Managing mitral regurgitation: focus on the MitraClip device

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Abstract

Based on the principle of surgical edge-to-edge mitral valve repair (MVR), the MitraClip percutaneous MVR technique has emerged as a minimally invasive option for MVR. This catheter-based system has been widely demonstrated to be safe, although inferior to surgical MVR. Studies examining patients with ≥3+ mitral regurgitation (MR) show that, for all patients treated, freedom from death, surgery, or MR ≥3+ is in the 75%–80% range 1 year following MitraClip implantation. Despite its inferiority to surgical therapy, in high-risk surgical patients, data suggest that the MitraClip system can be employed safely and that it can result in symptomatic improvement in the majority of patients, while not precluding future surgical options. MitraClip therapy also appears to reduce heart failure readmissions in the high-risk cohort, which may lead to an economic benefit. Ongoing study is needed to clarify the impact of percutaneous mitral valve clipping on long-term survival in high-risk populations, as well as its role in other patient populations, such as those with functional MR.

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Percutaneous repair or surgery for mitral regurgitation.

Ted Feldman, Elyse Foster, Donald Glower … (2011)

Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet. We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days. At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline. Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).

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Mitral-Valve Repair versus Replacement for Severe Ischemic Mitral Regurgitation

Michael A Acker, Michael K Parides, Louis P Perrault … (2014)

Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited. We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank. At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months. We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of Health; ClinicalTrials.gov number, NCT00807040.).

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Cardiac valve surgery--the "French correction".

Yvon Carpentier (1983)

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Journal

Journal ID (nlm-ta): Med Devices (Auckl)

Journal ID (iso-abbrev): Med Devices (Auckl)

Journal ID (publisher-id): Medical Devices: Evidence and Research

Title: Medical Devices (Auckland, N.Z.)

Publisher: Dove Medical Press

ISSN (Electronic): 1179-1470

Publication date Collection: 2016

Publication date (Electronic): 12 April 2016

Volume: 9

Pages: 53-60

Affiliations

[1 ]Division of Cardiac Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, Nashville, TN, USA

[2 ]Department of Medicine, Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN, USA

[3 ]Department of Cardiac Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA

Author notes

Correspondence: Ashish S Shah, Department of Cardiac Surgery, Vanderbilt University School of Medicine, 1215 21st Avenue South, Suite 5025, Nashville, TN 37232, USA, Tel +1 615 343 7363, Email ashish.s.shah@ 123456vanderbilt.edu

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Publisher ID: mder-9-053

DOI: 10.2147/MDER.S86645

PMC ID: 4835144

PubMed ID: 27110142

SO-VID: e09d3123-dcf4-4719-917d-caff719d9973

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The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

Managing mitral regurgitation: focus on the MitraClip device

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Most cited references 44

Percutaneous repair or surgery for mitral regurgitation.

Mitral-Valve Repair versus Replacement for Severe Ischemic Mitral Regurgitation

Cardiac valve surgery--the "French correction".

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