Safeguard pressure assisted device for local femoral hemostasis in neuroendovascular procedures: A single center study of 879 patients.

BACKGROUND: Various vascular closure devices (VCDs) are available for local hemostasis after percutaneous transfemoral approach for neuroendovascular procedures but they have been associated with an increased complication rate and limitations to a re-puncture of the artery. We evaluated the safety and efficacy of Safeguard® 24 cm pressure assisted device (Merit Medical, West Jordan, UT, USA) and the associated complications. METHODS: From September 2016 to December 2019, 879 patients underwent neuroendovascular procedures via transfemoral approach using an introducer sheath ranging from 4 to 6-French and they were included in a prospective database. We registered the demographic characteristics and procedural factors. We evaluated the device failure and associated complications. RESULTS: The Safeguard® was successful in 862 cases (98.1 %) with post-procedural local bleeding in 17 patients (1.9%). On univariate analysis, an association with local bleeding was observed with age >60 years (Odds ratio [OR] = 3.2, P = 0.04) and the use of an introducer sheath >4 F ([OR] = 3.1, P = 0.007). Female gender, antithrombotic medication and type of procedure (diagnostic or interventional) were not associated with local bleeding. On binary logistic regression analysis, there was association only for age >60 years ([OR] = 3, P = 0.04). CONCLUSION: The Safeguard® 24 cm is safe and efficient. It is simple to use and it can be applied independently from vessel anatomic characteristics. It should though be used with caution in case of a femoral introducer sheath larger than 4 Fr and patients older than 60 years.