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经皮完全穿刺与手术切开股动脉入路用于择期分叉型腹主动脉瘤腔内修复术

Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair.

作者信息

Gimzewska Madelaine, Jackson Alexander Ir, Yeoh Su Ern, Clarke Mike

机构信息

Cochrane Vascular, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Teviot Place, Edinburgh, UK, EH8 9AG.

University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton, UK, S016 6YD.

出版信息

Cochrane Database Syst Rev. 2017 Feb 21;2(2):CD010185. doi: 10.1002/14651858.CD010185.pub3.

Abstract

BACKGROUND

Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. It is, therefore, critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft introduced to the aneurysm in this way. This review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. The technique may, however, be less applicable in people with, for example, groin scarring or arterial calcification. This is an update of the review first published in 2014.

OBJECTIVES

This review aims to compare the clinical outcomes of percutaneous access with surgical cut-down femoral artery access in elective bifurcated abdominal endovascular aneurysm repair (EVAR).

SEARCH METHODS

For this update the Cochrane Vascular Information Specialist (CIS) searched their Specialised Register (last searched October 2016) and CENTRAL (2016, Issue 9). We also searched clinical trials registries and checked the reference lists of relevant retrieved articles.

SELECTION CRITERIA

We considered only randomised controlled trials. The primary intervention was a totally percutaneous endovascular repair. We considered all device types. We compared this against surgical cut-down femoral artery access endovascular repair. We only considered studies investigating elective repairs. We excluded studies reporting emergency surgery for a ruptured abdominal aortic aneurysm and those reporting aorto-uni-iliac repairs.

DATA COLLECTION AND ANALYSIS

Two review authors independently collected all data. Owing to the small number of trials identified we did not conduct any formal sensitivity analysis. Heterogeneity was not significant for any outcome.

MAIN RESULTS

Two studies with a total of 181 participants met the inclusion criteria, 116 undergoing the percutaneous technique and 65 treated by cut-down femoral artery access. One study had a small sample size and did not adequately report method of randomisation, allocation concealment or pre-selected outcomes. The second study was a larger study with few sources of bias and good methodology.We observed no significant difference in mortality between groups, with only one mortality occurring overall, in the totally percutaneous group (risk ratio (RR) 1.50; 95% confidence interval (CI) 0.06 to 36.18; 181 participants; moderate-quality evidence). Only one study reported aneurysm exclusion. In this study we observed only one failure of aneurysm exclusion in the surgical cut-down femoral artery access group (RR 0.17, 95% CI 0.01 to 4.02; 151 participants; moderate-quality evidence). No wound infections occurred in the cut-down femoral artery access group or the percutaneous group across either study (moderate-quality evidence).There was no difference in major complication rate between cut-down femoral artery access and percutaneous groups (RR 0.91, 95% CI 0.20 to 1.68; 181 participants; moderate-quality evidence); or in bleeding complications and haematoma (RR 0.94, 95% CI 0.31 to 2.82; 181 participants; high-quality evidence).Only one study reported long-term complication rates at six months, with no differences between the percutaneous and cut-down femoral artery access group (RR 1.03, 95% CI 0.34 to 3.15; 134 participants; moderate-quality evidence).We detected differences in surgery time, with percutaneous approach being significantly faster than cut-down femoral artery access (mean difference (MD) -31.46 minutes; 95% CI -47.51 minutes to -15.42 minutes; 181 participants; moderate-quality evidence). Only one study reported duration of ITU (intensive treatment unit) and hospital stay, with no difference found between groups.

AUTHORS' CONCLUSIONS: This review shows moderate-quality evidence of no difference between the percutaneous approach compared with cut-down femoral artery access group for short-term mortality, aneurysm exclusion, major complications, wound infection and long-term (six month) complications, and high-quality evidence for no difference in bleeding complications and haematoma. There was a difference in operating time, with moderate-quality evidence showing that the percutaneous approach was faster than the cut-down femoral artery access technique. We downgraded the quality of the evidence to moderate as a result of the limited number of studies, low event numbers and imprecision. As the number of included studies were limited, further research into this technique would be beneficial. The search identified one ongoing study, which may provide an improved evidence base in the future.

摘要

背景

腹主动脉瘤(AAA)是一种具有重大风险的血管疾病,尤其是在破裂时。因此,在其破裂并需要紧急手术之前,将其作为择期手术进行识别和修复至关重要。传统的修复方法是开放手术技术,需要在腹部做一个大切口。血管内腹主动脉瘤修复术(EVAR)现在是一种常见的替代方法。在这个手术中,通过切开暴露股总动脉,并以此方式将移植物引入动脉瘤。本综述探讨了一种完全经皮的EVAR方法。该技术提供了一种微创的股动脉入路方法,可能会降低腹股沟伤口并发症发生率并缩短恢复时间。然而,该技术可能不太适用于例如有腹股沟瘢痕或动脉钙化的人群。这是对2014年首次发表的综述的更新。

目的

本综述旨在比较在择期分叉腹主动脉瘤血管内修复术(EVAR)中,经皮入路与手术切开股动脉入路的临床结果。

检索方法

对于本次更新,Cochrane血管信息专家(CIS)检索了他们的专业注册库(最后检索时间为2016年10月)和CENTRAL(2016年第9期)。我们还检索了临床试验注册库,并检查了相关检索文章的参考文献列表。

入选标准

我们仅考虑随机对照试验。主要干预措施是完全经皮血管内修复。我们考虑了所有器械类型。我们将其与手术切开股动脉入路血管内修复进行比较。我们仅考虑研究择期修复的研究。我们排除了报告腹主动脉瘤破裂急诊手术的研究以及报告主动脉单髂动脉修复的研究。

数据收集与分析

两位综述作者独立收集了所有数据。由于识别出的试验数量较少,我们未进行任何正式的敏感性分析。任何结局的异质性均不显著。

主要结果

两项共纳入181名参与者的研究符合纳入标准,116人接受经皮技术,65人接受切开股动脉入路治疗。一项研究样本量较小,未充分报告随机化方法、分配隐藏或预先选定的结局。第二项研究规模较大,偏倚来源较少且方法良好。我们观察到两组之间死亡率无显著差异,总体仅发生一例死亡,在完全经皮组(风险比(RR)1.50;95%置信区间(CI)0.06至36.18;181名参与者;中等质量证据)。只有一项研究报告了动脉瘤隔绝情况。在这项研究中,我们观察到手术切开股动脉入路组仅发生一例动脉瘤隔绝失败(RR 0.17,95% CI 0.01至4.02;151名参与者;中等质量证据)。在两项研究中,切开股动脉入路组或经皮组均未发生伤口感染(中等质量证据)。切开股动脉入路组与经皮组之间主要并发症发生率无差异(RR 0.91,95% CI 0.20至1.68;181名参与者;中等质量证据);出血并发症和血肿方面也无差异(RR 0.94,95% CI 0.31至2.82;181名参与者;高质量证据)。只有一项研究报告了六个月时的长期并发症发生率,经皮组与切开股动脉入路组之间无差异(RR

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