Landmark NEJM Study Finds Device Therapy Prevents Heart Failure

Arthur Moss, M.D., and patient Todd Steverson share their experiences with MADIT-CRT.

A landmark study published online this week in the New England Journal of Medicine and presented by University of Rochester investigator Arthur J. Moss, M.D., at the European Society of Cardiology Congress in Barcelona, Spain, shows that patients who received an implanted cardiac resynchronization device combined with a defibrillator (CRT-D) had a 34 percent reduction in their risk of death or heart failure when compared to patients receiving only an implanted cardiac defibrillator (ICD).

The overall benefit observed from resynchronization therapy was driven by a 41 percent reduction in heart failure events. Women who received CRT-D had an astonishing 63 percent reduction in the risk of heart failure.

Animations show the resynchronization device and the path taken by the leads (wires) running from the device into the heart.

Previously, Moss and collaborators in the MADIT research group (Multicenter Automatic Defibrillator Implantation Trial) showed in the MADIT-II trial in 2002 that an ICD reduced the risk of death by 31 percent in cardiac patients. Shortly thereafter the therapy was approved by the U.S. Food and Drug Administration and became part of professional guidelines from the American Heart Association, the American College of Cardiology and the Heart Rhythm Society.

But then long-term follow-up studies showed that ICDs were so effective at preventing sudden death that patients were living longer and were subsequently at increased risk for heart failure. This created an urgent need to better address both risks in tandem.

Moss and his team designed MADIT-CRT to determine if preventive CRT-D therapy – the combination of an ICD with CRT – could reduce the risk of mortality and heart failure in patients with mild cardiac disease and few symptoms.

Over a four-and-a-half-year period, 1,820 patients from 110 medical centers in the U.S., Canada and Europe were followed in MADIT-CRT. The trial was sponsored by Boston Scientific Corp. through a research grant to the University of Rochester.

“The findings from MADIT-CRT show that CRT-D effectively reduces the risk of heart failure,” said Moss, a professor of Medicine. “There is a very large population of patients with heart disease whom we believe will benefit from CRT-D therapy.”

Prior to 2009, Moss received honoraria from Boston Scientific for talks at scientific programs. He holds no stock in any device company, has never been a member of any corporate speakers’ bureau, and since late last year has not accepted honoraria from Boston Scientific for any professional activity.