Tricuspid transcatheter edge-to-edge repair using the TriClip system successfully reduced tricuspid regurgitation to ≤moderate in 77% of patients at 30 days, with a 2.5% major adverse event rate.
Observational
Open-label
Yes
Does tricuspid transcatheter edge-to-edge repair safely reduce tricuspid regurgitation and improve symptoms in a real-world population with severe tricuspid regurgitation?
Transcatheter tricuspid edge-to-edge repair is safe and effectively reduces tricuspid regurgitation while improving symptoms at 30 days in a real-world, high-risk population.
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).
Lurz et al. (2023) conducted an observational in Severe tricuspid regurgitation. Tricuspid transcatheter edge-to-edge repair (TriClip system) was evaluated on Reduction of tricuspid regurgitation to ≤moderate at 30 days. Tricuspid transcatheter edge-to-edge repair using the TriClip system successfully reduced tricuspid regurgitation to ≤moderate in 77% of patients at 30 days, with a 2.5% major adverse event rate.