VCU news

By Pamela DiSalvo Lepley

A Virginia man who in April underwent implantation of the only total artificial heart approved by the U.S. Food and Drug Administration was in stable condition at Virginia Commonwealth University Medical Center’s Pauley Heart Center on Thursday, a day after surgery to implant a donor heart.

“The total artificial heart did a wonderful job supporting the patient’s circulatory system and other organs while he awaited a transplant,” said Dr. Vigneshwar Kasirajan, cardiothoracic surgeon and transplant team leader. “During his 50 days with the total artificial heart, he was in physical therapy and exercising and was able to receive a transplant under more optimal circumstances than if he had been sick with heart failure.”

The patient, whose name was not released, is a man in his late 50s who on April 4 was implanted with the CardioWest temporary Total Artificial Heart, or TAH-t. It was the first time the operation had been performed on the East Coast and was done to replace his damaged heart while he awaited a donor heart. Prior to implantation of the artificial device, the patient had been critically ill suffering from end-stage heart failure.

The transplant of the donor heart went very well and the patient’s long-term prognosis is very good, according to his physicians.

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 Communité 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. 

“We are delighted at the positive outcome for our patient and the bright future that this and other cutting-edge technology that we’re bringing here holds for patients in Central Virginia and across the country,” said John Duval, CEO of MCV Hospitals at the VCU Medical Center.

More than 300,000 Americans die every year from heart failure, and many die while waiting for a transplant.

“This procedure opens a whole new world for critically ill heart patients in that it provides a safety net to transplant that wasn’t previously available,” 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 Kasirajan, 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.

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.