Department of Radiology, Section of Interventional Radiology, Seattle Children's Hospital, University of Washington, 4800 Sand Point Way NE, Seattle, WA, 98105, USA.
Pediatr Radiol. 2019 Aug;49(9):1217-1221. doi: 10.1007/s00247-019-04442-0. Epub 2019 Jun 12.
The use of arterial closure devices in achieving femoral hemostasis has been well documented in adults but insufficiently studied in the pediatric population. An earlier study from our institution of 40 Angio-Seal devices in 38 patients concluded that the arterial closure device is safe in children with only a single minor complication. Ongoing experience with this device at our institution, however, suggests a higher rate of complication.
To retrospectively evaluate the safety and efficacy of the Angio-Seal in a pediatric population.
A retrospective analysis reviewed all cases in which the Angio-Seal was deployed from June 2011 to September 2017. Peri-procedural documentation was reviewed for pre-procedure labs, clinical effectiveness in achieving hemostasis and complications related to the use of this device. Logistic regression analysis was also used to evaluate the relationship between patient demographic, vessel size and indication for angiography, and the presence or absence of complications.
During the study period, 48 additional Angio-Seal devices were deployed in 41 consecutive patients. Five patients were excluded for being older than 18 years. The mean age of the patients was 13.3 years (range: 4-18 years) with 18 patients female. The mean common femoral artery diameter was 5.98 mm in short axis diameter (range: 4-9 mm). Complications were present in 6/43 cases (14%) including 3 minor and 3 major complications that included additional procedures. No significant relationship was identified between vessel size, age and the indication for angiography, and the rate of complication on logistic regression analysis.
While percutaneous arterial closure devices can be efficacious for achieving hemostasis, our experience demonstrates a higher rate of complications in children, contrary to a previous report. The deployment of such devices should be performed with prejudice in this population.
在成人中，动脉闭合装置在实现股动脉止血方面的应用已有充分的文献记载，但在儿科人群中的研究还不够充分。我们机构之前的一项研究纳入了 38 例患者的 40 个 Angio-Seal 装置，该研究得出的结论是，该动脉闭合装置在儿童中是安全的，仅有 1 例轻微并发症。然而，我们机构目前使用该装置的经验表明，其并发症发生率更高。
回顾性评估 Angio-Seal 在儿科人群中的安全性和有效性。
对 2011 年 6 月至 2017 年 9 月期间使用 Angio-Seal 的所有病例进行回顾性分析。评估了围手术期的实验室检查、实现止血的临床效果以及与使用该装置相关的并发症。还使用逻辑回归分析评估了患者的人口统计学、血管大小和血管造影适应证、以及并发症的有无之间的关系。
在研究期间，41 例连续患者中又植入了 48 个 Angio-Seal 装置。5 例因年龄大于 18 岁而被排除。患者的平均年龄为 13.3 岁（范围：4-18 岁），其中 18 例为女性。股总动脉短轴直径的平均直径为 5.98mm（范围：4-9mm）。43 例中出现并发症 6 例（14%），包括 3 例轻微并发症和 3 例严重并发症，需要进行其他操作。逻辑回归分析未发现血管大小、年龄和血管造影适应证与并发症发生率之间存在显著关系。
虽然经皮动脉闭合装置在实现止血方面可能有效，但我们的经验表明，在儿童中其并发症发生率更高，与之前的报告相反。在儿科人群中应谨慎使用此类装置。
