Endovascular Valve Edge-to-Edge Repair Study - EVEREST I

Description:

The goal of the phase I EVEREST I trial was to evaluate the safety and feasibility of percutaneous mitral valve repair using the Edge-to-Edge technique in patients with moderate or severe mitral regurgitation (MR).

Hypothesis:

Percutaneous mitral valve repair using the Edge-to-Edge technique will be safe and feasible in patients with moderate or severe MR.

Study Design

Patients Enrolled: 27
NYHA Class: Class III/IV 44%
Mean Follow Up: 30 days
Mean Patient Age: Mean age 69 years
Female: 41

Patient Populations:

Symptomatic moderate to severe or severe MR or asymptomatic moderate to severe or severe MR with left ventricular dysfunction and age ≥18 years; candidate for mitral valve surgery

Exclusions:

Ejection fraction <30% or LVESD >55 mm; renal insufficiency; endocarditis; rheumatic heart disease

Primary Endpoints:

Freedom from major adverse events (MAE) at 30 days from death, myocardial infarction, cardiac tamponade, cardiac surgery for failed clip/device, clip detachment, stroke, and septicemia

Secondary Endpoints:

Efficacy: MR ≤2+reduction
Safety: In-hospital vascular complication; 30 day and 6-month major bleeding, endocarditis, clip thrombosis, hemolysis, mitral valve injury; 6-month cardiac surgery for failed clip/device

Drug/Procedures Used:

The Edge-to-Edge technique involves approximation of the middle scallops of the anterior and posterior mitral leaflets with a suture, which results in a double-orifice mitral valve, re-establishing a functioning line of leaflet coaptation.

The procedure was done using a catheter-based percutaneous method with fluoroscopic and transesophageal echo guidance. A trans-septal approach is used to deliver a removable clip device that is positioned to grasp the mitral leaflet edges to create a double orifice. Thirty-two patients are expected to be enrolled in the trial.

Principal Findings:

Among the 27 patients enrolled, 24 had the clip implanted (89%) and the clip could not be implanted in 3 patients (11%). All three of these patients underwent surgery. Resultant MR ≤2+ at discharge was present in 67% of patients. For the first 10 cases, the procedures lasted 2-4 hours (mean 3.2 hours) and post-procedure hospital stay averaged 1.8 days.

At 30 days, 85% of patients met the criteria for freedom from MAE. Of the 15% of patients with a MAE (4/27), 1 patient had a stroke and 3 patients had clip detachment. Mean MR was reduced from 3.7 at baseline to 1.6 at discharge and 2.1 at one month follow-up. Among the 24 patients with clip implanted, 25% underwent surgery an average of 1.7 months after the initial procedure, and 75% were surgery free. In 18 surgery-free clip patients, mean New York Heart Association heart failure classification improved in 72% of patients (n=13) and was unchanged in 28% (n=5).

Interpretation:

Among patients with moderate or severe MR, percutaneous mitral valve repair using the Edge-to-Edge technique was feasible and appeared relatively safe in the first 27 patients enrolled in the study.

Although the phase I study is designed to enroll only patients who are candidates for surgery, one of the main potentials of the percutaneous procedure may be in patients who are unsuitable or at high risk for surgery. Further studies are warranted to more fully address the safety issues and to evaluate efficacy.

References:

Feldman T, Kar S, Rinaldi M, et al., on behalf of the EVEREST Investigators. Percutaneous Mitral Repair With the MitraClip System: Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort. J Am Coll Cardiol 2009;548:686-94.

Presented by Dr. Howard Herrmann at the American Heart Association Scientific Session, November 2004.

Presented by Dr. Ted Feldman at the American College of Cardiology Annual Scientific Session, March 2004.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: Sutures, Surgical Instruments, Stroke, Follow-Up Studies, Pectinidae, Mitral Valve Insufficiency, Heart Failure, Cardiac Surgical Procedures, Patient Discharge, Ventricular Dysfunction, Left, Length of Stay


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