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

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.