Abstract 4289: Safety and Efficacy Comparison Between Implanted and Non-Implanted Patients in the TITAN™ Trial Using the CARILLON® Mitral Contour System™ to Treat Functional Mitral Regurgitation
Background: Functional mitral regurgitation (FMR) increases the morbidity and mortality of patients with heart failure. The TITAN™ trial evaluated the safety and efficacy of percutaneous mitral annuloplasty with the CARILLON® Mitral Contour System™.
Methods: Inclusion criteria: dilated ischemic or non-ischemic cardiomyopathy, moderate to severe FMR, NYHA Class II–IV, LVEF <40%, and 6 minute walk distance >150 and <450 m. Permanent implantation occurred in patients with a peri-procedural reduction in FMR (n=36). Patients in whom implantation was not successful served as a non-randomized control (n=17). The primary safety endpoint was the rate of MAEs at 1 month. Secondary endpoints at 1 and 6 months included FMR as assessed by an echo core laboratory, and NYHA Class, 6 minute walk distance, and quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Results: At baseline, 94% of patients were NYHA III, EF was 28.4%, and LVEDD was 70mm. The MAE rate at 30-days for all 53 attempted patients was 1.9%. Reductions in FMR (EROA, MRJA/LAA, Rvol, VC) ranged from 21–27% at 1 month (n=34), and from 32– 43% at 6 months (n=21) for implanted patients. LVESV was reduced from 164±64 at baseline to 142±52 at 6 months (p<0.01). Complete interim results including baseline, one, and six month safety, hemodynamic, and functional data will be presented.
Conclusion: Percutaneous treatment of FMR with the CARILLON® Mitral Contour System™ was associated with reduction in FMR and a corresponding improvement in functional parameters.