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This investigation received a nonconditioned grant from Products & Features for the TRICUS/TRICUS EURO study. Drs Amat-Santos, Cruz-Gonzalez, Sanchez-Recalde, Briedis, and Abdul-Jawad Altisent have served as consultants and proctors for Products & Features. Dr Estevez-Loureiro has served as a proctor for Abbott Vascular. Dr Puri has served as a consultant for Products & Features and V -Dyne.

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

Publicated to:Jacc-Cardiovascular Interventions. 17 (1): 60-72 - 2024-01-08 17(1), DOI: 10.1016/j.jcin.2023.10.043

Authors: Blasco-Turrion, Sara; Briedis, Kasparas; Estevez-Loureiro, Rodrigo; Sanchez-Recalde, Angel; Cruz-Gonzalez, Ignacio; Pascual, Isaac; Mascherbauer, Julia; Altisent, Omar Abdul-Jawad; Nombela-Franco, Luis; Pan, Manuel; Trillo, Ramiro; Moreno, Raul; Delle Karth, Georg; Sanchez-Luna, Juan Pablo; Gonzalez-Gutierrez, Jose Carlos; Revilla-Orodoea, Ana; Zamorano, Jose Luis; Gomez-Salvador, Itziar; Puri, Rishi; Roman, J Alberto San; Amat-Santos, Ignacio J

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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 (R) 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 walktest. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was29.5%. 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 incongestive symptoms, N-terminal pro-B-type natriuretic peptide levels (P 1/40.032), 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. (TRICUS Study - Safety and Efficacy of the TricValve (R) Device; NCT03723239) (J Am Coll Cardiol Intv 2024;17:60-72) (c) 2024 by the American College of Cardiology Foundation.

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