Background

Various vascular closure devices (VCDs) are available for local hemostasis after percutaneous transfemoral approach for neuroendovascular procedures but they have been associated with an increased complication rate and limitations to a re-puncture of the artery. We evaluated the safety and efficacy of Safeguard® 24 cm pressure assisted device (Merit Medical, West Jordan, UT, USA) and the associated complications.

Methods

From September 2016 to December 2019, 879 patients underwent neuroendovascular procedures via transfemoral approach using an introducer sheath ranging from 4 to 6-French and they were included in a prospective database. We registered the demographic characteristics and procedural factors. We evaluated the device failure and associated complications.

Results

The Safeguard® was successful in 862 cases (98.1 %) with post-procedural local bleeding in 17 patients (1.9%). On univariate analysis, an association with local bleeding was observed with age >60 years (Odds ratio [OR] = 3.2, P = 0.04) and the use of an introducer sheath >4 F ([OR] = 3.1, P = 0.007). Female gender, antithrombotic medication and type of procedure (diagnostic or interventional) were not associated with local bleeding. On binary logistic regression analysis, there was association only for age >60 years ([OR] = 3, P = 0.04).

Conclusion

The Safeguard® 24 cm is safe and efficient. It is simple to use and it can be applied independently from vessel anatomic characteristics. It should though be used with caution in case of a femoral introducer sheath larger than 4 Fr and patients older than 60 years.

中文翻译：

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神经血管内手术中局部股骨止血的保护压力辅助装置：一项针对 879 名患者的单中心研究

背景

各种血管闭合装置 (VCD) 可用于神经血管内手术经皮经股入路后的局部止血，但它们与并发症发生率增加和再次穿刺动脉的限制有关。我们评估了 Safeguard® 24 cm 压力辅助装置（Merit Medical，West Jordan，UT，USA）的安全性和有效性以及相关并发症。

方法

从 2016 年 9 月到 2019 年 12 月，879 名患者使用 4 到 6-French 的导引鞘通过经股动脉入路接受了神经血管内手术，他们被纳入了前瞻性数据库。我们记录了人口统计学特征和程序因素。我们评估了设备故障和相关并发症。

结果

Safeguard® 在 862 例 (98.1%) 成功，17 名患者 (1.9%) 出现术后局部出血。在单变量分析中，观察到年龄 >60 岁（优势比 [OR] = 3.2，P  =  0.04）和使用导引鞘 >4 F（[OR] = 3.1，P  =  0.007）与局部出血相关. 女性、抗血栓药物和手术类型（诊断或介入）与局部出血无关。在二元逻辑回归分析中，只有年龄 > 60 岁有关联（[OR] = 3，P  =  0.04）。

结论

Safeguard® 24 cm 安全高效。它使用简单，可以独立于血管解剖特征应用。但是，对于大于 4 Fr 的股骨导引鞘和 60 岁以上的患者，应谨慎使用。