Valve-in-Valve After Transcatheter Mitral Valve Replacement: Anticipate the Future!

Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality.To study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system in a contemporary, real-world setting.The bRIGHT post-approval study is a prospective, single-arm, open-label, multicenter, post-market registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory.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 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 class (20% to 79% I/II, p < 0.0001) and KCCQ score (19 ± 23 points improvement, p < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller RAV and smaller tethering distance at baseline were independent predictors of TR reduction to ≤ moderate at discharge (OR:0.679, CI: [0.537, 0.858], p = 0.0012; OR: 0.722, CI: [0.564, 0.924], p=0.0097). Fourteen (2.5%) subjects experienced a major adverse event at 30 days.Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population.