Study examines earlier use of heart pumps in growing group of heart failure patients

Jan 24, 2011

The University of Michigan Cardiovascular Center and the University of Pittsburgh have been awarded $13.3 million to explore the potential benefits of heart devices for the large and growing group of Americans with heart failure.

The National Heart, Lung and Blood Institute and HeartWare International, a maker of left ventricular assist devices, are sponsoring the study of earlier access to these devices that support the circulation of patients with failing hearts.

In REVIVE-IT, researchers will compare whether non-transplant eligible patients with heart failure less advanced than that of current LVAD recipients do better with implanted devices than with current medical therapy.

Principal investigators include Keith Aaronson, M.D., M.S., medical director of the heart transplant program and Center for Circulatory Support at the U-M Cardiovascular Center, Francis A. Pagani, M.D., Ph.D., surgical director of the heart transplant program and the Center for Circulatory Support at the U-M and Robert Kormos, M.D., director of the UPMC Artificial Heart Program and co-director of the UPMC Heart Transplantation Program.

"The new study allows us to examine the use of heart devices earlier in the cascade of heart failure," says Aaronson, associate professor of medicine at the U-M medical school.

For most patients, either a past heart attack or certain conditions such as hypertension, heart muscle diseases, abnormal heart valves, or diabetes has lead to heart failure.

LVADs are currently used in patients with very advanced heart failure as a last resort to help them survive the wait for a heart transplant, or serve as a permanent alternative to heart transplantation.

"In REVIVE-IT we'll test the theory that heart failure patients whose condition impairs their daily lives, but who have not suffered serious consequences such as organ damage, malnourishment or immobility, would benefit from earlier implantation of an LVAD," says Pittsburgh's Kormos.

Kormos is also co-principal investigator of the NHLBI-sponsored Interagency Registry for Mechanical Circulatory Support, which contains information on nearly 2,000 approved assist devices.

"Ventricular assist devices have been shown to improve both the quality and length of life of late-stage ," says J. Timothy Baldwin, Ph.D., REVIVE-IT trial project officer, Division of Cardiovascular Sciences, NHLBI. "This trial promises to help us learn if there are advantages to providing these devices before patients reach late-stage heart failure."

The REVIVE-IT study device will be HeartWare's left ventricular assist device the HVAD, a battery- operated continuous blood flow pump that's surgically placed within the heart and the pericardial space surrounding the heart.

The pilot study will include 100 patients from selected U.S. hospitals, including the U-M and Pittsburgh. Site selection for the study will begin later this year. The U-M's Michigan Institute for Clinical and Health Research will coordinate the study.

"Our work may advance the treatment of heart failure by evaluating whether technology now reserved for very severe heart failure is ready for application to a broader group of patients in need," says Pagani, a cardiac surgeon and professor of surgery at the U-M.

U-M's Center for Circulatory Support is a multidisciplinary team of physicians, surgeons and allied health care providers dedicated to the care of patients with advanced or cardiogenic shock. Center clinicians and researchers have provided leadership in the clinical investigation of most of the implantable circulatory support devices in use today.

"The University of Michigan and University of Pittsburgh have been leaders in exploration and development of new technologies for mechanical circulatory support," says Doug Godshall, president and chief executive officer of HeartWare International. "We look forward to supporting their efforts, as they direct this first-of-its-kind clinical study."

Explore further: US scientists make embryonic stem cells from adult skin

add to favorites email to friend print save as pdf

Related Stories

New heart failure device is tested

Oct 17, 2006

Physicians at 50 U.S. medical facilities are taking part in a multinational clinical trial of a device designed to help heart failure victims.

Artificial pump effectively backs up failing hearts

Apr 02, 2009

Patients with severe heart failure can be bridged to eventual transplant by a new, smaller and lighter implantable heart pump, according to a just-completed study of the device. Results of this third-generation heart assist ...

Recommended for you

Leeches help save woman's ear after pit bull mauling

Apr 18, 2014

(HealthDay)—A pit bull attack in July 2013 left a 19-year-old woman with her left ear ripped from her head, leaving an open wound. After preserving the ear, the surgical team started with a reconnection ...

New pain relief targets discovered

Apr 17, 2014

Scientists have identified new pain relief targets that could be used to provide relief from chemotherapy-induced pain. BBSRC-funded researchers at King's College London made the discovery when researching ...

User comments : 0

More news stories

Cancer stem cells linked to drug resistance

Most drugs used to treat lung, breast and pancreatic cancers also promote drug-resistance and ultimately spur tumor growth. Researchers at the University of California, San Diego School of Medicine have discovered ...

Poll: Big Bang a big question for most Americans

Few Americans question that smoking causes cancer. But they have more skepticism than confidence in global warming, the age of the Earth and evolution and have the most trouble believing a Big Bang created the universe 13.8 ...

Making graphene in your kitchen

Graphene has been touted as a wonder material—the world's thinnest substance, but super-strong. Now scientists say it is so easy to make you could produce some in your kitchen.