1. Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study.
- Author
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Lurz P, Rommel KP, Schmitz T, Bekeredjian R, Nickenig G, Möllmann H, von Bardeleben RS, Schmeisser A, Atmowihardjo I, Estevez-Loureiro R, Lubos E, Heitkemper M, Peterman K, Lapp H, and Donal E
- Subjects
- Humans, Male, Female, Aged, Prospective Studies, Treatment Outcome, Tricuspid Valve surgery, Tricuspid Valve diagnostic imaging, Registries, Aged, 80 and over, Follow-Up Studies, Echocardiography, Quality of Life, Cardiac Catheterization methods, Europe epidemiology, Time Factors, Severity of Illness Index, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency mortality
- Abstract
Background: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated., Objectives: We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting., Methods: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment., Results: Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, P <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume., Conclusions: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089)., Competing Interests: Funding Support and Author Disclosures The bRIGHT study is sponsored by Abbott Cardiovascular. Prof Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, Boehringer Ingelheim, and Daiichi-Sankyo; and has stock options with Innoventric. Prof von Bardeleben has received institutional research grants and speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Cardiovascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. 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 Estevez-Loureiro has been a consultant for Abbott Structural Heart, Edwards Lifesciences, Boston Scientific, and Venus Medtech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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