Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair.

OBJECTIVE

The objective of this study was to evaluate the performance of percutaneous femoral access with large-bore sheaths (>21F outer diameter) mainly employed for thoracic and thoracoabdominal aortic endovascular treatment and to stratify the outcomes on the basis of the introducer size.

METHODS

Between December 2015 and December 2018, all consecutive patients who received endovascular repair through a percutaneous approach with a suture-mediated vascular closure device (VCD) and the preclose technique were included in a retrospective single-center study called Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO). The morphologic characteristics of the access vessels and patients' demographics were recorded, and 30-day closure success was defined as the primary end point. Analysis of the closure success comparing large-bore sheaths vs small-bore sheaths (≤21F outer diameter) was performed after 1:1 propensity score matching of preoperative confounding variables.

RESULTS

The closure success rate of the entire study cohort was 94% (622 femoral accesses in 360 patients; median age, 74 years; 84% male). Univariate analysis identified eight different factors associated with failure, but only two remained significant on multivariate analysis: diabetes (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.2; P = .011) and common femoral artery stenosis >50% (OR, 4.5; 95% CI, 1.3-13.7; P = .019). After propensity score matching (1:1, 172 femoral accesses per group), closure success rate was not significantly different between large-bore and small-bore sheaths (90.7% vs 93.0%; P = .43). Multivariate analysis of the large-sheath group identified two factors associated with failure: small (<9 mm) femoral arteries (OR, 6.9; 95% CI, 1.5-31.6; P = .13) and access vessel calcifications involving more than one-third of the circumference (OR, 7.9; 95% CI, 2.1-29.4; P = .002). Neither previous femoral cutdown (44 accesses [23%]) nor percutaneous closure with VCDs (38 accesses [20%]) affected the closure success rate in the large-sheath group. Closure failure did not significantly increase the need for postoperative blood transfusions or hospital length of stay.

CONCLUSIONS

Off-label use of VCDs and the preclose technique for percutaneous approach with large-bore sheaths needed for complex aortic endovascular procedures is safe and feasible. Closure success rate is not significantly different from that obtained with on-label application of VCDs with smaller sheaths.