The EVEREST trial suggests MitraClip® for mitral regurgitation is effective

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April 1, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [1]

SCAI-ACCi2 08-Chicago, IL: Percutaneous mitral valve repair with the Mitraclip® device for functional mitral regurgitation is effective with low major adverse events and significant reverse remodeling at one year in the initial EVEREST cohort. Dr. James Hermiller presented the results at the SCAI-i2 summit Annual Scientific Sessions in Chicago today. This presentation was followed by a commentary by Dr. Todd K. Rosengart, Stony Brook NY.

The EVEREST study evaluated the safety and efficacy of isolated leaflet repair using the MitraClip® device in patients with functional mitral regurgitation. This new device enables proper coaptation of the mitral valve leaflets. The investigators hypothesized that this might result in a reduction of left ventricular volume overload by reducing the amount of mitral regurgitation.

This study consisted of patients aged 18 years or older (n=23) with functional moderate to severe (3+) or severe (4+) mitral regurgitation who were symptomatic. This study also consisted of asymptomatic patients with a LV ejection fraction < 60% or an LV end systolic diameter > 40mm. In addition, the MR was required to be due to A2-P2 mal-coaptation, the patients were required to be candidates for mitral valve surgery and transseptal puncture was required to be feasible. The exclusion criteria consisted of patients with LVEF < 25% or LV end systolic dimensions (LVESD) >55 mm, renal impairment, patients with endocarditis and rheumatic heart disease.

The implantation of the clip was attempted in all patients. Acute procedural success was achieved in 83% of cases. Following discharge 53% of cases had grade 1 mitral regurgitation. There was a significant improvement in the LV end systolic/diastolic dimension from baseline to 12 months [4.5 cm vs. 4 cm (p=<0.03)/6 cm vs. 5.4 cm (p<0.04)]. There was a significant improvement in the LV end diastolic volume between baseline and 12 months (208 ml vs. 178 ml, p=0.006).

During 36 month follow-up, the event free survival (free from death, mitral valve surgery or mitral regurgitation grade > 2) was 74%. 89% of patients were free of mitral regurgitation grade 2 at 36 months of follow-up. Three patients underwent cardiac surgery following clip implantation.

The investigators of the EVEREST study concluded that the Mitraclip® device is effective in reducing functional mitral regurgitation. There was a significant improvement in LV remodeling at 1 year and there was clinical improvement among patients with NYHA class I. Approximately 79% of patients had freedom from death, surgery for valve dysfunction and MR >2+ at 1-year.

This study is limited by the fact that it is not randomized consisting of a small number of patients.

Source

Late Breaking Clinical Trials Session: SCAI Annual Scientific Sessions in partnership with ACC i2 summit, April 1, 2008 Chicago

Reference