Mid- to long-term outcomes of covered balloon-expandable stent implantation for the management of vascular injuries in patients undergoing transfemoral transcatheter aortic valve implantation: the BE-SAFE Registry : for the RECOVER (REsults after percutaneous interventions with COVERed stents) Investigators.

Abstract

Background and aims: Vascular complications occur in a non-negligible proportion of transfemoral transcatheter aortic valve implantation (Tf-TAVI) procedures. There is only limited evidence regarding the efficacy and safety of covered balloon-expandable (CBE) stents in the management of Tf-TAVI related vascular complications. We aimed to investigate the efficacy and safety of CBE stent implantation to treat access-related vascular complications in patients undergoing Tf-TAVI.

Methods: The present retrospective analysis included patients undergoing CBE stent implantation following Tf-TAVI from April 2012 to January 2023 at our centre. The primary endpoint was technical success defined as successful device delivery and implantation at the intended location with angiographic confirmation of vessel patency and absence of residual bleeding. Clinical outcomes and color Doppler ultrasonography findings were evaluated at discharge, 30 days and longest available follow-up.

Results: Among 3331 Tf-TAVI procedures, 93 patients (2.8%) required covered stent implantation for the treatment of access related vascular complications. Technical success was achieved in 92 patients (98.9%). BeGraft and Atrium Advanta V12 CBE stents were implanted in 76 (81.7%) and 17 (18.3%) patients, respectively. Median clinical follow-up was 455 [304; 798] days, with both in-hospital and 30-days mortality equaling 4.3% and 1-year mortality 15.1%. Pre-discharge Doppler ultrasonography was performed in 98.9% patients, with normal findings in 79.8% and minor findings (such as pseudoaneurysm, non-flow-limiting dissection, arterio-venous fistula) in the remaining patients. Clinical follow-up was available in 96.2% patients; no cases of new-onset claudication, need for repeat surgical or transcatheter vascular interventions were recorded. Follow-up Doppler ultrasonography (54.4% patients) showed persistent patency and no signs of stent failure in all patients.

Conclusions: CBE stent implantation for the treatment of access site related vascular complications after Tf-TAVI is associated with excellent technical success rates, optimal short- to mid-term patency rates as well as satisfactory long-term clinical outcomes.