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Acute reverse annular remodeling during MitraClip® therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study.

ABSTRACT: Transcatheter mitral valve repair (TMVR) has been shown to have acute effects on mitral valve geometry in patients with functional mitral regurgitation (FMR). This study investigates the impact of MitraClip® therapy-induced annular remodeling on clinical outcome and mitral regurgitation in heart failure patients.TMVR was performed successfully in 45 patients with FMR. In this study, mitral valve datasets were obtained before and directly after MitraClip® implantation using three-dimensional (3D) transesophageal echocardiography, and were analyzed offline retrospectively using dedicated 3D reconstruction software. Patients underwent clinical and echocardiographic evaluation at baseline and after 6 months. At follow-up, the patients were allocated into two groups according to their improvement in New York Heart Association (NYHA) functional class: a Low Responder group with ?NYHA <1.5 (n = 25); and a High Responder group with ?NYHA ?1.5 (n = 20).At 6-month follow-up, data analysis revealed that while mitral regurgitation was reduced significantly in both groups, only the High Responder group had experienced significant downsizing of the 3D circumference (137 ± 14 mm to 126 ± 13 mm; p < 0.01) and the anterior-to-posterior diameter (33 ± 5 mm to 29 ± 4 mm; p < 0.01) of the mitral annulus during the intervention. Furthermore, only the High Responder group with reverse annular remodeling as shown had substantial advances in quality of life (Minnesota living with heart failure questionnaire: 55 ± 10 to 34 ± 14 points; p < 0.01) and functional status (6-min walk distance: 290 ± 104 m to 462 ± 111 m; p = 0.07).Our study demonstrates that instantaneous left ventricular annular remodeling during MitraClip® implantation is associated with improved clinical outcome of heart failure patients with functional mitral regurgitation. Trial registration The study was approved by the local ethics committee (Study Number 4497R, Registration ID: 2013121585).NCT02033811 Retrospectively registered January 9, 2014.

SUBMITTER: Herbrand T

PROVIDER: S-EPMC5607606 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Acute reverse annular remodeling during MitraClip<sup>®</sup> therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study.

Herbrand Theresa T Eschenhagen Silke S Zeus Tobias T Kehmeier Eva E Hellhammer Katharina K Veulemans Verena V Kelm Malte M Balzer Jan J

European journal of medical research 20170920 1

<h4>Background</h4>Transcatheter mitral valve repair (TMVR) has been shown to have acute effects on mitral valve geometry in patients with functional mitral regurgitation (FMR). This study investigates the impact of MitraClip<sup>®</sup> therapy-induced annular remodeling on clinical outcome and mitral regurgitation in heart failure patients.<h4>Methods</h4>TMVR was performed successfully in 45 patients with FMR. In this study, mitral valve datasets were obtained before and directly after MitraC ...[more]

PMID: 28931437

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Project description:AimsThe purpose of this study is to identify echocardiography predictors of clinical response and reverse left ventricular (LV) remodelling in patients with functional mitral regurgitation (FMR) treated with MitraClip.Method and resultsWe retrospectively analysed 86 high surgical risk patients with severe FMR; of those, 58 were implanted a MitraClip, and 28 received medical treatment and served as controls. At baseline and at 1-year follow-up, we performed clinical and echocardiography evaluation to assess global longitudinal strain (GLS) and myocardial work [global work index (GWI), global constructive work (GCW), global wasted work (GWW), global work efficiency (GWE)]. Mitral regurgitation was significantly reduced after MitraClip implantation (3.7 ± 0.4 vs. 1.7 ± 0.8, P < 0.001), and the procedure was associated with improvement in brain natriuretic peptide levels (980 ± 1027 vs. 420 ± 338 pg/mL, P < 0.001), New York Heart Association class status (3.2 ± 0.55 vs. 2.0 ± 0.6, P < 0.001), 6-min walking test (233 ± 154 vs. 286 ± 114 m, P = 0.01) at follow-up and reduction of left ventricle end-systolic (LVESV) and left ventricle end-diastolic volumes (LVEDV) (152 ± 68 vs. 136 ± 43 mL, P = 0.004 & 219 ± 74 vs. 193 ± 66 mL, P = 0.001, respectively). MitraClip procedure was associated with improvement of LV performance and significant increase of GWI (607 ± 282 vs. 650 ± 260 mmHg%, P = 0.045) and GCW (854 ± 288 vs. 949 ± 325 mmHg%, P < 0.001). Baseline ejection fraction (EF), GLS, GWI, GCW, and effective regurgitant orifice area were the variables that were associated with reduction of LVEDV 1 year after intervention (P < 0.05 for all) and baseline GCW of the LV was the only variable associated with reduction of LVESV (P = 0.002). Receiver operating characteristic curve analysis identified that a GLS cut-off value of -8.65% (AUC 0.815, P = 0.007) was associated with a 20% reduction of the LVEDV with a sensitivity and specificity of 72% and 70%, respectively, and that a GCW cut-off value of 846 mmHg% (AUC 0.759, P = 0.007) was associated with a 10% reduction of LVESV with sensitivity and specificity 79% and 74%, respectively.ConclusionsMitral valve repair with MitraClip has positive clinical and echocardiographic impact in patients with FMR 1 year after implantation. Preserved GLS and GCW values appear to be associated with LV reverse remodelling post intervention.

Project description:ObjectiveTo introduce a novel technology currently under final development before regulatory approvals for the furtherment of cataract surgery, using the FemtoMatrix® laser system, and to demonstrate its safety and efficacy as compared to standard ultrasound phacoemulsification.MethodsThirty-three patients with bilateral cataracts were operated on with one eye undergoing PhotoEmulsification® treatment on the FemtoMatrix® device and the contralateral eye receiving the control procedure, i.e., standard ultrasound phacoemulsification treatment. The number of "zero-phaco" procedures (denoting that I/A alone was sufficient to aspirate the lens fragments and that no ultrasound energy was needed) was recorded and Effective Phaco Time (EPT) values were compared. The patient follow-up was 3 months.ResultsThirty-three eyes from a population with a mean cataract grade of 2.6 were treated on the FemtoMatrix®, of which 29 were "zero-phaco" (88%). All patients were operated on by a single surgeon who was a relative novice to the technology (63 patients treated prior to this study). Conversely, of the 33 fellow eyes who underwent standard ultrasound phacoemulsification, none were zero-phaco (0%) - all required varying degrees of ultrasound energy to make lens aspiration possible. The mean EPT was significantly lower in the PhotoEmulsification® laser group (0.2 ± 0.8 s) than in the phaco group (1.3 ± 1.2 s) (p < 0.0001). The safety profiles of the two procedures were comparable, with no device-related adverse events noted.ConclusionFemtoMatrix® is a promising femtosecond laser platform that, when compared to phacoemulsification, significantly decreases or eliminates EPT altogether. The system is used to perform PhotoEmulsification®, making zero-phaco cataract procedures feasible including in high-grade cataracts (>3). It enables personalized treatment by automatically measuring and adapting the laser energy required to obtain the most efficient cutting of the crystalline lens. This new technology appears to be safe and effective in cataract surgery.

Dataset Information

Acute reverse annular remodeling during MitraClip® therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study.

Publications

Acute reverse annular remodeling during MitraClip<sup>®</sup> therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study.

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