A new Percutaneous technique for effective vascular Access Site closure in patients undergoing Transfemoral aortic valve implantation and thoraco-abdominal aortic aneurysm rEpair: the PASTE study

Aims: The success of transfemoral transcatheter aortic valve implantation (TAVI) and thoraco-abdominal aneurysm repair (TAAR) depends on haemostatic control of the access site, which is usually obtained with suture-based closure devices (Prostar or two ProGlide). A single ProGlide/Glubran technique, involving a suture placement on the vessel wall followed by tissue glue injection around the vessel wall, has not been previously investigated in this clinical setting. Our aim was to study the feasibility and safety of a single ProGlide/Glubran technique for vascular access-site closure after transfemoral TAVI and TAAR. Methods and results: This technique was used in 250 patients from 2012 to 2017. The primary endpoint was the success of the technique, defined as access-site haemostasis without complications and not requiring any additional intervention within 30 days of the index procedure. Patients had a mean age of 82.4 +/- 1.93 years, with a logistic EuroSCORE of 20.2 +/- 2.32. A total of 218 TAVI and 32 TAAR procedures were performed with a mean sheath size of 18.09 +/- 1.55 Fr. The mean sheath to femoral artery ratio was 1.04 +/- 0.16, with mean femoral artery minimal lumen diameter 6.65 +/- 0.64 mm. The overall success rate of this technique was 98.4%. Four patients (1.6%) developed critical stenosis of the femoral artery requiring balloon dilatation. No major VARC-2 vascular complications were observed. Thirty-day mortality was 0.4% (non-cardiovascular). Conclusions: The results of this study suggest that the single ProGlide/Glubran technique is a safe and effective method of closing the arterial access site after transfemoral TAVI and TAAR. The results of our study need to be confirmed in a randomised controlled trial before being adopted in routine clinical practice.