A novel transcatheter tricuspid annuloplasty for severe tricuspid valve regurgitation via the K-clip™ system: early experience in China

作者：Rongfeng Xu, Lijuan Chen, Xiaoli Zhang, Xiuxia Ding, Zhen Wang, Qitong Lu, Xiaoguo Zhang, Jiandong Ding, Genshan Ma · 发表于：Frontiers in Cardiovascular Medicine · 年份：2025 · DOI：10.3389/fcvm.2025.1598644 · 被引用次数：1 · 研究领域：Cardiac Valve Diseases and Treatments、Shoulder Injury and Treatment、Pulmonary Hypertension Research and Treatments

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 mm 2 VS 0.42 ± 0.11 mm 2 , 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 ± 46.4...