Patients Physicians Studies Publications News Company Contact Media Kit Publications ESC Heart Failure Giallauria et al. December 2020 Individual patient data meta‐analysis of the effects of the Carillon Mitral Contour System16 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. March 2021 Effect of Carillon Mitral Contour System on Patient Reported Outcomes in Functional Mitral Regurgitation – An Individual Participant Data Meta-Analysis18 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 Clinical and Echocardiographic 1-Year Outcomes with Percutaneous Mitral Valve Annuloplasty for Mild to Moderate Regurgitation 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.” See More Long-term Survival Publications LONG-TERM SURVIVAL See More Remodelling and Improved Hemodynamics Publications REMODELLING AND IMPROVED HEMODYNAMICS See More Cost Effectiveness Publications COST EFFECTIVENESS See More CRT Compatibility Publications CRT COMPATIBILITY Show footnotes Join our mailing list for invitations to studies along with company announcements. © 2021 Cardiac Dimensions. All rights reserved. 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