New use of CRT-D device for mild heart failure gets a thumbs up
The FDA has given a thumbs up to a new heart failure device that can help patients with heart disease live longer. The heart failure device is a cardiac resynchronization therapy defibrillator (CRT–D) that serves the dual purpose of protecting patients with heart disease from sudden cardiac death from arrhythmia while simultaneously improving the pumping action of the heart for patients with heart damage.
The combination defibrillator cardiac resynchronization device is already approved and has been used for patients with severe heart failure. When a dangerous heart rhythm occurs the defibrillator shocks the heart back into rhythm, preventing sudden cardiac death. The resynchronization therapy from the device improves symptoms of heart failure that include shortness of breath, fatigue, and fluid retention.
An advisory panel has now recommended that the FDA to approve the cardiac resynchronization therapy defibrillator (CRT–D) for patients with mild heart failure, based on extensive studies throughout the US, conducted under the leadership of cardiologist Arthur Moss, M.D., professor of Medicine at the University of Rochester Medical Center.
Study results of the CRT-D heart failure device compiled from the MADIT-CRT trial, published last year in NEJM found a thirty four percent reduction in heart failure compared to patients with implantable cardioverter defibrillator (ICD) alone. Overall improvement for heart failure was forty one percent. For women, heart failure was reduced by 63 percent from the combination of CRT-D.
Last week Dr. Moss presented study evidence at a meeting of the FDA’s Circulatory System Devices panel that patients with mild heart failure experience better quality of life from the CRT-D device.
“The panel’s recommended approval of this therapy is great news for a large population of patients in which it could effectively prevent heart failure progression,” said Moss. “The ultimate goal of this new therapy is to not only help patients live longer, but to help them live better.”
Class I and class II heart failure that produces few to mild symptoms, affects approximately 70 percent of patients with heart disease, of which there are 5.5 million in the US. The new application of the CRT-D heart failure device that has been given approval by the FDA advisory panel could mean that 3.1 million patients with heart disease would experience improved quality of life – based on the four and a half year study that included 1,820 patients from 110 medical centers in the United States and sponsored by the manufacturer, Boston Scientific.