Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial
Ralph Stephan von Bardeleben, Philipp Lurz, Paul Sorajja, T. Ruf, Jörg Hausleiter, Marta Sitges, Jaqueline G. da Rocha e Silva, Michael Näbauer, Marcel Weber, Gilbert H.L. Tang, Megan Heitkemper, Shih‐Wa Ying, Jean‐Noël Trochu, Saibal Kar, Rebecca T. Hahn, Georg Nickenig, Georg Nickenig, Ralph Stephan von Bardeleben, Martin Geyer, Peter Wenaweser, Patric Biaggi, Ioannis Kapos, Said Alsidawi, Philipp Lurz, Dabit Arzamendi, Regueiro Ander, Manuel Sabaté, Anuradha Lala-Trindade, David Adams, Julie A. Swain, Mathias Orban, Jörg Hausleiter, Ottavio Alfieri, Eustachio Agricola, Matteo Montorfano, Jan‐Malte Sinning, Alexander Tamm, Steffen Hoffmann, Marek Kowalski, Andrea Garatti, Alessandra Pecoraro, Gessica Motta, Maurizio Tusa, Michel Züber, Stephan Windecker, Michael A. Samara, Karol Mudy, Sachin Parikh, Dee Dee Wang, Nicolas Piriou, Karl‐Philipp Rommel, Christian Binner, Gustavo Jiménez, Xavier Freixa, Antonio Serra, D. Scott Lim, Stamatios Lerakis, Nicola Buzzatti, Marta Baragagna, Claudia Tiburtius, Carmelo Grasso, Federico De Marco, Francesco Maisano, Maurizio Taramasso, Richard Bae, Tiberio Frisoli, Patrice Guérin, Philipp Hartung, Sumeet S. Mitter, Noah Moss, Thomas J. Stocker, Francesco Ancona, Eustachio Agricola, Cristina Capogrosso
Abstract
BACKGROUND: Tricuspid regurgitation (TR) is a common and progressive valve disease with significant mortality and hospitalization burden. Tricuspid transcatheter edge-to-edge repair provides a treatment option for high-risk patients with primary and secondary TR. METHODS: The TRILUMINATE trial ([Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation]; n=85) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of tricuspid transcatheter edge-to-edge repair with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessment was performed at a core laboratory. Outcomes included safety and clinical effectiveness and echocardiographic assessment of TR. RESULTS: At 2 years, TR was reduced to moderate or less in 60% of subjects, and reduction of at least 1 grade was achieved in 85.4% of subjects. TR reduction was sustained in 75% of the patients. While most metrics suggest the majority of favorable remodeling occurred within the first 30 days post-procedure, both right ventricular end diastolic diameter and tricuspid annular plane systolic excursion show signals of continued favorable remodeling through 2 years. Substantial improvements in 6-minute walking distance, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire score were sustained from 30 days to 2 years. Even with low rates of cardiovascular mortality (15.3%) and all-cause mortality (18.7%) noted at 2 years, all-cause hospitalization rate decreased from 1.30 events per patient-year 1 year before device implantation to 0.66 events per patient-year 2 years after the TriClip procedure, representing a reduction of 49% ( P <0.0001). CONCLUSIONS: Tricuspid transcatheter edge-to-edge repair using the TriClip implant was found to be safe and effective, with sustained benefits at 2 years in subjects with symptomatic moderate or greater TR. Repair efficacy was durable at 2 years in 75% of the patients. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03227757.