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J Am Coll Cardiol. 2015 Dec 29;66(25):2844-2854. doi: 10.1016/j.jacc.2015.10.018.

Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II.

Author information

1
Department of Medicine, Division of Cardiology, Evanston Hospital, Evanston, Illinois. Electronic address: tfeldman@tfeldman.org.
2
Department of Medicine, Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California.
3
Department of Medicine, Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts; Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Boston, Massachusetts.
4
Department of Medicine, Division of Cardiology, Evanston Hospital, Evanston, Illinois.
5
Department of Surgery, Division of Cardiovascular Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
6
Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Boston, Massachusetts.
7
Department of Medicine, Division of Cardiology, Terrebonne General Medical Center, Houma, Louisiana.
8
Department of Medicine, Division of Cardiology, Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina.
9
Department of Medicine, Division of Cardiology, The Memorial Hermann Heart and Vascular Institute, Houston, Texas.
10
Department of Medicine, Division of Cardiology, St. Vincent Medical Group, Indianapolis, Indiana.
11
Department of Surgery, Division of Cardiovascular Surgery, St. Vincent Medical Group, Indianapolis, Indiana.
12
Department of Medicine, Division of Cardiology, Columbia University Medical Center, New York, New York.
13
Department of Medicine, Division of Cardiology, Baylor University, Dallas, Texas.
14
Department of Surgery, Division of Cardiovascular Surgery, Baylor University, Dallas, Texas.
15
Department of Medicine, Division of Cardiology, University of Virginia, Charlottesville, Virginia.
16
Department of Surgery, Division of Cardiovascular Surgery, University of Virginia, Charlottesville, Virginia.
17
Department of Medicine, Division of Cardiology, University of Pennsylvania, Philadelphia, Pennsylvania.
18
Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
19
Department of Medicine, Division of Cardiology, University of California, San Francisco, California.
20
Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
21
Department of Surgery, Division of Cardiovascular Surgery, Duke University Medical Center, Durham, North Carolina.
22
Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Boston, Massachusetts; Department of Medicine, Division of Cardiology, Brigham and Women's Hospital, Boston, Massachusetts.

Abstract

BACKGROUND:

In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year.

OBJECTIVES:

This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery.

METHODS:

Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up.

RESULTS:

At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival.

CONCLUSIONS:

Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274).

KEYWORDS:

mitral insufficiency; regurgitant lesion; valve therapy

PMID:
26718672
DOI:
10.1016/j.jacc.2015.10.018
[Indexed for MEDLINE]
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