Device Gets FDA Nod for Mild Heart Failure
The FDA has expanded the indication for Medtronic's cardiac resynchronization therapy (CRT) device to include patients with less severe heart failure.
The expanded indication now allows implantation of a CRT device in patients with New York Heart Association (NYHA) class II heart failure, a left ventricular ejection fraction (LVEF) of ≤30%, left bundle branch block, and a QRS duration ≥130 ms.
When the QRS is narrow, patients benefit from the addition of a defibrillator to the CRT device (CRT-D).
"We now for the first time are able to treat mildly symptomatic heart failure patients with devices, which allows us not only to save lives but improve their overall functional status and slow the progression of their disease," Michael Gold, MD, director of cardiology at the Medical University of South Carolina in Charleston, told MedPage Today .
The FDA based its decision for the expanded indication on two pivotal clinical trials: REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial).
In the , reported at the 2008 American College of Cardiology meeting, 1-year data showed that patients with NYHA class I and II heart failure outfitted with a CRT or CRT-D device had reverse left ventricular (LV) remodeling, which translated into a significant improvement in LVEF.
However, there were no significant improvements in quality of life or 6-minute walk test between the CRT group and the group receiving optimal medical therapy.
At the time the REVERSE results were reported, several people noted that CRT was an expensive option for class I or II disease.
But the lead investigator said the risks are outweighed by the benefits, including reverse remodeling as well as reductions in heart failure hospitalizations.
A cost-effective analysis performed in the European cohort of REVERSE showed CRT to be "very good," Gold said.
The study found that within two years, one-third of patients not on resynchronization therapy will worsen.