Valvular & structural heart diseaseCohort study
Bicaval TricValve Implantation in Patients With Severe Tricuspid Regurgitation
- Retrospective multicentre registry study
- consecutive patients
Authors' conclusion
In this highly comorbid population with severe TR, caval valve implantation using the TricValve system led to significant 1-year clinical improvement, with mortality rates aligned with baseline TRI-SCORE.
Study context
- Population
- Patients with severe tricuspid regurgitation treated with the TricValve system
- Participants
- 204 patients
- Outcome
- Efficacy and safety of the TricValve system
- Follow-up
- 1-year follow-up
Main finding
As reported in the abstract
Intraprocedural success
96.1%
Clinical success at 30 days
83%
NYHA class I or II, baseline vs follow-up (median 8.8 months)
19.8% vs 81.5% (P < 0.001)
HF hospitalisations, year preimplantation vs follow-up (events per 100 patient-years)
60.8 [95% CI: 50.5-73.1] vs 26.9 [95% CI: 19.1-37.8]; P < 0.001
Observational data: associations, not effects.
Further findings
NYHA class I or II, baseline vs follow-up · median 8.8 months (Q1-Q3: 1.5-12.3 months)
- NYHA class I or II at baseline vs follow-up
- 19.8% vs 81.5%, P < 0.001
HF hospitalizations, year preimplantation vs follow-up (events per 100 patient-years)
- Year preimplantation
- 60.8 [95% CI: 50.5-73.1]
- During follow-up
- 26.9 [95% CI: 19.1-37.8]
- P < 0.001
Inferior vena cava pressure and signs of right HF
- Significant IVC pressure reduction and marked decrease in signs of right HF
Mortality by TRI-SCORE · 1 year
- TRI-SCORE 0-3 points
- 6.7% [95% CI: 1.7%-24.6%]
- TRI-SCORE 4 or 5 points
- 23.4% [95% CI: 14.4%-36.7%]
- TRI-SCORE ≥6 points
- 28.8% [95% CI: 19.8%-40.8%]
- log-rank P = 0.020
Safety
Major adverse events · 1 year
- Major adverse event rate
- 19.1%
Original publication
Summarised from the published abstract; every number is checked against it