Edwards Lifesciences' Evoque transcatheter tricuspid valve replacement (TTVR) system continues to show substantial benefits for patients with severe tricuspid regurgitation (TR), with new data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 meeting demonstrating significant improvements in symptoms and quality of life (QOL) at one year.
The findings stem from an analysis of one-year QOL data from the TRISCEND II clinical trial, which compared TTVR with Evoque to optimal medical therapy (OMT) alone. The study included nearly 400 patients with severe TR, with 259 undergoing TTVR and 133 receiving OMT. The mean age of patients in both groups was 79 years, and the majority were women.
Sustained Quality of Life Improvements
Researchers, led by Suzanne V. Arnold, MD, an interventional cardiologist with Saint Luke’s Mid America Heart Institute, tracked QOL using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS). Results indicated that QOL was consistently better for patients who underwent TTVR at 30 days, six months, and one year.
Greater Benefits in Severe Cases
Notably, over 56% of patients presented with massive or torrential TR. In this subgroup, KCCQ-OS improvements were twice as large as those observed in patients with severe TR, suggesting that individuals with more advanced TR may derive the greatest benefit from transcatheter treatment.
FDA Approval and Clinical Context
In February, the FDA approved the Evoque system, making it the first device of its kind available in the U.S. for treating symptomatic severe TR that does not improve with OMT. The approval was based on the TRISCEND II trial, which demonstrated significantly better outcomes with Evoque compared to medical therapy alone.
These findings were published in the Journal of the American College of Cardiology.
