Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.
OBJECTIVE
The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate.


BACKGROUND
Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR.


METHODS
Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care.


RESULTS
Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034).


CONCLUSIONS
The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).
Cleveland Clinic, Ohio 44195, USA. whitlop@ccf.org
Patrick L
PL
Whitlow
Ted
T
Feldman
Wes R
WR
Pedersen
D Scott
DS
Lim
Robert
R
Kipperman
Richard
R
Smalling
Tanvir
T
Bajwa
Howard C
HC
Herrmann
John
J
Lasala
James T
JT
Maddux
Murat
M
Tuzcu
Samir
S
Kapadia
Alfredo
A
Trento
Robert J
RJ
Siegel
Elyse
E
Foster
Donald
D
Glower
Laura
L
Mauri
Saibal
S
Kar
D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D057510:Endovascular Procedures / Q000401:mortality*; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000401:mortality*; D006801:Humans; D008297:Male; D008943:Mitral Valve; D008944:Mitral Valve Insufficiency / Q000209:etiology / Q000401:mortality* / Q000601:surgery; D011183:Postoperative Complications / Q000453:epidemiology*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology