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May 24, 2004

Heart Failure and Transplant Program at the Hospital of the University of Pennsylvania
Evaluates Heart Failure Treatments for Landmark Nationwide Study

Study Data Reveals Up to 36 Percent Reduction in Death Rate for Patients

(Philadelphia, PA)—“Heart failure is a leading cause of death and nearly 5 million people in the United States suffer from it,” says Mariell Jessup, MD, Professor of Medicine and Medical Director of the Heart Failure and Transplantation Program at the Hospital of the University of Pennsylvania (HUP). Jessup, along with David Callans, MD, Professor of Medicine and Director of the Electrophysiology Laboratory, served as co-principle investigators for HUP’s component of the largest heart-failure device trial ever undertaken to investigate whether an implantable pacemaker-type device will reduce death and hospitalization for advanced heart failure patients. Results from the three-year, multi-center Comparison of Medical Therapy, Pacing and Defibrillation in Chronic Heart Failure Study, or COMPANION, trial appear in the May 20th issue of The New England Journal of Medicine. A total of 16 HUP patients were enrolled in the trial. The COMPANION trial took place at 128 other sites with about 1500 participants total.

“For years, we have struggled with a critical dilemma in the management of heart failure -- how to effectively treat the patients’ problems, provide them with improved quality of life and prolong their longevity,” Jessup said. “This study is important because it helps us further clarify which patients will benefit most from which therapies.”

Results indicate that cardiac resynchronization therapy (CRT) and optimized pharmacologic therapy (OPT) used in concert significantly improve participants’ quality and length of life. CRT devices use electrical stimulation to synchronize contractions of the right and left ventricles. When compared with OPT alone, the COMPANION study showed a 19 percent reduction in combined overall mortality or hospitalization for heart-failure patients implanted
with Guidant CRT pacemakers, as well as a similar reduction (20 percent) for patients implanted with Guidant CRT defibrillators. There was a 36 percent reduction in all-cause mortality for heart-failure patients who were implanted with Guidant’s CRT defibrillators.

Although not a specific disease, heart failure describes an irreversible condition in which the heart muscle chambers “fail” to pump an adequate flow of oxygen and nutrient-rich blood throughout the body. As a result, many patients describe their debilitating symptoms-- exhaustion, breathlessness, and fluid accumulation-- as living while slowly dying.

There are several causes of heart failure: the heart can become weakened by many disorders, such as chronic high blood pressure, coronary heart disease, a large heart attack, or diabetes; or can be brought on because the patient was born with structural defects in his or her heart. Usually medications are unable to completely reverse the damage done to the heart and the only so-called cure is to undergo a heart transplant.

According to Jessup, heart failure is the cause for “at least 20 percent of all hospital admissions among persons older than 65 and over the past decade; the rate of hospitalization for heart failure has increased by 159 percent.” (This data appeared in the May 15, 2003 review article in The New England Journal of Medicine that Jessup co-authored with Susan Brozena, MD, Associate Professor of Medicine.)

HUP’s Heart Failure and Transplant Program is uniquely qualified to provide treatment to heart failure patients. It provides an integrated environment specializing in the care of patients with heart failure or heart transplants. The team includes six full-time heart-failure physicians; six full-time heart-failure nurses; three full-time research coordinators to handle the multiple pharmacology, NIH-funded and Penn-based studies of heart failure; and six full-time transplant coordinators. They work in close association with a team of 11 full-time cardiac electrophysiologists who focus on the rhythm disorders that are frequently found in patients with various forms of heart failure. In addition, their efforts are supported by a team of cardiac surgeons who are able to complement medical and electrical treatments with transplant or other pioneering surgical techniques.

Guidant Corporation was the sole sponsor of the COMPANION clinical trial.

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The researchers for this study have received grant support from Guidant.

PENN Medicine is a $2.5 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System (created in 1993 as the nation’s first integrated academic health system).

Penn’s School of Medicine is ranked #3 in the nation for receipt of NIH research funds; and ranked #4 in the nation in U.S. News & World Report’s most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.Penn Health System consists of four hospitals (including its flagship Hospital of the University of Pennsylvania, consistently rated one of the nation’s “Honor Roll” hospitals by U.S. News & World Report), a faculty practice plan, a primary-care provider network, three multispecialty satellite facilities, and home health care and hospice.

Release available online at http://www.uphs.upenn.edu/news/News_Releases/may04/COMPANION Study.html