Participants were randomized to treatment with MitraClip - a minimally invasive treatment that fastens the mitral valve leaflets together - and medical therapy or medical therapy alone. The researchers then compared the number of heart failure-related hospitalizations and deaths over 24 months in both groups.
Patients who had the minimally invasive procedure had 47 percent fewer heart failure-related hospitalizations and 38 percent fewer deaths than those who were managed medically.
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"The improvement in symptoms and reduction in need for hospitalization due to heart failure was almost immediate after the MitraClip. In contrast, the improvement in survival emerged about a year after the procedure, a delayed response consistent with the long-term benefits of reducing volume overload on the heart," said Dr. Stone.
The procedure was also associated with significant improvements in quality of life and functional capacity. The treatment was determined to be safe, with low 30-day rates of death or stroke, and the reduction in MR was durable through the 2-year follow-up of the study.
"Patients with heart failure and severe secondary or functional MR who remain symptomatic despite all the best medical therapies now have substantially more hope because we can improve their quality of life and survival by reducing their MR with a safe, low-risk procedure," said Dr. Stone.
Other authors: JoAnn Lindenfeld, Vanderbilt University, Nashville; William T. Abraham, The Ohio State University, Columbus; Saibal Kar, Cedars-Sinai Medical Center, Los Angeles; Scott Lim, University of Virginia, Charlottesville; Jacob Mishell, Kaiser Permanente - San Francisco Hospital, San Francisco; Brian Whisenant, Intermountain Medical Center, Murray, Utah; Paul Grayburn, Baylor University Medical Center, Dallas; Michael Rinaldi, Carolinas Medical Center, Charlotte, North Carolina; Samir R. Kapadia, Cleveland Clinic, Cleveland; Vivek Rajagopal, Piedmont Hospital, Atlanta; Ian J. Sarembock, The Christ Hospital, Cincinnati; Andreas Brieke, University of Colorado Hospital, Aurora; Steven O. Marx X, NewYork-Presbyterian/Columbia University Irving Medical Center and Columbia University Vagelos College of Physicians and Surgeons; David J. Cohen, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri; Neil J. Weissman, Medstar Health Research Institute, Hyattsville, Maryland; and Michael J. Mack, Baylor Scott & White Heart Hospital Plano, Plano, Texas.
