Preliminary experience using the transcatheter mitral valve leaflet repair procedure

Department of Cardiology, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel.
The Israel Medical Association journal: IMAJ (Impact Factor: 0.9). 10/2013; 15(10):608-12.
Source: PubMed


Mitral regurgitation (MR) causes increased morbidity and mortality in heart failure patients and is often associated with augmented surgical risk.
To assess the preliminary results oftranscatheter mitral valve leaflet repair (TMLR) in a single academic center.
Data were collected prospectively in the cardiology department of Rabin Medical Center in 2012. Ten consecutive patients (age 69.3 +/- 15.9 years, ejection fraction 36.5 +/- 9.4) who were poor surgical candidates with severe functional MR underwent general anesthesia, followed by trans-septal puncture and a TMLR procedure using the MitraClip device.
All 10 patients were considered to have severe functional MR prior to TMLR treatment and were all symptomatic; the mean New York Heart Association (NYHA) class was 3.4 +/- 0.5. The MR severity was 4 +/- 0. There were no immediate complications or failures of the procedure. One patient died on day 5 due to massive gastrointestinal bleeding. Immediately following TMLR all 10 patients showed a profound MR reduction to a mean severity grade of 1.6 +/- 0.6. At one month after the procedure, NYHA had decreased to an average of 1.7 +/- 1.0 and was at least grade 2 in all but one patient. After 6 months the MR remained < or = 2 in six of eight patients, with a NYHA average of 1.4 +/- 0.5.
The MitraClip procedure was shown to be relatively safe, providing significant clinical benefit to a relatively sick population with severe MR. It is therefore an important alternative to surgery in these high risk patients.

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Available from: Leor Perl, Mar 30, 2015
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    ABSTRACT: Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% [75% to 83%]) were in class New York Heart Association I/II and 57 (11% [8% to 14%]) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% [20% to 31%]) of the patients and 78 (15% [1% to 17%]) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation. Copyright © 2015 Elsevier Inc. All rights reserved.
    The American Journal of Cardiology 04/2015; 116(2). DOI:10.1016/j.amjcard.2015.04.025 · 3.28 Impact Factor

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