September 8, 2006

First Totally Implanted Permanent Artificial Heart Approved

surgical procedure

This week, the U.S. Food and Drug Administration approved the first totally implanted artificial heart for patients with advanced heart failure in both of the heart's pumping chambers. The new device can extend and improve the quality of life for patients who have no other treatment option.

Heart failure is a serious condition in which the heart is unable to pump enough blood throughout the body. About five million people in the United States have heart failure, and it contributes to or causes about 300,000 deaths every year. Unfortunately, last year almost 22% of the people on the waitlist for a heart transplant were still waiting one year later, according to the University of Michigan's Arbor Research Collaborative for Health. Over 12% died without a transplant within one year after joining the list. A totally implanted artificial heart could potentially save many lives.

Since the 1960s, NIH's National Heart, Lung, and Blood Institute (NHLBI) has supported the research that led to the development of the first totally implanted artificial heart. NHLBI funded extensive basic research to develop a range of mechanical heart support devices, including the total artificial heart and ventricular assist devices. This research led to the development of the devices in use today, which are smaller, more durable and compatible with the body than early models. Among the key clinical studies was an NHLBI-supported trial of left ventricular assist devices in patients with end stage-heart failure. The trial, called Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure, or REMATCH, was an important step along the way toward the development of the total artificial heart, providing data on both the benefits and problems associated with long term mechanical support.

The two-pound mechanical heart approved this week is the AbioCor Implantable Replacement Heart. Made by Abiomed, Inc. of Danvers, MA, it takes over the pumping function of the diseased heart, which is removed during the implantation procedure. A controller and an internal battery are also implanted in the patient's abdomen. A power transfer coil powers the system across the skin, recharging the internal battery from the outside. The controller monitors and controls the device, including the pumping rate of the heart. The internal battery allows the recipient to be free from all external connections for up to one hour. The system also includes two external batteries that allow free movement for up to two hours. During sleep and while the batteries are being recharged, the system can be plugged into an electrical outlet.

The new device is intended for patients who aren't eligible for a heart transplant and whose life expectancy without the device is only a month. Potential recipients must have a chest volume large enough to hold the device and meet other criteria as well.

NIH Director Dr. Elias A. Zerhouni said, "For over half a century, scientists and engineers have dreamed of a total artificial heart. The National Heart, Lung, and Blood Institute's long-term commitment to this technology has helped to make this dream a reality."

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