CRT devices used in combination with optimized pharmacologic therapy (OPT) significantly impact patient's quality and length of life

May 25 2004

UI Heart Care researchers are among the first in the nation to evaluate the effectiveness of cardiac resynchronization therapy (CRT) devices to reduce the risk of mortality and hospitalization in advanced heart failure patients.

The UI team conducted its evaluation as part of the landmark COMPANION Trial (Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure) with other top medical facilities around the nation. The results of the trial appear in the current issue of the New England Journal of Medicine. The findings indicate CRT devices used in combination with optimized pharmacologic therapy (OPT) have a significant impact on a patient's quality and length of life.

As one of the study's clinical trial sites, UI Hospitals and Clinics is among the first to bring this lifesaving technology to Iowans. Brian Olshansky, M.D. (left), director of electrophysiology for UI Heart Care, and Ron Oren, M.D. (right), director of heart failure services, led the study at UI Hospitals and Clinics. The research participants were diagnosed with Class III or IV heart failure, the most advanced stages of the disease.

"We were pleased to provide this important opportunity for our patients to enroll in this cutting-edge research trial," Olshansky said. "The results are impressive and help to advance the level of care we can deliver to these seriously ill patients."

The COMPANION Trial included more than 1,600 heart failure patients from across the country. While previous clinical studies demonstrated that CRT devices improve performance and quality of life only, the COMPANION Trial yielded the following impressive results:

• 19 percent reduction in combined all-cause mortality or all-cause hospitalization for heart failure patients implanted with Guidant's cardiac resynchronization therapy pacemakers (CRT-P);
• 20 percent reduction in combined all-cause mortality or all-cause hospitalization for heart failure patients implanted with Guidant's cardiac resynchronization therapy defibrillators (CRT-D); and
• 36 percent reduction in all-cause mortality for heart failure patients who received Guidant's CRT-D device.

Cardiac resynchronization therapy devices use electrical stimulation to synchronize, or pace, the contractions of the right and left ventricles of the heart. CRT-D devices function like regular CRT devices, but also include a defibrillation function, which sends an electrical shock to the heart to stop dangerously rapid rhythms that can result in sudden cardiac death.

Heart failure is a debilitating condition that affects not only a patient's quality of life, but also life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively. More than five millions Americans currently suffer from heart failure. Nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.

The COMPANION Trial, sponsored solely by Guidant, was a prospective, multi-center, randomized study of patients with advanced heart failure (NYHA Class III or IV). The patients studied in this trial had a poorly functioning left ventricle, the heart's main pumping chamber. The study enrolled 1,634 patients at 128 centers in the United States. The COMPANION study used Guidant's CONTAK TR cardiac resynchronization therapy pacemaker (CRT-P) and the CONTAK CD cardiac resynchronization therapy defibrillator (CRT-D) in the device treatment arms.

University of Iowa Health Care describes the partnership between the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.