Short-frame, self-expanding, fully recapturable transcatheter aortic valve replacement device in pure aortic...

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.

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.

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.

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.