Abstract 3051: Percutaneous Repair of Functional Mitral Regurgitation Using CARILLON ™ Mitral Contour System. Acute Transesophageal Echocardiography Results from AMADEUS ™ Trial

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Tomasz Siminiak ◽  
Uta C Hoppe ◽  
Joachim Schofer ◽  
Michael Haude ◽  
Jean-Paul Herrman ◽  
...  

Left ventricular dilatation with subsequent mitral insufficiency exacerbates heart failure. New techniques for percutaneous repair of Functional Mitral Regurgitation (FMR) are being developed to minimize the high procedural risk of conventional cardiac surgery therapies. To evaluate the feasibility and procedural safety of percutaneous mitral valve repair with CARILLON ™ Mitral Contour System ™ (Cardiac Dimensions® Inc.) in FMR patients AMADEUS ™ trial has been designed. Patients with FMR of both ischemic and non-ischemic origin were enrolled to this multicenter phase I trial. The device is implanted into the coronary venous system and applies tension to the mitral ring in order to improve coaptation of the leaflets. Transesophageal echocardiography (TEE) was used to assess the MR changes. Acute procedural data, obtained in the cath lab immediately before and after the procedure, are reported. Percutaneous mitral annuloplasty in patients with FMR and dilated cardiomyopathy resulted in acute MR reduction (grade 3.0±0.6 to 2.0±0.8, p<0.0001) and permanent device implantation in 30 out of 43 attempts. Additional measurements in final 20 implanted patients showed reductions in vena contracta (0.69±0.29 cm to 0.46±0.26 cm, p<0.0001), effective regurgitant orifice area (0.33±0.17 cm 2 to 0.19±0.08 cm 2 , p<0.0001), regurgitant volume (40±20 ml to 24±11 ml, p= 0.0005), and jet area/left atrial area (45±13% to 32±12%, p<0.0001). Coronary arteries were crossed in 36 patients (84%), but arterial compromise contributed to lack of implantation in 6 patients (14%). All unsuccessful implants were recaptured and removed in these patients without procedural complications. Permanent implantation of the device is safely achievable in the majority of eligible patients resulting in acute MR reduction. Arteries are crossed in most patients and without significant impact. Phase two trials including long term clinical observations on larger number of patients are needed to asses the clinical value of the technique.

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Olga Jerzykowska ◽  
Piotr Kalmucki ◽  
Maciej Woloszyn ◽  
Tomasz Grotowski ◽  
Rafal Link ◽  
...  

Background : Despite recent advancements, Functional Mitral Regurgitation (FMR), secondary to dilated cardiomyopathy remains a common clinical problem. Conventional cardiac surgery therapies have high procedural risk and therefore new techniques for percutaneous repair of mitral valve are being developed. Aim. The purpose of the study was to verify the acute efficacy of percutaneous mitral valve repair in patients with FMR by transesophageal echocardiography (TEE) Methods : We analyzed consecutive cases of percutaneous mitral valve repair with CARILLON ™ Mitral Contour System ™ (Cardiac Dimensions® Inc.) performed in a single center. The technique is based on implantation into the coronary venous system, where the device applies tension to the mitral ring in order to improve coaptation of the leaflets. TEE was performed during the procedure in the cath lab. Measurements before and immediately after the device release at the end of the procedure are given. Results The procedure was attempted in 17 cases of secondary MR with no apparent organic changes on the leaflets. Successful implantation of the device was performed in 13 patients (12M and 1F, aged 48 – 67 yrs). The TEE parameters of the MR significantly changed after the procedure as compared to before the procedure, including vena contracta (0.43±0.13 vs 0.68±0.16cm, p=0.024), EROA (0.21±0.06 vs 0.27±0.08cm 2 , p=0.019) and MR jet area/LA area (37.31 ±11,51 vs 53.82±14,14%, p=0.001). In 4 patients the device was recaptured due to compromised circumflex artery (3pts) and/or lack of measurable improvement in TEE (2 pts). No procedural complications were observed. Conclusion The implantation of CARILLON ™ system is feasible and safe in patients with Functional MR. Initial observations on efficacy justify completion of large clinical trials aiming at establishing the role of the technique in clinical practice.


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
S Stoebe ◽  
K Kreyer ◽  
D Lavall ◽  
U Laufs ◽  
A Hagendorff

Abstract Background Secondary or functional mitral regurgitation (FMR) is associated with increased morbidity and mortality, especially in heart failure patients, patients with many comorbidities and/or in the elderly. Previous studies about percutaneous mitral annuloplasty have shown evidence for long-term reduction of degree of FMR severity and left ventricular (LV) remodeling. In comparison to previous studies the present study did focus on the echocardiographic analysis of acute effects after percutaneous mitral annuloplasty (PMA). Methods Transthoracic echocardiography (TTE) has been performed in 30 patients with moderate or severe FMR before and after (± 3.5 days) percutaneous mitral annuloplasty (Carillon®). LV volumes and LV ejection fraction and semi-quantitative parameters, e.g. tenting Area, vena contracta and velocity-time-integral ratios of transmitral inflow and LV outflow (VTIMV/VTILVOT) were assessed. The assessment of the regurgitant volume (RV), regurgitant fraction (RF) and effective regurgitant orifice area (EROA) was quantitatively performed by the PISA method. RV and RF was also estimated by subtracting the effective forward stroke volume (SVLVOT, SVRVOT) from the total stroke volume (SVLV planimetry). Further, parameters of left ventricular contractility, e.g. global longitudinal strain (GLS), cardiac efficiency, peak power index etc., were assessed. Results a postinterventional reduction of degree of FMR severity was achieved in 25/30 patients (83%). In average, RF was reduced from 49 ± 11% to 34 ± 13% (p &lt; 0.001), RV from 33 ± 13ml to 25 ± 12ml (p &lt; 0.001) and EROA from 0.24 ± 0.1cm2 to 0.19 ± 0.1cm2 (p &lt; 0.05). Significant decreases were also noted for vena contracta and VTIMV/LVOT. DiamMV (long axis) was reduced from 3.6 ± 0.6cm to 3.4± 0.6cm (p &lt; 0.001), DiamMV (4-chamber view) from 3.9 ± 0.5cm to 3.6 ± 0.6cm (p &lt; 0 .05). In patients with sinus rhythm (SR) or pacemacer stimulation a considerably higher reduction of RF was observed (ΔRF 20 ± 12%) in comparison to patients with atrial fibrillation (ΔRF 10 ± 12%). No significant changes were obtained for parameters of LV remodeling and LV contractility, e.g. GLS, cardiac efficiency, peak power index. Conclusion A reduction of degree of FMR severity can be achieved by percutaneous mitral annuloplasty (PMA) and acute effects can be quantitatively assessed by echocardiography. Further data are necessary to evaluate whether these acute effects will maintain in follow-up investigations. Abstract P912 Figure. Fig1-Reduction of RF and VC after PMA


2020 ◽  
Vol 50 (6) ◽  
pp. 1552-1558
Author(s):  
Göktuğ SAVAŞ ◽  
Ömer ŞAHİN ◽  
Mustafa YAŞAN ◽  
Uğur KARABIYIK ◽  
Nihat KALAY ◽  
...  

Background/aim: Diagnosing and managing functional mitral regurgitation (MR) is often challenging and requires an integrated approach including a comprehensive echocardiographic examination. However, the effects of volume overload on the echocardiographic assessment of MR severity are uncertain. The purpose of this study was to weigh the effects of volume overload in the echocardiographic assessment of MR severity among patients with heart failure (HF).Materials and methods: Twenty-nine patients with decompensated HF, who had moderate or severe MR, were included in the present study. The volume status and the N-terminal pro-B-type natriuretic peptide (proBNP) levels were recorded and the echocardiographic parameters were assessed. After the conventional treatment for HF, the proBNP levels and the echocardiographic parameters were assessed again.Results: The mean age of the patients was 72 ± 9 years and the average hospitalization time was 10.9 ± 5.9 days. Between the beginning and the end of the treatment, there were significant reductions in the effective regurgitant orifice area (EROA) (0.36 ± 0.09 cm2 to 0.29 ± 0.09 cm2, P < 0.001), vena contracta (VC) (P < 0.001), the regurgitant volume (RV) (P < 0.001), and systolic pulmonary artery pressure (sPAP) (P < 0.001). Conclusion: This is the first study to investigate the relationship of changes in severity of MR with volume-load by monitoring the proBNP levels among patients with HF. The present results demonstrated that volume reduction, as evidenced by a decline in the proBNP levels, was accompanied by a marked reduction in the EROA, VC, and the RV among patients with left ventricular dysfunction.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Spinka ◽  
P Bartko ◽  
H Arfsten ◽  
G Heitzinger ◽  
N Pavo ◽  
...  

Abstract Abstract Background Mechanistic features of functional mitral regurgitation (FMR) include papillary muscle displacement due to left ventricular remodeling. Intraventricular conduction delay might further augment this condition by introducing interpapillary muscle dyssynchrony. Objectives To define this mechanism as a major contributing factor in FMR and prove the reversibility of FMR by interpapillary muscle resynchronization. Methods We enrolled 269 chronic HFrEF patients with conduction delay and comprehensively assessed dyssynchrony by complementary echocardiographic techniques. Opposing wall delay, calculated by speckle tracking, was determined as the time difference between peak longitudinal strain of the mid-anterior and inferior wall from a 2-chamber view. Furthermore, opposing wall delay was assessed as the time difference between peak strain values from tissue Doppler velocity-coded data of the mid-inferior septal and mid-lateral wall segments. Results Patients with severe FMR had markedly increased interpapillary longitudinal dyssynchrony (160ms [IQR 120–200]) compared to those with moderate (70ms [IQR 40–110]), no, or mild FMR (60ms [IQR 30–100]; P<0.001). Increased interpapillary muscle dyssynchrony was correlated with effective regurgitant orifice area (P<0.001; Figure A), regurgitant volume (P<0.001, Figure B) and vena contracta width (P<0.001, Figure C). Restoration of longitudinal papillary muscle synchronicity by cardiac resynchronization therapy (CRT) was correlated with FMR regression, as reflected by the reduction in regurgitant volume (P<0.001) and vena contracta width (P<0.001). Conversely, the improvement of FMR was associated with improved interpapillary radial (P=0.006) and longitudinal (P<0.001) dyssynchrony. The improvement of dyssynchrony-mediated FMR signified a better prognosis compared to no improvement in FMR during the 8-year follow-up period even after comprehensive adjustment by a bootstrap-selected confounder model (adj. HR of 0.41; 95% CI 0.18–0.91; P=0.028; Figure D). The results remained virtually unchanged after adjustment for left bundle branch block. Figure 1. Dyssynchrony-FMR-CRT Conclusion Intraventricular dyssynchrony introduces unequal contraction by papillary muscle bearing walls, which has an adverse effect on FMR. CRT can effectively restore interpapillary balance and thus create a less tented leaflet configuration, resulting in a clinically meaningful reduction of FMR. The restoration of papillary muscle synchronicity in dyssynchrony-mediated FMR translates into a significantly better prognosis.


2009 ◽  
Vol 5 (1) ◽  
pp. 67
Author(s):  
Lutz Buellesfeld ◽  
Lazar Mandinov ◽  
Eberhard Grube ◽  
◽  
◽  
...  

Functional mitral regurgitation affects a substantial proportion of patients with congestive heart failure due to myocardial infarction or dilated cardiomyopathy. Functional mitral regurgitation greatly increases morbidity and mortality. Surgical annuloplasty is the standard of care for symptomatic patients with moderate or severe functional mitral regurgitation; however, a large number of patients are refused surgery. Several percutaneous approaches have been developed to address the need for less invasive treatment of mitral annulus dilatation. Devices using coronary sinus to cinch the mitral annulus are relatively easy to use; however, a number of factors may limit their clinical application, such as suboptimal anatomical relationship between the coronary sinus and mitral annulus, risk of coronary artery compression, large variability in the coronary venous anatomy and conflict with other therapies such as ablation or cardiac resynchronisation. Direct mitral annuloplasty is anticipated to be more effective than the coronary sinus approaches; however, it has yet to prove its safety and efficacy in carefully designed clinical trials. The best candidates and the best timing for each percutaneous mitral annuloplasty therapy, whether direct or indirect, have yet to be identified.


2020 ◽  
Vol 75 (5) ◽  
pp. 514-522
Author(s):  
Alexey S. Ryazanov ◽  
Konstantin I. Kapitonov ◽  
Mariya V. Makarovskaya ◽  
Alexey A. Kudryavtsev

Background. Morbidity and mortality in patients with functional mitral regurgitation (FMR) remains high, however, no pharmacological therapy has been proven to be effective.Aimsto study the effect of sacubitrile/valsartan and valsartan on functional mitral regurgitation in chronic heart failure.Methods.This double-blind study randomly assigned sacubitrile/valsartan or valsartan in addition to standard drug therapy for heart failure among 100 patients with heart failure with chronic FMR (secondary to left ventricular (LV) dysfunction). The primary endpoint was a change in the effective area of the regurgitation hole during the 12-month follow-up. Secondary endpoints included changes in the volume of regurgitation, the final systolic volume of the left ventricle, the final diastolic volume of the left ventricle, and the area of incomplete closure of the mitral valves.Results.The decrease in the effective area of the regurgitation hole was significantly more pronounced in the sacubitrile/valsartan group than in the valsartan group (0.070.066against0.030.058sm2; p=0.018)in the treatment efficacy analysis, which included 100patients (100%). The regurgitation volume also significantly decreased in the sacubitrile/valsartan group compared to the valsartan group (mean difference:8.4ml; 95%CI, from 13.2 until 1.9;р=0.21). There were no significant differences between the groups regarding changes in the area ofincomplete closure of the mitral valves and LV volumes, with the exception of the index of the final LV diastolic volume (p=0.07).Conclusion.Among patients with secondary FMR, sacubitril/valsartan reduced MR more than valsartan. Thus, angiotensin receptor inhibitors and neprilysin can be considered for optimal drug treatment of patients with heart failure and FMR.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Benito Gonzalez ◽  
X Freixa ◽  
C Godino ◽  
M Taramasso ◽  
R Estevez-Loureiro ◽  
...  

Abstract Background Limited information has been reported regarding the impact of percutaneous mitral valve repair (PMVR) on ventricular arrhythmic (VA) burden. The aim of this study was to address the incidence of VA and appropriate antitachycardia implantable cardiac defibrillator (ICD) therapies before and after PMVR. Methods We retrospectively analyzed all consecutive patients with heart failure with reduce left ventricular ejection fraction, functional mitral regurgitation grade 3+ or 4+ and an active ICD or cardiac resynchronizer who underwent PMVR in any of the eleven recruiting centers. Only patients with complete available device VA monitoring from one-year before to one year after PMVR were included. Baseline clinical and echocardiographic characteristics were collected before PMVR and at 12-months follow-up. Results 93 patients (68.2±10.9 years old, male 88.2%) were enrolled. PMVR was successfully performed in all patients and device success at discharge was 91.4%. At 12-months follow-up, we observed a significant reduction in mitral regurgitation severity, NT-proBNP and prevalence of severe pulmonary hypertension and severe kidney disease. Patients also referred a significant improvement in NYHA functional class and showed a non-significant trend to reserve left ventricular remodeling. After PMVR a significant decrease in the incidence of non-sustained ventricular tachycardia (VT) (5.0–17.8 vs 2.7–13.5, p=0.002), sustained VT or ventricular fibrillation (0.9–2.5 vs 0.5–2.9, p=0.012) and ICD antitachycardia therapies (2.5–12.0 vs 0.9–5.0, p=0.033) were observed. Conclusion PMVR was related to a reduction in arrhythmic burden and ICD therapies in our cohort. Proportion of patients who presented ven Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Yi Zhang ◽  
Wei-feng Yan ◽  
Li Jiang ◽  
Meng-ting Shen ◽  
Yuan Li ◽  
...  

Abstract Background Functional mitral regurgitation (FMR) is one of the most common heart valve diseases in diabetes and may increase left ventricular (LV) preload and aggravate myocardial stiffness. This study aimed to investigate the aggravation of FMR on the deterioration of LV strain in type 2 diabetes mellitus (T2DM) patients and explore the independent indicators of LV peak strain (PS). Materials and methods In total, 157 T2DM patients (59 patients with and 98 without FMR) and 52 age- and sex-matched healthy control volunteers were included and underwent cardiac magnetic resonance examination. T2DM with FMR patients were divided into T2DM patients with mild (n = 21), moderate (n = 19) and severe (n = 19) regurgitation. LV function and global strain parameters were compared among groups. Multivariate analysis was used to identify the independent indicators of LV PS. Results The T2DM with FMR had lower LV strain parameters in radial, circumferential and longitudinal direction than both the normal and the T2DM without FMR (all P < 0.05). The mild had mainly decreased peak diastolic strain rate (PDSR) compared to the normal. The moderate had decreased peak systolic strain rate (PSSR) compared to the normal and PDSR compared to the mild and the normal. The severe FMR group had decreased PDSR and PSSR compared to the mild and the normal (all P < 0.05). Multiple linear regression showed that the regurgitation degree was independent associated with radial (β = − 0.272), circumferential (β = − 0.412) and longitudinal (β = − 0.347) PS; the months with diabetes was independently associated with radial (β = − 0.299) and longitudinal (β = − 0.347) PS in T2DM with FMR. Conclusion FMR may aggravate the deterioration of LV stiffness in T2DM patients, resulting in decline of LV strain and function. The regurgitation degree and months with diabetes were independently correlated with LV global PS in T2DM with FMR.


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