Valvular & structural heart disease
Transcatheter annuloplasty with the K-Clip system for tricuspid regurgitation: one-year results from the TriStar study
Authors' conclusion
The 1-year experience using the K-Clip tricuspid annuloplasty system demonstrated high survival and low rehospitalisation rates with durable TR reduction and clinical benefits in functional status and quality-of-life outcomes.
Study context
- Population
- Patients with ≥severe secondary tricuspid regurgitation (TR) despite optimal medical therapy, deemed candidates for transcatheter tricuspid repair by the local Heart Team and a multidisciplinary screening committeepatients enrolled
- Participants
- 96 patients
- Exposure
- 1-year outcomes compared with baseline
- Outcome
- Technical success
Methodological details11 centres in China
- 11 centres in China
Main finding
As reported in the abstract
Technical success rate
97.9%
Observational data: associations, not effects.
Further findings
| Outcome | Average reduction | P value |
|---|---|---|
| Annular septolateral diameter · 1 year1 year vs baseline | 11.3% | P < 0.01 |
- Annular septolateral diameter: 41.9 mm vs 37.1 mm; with marked right ventricular remodelling
TR grade · 1 year
- ≤moderate TR
- 82.5%
- ≥1 grade reduction
- 97.7%
NYHA Functional Class I/II · 1 year
- NYHA I/II, baseline to 1 year
- 32.6% to 96.5%
- p<0.001
6-minute walk distance · 1 year
- Increase
- 31.9±71.8 m
- p<0.001
Overall Kansas City Cardiomyopathy Questionnaire score · 1 year
- Increase
- 7.6±17.7 points
- p<0.001
Survival and freedom from heart failure rehospitalisation (Kaplan-Meier estimates) · 1 year
- Survival
- 97.8%
- Freedom from heart failure rehospitalisation
- 95.1%
Safety
Cardiovascular death and reintervention · 30-day and 1-year follow-up
- Neither cardiovascular death nor reintervention recorded
Severe bleeding requiring further treatment · 1 year
- Patients with severe bleeding requiring further treatment
- 5
Original publication
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