Carillon Mitral Contour System Research Articles

Outcomes of COMBO therapy for severe mitral regurgitation compared with transcatheter edge-to-edge repair.

There are different types of transcatheter mitral valve repair (TMVr) currently in clinical use, including leaflet approximation, annular cinching, and restoration of the chordal apparatus of the mitral valve (MV). While the concomitant combination (COMBO) therapy of mitral transcatheter edge-to-edge repair (M-TEER) with another TMVr concept has been proven feasible, potentially offering patient-tailored treatment for severe mitral regurgitation (MR), a comparison with M-TEER alone has not been made. To evaluate the procedural and clinical outcome of COMBO therapies compared with M-TEER alone. We included consecutive patients undergoing COMBO and M-TEER between March 2015 and April 2018 at our Heart Valve Center, while excluding patients presenting a case of redo or with previous MV surgery. Procedural outcomes and all-cause mortality were compared between COMBO therapy vs. M-TEER alone. A total of 357 patients (mean age 78.9 ± 7.0 years, 53.2% male, M-TEER n = 322, COMBO n = 35; COMBO: MitraClip and the Carillon mitral contour system n = 26, MitraClip and Cardioband n = 5, and MitraClip and NeoChord n = 4) were analyzed. Patients with COMBO therapy had larger left chamber sizes, a lower left ventricular systolic ejection fraction (LVEF; COMBO: 37.4 ± 13.8%, M-TEER: 47.9 ± 14.3%, p < 0.001), and a more severe MR grade (p < 0.001). There were no significant differences in the prevalence of residual MR ≧2+. However, the need for re-intervention, always employing M-TEER, was more common in the COMBO group. During a mean 3.6-year long-term follow-up, there was no significant difference of all-cause mortality between both groups (Log rank p = 0.921). COMBO therapy may still be a beneficial therapy option for patients with severe MR who already have a more dilated left ventricle (LV), a more severe MR, and a more pronounced LV systolic dysfunction. The higher need for re-intervention in the COMBO group may signal more complex anatomies and possibly underlines the necessity of treating significant MR earlier. Future research is required to establish the COMBO approach as a toolbox-like treatment option, thus offering a patient-tailored approach depending on the individual anatomy and pathology.

The CINCH-FMR postmarket registry: Real-world long-term outcomes with percutaneous mitral valve repair with the Carillon Mitral Contour System®

BackgroundThe 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. AimsThe 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. MethodsThe 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. ResultsA 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. ConclusionsIn 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.

Reverse cardiac remodeling in patients undergoing combination therapy of transcatheter mitral valve repair.

For patients with severe mitral valve regurgitation (MR), different kinds of transcatheter mitral valve repair (TMVr) exist, targeting the leaflets, annulus, and chordae. The concomitant combination (COMBO) therapy of TMVrs is rarely used as treatment, and there are very few publications about this therapeutic strategy. We evaluated the effect of COMBO-TMVr on the cardiac left chambers and clinical data, including survival. We included 35 patients at high risk who underwent concomitant sequential transcatheter mitral valve edge-to-edge repair (M-TEER) and another TMVr for severe MR in our hospital between March 2015 and April 2018. Of these, 13 had adequate follow-up transthoracic echocardiography (TTE) up to around 1 year after the procedure. Survival for all patients was 83% at 1 year, 71% at 2 years, and 63% at 3 years, respectively. In the 13 patients with adequate TTE follow-up, M-TEER plus either Cardioband (n = 4), Carillon Mitral Contour System (n = 7), or Neochord (n = 2) were used, respectively. Ten patients had secondary, and three patients primary MR. After 1 year, changes [median (Q1, Q3)] of left ventricular (LV) end-systolic diameter of -9.9 cm (-11.1, 0.4), LV end-diastolic diameter of -3.3 cm (-8.5, 0.0), LV end-systolic volume (LVESV) of -17.4 mL (-32.6, -0.4), LV end-diastolic volume (LVEDV) of -13.5 mL (-15.9, -3.2), LV mass of -19.5 g (-24.2, -7.6), and left atrial volume (LAV) index (LAVi) of -16.4 mL (-23.3, -11.3) were observed. A significant reduction was also seen in the change ratios of LVESV, LVEDV, LV mass, and LAVi, respectively. We found that COMBO therapy of TMVr seems feasible and may support reverse remodeling of left cardiac chambers during 1 year after the procedure in a cohort of patients at high risk.

TCT-416 Interim Results of the CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation (FMR) With the Carillon Mitral Contour System

TCT-416 Interim Results of the CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation (FMR) With the Carillon Mitral Contour System

C34 INDIRECT MITRAL ANNULOPLASTY USING THE CARILLON CONTOUR SYSTEM, SINGLE CENTER EXPERIENCE

Abstract Mitral Regurgitation (MR) is both the most common and the most underdiagnosed valvulopathy in Western countries. When MR’s entity is moderate to severe it is highly burdened by incident heart failure causing an important impact on prognosis, in terms of mortality and re–hospitalization. Unfortunately a lot of symptomatic patients are not elegible to reparative or replacement surgery also due to the high procedural risks. Hence, the need for a less invasive treatment has grown, so endovascular repair techniques have been developed such as the CARILLON Mitral Contour System, a percutaneous procedure for reshape the mitral annulus reducing its dilation and mitral regurgitation. This technique is indicated for patients with secondary mitral regurgitation. The CARILLON is a simple and fast procedure with a right jugular approach that requires neither general anesthesia nor anticoagulant/antiplatelet therapy. Four patients including 3 men, aged 37–64 years, suffering from heart failure and moderate to severe secondary mitral regurgitation who were symptomatic in optimal medical therapy, NYHA II – III class, were admitted to our Cardiological Intensive Care Unit from April to September 2021. All patients underwent coronary angiography and three patients had no obstructive coronary artery disease (CAD). All patients underwent transthoracic and transesophageal echocardiography showing severely dilated left ventricles (DTD 70 ± 10mm, DTS 46 ± 21mm, VTD 264 ± 6ml, VTS 204 ± 6ml), severe reduction in ejection fraction (mean EF 24 ± 5%), severely dilated left atrium, mean volume values 47 ± 13ml/m2, moderate to severe mitral regurgitation (vena contracta 6 ± 2mm, EROA 34 ± 9mm2, regurgitation volume 37 ± 12 ml, regurgitation fraction mean 54 ± 4%). After implantation of the Carillon no complications were observed. In the 3–month follow–up, patients reported improvement in symptoms, exercise capacity and NYHA class. At the echocardiographic evaluation we saw improvement in contractile function and left ventricular size, reduction in the degree of mitral regurgitation to mild–moderate. There were no further hospitalizations for heart failure during the follow–up. The data, albeit limited to our little experience, show how the Carillon reduces mitral regurgitation and improves clinical outcomes in terms of exercise tolerance, quality of life and reduction of hospital admissions, which have social and economic relevance.

Prognostic Value of Nutritional Indexes in Evaluating the 1-Year Results after Implantation of the Carillon Mitral Contour System.

The prognostic importance of nutritional indexes has been shown in some diseases. We aimed to examine the prognostic value of these indexes in patients implanted with the Carillon Mitral Contour System (CMCS). Fifty-four patients who underwent successful CMCS implantation were evaluated. Prognostic nutritional index (PNI), geriatric nutritional risk index (GNRI) and controlling nutritional status (CONUT) scores were calculated. The relationships between these indexes and 1-year clinical outcomes including all-cause mortality and re-hospitalization due to heart failure were investigated. In Kaplan-Meier analysis, 1-year all-cause mortality rates were significantly higher in the patients with low PNI and GNRI and high CONUT scores (52.0% vs. 0%, p < 0.001; 54.2% vs. 0%, p < 0.001; 52.4%, 6.1%, p < 0.001; respectively). For the composite endpoint, a significant difference was observed between those below and above the cut-off values (70.0% vs. 16.7%, p < 0.001; 75.0% vs. 23.3%, p < 0.001; 66.7% vs. 20.8%, p < 0.001, respectively). In multivariate Cox regression analysis, GNRI was determined to be an independent predictor of 1-year all-cause mortality [hazard ratio: 0.707; 95% confidence interval: 0.510-0.979; p = 0.037]. Nutritional indexes have prognostic value in predicting 1-year all-cause mortality in severe functional mitral regurgitation patients undergoing CMCS implantation. In particular, GNRI can guide the selection of patients who will benefit from CMCS.

Mitral valve edge-to-edge repair versus indirect mitral valve annuloplasty in atrial functional mitral regurgitation.

We aimed to compare indirect mitral annuloplasty using the Carillon Mitral Contour System and edge-to-edge repair via MitraClip in atrial functional mitral regurgitation (aFMR). In patients with left ventricular dilation, both edge-to-edge repair and indirect mitral annuloplasty are effective in reducing mitral regurgitation, while no clinical trial has compared both interventional methods in aFMR. In a retrospective single-center analysis, 41 patients with aFMR underwent either edge-to-edge mitral valve repair (MitraClip group, n = 20) or indirect annuloplasty (Carillon group, n = 21). Both treatment groups showed high procedural success (100%) and low complication rates. Both treatment groups showed a comparable reduction of New York Heart Association (NYHA) classification postimplantation, after 3- and 12-months follow-up. Quantitative reduction in echocardiographic FMR parameters was significantly pronounced in the MitraClip group (reduction in vena contracta MitraClip vs. Carillon: postimplantation -74.6 ± 25.8 vs. -29.1 ± 17.8%, 3-months follow-up -65.8 ± 31.2 vs. -33.9 ± 17.5%, 12-months follow-up -50.8 ± 27.9 vs. -23.9 ± 17.0%, p < 0.05). Qualitative mitral valve assessment showed improved FMR class postimplantation, at 3-and 12-months follow-up in both treatment groups. Edge-to-edge repair revealed better results with lower average FMR classification compared to indirect coronary sinus-based annuloplasty. After 12-months left atrial (LA) volume was significantly reduced in the Carillon group, while in the MitraClip group no LA remodeling was found (reduction in LA volume MitraClip vs. Carillon at 12 months: +9.6 ± 25.1% vs. -12.3 ± 12.7%, p < 0.05). Both indirect mitral valve annuloplasty and edge-to-edge repair are feasible and safe in patients with aFMR, while the reduction in FMR was pronounced in the edge-to-edge repair group.

Evaluation of percutaneous annuloplasty for treatment of functional mitral regurgitation: A retrospective study.

The management of severe functional mitral regurgitation (FMR) in patients with heart failure (HF) and low ejection fraction is controversial, but percutaneous transcatheter procedures are promising. In this retrospective analysis, we aimed to assess the efficacy of the Carillon Mitral Contour System in patients with "inoperable" severe FMR. Seventy three patients (mean age 66.89, range 31-90 years) with congestive heart failure (CHF), severe FMR, and reduced ejection fraction (<35%) who underwent Carillon device implantation were examined. The study group consisted of patients with successfully implanted devices whereas the control group comprised patients in whom the device could not be deployed. The primary endpoint was combined all-cause mortality and first hospitalization for HF (whichever came first). The median (Q1, Q3) follow-up was 31 (11-49) months. The device was deployed successfully in 50 patients (implant group) and not in 23 patients (non-implant group). Both the primary endpoint and all-cause mortality were lower in the "implant" group, but the differences were not significant. The median to primary endpoint was 21 [95% confidence interval (CI) 8.8-33.2] and six (95% CI 0.1-11.9) months for the implant group and the non-implant group, respectively (p=0.078). Carillon Mitral Contour System implantation is a safe procedure and results in the reduction of all-cause mortality and combined endpoint of mortality and hospitalizations for HF in inoperable patients with severe FMR and low ejection fraction, although the difference did not meet the significance level.

Percutaneous Mitral Valve Annuloplasty in Patients With Secondary Mitral Regurgitation and Severe Left Ventricular Enlargement

ObjectivesThis 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. BackgroundThe clinical impact of the Carillon device in patients with severe LV dilation is not well established. MethodsThis 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). ResultsA 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 cm3 (p = 0.005), and LV end-systolic volume decreased by 21 cm3 (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). ConclusionsIn 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.

Effect of Carillon Mitral Contour System on patient-reported outcomes in functional mitral regurgitation: an individual participant data meta-analysis.

AimsThe Carillon Mitral Contour System has been shown to reduce mitral regurgitation and left ventricular volumes in symptomatic heart failure patients with functional mitral regurgitation. We sought to evaluate the effects of the Carillon device on quality of life and functional capacity in these patients.Methods and resultsAn individual participant data meta‐analysis was conducted utilizing data from REDUCE‐FMR, TITAN, and TITAN II studies. The main outcomes assessed were changes from baseline in Kansas City Cardiomyopathy Questionnaire overall summary scores (KCCQ‐OSS), 6 min walk test (6MWT) distance, and New York Heart Association (NYHA) classification at Months 1 and 12 after device implantation. Subgroup analyses were conducted for patients with severe functional mitral regurgitation (Grade 3 or 4). Pooled estimates were calculated using a random‐effects model and are presented as weighted proportions or weighted mean differences along with 95% confidence intervals (CIs). Among 139 patients included in the analysis, Carillon device significantly improved the 6MWT distance (63.0 m; 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 (64.1 m; 95% CI 13.2–115.0, P = 0.0141, for 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 analysed. The pooled estimates of 30 day and 1 year all‐cause mortality were 2.2% (95% CI 0.7–6.5) and 17.3% (95% CI 11.8–24.5), respectively.ConclusionsThe Carillon Mitral Contour System significantly improved patient‐reported quality‐of‐life outcomes in heart failure patients with functional mitral regurgitation.

Functional outcomes with Carillon device over 1year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE-FMR trial.

AimsThe objective of this study was to compare functional outcomes through 1 year in patients with core‐lab verified moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control in the blinded sham‐controlled REDUCE‐FMR (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation) study.Methods and resultsThe main outcomes of this analysis were the change in 6 min walk test (6MWT) distance, incidence of heart failure hospitalization or death, change in New York Heart Association (NYHA) class, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 1 year of follow‐up. The minimum clinically important difference (MCID) was defined as a ≥30 m increase in 6MWT distance, an NYHA decrease in ≥1 class, and a ≥3 point increase in KCCQ score. The proportion of patients achieving the MCID in each treatment group was compared using Fisher's exact test, and the number needed to treat (NNT) with the Carillon device was calculated. Among 83 patients (62 Carillon and 21 sham), no statistically significant group differences were observed in the baseline characteristics. All outcomes at 1 year numerically favoured the Carillon group, including MCID for the 6MWT distance (59% vs. 23%, P = 0.029; NNT = 2.8), NYHA class (48% vs. 33%, P = 0.38; NNT = 6.9), KCCQ score (69% vs. 47%, P = 0.14; NNT = 4.5), and freedom from heart failure hospitalization or death (60% vs. 48%, P = 0.45; NNT = 8.3).ConclusionsREDUCE‐FMR was the first blinded sham‐controlled trial to report outcomes with percutaneous therapy for the treatment of FMR. Trends towards improvement in mean 6MWT distance, KCCQ score, and NYHA class were observed with the Carillon device. A substantially higher number of patients achieved MCID for all patient‐centred outcomes with the Carillon device compared with the sham procedure.

Long-term prognosis of patients treated by coronary sinus-based percutaneous annuloplasty: single centre experience.

AimsThis study aims to report long‐term mortality, echocardiographic, and clinical outcomes of patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device.Methods and resultsThis was a single centre analysis of prospectively collected data from patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline‐directed medical therapy, who were included from a single centre from the TITAN II study. All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction. Surviving patients were evaluated for long‐term follow‐up post‐procedure, averaging 6.9 years. Fifteen (15) patients (mean age 72 years, 60% male, 100% NYHA class III or IV, 50% MR grade 3+ or 4+) were treated with the Carillon device. The Kaplan–Meier mortality rate was 40% at 6 years of follow‐up. Long‐term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non‐survivors from baseline to 1 year follow‐up, −9.0 ± 5.6 vs. −1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow‐up between survivors versus non‐survivors, P = 0. 05) which was sustained throughout follow‐up. All patients at 6 year follow‐up had ≤2+ MR, with 6 of 7 having 0–1+ MR. Left ventricular end‐diastolic volume was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL at 6 year follow‐up, P = 0.03 in survivors with both measurements.ConclusionsAmong patients with congestive heart failure treated with the Carillon device, long‐term survival is associated with favourable 1 year and sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status.

CT‐Angiography to predict outcome after indirect mitral annuloplasty in patients with functional mitral regurgitation

Coronary sinus (CS) based mitral annuloplasty using the Carillon device is effective in reducing functional mitral valve regurgitation (FMR). However, this positive effect might be dependent on the relation between CS and the mitral annulus. Computed tomography (CT) assessment prior to mitral valve interventions is an emerging technique to optimize patient selection. In a retrospective analysis 30 patients underwent Carillon device implantation and received CT-angiography prior to CS based percutaneous mitral valve repair. Patients were assigned to responders or non-responders according to the 3-month transthoracic echocardiographic follow-up including quantitative mitral valve regurgitation assessment. A prototype software for CS reconstruction was used to assess distance and angle of both CS and mitral annulus planes. Comparison of the distance and angle of the CS plane and the mitral valve annulus plane showed a significant shorter distance and lower angle in the responder group implicating an impact on procedure success. Our results suggest a CS plane and MV annulus plane with a favorably distance of <7.8 mm and an optimal angle of <14.2° could be considered favorably for mitral annuloplasty using a Carillon device. Distance and angle of mitral annulus and CS planes determined by three-dimensional reconstructions of CT-angiography might predict a reduction in echocardiographic FMR using Carillon Mitral Contour System.

Transcatheter indirect mitral annuloplasty induces annular and left atrial remodelling in secondary mitral regurgitation.

AimsMitral annuloplasty using the Carillon Mitral Contour System (CMCS) reduces secondary mitral regurgitation (SMR) and leads to reverse left ventricular remodelling. The aim of this study was to evaluate the effect of the CMCS on the mitral valve annulus (MA) and left atrial volume (LAV).Methods and resultsWe retrospectively evaluated the data of all patients treated with the CMCS at our centre. Using transthoracic echocardiography, MA diameters were assessed by measuring the anterolateral to posteromedial extend (ALPM) and the anterior to posterior (AP) dimensions, respectively. Also, LAV and left ventricular end‐diastolic volume (LVEDV) were assessed. Patients were examined at three time points: baseline, at 20–60 days (30dFUP), and at 9–15 months (1yFUP), using paired analysis. From July 2014 until March 2019, 75 cases of severe SMR were treated using CMCS. Cases in which other devices were used in combination (COMBO therapy, n = 35) or in which the device could not be implanted (implant failure, n = 3) were excluded, leaving 37 patients in the present analysis. Analysis at 30dFUP showed a significant reduction of 16% in the mean ALPM diameter (7.27 ± 5.40 mm) and 15% in the AP diameter (6.57 ± 5.33 mm). Analysis of LAV also showed a significant reduction of 21% (36.61 ± 82.67 mL), with no significant change in LVEDV. At 1yFUP, the reduction of both the mean ALPM diameter of 14% (6.24 ± 5.70 mm) and the mean AP diameter of 12% (5.46 ± 4.99 mm) remained significant and stable. The reduction in LAV was also maintained at 23% (37.03 ± 56.91 mL). LAV index was significantly reduced by 17% at 30dFUP (15.44 ± 40.98 mL/m2) and by 13% at 1yFUP (11.56 ± 31.87 mL/m2), respectively. LVEDV index showed no significant change at 30dFUP and a non‐significant 10% reduction at 1yFUP (17.75 ± 58.79 mL/m2).ConclusionsThe CMCS successfully treats symptomatic SMR with a stable reduction of not only the AP diameter of the MA, but the current study also demonstrates an additional reduction of the ALPM dimension at both 30dFUP and 1yFUP. We have also shown for the first time that LAV and LAV index are significantly reduced at both 30dFUP and 1yFUP and a non‐significant positive remodelling of the LVEDV. This positive left atrial remodelling has not been looked for and demonstrated in earlier randomized studies of CMCS.

The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation

ObjectivesThis study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling. BackgroundFunctional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis. MethodsIn this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis. ResultsPatients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: −11.7 to −2.5] vs. an increase of 3.3 ml/beat [95% CI: −6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: −18.5 to −2.4] vs. an increase of 6.5 ml [95% CI: −5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: −12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: −1.42 to 13.6]; p = 0.04). ConclusionsThe Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830)

Implantation of CARILLON® Mitral Contour System with transvenous left ventricular lead in place.

Cardiac resynchronisation therapy (CRT) is an established treatment option for chronic heart failure patients with left bundle branch block. Although a concomitant functional mitral regurgitation is often reduced by CRT, many patients need additional mitral valve repair. Placing a CARILLON® Mitral Contour System (CMCS) over a transvenous CRT lead is currently not recommended, since both of them are implanted in the coronary sinus (CS). The aim of this study was to investigate the feasibility of sequential implantation of a transvenous LV lead followed by CMCS implantation, and to assess LV lead performance and possibility of extraction. Standard transvenous LV leads were implanted in the CS of five female sheep. After establishing regular anatomical position with stable electrical parameters of the LV lead, a CMCS was additionally implanted in the CS. After an observation period of 100days, lead performance and positions of lead and CMCS were studied. Sequential implantation of the two components was feasible in sheep. After 100days, all leads showed regular measurements of impedance, threshold, and sensing. There was no migration of either the LV lead or the CMCS. In all cases, the LV lead could be completely extracted without migration of the CMCS. There were no acute or long-term complications. In an animal model of healthy adult sheep, implantation of CMCS with a transvenous LV lead already in place was feasible and without major problems with either the CMCS or the LV lead. Electrical performance of the LV leads was excellent. All LV leads could be extracted without migration of the CMCS.

A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure—Trial design of the REDUCE FMR study

The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus–based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included.

Treatment of functional mitral regurgitation by percutaneous annuloplasty using the Carillon Mitral Contour System-Currently available data state.

The purpose of this study is to provide a systematic review of currently available data about the percutaneous trans-coronary-venous mitral annuloplasty with the Carillon Mitral Contour System. A systematic literature search was conducted using the common medical and scientific databases. The documented parameters included among others grade of mitral regurgitation (MR), vena contracta (VC), effective regurgitant orifice area (EROA), 6 minute-walk-test (6MWT), NYHA-classification, and Quality of Life (QoL) at baseline, 30 days and in the long-term follow-up. The exact total number of successfully implantations with available data remains unclear because so many publications are either of the same institution or study group, or they present overlapping results. Reduction of functional mitral regurgitation (FMR) was associated with significant inverse left-ventricular (LV)) remodeling, improvement in 6MWT, QoL and NYHA-class during the 12-month follow-up. In almost half of the enrolled patients, the Carillon System could not be implanted or had to be removed due to coronary compromission. Adverse advent rate (AE) ranged between 2.8-39%. Results with regard to reduction of MR and inverse LV remodeling have been remarkable. Indication and selection criteria for suitable patients, the expected complications, and the long-term results with regard to survival and quality of life still remain unclear. The available results do not establish superiority of the Carillon Mitral Contour System and support the lack of a clear benefit. The approach with the Carillon Mitral Contour System should be limited to participants of prospective and randomized trials.

TCT-815 Treatment of Functional Mitral Regurgitation by Percutaneous Annuloplasty Using the Carillon Mitral Contour System Results in Improved Clinical Efficacy – The TITAN II Study

Functional mitral regurgitation (FMR) contributes to both morbidity and mortality of patients with systolic heart failure. Percutaneous mitral annuloplasty (PMA), using the Carillon Mitral Contour System, to reduce FMR is feasible in these patients. The aim of the study was to assess whether the

Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial

AimsFunctional mitral regurgitation (FMR) contributes to morbidity and mortality in heart failure (HF) patients. The aim of this study was to determine whether percutaneous mitral annuloplasty could safely and effectively reduce FMR and yield durable long-term clinical benefit.Methods and resultsThe impact of mitral annuloplasty (Carillon Mitral Contour System) was evaluated in HF patients with at least moderate FMR. Patients in whom the device was placed then acutely recaptured for clinical reasons served as a comparator group. Quantitative measures of FMR, left ventricular (LV) dimensions, New York Heart Association (NYHA) class, 6 min walk distance (6MWD), and quality of life were assessed in both groups up to 12 months. Safety and key functional data were assessed in the implanted cohort up to 24 months. Thirty-six patients received a permanent implant; 17 had the device recaptured. The 30-day major adverse event rate was 1.9%. In contrast to the comparison group, the implanted cohort demonstrated significant reductions in FMR as represented by regurgitant volume [baseline 34.5 ±11.5 mL to 17.4 ±12.4 mL at 12 months (P < 0.001)]. There was a corresponding reduction in LV diastolic volume [baseline 208.5 ±62.0 mL to 178.9 ±48.0 mL at 12 months (P =0.015)] and systolic volume [baseline 151.8 ±57.1 mL to 120.7 ±43.2 mL at 12 months (P =0.015)], compared with progressive LV dilation in the comparator. The 6MWD markedly improved for the implanted patients by 102.5 ±164 m at 12 months (P =0.014) and 131.9 ±80 m at 24 months (P < 0.001).ConclusionPercutaneous reduction of FMR using a coronary sinus approach is associated with reverse LV remodelling. Significant clinical improvements persisted up to 24 months.