First artificial heart implant on the East Coast

Apr 6 2006

A cardiac surgery team at Virginia Commonwealth University's Pauley Heart Center has performed the first artificial heart implant on the East Coast. The CardioWest temporary Total Artificial Heart, or TAH-t, is the only total artificial heart approved by the U.S. Food and Drug Administration.

The patient, a man in his late 50's from Virginia, was in stable condition today 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 of the 1980s. Survival rates have increased dramatically because of technological advances that provide improved blood flow, along with 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 Communiti Europeenne.

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

"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. We also continue to introduce other diagnostic and therapeutic advances in the treatment of heart failure through the VCU Pauley Heart Center," said Dr. Sheldon M. Retchin, CEO, VCU Health System and VCU vice president for Health Sciences.

According to UNOS, the United Network for Organ Sharing, which coordinates U.S. organ transplant activities, more than 100 patients in Virginia are awaiting heart transplants. The TAH-t serves as a bridge to heart transplant for critically ill patients with end-stage biventricular failure, a condition in which both heart ventricles, the major portions of the heart that pump blood, fail to pump enough blood to sustain health. The TAH-t 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. In 2004, the American Heart Association named the TAH-t the No. 1 advance in cardiovascular medicine. An August 2004 paper in the New England Journal of Medicine found in a pivotal clinical trial that the one-year survival rate following human heart transplant for patients receiving the TAH-t was 70 percent, versus 31 percent for control patients.

The transplant team at VCU's Pauley Heart Center, led by Dr. Vigneshwar Kasirajan, cardiothoracic surgeon, 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."

The American Nurses Credentialing Center recently awarded the VCU Health System Magnet status, the highest honor and level of recognition for nursing excellence in national and international health care.

"The VCU Medical Center, through its Pauley Heart Center, has one of the oldest major transplant programs in the country and is recognized as a national leader in developing and implementing cardiovascular procedures," said Eugene P. Trani, Ph.D., VCU president and president and chair of the VCU Health System. "The TAH-t program reaffirms our tradition as a leader in advanced cardiac care."

The CardioWest TAH-t is manufactured by SynCardia Systems, Inc., which was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and noted cardiovascular surgeon Jack Copeland, M.D. All three men, along with other medical professionals, are instructors for the TAH-t certification training program.

http://www.vcu.edu