LOUISVILLE, Ky.—The surgical team at Jewish Hospital, led by University of Louisville surgeons Laman Gray, M.D., Rob Dowling, M.D. and Steven Etoch, M.D., announced the implantation of a permanent left ventricular assist device (LVAD).
The patient is in serious but stable condition after a three-hour surgery on October 28, 2003. At the request of the patient’s family, the patient’s name will not be released.
“The patient is doing very nicely, and we’re pleased with the progress,” said Dr. Gray. “The device has functioned flawlessly, and this represents a significant advance in the care of heart failure patients.”
“We are excited to be involved in this clinical trial. This is the only LVAD system that is totally implantable. Furthermore, this device is designed for permanent use as opposed to other LVADs that are designed for temporary support as a bridge to transplant,” added Dr. Dowling.
The Jewish Hospital/University of Louisville team is one of eight centers involved in the clinical trial of the LionHeart® Left Ventricular Assist System (LVAS), manufactured by Arrow International of Reading, Penn. The LionHeart system includes an LVAD and accessories needed to operate the device.
Known as destination therapy, the LionHeart LVAD is a permanent implant that is attached to the weakened heart to help it circulate blood better. Unlike the implantation of an artificial heart, the patient’s native heart is not removed.
Patients who qualify for the LionHeart trial are not candidates for transplants and have severe heart failure despite medical and drug therapy.
The major difference is that patients who qualify for the LionHeart
have failure of the left ventricle, with some function in the right
side of their heart remaining. Patients who
qualify for the AbioCor have total heart failure.
Left ventricular assist devices have been in use for about 20
years as a bridge to transplant. Dr. Laman Gray implanted the first
LVAD in the state at Jewish Hospital in a
patient awaiting transplant in 1985. Ventricular assist devices have FDA approval for use as a bridge to transplant. The clinical trial will assist the company in obtaining FDA approval to use the LionHeart LVAS as destination therapy.
The LionHeart system includes a pump, battery and controller that are implanted in the chest and abdomen area. The system is powered by a transcutaneous energy transfer or TET coil that provides power to the internal system through radio waves. No tubes or wires pierce the skin. Patients carry a small external battery pack that provides power to the system through rechargeable batteries. Implanted internal rechargeable batteries provide power for short periods that allows patients to change clothes, shower or even swim.
A control system adjusts automatically to the body’s needs for increases and decreases in the blood flow. Physicians and hospital staff can monitor the system at the bedside or remotely through a modem once the patient is discharged.
The patient is the tenth patient in the United States to receive
a LionHeart LVAS. Another 26 devices have been implanted in Europe.
Jewish Hospital is one of the premier heart hospitals in the United States, dedicated to excellence in clinical care, research and education. Jewish Hospital has been the site of many “firsts,” including the world's first and second successful AbioCor® artificial heart implants and the world's first and nation’s second successful hand transplants. In 2001, Jewish Hospital became the first hospital in the region to earn the Magnet designation, the highest honor for nursing services and also received, for the fifth consecutive year, the Consumer Choice Award as the most preferred hospital in Louisville.