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Functional mitral regurgitation (FMR) is a common valvular heart disease in the geriatric population across the United States. This patient cohort is multimorbid and often has a prohibitive risk for conventional open-heart surgery. The diverse anatomic pathology of FMR is a complex problem and unfortunately does not have a universal solution. Carillon Mitral Contour System (Cardiac Dimensions, Kirkland, WA, USA) is a new device that provides transcatheter annular remodeling. In this review article, the authors summarize the evidence for the Carillon Mitral Contour System for FMR., Competing Interests: Disclosures No conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The Carillon® Mitral Contour System® has been studied in 4 prospective controlled studies in the treatment of functional mitral regurgitation (FMR) where it has been found to reduce mitral regurgitation, reduce left ventricular and atrial volumes, and be associated with improvements in clinical parameters., Aims: The CINCH post-market registry is designed to evaluate immediate, mid-term and long-term outcomes from a post-approval study of the Carillon® device evaluated in real-world practice., Methods: The CINCH post-market registry is a single-arm study of percutaneous mitral annuloplasty with the Carillon device in patients with functional (secondary) mitral regurgitation and symptomatic congestive heart failure when utilized in real-world conditions. Patient selection, echocardiographic hemodynamic measurements, and patient follow-up requirements were performed per standard of care at each institution., Results: A total of 101 patients treated with the Carillon device at 13 sites in Germany were enrolled in the CINCH registry. The mean age was 75 ± 9 years, 57 % were male, and patient presentation included primarily NYHA class III (69 %) with MR grade 3 (68 %). Over 5 years of follow-up, all-cause mortality was 40.1 %, the incidence of HFH was 53.9 %, and the composite outcome of HFH or death was 66.4 %. At each follow-up interval through 5 years, statistically significant reductions in NYHA class (p < 0.05) and MR grade (p < 0.01) were reported., Conclusions: In this "real world" registry of the Carillon Mitral Contour System, procedural safety and medium-term follow-up outcomes is similar to the outcomes seen in the prospective, controlled clinical trials, despite being used in populations of patients that extend outside of those studied in the trials. The use of this therapy in patients with atrial functional mitral regurgitation, and heart failure with preserved ejection fraction, was notable, since these types of patients were excluded from the prospective, controlled trials. This supports possible additional patient populations who might benefit from this type of mechanical therapy. The safety profile of this therapy in this registry and in the earlier trials may support a potential role in earlier forms of secondary mitral regurgitation., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Inc.)

Objectives: This study sought to determine the effect of percutaneous mitral valve annuloplasty with the Carillon device versus guideline-directed medical therapy (GDMT) alone in patients with secondary mitral regurgitation (MR) and severe left ventricular (LV) enlargement., Background: The clinical impact of the Carillon device in patients with severe LV dilation is not well established., Methods: This is a pooled analysis involving 3 prospective trials (TITAN [Transcatheter Implantation of Carillon Mitral Annuloplasty Device], TITAN II, and REDUCE FMR [CARILLON Mitral Contour System for Reducing Functional Mitral Regurgitation] trials) in which patients with functional MR and severe LV enlargement (LV end-diastolic diameter >65 mm) were treated with GDMT and the Carillon device versus GDMT alone. Key outcomes of this analysis were changes over 1 year of follow-up in mitral valve and LV echocardiographic parameters, functional outcome, quality of life, mortality, and heart failure hospitalization (HFH)., Results: A total of 95 patients (67 in the Carillon group, 28 in the GDMT group) with severe LV enlargement were included. In the Carillon group, all mitral valve and LV morphology parameters were significantly improved at 1 year. Regurgitant volume decreased by 12 ml (p < 0.001), MR grade decreased by 0.6 U (p < 0.001), LV end-diastolic volume decreased by 25 cm 3 (p = 0.005), and LV end-systolic volume decreased by 21 cm 3 (p = 0.01). Significant functional improvement differences were also noted between the Carillon group and the GDMT group including an improvement of Kansas City Cardiomyopathy Questionnaire score (15 ± 4 vs. 6 ± 6; p = 0.03). The incidence of HFH was 29.9% versus 50.0% and the cumulative rate of HFH was 0.43 versus 0.75 (p < 0.001)., Conclusions: In patients with functional MR and severe LV enlargement, the Carillon device improved mitral valve function, LV morphology, and functional outcome compared with patients receiving GDMT only. Preoperative LV dimension should not be a limiting factor when evaluating patient eligibility or anticipated response to therapy with the Carillon device., Competing Interests: Funding Support and Author Disclosures The trial was sponsored by Cardiac Dimensions (Kirkland, Washington). Dr. Anker has received grants and personal fees from Vifor and Abbott Vascular; and personal fees from AstraZeneca, Bayer, Brahms, Boehringer Ingelheim, Cardiac Dimensions, Novartis, Occlutech, Servier, and Vifor. Dr. Starling has served on the advisory board for the PARAGLIDE Trial (Novartis) and Cardiac Dimensions; and has conducted sponsored research Corvia. Dr. Filippatos has received lecture fees and/or Committee Member contributions in trials sponsored by Medtronic, Vifor, Servier, Novartis, Bayer, Amgen, and Boehringer Ingelheim. Dr. Butler has received consulting fees from Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave, Vifor, and Cardiac Dimensions. Dr. von Bardeleben has received consultancy and lecture honoraria from Abbott Vascular, Cardiac Dimensions, Edwards Lifesciences, GE Health Systems, and Philips Healthcare. Dr. Lindenfeld has received grant support from AstraZeneca; and consulting income from Abbott Vascular, Edwards Lifesciences, Boston Scientific, RESMED, Relypsa, Boehringer Ingelheim, and V-Wave. Dr. Coats has received honoraria and/or lecture fees from AstraZeneca, Bayer, Menarini, Novartis, Nutricia, Servier, Vifor, Actimed, Cardiac Dimensions, CVRx, Enopace, Faraday, Gore, Impulse Dynamics, Respicardia, Stealth Peptides, V-Wave, Corvia, Arena, and ESN Cleer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Functional mitral regurgitation (FMR) is common in severe heart failure. Medical therapy is the standard of care since the role of surgery is less established. Various trans-catheter percutaneous techniques may avoid the risks of surgery; such as edge-to-edge repair using MitraClip system (Abbott Vascular, Illinois, USA) and CARILLON® Mitral Contour System® (Model XE2; Cardiac Dimensions., Kirkland, WA, USA). We present the case of a 41-year-old man with severe dilated cardiomyopathy, NYHA IIIb, and grade 3 MR. Due to high surgical risk (logistic EuroScore 35.1) he initially underwent single MitraClip insertion with significant echocardiographic and clinical improvement (MR reduced from 3+ to 1+, NYHA classes III to II). Fifteen months later, he developed heart failure symptoms due to recurrence of severe MR and was retreated with percutaneous CARILLON® Mitral Contour System® with resolution of MR and doing well at nine-month follow-up. A combined approach of MitraClip followed by percutaneous mitral annuloplasty demonstrated clinically meaningful reduction of MR and resulted in significant symptomatic improvement for up to 6months. Follow-up for longer period is warranted to ensure sustained favorable outcome., (Copyright © 2016 Elsevier Inc. All rights reserved.)