Core Insights - Abbott's TriClip transcatheter edge-to-edge repair system shows significant and sustained improvements in treating tricuspid regurgitation (TR) after two years, reducing hospitalizations due to heart failure compared to medical therapy [1][6][7] - The TRILUMINATE Pivotal trial highlights the device's effectiveness in improving patients' quality of life and reducing the severity of TR [4][5][6] Group 1: Trial Results - The TRILUMINATE Pivotal trial demonstrated that after two years, TriClip therapy significantly reduced heart failure hospitalizations (HFH) compared to the control group, with rates of 0.19 vs. 0.26 events per patient-year [7] - 84% of patients treated with TriClip achieved a reduction in TR to moderate or less (grade ≤ 2), compared to only 21% in the control group [7] - Patients receiving TriClip experienced an average improvement of over 15 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, indicating enhanced quality of life [7] Group 2: Patient Impact - TriClip offers a viable treatment option for patients with severe TR who are not suitable candidates for surgery, improving their quality of life and reducing hospitalization risks [2][5] - The trial results reinforce the importance of TriClip in managing TR, allowing patients to reclaim their lives while minimizing the risk of heart failure [5][6] Group 3: Study Details - The TRILUMINATE Pivotal trial is the first randomized, controlled study comparing the safety and effectiveness of the TriClip system against medical therapy alone for severe TR [8] - The primary endpoint of the trial included all-cause mortality, tricuspid valve surgery, heart failure hospitalizations, and quality-of-life improvement as measured by the KCCQ score [8]
New Late-Breaking Data Reinforce Benefits of Abbott's TriClip™ for People With Leaky Tricuspid Heart Valve