Editor's Choice - Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials

Abstract

Objective: To investigate whether a percutaneous approach has better clinical outcomes than surgical access for standard endovascular repair of abdominal aortic aneurysms.

Data sources: MEDLINE and Embase were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence.

Review methods: Randomised controlled trials (RCTs) that compared percutaneous and cutdown endovascular aneurysm repair (EVAR) were considered. Pooled effect estimates were calculated using the odds ratio (OR), risk difference, or mean difference (MD) and 95% confidence interval (CI). The Mantel-Haenszel or inverse variance statistical method was used as appropriate. Trial sequential analysis was performed to quantify the available evidence and control for the risk of type 1 and type 2 error. Risk of bias was assessed with the revised tool developed by Cochrane and the quality of evidence was graded using the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation).

Results: Four RCTs were identified, reporting a total of 368 patients and 530 access sites. Meta-analysis showed no difference in access site complications or infection, post-operative bleeding/haematoma, access related arterial injury, femoral artery occlusion, pseudo-aneurysm, or peri-operative mortality between percutaneous and cutdown EVAR. Seroma/lymphorrhoea was significantly less frequent after percutaneous EVAR (0%) compared with cutdown EVAR (3%; OR 0.18 [95% CI 0.04-0.83]) and the procedure time was significantly shorter (MD -11.53 minutes; 95% CI -15.71-7.34), but hospital length of stay was not different between treatments. Neither the O'Brien-Fleming boundaries nor the futility boundaries were crossed by the cumulative Z curve, and the required information size was not reached for any of the outcomes. All trials were judged to be high risk of bias or have some concerns, and the level of the body of evidence was low or very low for all outcomes.

Conclusion: The evidence is very uncertain about the effect of percutaneous EVAR on clinically important outcomes.

Keywords: Aortic aneurysm; EVAR; Endovascular aneurysm repair; Percutaneous.