Thomas Christoph, Steger Volker, Heller Stefan, Heuschmid Martin, Ketelsen Dominik, Claussen Claus D, Brechtel Klaus
Diagnostic and Interventional Radiology, Department of Radiology, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany.
Radiol Res Pract. 2013;2013:875484. doi: 10.1155/2013/875484. Epub 2013 Jan 14.
Purpose. The purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective. Materials and Methods. All patients (n = 50) who had received percutaneous vascular closing with the Prostar XL device in our institution with follow-up data of at least 6 months were retrospectively included. Primary (freedom from surgical conversion) and continued (freedom from groin surgery in further course) technical success and major (deviations from expected outcome requiring surgery) and minor (other deviations from expected outcome) complications were assessed. Success and complications rates were correlated with delivery system size (Mann-Whitney Rank Sum Tests) and operator experience (paired samples t-test). Results. Rates of primary and continued technical success as well as major and minor complications were 93.6%, 89.7%, 10.3%, and 10.3% (groin based) and 90.0%, 84.0%, 16.0%, and 16.0% (patient based), respectively. No correlation of success and complications rate was found with delivery system sizes and operator experience. Conclusions. Application of the Prostar XL device for percutaneous closure of large arterial access sites is safe with a relatively high rate of technical success and low rate of major complications. Sizes of the delivery systems and the experience of the operator did not influence the results.
目的。本研究的目的是回顾性评估Prostar XL装置在未经挑选的患者群体和操作者群体中用于经皮大穿刺部位闭合的有效性和安全性。材料与方法。回顾性纳入了在我们机构接受Prostar XL装置经皮血管闭合且有至少6个月随访数据的所有患者（n = 50）。评估主要（无需手术转换）和持续（后续无需腹股沟手术）技术成功率以及主要（与预期结果偏差需要手术）和次要（与预期结果的其他偏差）并发症。成功率和并发症发生率与输送系统尺寸（曼-惠特尼秩和检验）和操作者经验（配对样本t检验）相关。结果。主要和持续技术成功率以及主要和次要并发症发生率分别为93.6%、89.7%、10.3%和10.3%（基于腹股沟）以及90.0%、84.0%、16.0%和16.0%（基于患者）。未发现成功率和并发症发生率与输送系统尺寸及操作者经验之间存在相关性。结论。Prostar XL装置用于经皮闭合大动脉穿刺部位是安全的，技术成功率相对较高且主要并发症发生率较低。输送系统尺寸和操作者经验并未影响结果。
