A post-approval registry study of the MitraClip mitral valve repair device from Abbott (NYSE:ABT) showed positive results at one year, according to late-breaking results presented this week at the annual meeting of the Society for Cardiovascular Angiography & Interventions in San Diego.
The real-world study, of the first 2,000 MitraClip patients treated in the Transcatheter Valve Therapy Registry, showed that 86.8% of patients had post-procedural mitral regurgitation of ≤2+ and a survival rate of 81.7% after a year. Echocardiograms showed improvement in left ventricular end-diastolic volume and left ventricular internal diameter end diastole and end systole, with 8.5ml and 0.2 cm mean reduction, respectively.
“This is a rigorous, real-world study that includes more data than we’ve seen before. For the first time, we evaluated results of an echocardiogram and walk test, and assessed the patient’s quality of life to further evaluate the effectiveness of MitraClip therapy,” lead author Dr. James Hermiller, of the Heart Center of Indiana in Indianapolis, said in prepared remarks. “The outcomes were extremely encouraging and reinforce the safety and efficacy of this treatment option in real world practice. We think it has the potential to be a new standard of care for select patients with mitral valve regurgitation.”
MitraClip won pre-market approval from the FDA in October 2013.