Expanded Data Presented From Abbott's MitraClip Postapproval Registry
April 30, 2018—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the presentation of 1-year findings from the postapproval registry evaluating the safety and efficacy of the MitraClip (Abbott Structural Heart) in a real-world, commercial setting. The data were presented at the SCAI 2018 scientific sessions held April 25–28 in San Diego, California.
SCAI summarized the findings from the prospective, single-arm, multicenter, observational study, which includes echocardiographic, functional, and quality-of-life outcomes. The study is based on data extracted from the first 2,000 MitraClip patients consecutively entered into the National Transcatheter Valve Therapy Registry.
According to SCAI, clinical, echocardiographic, functional, and quality-of-life outcomes were analyzed at 30 days and 1 year after the device was implanted. The study included a patient population that was 56.5% men and were a mean age of 79 ± 10 years. Additionally, 85.6% of patients were classified as New York Heart Association III/IV, with 90% indicated as a prohibitive risk at baseline.
At 1 year, 86.8% of patients had postprocedural mitral regurgitation of ≤ 2+ and there was 81.7% freedom from all-cause mortality. Measurements of the left ventricle by echocardiography showed improvement in left ventricular end-diastolic volume (LVEDV) and left ventricular internal diameter end diastole and end systole (LVIDd) with 8.5 mL and 0.2-cm mean reduction, respectively. Clinical measures show mean improvement of 37.9 meters in the 6-minute walk test and 83.4% improvement in New York Heart Association I/II at the 1-year mark.
Lead Investigator James Hermiller, MD, commented in the SCAI press release, “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. 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.”
In the United States, MitraClip is currently indicated for the treatment of degenerative mitral valve regurgitation. The MitraClip system was approved by the US Food and Drug Administration in 2013.