THE K-CLIP transcatheter tricuspid annuloplasty system has demonstrated high success rates, significant reduction in tricuspid regurgitation (TR), and marked improvements in clinical outcomes and quality of life at one year in patients with severe functional TR.
The TriStar study aimed to evaluate the mid-term outcomes of the K-Clip transcatheter tricuspid annuloplasty system in patients with severe functional TR who were resistant to medical management. In this confirmatory clinical trial, 96 patients (mean age 72.6 years; 59.4% women) with TR grade ≥4 were selected based on core laboratory assessments. The study was conducted under strict oversight, with endpoints and safety events adjudicated by an independent clinical committee.
The procedure achieved a 97.9% implantation success rate, and patients were assessed at 30 days, 6 months, and 1 year for echocardiographic changes, functional status, and quality of life measures. At one year, TR reduction of at least one grade was achieved in 94.2% of patients, with 87.2% experiencing a decrease of two or more grades. Kaplan-Meier estimates demonstrated 94.7% survival and 90.4% freedom from heart failure rehospitalisation. The 6-minute walk distance improved by 42.8 metres, while the Kansas City Cardiomyopathy Questionnaire score increased by 7.0 points (both P < 0.001). Importantly, 97.7% of patients reached NYHA functional class I or II, reflecting significant symptomatic improvement. The composite major adverse event rate was 19.8%, with no device-related reinterventions and all-cause mortality reported at 5.2%.
These findings indicate that the K-Clip system is a safe and effective transcatheter intervention for patients with severe functional TR, delivering sustained reductions in TR and improving functional capacity, symptoms, and quality of life over one year. The high procedural success and encouraging safety profile underscore the system’s potential role in clinical practice as an alternative for patients unsuitable for surgical intervention. Future considerations include longer-term studies to evaluate durability and further comparisons with alternative transcatheter and surgical therapies.
Katrina Thornber, EMJ
Reference
Xu H et al. Mid-term outcomes of K-Clip transcatheter tricuspid annuloplasty system in patients with severe functional tricuspid regurgitation. Cardiovascular Interventions. 2024;17(23):2796-807.
