CRT Compatibility

doi: 10.12998/wjcc.v4.i5.127

December 2013

Cardiac resynchronization therapy after percutaneous trans-coronary- venous mitral annuloplasty ¹¹

Carillon can be implanted prior to CRT and may provide additional benefit to HF patients with FMR, low ejection fraction and wide QRS.

Case study of a 45-year-old male with ischemic heart failure who underwent successful implantation of a Carillon device.
The procedure resulted in clinical improvements and a decrease in FMR.
Fifteen months post implant, the patient was a candidate for CRT and underwent successful implantation, which resulted in further improvement of clinical and echocardiographic parameters.

Catheter Cardiovasc Interv.

doi: 10.1002/ccd.22097

September 2009

Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy ¹⁴

It is possible to implant the Carillon device prior to a CRT device in HF patients with low ejection fraction, wide QRS and FMR.

Three patients meeting current guidelines for cardiac resynchronization therapy (CRT) included in the AMADEUS trial underwent CRT implantation 7-8 months after implantation of a mitral valve annuloplasty device.
Access to the coronary sinus and placement of the left ventricular lead into a posterolateral cardiac vein was not at all compromised by the mitral valve annuloplasty device in any patient.

>> Show footnotes
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.

Amar Krishnaswamy, Samir R Kapadia. Indirect Mitral Annuloplasty Using the Carillon Device. Front Cardiovasc Med. 2020. doi: 10.3389/fcvm.2020.576058.

Kalmucki P, Lipiecki J, Witte K, Goldberg S, Baszko A, Siminiak T. Percutaneous mitral annuloplasty with the Carillon device: Outcomes in proportionate and disproportionate functional mitral regurgitation. Am Heart J 2023;265:137–142

Lipiecki, J, Kaye D, Witte K, Haude M, Kapadia S, Sievert H, Goldberg S, Levy W, Siminiak T.

Witte. New Results from the CINCH-FMR Post-Market Registry: Treatment of Heart Failure Patients with Functional Mitral Regurgitation with the Carillon Mitral Contour System. THT 2025. Symposium Presentation

Priebe-Brämer. 200+ Patients, Real-World Impact: Carillon Therapy in Routine Care. THT 2025. Symposium Presentation

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CAUTION: USA: Investigational device. Limited by Federal (or United States) law to investigational use.

Canada: Investigational device. To be used by qualified investigators only.

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