Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes

Sara Blasco-Turrión, Kasparas Briedis, Rodrigo Estévez-Loureiro, Angel Sánchez-Recalde, Ignacio Cruz-González, Isaac Pascual, Julia Mascherbauer, Omar Abdul-Jawad Altisent, Luis Nombela-Franco, Manuel Pan, Ramiro Trillo, Raul Moreno, Georg Delle Karth, Juan Pablo Sánchez-Luna, Jose Carlos Gonzalez-Gutiérrez, Ana Revilla-Orodoea, Jose Luis Zamorano, Itziar Gómez-Salvador, Rishi Puri, J Alberto San RománIgnacio J Amat-Santos*

*Corresponding author for this work

Research output: Journal article (peer-reviewed)Journal article

3 Citations (Scopus)

Abstract

Background: Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. Objectives: This study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. Methods: The TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. Results: Forty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro–B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. Conclusions: Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates.

Original languageEnglish
Pages (from-to)60-72
Number of pages13
JournalJACC: Cardiovascular Interventions
Volume17
Issue number1
Early online date13 Nov 2023
DOIs
Publication statusPublished - 08 Jan 2024

Keywords

  • TTVR
  • TricValve
  • tricuspid regurgitation
  • Severity of Illness Index
  • Heart Valve Prosthesis Implantation
  • Prospective Studies
  • Follow-Up Studies
  • Tricuspid Valve/diagnostic imaging
  • Humans
  • Tricuspid Valve Insufficiency/diagnostic imaging
  • Male
  • Treatment Outcome
  • Cardiac Catheterization
  • Aged, 80 and over
  • Quality of Life
  • Female
  • Aged

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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