ESC Heart Failure
- Patients implanted with the Carillon Mitral Contour System were evaluated for long‐term follow‐up post‐procedure up to 7.5 years.
- Patients experienced a clinically significant reduction in heart failure hospitalizations and symptom improvement post procedure which was sustained through the 6+ year follow-up period.
- Long-term mortality was 40% at 6 years, which compares favorably to several prior studies that have evaluated medically managed patients with FMR.
Patients treated with the Carillon device continue to show sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status 6+ years post procedure. All patients at 6 year follow-up had MR 2+ or less with over half having MR 1+ or trace, and LVEDV was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL (p=0.03).
Department of Cardiology, Frankfurt University Hospital, Frankfurt, Germany
- First study to directly compare patients treated with either Carillon (n=37) or MitraClip (n=137).
- MR grade was significantly reduced (p<0.001) in both groups after procedure.
- MR grade remained reduced in Carillon patients at 2 years (n=9).
- Survival was assessed up to 5 years.
- Median survival in the Carillon group was 3.92 years vs 1.66 years in the MitraClip group (p = 0.01).
- Numerous baseline factors may contribute to the difference in survival benefit observed.
- Pulmonary artery pressure was reduced in both groups after intervention (p<0.05), however, continued decrease at later follow up was observed only in the Carillon group.
This analysis brings new insights into the long-term role of the Carillon Mitral Contour system for the treatment of symptomatic congestive heart failure with functional mitral regurgitation.
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 were 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.
- 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.
- 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.
- 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.
- Dennis Rottländer, MD; Miriel Gödde, MD; Hubertus Degen, MD; Alev Ögütcü, MD; Michael Haude, MD, PhD. Percutaneous Coronary Sinus-Based Mitral Valve Annuloplasty in Atrial Functional Mitral Regurgitation. JACC: Cardiovascular Interventions. December 28, 2020
- Lipiecki, J, Fahrat, H, Séverine, M, et al. Long-term prognosis of patients treated by coronary sinus-based annuloplasty: single centre experience. ESC Heart Failure. October, 2020.
- Stephan Heyl, Aria Nikkhoo, Markus Wieszner, Stephan Fichtlscherer, Florian Seeger, Birgit Assmus, Brigitte Luu, Katrin Hemmann, Claudia Walther, Joerg Honold. Comparison of effectiveness and survival after the MitraClip or Carillon procedure for severe functional mitral regurgitation: a single-center retrospective analysis. Arch Med Sci Atheroscler Dis. June, 2020.
- Stephan Stöbe, Kristin Kreyer, Daniel Jurisch, Dietrich Pfeiffer, Daniel Lavall, Gerardo Farese, Ulrich Laufs, Andreas Hagendorff. Echocardiographic analysis of acute effects of percutaneous mitral annuloplasty on severity of secondary mitral regurgitation. ESC Heart Failure. May, 2020.
- Tobias Friedrich Ruf, Felix Kreidel, Alexander Robert Tamm, Martin Geyer, Omar Hahad, Julia Claudia Zirbs, Ben Luca Schwidtal, Andres Beiras-Fernandez, Klaus K. Witte, Thomas Münzel, Ralph Stephan von Bardeleben. Transcatheter indirect mitral annuloplasty induces annular and left atrial remodelling in secondary mitral regurgitation. ESC Heart Failure. April, 2020.
- 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. February, 2020.
- Kałmucki P., Jerzykowska O., Dankowski R., Baszko A., Kramer L., Szyszka A., Siminiak T. Percutaneous Trans-Coronary Venous Mitral Annuloplasty in Patients With Functional Mitral Regurgitation: Analysis of Poznan Carillon Registry Data. J Interv Cardiol. 2016.
- Klein, N. et al. Mitral Annuloplasty Device Implantation for Non-Surgical Treatment of Mitral Regurgitation: Clinical Experience after the Approval Studies. Journal of Invasive Cardiology. February, 2016.
- Borisenko, O., Haude, M., Hoppe, UC., Siminiak, T., Lipiecki, J., Goldberg, S., Mehta, N., Bouknight, O., Bjessmo S., Reuter DG. Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings. BMC Cardiovascular Disorders. 2015;15:43.
- Soofi, M.A., Alsamadi F. Restoration of Normal Left Ventricular Geometry after Percutaneous Mitral Annuloplasty: Case Report and Review of Literature. Catheterization and Cardiovascular Interventions. 2014.
- Siminiak T, Jerzykowska O, Kałmucki P, Link R, Baszko A. Cardiac resynchronization therapy after percutaneous trans-coronary-venous mitral annuloplasty. Kardiol Pol. 2013;71(12):1293-4.
- Woloszyn M, Jerzykowska O, Kałmucki P, Lunk R, Firek L, Kuzemczak M, Siminiak T. Functional assessment of patients after percutaneous mitral valvuloplasty with Carillon device: a preliminary report. Kardiol Pol. 2011;69(3):228-33.
- Jerzykowska O, Kalmucki P, Woloszyn M, Smuszkiewicz P, Firek L, Siminiak T. Echocardiographic evaluation of percutaneous vavle repair in patients with mitral regurgitation using the Carillon system. Kardiol Pol. 2010;68(1):57-63.
- Hoppe UC, Brandt MC, Degen H, Dodos F, Schneider T, Stoepel C, Kroener A, Haude M. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
- Lainscak M, Bohm, M. Embracing secondary mitral regurgitation with Carillon: past, present, and future. ESC Heart Failure 2020; 7: 3268-3270.
- Giallauria F, Di Lorenzo A, Parlato A, et. al. Individual patient data meta-analysis of the effects of the CARILLON® mitral contour system. ESC Heart Failure 2020; 7: 3383-3391.
- Khan MS et al.; Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE-FMR trial; ESC Heart Failure (2021); Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ehf2.13273.
- Khan MS et al.; Effect of Carillon Mitral Contour System on patient‐reported outcomes in functional mitral regurgitation: an individual participant data meta‐analysis; Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ehf2.13301.
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*NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.