IFT01 - Safety and effectiveness of single Prostyle™ vascular preclose technique in patients undergoing endovascular procedures: a single center prospective study

Objectives: The Perclose ProStyle™ Suture Mediated Closing System (Abbott Vascular Inc, United States) is indicated for closing common femoral artery percutaneous accesses site of patients who have undergone diagnostic or interventional catheterization procedures. Instructions for use of the device indicates that at least two devices and the pre-close technique are required for arterial sheath sizes greater than 8 Fr. Our clinical experience suggest that a single ProStyle™ pre-implantation could safely close a percutaneous access till 16 Fr.
The aim of this study is to analyze the efficacy of using a single ProStyle™ in closing access sites with sheath diameters greater than 8 Fr up to 16 Fr, in patients undergoing endovascular procedures

Methods: A prospective study was performed in our University Hospital center and 57 patients from January 2023 to December 2023 were enrolled. Anatomical characteristics of the accesses were collected and carefully analyzed.
Every patient underwent ultrasound guided percutaneous femoral access with a single ProStyle™ pre-implanted positioning and an ultrasound control was performed at the end of each procedure. A manual compression was performed until complete hemostasis, when needed. On the 1st post-operative day, Duplex ultrasound was performed to assess the presence of any access-related complication.
The primary endpoint was the technical success, defined as the correct implantation of the device and the absence of open surgical conversion. Secondary endpoint was the clinical success, defined as the absence of bleeding, pseudoaneurysms, and arteriovenous fistulas in the postoperative period

Results: We performed 82 single ProStyle™ vascular pre-close closure in 57 patients undergoing endovascular procedures including EVAR, TEVAR, iliac branch, for access sites with sheath diameters greater up to 16 Fr. Technical success was achieved in all cases, in absence of open surgical conversion (100%). Nineteen accesses required manual compression with an average time of 2 minutes (Range: 0-10 minutes) for complete hemostasis (23%). Clinical success was achieved in all cases (100%): no bleedings, pseudoaneurysms, arteriovenous fistulas were found on color doppler ultrasound examination in the immediate post-operative and at the 1st post-operative day control

Conclusions: The first results of this study, still at the enrollment phase, demonstrate the efficacy and safety of using a Single ProStyle™ vascular pre-close technique in the closure of vascular accesses up to 16 Fr. Using a single closure system can lower the cost of endovascular procedures, and allow even small, less affluent centers to utilize this device, making this type of intervention faster and less expensive