What question did this study set out to answer?

This trial aimed to assess the safety and effectiveness of transcatheter aortic valve replacement (TAVR) for severe aortic valve regurgitation.

May 8, 2026

Transapical transcatheter valve implantation for aortic regurgitation: a multicenter, prospective trial

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Severe pure aortic valve regurgitation (AR) or mixed severe aortic valve regurgitation and aortic valve stenosis (AR+AS) (n=142). Intervention: Transapical TAVR using Ken-Valve. Primary outcome: Technical success.

Key Result

Transapical TAVR using the Ken-Valve in high-risk patients with pure or mixed aortic regurgitation achieved 97.2% technical success and 5.6% all-cause mortality at 1 year.

Key Points

This trial aimed to assess the safety and effectiveness of transcatheter aortic valve replacement (TAVR) for severe aortic valve regurgitation.
Multicenter, prospective trial conducted from 2021 to 2022 with 142 symptomatic patients.
Patients with pure aortic regurgitation (AR) or mixed aortic regurgitation and stenosis (AR+AS) underwent transapical TAVR with Ken-Valve.
Follow-up included clinical outcomes and echocardiography data analysis up to 1 year post-procedure.
Technical success rate achieved was 97.2%.
30-day mortality was 2.1%, and 1-year all-cause mortality was 5.6%.
Significant improvements in clinical symptoms and quality of life were noted, with no significant differences in outcomes between AR and AR+AS patients.

Study Design

Type

Observational (n=142)

Multicenter

Yes

Structured PICO

Is transapical TAVR using a dedicated self-expandable bioprosthesis safe and effective in high-risk patients with severe pure or mixed aortic regurgitation?

Population

142 symptomatic patients with severe pure aortic valve regurgitation (AR, n=109) or mixed severe AR and aortic valve stenosis (AR+AS, n=33), mean age 70.3 ± 5.5 years, considered high-risk or inoperable (mean STS score 5.9 ± 3.0%, 99.3% NYHA class III/IV), across 15 hospitals in China.

Intervention

Transapical transcatheter aortic valve replacement (TAVR) using a self-expandable bioprosthesis (Ken-Valve)

Outcome

Safety and efficacy up to 1-year follow-up

Transapical TAVR using a dedicated self-expanding valve demonstrated high technical success and acceptable 1-year safety and efficacy in high-risk patients with severe aortic regurgitation.

Abstract

OBJECTIVES: We evaluated the safety and efficacy of transcatheter aortic valve replacement (TAVR) up to 1-year follow-up for patients with severe pure aortic valve regurgitation (AR) or mixed severe aortic valve regurgitation and aortic valve stenosis (AR+AS) using a novel self-expandable bioprosthesis. METHODS: From 2021 and 2022, transapical TAVR using Ken-Valve (Jenscare Biotechnology Ltd, Ningbo, China) was performed in 142 symptomatic patients (mean age 70.3 ± 5.5 years) with pure AR (n = 109) or AR+AS (n = 33) across 15 hospitals in China. All patients were considered high-risk or inoperable after heart team evaluation, with a mean Society of Thoracic Surgeons score of 5.9 ± 3.0%, and 99.3% in NHYA class III/IV. Procedural characteristic, echocardiography data and clinical outcomes up to 1 year were analyzed. RESULTS: Technical success was achieved in 97.2% of cases. Two (1.4%) patients were converted to open surgery due to unsuitable anatomy or valve migration during the procedure. New permanent pacemakers were implanted in 20(14.1%) patients. Three (2.1%) patients had stroke, and 3(2.1%) patients had major bleeding. 30-day mortality was 2.1%, and all-cause mortality at 1-year was 5.6% (8/142). Mean aortic valve gradient and effective orifice area (EOA) at 1 year postoperatively were 9.4 ± 5.4 mmHg and 1.9 ± 0.6cm2, respectively. Significant improvement in clinical symptoms, positive left ventricular remodelling, and quality-of-life were observed up to 1-year. There was no significant difference in mortality, complications, and haemodynamic performance between patients with pure AR and AR+AS at 1-year. CONCLUSIONS: TAVR using the Ken-Valve was safe and effective in patients with pure AR or mixed AR+AS in mid-term.Transapical transcatheter valve implantation for aortic regurgitation: a multicentre, prospective trial.

Bookmark