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. 2017 Feb 21;2(2):CD010185.
doi: 10.1002/14651858.CD010185.pub3.

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

Affiliations

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

Madelaine Gimzewska et al. Cochrane Database Syst Rev. .

Update in

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.

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Conflict of interest statement

MG: none known AJ: has declared that he received travel and accommodation expenses for attendance of the Technologies in Endovascular Aortic Repair conference, December 2015. Funding was directly from the conference organisers and enabled an oral presentation of a previous iteration of this review. No other declarations of interest are known SEY: none known MC: none known

Figures

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Study flow diagram
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Risk of bias summary: review authors' judgements about each risk of bias item for each included study
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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Update of

References

References to studies included in this review

Nelson 2014 {published data only}
    1. Krajcer Z, Matos JM. Totally percutaneous endovascular abdominal aortic aneurysm repair: 30‐day results from the independent access‐site closure study of the PEVAR trial. Texas Heart Institute Journal 2013;40(5):560‐1. - PMC - PubMed
    1. Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, et al. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). Journal of Vascular Surgery May 2014;59(5):1181‐93. - PubMed
Torsello 2003 {published data only}
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References to studies excluded from this review

Hattab 2012 {published data only}
    1. Hattab M, Hakim M, Carreira VB, Elhadad S. TCT‐393 A randomized trial comparing two vascular closure devices: PROGLIDE and the novel EXOSEAL after percutaneous femoral procedures. Journal of the American College of Cardiology 2012;60(17_S):B112.
Ichihashi 2016 {published data only}
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Jean‐Baptiste 2008 {published data only}
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Krajcer 2010 {published data only}
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Xiong 2012 {published data only}
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References to ongoing studies

NCT02822560 {published data only}
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Vierhout 2015 {published data only}
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