KIRKLAND, Wash., Feb. 25, 2020 /PRNewswire/ -- Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the findings of a post hoc analysis of pooled prospectively collected data from three studies of the Carillon Mitral Contour System® with a focus on 5-year survival rate and the determinants of long-term survival. The data was presented in a late-breaking trials session at the Cardiovascular Research Technologies meeting (CRT 2020) in National Harbor, MD.
Dr. Janusz Lipiecki, a cardiologist in the Center for Interventional Cardiology of Pôle Santé République in Clermont-Ferrand, France, presented the data on behalf of all TITAN, TITAN II and REDUCE FMR clinical study investigators and commented, "The recent publication of the REDUCE FMR data demonstrated a significant reduction in regurgitant volume and favorable left ventricular remodeling1, confirming the results from prior studies, yet questions remained about the long-term impact of the Carillon device." He continued, "As an investigator, I am proud to present the results of this analysis demonstrating that patients with heart failure and moderate-to-severe FMR who underwent transcatheter mitral valve repair with the Carillon device, had a favorable 5-year survival rate which was associated with changes in clinical and hemodynamic parameters during the first year of follow-up."
A total of 74 patients from the TITAN, TITAN II and REDUCE FMR clinical studies who had symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction were assessed as part of the analysis. For all patients, echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. Key findings from the analysis include:
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Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling.2
The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years and 56.2% at 4 and 5 years of follow-up. 2