ESC Heart Failure
Giallauria et al.
An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled 209 heart failure patients with reduced ejection fraction and functional mitral regurgitation (FMR). Patients implanted with the Carillon Mitral Contour System or control were assessed for 12-month outcomes relating to mitral regurgitation severity, left ventricular (LV) remodeling, functional status, and heart failure‐related hospitalization.
- Patients implanted with the device showed significantly improved hemodynamics, MR severity (regurgitant volume and MR grade), left ventricular volume (LVEDV) and left atrial volume (LAV), as compared to those patients who did not receive a device at 12 months.
- Improvement of symptoms as assessed by change in NYHA class also significantly favored device implantation vs control (p<0.00001) with 69.9% (51/73) of implanted patients with baseline class III or IV improving by at least one class at 12 months.
- Similarly, the rate of hospitalizations due to heart failure (HFH) was significantly reduced in implanted patients (45.3% vs 64%, p=0.04).
- Sensitivity analysis performed on subjects with more severe MR (MR grade 3+/4+) at baseline supported the overall cohort in terms of hemodynamic improvement and maintained a significant improvement in HFH (43.9% vs 82.9%, p=0.04).
In conclusion, this comprehensive meta‐analysis of individual patient data has shown that the CARILLON device provides statistically significant and clinically meaningful benefits in LV volumes, NYHA functional class and indexes of mitral valve performance, along with a reduction in the rate of subsequent HFH.
ESC Heart Failure
Khan et al.
An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled heart failure patients with reduced ejection fraction and functional mitral regurgitation (FMR) implanted with the Carillon Mitral Contour System. The main outcomes assessed were changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Scores (KCCQ-OSS), six-minute walk test (6MWT) distance and New York Heart Association (NYHA) classification at month 1 and 12 post device implantation.
- Among 139 patients included in the analysis, Carillon device significantly improved the 6MWT distance (63.0m; 95%CI 18.8-107.2, p=0.0056) and KCCQ-OSS score (15.1; 95%CI 5.6-24.7, p=0.0022) at 1 month from baseline. These benefits were sustained at 12 months (64.1m; 95%CI 13.2-115.0, p=0.0141for 6MWT distance, and 12.3; 95%CI 4.7-19.8, p=0.0019 for KCCQ-OSS score).
- More than 50% of the patients had improvements in KCCQ-OSS by ≥ 5 (60.4%; 95%CI 47.4-72.1) and 10 points (50.5%; 95%CI 34.9-66.0) at 12 months.
- Almost half of the patients experienced a ≥1 class improvement in NYHA class after implantation of the device at 1 month (67.9%; 95%CI 37.3-88.3) and at 12 months (48.8%; 95%CI 31.8-66.2).
- Results remained similar for KCCQ-OSS, 6MWT distance and NYHA classification when only patients with grade 3 or 4 mitral regurgitation were analyzed.
The Carillon Mitral Contour System significantly improved patient reported quality of life outcomes in heart failure patients with functional mitral regurgitation. Quality of life improvement in patients who were treated with the Carillon device was similar or better than other recently reported heart failure trials.
ESC Heart Failure
Witte K et al. – 2021 EJHF
Although any degree of Secondary mitral regurgitation (SMR) is known to further complication heart failure symptoms and mortality, a treatment paradigm for patients with mild and moderate SMR is lacking.
The purpose of this investigation was to determine the effects of percutaneous mitral annuloplasty on symptoms, walk distance and left ventricular (LV) structure and function in patients with mild or moderate secondary mitral regurgitation (SMR) in heart failure with reduced ejection fraction. A total of 68 patients from all Carillon trials with mild and moderate SMR were analyzed in a retrospective study of 1 year outcomes.
- New York Heart Association class status was maintained (48%) or improved (46%) in most patients
- Mean KCCQ scores increased from baseline by 10 units [95% confidence interval (CI) 3 to17; P < 0.01]
- Mean 6-min walk test distance increased by 34 m (95% CI 12 to 57; 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).
- Survival over 1 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 was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.”
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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.
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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.