This study was carried out to assess the safety and efficacy of the TriClip (edge-to-edge repair) in patients with severe tricuspid regurgitation with persistent symptoms despite medical treatment and high surgical risk.
It is a prospective multicenter single arm study including 300 patients of mean age 78±7.6; 7.7% presented prior aortic intervention and 28% prior mitral intervention.
Primary end point was procedural related success, defined as survival at discharge with successful TriClip implantation. The study looked at patients with diverse tricuspid anatomies (real world population).
At 30 days, there was 91% implantation success rate, with average procedure duration 101 min, 71% of patients improved tricuspid regurgitation (vs 1% of baseline population). The safety profile at 30 days rendered 1% MACE.
Conclusions
The TriClip showed safety at 30 days seeing as there was 1% MACE, and reduced TR severity. The bRIGHT study is still enrolling (searching n=500) to assess the behavior of this device across diverse tricuspid anatomies.
Reference: Presented by en Late-breaking clinical trial en EuroPCR 2022 por Dr Phillipp Lurz.
Dr. Omar Tupayachi.
Member of the editorial board of SOLACI.org.
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