TY - JOUR
T1 - Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation
T2 - 1-Year Follow-Up Outcomes
AU - Blasco-Turrión, Sara
AU - Briedis, Kasparas
AU - Estévez-Loureiro, Rodrigo
AU - Sánchez-Recalde, Angel
AU - Cruz-González, Ignacio
AU - Pascual, Isaac
AU - Mascherbauer, Julia
AU - Abdul-Jawad Altisent, Omar
AU - Nombela-Franco, Luis
AU - Pan, Manuel
AU - Trillo, Ramiro
AU - Moreno, Raul
AU - Delle Karth, Georg
AU - Sánchez-Luna, Juan Pablo
AU - Gonzalez-Gutiérrez, Jose Carlos
AU - Revilla-Orodoea, Ana
AU - Zamorano, Jose Luis
AU - Gómez-Salvador, Itziar
AU - Puri, Rishi
AU - San Román, J Alberto
AU - Amat-Santos, Ignacio J
N1 - Publisher Copyright:
© 2024 American College of Cardiology Foundation
PY - 2024/1/8
Y1 - 2024/1/8
N2 - 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.
AB - 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.
KW - TTVR
KW - TricValve
KW - tricuspid regurgitation
KW - Severity of Illness Index
KW - Heart Valve Prosthesis Implantation
KW - Prospective Studies
KW - Follow-Up Studies
KW - Tricuspid Valve/diagnostic imaging
KW - Humans
KW - Tricuspid Valve Insufficiency/diagnostic imaging
KW - Male
KW - Treatment Outcome
KW - Cardiac Catheterization
KW - Aged, 80 and over
KW - Quality of Life
KW - Female
KW - Aged
UR - http://www.scopus.com/inward/record.url?scp=85181250075&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2023.10.043
DO - 10.1016/j.jcin.2023.10.043
M3 - Journal article
C2 - 38069986
SN - 1936-8798
VL - 17
SP - 60
EP - 72
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 1
ER -