Cardiac resynchronization therapy can have long-lasting benefits for patients with mild heart disease, including shrinking an enlarged heart, according to results of a long-term study presented in Munich, Germany, on Monday.
Called the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial, five years of data from 610 patients showed that Medtronic's cardiac resynchronization therapy devices also show low mortality and hospitalization rates over five years after implant.
Medtronic said Monday that the REVERSE trial is the first -- and longest -- study of its kind to show that cardiac resynchronization therapy structurally changes the heart in patients with mild disease, as well as having enduring, long-term positive effects. The results were presented at the European Society of Cardiology's ESC Congress 2012 in Munich.
"These findings show, for the first time, the overall magnitude of the long-lasting, lifesaving benefits of CRT in a mildly symptomatic patient population," said Dr. Cecilia Linde of Karolinska University Hospital in Stockholm. "This noteworthy data adds to the growing body of evidence further validating the clinical benefits of early intervention with CRT and confirms the sustaining benefit that patients can continue to receive over a five-year time span."
Medtronic said its data show that device therapy actually slows the progression of heart disease in patients with mildly symptomatic heart failure for at least five years following implant.
Heart failure patients suffer from enlarged hearts. In the Medtronic study, CRT therapy was shown to reverse this enlargement and even reverse it over time. In REVERSE, the change was greatest within the first two years of therapy and was sustained afterward.
"The REVERSE trial continues to provide the medical community with valuable, real-world insight on the benefits of CRT in providing optimal treatment to patients with early-stage heart failure," said Dr. David Steinhaus, Medtronic vice president and medical director for the Fridley-based company's Cardiac Rhythm Disease Management business.
"We are committed to providing physicians with the most advanced medical devices -- backed by strong clinical data -- to treat heart failure patients across the continuum of care, whether in the earliest or most severe stages of disease."
Medtronic said its study also demonstrates that CRT is cost-effective for patients with mild disease, showing lower treatment costs than for patients with other serious chronic conditions.
Sudden cardiac arrest accounts for more than 60 percent of deaths among patients with mild-to-moderate heart failure, Medtronic said. However, research suggests that earlier intervention with cardiac resynchronization therapy with defibrillation (CRT-D) can decrease the risk of death for people with mild symptoms.
CRT-D therapy works by resynchronizing the contractions of both ventricles by sending tiny electrical impulses to the heart muscles. Those impulses improve the heart's blood-pumping ability. If the heart stops, the device's defibrillation capability can deliver a lifesaving shock.
Senior analyst Thomas Gunderson of Piper Jaffray said Monday that the Medtronic study is not expected to have an impact on the company's fortunes, but does reinforce data from earlier studies.
James Walsh 612-673-7428