Individuals with SAA often present sizing constraints and a higher risk of PPM during transcatheter valve implantation. This pooled early-feasibility evaluation assessed the 30-day clinical and hemodynamic performance of a balloon-expandable THV featuring a single-piece biomimetic leaflet design.

One hundred individuals were treated with the small-sized valve (mean age 77.0 ± 7.3 years; 78% female; mean Society of Thoracic Surgeons [STS] score 4.7 ± 4.0%). The mean computed tomography-derived annular area measured 404 ± 37 mm², with an average diameter of 22.7 ± 1.0 mm. Technical success was 93%, and device success at 30 days was 91%. No deaths occurred, and stroke was reported in 2%.

Echocardiographic assessment showed a mean transprosthetic gradient of 8.2 ± 3.1 mmHg and a mean effective orifice area of 2.2 ± 0.3 cm², with a Doppler velocity index of 0.60 ± 0.10. Moderate or greater PPM occurred in 3%. No cases exceeded mild paravalvular leak, and new permanent pacemaker implantation occurred in 6%.

These findings indicate encouraging short-term results in a challenging anatomical population. The low rate of PPM is notable given the restricted annular size in SAA. Long-term follow-up in larger cohorts will be critical to determine durability and late clinical outcomes.