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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.)

Background: Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting., Methods: The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views., Results: The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7 ± 0.7 cm with a range of 2.5 to 6.2 cm. From the TG SAX view, the coaptation gap measured 8.1 ± 3.1 and 5.2 ± 2.3 mm in the central and mid regions of the anterior-septal coaptation line and 6.6 ± 3.2 and 3.8 ± 2.1 mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7 ± 2.4, 5.2 ± 2.4, and 4.6 ± 3.0 mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7 mm, 7 to 10 mm, and >10 mm., Conclusion: A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy., Competing Interests: Conflicts of Interest None., (Copyright © 2023 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Background: Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality., Objectives: The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) 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. Echocardiographic assessment was performed at a core laboratory., Results: Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days., Conclusions: Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR 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 This work was funded by Abbott Structural Heart. Dr Lurz has been a consultant to Abbott Structural Heart, Edwards Lifesciences, and ReCor. Dr Besler has received institutional (nonpersonal) lecture honoraria 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. Dr Möllmann has received honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Prof von Bardeleben has received institutional research grants and speaker honoraria from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Schmeisser has received research funding and speaker honoraria from Abbott. Dr Estevez-Loureiro has been a consultant for Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Lubos has received lecture fees and research grants from Abbott Vascular and Edwards Lifesciences; has received honoraria for advisory board activities from New Valve Technology; and has received travel expenses from Cardiovalve, Abbott Vascular, and Edwards Lifesciences. Drs Heitkemper and Huang are employees of Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)