Our study was a single center, prospective registry in which consecutive patients, who underwent TAVI between January 1, 2017 and December 31, 2018, were included. All patients were scheduled for TAVI by the Heart Team based on clinical indications and following multidisciplinary evaluation. All procedures were performed by an interventional cardiologist and cardiac surgeon, acting as a team. The choice between PA and SA as well as the left or right femoral artery access was left to the operators’ discretion, based on a computed tomography (CT) and cardiologist’s and surgeon’s consensus. Images from CT were evaluated for optimal access type and puncture site in terms of calcifications distribution within femoral and iliac arteries as well as their anatomic course. Percutaneous access was obtained after cross-over angiography performed with a pigtail catheter, to determine the optimal puncture site with subsequent 6 Fr sheath introduction followed by two Proglides insertion and an 8 Fr sheath. Finally, a delivery sheath was inserted. In both groups, unfractionated heparin was administrated with control activated clotting time between 250–300 s. TAVI procedure was performed typically under analgosedation. For arterial closure, two Proglide devices with additional 8 Fr Angio-Seal were used in the PA group, after the administration of 50 mg protamine sulphate. Cross-over angiography was also performed at the end of the procedure to exclude bleeding. In the PA direct left ventricle wire pacing was the dominant method of pacing without access to venous system [13 (link), 14 (link)]. Surgical access for TAVI required a transverse exposure of the common femoral artery. The procedure was performed in local anesthesia. It began with a skin incision as small as possible to minimize the wound size and further complications. The surgeon exposed the artery with subsequent puncture of the artery and insertion of 6 Fr sheath, followed by an exchange for a delivery sheath over the stiff wire. For the closure of the femoral artery, a suture was used with a subsequent contralateral contrast safety injection. Additional contralateral arterial and/or venous access sites were also closed with 6 Fr Angio-Seal devices in both groups.
Baseline clinical and echocardiographic characteristics, together with frailty evaluation by the Canadian Study of Health and Aging scale (CSHA) and procedural data were assessed [15 (link)]. Peri- and postprocedural complications, including bleeding, were assessed according to The Valve Academic Research Consortium endpoint definitions (VARC-2) criteria [16 (link)]. Finally, clinical outcomes at 30 days were assessed. The study was approved by the institutional ethics board.