Treffer: Evaluation of the Efficacy and Safety of a 3D Navigation-Guided Transcatheter Aortic Valve Implantation Technique in Patients With Severe Aortic Stenosis and a High Risk of Atrioventricular Conduction Disorders: Results of a Pilot Randomized Study.

Aim        To evaluate the efficacy and safety of a new 3D navigation-guided technique for transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS) and a high risk of atrioventricular (AV) conduction disorder.Material and methods    The study presents the results of a single-center prospective randomized pilot study. Sixty patients meeting inclusion and exclusion criteria with at least one criterion of a high risk for AV conduction disorder were enrolled in the study. All included patients were randomized 1:1 into two groups. In Group 1, TAVI was performed using a 3D navigation-guided technique, while in Group 2, the classical TAVI technique was used. The primary endpoint was the composite incidence of permanent pacemaker (PP) implantation and new-onset complete left bundle branch block (LBBB) at 6 months.Results  In the early postoperative period, the 3D navigation-guided TAVI group had a lower incidence of new-onset LBBB (10.3% vs. 33.3%; p=0.03), better parameters of intraventricular conduction according to electrophysiology study (EPS) (H-V interval 79.1±13.5 ms vs. 96.0±39.9 ms; p=0.03) and electrocardiography (QRS complex duration 108.0±16.3 ms vs. 119.0±22.6 ms; p=0.04). The incidence of PP implantation during the hospital stage, A-H interval duration, and Wenckebach point in the AV junction according to EPS did not differ significantly between the groups. The incidence of the primary endpoint (PP implantation + new-onset LBBB) during the 6-month follow-up period was 43.3% in the classical technique group and 16.7% in the 3D navigation-guided TAVI group (p=0.02). There were no statistically significant differences between the groups in the incidence of procedural complications or major adverse cardiovascular and cerebrovascular outcomes.Conclusion         This study demonstrated the efficacy and safety of a new 3D navigation-guided TAVI technique in reducing the composite rate of implantation PP and LBBB at 6 months post-procedure, with comparable rates of procedural complications and major adverse cardiac and cerebrovascular events (MACCE) during long-term follow-up. Implementation of these findings into clinical practice will enable personalization and optimization of transcatheter treatment outcomes in patients with severe AS.