PMID- 33478646 OWN - NLM STAT- MEDLINE DCOM- 20210809 LR - 20210809 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 77 IP - 3 DP - 2021 Jan 26 TI - Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. PG - 229-239 LID - S0735-1097(20)37905-5 [pii] LID - 10.1016/j.jacc.2020.11.038 [doi] AB - 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). CI - Copyright (c) 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Lurz, Philipp AU - Lurz P AD - Heart Center Leipzig at University of Leipzig, Leipzig, Germany. Electronic address: Philipp.Lurz@medizin.uni-leipzig.de. FAU - Stephan von Bardeleben, Ralph AU - Stephan von Bardeleben R AD - Universitats Medizin, Mainz, Germany. FAU - Weber, Marcel AU - Weber M AD - Heart Center University Hospital, Bonn, Germany. FAU - Sitges, Marta AU - Sitges M AD - Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques August Pi I Sunyer, Centro de investigacion Biomedica en Red Enfermedades Cardiovasculares, Spain. FAU - Sorajja, Paul AU - Sorajja P AD - Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA. FAU - Hausleiter, Jorg AU - Hausleiter J AD - Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universitat Munchen, Munich, Germany. FAU - Denti, Paolo AU - Denti P AD - Ospedale San Raffaele, Milano, Italy. FAU - Trochu, Jean-Noel AU - Trochu JN AD - Universite Nantes, CHU Nantes, CNRS, INSERM, l'institut du Thorax, Nantes, France. FAU - Nabauer, Michael AU - Nabauer M AD - Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universitat Munchen, Munich, Germany. FAU - Tang, Gilbert H L AU - Tang GHL AD - Mount Sinai Heath System, New York, New York, USA. FAU - Biaggi, Patric AU - Biaggi P AD - Heart Clinic Zurich, Zurich, Switzerland. FAU - Ying, Shih-Wa AU - Ying SW AD - Abbott Structural Heart, Santa Clara, California, USA. FAU - Trusty, Phillip M AU - Trusty PM AD - Abbott Structural Heart, Santa Clara, California, USA. FAU - Dahou, Abdellaziz AU - Dahou A AD - The Cardiovascular Research Foundation, New York, New York, USA. FAU - Hahn, Rebecca T AU - Hahn RT AD - The Cardiovascular Research Foundation, New York, New York, USA; New York Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA. FAU - Nickenig, Georg AU - Nickenig G AD - Heart Center University Hospital, Bonn, Germany. CN - TRILUMINATE Investigators LA - eng SI - ClinicalTrials.gov/NCT03227757 PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 SB - IM CIN - J Am Coll Cardiol. 2021 Jan 26;77(3):240-242. PMID: 33478647 MH - Aged MH - Aged, 80 and over MH - Echocardiography MH - Endovascular Procedures/*instrumentation MH - Female MH - Humans MH - Male MH - Prospective Studies MH - Tricuspid Valve/*surgery MH - Tricuspid Valve Insufficiency/diagnostic imaging/*surgery MH - Ventricular Remodeling OTO - NOTNLM OT - transcatheter tricuspid valve repair OT - tricuspid regurgitation OT - tricuspid valve COIS- Author Disclosures This study was funded by Abbott. Dr. Lurz has been a consultant to Abbott Structural Heart, Edwards Lifesciences, and Medtronic. Dr. von Bardeleben has received grants from Abbott Structural Heart, outside the submitted work. Drs. Sitges and Nickenig have received speakers' honoraria as well as travel and grant support from Abbott. Dr. Nickenig has received research funding from the Deutsche Forschungsgemeinschaft (DFG), the Federal Ministry of Education and Research (BMBF), The European Union, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical; has received honoraria for lectures or Advisory Boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Cardiovalve, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical; and has participated in clinical trials for Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Cardiovalve, Daiichi-Sankyo, Edwards Lifesciences Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical. Dr. Sorajja has received grants and personal fees from Abbott Vascular, outside the submitted work. Dr. Denti has received personal fees from Abbott and Edwards Lifesciences, outside the submitted work. Dr. Trochu has received speaker's honoraria, travel and grant support from Abbott and Novartis; has received honoraria for lectures or Advisory Boards from Amgen, Bayer, and Resmed; and has been an unpaid member of the Corvia Medical Scientific Advisory Group. Dr. Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences. Dr. Nabauer has received speaker honoraria form Abbott. Dr. Tang has received consultant fees and speakers' honoraria from Abbott. Dr. Biaggi has received proctoring and speaker's honoraria from Abbott. Shih-Wa Ying and Dr. Trusty have been employees of Abbott. Dr. Hahn has received speaker fees from Boston Scientific Corporation and Baylis Medical; has received consulting for Abbott Structural, Edwards Lifesciences, Medtronic, Navigate, Philips Healthcare, and Siemens Healthcare; has received nonfinancial support from 3mensio; and has been Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials for which she has received no direct industry compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. EDAT- 2021/01/23 06:00 MHDA- 2021/08/10 06:00 CRDT- 2021/01/22 05:46 PHST- 2020/10/07 00:00 [received] PHST- 2020/11/03 00:00 [accepted] PHST- 2021/01/22 05:46 [entrez] PHST- 2021/01/23 06:00 [pubmed] PHST- 2021/08/10 06:00 [medline] AID - S0735-1097(20)37905-5 [pii] AID - 10.1016/j.jacc.2020.11.038 [doi] PST - ppublish SO - J Am Coll Cardiol. 2021 Jan 26;77(3):229-239. doi: 10.1016/j.jacc.2020.11.038.