EVEREST Study Overview
Investigators have now treated more than 325 patients with more than 400 clips implanted in the EVEREST studies in the US and Canada. The EVEREST II study is a randomized, controlled, multicenter clinical trial evaluating the safety and efficacy of the MitraClip system in patients with moderate-to-severe or severe MR, compared with surgical repair or replacement. The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate-to-severe (3+) or severe (4+) MR at 12 months. The primary safety end-point is freedom from major adverse events at 30 days or hospital discharge whichever is longer. The national co-principal investigators are Ted Feldman, Director of the Cardiac Catheterization Lab at Evanston Northwestern Healthcare, and Don Glower, Professor of Surgery at Duke University An initial cohort of 107 non-randomized patients treated in the two EVEREST studies shows that the MitraClip device can be successfully implanted in a majority of patients. Investigators chose to implant the clip in more than 90% of these cases, of which approximately 75% achieved a reduction in MR to a level that is no longer clinically significant (2+ MR). Patients have been remarkably stable throughout the procedure, and a low complication rate was reported for this cohort. After the MitraClip procedure, patients were usually discharged home in two days without nursing care. These rates of hospital stay and lack of need for nursing care differ greatly from open arrested-heart surgery, where patients are in the hospital for five to seven days on average, with approximately 40% of valve surgery patients requiring nursing care after discharge from the hospital.
A New Alternative for a Serious Condition
Although many people have not heard of MR specifically, approximately50% of patients who suffer from heart failure in the US have significant MR. Sometimes heart failure causes MR, but more often MR is the cause of heart failure. Either way, MR results in a progressive worsening of heart failure. Treating MR in these patients may reduce the symptoms of heart failure, and, just as importantly, improve the quality of life for these patients. Since heart failure is a progressive disease, patients are frequently in and out of the hospital to treat their disease. A reduction in their MR may improve their clinical status and reduce the need for hospitalization. Successfully treating these patients may also have a positive economic impact on the healthcare system.