Department of Radiology, St. George's Hospital, Blackshaw Road, London SW17 0QT, UK.
Cardiovasc Intervent Radiol. 2011 Aug;34(4):723-38. doi: 10.1007/s00270-010-9981-0. Epub 2010 Oct 29.
The use of arterial closure devices (ACDs) in interventional radiology (IR) procedures has not yet been validated by large-scale randomised controlled trials or meta-analysis. Improved haemostasis and early mobilisation are publicised advantages; however, anecdotal evidence of haemorrhagic and ischaemic complications with ACDs is also apparent. Meta-analysis from interventional cardiology cannot be directly extrapolated for IR patients.
Systematic review, performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines was performed to assess four ACDs: Angioseal; StarClose; Perclose; and Duettin peripheral vascular interventions: uterine artery embolisation, transhepatic chemoembolisation, and cerebral diagnostic and interventional procedures. Procedures requiring cardiac, aortic, or nonfemoral access, as well as those requiring >8F sheath size, were excluded. The outcomes assessed were device deployment failure, haematoma, bleeding, groin pain, retroperitoneal haematoma, arteriovenous fistula, infection, distal ischaemia, need for vascular surgery, need for manual compression, and death.
Search of MEDLINE and other major databases identified 34 studies from 15,805 records. Twenty-one noncomparative studies (3,662 participants) demonstrated total complication rates of 3.1-11.4%. Thirteen comparative studies were analysed separately, and random-effects meta-analysis yielded 10 studies (2,373 participants).
Meta-analyses demonstrated no statistically significant difference, but there were marginally fewer complications with pooled ACDs compared with manual compression (odds ratio [OR] 0.87, 95% confidence interval [CI] 0.52-1.48, p = 0.13). The Angioseal group compared with the manual-compression group (total complication rate: OR 0.84, 95% CI 0.53-1.34, p = 0.49) and the Perclose group compared with the manual-compression group (total complication rate: OR 1.29, 95% CI 0.19-8.96, p = 0.01) each demonstrated trends for and against the specified ACD, respectively. Adequately powered randomised controlled trials are required to further elucidate the efficacy of ACDs.
在介入放射学（IR）程序中使用动脉闭合装置（ACD）尚未通过大规模随机对照试验或荟萃分析得到验证。止血和早期活动是宣传的优势；然而，也有关于 ACD 出血和缺血并发症的传闻证据。来自介入心脏病学的荟萃分析不能直接外推到 IR 患者。
根据系统评价和荟萃分析的首选报告项目进行系统评价，以评估四种 ACD：Angioseal；StarClose；Perclose；和 Duettin 外周血管介入：子宫动脉栓塞、经肝化疗栓塞和脑诊断和介入程序。排除需要心脏、主动脉或非股动脉入路的程序，以及需要>8F 鞘大小的程序。评估的结果是器械部署失败、血肿、出血、腹股沟疼痛、腹膜后血肿、动静脉瘘、感染、远端缺血、需要血管手术、需要手动压迫和死亡。
在 MEDLINE 和其他主要数据库中搜索，从 15805 条记录中确定了 34 项研究。21 项非对照研究（3662 名参与者）显示总并发症发生率为 3.1-11.4%。另外 13 项对照研究分别进行了分析，随机效应荟萃分析得出 10 项研究（2373 名参与者）。
荟萃分析显示没有统计学意义上的差异，但与手动压迫相比，使用 ACD 的并发症略少（优势比[OR]0.87，95%置信区间[CI]0.52-1.48，p=0.13）。与手动压迫组相比，Angioseal 组（总并发症发生率：OR 0.84，95%CI 0.53-1.34，p=0.49）和 Perclose 组（总并发症发生率：OR 1.29，95%CI 0.19-8.96，p=0.01）各自显示出对指定 ACD 的趋势。需要进行充分的随机对照试验来进一步阐明 ACD 的疗效。
