Penn State Intercom......March 15 , 2001

LionHeart implanted
in first U.S. patient

Timeline of significant events

By A'ndrea Messer
Public Information 3docs

The Milton S. Hershey Medical Center once again made medical history when surgeons there were the first in the U.S. to implant the Arrow LionHeart left ventricular assist system (LVAS) into a 64-year old male patient on Feb. 28.

The surgery, conducted by Dr. Walter Pae Jr., professor of surgery in the College of Medicine, and a surgical team, lasted five hours. As was expected, the patient remains in critical condition but is stable and resting comfortably.

The Arrow LionHeart received approval from the U.S. Food and Drug Administration for clinical testing in the United States on Feb. 9. The first heart-assist device powered via wireless electric transmission to reach clinical trial, the LVAS is the result of a seven-year collaboration among researchers affiliated with Penn State's Artificial Organs program and Arrow International Inc. of Reading. The clinical trials are sponsored by Arrow.

The Arrow LionHeart is not an artificial heart. It is a "heart helper" or left ventricle assist system for patients suffering from severe heart failure who are not eligible for a natural heart transplant. The patient's natural failing heart is left in place and the assist device is connected to it to boost circulation. Once the system is implanted in a patient, no wires, tubes or other connections protrude through the skin. The device is intended as final therapy for patients with end-stage heart failure. 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 LionHeart system, we hope to lengthen the lives of these patients and permit a desirable quality of life," said Pae.

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," said Dr. John Boehmer, the patient's cardiologist and an assistant professor of medicine. "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. 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."

The system has been in clinical trials in Europe for the past 19 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. That patient is home and doing well. The LionHeart has been implanted into 10 European patients before this first U.S. use.

The LVAS is based on an approach originated by Dr. William S. Pierce, retired founder of the Penn State artificial organs program, coupled with the latest in electronics and biomaterials technology. Penn State members of the design team include Dr. Gerson Rosenberg, professor of bioengineering; Dr. Alan Snyder, associate professor of surgery; and Dr. W. J. Weiss, assistant professor of surgery, as well as materials, energy and fluid flow researchers at the University Park campus.

Pierceand Rosenberg were members of the team that designed the first Penn State Heart-Assist Pump, a pneumatic device, that began development in the 1970s. The U.S. Food and Drug Administration approved use of this device in 1980 and it was in widespread use by 1984. This device is no longer approved for clinical use. The Penn State Heart-Assist Pump was designated an International Historic Mechanical Engineering Landmark by the American Society of Mechanical Engineers in 1990.

With minor modifications, two heart-assist pumps served as a total artificial heart in three patients at The Hershey Medical Center. The first was used on Oct. 18, 1985. The artificial organs program continued with a switch to an electromechanical device and eventually development of a fully-implantable left ventricular assist system.

The Arrow LionHeart marks a significant advancement in mechanical circulatory support technology because the system is totally implanted. The device has both internal rechargeable batteries, which remain in the body and an external battery pack fitted with a unique power delivery coupling. The external source, two battery packs worn on a belt, powers the motor via a transformer coil worn on the outside of the chest. When the external transformer coil is positioned over an internal transformer coil connected to the motor, it induces a current. The internal and external coils coupled wirelessly through the chest wall maintain the pump's operation. Should the patient want to be untethered from the external battery packs, for example, to take a shower, the internal batteries can supply power needs for a minimum of 20 minutes at a time. In addition, the wireless operation significantly lowers the potential for infection.

Pumping in the heart assist device is achieved when a metal plate presses on a plastic blood sac, forcing the blood out of the sac. In the Arrow LionHeart, the metal plate is driven by a new miniature electric motor and controller that responds to a patient's changing needs during exercise and resting, for example.

Other members of the surgical team included Dr. Benjamin Sun, assistant professor of surgery and director of cardiac transplantation; Dr. Stephen R. Longo, associate professor or anesthesiology and director of cardiothoracic anesthesia; Dr. Sanjay M. Mehta, assistant professor of surgery; Dr. Jennifer S. Lawton, chief resident in cardiothoracic surgery, and Dawn Christensen, M.S.N., ventricular assist device and cardiac transplant coordinator.

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Significant events in heart-assist device development at Hershey

Here are some of the significant events in the development of heart assist devices and the artificial heart at The Milton S. Hershey Medical Center:

1985: The Penn State Heart, an air-driven, total artificial heart, is first implanted in a patient. Pae

1986: The Penn State Heart is implanted in its second patient, who remains on the device for 13 months.

1988: The National Institutes of Health awards The Milton S. Hershey Medical Center a $5.7 million contract for research to develop an electrical, artificial heart.

1991: Holly the calf shatters the record for the longest living calf on any artificial heart. She survives for one year and 23 days.

1993: The Hershey Medical Center is one of only three institutions awarded a three-year, $5.4 million contract from the National Heart, Lung and Blood Institute to continue work in developing a permanently implantable electric heart.

1996: The Hershey Medical Center receives a $7.7 million federal contract awarded for research of the electromechanical heart.

1998: The Whitaker Foundation awards a grant of nearly $1 million to the Biomedical Engineering Institute at The Hershey Medical Center. The institute's purpose is to add a new educational component to the bioengineering program at Penn State.

1998: A newly FDA-approved heart assist device, the Vented Electric Left Ventricular Assist Device, is implanted for the first time in the country in a patient at The Hershey Medical Center. The device allows seriously ill heart patients to survive and wait at home for a heart transplant. The surgical team is led by Dr. Benjamin Sun, assistant professor of surgery in the College of Medicine and assistant director of heart transplantation at The Hershey Medical Center.

1999: As part of a multi-center clinical trial, a patient on a left ventricular assist device (LVAD) is placed on a portable driver-control unit that will power the LVAD. This is the first clinical use of the device in the United States. The device greatly improves the patient's mobility allowing her to leave the hospital while awaiting a heart transplant, according to Dr. Walter E. Pae Jr., professor of surgery in the College of Medicine and director of cardiac transplantation at The Hershey Medical Center.

Oct. 26, 1999: The first human implant of the LionHeart left ventricular assist system occurred at the German Heart Center in Bad Oeynhausen, Germany. This patient is living at home with the device continuing to function as expec ted. To date, 10 patients have been implanted with the Arrow LionHeart system as part of the ongoing European clinical investigation. Subsequent to implantation, all of the systems have operated as expected. The clinical sites for this European clinical investigation are the German Heart Center, Bad Oeynhausen, Germany; Hospital La Pitié, Paris, France; the University of Vienna Medical Center, Vienna, Austria; and the Berlin Heart Institute, Berlin, Germany.

Feb. 28, 2001: Physicians implant a new heart-assist system for the first time in the United States in a patient with end-stage heart failure who was not a candidate for transplantation. The new system is totally implantable and permanent -- not a bridge to transplantation or temporary heart helper. The lead investigator is Dr. Walter E. Pae Jr., professor of surgery. The device is called the Arrow LionHeart and was developed in the College of Medicine in conjunction with Arrow International Inc. of Reading.