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February 25, 2020

Pooled Analysis Supports Long-Term Benefits of Cardiac Dimensions’ Carillon System for FMR

February 25, 2020—Cardiac Dimensions, a developer of treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), announced the findings of a post hoc analysis of pooled, prospectively collected data from three studies of the company’s Carillon mitral contour system.

Data from the TITAN, TITAN II, and REDUCE FMR clinical studies focused on the 5-year survival rate and the determinants of long-term survival. Janusz Lipiecki, MD, presented the findings in a late-breaking trials session at CRT 2020, the Cardiovascular Research Technologies congress held February 22–25 in National Harbor, Maryland. The study was simultaneously published online by Dr. Lipiecki et al in Cardiovascular Revascularization Medicine.

According to Cardiac Dimensions, the results confirm a favorable long-term mortality benefit of the Carillon system, supporting the significant improvement in MR and favorable remodeling of the left ventricle shown in REDUCE FMR. The company asserted that the data reaffirm the effectiveness and safety of the Carillon system and highlight the value of early treatment to slow the deterioration of HF.

The company noted further that the long-term data presented at CRT suggest the primary clinical benefit of percutaneous mitral valve repair may be enhanced after the ventricle has had some time to remodel. The consistently demonstrated improvements in left ventricular dimensions are typically associated with mortality benefits, and these data support the long-term benefits from a decrease in left ventricular volume overload.

As summarized in the company’s announcement, the investigators assessed a total of 74 patients from the TITAN, TITAN II, and REDUCE FMR clinical studies who had symptomatic congestive HF despite guideline-directed medical therapy, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction. For all patients, echocardiographic parameters were available through the 12-month visitand vital status was available through 5 years. They used Cox proportional hazards regression to analyze the association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival.

Cardiac Dimensions reported the following key findings from the analysis.

  • During 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling.
  • 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.
  • Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up.
  • The 3-year mortality rate—compared with published outcomes of COAPT and guideline-directed medical therapy (GDMT) and using matched patient populations—was 33.7% for Carillon, 42.8% for MitraClip (Abbott) in COAPT, and 55.5% for GDMT.

In the company’s press release, Dr. Lipiecki commented, “The recent publication of the REDUCE FMR data demonstrated a significant reduction in regurgitant volume and favorable left ventricular remodeling, confirming the results from prior studies; yet questions remained about the long-term impact of the Carillon device.”

He continued, “As an investigator, I am proud to present the results of this analysis, demonstrating that patients with HF and moderate-to-severe FMR who underwent transcatheter mitral valve repair with the Carillon device had a favorable 5-year survival rate, which was associated with changes in clinical and hemodynamic parameters during the first year of follow-up.” Dr. Lipiecki is a cardiologist in the Center for Interventional Cardiology of Pôle Santé République in Clermont-Ferrand, France.

Cardiac Dimensions advised that the Carillon system offers a simple right heart approach to transcatheter mitral valve repair. It is designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, use the heart’s venous anatomy to cinch the mitral apparatus without compromising the valve or future treatment options. The Carillon system is designed to treat the primary cause of FMR in patients with MR grades 2+, 3+, and 4+.

The Carillon system received European CE Mark approval. In the United States, the Carillon system is limited to investigational use and is being studied in the pivotal CARILLON trial.

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