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Transcatheter Edge-to-Edge Repair in Patients With Complex Tricuspid Valve Anatomy
David H Adams1, Gilbert H L Tang2, Brian K Whisenant3
1Mount Sinai Health System, New York, New York, USA.
JACC. Cardiovascular Interventions
|December 11, 2024
Summary
Transcatheter edge-to-edge repair (TEER) using the TriClip system effectively treated severe tricuspid regurgitation in complex anatomies. This procedure demonstrated significant tricuspid regurgitation reduction and improved patient quality of life at one year.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Severe tricuspid regurgitation (TR) is associated with poor patient prognosis.
- Transcatheter edge-to-edge repair (TEER) offers a minimally invasive treatment option for TR.
Purpose of the Study:
- To evaluate the 1-year outcomes of TEER using the TriClip system in patients with complex tricuspid valve anatomies.
- To assess the safety and efficacy of TEER in a challenging patient population.
Main Methods:
- The TRILUMINATE Pivotal trial enrolled 100 patients with complex tricuspid valve anatomies.
- The primary endpoint was 1-year survival with a Kansas City Cardiomyopathy Questionnaire score improvement of ≥10 points.
- Outcomes included TR reduction, mortality, heart failure hospitalizations, and quality of life measures.
Main Results:
- The primary endpoint was met, with 46.2% of patients achieving the goal (performance goal: 30%; P = 0.0008).
- At 1 year, 81% of patients had moderate or less TR, with significant improvements in NYHA functional class and quality of life.
- One-year all-cause mortality was 15%, and heart failure hospitalization was 24%.
Conclusions:
- TEER with the TriClip system is procedurally safe for patients with complex tricuspid valve anatomies.
- The procedure leads to significant TR reduction and sustained improvements in quality of life at 1 year.
