6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation The TRICUS EURO Study
Por:
Estevez-Loureiro, R, Sanchez-Recalde, A, Amat-Santos, IJ, Cruz-Gonzalez, I, Baz, JA, Pascual, I, Mascherbauer, J, Altisent, OAJ, Nombela-Franco, L, Pan, M, Trillo, R, Moreno, R, Delle Karth, G, Salido-Tahoces, L, Santos-Martinez, S, Nunez, JC, Moris, C, Goliasch, G, Jimenez-Quevedo, P, Ojeda, S, Cid-Alvarez, B, Santiago-Vacas, E, Jimenez-Valero, S, Serrador, A, Martin-Moreiras, J, Strouhal, A, Hengstenberg, C, Zamorano, JL, Puri, R and Iniguez-Romo, A
Publicada:
11 jul 2022
Ahead of Print:
1 jul 2022
Resumen:
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 (R) 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 dass 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. (C) 2022 by the American College of Cardiology Foundation.
Filiaciones:
Estevez-Loureiro, R:
Complejo Hosp Univ Alvaro Cunqueiro, Vigo, Spain
Sanchez-Recalde, A:
Hosp Univ Ramon y Cajal, CIBERCV, Madrid, Spain
Amat-Santos, IJ:
Hosp Clin Univ Valladolid, CIBERCV, Valladolid, Spain
Cruz-Gonzalez, I:
Hosp Clin Univ Salamanca, CIBERCV, IBSAL, Salamanca, Spain
Baz, JA:
Complejo Hosp Univ Alvaro Cunqueiro, Vigo, Spain
Pascual, I:
Hosp Univ Cent Asturias, Oviedo, Spain
Mascherbauer, J:
Med Univ Vienna, Dept Internal Med 2, Div Cardiol, Vienna, Austria
:
Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
Nombela-Franco, L:
Hosp Clin San Carlos, IdISSC, Cardiovasc Inst, Madrid, Spain
Pan, M:
Hosp Univ Reina Sofia, Cordoba, Spain
Trillo, R:
Hosp Clin Univ Santiago de Compostela, CIBERCV, Santiago, Spain
Moreno, R:
Hosp Univ La Paz, Madrid, Spain
Delle Karth, G:
Hosp Floridsdorf, Vienna, Austria
Salido-Tahoces, L:
Hosp Univ Ramon y Cajal, CIBERCV, Madrid, Spain
Santos-Martinez, S:
Hosp Clin Univ Valladolid, CIBERCV, Valladolid, Spain
Nunez, JC:
Hosp Clin Univ Salamanca, CIBERCV, IBSAL, Salamanca, Spain
Moris, C:
Hosp Univ Cent Asturias, Oviedo, Spain
Goliasch, G:
Med Univ Vienna, Dept Internal Med 2, Div Cardiol, Vienna, Austria
Jimenez-Quevedo, P:
Hosp Clin San Carlos, IdISSC, Cardiovasc Inst, Madrid, Spain
Ojeda, S:
Hosp Univ Reina Sofia, Cordoba, Spain
Cid-Alvarez, B:
Hosp Clin Univ Santiago de Compostela, CIBERCV, Santiago, Spain
:
Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
Jimenez-Valero, S:
Hosp Univ La Paz, Madrid, Spain
Serrador, A:
Hosp Clin Univ Valladolid, CIBERCV, Valladolid, Spain
Martin-Moreiras, J:
Hosp Clin Univ Salamanca, CIBERCV, IBSAL, Salamanca, Spain
Strouhal, A:
Hosp Floridsdorf, Vienna, Austria
Hengstenberg, C:
Med Univ Vienna, Dept Internal Med 2, Div Cardiol, Vienna, Austria
Zamorano, JL:
Hosp Univ Ramon y Cajal, CIBERCV, Madrid, Spain
Puri, R:
Cleveland Clin, Cleveland, OH 44106 USA
Iniguez-Romo, A:
Complejo Hosp Univ Alvaro Cunqueiro, Vigo, Spain
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