ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. General Cardiovascular Medicine
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1598644
This article is part of the Research TopicTricuspid regurgitation - Time to assess more than the prognosisView all 6 articles
A Novel Transcatheter Tricuspid Annuloplasty for Severe Tricuspid Valve Regurgitation Via the K-ClipTM system: Early Experience in China
Provisionally accepted
Rongfeng Xu
Lijuan ChenXiaoli ZhangXiuxia DingZhen WangQitong LuXiaoguo Zhang
Jiandong Ding*
Genshan Ma*- Southeast University, Nanjing, China
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Background Patients who suffer from severe tricuspid regurgitation (TR) do not undergo standard care therapy because of the high surgical risk. As a result, safer and less invasive techniques are being sought after internationally. The objective of this study was to investigate the feasibility and safety of the K-Clip™ device, a novel interventional tricuspid annuloplasty system designed for transcatheter tricuspid repair that is positioned using ultrasound technology and fluoroscopy. Methods Four patients with severe symptomatic TR (3 with massive and 1 with torrential TR) and high surgical risk (STS score of 6.7 (5.6–11.1)) underwent tricuspid annular repair with the K-Clip™ device guided by echocardiography and fluoroscopy. Echocardiographic measurements (vena contracta width, regurgitant volume, effective regurgitant orifice area [EROA]), quality-of-life (QoL) measurements (NYHA functional class, Kansas City Cardiomyopathy Questionnaire score [KCCQ], and the 6-min walk test [6MWT]) were performed before the procedure and at the 30-day follow-up assessment. Results The K-Clip™ device was successfully implanted in all four patients (2 patients with 2 clips each and 2 patients with 1 clip each). No procedural or 30-day major adverse events occurred. The TR was reduced by at least 1 grade in all patients. EROA (0.93±0.40 mm2 VS 0.42±0.11 mm2, p<0.05), vena contracta width (17.95±8.19 mm VS 7.48±1.87 mm, p<0.05) and regurgitant volume (97.00±46.41 mL VS 43.50±17.13 mL, p<0.05) were obviously reduced at 30 days after the procedure. Significant improvements in the NYHA functional class, KCCQ score (37.58±6.48 VS 58.55±5.13, p < 0.01), and 6MWT (239.67±31.64 m VS 402.67± 41.53 m, p < 0.05) outcome were observed at the 30-day follow-up visit. Conclusions This report on the early experience of transcatheter tricuspid repair with the K-Clip™ in China revealed notable clinical improvement, acceptable safety, and high procedural success. Larger prospective trials with extended follow-up periods are required to validate these encouraging preliminary findings and to clarify the effects of the K-Clip™ on clinical outcomes.
Keywords: Tricuspid regurgitation, Tricuspid annuloplasty, Transcatheter tricuspid valve interventions, K-Clip, Transcatheter tricuspid repair
Received: 23 Mar 2025; Accepted: 15 Sep 2025.
Copyright: © 2025 Xu, Chen, Zhang, Ding, Wang, Lu, Zhang, Ding and Ma. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Jiandong Ding, dingjiandong@163.com
Genshan Ma, magenshan@hotmail.com
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