Three-year data from the TRILUMINATE study demonstrate that transcatheter edge-to-edge repair (TEER) with Abbott's TriClip device provides sustained benefits for patients with symptomatic moderate or greater tricuspid regurgitation (TR). The study, published in the Journal of the American College of Cardiology: Cardiovascular Interventions, reveals that TriClip reduces TR and improves quality of life (QOL) with a favorable safety profile.
Sustained TR Reduction and Improved Quality of Life
The TRILUMINATE study found that TEER with TriClip reduced TR to moderate or less in 79% of patients. This reduction, initially observed after one year, was maintained at the three-year mark, indicating the durability of the treatment's effect. Georg Nickenig, MD, a cardiologist with University Hospital Bonn in Germany and first author of the study, emphasized the sustained benefits, noting that patients treated with TriClip showed continued TR reduction and QOL improvements.
Significant improvements were also observed in heart failure symptoms. The proportion of patients with New York Heart Association (NYHA) class III or IV heart failure decreased from 76% at baseline to 19% after three years. This improvement highlights the potential of TriClip to alleviate the burden of TR-related symptoms.
Safety Profile and Future Directions
The study also confirmed the favorable safety profile of the TriClip device, with minimal major adverse events reported over the three-year follow-up period. This is particularly important given the lack of alternative treatment options for many patients with severe, symptomatic TR.
Despite the encouraging results, the authors acknowledge that it remains unclear whether the TR reduction achieved with TriClip significantly impacts a patient’s risk of mortality or hospitalization for heart failure. Nickenig et al. stated that the primary benefit identified in this analysis was related to QOL. However, they advocate for further controlled studies to evaluate the impact of TEER on these critical outcomes, especially considering the favorable safety profile and limited treatment options available.
"Our encouraging three-years results justify and warrant these further controlled studies on TEER in patients with severe, symptomatic TR, particularly in light of the favorable safety profile and the lack of other treatment options," the authors concluded.
