A Rich History
Over the Years
- 1976 - William S. Pierce, M.D., attaches the first Penn State air-driven heart pump (later known as the Pierce-Donachy pump) to a post-op patient who was having trouble coming off the heart-lung machine. The patient survives and returns home.
- 1985 - The Penn State Heart is first implanted in a patient.
- 1990 - The Pierce-Donachy pump is named an International Historic Mechanical Engineering Landmark by the American Society of Mechanical Engineers.
- 1992 - Winston the calf ushers in the era of the wireless, electric total artificial heart, living 118 days on the Penn State device.
- 1999 - A patient on the Pierce-Donachy pump goes home with a newly approved portable power unit. The patient is able to wait at home for a transplant.
- 2001 - A phase I research study begins on LionHeart™, a Penn State-developed left ventricular heart assist system for heart-failure patients who are not candidates for transplantation. It was developed in conjunction with Arrow International, Inc., of Reading, Pa. Penn State begins working with Abiomed™ Corp on the AbioCor II electrical artificial heart.
- 2003 - Gayle Snider of York, Pa., becomes the first U.S. patient with an Arrow LionHeart device to go home from the hospital.
- 2003 - November - the first results of the Arrow LionHeart European research study led by Walter Pae, Jr., M.D. are unveiled 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.
- 2008 - Penn State Hershey Heart and Vascular Institute’s ventricular assist device program becomes one of only a handful of programs nationwide to earn the Joint Commission’s Gold Seal of Approval™ for implanting VADs as destination therapy for patients with advanced heart failure.
- 2008 - June - Tim Ritchie, a 34-year-old Jonestown, Pa., man who received a heart pump six months earlier, leaves the Penn State Hershey Medical Center with a recuperated heart and no pump. It is rare that a failing heart recovers on a pump; typically patients remain on the pump permanently or until a donor heart is found.
In 1992, Jack Bateman, then a 58-year-old truck driver from Union County, Pa., was suffering from end-stage congestive heart failure. The once-burly, 6-foot-tall man was down to 121 pounds. Every breath was a struggle. “We were watching him die,” said his wife, Chris. “His heart wasn’t working. Fluid was constantly building up. He couldn’t sleep because he couldn’t lie down, he was always sitting up.”
His doctor delivered news that, at the time, seemed nearly as grim as death itself—Bateman’s only hope for survival was a heart transplant. The problem was donor hearts weren’t easy to come by and Bateman was growing weaker by the day.
That September, as he waited for a donor heart, physicians at Penn State Milton S. Hershey Medical Center attached Bateman’s heart to an air-powered pump that was pioneered at Penn State. Known as the Pierce-Donachy left ventricular assist device, it helped Bateman’s failing heart pump blood through his body until a donor heart could be transplanted.
Almost immediately, Bateman was able to breathe easier. His energy returned. Within two months, he was healthy enough to undergo a transplant.
Today, Bateman is a 72-year-old grandfather and going strong. In the years after the transplant, he walked four miles a day and, even more significant, he walked his daughter down the aisle.
“I don’t know where I’d be without the Medical Center team,” he said. “There’s no question they saved my life.”
A Team Effort
The entire heart research team—including surgeons, physicians, engineers, scientists, machinists, fabrication specialists, veterinarians, and animal care specialists—who comprise an arm of Penn State Hershey Heart and Vascular Institute have saved thousands of lives around the world. They’ve also earned Penn State a reputation as an international leader in the research, development, and clinical use of heart pumps and artificial hearts.
That’s no small accomplishment considering that Penn State College of Medicine is still in its infancy compared to some of the nation’s most well-respected teaching hospitals, such as Mayo Clinic, Cleveland Clinic, Johns Hopkins, and Massachusetts General.
Penn State accepted its first medical students in 1967, the year of the first human heart transplant. On any given day, more than 3,000 people are awaiting hearts in this country and, over the course of a year, only 2,200 hearts become available for transplantation. Nearly 25 percent of those on the list will die waiting. Another 200,000 people will die from heart failure.
The National Institutes of Health began funding artificial heart research in the 1960s. Out of the nearly three dozen medical research teams that embarked on a journey to design an artificial heart, only a few remain.
Ask anyone on the Penn State heart team about the driving force behind the program and they’ll point to William S. Pierce, M.D.
Pierce, now retired but still a strong presence at the College of Medicine, was recruited to Penn State in 1970 to serve as assistant professor of surgery. The hospital was scheduled to open that fall and Pierce was chosen to lead the heart research team.
While enrolled in medical school at the University of Pennsylvania, Pierce dreamed of replacing ailing hearts with artificial ones. By the time he finished his residency, he and a colleague already had a federal grant for artificial heart development.
Pierce chose Penn State College of Medicine for several reasons. First, the heart program had a strong commitment from the college’s leadership, including John A. Waldhausen, M.D., a heart surgeon chairing the surgery department. Second, Penn State had an excellent engineering program and both Pierce and Waldhausen believed collaboration between surgeons and engineers was vital to the success of the program—uncommon thinking at that time
And, unlike many of the teaching hospitals located in inner cities, the College of Medicine was located in the heart of farm country and could accommodate research on large animals, most notably calves. A calf’s heart is almost identical in size to an average man’s heart.
“One of the things that led me into this field was the risk involved in cardiac surgery. When I first started in cardiac surgery (in the early 1960s), the risk was 50-50,” Pierce said. “By 1970, a lot of people were having open heart surgery, but 5-10 percent of them still couldn’t come off the heart-lung machine after the surgery. They died on the table.
”Penn State’s first significant heart team accomplishment addressed this very problem. For several years, Pierce worked with a team that included James H. Donachy, fabrications director in the Division of Artificial Organs at Penn State, to engineer a pneumatic-driven assist pump that could help a weak heart pump blood in the aftermath of surgery and, ultimately, help that heart heal.
“The heart has to work hard right after surgery and we believed this assist pump could support circulation while the heart recovered,” Pierce said.
One of the biggest challenges was creating a pulsatile heart pump, meaning that the flow of blood adjusted as the person sat, stood, walked, or exercised—just like a normal-functioning heart. Other pumps being developed at the time had a continuous flow that did not adjust.
Initially, the first few designs failed, but by 1973 the team developed the first extremely smooth, seam-free, pulsatile blood pump and began research studies. The first few patients who were connected to the pump did not survive, although it wasn’t because of the pump’s design. All were “very high-risk patients,” Pierce said.
Then in 1976, Pierce attached the pump—the same one later used in Jack Bateman’s surgery—to the heart of a young woman who could not come off the heart-lung machine following surgery. As soon as the device was connected, her heart began pumping blood.
Within days, her heart recovered, she was removed from the machine, and she went home.
Soon, Other Success Stories Followed
By 1980, hospitals around the country were asking for the Pierce-Donachy heart pump and Penn State turned to Thoratec Corporation in California to further develop and manufacture it.
The pump, about the size of a fist, rested on a patient’s abdomen and was connected to the patient’s own heart with plastic tubes that passed through the chest. Powered by a drive unit the size of a dishwasher, patients could not leave the hospital. And, because it was attached through openings in the skin, infection was a constant risk.
But while Pierce originally envisioned the pump as a means to wean heart surgery patients off the heart-lung machine, it became more valuable to cardiac surgeons nationwide as a ‘bridge to transplantation.’
“By 1980, heart transplants were a very accepted technology, but nearly 25 percent of patients died before a heart became available,” Pierce said. “So instead of using our heart pump for a week or two while a patient recovers from surgery, it was now being used for six months or more while a transplant patient gained seniority on the waiting list.”
Today, the heart assist device is still manufactured by Thoratec and has been implanted in thousands of patients around the world with enhancements including a smaller power unit that allows more patient mobility—including the opportunity to go home while awaiting their heart transplant.
The pump has been recognized as an International Historic Mechanical Engineering Landmark by the American Society of Mechanical Engineers. It remains one of two air-driven pumps to win the Food and Drug Administration seal of approval for use as a bridge to transplantation.
As Penn State basked in the success of the Pierce-Donachy heart assist device, the heart research team was already working on a pneumatic artificial heart that could temporarily replace a human heart while a patient was awaiting a transplant.
By 1984, they set a world record when they implanted the first Penn State Heart into a calf that survived 354 days.
The following year, the artificial heart was implanted in Tony Mandia, a 44-year-old former Philadelphia recreation worker who lived with the device for eleven days before undergoing a heart transplant. Mandia died eighteen days after the transplant, but Penn State received international attention for the artificial heart that kept him alive until a donor heart could be located.
While the pneumatic Penn State Heart was never manufactured commercially like the Pierce-Donachy pump, it was used successfully in five patients at Penn State Hershey Medical Center as a bridge to transplant. Penn State and the Medical Center were highlighted in a 1987 New York Times article about using the pneumatic heart to sustain a 49-year-old Huntingdon County man for 397 days.
The Next Generation
Even as they were testing the pneumatic devices, the team recognized that for patients to enjoy quality of life—the ability to go home, return to work, and participate in daily activities—they needed to develop the next generation of artificial hearts and heart devices—implantable, electric, even wireless ones.
In 1988, the Medical Center received a $5.7 million grant from the National Institutes of Health to do just that. Gerson Rosenberg, Ph.D., professor of surgery and bioengineering, led the team, which combined the theories learned and tested from the pneumatic devices with the newest advancements in electronics and engineering. Changes had to be made to nearly every part of the system, from the pump and motor to the chambers and control systems. All in all, the development of the electric devices included more than 800 design steps.
The target patients for these devices also changed.
“By the mid-to-late 1980s, after the development of temporary heart assist devices, we realized there was an even larger market for people whose own hearts wouldn’t recover and needed a permanent device,” Rosenberg said.
During the next few years, the Medical Center experienced several groundbreaking accomplishments, the most important being the development of the LionHeart Ventricular Assist Pump and the Penn State Total Electric Artificial Heart. Both are destination therapies, meaning that they are designed as permanent treatments for end-stage heart failure patients who, because of health or age, cannot undergo a transplant. Both are totally implantable.
“These devices will greatly reduce the chance for infection, improve mobility for patients, and enhance their quality of life,” Rosenberg said.
The LionHeart debuted in 1999. Developed over the course of a seven-year collaboration between the Penn State team and Arrow International, Inc., of Reading, Pa., the LionHeart pump contains a plastic blood sack that fills with the patient’s blood after each “beat.” Then, the pump’s metal plate presses against the sack, forcing the blood out of it and into the body. An electric motor powers the LionHeart while an automatic control algorithm increases circulation during exercise and decreases it at rest.
While the patient carries an eight-pound battery pack that transmits currents through the skin to an internal transformer coil, the internal batteries have enough power that the patient can take off the external pack for 20 minutes—to swim or take a shower, for example—before the device begins beeping to let the patient know it is running out of power.
The first clinical research study took place in Europe beginning in 1999, with the United States clinical research studies starting in 2001. Walter E. Pae Jr., M.D., professor of surgery at the Medical Center and head of the U.S. clinical studies, reported that the European testing suggested that fully-implantable mechanical heart support is possible and reliable. Only three device failures were recorded in 17.3 years of support time.
In the United States, clinical research studies recently concluded. Penn State Hershey Medical Center hit a national milestone in 2003 when Gayle Snider of York, Pa., became the first person to leave the hospital with the LionHeart. While Snider originally was not a heart transplant candidate, he was able to undergo a transplant a year later thanks to the success of the LionHeart.
In 2000, Penn State began working with Abiomed, a Massachusetts-based company that manufactures cardiac assist devices, to design a total electric artificial heart for patients with end-stage congestive heart failure.
The heart—to be known as Abiocor II when it becomes commercially available—is scheduled to begin clinical research studies in late 2008. Researchers expect that the heart will last for five years and, because of its small size, will be suitable for both men and women.
The device is implanted with a controller and energy transmission system in the space left by removal of the patient’s heart. It has no wires, tubes, or other connections protruding through the skin.
Heart Assistance for the Smallest Patients
While the Penn State heart research team continues to build upon its successes, the focus now is on developing pumps small enough to provide heart support for infants, children, and teens. The researchers currently have a $5 million grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health.
Few heart assist pumps have been developed or adapted for use in children. Children in need of heart support typically suffer from congenital heart defects like hypoplastic left heart syndrome, in which the left part of the heart is underdeveloped or left ventricle dysfunction due to an infection or inflammation of the heart. A heart assist device could provide support for at least six months until the heart recovers or until a donor heart can be found.
Challenges with this type of device include developing smooth materials and making seamless connections that ensure red blood cells and platelets don’t form into clots that can break loose, travel through the blood stream, and cause a stroke. Heart assist pumps can also damage red blood cells by causing them to rupture.
Pediatric heart assist devices pose even more complex problems. Due to the smaller size of the blood pump, blood flow in the smaller version is completely different than in the larger adult heart devices.
“Making these pumps smaller is not just a matter of shrinking everything. We really have to be careful about how we design the pump. When you make blood pumps, or even grafts or tubes, the fluid dynamics change as the size changes,” said principle investigator William J. Weiss, Ph.D., professor of surgery and bioengineering. “In the smaller pumps, dead zones, or low-rate ¿ow zones, can form inside the blood pumps. This slow-flowing blood can create clots. Our challenge is to be sure the blood is neither too active nor too slow.”
Persistence Pays Off
No one doubts that Penn State will be just as successful in its pediatric endeavors as it has been in its research and development of heart assist devices and artificial hearts for adult patients.
Tim Baldwin, a program director at NIH’s National Heart, Blood, and Lung Institute, credits the Penn State team’s persistence for its many successes and contributions to heart assist research worldwide.
“Many of the teams that started out (in heart research) ran into hurdles that became too great or, because of financial reasons or because they had tried and were unsuccessful, they ended up switching gears. But Penn State has had a great group of investigators for a long time and they have been persistent. There have been a lot of novel ideas that came out of that team that have greatly benefited everyone working in heart research,” Baldwin said.