Percutaneous Repair of Mitral Regurgitation with the MitraClip® System

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The clip itself is a polyester-covered device that can be opened and closed repeatedly to grasp the leaflets to create a double-orifice mitral valve by co-apting the central leaflet scallops. The tissue can be released and the clip repositioned as necessary to achieve adequate MR reduction, and a second clip can be placed if necessary.
The procedure is performed under general anesthesia, primarily using realtime transesophageal echocardiography in a unique collaboration between the echocardiographer, anesthesiologist, and interventionalist.8 Patient selection using echocardiography is key to the success of the procedure. A minimum of three of the six American Society of Echocardiography (ASE) criteria for moderate to severe (3+) or severe (4+) MR as assessed by a core laboratory are required for study inclusion.9 In addition, specific leaflet dimensions and the origin of the regurgitant jet origin are assessed. An example of a patient treated with this technique is shown in Figure 2.

Results

Approximately 400 patients have now been enrolled in North American trials with the MitraClip system. The Endovascular Valve Edge-to-Edge Repair Study (EVEREST) I enrolled 55 patients in a phase I safety and feasibility trial.6,10 The ongoing EVEREST II trial is a pivotal randomized, prospective trial in 279 patients comparing the MitraClip device with standard surgical repair or replacement. Patients with either degenerative or functional MR are randomized 2:1 to the MitraClip or surgery, with a primary effectiveness end-point of freedom from surgery for valve dysfunction, death, or 3–4+ MR at one year. The EVEREST II trial, which is currently over 70% enrolled, will provide important information on efficacy compared with surgery, and will help cardiologists decide how to apply this new technique in practice. An additional 78 patients were enrolled in a non-randomized registry for patients with a high risk for surgical mortality.
The results obtained in 104 patients, including 55 patients in the EVEREST I feasibility trial and 49 non-randomized ‘roll-in’ patients in the EVEREST II trial, have been reported.6,10,11 These patients represent the first patients treated who have 30-day core laboratory follow-up. The mean age of patients was 71 years, and 61% were 65 years of age or older. Degenerative disease was present in most patients, but 22% had a functional etiology. A single clip was placed in most patients, 11% did not have a clip placed, and two clips were used in 29% of patients.

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