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Medtronic Study Shows CRT Devices Provide Little Help to Patients with Mild Heart Failure

Apr 3, 2008 | Parker Waichman Alonso LLP

Cardiac-resynchronization therapy (CRT) devices don't do much for patients with mild heart failure, according to a just completed clinical trial.  The clinical trial, called REVERSE, was funded by Medtronic Inc. in the hope that it could expand the market for its CRT devices to patients with mild heart failure.  As it stands now, CRT devices are only approved for people with severe heart failure.

About 5 million Americans have hearts so weak they don't pump enough oxygen-rich blood to fuel the body. CRT devices are typically implanted in patients diagnosed with severe heart failure, where the heart cannot pump enough blood through the body. CRTs are often designed to provide shocks when hearts get dangerously out of control. Such devices are known as CRT-Ds, as they also have a defibrillator function. They cost around $32,000, more than a typical high-end defibrillator.

The results of the REVERSE study were presented Tuesday at the American College of Cardiology annual meeting in Chicago.  According to Bloomberg.com, REVERSE was designed to see if patients who received an implanted rhythm-management device in addition to heart medication fared better than those on drugs alone. All 610 patients in the study had the CRT devices surgically implanted, though 191 didn't have them turned on.

The CRT study missed its primary goal on a measure of disease progression, but some patients saw their conditions improve. In the group with the devices on, 16% of patients worsened, versus 21% worsening in the group that left the device off. Researchers did not deem the difference between the groups to be statistically significant.   

However, Medtronic and advocates for expanded CRT device use did find encouragement in some of the findings.  The study did find that CRT devices triggered some improvements to enlarged hearts in less-sick patients.  Patients with the device also were 53 percent less likely to be hospitalized for the condition.

According to The Wall Street Journal, in December, a study funded by St. Jude also failed to find a benefit for CRT-Ds, in that case among patients whose hearts were beating mostly in sync. Still, Medtronic is not giving up on expanding the use of its CRT devices.  David Steinhaus, medical director of Medtronic's cardiac-rhythm unit,  told The Wall Street Journal that the company believed "there's enough in this study" to start a dialogue with the Food and Drug Administration on expanding approved uses.