TCT 2022 Poster
Goldberg S et al.
Prospective trials of the Carillon Mitral Contour System have shown effective hemodynamic and clinical improvement in patients with heart failure and functional mitral regurgitation (FMR) including beneficial left ventricular and left atrial remodeling.
The CINCH registry is a multi-center, real-world study of patients treated with the Carillon device as standard of care. It is intended to enroll up to 250 patients in up to 40 centers in Germany.
The poster presented shows an interim analysis of 101 patients with up to 5 years follow-up data, including mortality, device related safety, change in NYHA class and rate of heart failure hospitalizations.
Witte K et al.
Although any degree of secondary mitral regurgitation (SMR) is known to further complicate heart failure symptoms and mortality, a treatment paradigm for patients with mild and moderate SMR is lacking. The recent publication on Carillon in the European Journal of Heart Failure – Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation – was particularly enlightening.
The purpose of the authors’ investigation was to determine the effects of percutaneous mitral annuloplasty on symptoms, 6-minute walk distance, and left ventricular (LV) structure and function in patients with mild or moderate SMR in heart failure with reduced ejection fraction. They examined a total of 68 patients from all Carillon trials who had mild and moderate SMR in a retrospective study of one-year outcomes. The findings were very encouraging:
- Mean 6-minute walk test distance increased by 34 m (95% CI 12 to 57; P < 0.01)
- Mean KCCQ scores increased from baseline by 10 units [95% confidence interval (CI) 3 to 17; P < 0.01]
- SMR grade improved in 25% of patients and was maintained in 58% of patients with changes in mean regurgitant volume of −7 mL (95% CI −11 to −3; P < 0.001), vena contracta −0.11 cm (95% CI −0.20 to −0.02; P < 0.05), and effective regurgitant orifice area −0.03 cm2 (95% CI −0.06 to −0.01; P < 0.05)
- New York Heart Association class status was maintained (48%) or improved (46%) in the vast majority of patients
- Survival over one year was 89% and freedom from HF hospitalization was 73%
The authors conclude: “Among patients with symptomatic HF and mild or moderate SMR on guideline-directed medical therapy, percutaneous mitral annuloplasty [i.e., the Carillon therapy] was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.”
Eur J Cardiothorac Surg
Rudzinski et al.
This publication documents the case of a 70-year-old female with symptomatic severe native aortic regurgitation, acquired dextrocardia, moderate-to-severe secondary mitral regurgitation and prohibitive surgical risk. Six months after treatment with aortic valve replacement, the patient remained symptomatic due to moderate-to-severe secondary mitral regurgitation. The patient was treated with the Carillon therapy which resulted in a significant reduction of mitral regurgitation and uneventful follow-up.
This case illustrates the flexibility of the Carillon implant to be used successfully alongside other therapies and highlights the short user learning curve of the Carillon therapy as the procedure was performed by a cardiac surgeon, not an interventional cardiologist.
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- 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.
- Anker SD, Starling RC, Khan MS, Friede T, Filippatos G, Lindenfeld J, Stephan von Bardeleben R, Coats AJS, Butler J. Percutaneous Mitral Valve Annuloplasty in Patients With Secondary Mitral Regurgitation and Severe Left Ventricular Enlargement. JACC Heart Fail. 2021. doi: 10.1016/j.jchf.2021.03.002.
- Klaus K Witte, David M Kaye, Janusz Lipiecki, Tomasz Siminiak, Steven L Goldberg, Ralph S von Bardeleben, Horst Sievert, Wayne C Levy, Randall C Starling. Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation.
Eur J Heart Fail. 2021. doi: 10.1002/ejhf.2310.
- Piotr Nikodem Rudziński, Markus Mach, Christoph Gross, Martin Andreas. Complex transcatheter aortic valve replacement in aortic regurgitation and transcatheter mitral annuloplasty in severe dextrocardia. Eur J Cardiothorac Surg. 2021. doi: 10.1093/ejcts/ezab124.
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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.