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J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.

Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study.

Author information

1
Duke University Medical Center, Durham, North Carolina. Electronic address: d.glower@duke.edu.
2
Heart Institute, Cedars Sinai Medical Center, Los Angeles, California.
3
Division of Pediatric Cardiology, University of Virginia, Charlottesville, Virginia.
4
Aurora Cardiovascular Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Milwaukee, Wisconsin; University of Wisconsin School of Medicine and Public Health, Milwaukee, Wisconsin.
5
Baptist Hospital of Miami, Miami, Florida.
6
Cleveland Clinic, Cleveland, Ohio.
7
Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina.
8
Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas.
9
Brigham and Women's Hospital, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts.
10
Division of Cardiac Surgery, Northwestern University, Chicago, Illinois.
11
Northshore University Health System, Chicago, Illinois.

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).

KEYWORDS:

high surgical risk; mitral valve insufficiency; percutaneous

PMID:
25011722
DOI:
10.1016/j.jacc.2013.12.062
[Indexed for MEDLINE]
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