Department of Vascular and Endovascular Surgery, Maine Medical Center, Portland, Me.
Department of Vascular and Endovascular Surgery, Maine Medical Center, Portland, Me.
J Vasc Surg. 2018 Sep;68(3):887-899. doi: 10.1016/j.jvs.2018.05.019. Epub 2018 Jun 29.
The aim of this review was to provide an up-to-date summarization of available Food and Drug Administration-approved vascular closure devices (VCDs) and to analyze current evidence comparing individual devices with one another and with manual compression (MC). The review includes indications for use, advantages and disadvantages, safety and efficacy, and outcomes.
A review of literature available on VCDs was conducted using PubMed and MEDLINE. Only clinical trials published within the last 10 years evaluating the efficacy of different VCDs with access obtained through common femoral artery or vein were included. All literature included in this review was published in English and used human participants.
The search strategy yielded 34 relevant articles. These studies included procedures ranging from diagnostic catheterizations to percutaneous endovascular aneurysm repair. There is considerable heterogeneity in the studies, with a wide variety of definitions and different outcome measures. The review demonstrated that VCDs provided improvement in the patients' comfort and satisfaction as well as in the time to hemostasis and ambulation. Most studies are underpowered to show differences, but even after meta-analysis or Cochrane review, complication rates as well as safety and efficacy between devices and MC remained comparable.
VCDs have shown marked improvement in patients' comfort and satisfaction as well as in time to hemostasis and ambulation after percutaneous vascular procedures. According to multiple small randomized controlled trials, meta-analyses, and a Cochrane review, complication rates, safety and efficacy, and outcomes remain comparable between VCDs and MC (12% for VCDs vs 13% for MC). VCDs have a low incidence of major complications and high success rates, which provides convenience for the practitioner and facilitates turnover of patients. VCDs have a risk of infectious (0.6% with VCDs vs 0.2% with MC) and thrombotic complications (0.3% with VCDs vs none with MC) that is small but may be increased compared with MC. It is important to balance the goals of comfort of the patient, resources of the staff, and early ambulation against periprocedural and anatomic risk factors (ie, individualize use of VCDs to specific clinical scenarios). Users must be familiar with a device and its limitations to safely and effectively achieve hemostasis after femoral artery puncture.
本综述旨在提供对现有食品和药物管理局批准的血管闭合装置（VCD）的最新总结，并分析比较各个设备之间以及与手动压迫（MC）的当前证据。该综述包括适应证、优缺点、安全性和有效性以及结果。
使用 PubMed 和 MEDLINE 对 VCD 文献进行综述。仅包括在过去 10 年内发表的评估不同 VCD 疗效的临床试验，这些试验通过股动脉或股静脉获得。本综述中包含的所有文献均以英文发表，使用人类参与者。
搜索策略产生了 34 篇相关文章。这些研究包括从诊断性导管插入术到经皮血管内动脉瘤修复术的各种程序。研究之间存在相当大的异质性，定义和不同的结果测量方法多种多样。该综述表明，VCD 可改善患者的舒适度和满意度，以及止血和活动的时间。大多数研究的效力不足，无法显示差异，但即使在荟萃分析或 Cochrane 综述后，设备与 MC 之间的并发症发生率以及安全性和有效性仍然相当。
VCD 可显著改善经皮血管手术后患者的舒适度和满意度，以及止血和活动的时间。根据多项小型随机对照试验、荟萃分析和 Cochrane 综述，并发症发生率、安全性和有效性以及结果在 VCD 和 MC 之间仍然相当（VCD 为 12%，MC 为 13%）。VCD 的主要并发症发生率低，成功率高，为从业者提供了便利，并且有利于患者周转。VCD 有感染（VCD 为 0.6%，MC 为 0.2%）和血栓形成并发症（VCD 为 0.3%，MC 无）的风险较小，但与 MC 相比，风险可能会增加。平衡患者舒适度、员工资源和早期活动能力与围手术期和解剖危险因素（即根据特定临床情况个体化使用 VCD）非常重要。使用者必须熟悉设备及其局限性，以安全有效地实现股动脉穿刺后的止血。
