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World's first internal transplant of a miniature LVAD performed at Texas Heart Institute.

The world's first human recipient of a Jarvik 2000 miniaturized left ventricular assist device (LVAD) "looks great" and "is doing fine," according to surgeon OH Frazier, MD, chief of cardiopulmonary transplantation at the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston.

On April 13, Frazier implanted the battery-powered pump, about the size of a wine cork, directly into the left ventricle of a woman with congestive heart failure (CHF). Frazier was assisted in the operation by Robert Jarvik, the pump's New York-based inventor, and Stephen Westaby, MD, a prominent British surgeon.

Although the landmark procedure was performed as a stopgap until a donor heart can be found, it brings the 40,000 Americans with end-stage CHF a giant step closer to a permanent alternative to heart transplantation. Moreover, by giving the damaged heart a chance to rest, the device may even allow recovery of natural cardiac function.

Unlike previous pumps, which were large, bulky, and had external components, the Jarvik 2000 is small enough to fit in a child. It is entirely internal except for a thin wire and small dial that allows blood flow to be turned up during strenuous activity. In some patients, as the weakened heart regains strength, the dial can be turned down until the heart is completely weaned off the assist device.

Because of its tiny size, the Jarvik 2000 is easier to implant and remove than its predecessors and results in significantly less blood loss during insertion. Patients generally lose 20-30 units of blood during implantations of larger LVADs, Frazier said, whereas "this patient [who received the Jarvik 2000) lost one-fifth of one unit."

The FDA gave the Texas Heart Institute permission to implant the device in a limited number of patients. Houston is the only US site of the pilot study, but the pump also will be tested in England.

Ten years in the making, the Jarvik 2000 is the latest in a four-decade quest to find a permanent alternative to heart transplantation. Frazier credits legendary heart surgeon Michael DeBakey of the Baylor College of Medicine in Houston with initiating all research into circulatory support systems. "Without Dr. DeBakey's role in 1963 when he got [federal] funding for the artificial heart program, none of this would have been possible," said Frazier, a former DeBakey trainee.

In 1966, DeBakey implanted the first successful LVAD, which he helped develop, in the heart of a 37-year-old woman from Mexico whose heart would not restart after surgery. The LVAD kept her alive for 10 days, until her own heart recovered its pumping ability. Some 20 years later, DeBakey, now 91, invented a small continuous flow pump that fits beneath the heart. It has been implanted as a bridge to transplant in 28 people in Europe, and the surgeon expects to receive FDA approval this year to study the device in the United States.

Barney Clark, in 1982, was the first person to receive a Jarvik-7 LVAD. He lived for 112 days tethered to a large console of electronics. Four others would get the device in the following 2 years, but only one lived longer than 12 months. In 1986, Jarvik and Frazier began developing a miniaturized continuous flow pump. By 1997, 4 heart-assist devices-far smaller and more efficient than the Jarvik-7 but not as tiny as the Jarvik 2000-were in common use. And in 1998, DeBakey's miniature LVAD was implanted in a 56-year-old Berlin man.

The Texas Heart Institute plans to test a total replacement heart, which it has developed in conjunction with Danvers, MA-based Abiomed Inc., by year's end.
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Comment:World's first internal transplant of a miniature LVAD performed at Texas Heart Institute.
Publication:Transplant News
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Geographic Code:1USA
Date:Apr 28, 2000
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