Original Investigation
Percutaneous Mitral Valve Repair for Mitral Regurgitation in High-Risk Patients: Results of the EVEREST II Study

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Abstract

Background

The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States.

Objectives

The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair.

Methods

Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled.

Results

In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%.

Conclusions

The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274)

Key Words

high surgical risk
mitral valve insufficiency
percutaneous

Abbreviations and Acronyms

DMR
degenerative mitral regurgitation
ECL
echocardiographic core laboratory
FMR
functional mitral regurgitation
HF
heart failure
LVEF
left ventricular ejection
MR
mitral regurgitation
MV
mitral valve
TEE
transesophageal echocardiography
TTE
transthoracic echocardiography

Cited by (0)

Dr. Kar has received honoraria and institutional research support from Abbott. Dr. Lim is a consultant for and has received research grants from Abbott Vascular. Dr. Whitlow’s institution has received research support for participating in the EVEREST trials from Abbott. Dr. Rinaldi is a consultant for Abbott. Dr. Grayburn has received grants from Abbott, Medtronic, Baxter, ValTech Cardio, and Guided Delivery Systems; and has received consulting fees and/or honoraria from Abbott, Tendyne, and Bracco Diagnostics. Dr. Mauri’s institution has received research grants from Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly, Daiichi-Sankyo, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. McCarthy is a consultant to Abbott and Edwards Lifesciences; and receives royalties from Edwards Lifesciences. Dr. Feldman is a consultant for and has received honoraria and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and WL Gore. All other authors have reported they have no relationships relevant to the contents of this paper to disclose.

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