Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation.

BACKGROUND

Conservative treatments for tricuspid regurgitation (TR) frequently yield suboptimal outcomes. Transcatheter interventions provide a new therapeutic avenue, with ongoing assessments of safety and effectiveness.

OBJECTIVES

The TriStar (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System) study investigated 1-year outcomes of the K-Clip transcatheter tricuspid annuloplasty system in treating patients with severe functional TR.

METHODS

Patients with TR grade ≥4, resistant to medical management, were enrolled and selected by core laboratory evaluation. Oversight by a data and safety monitoring board and event adjudication by a clinical events committee occurred. Assessments at 30 days, 6 months, and 1 year included echocardiographic data, clinical symptoms, quality of life, study endpoints, and major adverse events.

RESULTS

A total of 96 patients (mean age 72.6 years, 59.4% women) were included, with a 97.9% implantation success rate. One-year outcomes showed 5.2% all-cause mortality, a 19.8% composite major adverse event rate, and no device-related reinterventions. TR decreased by ≥1 grade in 94.2%, and by ≥2 grades in 87.2% of patients. Kaplan-Meier estimates demonstrated 94.7% ± 2.3% survival and 90.4% ± 3.0% freedom from heart failure rehospitalization. NYHA functional class significantly improved (P < 0.001), with 97.7% reaching functional class I or II. The 6-minute walk distance improved by 42.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score increased by 7.0 points (P < 0.001).

CONCLUSIONS

The K-Clip transcatheter tricuspid annuloplasty system showed high procedural success, a favorable safety profile, sustained TR reduction, and marked improvements in clinical outcomes and quality of life at 1 year. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System [TriStar]; NCT05173233).