Transcatheter tricuspid valve repair using the TriClip system reduced tricuspid regurgitation to moderate or less in 71% of patients at 1 year compared to 8% at baseline (p<0.0001).
Cohort (n=85)
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Does transcatheter tricuspid valve repair using the TriClip device improve outcomes in patients with moderate or greater tricuspid regurgitation?
Transcatheter tricuspid valve repair with the TriClip device safely and effectively reduces tricuspid regurgitation and improves clinical symptoms at 1 year in high-risk patients.
Tasa de eventos absoluta: 71% vs 8%
valor p: p=<0.0001
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).
Lurz et al. (Fri,) conducted a cohort in Moderate or greater tricuspid regurgitation (n=85). TriClip transcatheter tricuspid valve repair system was evaluated on Reduction of tricuspid regurgitation to moderate or less (p=<0.0001). Transcatheter tricuspid valve repair using the TriClip system reduced tricuspid regurgitation to moderate or less in 71% of patients at 1 year compared to 8% at baseline (p<0.0001).