Percutaneous Mitral Valve Repair for Mitral Regurgitation

New Orleans—Through 2 years of treatment, patients who underwent percutaneous mitral valve repair had reduced mitral regurgitation (MR) and experienced meaningful clinical benefits, according to a randomized controlled trial that compared percutaneous mitral valve repair with surgery. The authors found that surgery provided more complete MR reduction, but percutaneous repair led to better safety. Results after 2 years of the ongoing EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial were presented at the ACC meeting. The 1-year findings were similar, with percutaneous mitral valve repair demonstrating increased safety but less reduction in MR compared with surgery. The researchers used Abbott Laboratories’ MitraClip, which is intended to reduce MR. Patients were included in the study if they were candidates for mitral valve surgery and had moderately severe (grade 3+) or severe (grade 4+) MR. Exclusion criteria included an acute myocardial infarction within 12 weeks, a need for other cardiac surgery, renal insufficiency (defined as creatinine >2.5 mg/dL), endocarditis, and rheumatic heart disease. The study enrolled 279 patients at 37 states who were randomized in a 2:1 ratio to the percutaneous group (n=184) or the surgery group (n=95). Patients were assessed at baseline as well as at 30 days, 6 months, 1 year, 18 months, and then annually for 5 years. The baseline demographics were similar between the groups except for a history of congestive heart failure (91% in the percutaneous group vs 78% in the surgery group; P=.005). After 2 years, 172 of the 184 patients (93%) in the percutaneous group and 83 of the 95 patients (87%) in the surgery group remained enrolled in the study. The primary efficacy end point was defined as freedom from death, mitral valve surgery or reoperation, or grade 3+ or 4+ MR. The researchers performed 2 analyses. In the intention-to-treat analysis, they considered any mitral valve surgery after percutaneous repair as an end point event. Meanwhile, in the comparison of treatment strategies analysis, they did not consider mitral valve surgery after an unsuccessful inhospital percutaneous repair as an end point event. At 2 years, the intention-to-treat analysis found that 51.7% of patients in the percutaneous group had achieved the primary end point compared with 66.3% of patients in the surgery group (P<.001). In the comparison of treatment strategy analysis, 62.7% of patients in the percutaneous group had achieved the primary end point compared with 66.3% of patients in the surgery group (P=.67). Researchers also assessed clinical outcome measures such as MR grade, left ventricular (LV) volumes, and New York Heart Association (NYHA) functional classification. At 2 years, patients who underwent percutaneous mitral valve repair had significant improvements in LV end diastolic volume, LV end systolic volume, and NYHA functional classification compared with patients who had surgery (P<.005 in all comparisons). The authors concluded that patients with significant MR could benefit from percutaneous mitral valve repair and that future results would provide a better understanding of the procedure’s safety and effectiveness.