EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation

Evanston Hospital, NorthShore University Health System, Evanston, IL 60201, USA.
New England Journal of Medicine (Impact Factor: 55.87). 04/2011; 364(15):1395-406. DOI: 10.1056/NEJMoa1009355
Source: PubMed


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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    • "Continued First Author Trial Name or Identifier Journal and Year N Intervention Control Primary Outcomes Bonow et al 2011 30 STITCH NEJM 2011 601 CABG Medical therapy Mortality (1 year) Feldman et al 2011 31 EVEREST II NEJM 2011 279 "
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    ABSTRACT: Background: There is currently no accepted standard for reporting outcomes following cardiac surgery. The objective of this paper was to systematically review the literature to evaluate the current use and definition of perioperative outcomes reported in cardiac surgery trials. Methods and results: We reviewed 5 prominent medical and surgical journals on Medline from January 1, 2010, to June 30, 2014, for randomized controlled trials involving coronary artery bypass grafting and/or valve surgery. We identified 34 trials meeting inclusion criteria. Sample sizes ranged from 57 to 4752 participants (median 351). Composite end points were used as a primary outcome in 56% (n=19) of the randomized controlled trials and as a secondary outcome in 12% (n=4). There were 14 different composite end points. Mortality at any time (all-cause and/or cardiovascular) was reported as an individual end point or as part of a combined end point in 82% (n=28), myocardial infarction was reported in 68% (n=23), and bleeding was reported in 24% (n=8). Patient-centered outcomes, such as quality of life and functional classification, were reported in 29% (n=10). Definition of clinical events such as myocardial infarction, stroke, renal failure, and bleeding varied considerably among trials, particularly for postoperative myocardial infarction and bleeding, for which 8 different definitions were used for each. Conclusions: Outcome reporting in the cardiac surgery literature is heterogeneous, and efforts should be made to standardize the outcomes reported and the definitions used to ascertain them. The development of standardizing outcome reporting is an essential step toward strengthening the process of evidence-based care in cardiac surgery.
    Journal of the American Heart Association 08/2015; 4(8). DOI:10.1161/JAHA.115.002204 · 4.31 Impact Factor
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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 · 0.70 Impact Factor
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    • "It should be noted that the protocol allowed implantation of more than one clip in case of unsatisfactory results only after the first 10 patients were enrolled. The success of the EVEREST I trial provided a stimulus for the design of the phase II EVEREST II study in which 279 patients with moderate to severe mitral regurgitation were randomized 2: 1 either to MitraClip implantation or open heart surgical valve repair [10]. As in the EVEREST I trial most patients had degenerative disease and preserved left ventricular function. "
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    ABSTRACT: The percutaneous edge-to-edge repair of mitral regurgitation with a MitraClip device has been recently approved in Europe. The results of the randomized EVEREST II study showed a favourable safety profile of the technique. However, the efficacy in terms of regurgitation reduction in a population with predominantly degenerative mitral disease was inferior as compared to the results of conventional open heart surgery. Nevertheless, up to 50% of symptomatic heart failure patients with severe mainly functional mitral regurgitation are not treated surgically because of very high procedural risk. The registry data suggest that the minimally invasive and generally well-tolerated MitraClip procedure reduces symptoms and need for recurrent hospitalization and improves left ventricular function in inoperable subjects. The ongoing randomized clinical trials with clinical endpoints will further define the current role of percutaneous edge-to-edge repair in heart failure patients with mitral regurgitation.
    Postepy w Kardiologii Interwencyjnej / Advances in Interventional Cardiology 11/2013; 9(4):383-9. DOI:10.5114/pwki.2013.38869 · 0.15 Impact Factor
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