Impact of Carillon on COAPT Eligible/Non-Eligible Patients

Introduction The COAPT trial demonstrated a clinical benefit in pts meeting fairly strict criteria for entry. Most notable was a criteria that pts had an EROA ≥ 0.3, or a regurgitant volume (RV) ≥ 45. The Carillon device has been studied in 3 prospective trials with independent core lab echo assessments. Methods Pts receiving a Carillon device from these trials were pooled for analysis and divided into 2 groups; those with EROA Results Baseline data are summarized in Table 1. Pts with more severe baseline MR had a higher proportion of afib and ischemic etiology of cardiomyopathy, in addition to larger LV and left atrial volumes. Echo parameter changes at one year are provided in Table 2. Marked improvements for RV,LVEDV and LVESV were observed in both groups, although there was slightly more improvements in the pts with more baseline MR. EF improved more in pts with lesser degrees of MR, suggesting a benefit to treating earlier in the disease process. Conclusions Treatment of functional mitral regurgitation (FMR) with the Carillon Device in “COAPT eligible” patients resulted in marked remodeling. Similar outcomes were observed in patients with less severe FMR, suggesting earlier intervention may be beneficial.