6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study
Rodrigo Estévez-Loureiro, Angel Sánchez-Recalde, Ignacio J Amat-Santos, Ignacio Cruz-González, Jose A Baz, Isaac Pascual, Julia Mascherbauer, Omar Abdul-Jawad Altisent, Luis Nombela-Franco, Manuel Pan, Ramiro Trillo, Raul Moreno, Georg Delle Karth, Luisa Salido-Tahoces, Sandra Santos-Martinez, Jean C Núñez, Cesar Moris, Georg Goliasch, Pilar Jimenez-Quevedo, Soledad Ojeda, Belén Cid-Álvarez, Evelyn Santiago-Vacas, Santiago Jimenez-Valero, Ana Serrador, Javier Martín-Moreiras, Andreas Strouhal, Christian Hengstenberg, Jose Luis Zamorano, Rishi Puri, Andrés Íñiguez-Romo, Rodrigo Estévez-Loureiro, Angel Sánchez-Recalde, Ignacio J Amat-Santos, Ignacio Cruz-González, Jose A Baz, Isaac Pascual, Julia Mascherbauer, Omar Abdul-Jawad Altisent, Luis Nombela-Franco, Manuel Pan, Ramiro Trillo, Raul Moreno, Georg Delle Karth, Luisa Salido-Tahoces, Sandra Santos-Martinez, Jean C Núñez, Cesar Moris, Georg Goliasch, Pilar Jimenez-Quevedo, Soledad Ojeda, Belén Cid-Álvarez, Evelyn Santiago-Vacas, Santiago Jimenez-Valero, Ana Serrador, Javier Martín-Moreiras, Andreas Strouhal, Christian Hengstenberg, Jose Luis Zamorano, Rishi Puri, Andrés Íñiguez-Romo
Abstract
Background: Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients are often deemed to be at high surgical risk. Heterotopic bicaval stenting is an emerging, attractive transcatheter solution for these patients.
Objectives: The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava.
Methods: TRICUS EURO (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) is a nonblinded, nonrandomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 and February 2021. High-risk individuals with severe symptomatic TR despite optimal medical therapy were included. The primary endpoint was quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire score and New York Heart Association (NYHA) functional class improvement at 6-month follow-up.
Results: Thirty-five patients (mean age 76 ± 6.8 years, 83% women) were treated using the TricValve system. All patients at baseline were in NYHA functional class III or IV. At 30 days, procedural success was 94%, with no procedural deaths or conversions to surgery. A significant increase in QOL at 6 months follow-up was observed (baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores 42.01 ± 22.3 and 59.7 ± 23.6, respectively; P = 0.004), correlating with a significant improvement in NYHA functional class, with 79.4% of patients noted to be in functional class I or II at 6 months (P = 0.0006). The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively.
Conclusions: The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and functional classification at 6 months follow-up.
Keywords: CAVI; right heart failure; tricuspid regurgitation.
Conflict of interest statement
Funding Support and Author Disclosures Dr Estévez-Loureiro has received speaker fees from Products and Features. Dr Puri serves as a consultant to Products and Features and V-Dyne. Drs Sánchez-Recalde, Amat-Santos, Cruz-González, and Altisent have received proctor and speaker fees from Products and Features. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed