Short-frame, self-expanding, fully recapturable transcatheter aortic valve replacement device in pure aortic regurgitation: Procedural performance and 30-day outcomes.

Abstract

Background: Achieving stable anchoring and effective sealing remains the principal limitation of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (PNAR). A short-frame, fully recapturable self-expanding valve may expand the procedural margin by enabling iterative repositioning and implantation depth optimisation in non-calcified anatomy.

Methods: We analysed 13 consecutive patients with symptomatic moderate-to-severe or severe PNAR who underwent transfemoral TAVR with the ScienCrown® (Lepu Medical, Beijing, China) system. The primary endpoint was technical success at exit from the procedure room according to VARC-3 criteria. Secondary endpoints included device success and early safety at 30 days.

Results: Technical success was achieved in all patients (13/13, 100%), and device success at 30 days was also achieved in all patients (13/13, 100%). The 30-day early safety endpoint was met in 12 patients (92.3%). The mean prosthesis size was 27.62 ± 1.26 mm, with a mean prosthesis diameter oversizing relative to the average annular diameter of 12.90 ± 3.54%; no balloon predilatation was performed. The mean number of deployment attempts was 1.62 ± 0.77. All procedures were completed without valve embolisation/migration, coronary obstruction, second-valve implantation, or emergency surgery. One patient (7.69%) developed complete atrioventricular block on postoperative day 3 and underwent permanent pacemaker implantation; no additional pacemaker implantations occurred through 30 days. Predischarge diffusion-weighted magnetic resonance imaging demonstrated no new acute cerebral infarction. At 30 days, there were no deaths, strokes or transient ischaemic attacks, myocardial infarction, life-threatening/major bleeding, major vascular complications, endocarditis, or valve-related reinterventions. Mean transvalvular gradients were 7.67 ± 5.20 mmHg, and all patients had improved or stable NYHA functional class with no moderate or severe residual aortic regurgitation.

Conclusions: In this exploratory single-centre series, transfemoral TAVR using a short-frame, fully recapturable self-expanding valve achieved 100% technical success and favourable early safety and haemodynamic performance in selected patients with PNAR. Prospective multicentre studies with longer follow-up and appropriate comparator groups are warranted.