Teleflex Incorporated, Morrisville, NC USA.
J Int Med Res. 2024 Sep;52(9):3000605241279236. doi: 10.1177/03000605241279236.
To collect real-world data to demonstrate the safety and performance of Arrowg+ard Blue® /Arrowg+ard Blue Plus® (AGB/AGB+) central venous catheters (CVCs).
This observational, retrospective study involved patients who required AGB/AGB+ CVCs at designated general hospitals in USA (22), UK (19) and Germany (2). Data were extracted from electronic medical records. There were no specific inclusion/exclusion criteria. Primary endpoint was successful treatment without an adverse event (AE). Secondary endpoint was rate of AEs.
In total, 384 cases were included from 43 centres and most patients (74%) were >35 years of age. A success rate of 99%, and an overall AE rate of 0.8% were observed. Moreover, the overall infection rate was lower than typically reported for standard catheters. In addition, power injection of contrast media was successful in all 51 cases.
This study indicates the AGB/AGB+ CVCs perform as intended with a high success rate and few AEs. Further large-scale, controlled studies are required to confirm our findings.
收集真实世界的数据,以证明 Arrowg+ard Blue® / Arrowg+ard Blue Plus®(AGB/AGB+)中心静脉导管(CVC)的安全性和性能。
这是一项观察性、回顾性研究,涉及在美国(22 个)、英国(19 个)和德国(2 个)指定的综合医院需要使用 AGB/AGB+ CVC 的患者。数据从电子病历中提取。没有特定的纳入/排除标准。主要终点是没有不良事件(AE)的成功治疗。次要终点是 AE 发生率。
共纳入 384 例来自 43 个中心的病例,大多数患者(74%)年龄>35 岁。观察到成功率为 99%,总 AE 发生率为 0.8%。此外,总体感染率低于标准导管的典型报告。此外,在所有 51 例中,均成功进行了对比剂的动力注射。
本研究表明,AGB/AGB+ CVC 按照预期进行操作,成功率高,AE 少。需要进一步进行大规模、对照研究来证实我们的发现。