What question did this study set out to answer?

Explore two-year clinical outcomes of the VitaFlow Liberty transcatheter aortic valve system in high-surgical-risk patients with severe aortic stenosis.

June 16, 2026Open Access

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

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Severe aortic stenosis (n=163). Intervention: VitaFlow LibertyTM transcatheter aortic valve system vs. Objective Performance Goal. Primary outcome: 1-year all-cause mortality.

SCS S ChenSun Yat-sen University ZZZhi ZhanBial (Portugal)DCDandan ChenSun Yat-sen University

Key Result

Transcatheter aortic valve replacement with the VitaFlow Liberty system in high-surgical-risk patients with severe aortic stenosis resulted in a 1-year all-cause mortality of 6.1%, successfully meeting the prespecified performance goal of less than 27%.

Key Points

Explore two-year clinical outcomes of the VitaFlow Liberty transcatheter aortic valve system in high-surgical-risk patients with severe aortic stenosis.
Prospective, multicenter, single-arm study conducted at 22 Chinese sites
Follow-up evaluations at 30 days, 6 months, 1 year, and annually through 5 years
Primary endpoint assessed was 1-year all-cause mortality.
All-cause mortality at 2 years was 13.5%
Incidence of any stroke was 7.6%
New permanent pacemaker implantation was required in 19.5% with improved mean aortic valve gradient and effective orifice area.

Study Design

Type

Cohort (n=163)

Blinding

Open-label

Multicenter

Yes

Structured PICO

Population

163 high-surgical-risk patients older than 70 years with symptomatic severe aortic stenosis who underwent transcatheter aortic valve replacement and were followed for 2 years.

Intervention

Transcatheter aortic valve replacement (TAVR) with the VitaFlow Liberty system (bovine-pericardial supra-annular self-expanding valve mounted on a nitinol frame with a retrievable delivery catheter)

Outcome

Cumulative all-cause mortality at 1 yearhard clinical

TAVR with the VitaFlow Liberty system demonstrated favorable 2-year safety, efficacy, and sustained hemodynamic performance in high-surgical-risk patients with severe aortic stenosis, including a high proportion with bicuspid anatomy.

Main Result

Absolute Event Rate: 6.1% vs 27%

Limitations

Single-arm design precludes direct comparison with surgery or with other TAVR devices.
2-year follow-up remains insufficient to fully assess long-term durability.
Not all later VARC-3-style long-term composite elements were prospectively captured across all centers.
Complete baseline conduction-subgroup data, uniform electrophysiological testing, and cohort-wide standardized implantation-depth measurements were not available.
The trial was not designed or powered for a formal center-level comparison of procedural or clinical outcomes.

Abstract

Mid-term clinical evidence for the VitaFlow LibertyTM transcatheter aortic valve system in anatomically complex populations is limited. 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. 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 cm 2 to 2.00 ± 0.51 cm 2 . Moderate paravalvular leak was present in 4.5% of patients at 2 years. TAVR with the VitaFlow LibertyTM system demonstrated favorable 2-year safety and efficacy in a challenging population, with sustained hemodynamic performance. NCT04414878.

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