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J Am Coll Cardiol, 2009; 54:686-694, doi:10.1016/j.jacc.2009.03.077
© 2009 by the American College of Cardiology Foundation
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Percutaneous Mitral Repair With the MitraClip System

Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort

Ted Feldman, MD*,*, Saibal Kar, MD{dagger}, Michael Rinaldi, MD{ddagger}, Peter Fail, MD§, James Hermiller, MD||, Richard Smalling, MD, PhD, Patrick L. Whitlow, MD#, William Gray, MD**, Reginald Low, MD{dagger}{dagger}, Howard C. Herrmann, MD{ddagger}{ddagger}, Scott Lim, MD§§, Elyse Foster, MD||||, Donald Glower, MD¶¶ for the EVEREST Investigators

* Evanston Hospital, Evanston, Illinois
{dagger} Cedar Sinai Medical Center, Los Angeles, California
{ddagger} Carolina Heart Institute, Charlotte, North Carolina
§ Terrebonne General Medical Center, Houma, Louisiana
|| The Care Group, Indianapolis, Indiana
Houston Health Sciences Center, Houston, Texas
# The Cleveland Clinic, Cleveland, Ohio
** Columbia University, New York, New York
{dagger}{dagger} University of California at Davis, Sacramento, California
{ddagger}{ddagger} University of Pennsylvania, Philadelphia, Pennsylvania
§§ University of Virginia, Charlottesville, Virginia
|||| University of California at San Francisco, San Francisco, California
¶¶ Duke University Medical Center, Durham, North Carolina


Figure 1
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Figure 1 Double Orifice Surgical MV Repair With Suture

Illustration depicts a double-orifice mitral valve (MV) surgical repair. The MV is viewed from the left atrial side. The middle scallops of the anterior and posterior leaflets have been sutured together, which creates a double orifice, edge-to-edge, or bow-tie repair.

 

Figure 2
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Figure 2 The MitraClip Device

The device is covered with polyester fabric to facilitate tissue in-growth. The distal gripping element helps with leaflet fixation. The clip delivery system exits through a guide catheter.

 

Figure 3
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Figure 3 Key Anatomic Eligibility Criteria

The coaptation length must be at least 2 mm. Coaptation depth must be <11 mm. If a flail leaflet exists, the flail gap must be ≤10 mm, and the flail width must be ≤15 mm. These anatomic characteristics are necessary for sufficient leaflet tissue for mechanical coaptation when the MitraClip device is used.

 

Figure 4
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Figure 4 Efficacy Results Through Discharge

This chart shows the flow of patients from the point of clip procedure attempt through hospital discharge. *Acute procedural success (APS) is defined as placement of 1 or more clips resulting in a discharge mitral regurgitation (MR) severity of ≤2+, as determined by the Core Laboratory.

 

Figure 5
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Figure 5 Surgical Patient Flow Chart

Flow chart depicting the outcomes of patients who had surgery after a clip attempt. MV = mitral valve.

 

Figure 6
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Figure 6 Kaplan-Meier Curves for Patients With Acute Procedure Success

Freedom from death and freedom from surgery are depicted.

 




 
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