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Dr. Clayson - Study of HeartWare HVAD - The Heart Institute at Intermountain Medical Center

Dr. Clayson from the Heart Institute at Intermountain Medical Center

Study of Potentially-Revolutionary Miniature Artificial Heart Device Launched in Utah at Intermountain Medical Center

Jess Gomez

 (801) 507-7455

 Jess.Gomez@imail.org

 12/15/2009

A tiny artificial heart device that fits in the palm of the hand might be the key to survival for thousands of patients suffering from heart failure. Now, thanks to a new national clinical trial of the miniature device at the Heart Institute at Intermountain Medical Center in Murray, patients in Utah and throughout the Intermountain West will have access to this new technology.

Doctors from the Utah Artificial Heart Program at Intermountain Medical Center announced today that the Heart Institute at Intermountain Medical Center is one of only 40 centers in the country participating in the study of the device, called the HeartWare HVAD. This is the first miniature centrifugal flow heart pump to be used as a bridge-to-transplantation for heart failure patients.

Intermountain Medical Center is the only hospital in the Intermountain West involved in the national clinical trial. The study in the United States follows a successful international clinical trial that included 50 patients from five centers in Europe and Australia.

One of the key features of the tiny device is its small size, which allows it to be implanted in the chest directly adjacent to the heart, eliminating the need for abdominal surgery that is generally required to implant most heart devices.

“Never before have we had a pump this small – it’s so well designed that it is practically part of the heart itself. It has already shown positive results in Europe, so we are very hopeful to have a successful experience here in Utah,” says Bruce Reid, MD, surgical director of the Utah Artificial Heart Program at Intermountain Medical Center.

Previous pumps have been significantly larger and required surgeons to make a pocket within the patient’s abdominal muscles to house the pump. The HeartWare HVAD is so small that it fits within the pericardial space and is implanted immediately adjacent to the heart, almost as if it were part of the heart itself. This means that surgery is shorter and requires less dissection.

“Eliminating abdominal surgery is a significant advancement. We believe that this will contribute to faster recovery times due to reduced time in the operating room and fewer complications after surgery,” says Dr. Reid.

The HeartWare HVAD is also unique because it is the only heart pump available in the U.S. that uses a proprietary technology combination: the pump’s impeller is suspended inside the pump housing by a combination of magnetic and hydrodynamic forces. The impeller does not make contact with any other surfaces inside the pump housing making it a virtually frictionless system. This means that the pump is expected to last much longer as its internal parts are free from wear and tear.

“Because of it’s unique design and engineering, we anticipate that this will be more durable than any other pump that we’ve used,” says Stephen Clayson, MD, associate surgical director of the Utah Artificial Heart Program at the Heart Institute at Intermountain Medical Center. ”That’s been the trend in artificial heart technology and mechanical circulatory support for the heart. We’ve now gone to smaller, yet more durable pumps.”

Heart failure is a leading cause of death in the world, estimated to impact over 20 million people worldwide. In the United States, nearly five million patients suffer from heart failure. Each year 550,000 new cases are diagnosed and some 300,000 patients die as a result of the condition.

"The incremental progress in mechanical circulatory support technology over recent years is very timely due to the continued substantial shortage of organ donors for patients in need of heart transplantation. More patients with end-stage heart failure are getting sicker as their waiting time on the transplant list grows longer. This new heart assist pump provides an excellent option for our patients given its superior performance and, especially, its expected long-term durability." says A.G. Kfoury, MD, director of the Heart Failure Program at the Heart Institute at Intermountain Medical Center.

The U.S. Food & Drug Administration has granted an investigational device exemption for the clinical trial. Researchers hope to enroll 150 patients at up to 40 centers across the country.

“One of the reasons that our program was selected to participate in this very important clinical trial is because of our extensive and impressive track record implanting these artificial heart devices and caring for these very sick patients once they come out of surgery. We’re very proud of the program that is in place here at Intermountain Medical Center, and for the opportunity to help patients suffering from advanced heart failure throughout the Intermountain West,” says Brad Rasmusson, MD, cardiovascular critical care medicine director for the program.

For the past 16 years, Intermountain's Utah Artificial Heart Program has been one of the most active centers in the country and is a national leader in extending lives, conducting research and testing experimental devices that are now being used around the world.

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