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Remodelling and Improved Hemodynamics

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

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crf_tct_logo

TCT 2022 Poster

Goldberg S et al.
2022

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

Prospective trials of the Carillon Mitral Contour System have shown effective hemodynamic and clinical improvement in patients with heart failure and functional mitral regurgitation (FMR) including beneficial left ventricular and left atrial remodeling.

The CINCH registry is a multi-center, real-world study of patients treated with the Carillon device as standard of care. It is intended to enroll up to 250 patients in up to 40 centers in Germany.

The poster presented shows an interim analysis of 101 patients with up to 5 years follow-up data, including mortality, device related safety, change in NYHA class and rate of heart failure hospitalizations.

Compared to baseline
>90%
MR grade improved after 5 years follow-up period
>50%
 
NYHA class and MR grade at least maintained after 5 years follow-up period
>80%
NYHA class improved after 5 years follow-up period
Mortality and HF hospitalization rate trending notably better than GDMT for 24 months

Treating Symptoms and Reversing Remodelling: Clinical and Echocardiographic 1-Year Outcomes with Percutaneous Mitral Valve Annuloplasty for Mild to Moderate Regurgitation

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ESC

EJHF

Witte K et al.
2021

Treating Symptoms and Reversing Remodelling: Clinical and Echocardiographic 1-Year Outcomes with Percutaneous Mitral Valve Annuloplasty for Mild to Moderate Regurgitation20

Although any degree of secondary mitral regurgitation (SMR) is known to further complicate heart failure symptoms and mortality, a treatment paradigm for patients with mild and moderate SMR is lacking. The recent publication on Carillon in the European Journal of Heart Failure – Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation – was particularly enlightening.

The purpose of the authors’ investigation was to determine the effects of percutaneous mitral annuloplasty on symptoms, 6-minute walk distance, and left ventricular (LV) structure and function in patients with mild or moderate SMR in heart failure with reduced ejection fraction. They examined a total of 68 patients from all Carillon trials who had mild and moderate SMR in a retrospective study of one-year outcomes. The findings were very encouraging:

  • Mean 6-minute walk test distance increased by 34 m (95% CI 12 to 57; P < 0.01)
  • Mean KCCQ scores increased from baseline by 10 units [95% confidence interval (CI) 3 to 17; 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)
  • New York Heart Association class status was maintained (48%) or improved (46%) in the vast majority of patients
  • Survival over one 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 [i.e., the Carillon therapy] was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.”

Treating Symptoms and Reversing Remodelling: Clinical and Echocardiographic 1-Year Outcomes with Percutaneous Mitral Valve Annuloplasty for Mild to Moderate Regurgitation

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

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jacc

JACC: Heart Failure

Anker et al.
May 2021

Percutaneous Mitral Valve Annuloplasty in Patients with Secondary Mitral Regurgitation and Severe Left Ventricular Enlargement19

Although COAPT was successful, MITRA.fr was not. The prevailing theories as to the difference in the trials is the amount of left ventricular dysfunction in enrolled patients. This is a pooled analysis of patients with functional MR and severe LV enlargement (LV end-diastolic diameter > 65 mm) who were treated with GDMT and the Carillon device vs GDMT alone – i.e., MITRA.fr patients. 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).

  • A total of 95 patients (67 Carillon group; 28 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 units (p<0.001)
    • LV end-diastolic volume decreased by 25 cc (p=0.005)
    • LV end-systolic volume decreased by 21 cc (p=0.01)
  • Significant functional improvement differences were also noted between the Carillon group vs. GDMT group:
    • Improvement of KCCQ score (15±4 vs 6±6; p=0.03)
    • Incidence of HFH was 29.9% vs. 50.0% and the cumulative rate of HFH was 0.43 vs. 0.75 (p<0.001)

In conclusion, “In patients with functional MR and severe LV enlargement, the Carillon device improved mitral valve function, LV morphology, and functional outcome compared to 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

esoc

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.

effect of carillon mitral contour system on patient reported outcomes in functional mitral regurgitation – an individual participant data meta-analysis1
effect of carillon mitral contour system on patient reported outcomes in functional mitral regurgitation – an individual participant data meta-analysis2
effect of carillon mitral contour system on patient reported outcomes in functional mitral regurgitation – an individual participant data meta-analysis3

Indirect Annuloplasty of the Mitral Valve The Carillon Mitral Contour System

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cathlab

CATH’LAB

Lipiecki et al.
March 2021

Indirect Annuloplasty of the Mitral Valve The Carillon Mitral Contour System*

This article addresses the millions of heart failure patients worldwide that have a significantly increased risk of mortality because of functional mitral regurgitation (FMR). The article goes on to discuss the extensive clinical experience available for the Carillon device in treating FMR, advantages of the Carillon approach over alternative therapies, and highlights numerous patient groups that could benefit from treatment with the Carillon device. The authors conclude:

  • The results of studies conducted to date suggest that FMR treatment with the Carillon device is both safe and effective in reducing both mitral regurgitation and left ventricular dysfunction.
  • The short procedure time and the easy deployment of the device are certainly an advantage over other techniques available on the market.
  • The prospective CARILLON US trial, currently underway, evaluates the effectiveness of the Carillon device on morbidity and mortality, and should validate the Carillon Mitral Contour System as a first-line interventional therapy.
Indirect Annuloplasty of the Mitral Valve The Carillon Mitral Contour System

*Original article published in the March 2021 edition of CATH’LAB. The article summary above has been translated from the original French publication with the assistance of machine translation (DeepL).

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

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esoc

ESC Heart Failure

Khan et al.
February 2021

Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE‐FMR trial17

Patients with heart failure often have impaired physical function and reduced quality of life (QoL). Therefore, improving QoL by a minimum clinically important difference (MCID) is an important measure of the effectiveness of heart failure management.

This recently published paper is a rigorous analysis of the REDUCE FMR trial, focusing on the intended patient population based on core-lab adjudication*. It shows convincing 12-month results for the only sham-controlled randomized blinded study ever conducted in heart valve treatment.

  • A substantially higher number of patients achieved MCID for all patient‐centered outcomes with the Carillon device compared with the sham procedure. 
    • Improvement for the 6 minute walk test (6MWT)
    • Improvement in NYHA class
    • Improvement in QoL, based on the KCCQ survey
    • Decrease in heart failure hospitalization
  • In particular, the proportion of patients who achieved MCID improvement in the 6MWT (≥30 m increase) at 1 year of follow‐up from baseline was significantly higher in the Carillon device group compared with the sham group (59% vs. 23%, respectively; P = 0.029), even though REDUCE-FMR was only powered to detect the mechanistic endpoint of mitral regurgitation reduction.
  • The number needed to treat (NNT) for a ≥30 m increase in 6MWT distance with the Carillon device was 2.8, and the NNT for a ≥20 m increase in 6MWT distance was 3.6.
  • Additionally, all other clinical improvements of patients receiving the device relative to control are also encouraging and support the continued utilization of the Carillon device.

The authors conclude: “The patient population in this subgroup of those enrolled in REDUCE‐FMR (EROA, 0.31 cm2; LVDD, 66 mm) resembles that of the MITRA‐FR trial and is more generalizable to patients with HF and moderate to severe FMR. However, unlike the MITRA‐FR trial, our results show a trend towards improvement in patient‐centred outcomes with the Carillion device. In fact, the low NNT for all patient‐centred outcomes suggests that the Carillon device is likely to provide benefit in a large proportion of patients with FMR, rather than just a small subset. Furthermore, unlike the COAPT and MITRA‐FR trials, the REDUCE‐FMR trial used a sham procedure in the control group, which increases the reliability of its results by minimizing placebo and nocebo effects.”

*The intended patient population analysis was conducted to assess functional outcomes of patients with heart failure with reduced ejection fraction and moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control. Since 29.7% of patients were enrolled with only mild core-lab adjudicated MR grade 1+, this analysis focused on the intended patient population of the REDUCE FMR Trial with inclusion criteria of MR grades 2+ to 4+.

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
Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+- results from the REDUCE‐FMR trial2

Percutaneous Coronary Sinus–Based Mitral Valve Annuloplasty in Atrial Functional Mitral Regurgitation

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jacc

JACC: Cardiovascular Interventions

Rottländer et al.
December 2020

Percutaneous Coronary Sinus–Based Mitral Valve Annuloplasty in Atrial Functional Mitral Regurgitation1

Echographic outcomes of patients with atrial derived FMR (aFMR) and heart failure with preserved ejection fraction (HFpEF) were compared to patients with ventricular derived FMR (vFMR) and heart failure with reduced ejection fraction (HFrEF) after percutaneous mitral valve repair with the Carillon Mitral Contour System.

  • Patients with aFMR showed similar reductions in mitral annulus diameter and concomitant reduction in regurgitant volume through 3 months compared to those with vFMR.
  • Significant reduction in MR as assessed by vena contracta, effective regurgitant volume as well as MR was seen as soon as 3 months after procedure in both groups.
  • Similarly, after 3 months the proportion of patients with NYHA class III or IV was reduced from 92.8% to 42.8% which was maintained throughout 12 month follow-up.

The Carillon device is feasible in HFpEF patients with aFMR and is associated with significant reductions in MR.

Percutaneous Coronary Sinus–Based Mitral Valve Annuloplasty in Atrial Functional Mitral Regurgitation

Individual patient data meta‐analysis of the effects of the Carillon Mitral Contour System

ESC

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.

CDI-Indiv-Patient-Data-Meta-Analysis

Embracing secondary mitral regurgitation with Carillon: past, present, and future

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esoc

ESC Heart Failure

Mitja Lainscak and Michael Böhm
December 2020

Embracing secondary mitral regurgitation with Carillon: past, present, and future15

In this editorial Dr. Lainscak and Professor Böhm discuss the optimal management strategy for patients with Functional Mitral Regurgitation. There is a need in the therapeutic spectrum for additional therapies that are safe and can be deployed as an early intervention to reduce the need for repeated hospitalizations. The data presented by Gialluria et al. supports the use of the Carillon Mitral Contour System to achieve this goal. Owing to less invasive approaches, favourable effects on left ventricular volumes, and possibility of step‐wise upgrade with other interventions, Carillon could be considered early in the patient trajectory for a timely and effective management of heart failure patients with reduced ejection fraction and functional mitral regurgitation.

Embracing secondary mitral regurgitation with Carillon- past, present, and future

Echocardiographic analysis of acute effects of percutaneous mitral annuloplasty on severity of secondary mitral regurgitation

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esoc

ESC Heart Failure

doi: 10.1002/ehf2.12719
May 2020

Echocardiographic analysis of acute effects of percutaneous mitral annuloplasty on severity of secondary mitral regurgitation4

  • 30 patients with symptomatic moderate or severe SMR [FMR] were assessed for the acute effects of Carillon therapy by advanced echocardiography 1 day prior to procedure and at discharge.
  • Treatment of SMR [FMR] with the Carillon device leads to acute reduction of MR severity in 83% of patients after the procedure. 
    • Both PISA based measurements of regurgitant volume as well as measurements derived from regurgitant fraction were significantly improved (p<0.05) after the procedure.
  • Effective [forward] stroke volume was significantly improved (p<0.001) and ejection fraction was non-significantly improved (p = 0.06) immediately after the intervention.
Echocardiographic analysis of acute effects of percutaneous mitral annuloplasty on severity of secondary mitral regurgitation

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