Carillon device for mitral valve repair may improve long-term survival
Patients with congestive HF and grade 2 to 4 functional mitral regurgitation despite medical therapy who underwent transcatheter mitral valve repair with the Carillon device had favorable survival rates at 5 years, according to a pooled analysis presented at a late-breaking science session at Cardiovascular Research Technologies.
Findings from the trial have been simultaneously published in Cardiovascular Revascularization Medicine.
“The Carillon device shows extremely encouraging long-term mortality data from prospective-controlled trials in comparison to guideline-directed medical therapy and COAPT results in symptomatic patients with functional mitral regurgitation,” Janusz Lipiecki, MD, a cardiologist in the Center for Interventional Cardiology of Pôle Santé République in Clermont-Ferrand, France, said during the presentation.
Researchers analyzed data from 74 patients (mean age, 67 years; 72% men) with symptomatic congestive HF despite guideline-directed medical therapy and grade 2+ to 4+ functional mitral regurgitation. These patients were treated with the Carillon device (Cardiac Dimensions) in the TITAN, TITAN II and REDUCE FMR trials. Data in this pooled analysis included functional and echocardiographic results through 1-year follow-up, baseline patient characteristics and survival through final follow-up.
The primary outcome was the Kaplan-Meier survival estimate during follow-up through 5 years.
Of the patients in the study, 42 had mitral regurgitation of grade 3 or 4.
During 1-year of follow-up, 64% of patients had a decrease in NYHA class. There were also improvements in 6-minute walk test (311 m at baseline to 399 m at 1 year; P < .001). Patients treated with this device had significant decreases in mitral regurgitation grade and left ventricular volumes and increases in ejection fraction.
The Kaplan-Meier survival estimates were 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.
In patients who survived for at least 1 year, the predictors of long-term survival were a decrease in NYHA class (HR per one class decrease = 2.56; P < .01), increase in 6-minute walk test (HR per 100-m increase = 1.54; P = .03) and a decrease in regurgitant volume (HR per 10% decrease = 1.24; P = .02).
“Long-term clinical benefits will continue to be evaluated in conjunction with the CARILLON trial,” Lipiecki said during the presentation. “The CARILLON trial is an ongoing, blinded, sham-controlled pivotal trial with clinical endpoints being performed primarily in the U.S.” – by Darlene Dobkowski
References:
Lipiecki J. Late-Breaking Trials: Session III. Presented at: Cardiovascular Research Technologies; Feb. 22-25, 2020; National Harbor, Md.
Lipiecki J, et al. Cardiovasc Revasc Med. 2020;doi:10.1016/j.carrev.2020.02.012.
Disclosures: Lipiecki reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.