Real-world MitraClip data show positive 1-year outcomes
A post-approval study of Abbott’s MitraClip device showed positive one-year results for the first 2,000 patients entered into the national Transcatheter Valve Therapy registry, according to late-breaking science presented April 26 at SCAI 2018 in San Diego.
The MitraClip is a minimally invasive option to treat degenerative mitral regurgitation for patients deemed at prohibitive risk for mitral valve surgery. The device received its CE mark in 2008 and was approved by the FDA in 2013.
However, this study was the first to report one-year results from the MitraClip’s real-world, commercial use. The study population was 79 years old on average and 56.5 percent male, and 85.6 percent of patients were categorized into the New York Heart Association (NYHA) functional classes III and IV at baseline.
One-year survival was 78.1 percent and 83.4 percent of survivors improved to NYHA functional classes I or II. Among 710 patients with baseline and one-year measures of mitral regurgitation, 86.6 percent had mitral regurgitation of 2 or lower on a four-part scale—a marked improvement from the 5.1 percent observed at baseline.
“The outcomes were extremely encouraging and reinforce the safety and efficacy of this treatment option in real world practice,” lead author James Hermiller, MD, from St. Vincent Heart Center in Indianapolis, said in a press release. “We think it has the potential to be a new standard of care for select patients with mitral valve regurgitation.”
The study was also the first to include functional and quality of life outcomes for this patient population. Hermiller and colleagues noted an average improvement of 37.9 meters in a six-minute walk test from baseline to one year, as well as a 30-point bump on a quality of life assessment (the Kansas City Cardiomyopathy Questionnaire).
According to the press release, results of the randomized COAPT trial are expected to be shared later this year. COAPT is evaluating the efficacy of the MitraClip among patients with functional mitral regurgitation (FMR) and heart failure. The device is currently only FDA approved for degenerative mitral regurgitation, but Abbott is seeking an expanded indication for FMR if the study is successful.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.