Cardiac Dimensions Carillon Mitral Contour System Evaluated in Two Meta-Analyses

April 7, 2021—Cardiac Dimensions announced the publication of a second individual patient data meta-analysis demonstrating clinically significant outcomes for the Carillon mitral contour system in the European Society of Cardiology’s journal, ESC Heart Failure. This publication adds to other recently published findings on the Carillon transcatheter-based indirect annuloplasty device.

Both of the published meta-analyses were conducted from three prospective, core lab reviewed, clinical events committee/data safety monitoring board-adjudicated, and third-party monitored clinical studies which enrolled a total of 209 heart failure patients with reduced ejection fraction and functional mitral regurgitation (MR).

The first meta-analysis, which focused on patient echocardiographic data, was published online in December 2020 in ESC Heart Failure by Francesco Giallauria, MD, et al. The investigators concluded, “This comprehensive meta-analysis of individual patient data has shown that Carillon device provides statistically significant and clinically meaningful benefits on MR severity, left atrial and left ventricle volumes, and remodeling and rates of subsequent heart failure hospitalization” at 12 months as compared to baseline measures.

Professor Andrew Coats, MD, senior author of the publication stated in the company’s announcement, “The findings of this paper are very compelling, consistent with other published Carillon results and would indicate the Carillon device should be seriously considered in the treatment of this ever-growing patient population.”

On March 30, 2021, the second meta-analysis was published by Muhammad Shahzeb Khan, MBBS, et al online in ESC Heart Failure. This study was based on the same patient population as the first but follows a different path that concentrated more on the clinical outcomes of patients.

According to Cardiac Dimensions, the results from this meta-analysis showed significant improvement in 6-minute walk test (6MWT) distance and Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 1 and 12 months from baseline. In addition, more than 50% of the patients had improvements in KCCQ score of > 5 points at 12 months and > one class improvement in New York Heart Association (NYHA) classification out to 12 months. The company noted that these positive results remained similar for the parameters analyzed when reviewing the subset of the MR 1+ and 2+ population as compared to the MR 3+ or 4+ population.

“Heart failure patients often suffer from reduced quality-of-life and compromised physical function, which is why improving their quality-of-life end points should be the primary consideration,” stated Professor of Cardiology Stefan Anker, MD, an author on the second meta-analysis, in Cardiac Dimensions’ press release. “Our patients don’t care if they have regurgitant volume when they come to the hospital. Their focus is around symptoms, quality-of-life, hospitalizations, and, as the ultimate goal, long-term survival.”

The company stated that these new meta-analyses add to the wide range of recently published materials on the Carillon device. These include the rigorous clinical outcome analysis of the landmark, randomized, blinded, sham-controlled REDUCE FMR trial reported in Journal of the American College of Cardiology: Heart Failure showing a substantially higher number of patients achieved minimum clinically important differences at 12 months as compared to the sham procedure in 6MWT, KCCQ, NYHA class and reduced heart failure hospitalization (2019;7:945-955).

Recent publications have also presented data on long-term patient survival, including one announced by the company in February 2020 that reported 56% survival through 5 years. This was published by Janusz Lipiecki, MD, et al in Cardiovascular Revascularization Medicine (2020;21:712-716).

Dr. Lipiecki commented in the company’s announcement, “Given medical management of these heart failure patients results in a survival rate of 45% at 3 years, the 67.9% rate of survival for patients receiving the Carillon device at 3 years is compelling while the 56% survival rate at 5 years is simply impressive.”

Cardiac Dimensions stated that the Carillon device, which offers a right heart approach to transcatheter mitral valve repair, 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, utilize 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 functional MR in patients with MR grades 2+, 3+, and 4+.

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