Abbott reports data from trials of its heart devices to treat valve diseases

Abbott announced data from late-breaking presentations showing the impact of its minimally invasive heart devices in treating mitral and tricuspid valve disease. Data include findings from the TRILUMINATE pivotal trial that reinforce the safety and effectiveness of the TriClip transcatheter edge-to-edge repair, or TEER, system for patients with symptomatic, severe tricuspid regurgitation, or TR, despite optimal medical therapy. The company also presented late-breaking data from the MitraClip EXPAND G4 real-world registry that highlights the device’s benefits across a broad group of patients with mitral regurgitation, or MR. Leaky valves in people with MR and TR can reduce the amount of blood being pumped through the body and make the heart work harder than it should. While historically surgery was often necessary to combat MR and TR, Abbott’s minimally invasive portfolio of structural heart devices has allowed more people around the world to be effectively treated without the risk of surgical complications. Key findings from the TRILUMINATE pivotal trial through one year include: Consistent with and reinforcing the findings in the primary randomized population, TriClip therapy demonstrated significant improvements in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire score for the full randomized group, along with an excellent safety profile. The single-arm group with more complex anatomies and advanced disease met its primary endpoint. The data demonstrated that TriClip was safe, with 81% of patients achieving TR reduction to moderate or less and reporting a similar degree of KCCQ improvement to the randomized population. Key findings from the EXPAND G4 study at one year include: The highest reported MR reduction in a mitral TEER study to date, sustained through one year, with MR reduction to mild or less achieved in 93% of patients, and trace or less MR achieved in 44% of patients. Significant clinical improvements, including 82% of patients achieving New York Heart Association Functional Class I/II, an improvement from 36% at baseline; and a 19-point improvement in KCCQ score. MitraClip showed the lowest rates of all-cause mortality, 12%, and hospitalization for heart failure, 17%, in a global, real-world mitral TEER study.