Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial.
OBJECTIVE
This study sought to evaluate the clinical results of a percutaneous approach to mitral valve repair for mitral regurgitation (MR).


BACKGROUND
A surgical technique approximating the middle scallops of the mitral leaflets to create a double orifice with improved leaflet coaptation was introduced in the early 1990s. Recently, a percutaneous method to create the same type of repair was developed. A trans-septal approach was used to deliver a clip device that grasps the mitral leaflet edges to create the double orifice.


METHODS
General anesthesia, fluoroscopy, and echocardiographic guidance are used. A 24-F guide is positioned in the left atrium. The clip is centered over the mitral orifice, passed into the left ventricle, and pulled back to grasp the mitral leaflets. After verification that MR is reduced, the clip is released.


RESULTS
Twenty-seven patients had six-month follow-up. Clips were implanted in 24 patients. There were no procedural complications and four 30-day major adverse events: partial clip detachment in three patients, who underwent elective valve surgery, and one patient with post-procedure stroke that resolved at one month. Three additional patients had surgery for unresolved MR, leaving 18 patients free from surgery. In 13 of 14 patients with reduction of MR to < or =2+ after one month, the reduction was maintained at six months.


CONCLUSIONS
Percutaneous edge-to-edge mitral valve repair can be performed safely and a reduction in MR can be achieved in a significant proportion of patients to six months. Patients who required subsequent surgery had elective mitral valve repair or intended replacement.
Feldman
Ted
T
Evanston Hospital, Cardiology Division-Burch 300, Evanston, Illinois 60201, USA. tfeldman@enh.org
Wasserman
Hal S
HS
Herrmann
Howard C
HC
Gray
William
W
Block
Peter C
PC
Whitlow
Patrick
P
St Goar
Fred
F
Rodriguez
Leonardo
L
Silvestry
Frank
F
Schwartz
Allan
A
Sanborn
Timothy A
TA
Condado
Jose A
JA
Foster
Elyse
E
D000368:Aged; D006328:Cardiac Catheterization; D002983:Clinical Competence; D017321:Clinical Trials, Phase I as Topic; D015150:Echocardiography, Doppler; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D020007:Implants, Experimental; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000601:surgery*; D011474:Prosthesis Design; D016896:Treatment Outcome