Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort.
OBJECTIVE
We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California).


BACKGROUND
Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets.


METHODS
Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory.


RESULTS
A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of < or =1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability.


CONCLUSIONS
Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).
Feldman
Ted
T
Evanston Hospital, Cardiology Division-Walgreen Building, Evanston, IL 60201, USA. tfeldman@scai.org
Kar
Saibal
S
Rinaldi
Michael
M
Fail
Peter
P
Hermiller
James
J
Smalling
Richard
R
Whitlow
Patrick L
PL
Gray
William
W
Low
Reginald
R
Herrmann
Howard C
HC
Lim
Scott
S
Foster
Elyse
E
Glower
Donald
D
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization; D006348:Cardiac Surgical Procedures / Q000295:instrumentation / Q000379:methods*; D005240:Feasibility Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000401:mortality / Q000601:surgery*; D011446:Prospective Studies; D013536:Suture Techniques; D016896:Treatment Outcome