Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

Cleveland Clinic, Ohio 44195, USA.
Journal of the American College of Cardiology (Impact Factor: 15.34). 01/2012; 59(2):130-9. DOI: 10.1016/j.jacc.2011.08.067
Source: PubMed

ABSTRACT The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate.
Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR.
Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care.
Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034).
The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background Patients with diabetes mellitus show a negative outcome in percutaneous coronary intervention, aortic valve replacement and cardiac surgery. The impact of diabetes on patients undergoing treatment of severe mitral regurgitation (MR) using the MitraClip system is not known. We therefore sought to assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with diabetes mellitus. Methods and Results We included 58 patients with severe and moderate-to-severe MR in an open-label observational single-center study. Ninteen patients were under oral medication or insulin therapy for type II diabetes mellitus. MitraClip devices were successfully implanted in all patients with diabetes and in 97.4% (n = 38) of patients without diabetes (p = 0.672). Periprocedural major cardiac adverse and cerebrovascular events (MACCE) occurred in 5.1% (n = 2) of patients without diabetes whereas patients with diabetes did not show any MACCE (p = 0.448). 30-day mortality was 1.7% (n = 1) with no case of death in the diabetes group. Short-term follow up of three months showed a significant improvement of NYHA class and quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire in both groups, with no changes in the 6-minute walk test. Conclusions Mitral valve repair with the MitraClip system is safe and effective in patients with type II diabetes mellitus. Trial Registration MitraClip Registry NCT02033811
    PLoS ONE 11/2014; 9(11):e111178. DOI:10.1371/journal.pone.0111178 · 3.53 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Mitral regurgitation (MR) is the most common valve disease in the United States. However, a significant number of patients are denied surgery due to increased age, poor ventricular function, or associated comorbidities, putting them at high risk for adverse events. Moreover, the benefit of surgery for MR is unclear in patients with functional (secondary) MR. Recently, percutaneous repair of the mitral valve with a particular device (MitraClip, Abbott, Menlo Park, California) has emerged as a novel therapeutic option for patients with secondary MR or those deemed to be high risk for surgery. We review data from its initial concept through clinical trials and current data available from several registries. We focused on lessons learned regarding adequate patient selection, along with current and future perspectives on the use of device therapy for the treatment of MR. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    Journal of the American College of Cardiology 12/2014; 64(24):2688-2700. DOI:10.1016/j.jacc.2014.08.049 · 15.34 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Mitral regurgitation (MR) is a common valvular lesion in the general population with considerable impact on mortality and morbidity. The MitraClip System (Abbot Laboratories, Abbot Park, IL, USA) is a novel percutaneous approach for treating MR which involves mechanical edge-to-edge coaptation of the mitral leaflets. We present our initial experience with the MitraClip System in 5 patients. In our series, the cause of MR was both degenerative and functional. Two patients received two MitraClips due to unsatisfactory results after the implantation of the first clip. Acute procedural success was seen in 4 patients. Blood transfusion was required for 2 patients. All the patients, except one, reported improvement in functional status during a 2-month follow-up period. Our initial experience with MitraClip implantation indicates that the technique seems feasible and promising with acceptable results and that it could be offered to a broader group of patients in the near future.
    Journal of Tehran University Heart Center 01/2014; 9(1):46-51.

Full-text (2 Sources)

Available from
May 29, 2014