A Medical Device Daily

A cardiac surgery team at Virginia Commonwealth University 's (VCU; Richmond, Virginia) Pauley Heart Center has performed the first artificial heart implant on the East Coast using a CardioWest temporary total artificial heart (TAH-t), developed by SynCardia Systems (Tucson, Arizona).

The CardioWest is the only TAH-t system approved by the FDA, winning bridge-to-transplant final approval in October 2004 (Medical Device Daily, Oct. 19, 2004).

The patient, a man in his late 50s from Virginia, was reported to be in stable condition Tuesday in the Pauley Center's intensive care unit following a seven-hour surgery on Monday to implant the TAH-t. He had been critically ill, suffering from end-stage heart failure. The TAH-t replaces his damaged heart while he waits for a donor heart to become available for transplant.

The TAH-t is a modern version of the Jarvik-7 artificial heart, developed by Robert Jarvik, MD, in the 1980s. Since Jarvik's initial efforts, survival rates have increased dramatically because of major therapeutic advancements to reduce the occurrence of strokes and life threatening bleeding. The TAH-t is the only total artificial heart approved by the FDA, Health Canada and the European Union.

The VCU Medical Center is one of just three hospitals in the U.S., and seven others worldwide, currently certified to implant the TAH-t. The two other U.S. hospitals are the University Medical Center (Tucson) and the Cleveland Clinic (Cleveland).

The company recently said it plans to have 28 hospitals certified to use the CardioWest system by the end of the year (MDD, Feb. 24, 2006).

“More than 300,000 Americans die every year from heart failure, and many die while waiting for a transplant. As a national leader in treating heart failure and in heart transplantation, we are excited to be among the first to introduce this new technology to the nation,“ said Sheldon Retchin, MD, CEO of the VCU Health System and VCU vice president for Health Sciences.

The TAH-t serves as a bridge to heart transplant for critically ill patients with end-stage biventricular failure. The device replaces the damaged heart.

The TAH-t pumps up to 9.5 liters of blood per minute through both ventricles – more than any other device – helping to rejuvenate vital organs that have atrophied due to a failing heart.

The transplant team at VCU's Pauley Heart Center, led by cardiothoracic surgeon Vigneshwar Kasirajan, MD, underwent rigorous training in Tucson and Richmond to ensure that the hospital and the team were implant ready. All TAH-t certified hospitals have years – and often decades – of experience in human heart transplantation.

“This is an extraordinary interdisciplinary team of physicians, nurses, perfusionists and medical technicians,“ Kasirajan said. “The role of nursing care is particularly crucial and one of the reasons that we were able to be TAH-t certified.“