McGowan Institute for Regenerative Medicine-Developed Technology: Study Utilizing HeartMate II® Receives FDA Nod
McGowan Institute for Regenerative Medicine faculty member Robert Kormos, MD, professor with tenure specializing in cardiothoracic surgery at the University of Pittsburgh, director of the University of Pittsburgh Medical Center (UPMC) Artificial Heart Program, and co-director of the UPMC Heart Transplantation Program, along with Keith Aaronson, MD, MS, medical director of the heart transplant program and Center for Circulatory Support at the University of Michigan Cardiovascular Center (UM-CVC), and Francis D. Pagani, MD, PhD, surgical director of the heart transplant program and Center for Circulatory Support at the UM-CVC, are co-principal investigators of the REVIVE-IT (Randomized Evaluation of VAD InterVEntion before Inotropic Therapy) prospective, randomized, controlled trial designed to compare the use of the HeartMate II left ventricular assist device (LVAD) with optimal medical management (OMM) in patients with New York Heart Association (NYHA) Class III heart failure. This feasibility study is intended to provide initial scientific evidence regarding the potential advantages of mechanical circulatory support (MCS) therapy in treating earlier-stage, less ill heart failure patients who are currently not indicated for LVAD support.
Recently, Thoratec Corporation, a world leader in device-based MCS therapies to save, support, and restore failing hearts, announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to commence the REVIVE-IT study utilizing the HeartMate II Left Ventricular Assist System (LVAS).
“IDE approval represents a significant milestone for REVIVE-IT, and we are excited to move forward with this important study, which will allow us to examine the use of LVAD technology earlier in the spectrum of heart failure,” said Dr. Aaronson.
The REVIVE-IT pilot study is designed to enroll up to 100 patients in NYHA Class III heart failure from leading heart failure programs across the U.S. Patients will receive either the HeartMate II LVAD or OMM (drug therapy). The primary endpoint for the study is a composite measure of survival, freedom from disabling stroke, and improvement in functional outcomes, as measured by the 6-minute walk test.
“REVIVE-IT will evaluate the use of the HeartMate II in heart failure patients currently not indicated for LVAD support. These patients suffer from highly impaired quality of life and functional capacity, but their disease has not yet advanced to the point of more serious consequences, such as organ damage or immobility,” stated Dr. Kormos.
The HeartMate II is intended for a broad range of advanced heart failure patients and is the only continuous-flow LVAD approved by the FDA for both Bridge to Transplantation and Destination Therapy. The device is a miniature rotary pump with axial flow bearings and is intended for patients with end-stage heart failure. A key feature of the design is a sophisticated control system developed by researchers at the McGowan Institute for Regenerative Medicine that senses when to increase or decrease the rate of blood flow. Other approved and experimental devices require manual adjustments. The control system developed by the researchers involves a patented algorithm that permits the LVAS to respond to the needs of the patient based on the level of activity, generating up to10 liters of blood flow per minute, a rate that would be required to climb stairs, for example. The controller was the brainchild of McGowan Institute for Regenerative Medicine affiliated faculty member James Antaki, PhD, associate professor in Biomedical Engineering at Carnegie Mellon University and adjunct professor in the University of Pittsburgh’s Departments of Surgery and Bioengineering.
The HeartMate II is placed just below the diaphragm and is connected to the left ventricle, returning blood flow to the aorta, the main artery that carries oxygenated blood to the entire body. With only one moving part, a continuously spinning rotor, HeartMate II is designed to provide exceptional reliability. An external, wearable system that includes a small controller and two batteries is attached by a percutaneous driveline. More than 200 peer-reviewed publications have featured studies regarding the HeartMate II, far exceeding the volume of published data on all other LVADs combined. To date, over 13,000 patients have been implanted with the HeartMate II, including over 5,500 currently on support.
The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health and Thoratec are sponsoring the REVIVE-IT study, through a $5 million contract from the NHLBI and a funding commitment of up to $11 million from Thoratec. The NHLBI is providing executive and scientific guidance on the conduct of the study.
“We appreciate the leadership demonstrated by the NHLBI in this pioneering study, as well as our partnership with Thoratec,” said Dr. Pagani. “The HeartMate II device has been extensively studied for long-term support of advanced heart failure patients and has a very well-defined efficacy and safety profile. We look forward to exploring its utilization and potential benefits, including extended survival and improved functional status, in earlier-stage patients.”
In addition to REVIVE-IT, Thoratec maintains a firm commitment to the completion of the ongoing ROADMAP (Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) study. “ROADMAP and REVIVE-IT are complementary studies which together should advance the field’s understanding of LVAD therapy in Class III and earlier-stage Class IV heart failure patients,” stated David Farrar, PhD, Vice President, Research and Scientific Affairs at Thoratec. ROADMAP is a post-market study of the HeartMate II, involving ambulatory advanced heart failure patients who are not yet dependent on intravenous inotropic support and are typically categorized as INTERMACS profiles 4-6, within the existing FDA-approved indication for Destination Therapy, whereas REVIVE-IT will include Class III patients currently not approved for LVAD support. As of the end of 2012, 90 patients have been enrolled in ROADMAP, and Thoratec expects the full cohort of 200 patients to be enrolled by the end of 2013.
“Thoratec’s mission is to advance the treatment of heart failure and the field of mechanical circulatory support. To that end, we are pleased to partner with preeminent VAD programs across the U.S., under the leadership of the UM-CVC and UPMC, in the REVIVE-IT study,” commented Gary F. Burbach, President and Chief Executive Officer of Thoratec.
For more information regarding the REVIVE-IT study, visit ID# NCT01369407. Given the change in sponsorship of the study, however, some information on this website is subject to change, including information about the study device as well as the investigational sites that will be participating in the study. For more information regarding the ROADMAP study, visit ID# NCT01452802.