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 CLEVELAND, Sept. 30 /PRNewswire/ -- A totally implantable artificial heart is expected to become a reality by the end of this decade, with the help of a seven-year, $13.7 million National Institutes of Health (NIH) contract just awarded to a joint venture of the Cleveland Clinic and Nimbus, Inc., a biotechnology firm in Rancho Cordova, Calif. The first phase of this contract is for approximately $1.8 million per year for three years. The clinic's contract for the second, four-year phase will depend on the performance of the clinic's model.
 The clinic is one of only a few sites receiving NIH's National Heart, Lung and Blood Institute contracts to develop an artificial heart.
 "The development of the artificial heart is the Holy Grail of cardiac surgery," says Patrick M. McCarthy, M.D., a heart surgeon at the Cleveland Clinic and a co-investigator of the clinic's artificial heart team. McCarthy will be the first to use the device in patients at the clinic at the conclusion of the program. "The quest is for a device we can pull off the shelf to support people dying of heart disease without causing strokes. We hope to get to this point within 10 years."
 Raymond Kiraly, M.S., is the principal investigator of the development program at the Cleveland Clinic. Hiroaki Harasaki, M.D., Ph.D., is a co-investigator with McCarthy.
 The clinic was the first to pursue development of an artificial heart, beginning in the 1950s. The design has evolved over the years and features an electric, motor-driven pump implanted inside the patient's body -- except for the batteries, which are carried in a vest or belt. The design would allow the patient to lead a fairly normal life.
 The Cleveland Clinic's design includes a high-pressure, electro- hydraulic system in between the two ventricles of the artificial heart. The hydraulic pressure keeps a piston moving back and forth within a cylinder, producing a pulse from the right ventricle while the left fills with blood, and then vice-versa. The artificial heart pumps at a rate of up to 160 beats per minute, ejecting more than two ounces of blood. A normal, natural heart rate is 72 beats per minute, but can go up to about 200 with heavy exercise, McCarthy says.
 The Cleveland Clinic's artificial heart is four inches in diameter, weights about two pounds and is made of a carbon fiber and epoxy composite that also is used in advanced aircraft and sporting goods, including ski equipment and bicycle frames. The other material is primarily titanium.
 "From a surgical standpoint, this is a good design partly because it is smaller than, say, the original Jarvik heart," McCarthy says, referring to the first permanent artificial heart implanted in a person, the Jarvik 7. "Ours will fit into a majority of adults, both men and women."
 Additionally, the Cleveland Clinic's design features a special lining developed by Harasaki -- a biolyzed protein layer on all of the surfaces that come into contact with blood. Blood is compatible with this lining and does not cause clots that can lead to strokes.
 "That was one of the big limitations for Barney Clark and the artificial heart -- strokes," McCarthy says. Clark, a retired dentist from Seattle, was the first person to receive the Jarvik 7 heart. He died in 1983, 112 days after the experimental surgery at the University of Utah. Four others receiving the same type of device died as well.
 "The most dramatic advance from the Jarvik heart experience is that the new, electrically powered heart will allow the patient to move about without being tethered to a machine," McCarthy says. "Patients will be able to go home and will be active and exercising. The quality of life should be far superior to that which was available with the original Jarvik heart."
 In the last few years, much progress has been made in saving the lives of people with end-stage heart disease through the use of left ventricular assist devices -- LVADS -- which are currently used in people waiting for a heart transplant. The Cleveland Clinic has implanted the HeartMate(R) LVAD in 19 people awaiting transplants. "Because of the LVAD lining, none of the 19 patients has had a stroke," McCarthy says. "The lining of our total artificial heart, although different from that of the HeartMate(R), also should help avoid strokes."
 In the near future, portable, heart-assist devices and artificial hearts will be among a complement of devices and procedures to help people with severe heart failure -- people hospitalized or homebound because of heart failure, McCarthy predicts.
 According to the Institute of Medicine, an organization of the National Academy of Sciences that studies the nation's major health problems, in 10 to 15 years, about 70,000 people each year in the United States will need a heart replacement or some kind of heart-assist device. However, the number of donor hearts available has leveled off since 1990 to only about 2,000 a year -- hence the need for a reliable, implantable artificial heart.
 Currently, people over the age of 65 usually do not receive donor hearts, McCarthy says. But with an artificial heart, those same constraints would not exist, he says. Conceivably, as long as people are otherwise healthy, they might be candidates for artificial hearts, even in their 70s.
 The Cleveland Clinic and other institutions have participated in the initial phase of artificial heart research under NIH contracts since 1988. The contract the Clinic has had since 1988 and the new contract are different from normal research grants because they involve device development, as opposed to research and study, and because the NIH specified the performance capabilities the design should have.
 During the next phase -- 1994 through 1996 -- the Cleveland Clinic and Nimbus will complete their development of the heart, make it fully operational and demonstrate reliability. In the project's final phase, the team will build and test 14 artificial hearts, according to regulations set forth by the federal Food and Drug Administration.
 Others on the Cleveland Clinic's artificial heart team are Ji-Feng Chen; Robert Cloesmeyer; J. Fredrick Cornhill, D.Phil., director of the Department of Biomedical Engineering; Kiyotaka Fukamachi, M.D.; Fumio Fukumura, M.D.,; Stephen Himley; Alex Missiello; Dale Mitchell; Kazuhiro Muramoto, M.D.; Robert Savage, M.D.; Kent Wika; and Qun Zhou.
 The Cleveland Clinic Foundation is a multispecialty academic medical center providing state-of-the-art care while advancing the frontiers of medicine. Since its founding in 1921, the integration of clinical and hospital care with research and education in a private, non-profit group practice has distinguished the Cleveland Clinic in American medicine. Today at the Cleveland Clinic and Cleveland Clinic Florida, nearly 600 full-time salaried physicians represent more than 100 medical specialties and subspecialties. Every year the Cleveland Clinic and Cleveland Clinic Florida provide for more than 780,000 outpatient visits and 32,000 hospital admissions from throughout the United States and over 80 countries.
 -0- 9/30/93
 /CONTACT: Elaine DeRosa, 216-444-8927, or Jim Armstrong, 216-444-9455, both of The Cleveland Clinic Foundation/

CO: The Cleveland Clinic Foundation; Nimbus, Inc. ST: Ohio, California IN: MTC SU: CON

AR -- CL018 -- 7498 09/30/93 17:05 EDT
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Date:Sep 30, 1993

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