Transcatheter Edge-to-Edge Repair in Patients With Complex Tricuspid Valve Anatomy.

Abstract

Background: Untreated severe tricuspid regurgitation (TR) carries a poor prognosis.

Objectives: The authors report the 1-year outcomes of transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Structural Heart) in patients with complex tricuspid valve anatomies.

Methods: The multicenter, international TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal) trial included a single-arm cohort, with complex tricuspid valve anatomies excluded from the randomized arm (ie, anticipated TR reduction but not to moderate or less after TEER). The primary outcome endpoint of the single arm was 1-year survival with a Kansas City Cardiomyopathy Questionnaire score improvement ≥10 points.

Results: In the primary analysis population (N = 100), the mean age was 80 ± 6 years, and 35% had a cardiac implantable electronic device lead. Nearly 90% of patients had massive or torrential TR, 44% had prior left-sided valve interventions, 63% had ≥4-segmental tricuspid leaflet morphology, and the coaptation gap averaged 7.4 ± 2.7 mm. The primary endpoint was met (outcome: 46.2%, performance goal: 30%; P = 0.0008). A total of 81% of subjects had moderate or less TR at 1 year. No major adverse events or deaths occurred within 30 days postprocedure. One-year all-cause mortality and heart failure hospitalization were 15% and 24%, respectively. Significant improvements in NYHA functional class and Kansas City Cardiomyopathy Questionnaire overall scores occurred and were maintained at 1 year.

Conclusions: In patients with complex tricuspid anatomies, TEER with the TriClip system demonstrated excellent procedural safety with significant TR reduction and associated improvements in quality of life at 1 year.