The evolution of heart assist devices and the artificial heart at Penn State Milton S. Hershey Medical Center
1976 Dr. William S. Pierce, M.D., attached the first Penn State pneumatic ventricular assist pump to the heart of a patient who had undergone open heart surgery at Penn State Hershey Medical Center.
1983 Penn State researchers implanted a cam-type electric motor artificial heart in a calf named E.T. who survived for 222 days with an electric total artificial heart, setting a world record.
1984 A calf survived for 354 days with a Penn State pneumatic artificial heart, setting a world record for an experimental animal with an artificial heart.
1985 The Penn State Heart, an air-driven total artificial heart, is first implanted in a patient.
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 Penn State Milton S. Hershey Medical Center a $5.7 million contract for research to develop an electrical, artificial heart.
1990 The Penn State Heart-Assist Pump was named an International Historic Mechanical Engineering Landmark by the American Society of Mechanical Engineers.
1991 Holly the calf shatters the record for the longest living calf on any artificial heart. She survives for one year and 23 days.
1992 Winston the calf ushered in the era of the wireless, electric total artificial heart living 118 days on the Penn State device.
1993 Penn State 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 Penn State Hershey Medical Center receives a $7.7 million federal contract awarded for research on the electromechanical heart.
1998 The Whitaker Foundation awards a grant of nearly $1 million to the Biomedical Engineering Institute at Penn State Hershey Medical Center. The institute's purpose is to add a new educational component to the bioengineering program at Penn State.
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 Penn State 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 surgeon Benjamin Sun, M.D., who has since left the institution.
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 Walter Pae, Jr., M.D., professor of surgery at Penn State College of Medicine and director of cardiac transplantation at Penn State Hershey Medical Center.
Physicians begin implanting a new heart-assist system in patients with end-stage heart failure who are not candidates for transplantation. The new system is totally implantable and permanent - not a bridge to transplantation or temporary heart helper. The lead investigator is Walter E. Pae, Jr., professor of surgery. The device is called the Arrow LionHeart™ and was developed at Penn State College of Medicine in conjunction with Arrow International, Inc., of Reading, Pennsylvania.
The first human implant of the Arrow LionHeart™ LVAS occurred on October 26, 1999 at The Heart and Diabetes Center in Bad Oeynhausen, Germany.
2001 Arrow receives an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a Phase I human clinical trial in the United States. The lead investigator for this pilot study is Dr. Walter Pae of Penn State's Hershey Medical Center. Other trial sites are: University of Arizona; University of Pennsylvania; University of Iowa, Loyola University.
The first U.S. recipient of the LionHeart™ receives the device February 28, 2001 at Penn State Milton S. Hershey Medical Center. On July 26, Penn State Hershey Medical Center reported that the first U.S. patient died.
2002 First part of U.S. Phase I trial completed.
At the American College of Cardiology 51st Annual Scientific session held March 2002 in Atlanta, Walter E. 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, reported that nine of the 22 European patients receiving a LionHeart™ implant prior to March 1, 2002 were alive and that seven were now living at home. Three of the nine patients have been living over one year with the Lionheart™ and one of these three has passed the two year mark. A fourth patient lived just short of two years with the device.
FDA approves second set of seven U.S. patients with a slightly different list of qualifications for patient inclusion. Also, additional trial sites were added: Washington Hospital Center, Columbia University, University of Louisville, and LSS Hospital.
July 31, 2002, University of Iowa physicians implant the LionHeart into the first patient in the second set of seven U.S. patients.
May 14 The second U.S. patient in the second set of Phase I clinical trials receives Arrow LionHeart at Penn State Milton S. Hershey Medical Center.
May European Trial closes. Arrow International applies for CE Mark, the equivalent of FDA approval in the United States. The CE Mark would allow the device to be offered in Europe as an option to patients with end-stage heart failure.
June 23 Gayle Snider of York, Pennsylvania, becomes the first U.S. patient with an Arrow LionHeart heart assist device to go home from the hospital.
Fall Gayle Snider takes a trip to a NASCAR event at Dover Downs, Delaware.
November The first results of the European trial of the Arrow LionHeart led by Walter E. Pae Jr., M.D., are unveiled by Pae and John P. Boehmer, M.D., both from Penn State Hershey Medical Center, at the American Heart Association’s 76th Scientific Sessions. The study suggests that fully-implantable mechanical heart support is possible and reliable. Only three device failures were recorded in 17.3 years of support time.
Arrow International, Inc., announces that it received authorization from its European Notified Body, TUV Product Services of Munich, Germany, to CE-mark the Arrow LionHeart, based on the results of the European trial. The CE-mark provides authorization to market the device within the European Economic Area for permanent implantation or “destination therapy”. The Arrow LionHeart is the first left ventricular assist system to receive CE-marking authorization specifically for destination therapy.
January Gayle Snider is added to the heart transplant list.
May 14 Gayle Snider marks one year milestone with Arrow LionHeart.