Aksoy M, Becquemin J-P, Desgranges P, Allaire E, Kobeiter H
Department of General Surgery, Medical Faculty of Istanbul, Istanbul, Turkey.
Eur J Vasc Endovasc Surg. 2006 Jul;32(1):90-3. doi: 10.1016/j.ejvs.2005.12.014. Epub 2006 Feb 14.
The aim of this study was to evaluate the safety and efficacy of the closure device Angioseal.
All consecutive patients, who underwent a therapeutic radiological intervention using the femoral artery approach from January 2001 to January 2005 in the Service of Vascular Surgery, Henri Mondor Hospital, Creteil, France, were prospectively included in the study. The efficacy of Angioseal was defined by the ability of the device to cover the puncture site and stop bleeding. The safety was defined by the rate of complications.
A total of 79 Angioseal devices were employed on 77 patients. There were 62 (78.5%) males and 17 (21.5%) females. The mean age of the patients was 65.2+/-11.6 years (mean+/-SD). All Angioseal devices were deployed successfully. There were 62 (78.4%) 6F and 17 (21.6%) 8F sheaths employed during the procedures. There were two minor (2.5%) hematomas, one (1.2%) major hematoma and one (1.2%) pseudoaneurysm after the procedure. The mean time of discharge from the hospital was 2.1+/-1.8 (mean+/-SD) days. The patients were followed up for a mean of 9.0+/-9.3 (1-60 months) months.
Angioseal provides a safe and effective way of closing the femoral artery puncture site with acceptable morbidity rates.
本研究旨在评估血管闭合装置Angioseal的安全性和有效性。
前瞻性纳入2001年1月至2005年1月在法国克雷泰伊亨利·蒙多医院血管外科接受经股动脉途径治疗性放射介入的所有连续患者。Angioseal的有效性定义为该装置覆盖穿刺部位并止血的能力。安全性定义为并发症发生率。
共对77例患者使用了79个Angioseal装置。男性62例（78.5%），女性17例（21.5%）。患者的平均年龄为65.2±11.6岁（平均值±标准差）。所有Angioseal装置均成功部署。手术过程中使用了62个（78.4%）6F鞘管和17个（21.6%）8F鞘管。术后发生2例轻微血肿（2.5%）、1例严重血肿（1.2%）和1例假性动脉瘤（1.2%）。平均住院天数为2.1±1.8（平均值±标准差）天。患者平均随访9.0±9.3（1 - 60个月）个月。
Angioseal提供了一种安全有效的闭合股动脉穿刺部位的方法，并发症发生率可接受。
