Article

Percutaneous Repair or Surgery for Mitral Regurgitation

Evanston Hospital, NorthShore University Health System, Evanston, IL 60201, USA.
New England Journal of Medicine (Impact Factor: 54.42). 04/2011; 364(15):1395-406. DOI: 10.1056/NEJMoa1009355
Source: PubMed

ABSTRACT 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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    • "The minimally invasive technology of the application of mitral clips to the valve via percutaneous surgery (catheter with femoral access) is used to reduce mitral regurgitation. Originating in the United States (the first trial ended in 2006 and involved patients considered inoperable by traditional methods of repair and valve replacement) [1] [2] [3] [4] [5] [6] [7] [8], this method subsequently reached Europe where more and more centres have started to use this new technology [9] [10] [11] [12] [13]. For this reason, it has become necessary for the AOUC to analyse the impact of the device within the hospital, by comparing it to both traditional surgical and pharmacological treatments. "
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    ABSTRACT: This study, carried out at the Florence Teaching Hospital Careggi (AOUC), reports the technological evaluation, through the use of Health Technology Assessment (HTA), on the application of mitral clips in the treatment of mitral insufficiency. The assessment, carried out by analyzing the clinical, technological, social, procedural, safety and economic elements, sought to answer the following research questions: Evaluation of the general technological status of the mitral clips in the treatment process of mitral regurgitation, with particular reference to traditional methods; and contextualisation of the analyses within the hospital structure, by identifying criticality issues and improvements.METHODS: The methodology was based on the following steps: technological description; areas of evaluation and the selection of Key Performance Indicators; research of scientific facts and the collection of expert opinions; evaluation and reporting of findings. The results are based on an analysis which included a total of 50 indicators, effectively evaluating 86.5{\%} of them, from the least from the clinical sector (80%) to the most in the areas of procedure, safety and social (100%). Traditional surgery (repair or valve replacement) still represents the gold standard for the treatment of mitral regurgitation due to its maturity both on a technological and clinical level. The minimally invasive procedures which use the mitral clips present interesting opportunities both on a social level (minimum stay in hospital and no post-operative rehabilitation) and clinical level, especially as an alternative to medication, even if they are still at an emergent level (the long-term results are unknown) and complex to use. From the clinical point of view they show some interesting findings related to immediate and post-operative mortality (none during the operation and a minor and equal amount 30 days and 12 months later in comparison to traditional methods) whilst economically, despite the fact that the cost of the device is greater than those used in traditional interventions, the cost-refund relationship does not show significant differences compared to the traditional types of treatment. The HTA evaluation of minimally invasive technologies that use clips for the treatment of mitral regurgitation shows, in the hospital setting, very interesting results, particularly for inoperable patients, where the clinical and social improvements are significant compared to pharmacological treatments, whilst for 'operable' patients, the traditional techniques are still the most appropriate.
    Technology and health care: official journal of the European Society for Engineering and Medicine 11/2013; 21(6). DOI:10.3233/THC-130756 · 0.64 Impact Factor
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    • "Robbins et al. [2] reported a prevalence of 59% of moderate or greater MR in patients with systolic failure. In many of these patients, surgery carries a high risk of mortality and morbidity [3] and select patients can be referred for a transcatheter alternative for mitral valve edge-toedge repair using a clip implant [4] [5] [6]. We report a case of a patient with severe functional MR and concomitant coronary artery disease which highlights the need for a comprehensive evaluation in these often critically ill patients. "
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    ABSTRACT: Functional mitral regurgitation (MR) is common in patients with ischemic cardiomyopathy. We present a case of an 83-year-old patient with ischemic heart disease and ischemic cardiomyopathy, who was repeatedly admitted for pulmonary edema and underwent a percutaneous trans-septal MitraClip procedure. During coronary angiography, a severe left main stenosis was demonstrated. Treatment included both percutaneous coronary intervention and the implantation of two MitraClip devices, with very good results. We believe that this case illustrates the need for comprehensive assessment of ischemia in patients with functional MR.
    Cardiovascular revascularization medicine: including molecular interventions 07/2013; DOI:10.1016/j.carrev.2013.05.006
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    • "Following promising early feasibility studies [2] [3], MitraClip was evaluated in the treatment of moderate-severe MR in the EVEREST II study, in which patients were randomised to percutaneous repair or surgical therapy [4]. This trial demonstrated that although the MitraClip device was less effective than surgery at reducing MR, it was associated with superior safety (mostly driven by lessened blood transfusion requirements) and similar improvements in clinical outcomes. "
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    ABSTRACT: Surgical therapies have represented the primary evidence-based intervention to alter the natural history of valvular heart disease (VHD), however, the increasing incidence of patients at high surgical risk due to age and related co-morbid conditions has given rise to the need for alternative strategies. Thus, percutaneous approaches to VHD therapy have emerged as an important therapeutic option. Cardiovascular imaging plays a critical role in patient screening for percutaneous valvular interventions, during the procedure itself, and as part of follow-up for the identification of implant success/failure and complications. The technical demands on imaging in this context are highly specific. Although imaging has a significant role in the broader evaluation of valvular heart disease mechanism and severity, the purpose of this paper is to summarise the particular goals of cardiovascular imaging in the work-up for, during, and in the follow-up of percutaneous valvular intervention.
    Heart, Lung and Circulation 05/2013; 22(9). DOI:10.1016/j.hlc.2013.03.080 · 1.17 Impact Factor
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