30-Day Outcomes of a Controlled-Bending Delivery System for TAVR in Severe Aortic Stenosis

This report presents the first-in-human experience with a 3-dimensional controlled-bending, fully retrievable delivery system for transfemoral transcatheter aortic valve replacement in severe aortic stenosis with anatomical challenge. In a prospective single-center series (September-December 2023) of 6 high-risk patients (mean age: 68.0 ± 3.9 years, 84% bicuspid valve, all with complex features such as horizontal heart or dilated ascending aorta), the device success rate was 100%, implantation was coaxial (implantation depth difference: 2.32 ± 1.53 mm), and postprocedural paravalvular leak was none to trivial. Hemodynamics improved substantially (gradient decreased from 75.5 ± 12.3 to 7.9 ± 2.1 mm Hg, effective orifice area increased from 0.61 ± 0.15 to 2.26 ± 0.34 cm²; P < 0.001). There were no deaths or strokes at 30 days postprocedure, and all patients reached NYHA functional class I or II. These early results suggest that controlled-bending delivery may enhance the precision and safety of transcatheter aortic valve replacement in complex anatomy, particularly with respect to the bicuspid valve.