European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery
August 1, 2026 Ā· via Europe PMC
Transapical Transcatheter Valve Implantation for Aortic Regurgitation: A Multicentre, Prospective Trial.
Xiao B, Li M, Liu L, +20 more, Guo Y.
AI summary ā for doctors, generated from the abstract only
In a multicentre prospective study, transapical TAVR using the Ken-Valve device was technically successful in the large majority of high-risk patients with aortic regurgitation, with acceptable safety and sustained symptom improvement through 1 year.
What was studied
A prospective study of 142 symptomatic, high-risk or inoperable patients (mean age 70.3 years) with pure aortic regurgitation (n=109) or mixed aortic regurgitation and stenosis (n=33) across 15 hospitals in China, treated with transapical transcatheter aortic valve replacement using the self-expandable Ken-Valve, with procedural, echocardiographic, and clinical outcomes followed to 1 year.
Key findings
- Technical success was achieved in 97.2% of cases; 2 patients (1.4%) were converted to open surgery, and new permanent pacemakers were implanted in 14.1% of patients.
- Thirty-day mortality was 2.1%, 1-year all-cause mortality was 5.6% (8/142), stroke occurred in 2.1%, and major bleeding in 2.1% of patients.
- At 1 year, mean aortic valve gradient was 9.4 mmHg and effective orifice area was 1.9 cm2, with significant improvement in clinical symptoms and quality of life, and no significant differences in outcomes between patients with pure aortic regurgitation versus mixed regurgitation and stenosis.
Clinical relevance
The findings suggest transapical TAVR with the Ken-Valve device may be a feasible and reasonably safe option for high-risk or inoperable patients with pure aortic regurgitation or mixed regurgitation/stenosis, a population with few approved transcatheter options, though this was a single-arm study without a comparator treatment.
Who should care
Limitations
This was a single-arm study without a surgical or alternative-device comparison group; follow-up was limited to 1 year, so longer-term valve durability is not yet known, and the population was specific to Chinese centers.
Transapical TAVR with the Ken-Valve device showed good 1-year safety and symptom improvement in high-risk patients with aortic regurgitation.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates ā verify against the original source before acting on it.
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 to 2022, transapical TAVR using Ken-Valve (Jenscare Biotechnology Ltd, Ningbo, China) was performed in 142 symptomatic patients (mean age 70.3āĀ±ā5.5 years) with pure AR (nā=ā109) or AR+AS (nā=ā33) 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 5.9āĀ±ā3.0%, and 99.3% in NYHA class III/IV. Procedural characteristics, echocardiography data, and clinical outcomes up to 1-year were analysed.
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. Thirty-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 9.4āĀ±ā5.4 mmHg and 1.9āĀ±ā0.6 cm2, 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.
Clinical registration number
NCT03788590.
DOI
10.1093/ejcts/ezag065
PMID
42087322
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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