University of Colorado Hospital's role in clinical trial helps lead to FDA approval of HeartMate II for “Destination Therapy”
HeartMate II Left Ventricular Assist System (LVAS) Now Available for Advanced Heart Failure Patients Who Do Not Qualify for Heart Transplantation
AURORA, Colo. – The Food and Drug Administration has approved the HeartMate II Left Ventricular Assist System (LVAS) for "destination therapy," a long-term treatment option for patients suffering from advanced stage heart failure. University of Colorado Hospital (UCH) played an integral role in the HeartMate II® Destination Therapy Clinical Trial.
The HeartMate II is designed
to take over the pumping
ability of a weakened heart's
The HeartMate II is an implantable LVAS powered by a rotary pumping mechanism. It is designed to have a much longer functional life than pulsatile devices. The LVAS is designed to take over the pumping ability of the weakened heart’s left ventricle. It can pump up to 10 liters of blood per minute, covering the full output of a healthy heart. It is also smaller and easier to implant than a pulsatile device.
Only Colorado hospital certified by Joint Commission
University of Colorado Hospital is the only hospital in the state of Colorado with Joint Commission certification in ventricular assist device therapy for destination therapy. To earn this distinction, a disease management program undergoes an extensive, unannounced, on-site evaluation by a team of Joint Commission reviewers every two years. The program is evaluated against Joint Commission standards through an assessment of a program’s processes, the program’s ability to evaluate and improve care within its own organization, and interviews with patients and staff.
“Our program began in 2001 and currently maintains outstanding outcomes with our mechanical circulatory support program,” said Joseph C. Cleveland, Jr., MD, surgical director of transplantation and mechanical circulatory support at University of Colorado Hospital. “Given our two year survival rates in excess of 50% with destination therapy, we anticipate dramatically improving the lives of patients with no other options to relieve their advanced heart failure.”
Transplants not a viable option for many
Heart transplants offer hope to approximately 2,000 advanced heart failure patients each year. But for more than 250,000 heart failure patients, there is no viable treatment. They are considered at high risk for repeated hospitalizations, severely diminished quality of life and limited life expectancy. During the clinical trial, destination therapy patients at UCH lived longer than they would have without the LVAS. They also experienced better quality of life and fewer hospitalizations due to their advanced heart failure.
UCH has performed more than 70 successful implantations of ventricular assist devices (VADs) since 2001, including 25 HeartMate II implants.
The University of Colorado Hospital is the Rocky Mountain region's leading academic medical center, and has been recognized as one of the United States’ best hospitals, according to U.S. News & World Report. It is best known as an innovator in patient care and often as one of the first hospitals to bring new medicine to patients’ bedsides. Located at the Anschutz Medical Campus in Aurora, Colo., the hospital’s physicians are all affiliated with the University of Colorado School of Medicine, part of the University of Colorado system. For more information, visit the UC Denver Newsroom.