Valvular & structural heart diseaseCohort study
Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation
- Single-arm prospective study
- core laboratory selection
- data and safety monitoring board
- clinical events committee adjudication
Authors' conclusion
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.
Study context
- Population
- Patients with severe functional tricuspid regurgitation (TR) (grade ≥4) resistant to medical management
- Participants
- 96 patients
Main finding
As reported in the abstract
Implantation success and TR reduction · 1 year
Implantation success rate
97.9%
TR decreased by ≥1 grade
94.2%
TR decreased by ≥2 grades
87.2%
Observational data: associations, not effects.
Further findings
Clinical outcomes · 1 year
- All-cause mortality
- 5.2%
- Composite major adverse event rate
- 19.8%
- Survival (Kaplan-Meier)
- 94.7% ± 2.3%
- Freedom from HF rehospitalization (Kaplan-Meier)
- 90.4% ± 3.0%
- No device-related reinterventions
Functional status and quality of life · 1 year
- NYHA class significantly improved
- P < 0.001
- NYHA class I or II
- 97.7%
- 6-minute walk distance improvement
- 42.8 m (P < 0.001)
- KCCQ score increase
- 7.0 points (P < 0.001)
Original publication
Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation. JACC Cardiovasc Interv. Published 9 December 2024. doi:10.1016/j.jcin.2024.10.007
Summarised from the published abstract; every number is checked against it