A pooled analysis of prospective trials demonstrates promising long-term survival after transcatheter mitral valve repair (TMVR) with the Carillon Device (Cardiac Dimensions, Kirkland, Washington) for patients with functional mitral regurgitation (FMR).
The findings of this study were presented Tuesday by Janusz Lipiecki, MD, PhD, of Centre de Cardiologie Interventionnelle, Elsan, Pôle Santé République, Clermont-Ferrand, France, at Cardiovascular Research Technologies (CRT) 2020 in National Harbor, Maryland. They were also simultaneously published online in Cardiovascular Revascularization Medicine.
This post hoc analysis was from three studies of the Carillon device in which long-term data were available and pooled together (n=74 patients). The patients (mean age 67 years, 72% male) enrolled in these trials included those with symptomatic congestive heart failure despite being on guideline-directed medical therapy, left ventricular enlargement, reduced ejection fraction, and grade 2 or worse FMR (59% MR grade 3 or 4). Echocardiographic data were available through 1 year and vital status for up to five years.
At 1 year of follow-up, New York Heart Association (NYHA) class decreased in 64% of patients and 6-minute walk test increased. In addition, there was a significant decrease in MR grade and favorable ventricular remodeling. Using Cox proportional hazards regression, 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. Long-term survival was seen most when in the first year there was a decrease in NYHA class, an increase in 6-minute walk test distance and a decrease in regurgitant volume.
One main limitation of this study is that patients enrolled in these three trials who ultimately did not receive a Carillon device owing to implantation failure or control group assignment were not followed over the long term, and therefore, investigators were unable to make direct comparisons to a control group in this patient-level analysis. Second, there is a relatively small number of patients in this present dataset, and 34% of patients were lost to follow-up or had not yet completed 5 years of follow-up.
Despite these limitations, this is the first report of long-term survival in patients treated with the Carillon device. The results of this pooled analysis show promising results. Ongoing analysis and follow-up are needed to confirm these findings.