Philipp Lurz1, Ralph Stephan von Bardeleben2, Marcel Weber3, Marta Sitges4, Paul Sorajja5, Jörg Hausleiter6, Paolo Denti7, Jean-Noël Trochu8, Michael Nabauer6, Gilbert H L Tang9, Patric Biaggi10, Shih-Wa Ying11, Phillip M Trusty11, Abdellaziz Dahou12, Rebecca T Hahn13, Georg Nickenig3. 1. Heart Center Leipzig at University of Leipzig, Leipzig, Germany. Electronic address: Philipp.Lurz@medizin.uni-leipzig.de. 2. Universitäts Medizin, Mainz, Germany. 3. Heart Center University Hospital, Bonn, Germany. 4. Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi I Sunyer, Centro de investigación Biomedica en Red Enfermedades Cardiovasculares, Spain. 5. Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA. 6. Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München, Munich, Germany. 7. Ospedale San Raffaele, Milano, Italy. 8. Université Nantes, CHU Nantes, CNRS, INSERM, l'institut du Thorax, Nantes, France. 9. Mount Sinai Heath System, New York, New York, USA. 10. Heart Clinic Zurich, Zurich, Switzerland. 11. Abbott Structural Heart, Santa Clara, California, USA. 12. The Cardiovascular Research Foundation, New York, New York, USA. 13. The Cardiovascular Research Foundation, New York, New York, USA; New York Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
Abstract
BACKGROUND: Tricuspid regurgitation (TR) is a frequent disease with a progressive increase in mortality as disease severity increases. Transcatheter therapies for treatment of TR may offer a safe and effective alternative to surgery in this high-risk population. OBJECTIVES: The purpose of this report was to study the 1-year outcomes with the TriClip transcatheter tricuspid valve repair system, including repair durability, clinical benefit and safety. METHODS: The TRILUMINATE trial (n = 85) is an international, prospective, single arm, multicenter study investigating safety and performance of the TriClip Tricuspid Valve Repair System in patients with moderate or greater TR. Echocardiographic assessment was performed by a core laboratory. RESULTS: At 1 year, TR was reduced to moderate or less in 71% of subjects compared with 8% at baseline (p < 0.0001). Patients experienced significant clinical improvements in New York Heart Association (NYHA) functional class I/II (31% to 83%, p < 0.0001), 6-minute walk test (272.3 ± 15.6 to 303.2 ± 15.6 meters, p = 0.0023) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (improvement of 20 ± 2.61 points, p < 0.0001). Significant reverse right ventricular remodeling was observed in terms of size and function. The overall major adverse event rate and all-cause mortality were both 7.1% at 1 year. CONCLUSION: Transcatheter tricuspid valve repair using the TriClip device was found to be safe and effective in patients with moderate or greater TR. The repair itself was durable at reducing TR at 1 year and was associated with a sustained and marked clinical benefit with low mortality after 1 year in a fragile population that was at high surgical risk. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR; NCT03227757).
BACKGROUND:Tricuspid regurgitation (TR) is a frequent disease with a progressive increase in mortality as disease severity increases. Transcatheter therapies for treatment of TR may offer a safe and effective alternative to surgery in this high-risk population. OBJECTIVES: The purpose of this report was to study the 1-year outcomes with the TriClip transcatheter tricuspid valve repair system, including repair durability, clinical benefit and safety. METHODS: The TRILUMINATE trial (n = 85) is an international, prospective, single arm, multicenter study investigating safety and performance of the TriClip Tricuspid Valve Repair System in patients with moderate or greater TR. Echocardiographic assessment was performed by a core laboratory. RESULTS: At 1 year, TR was reduced to moderate or less in 71% of subjects compared with 8% at baseline (p < 0.0001). Patients experienced significant clinical improvements in New York Heart Association (NYHA) functional class I/II (31% to 83%, p < 0.0001), 6-minute walk test (272.3 ± 15.6 to 303.2 ± 15.6 meters, p = 0.0023) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (improvement of 20 ± 2.61 points, p < 0.0001). Significant reverse right ventricular remodeling was observed in terms of size and function. The overall major adverse event rate and all-cause mortality were both 7.1% at 1 year. CONCLUSION: Transcatheter tricuspid valve repair using the TriClip device was found to be safe and effective in patients with moderate or greater TR. The repair itself was durable at reducing TR at 1 year and was associated with a sustained and marked clinical benefit with low mortality after 1 year in a fragile population that was at high surgical risk. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR; NCT03227757).
Authors: Varius Dannenberg; Matthias Koschutnik; Carolina Donà; Christian Nitsche; Katharina Mascherbauer; Gregor Heitzinger; Kseniya Halavina; Andreas A Kammerlander; Georg Spinka; Max-Paul Winter; Martin Andreas; Markus Mach; Matthias Schneider; Anna Bartunek; Philipp E Bartko; Christian Hengstenberg; Julia Mascherbauer; Georg Goliasch Journal: Front Cardiovasc Med Date: 2022-06-02
Authors: Andrea Simone Deichl; Philipp Lacour; Evgeny Belyavskiy; Burkert Pieske; Elisabeth Pieske-Kraigher; Florian Blaschke; Matthias Schneider Journal: Front Cardiovasc Med Date: 2021-06-04