Real-world 1-Year Results of Tricuspid Edge-to-Edge Repair from the bRIGHT Study

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: To report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system in a contemporary, real-world setting.

Methods: The bRIGHT post-approval study is a prospective, single-arm, open-label, multicenter, post-market registry conducted at 26 sites in Europe with central event adjudication and echocardiographic core-lab assessment.

Results: Enrolled subjects were elderly (79±7 years) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR and 80% percent of subjects were in NYHA class III/ IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA class (21% to 75% I/II, P<0.0001) and 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 that achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline 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, nor 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.

Keywords: TriClip; leaflet repair; transcatheter edge-to-edge repair; tricuspid regurgitation; tricuspid repair.