Penn State Milton S. Hershey Medical Center performs first U.S. implant of the Arrow Lionheart™

Hershey, Pa.- Walter Pae, Jr., M.D., professor of surgery at Penn State College of Medicine and director of transplantation at Penn State Milton S. Hershey Medical Center, successfully implanted the Arrow Lionheart™ left ventricular assist system (LVAS) for the first time in the United States yesterday (Feb. 28).

The surgery, which took place at the Penn State Milton S. Hershey Medical Center, lasted five hours. The patient is in critical condition and recovering as expected at the Medical Center.

The Arrow Lionheart™, which is capable of taking over the entire work load of the left ventricle, received approval from the U. S. Food and Drug Administration for clinical testing in the United States less than one month ago. The system has been undergoing clinical trials in Europe for the past nineteen months. Pae led the surgical team that performed the first implant of the LVAS at the German Heart Center in Bad Oeynhausen, Germany on a 67-year-old male. The patient is at home and doing well.

The Arrow Lionheart™ is intended as final therapy for patients with end-stage heart failure who are not candidates for heart transplantation. Today's LVAS recipient fits those criteria. According to Pae, such patients have an extremely poor quality of life and a low probability of surviving six months. Through implantation of the Arrow LionHeartTM system we hope to lengthen the lives of these patients and permit a desirable quality of life.

The Arrow Lionheart™ marks a significant advancement in mechanical circulatory support technology because the system is totally implanted. Energy from an external battery pack is transmitted across intact skin to power the system and charge an implanted battery.

"The transcutaneous (across the skin) power source means that there are no external lines or cables protruding through the skin. This alone offers significant advantage to the patient because the percutaneous (through the skin) tubes or wires used in other systems presents a significant risk of infection, says Pae.

"Arrow Lionheart™ recipients have a better quality of life and are more mobile because of this system. The Arrow Lionheart™ provides therapy for critically ill patients considered ineligible for heart transplantation because of age or other significant medical problems such as diabetes. I expect this will help thousands of people around the world."

About 4 million patients in the U.S. are victims of heart failure and nearly 400,000 new cases are diagnosed each year. Of those patients, only about 2,800 receive heart transplants.

"Our patient meets all the criteria for this groundbreaking surgery," he says. "In addition to meeting the medical criteria, a patient must have a positive attitude, a solid support system, and be motivated to follow medication and therapy regimens following surgery," says John Boehmer, M.D., the patient's cardiologist. "The patient also must understand the operation of the battery pack and take care to keep the apparatus charged. Although all Arrow Lionheart™ candidates are extremely ill, patients selected for surgery must be strong enough to tolerate the operation."

Pae explains, "The surgery involves attaching a mechanical circulatory assist device to the patient's natural heart. At the beginning of the implant procedure, the surgeon creates pockets in the abdominal and chest walls to hold the blood pump assembly, transcutaneous energy source (an internal coil) to power the hermetic (protected against moisture) motor, motor controller and internal batteries. Then, the patient is placed on a heart-lung machine to keep blood circulating and oxygenated during the surgery and cannulae (tubes) are placed to connect the patient's heart and main blood vessel (aorta) to the pump.

Electrical connections are made from the pump and internal coil to the internal battery motor and motor controller. Once the LVAS is implanted, telemetry is used to monitor the unit. The rate of the pump is increased until the patient can be weaned from the heart-lung machine. The automatic control system is switched on and the pump completely takes over operation of the patient's left ventricle creating a physiologically normal pumping heart.

"Although the risks are similar to those typically associated with any complex heart surgery-infection, bleeding, an irregular heartbeat, stroke, and major organ failure, the operative risks are much higher because the patients are older and sicker," says Pae. The technology used in the Arrow Lionheart™ was developed at Penn State during a period of more than 20 years. The Arrow Lionheart™ was developed by a team at Penn State's College of Medicine and Arrow International, Inc. of Reading, Pa.

Penn State College of Medicine is located on the Penn State Milton S. Hershey Medical Center campus in Hershey, Pa. The services of this academic medical facility range from clinical care through its more than 800 affiliated physicians and 11 University Physician Group sites that offer primary, specialty and subspecialty care and complement the complex tertiary services at the Medical Center.

EDITORS: News updates, background information, photos and video are posted at http://www.psu.edu/ur/heartdevices/ or at ">http://hmc.psu.edu/lionheart/