Safety and effectiveness of single ProStyle™/ProGlide™ for aortic endovascular procedures: single-style study

Background: The Perclose ProStyleTM/ProGlideTM Suture-Mediated Closure and Repair (SMCR) System is designed to close the common femoral artery (CFA) access during percutaneous endovascular procedures. Instructions for use (IFU) recommend the use of at least two devices, per single access, and the pre-close technique for arterial sheath sizes greater than 8 F. Besides, recent clinical studies suggest that a single ProStyleTM/ProGlideTM pre-implantation can safely close percutaneous access for larger diameters. Aim: The purpose of this study was to analyse the ef cacy of a single pre- implanted ProStyleTM/ProGlideTM in closing the Common Femoral Artery (CFA) access site in patients undergoing aortic endovascular procedures using sheaths with diameter 12 16 French (F). Methods: We performed a prospective study including 72 consecutive patients who underwent aortic endovascular surgery from December 2022 to June 2024 in our University Hospital. In this group, only a single pre-implanted ProStyleTM/ProGlideTM was used to close the access site in the CFA after using sheaths with diameters 12 16 F. The primary endpoint was technical success, de ned as the absence of intraoperative open surgical conversion. The secondary endpoint was clinical success, de ned as the absence of bleeding, pseudoaneurysms, and arteriovenous stulas in the peri and postoperative period. We compared the results of this group with a cohort of patients in whom two ProStyleTM/ProGlideTM were used to close the access site in the CFA. Result: Technical success was achieved in all cases (100%). Clinical success was achieved in 98% of cases. Only two minor bleedings occurred: one resulted in a small pseudoaneurysm, completely thrombosed 48 h after the procedure. One patient suffered from CFA dissection, requiring an open surgical endarterectomy. There were no statistically signi cant differences of clinical and technical success rates between the two groups. Conclusions: This study demonstrates that a Single ProStyleTM/ProGlideTM preimplantation can be safe and effective in the closure of vascular accesses up to 16 Fr, with a low complication rate.