Four year follow up on EVEREST II study of Mitra Clip (Abbott)

Four-year follow-up of the Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II) show no differences in the primary end point between the Mitra Clip (Abbott) procedure and surgery and significantly more follow-up surgeries for residual mitral regurgitation (MR) in the clip group.At four years, surgery for mitral-valve dysfunction was needed for one out of every four patients treated with the Mitra Clip compared with just 5.5% of patients who underwent surgery. The rate of the primary effectiveness end point, a composite that includes freedom from death, surgery, or 3+ or 4+ MR, was 39.8% in the percutaneous-repair arm and 53.4% in the surgical group, a difference that was not statistically significant (p=0.070).

Dr Laura Mauri (Brigham and Women's Hospital, Boston ), the lead author of the four-year EVEREST II report, which is published online May 6, 2013 in the Journal of the American College of Cardiology, said that while the comparison of the procedures in a surgical population favors surgery, the "trial is important in that it provides useful information about the long-term durability of the device." Dr Mauri explained that treatment with the Mitra Clip was associated with mortality rates similar to surgery at one year, but the degree of MR reduction was less with percutaneous repair. At one year, approximately 20% of Mitra Clip patients required mitral-valve surgery to treat moderate or severe MR compared with 2.2% of patients treated with surgery.