UofL surgeons implant permanent LionHeart ventricular assist device
A team led by University of Louisville surgeons Laman Gray Jr., M.D., Rob Dowling, M.D., and Steven Etoch, M.D., implanted a LionHeart left ventricular assist device in a patient at Jewish Hospital on Oct. 28 as part of a new clinical trial.
"The patient is doing very nicely, and we're pleased with the progress," Gray said, noting that the permanently implanted device "has functioned flawlessly."
"This represents a significant advance in the care of heart failure patients," he added.
The Jewish Hospital/University of Louisville team is one of eight involved in the clinical trial of the LionHeart Left Ventricular Assist System, manufactured by Arrow International of Reading, Penn. The LionHeart system includes an LVAD and accessories needed to operate the device.
In a practice called destination therapy, the LionHeart is permanently attached to a patient's weakened heart to help it circulate blood.
"We are excited to be involved in this clinical trial," Dowling said. "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."
Patients who qualify for the LionHeart trial are not candidates for transplants and have severe heart failure despite maximum medical therapy.
However, their heart failure is confined mainly to the left ventricle, with some function remaining in the right side of the heart. In contrast, patients who qualify for implantation of the AbioCor artificial replacement heart have total heart failure.
Left ventricular assist devices have been in use for about 20 years as a "bridge to transplant" -- a temporary aid until a viable donor heart can be implanted.
In 1984, Gray was only the second surgeon in the United States to implant a bi-ventricular assist device for use as a bridge to transplant, following the first such procedure by about a week.
The LionHeart clinical trial will assist Arrow International in obtaining FDA approval to use the new system 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 via radio waves. No tubes or wires pierce the skin. Patients carry a small external battery pack that provides power to the system. Implanted rechargeable batteries provide power for short periods, allowing patients to change clothes, shower or even swim.
A control system adjusts automatically to the body's needs for increases and decreases in blood flow. Physicians and hospital staff can monitor the system at the bedside or remotely through a modem once a patient is discharged.
The patient is the 10th to receive a LionHeart system in the United States. Another 26 devices have been implanted in Europe.
Gray and Dowling were the lead surgeons on another Jewish Hospital team that performed the world's first and second AbioCor artificial heart implants in 2001.