JACC. Cardiovascular interventions · 2025
Heterotopic Crosscaval Transcatheter Tricuspid Valve Replacement for Patients With Tricuspid Regurgitation: The Trillium Device.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Lurz Philipp, Kresoja Karl-Patrik, Besler Christian, Verheye Stefan, Vermeersch Paul, Rudolph Volker, Friedrichs Kai, Abdul-Jawad Altisent Omar, Freixa Xavier, Sanchis Laura, Cruz-Gonzalez Ignacio, Antunez-Muiños Pablo, Bartunek Jozef, Vanderheyden Marc, Sherif Mohammad, Trippel Tobias Daniel, Estevez-Loureiro Rodrigo, Barreiro-Perez Manuel, Vaknin Assa Hana, Kornowski Ran
Аннотация
BACKGROUND: Transcatheter tricuspid interventions are an emerging therapy for patients with severe tricuspid regurgitation (TR), but a significant proportion of patients with TR are unsuitable for orthotopic tricuspid valve (TV) approaches.
OBJECTIVES: The aim of this study was to investigate the performance of a dedicated heterotopic valve replacement system in patients with severe or greater TR.
METHODS: This single-arm, multicenter study assessed the technical performance, efficacy, and safety of heterotopic cross-caval transcatheter TV replacement using the Trillium device at 30 days. Patients with severe or greater TR ineligible for surgical or other interventional orthotopic TV treatment were included.
RESULTS: Between 2021 and 2023, 20 patients (median age 81 years, 40% women) were included. Device implantation was successful in all cases, and no intraprocedural deaths or conversions to surgery occurred. Postprocedurally, central venous pressure was reduced (median -3 mm Hg; Q1-Q3: -5 to -1 mm Hg; P = 0.003), and TR severity as assessed at the level of the Trillium device was reduced in all cases (P < 0.001). Within the 30-day follow-up period, 1 patient died, 2 patients experienced heart failure hospitalization, 2 required hemodialysis, and 2 experienced major bleeding. There was an improvement in NYHA functional class (P = 0.005) and a trend toward a reduction in edema severity score (median -0.5; Q1-Q3: -1 to -0; P = 0.052).
CONCLUSIONS: The Trillium device is a safe and effective device for the treatment of patients with severe or greater TR ineligible for other therapeutic options. The device leads to a hemodynamic and symptomatic improvement of the burden of TR, whether this translates into favorable outcomes is to be proven in randomized trials.
OBJECTIVES: The aim of this study was to investigate the performance of a dedicated heterotopic valve replacement system in patients with severe or greater TR.
METHODS: This single-arm, multicenter study assessed the technical performance, efficacy, and safety of heterotopic cross-caval transcatheter TV replacement using the Trillium device at 30 days. Patients with severe or greater TR ineligible for surgical or other interventional orthotopic TV treatment were included.
RESULTS: Between 2021 and 2023, 20 patients (median age 81 years, 40% women) were included. Device implantation was successful in all cases, and no intraprocedural deaths or conversions to surgery occurred. Postprocedurally, central venous pressure was reduced (median -3 mm Hg; Q1-Q3: -5 to -1 mm Hg; P = 0.003), and TR severity as assessed at the level of the Trillium device was reduced in all cases (P < 0.001). Within the 30-day follow-up period, 1 patient died, 2 patients experienced heart failure hospitalization, 2 required hemodialysis, and 2 experienced major bleeding. There was an improvement in NYHA functional class (P = 0.005) and a trend toward a reduction in edema severity score (median -0.5; Q1-Q3: -1 to -0; P = 0.052).
CONCLUSIONS: The Trillium device is a safe and effective device for the treatment of patients with severe or greater TR ineligible for other therapeutic options. The device leads to a hemodynamic and symptomatic improvement of the burden of TR, whether this translates into favorable outcomes is to be proven in randomized trials.