Two-year outcomes of transcatheter aortic valve replacement with the vitaflow libertyTM system in high-surgical-risk patients with severe aortic stenosis.

BACKGROUND

Mid-term clinical evidence for the VitaFlow LibertyTM transcatheter aortic valve system in anatomically complex populations is limited.

METHODS

This was a prospective, multicenter, single-arm Objective Performance Criteria study performed at 22 Chinese sites, with follow-up at 30 days, 6 months, 1 year, and annually through 5 years. The prespecified primary endpoint of the parent study was 1-year all-cause mortality. Other clinical events were adjudicated according to Valve Academic Research Consortium-2 definitions.

RESULTS

A total of 163 patients underwent transcatheter aortic valve replacement (TAVR) with the VitaFlow LibertyTM system. The mean age was 76.8 ± 5.0 years, 65.0% were male, the mean STS-PROM score was 7.87 ± 2.70, and 46.6% had bicuspid aortic valve anatomy. At 2 years, all-cause mortality was 13.5%, any stroke occurred in 7.6%, and new permanent pacemaker implantation was required in 19.5%. Mean aortic valve gradient improved from 59.22 ± 19.76 mmHg at baseline to 9.04 ± 6.07 mmHg at 2 years, and effective orifice area improved from 0.57 ± 0.21 cm2 to 2.00 ± 0.51 cm2. Moderate paravalvular leak was present in 4.5% of patients at 2 years.

CONCLUSIONS

TAVR with the VitaFlow LibertyTM system demonstrated favorable 2-year safety and efficacy in a challenging population, with sustained hemodynamic performance.

TRIAL REGISTRATION: NCT04414878.