Department of Diagnostic and Interventional Radiology, Klinikum Ingolstadt, Krumenauerstraße 25, 85049 Ingolstadt, Germany.
Cardiovasc Intervent Radiol. 2013 Jun;36(3):659-68. doi: 10.1007/s00270-012-0501-2. Epub 2012 Oct 17.
To assess the efficacy and safety of the Exoseal vascular closure device for antegrade puncture of the femoral artery.
In a prospective study from February 2011 to January 2012, a total of 93 consecutive patients received a total of 100 interventional procedures via an antegrade puncture of the femoral artery. An Exoseal vascular closure device (6F) was used for closure in all cases. Puncture technique, duration of manual compression, and use of compression bandages were documented. All patients were monitored by vascular ultrasound and color-coded duplex sonography of their respective femoral artery puncture site within 12 to 36 h after angiography to check for vascular complications.
In 100 antegrade interventional procedures, the Exoseal vascular closure device was applied successfully for closure of the femoral artery puncture site in 96 cases (96 of 100, 96.0 %). The vascular closure device could not be deployed in one case as a result of kinking of the vascular sheath introducer and in three cases because the bioabsorbable plug was not properly delivered to the extravascular space adjacent to the arterial puncture site, but instead fully removed with the delivery system (4.0 %). Twelve to 36 h after the procedure, vascular ultrasound revealed no complications at the femoral artery puncture site in 93 cases (93.0 %). Minor vascular complications were found in seven cases (7.0 %), with four cases (4.0 %) of pseudoaneurysm and three cases (3.0 %) of significant late bleeding, none of which required surgery.
The Exoseal vascular closure device was safely used for antegrade puncture of the femoral artery, with a high rate of procedural success (96.0 %), a low rate of minor vascular complications (7.0 %), and no major adverse events.
评估 Exoseal 血管闭合装置用于股动脉顺行穿刺的疗效和安全性。
在 2011 年 2 月至 2012 年 1 月进行的一项前瞻性研究中，共有 93 例连续患者接受了 100 例经股动脉顺行穿刺的介入治疗。所有病例均采用 Exoseal 血管闭合装置（6F）进行闭合。记录穿刺技术、手动压迫时间和压迫绷带的使用情况。所有患者在血管造影后 12 至 36 小时内均通过血管超声和彩色双功能超声对各自的股动脉穿刺部位进行监测，以检查血管并发症。
在 100 例经股动脉介入治疗中，96 例（96 例，96.0%）成功应用 Exoseal 血管闭合装置闭合股动脉穿刺部位。由于血管鞘导入器的扭结，有 1 例无法部署血管闭合装置，由于生物可吸收塞未正确输送到紧邻动脉穿刺部位的血管外空间，而被输送系统完全取出（3 例，3.0%），有 3 例无法部署血管闭合装置。在术后 12 至 36 小时，93 例（93.0%）患者的股动脉穿刺部位经血管超声检查无并发症。7 例（7.0%）发现轻微血管并发症，其中 4 例（4.0%）为假性动脉瘤，3 例（3.0%）为明显迟发性出血，均无需手术。
Exoseal 血管闭合装置用于股动脉顺行穿刺安全有效，手术成功率高（96.0%），轻微血管并发症发生率低（7.0%），无重大不良事件。
