Abstract 4621: Reverse Remodeling Observed After Percutaneous Reduction of Functional Mitral Regurgitation Using the CARILLON® Mitral Contour System™ in the TITAN™ Trial
Background: The volume overload associated with mitral regurgitation and heart failure contributes to ventricular remodeling. Therapies that reduce mitral regurgitation have the potential to diminish the volume overload, and thereby stabilize, or reverse, the remodeling process. The CARILLON® Mitral Contour System™ is a percutaneously deployed permanent implant designed to reduce functional MR (FMR). Its impact on reverse remodeling was evaluated in the Phase I TITAN trial.
Methods: Eligible patients for the TITAN™ trial included those with either ischemic or non-ischemic dilated cardiomyopathy, moderate to severe FMR, LVEF <40%, NYHA Class II–IV, 6 minute walk distance >150 and <450 m, and stable heart failure medications for three months. Permanent implantation occurred in patients demonstrating a peri-procedural reduction in FMR (n=36). An echocardiographic core lab assessed both changes in FMR, and left ventricular dimensions.
Results: At baseline, the average age of the 53 patients was 62 years, 62% had HF with an ischemic etiology, 94% were NYHA III, and the average EF was 28%. Implantation was successful in 68% of patients. Non-implantation was primarily related to access issues, transient coronary compromise, or insufficient MR reduction. The following table⇓ documents the reduction in FMR, as measured by regurgitant volume, and left ventricular end diastolic (LVEDV) and systolic (LVESV) volumes between baseline and 6 months.
Conclusion: In the TITAN™ trial, treatment with the CARILLON® Mitral Contour System™ was associated with not only a reduction in FMR, but also improvement in both systolic and diastolic LV volumes over a period of 6 months.