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

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Device Technology

Background:

• The Perclose ProStyle™/ProGlide™ Suture-Mediated Closure and Repair (SMCR) System is indicated for common femoral artery (CFA) access closure post-percutaneous endovascular procedures.
• Current guidelines recommend at least two devices for arterial sheath sizes >8 French (F), utilizing a pre-close technique.
• Emerging clinical evidence suggests single-device pre-implantation may suffice for larger diameter closures.

Purpose of the Study:

• To evaluate the efficacy of a single pre-implanted ProStyle™/ProGlide™ device for closing CFA access sites.
• To assess outcomes in patients undergoing aortic endovascular procedures with large-bore sheaths (12-16 F).

Main Methods:

• A prospective study included 72 consecutive patients undergoing aortic endovascular surgery between December 2022 and June 2024.
• A single ProStyle™/ProGlide™ device was used for CFA access closure in all patients with 12-16 F sheaths.
• Technical success (no surgical conversion) and clinical success (absence of bleeding, pseudoaneurysms, AV fistulas) were primary and secondary endpoints, respectively.
• Results were compared to a historical cohort using two devices.

Main Results:

• 100% technical success was achieved, with no intraoperative open surgical conversions required.
• 98% clinical success rate observed, with only two minor bleeding events and one case of CFA dissection requiring surgical intervention.
• No statistically significant differences in technical or clinical success rates were found when compared to the two-device group.

Conclusions:

• Single ProStyle™/ProGlide™ pre-implantation is a safe and effective method for closing large vascular accesses (up to 16 Fr).
• This approach is associated with a low rate of complications, offering a viable alternative to current recommendations for specific patient populations.