The University of Pittsburgh and the University of Michigan (U-M) Cardiovascular Center 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. Principal investigators of the 5-year effort include:
- McGowan Institute for Regenerative Medicine
faculty member Robert Kormos, M.D., director of the UPMC Artificial Heart Program, co-director of the UPMC Heart Transplantation Program, and Medical Director of Vital Engineering,
- Keith Aaronson, M.D., M.S., medical director of the heart transplant program and Center for Circulatory Support at the U-M Cardiovascular Center, and
- Francis A. Pagani, M.D., Ph.D., surgical director of the heart transplant program and the Center for Circulatory Support at the U-M.
The National Heart, Lung and Blood Institute (NHLBI) and HeartWare, a maker of left ventricular assist devices (LVAD), are sponsoring the study of earlier access to these devices that support the circulation of patients with failing hearts.
In REVIVE-IT (Randomized Evaluation of VAD InterVEntion before Inotropic Therapy), researchers will compare whether patients with heart failure less advanced than that of current LVAD recipients and are not eligible for a heart transplant do better with implanted devices than with current medical therapy.
“The new study allows us to examine the use of heart devices earlier in the cascade of heart failure,” says Dr. 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 Dr. Kormos.
Dr. 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 heart failure patients,” 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 pump, 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 hospitals across the United States, 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 Dr. Pagani, a cardiac surgeon and professor of surgery at the U-M Medical School.
In 1985, the first artificial heart device – the Jarvik Artificial Heart – was implanted at the University of Pittsburgh Medical Center (UPMC). Five years later, UPMC became the first medical center ever to discharge a patient on a VAD. Since these milestones, UPMC’s Artificial Heart Program has treated more than 600 patients with mechanical circulatory support devices and has continued to uphold its long history as an international leader in this field.
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 heart failure 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.”
Illustration: HVAD. –HeartWare.
Michigan Institute for Clinical & Health Research News (01/19/11)
University of Michigan Health System Press Release (01/24/11)
PR Newswire (01/24/11)
Medical News Today (01/25/11)
Bio: Dr. Robert Kormos