Abstract 21205: Reduction of Functional Mitral Regurgitation via Percutaneous Annuloplasty Associated With Exercise Improvement and Reverse Remodeling
Background: Functional Mitral Regurgitation (FMR) contributes to both ventricular remodeling and exercise intolerance. Whether percutaneous reduction in FMR is sufficient to confer functional benefit and a durable repair, or whether reverse remodeling (RR) contributes to this process, is unknown. The TITAN™ trial used the coronary sinus based CARILLON® XE2 device to treat FMR and compared functional and hemodynamic measures between implanted and non-implanted patients.
Hypothesis: FMR reduction alone is sufficient to confer exercise improvement.
Methods: Heart failure patients with moderate to severe FMR, LVEF<40%, and 6 minute walk distance (6MWD) 150–450 meters were enrolled in the trial. Peri-procedural reduction in FMR and confirmation of unaltered coronary flow were prerequisites to permanent implantation (n=36). Non-implanted patients (i.e., device recaptured) served as non-randomized, non-blinded controls (n=17). Efficacy was measured at 1 and 12 months by both exercise tolerance (6MWD) as well as echo core lab derived quantification of FMR and LV Dimensions.
Results: At baseline, 94% of patients were NYHA III, EF was 28.4%, and LVEDD was 67mm. At 1 month there was a significant reduction in both mitral annular diameter (MAD) and Regurgitant Volume (RVol), and a corresponding improvement in 6MWD. Although there was no evidence of RR at 1 month, there was significant RR between 1 and 12 months, and a corresponding further improvement in RVol. In contrast to the implanted cohort, the non-implanted cohort demonstrated continued deterioration of LV size.
Conclusions: Percutaneous reduction of FMR is sufficient to produce both a durable hemodynamic repair and significant improvement in exercise tolerance. RR was observed at 12 months, and was associated with a further reduction in FMR.
- © 2010 by American Heart Association, Inc.