Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial.
Publication Title
Circulation
Document Type
Article
Publication Date
6-10-2025
Keywords
Humans; Tricuspid Valve Insufficiency; Male; Female; Aged; Treatment Outcome; Middle Aged; Heart Failure; Severity of Illness Index; Cardiac Catheterization; Tricuspid Valve; Quality of Life; Heart Valve Prosthesis Implantation; Hospitalization; Time Factors; Aged, 80 and over; Follow-Up Studies; hospitalization; tricuspid valve insufficiency; oregon; psvmc
Abstract
BACKGROUND: One-year outcomes of TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal) found that transcatheter edge-to-edge repair (TEER) for the treatment of severe, symptomatic tricuspid regurgitation improved quality of life compared with medical therapy alone with similar rates of mortality and heart failure hospitalization. However, additional follow-up is necessary to determine the prolonged benefits of tricuspid TEER.
METHODS: A total of 572 patients with severe, symptomatic tricuspid regurgitation were randomized to either tricuspid TEER+medical therapy (device group) or medical therapy alone (control). Two-year prespecified end points were recurrent heart failure hospitalization and freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention after treatment visit, assessed in the intention-to-treat population.
RESULTS: The annualized rate of recurrent heart failure hospitalizations through 2 years was significantly lower with tricuspid TEER compared with control (0.19 event per patient-year versus 0.26 event per patient-year;
CONCLUSIONS: At the 2-year follow-up, tricuspid TEER appeared safe, significantly reduced tricuspid regurgitation severity, and decreased rates of heart failure hospitalization compared with medical therapy alone.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03904147.
Area of Special Interest
Cardiovascular (Heart)
Specialty/Research Institute
Cardiology
DOI
10.1161/CIRCULATIONAHA.125.074536
