February 26, 2020
Carillon System data was presented by Dr. Janusz Lipiecki, a cardiologist in the Center for Interventional Cardiology of Pôle Santé République in Clermont-Ferrand, France, on behalf of all TITAN, TITAN II and REDUCE FMR clinical study investigators.
He commented, “The recent publication of the REDUCE FMR data demonstrated a significant reduction in regurgitant volume and favorable left ventricular remodeling1, confirming the results from prior studies, yet questions remained about the long-term impact of the Carillon System device.” He continued, “As an investigator, I am proud to present the results of this analysis demonstrating that patients with heart failure and moderate-to-severe FMR who underwent transcatheter mitral valve repair with the Carillon System 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.”
A total of 74 patients from the TITAN, TITAN II and REDUCE FMR clinical studies who had symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction was assessed as part of the analysis. For all patients, echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. Key findings from the analysis include:
- Over 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.2
- 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. 2
- 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. 2
- Three-year mortality rate compared to published outcomes of COAPT and guideline-directed medical therapy (GDMT), using matched patient populations, was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 55.5% for GDMT – Figure 1. 2
“Mitral regurgitation in the context of heart failure is strongly associated with increased morbidity and mortality,” commented Steven L. Goldberg, MD, Tyler Heart Institute, Community Hospital of the Monterey Peninsula and Chief Medical Officer at Cardiac Dimensions. “We continue to see a growing body of evidence demonstrating the consistent effectiveness and safety of the Carillon System. The long-term data presented today suggests the primary clinical benefit of percutaneous mitral valve repair may be enhanced after the ventricle has had some time to remodel.” He continued, “We have consistently seen improvements in left ventricular dimensions, which typically is associated with mortality benefits. One would, therefore, anticipate long-term benefits from a decrease in LV volume overload, and these data are supportive.”
Gregory D. Casciaro, President and CEO of Cardiac Dimensions, commented, “This analysis of three important FMR clinical studies is the first to look at five-year follow-up and brings new insights into the long-term role of percutaneous treatment.” He continued, “We are pleased 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, as shown in REDUCE FMR. This reaffirms the effectiveness and safety of the Carillon System and underlines the value of early treatment to slow the deterioration of heart failure.”
An estimated 26 million people, worldwide, suffer from heart failure3 and of those, approximately 70 percent have FMR. Heart failure is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.4
- Witte K, et al, A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. J Am Coll Cardiol, HF I, DOI: 10.1016/j,jchf.2019.06.011
- Lipiecki J, Kaye DM, Witte KK, et al. Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovascular Revascularization Medicine. Advance online publication. doi:10.1016/j.carrev.2020.02.012.
- Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25.
- Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.
- Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
- Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
- Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3
- Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
- Sievert, H. 2018. REDUCE-FMR: A Sham Controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.