by Amy M. Buzinski ’03

The heart is one of the strongest muscles in the human body, pumping 75 to 90 gallons of blood per hour. When it is working properly, it is a masterpiece of timed precision, with heart valves opening and closing on cue. But, what happens when there is a glitch in the system? “Heart failure,” says Dan Frank ’92, engineering manager for Arrow International Inc.’s Cardiac Assist Division and an instrumental player in the development of its new left ventricular assist device tagged the Arrow LionHeart.

“The LionHeart is a blood assist pump that completely replaces the function of the heart’s left ventricle, which is the main pumping chamber for the body,” he says. The patient’s natural failing heart is left in place and the assist device is connected to it in order to boost circulation. Once the system is implanted in a patient, no wires, tubes or other connections protrude through the skin. “The advantage is that the LionHeart is totally implantable which decreases the risk of infections,” Frank says.

The LionHeart is for patients who are not eligible for transplantation and are considered to be in end-stage heart failure. People who suffer with end-stage heart failure typically live a ‘bed-to-chair’ existence where they have to take multiple medications, struggle to breathe, and undergo frequent hospitalizations. Also, more than 100,000 people worldwide die each year from end-stage heart failure. “Hopefully, that number will begin to decrease in the following years,” says Frank.

While other assist pumps are only meant to sustain the life of a patient until a donor heart is available for transplant, the LionHeart would be a permanent solution. For the thousands of people who will not receive donor hearts, the LionHeart would allow them to lead normal lives. “Recipients would still need a good right ventricle but the need for left ventricular assistance is much greater,” says Frank.

The LionHeart is the result of an eight-year collaboration among researchers affiliated with Penn State’s Artificial Organs program at the Milton S. Hershey Medical Center and Arrow Inc. of Reading. The partnership involved, “people from all walks of life, ranging from surgeons to software engineers, to tool and dye makers to statisticians,” he says.

The first LionHeart implant surgery was performed in October 1999 at the Heart and Diabetes Center in Bad Oeynhausen, Germany. The patient is now living at home and the LionHeart continues to function as expected. Phase I clinical trials of the LionHeart are currently being held in the United States as well as Europe. Frank says he tries to see the patients as often as he can. “I was recently in Europe seeing several patients, assessing the function of the device and monitoring their systems.”

While official approval from the U.S. Food and Drug Administration may take several more months or years, Frank sees a bright future for this device. “I would like to see it placed as routinely as pacemakers are placed today. I hope to see it evolve to that point.”