Transaortic transcatheter aortic valve implantation: Results of the Polish arm of the ROUTE registry

Abstract

Background: Transaortic (TAo) transcatheter aortic valve implantation (TAVI) is an alter­native approach in patients considered to be at high risk for classical open surgery with poor peripheral vessel access. The purpose of this study was to determine the feasibility of using TAo access for TAVI procedures employing the Edwards SAPIEN transcatheter heart valve. The primary objective was to determine overall 30-day mortality.

Methods: A total of 32 patients with severe aortic valve stenosis underwent TAo-TAVI using Edwards SAPIEN bioprostheses. Postoperative results were collected according to the Registry of the Utilization Of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) study protocol. Complications were assessed using Valve Academic Research Consortium- 2 (VARC-2) criteria.

Results: The mean age of the population was 80.9 ± 5.2 years, with 53.1% being female. All patients received either the SAPIEN XT or the SAPIEN 3 bioprosthesis (Edwards Lifesciences). Device success was achieved in 100% of cases. One (3.25%) patient subsequently suffered an aortic dissection and required ascending aorta replacement. Paravalvular leakage was absent or mild in 26 (81%) patients, and moderate in 6 (19%) patients. Other complications included permanent pacemaker implantation in 2 (6.5%), and transient post operative delirium in 2 (6.5%) patients. The total hospital stay was 6.7 ± 2.4 days. New York Heart Association class decreased significantly on follow-up. Thirty-day mortality rate was 2 (6.5%) patients.

Conclusions: Use of TAo access for TAVI procedures has a reasonable clinical outcome and is a safe alternative to the transfemoral and transapical approaches, especially for patients with high-risk peripheral vessel access.