Evidence map›Paper›PMID 40028730›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2025

Transcatheter annuloplasty with the K-Clip system for tricuspid regurgitation: one-year results from the TriStar study.

Xiaochun Zhang, Qinchun Jin, Wei Li, Cuizhen Pan, Kefang Guo, Xue Yang, Weidong Li, Guangyuan Song, Jiangfang Luo, Jie Li and 9 more

Abstract readClinical StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
  6. Tricuspid annuloplasty: a piece of the puzzle or the whole picture?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Xiaochun ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Qinchun JinDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Wei LiDepartment of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Disease, Shanghai Institute of Medical Imaging, Shanghai, China.
Cuizhen PanDepartment of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Disease, Shanghai Institute of Medical Imaging, Shanghai, China.
Kefang GuoDepartment of Anaesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Xue YangDepartment of Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Weidong LiDepartment of Cardiovascular Surgery, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Guangyuan SongInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Jiangfang LuoGuangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Jie LiGuangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Xianbao LiuDepartment of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Shasha ChenDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Lei ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Dandan ChenDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Shiqiang HouDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Juying QianDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Jianan WangDepartment of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Daxin ZhouDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Junbo GeDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the fact that morbidity and mortality rates significantly increase with tricuspid regurgitation (TR) severity, limited treatment options are available for treating severe TR.

aimsThe single-arm, multicentre, prospective Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System (TriStar) evaluated the 1-year outcomes of the novel transcatheter K-Clip annuloplasty system in treating secondary TR.

methodsBetween May 2022 and October 2022, patients with ≥severe secondary TR despite optimal medical therapy at 11 centres in China were deemed candidates for transcatheter tricuspid repair by the local Heart Team and a multidisciplinary screening committee. Echocardiographic parameters, clinical and quality-of-life measures, and major adverse events were collected at 1 year.

resultsNinety-six patients were enrolled (mean age 72.6±7.0 years, 60.4% female, mean TRI-SCORE 5.4±2.1). The technical success rate was 97.9%. At 1 year, echocardiographic follow-up showed an average reduction in the annular septolateral diameter of 11.3% (41.9 mm vs 37.1 mm; p<0.01), compared with baseline, with marked right ventricular remodelling. A total of 82.5% of patients had ≤moderate TR, and 97.7% had a ≥1 grade reduction. Patients experienced significant clinical improvements in New York Heart Association Functional Class I/II (32.6% to 96.5%; p<0.001), the 6-minute walk distance increased by 31.9±71.8 m (p<0.001), and the overall Kansas City Cardiomyopathy Questionnaire score increased by 7.6±17.7 points (p<0.001). Neither cardiovascular death nor reintervention were recorded at the 30-day or 1-year follow-up, while severe bleeding requiring further treatment was noted in 5 patients at 1 year. The Kaplan-Meier estimates of survival and freedom from heart failure rehospitalisation were 97.8% and 95.1%, respectively, at 1 year.

conclusionsThe 1-year experience using the K-Clip tricuspid annuloplasty system demonstrated high survival and low rehospitalisation rates with durable TR reduction and clinical benefits in functional status and quality-of-life outcomes.

Indexed as

Cardiac CatheterizationCardiac Valve AnnuloplastyHeart Valve Prosthesis ImplantationTricuspid ValveTricuspid Valve InsufficiencyAgedAged, 80 and overEchocardiographyFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeTreatment Outcome

Identifiers

PMID40028730
PMCPMC11849535

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.