Rochester-led study leads to recommendation for use of heart failure treatment nationwide
EurekAlert!
A new therapy that reduces the risk of mortality and heart failure in patients with mild cardiac disease received a thumb's up this week from an advisory panel to the U.S. Food and Drug Administration. The panel recommended that the cardiac resynchronization therapy defibrillator (CRT-D), tested extensively nationwide under the leadership of cardiologist Arthur Moss, M.D., professor of Medicine at the University of Rochester Medical Center, be approved for use in patients with mild heart failure in the United States.
The device under review was developed by Boston Scientific and is already approved to treat patients with severe heart failure. With device approval by the FDA, nearly 4 million more Americans could be candidates for treatment with the CRT-D. The recommendations by its panels are often, but not always, followed by the FDA.
In the major study which tested the device - the MADIT-CRT trial - patients who had a cardiac resynchronization device combined with a defibrillator (CRT-D) implanted had a 34 percent reduction in their risk of death or heart failure compared to patients receiving only an implantable cardioverter defibrillator (ICD). Heart failure alone was reduced by 41 percent in all patients, with a remarkable 63 percent reduction of heart failure in women. The study results were published last year in the New England Journal of Medicine.