PMID- 35583363 OWN - NLM STAT- MEDLINE DCOM- 20220711 LR - 20220807 IS - 1876-7605 (Electronic) IS - 1936-8798 (Linking) VI - 15 IP - 13 DP - 2022 Jul 11 TI - 6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study. PG - 1366-1377 LID - S1936-8798(22)00948-7 [pii] LID - 10.1016/j.jcin.2022.05.022 [doi] AB - 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 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. CI - Copyright (c) 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Estevez-Loureiro, Rodrigo AU - Estevez-Loureiro R AD - Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain. Electronic address: roiestevez@hotmail.com. FAU - Sanchez-Recalde, Angel AU - Sanchez-Recalde A AD - Hospital Universitario Ramon y Cajal, CIBERCV, Madrid, Spain. FAU - Amat-Santos, Ignacio J AU - Amat-Santos IJ AD - CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain. FAU - Cruz-Gonzalez, Ignacio AU - Cruz-Gonzalez I AD - Hospital Clinico Universitario de Salamanca, CIBERCV, IBSAL, Salamanca, Spain. FAU - Baz, Jose A AU - Baz JA AD - Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain. FAU - Pascual, Isaac AU - Pascual I AD - Hospital Universitario Central de Asturias, Oviedo, Spain. FAU - Mascherbauer, Julia AU - Mascherbauer J AD - Division of Cardiology, Department for Internal Medicine II, Medical University of Vienna, Vienna, Austria. FAU - Abdul-Jawad Altisent, Omar AU - Abdul-Jawad Altisent O AD - Hospital Universitario Germans Trias i Pujol, Barcelona, Spain. FAU - Nombela-Franco, Luis AU - Nombela-Franco L AD - Cardiovascular Institute, Hospital Clinico San Carlos, IdISSC, Madrid, Spain. FAU - Pan, Manuel AU - Pan M AD - Hospital Universitario Reina Sofia, Cordoba, Spain. FAU - Trillo, Ramiro AU - Trillo R AD - Hospital Clinico Universitario de Santiago de Compostela, CIBERCV, Santiago, Spain. FAU - Moreno, Raul AU - Moreno R AD - Hospital Universitario La Paz, Madrid, Spain. FAU - Delle Karth, Georg AU - Delle Karth G AD - Hospital Floridsdorf, Vienna, Austria. FAU - Salido-Tahoces, Luisa AU - Salido-Tahoces L AD - Hospital Universitario Ramon y Cajal, CIBERCV, Madrid, Spain. FAU - Santos-Martinez, Sandra AU - Santos-Martinez S AD - CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain. FAU - Nunez, Jean C AU - Nunez JC AD - Hospital Clinico Universitario de Salamanca, CIBERCV, IBSAL, Salamanca, Spain. FAU - Moris, Cesar AU - Moris C AD - Hospital Universitario Central de Asturias, Oviedo, Spain. FAU - Goliasch, Georg AU - Goliasch G AD - Division of Cardiology, Department for Internal Medicine II, Medical University of Vienna, Vienna, Austria. FAU - Jimenez-Quevedo, Pilar AU - Jimenez-Quevedo P AD - Cardiovascular Institute, Hospital Clinico San Carlos, IdISSC, Madrid, Spain. FAU - Ojeda, Soledad AU - Ojeda S AD - Hospital Universitario Reina Sofia, Cordoba, Spain. FAU - Cid-Alvarez, Belen AU - Cid-Alvarez B AD - Hospital Clinico Universitario de Santiago de Compostela, CIBERCV, Santiago, Spain. FAU - Santiago-Vacas, Evelyn AU - Santiago-Vacas E AD - Hospital Universitario Germans Trias i Pujol, Barcelona, Spain. FAU - Jimenez-Valero, Santiago AU - Jimenez-Valero S AD - Hospital Universitario La Paz, Madrid, Spain. FAU - Serrador, Ana AU - Serrador A AD - CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain. FAU - Martin-Moreiras, Javier AU - Martin-Moreiras J AD - Hospital Clinico Universitario de Salamanca, CIBERCV, IBSAL, Salamanca, Spain. FAU - Strouhal, Andreas AU - Strouhal A AD - Hospital Floridsdorf, Vienna, Austria. FAU - Hengstenberg, Christian AU - Hengstenberg C AD - Division of Cardiology, Department for Internal Medicine II, Medical University of Vienna, Vienna, Austria. FAU - Zamorano, Jose Luis AU - Zamorano JL AD - Hospital Universitario Ramon y Cajal, CIBERCV, Madrid, Spain. FAU - Puri, Rishi AU - Puri R AD - Cleveland Clinic, Cleveland, Ohio, USA. FAU - Iniguez-Romo, Andres AU - Iniguez-Romo A AD - Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20220517 PL - United States TA - JACC Cardiovasc Interv JT - JACC. Cardiovascular interventions JID - 101467004 SB - IM CIN - JACC Cardiovasc Interv. 2022 Jul 11;15(13):1378-1381. PMID: 35798481 MH - Aged MH - Aged, 80 and over MH - Cardiac Catheterization/adverse effects MH - *Cardiomyopathies MH - Female MH - *Heart Valve Prosthesis Implantation/adverse effects MH - Humans MH - Male MH - Prospective Studies MH - Quality of Life MH - Severity of Illness Index MH - Treatment Outcome MH - Tricuspid Valve/diagnostic imaging/surgery MH - *Tricuspid Valve Insufficiency/diagnostic imaging/surgery OTO - NOTNLM OT - CAVI OT - right heart failure OT - tricuspid regurgitation COIS- Funding Support and Author Disclosures Dr Estevez-Loureiro has received speaker fees from Products and Features. Dr Puri serves as a consultant to Products and Features and V-Dyne. Drs Sanchez-Recalde, Amat-Santos, Cruz-Gonzalez, 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. EDAT- 2022/05/19 06:00 MHDA- 2022/07/12 06:00 CRDT- 2022/05/18 09:13 PHST- 2022/01/18 00:00 [received] PHST- 2022/05/10 00:00 [revised] PHST- 2022/05/10 00:00 [accepted] PHST- 2022/05/19 06:00 [pubmed] PHST- 2022/07/12 06:00 [medline] PHST- 2022/05/18 09:13 [entrez] AID - S1936-8798(22)00948-7 [pii] AID - 10.1016/j.jcin.2022.05.022 [doi] PST - ppublish SO - JACC Cardiovasc Interv. 2022 Jul 11;15(13):1366-1377. doi: 10.1016/j.jcin.2022.05.022. Epub 2022 May 17.