the routine ultrasound guidance access for patients who underwent the EVT procedure showed high efficacy and safety outcomes.
评估在接受经股动脉入路血管内治疗（EVT）的患者中常规使用超声引导穿刺及血管闭合装置（VCD）的安全性和有效性。这是一项单中心、非随机的临床研究，纳入了513例经股动脉入路接受EVT的患者，其中使用VCD实现止血（406例患者在EXOSEAL组，107例患者在PROGLIDE组）。所有病例均通过常规使用超声引导入路进行。主要终点是实现止血且无围手术期及30天内主要或次要穿刺部位相关并发症的发生率。91.6%的病例（470/513）达到了主要终点，EXOSEAL组成功率更高（93.6%）。在整个队列中，共5例患者（0.9%）出现主要并发症，EXOSEAL组治疗的患者中有3例（0.7%），而PROGLIDE组有2例患者（1.8%）（p = 0.32）。对于接受EVT手术的患者，在常规超声引导入路的基础上联合使用两种VCD显示出高疗效和安全性结果。
