6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study.

Autor:	Estévez-Loureiro R; Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain. Electronic address: roiestevez@hotmail.com., Sánchez-Recalde A; Hospital Universitario Ramon y Cajal, CIBERCV, Madrid, Spain., Amat-Santos IJ; CIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Cruz-González I; Hospital Clinico Universitario de Salamanca, CIBERCV, IBSAL, Salamanca, Spain., Baz JA; Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain., Pascual I; Hospital Universitario Central de Asturias, Oviedo, Spain., Mascherbauer J; Division of Cardiology, Department for Internal Medicine II, Medical University of Vienna, Vienna, Austria., Abdul-Jawad Altisent O; Hospital Universitario Germans Trias i Pujol, Barcelona, Spain., Nombela-Franco L; Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain., Pan M; Hospital Universitario Reina Sofia, Córdoba, Spain., Trillo R; Hospital Clinico Universitario de Santiago de Compostela, CIBERCV, Santiago, Spain., Moreno R; Hospital Universitario La Paz, Madrid, Spain., Delle Karth G; Hospital Floridsdorf, Vienna, Austria., Salido-Tahoces L; Hospital Universitario Ramon y Cajal, CIBERCV, Madrid, Spain., Santos-Martinez S; CIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Núñez JC; Hospital Clinico Universitario de Salamanca, CIBERCV, IBSAL, Salamanca, Spain., Moris C; Hospital Universitario Central de Asturias, Oviedo, Spain., Goliasch G; Division of Cardiology, Department for Internal Medicine II, Medical University of Vienna, Vienna, Austria., Jimenez-Quevedo P; Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain., Ojeda S; Hospital Universitario Reina Sofia, Córdoba, Spain., Cid-Álvarez B; Hospital Clinico Universitario de Santiago de Compostela, CIBERCV, Santiago, Spain., Santiago-Vacas E; Hospital Universitario Germans Trias i Pujol, Barcelona, Spain., Jimenez-Valero S; Hospital Universitario La Paz, Madrid, Spain., Serrador A; CIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Martín-Moreiras J; Hospital Clinico Universitario de Salamanca, CIBERCV, IBSAL, Salamanca, Spain., Strouhal A; Hospital Floridsdorf, Vienna, Austria., Hengstenberg C; Division of Cardiology, Department for Internal Medicine II, Medical University of Vienna, Vienna, Austria., Zamorano JL; Hospital Universitario Ramon y Cajal, CIBERCV, Madrid, Spain., Puri R; Cleveland Clinic, Cleveland, Ohio, USA., Íñiguez-Romo A; Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain.
Jazyk:	angličtina
Zdroj:	JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2022 Jul 11; Vol. 15 (13), pp. 1366-1377. Date of Electronic Publication: 2022 May 17.
DOI:	10.1016/j.jcin.2022.05.022
Abstrakt:	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. Competing Interests: 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.)
Databáze:	MEDLINE
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