학술논문
Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes.
Document Type
Academic Journal
Author
Blasco-Turrión S; Hospital Clínico Universitario de Valladolid, Valladolid, Spain.; Briedis K; Kaunas Klinikos, Lithuanian University of Health Sciences, Kaunas, Lithuania.; Estévez-Loureiro R; Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain.; Sánchez-Recalde A; Hospital Universitario Ramon y Cajal, Madrid, Spain.; Cruz-González I; Instituto de Investigación Biomédica de Salamanca, Hospital Clínico Universitario de Salamanca, Salamanca, Spain.; Pascual I; Hospital Universitario Central de Asturias, Oviedo, Spain.; Mascherbauer J; Department of Cardiology, University Hospital Sankt Poelten, Karl Landsteiner University of Health Sciences, Krems, Austria.; Abdul-Jawad Altisent O; Hospital Universitario Germans Trias i Pujol, Barcelona, Spain.; Nombela-Franco L; Hospital Clínico Universitario San Carlos, Madrid, Spain.; Pan M; Hospital Universitario Reina Sofia, Córdoba, Spain.; Trillo R; Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Madrid, Spain.; Moreno R; Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario La Paz, Madrid, Spain.; Delle Karth G; Hospital Floridsdorf, Vienna, Austria.; Sánchez-Luna JP; Hospital Clínico Universitario de Valladolid, Valladolid, Spain.; Gonzalez-Gutiérrez JC; Hospital Clínico Universitario de Valladolid, Valladolid, Spain.; Revilla-Orodoea A; Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Madrid, Spain.; Zamorano JL; Hospital Universitario Ramon y Cajal, Madrid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Madrid, Spain.; Gómez-Salvador I; Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Madrid, Spain.; Puri R; Cleveland Clinic, Cleveland, Ohio, USA.; San Román JA; Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Madrid, Spain.; Amat-Santos IJ; Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Madrid, Spain. Electronic address: ijamat@gmail.com.
Source
Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE
Subject
Language
English
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. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).
Competing Interests: Funding Support and Author Disclosures This investigation received a nonconditioned grant from Products & Features for the TRICUS/TRICUS EURO study. Drs Amat-Santos, Cruz-Gonzalez, Sánchez-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.
(Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).
Competing Interests: Funding Support and Author Disclosures This investigation received a nonconditioned grant from Products & Features for the TRICUS/TRICUS EURO study. Drs Amat-Santos, Cruz-Gonzalez, Sánchez-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.
(Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)