Valvular & structural heart diseaseCohort study
Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation
- Prospective single-arm trial (pooled TRICUS and TRICUS EURO)
- nonblinded
- nonrandomized
- early-in-man
Authors' conclusion
Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates.
Study context
- Population
- NYHA class III or IV severe tricuspid regurgitation (TR), optimally medicated, ineligible for open heart surgery, with significant caval backflowcombined cohort
- Participants
- 44 participants
- Outcome
- Quality of life (QOL) metrics and functional status
- Follow-up
- 1 year
Main finding
As reported in the abstract
Clinical improvement achieved, n (%)
42 (95.5%)
Observational data: associations, not effects.
Further findings
Abolished hepatic vein backflow, persisting
- Patients with abolished, persisting hepatic vein backflow
- 63.8%
HF rehospitalization · 1 year
- HF rehospitalization rate
- 29.5%
Death · 1-year follow-up
- Deaths, n (%)
- 3 (6.8%)
- CV deaths
- 1
N-terminal pro-B-type natriuretic peptide levels
- Reduction in N-terminal pro-B-type natriuretic peptide levels
- P = 0.032
Safety
Stent fracture, conduction system disturbances, clinically significant leaflet thrombosis
- Not detected
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Summarised from the published abstract; every number is checked against it