A systematic literature review of the efficacy and safety of the Prostar XL device for the closure of large femoral arterial access sites in patients undergoing percutaneous endovascular aortic procedures

Abstract

Objectives: To identify and analyse existing evidence from published studies evaluating the efficacy and safety of a percutaneous vessel closure device for the closure of large arterial femoral arterial access sites (≥ 10 French).

Design: This study was a systematic literature review and meta-analysis.

Materials and methods: Electronic databases were searched for studies published on the evaluation of the Prostar XL vessel closure device. There was no restriction by study design or patient population. Appraisal of studies for inclusion and data extraction were performed independently by two reviewers. Meta-analysis was performed where feasible.

Results: Twenty-one studies were included, which reported data specifically for closure of large (≥ 10 Fr) femoral arterial access sites using the Prostar XL device. The Prostar XL device, used for closure of these large femoral artery access sites, had a high rate of procedural success equal to that reported for closure by femoral artery surgical cut-down. There was evidence for reduced procedural time, time to discharge and time to ambulation. Complication rates were lower, but not significantly so, with Prostar XL vs. surgical cut-down.

Conclusions: The Prostar XL is an effective and safe device for use in percutaneous closure of large (≥ 10 Fr) femoral artery access sites, comparable to open surgical femoral artery cut-down. Furthermore, it may reduce procedure times and hospitalisations, thereby leading to potential cost savings.