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| Contact: Daniel Stolte, (520) 626-4083 / stolte@email.arizona.edu |
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June 10, 2000 Boy's Operation at UMC Marks First Use of 'Berlin Heart' in the United States |
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A 7-year-old boy from Nogales, Ariz., has become the first patient
in the United States to receive a "Berlin Heart," a biventricular
assist device made in Germany. A competitive chess player, Carlos was first diagnosed with heart problems about three and a half years ago, when doctors discovered a defect in his tricuspid valve. When open, the valve lets blood flow from the right atrium into the right ventricle; when closed, it prevents blood from going back into the body. The problem was corrected, but then Carlos developed restrictive cardiomyopathy, a rare condition that causes the heart muscle to become stiff, reducing its ability to pump. After a May 11 procedure to relieve pressure on Carlos' heart, his condition worsened, leading Dr. Copeland to look for something to help his heart do its job. The search would have been relatively easy if Carlos had been an adult, but because of his size, the assist devices available for use in the United States were far too big. The only option was the "Berlin Heart," which comes in several sizes and is used throughout Europe. The device, however, not been approved for use in the United States, which meant UMC needed special permission from the Food and Drug Administration. That task was assigned to Richard G. Smith, director of UMC's Marshall Foundation Artificial Heart Program and vice president of CardioWest Technologies, Inc., which manufactures and distributes a total artificial heart. After five days of phone calls and e-mails with federal officials and the German company that makes the "Berlin Heart," the FDA granted "emergency use" permission and a German engineer boarded a plane bound for Arizona. The device works by helping the heart pump blood. In a normal heart, blood moves from the right atrium into the right ventricle, which then pumps the blood through the pulmonary artery into the lungs. The blood then returns to the heart via the left atrium, then to the left ventricle and finally into the aorta, which carries the blood to the body. The "Berlin Heart" takes some the load off the ventricles by taking blood from the atria and pumping it to the lungs and the body. Once Carlos becomes stronger, he will be placed on the waiting list for a heart transplant. |