By Daryl Lang
Collegian Staff Writer

HERSHEY -- Too Close is a five-month-old Holstein.

He's a healthy calf who will gladly take a break from munching on hay to have a visitor scratch his ears.

And he seems blissfully unaware that he has no heart.

About three weeks ago, Penn State researchers at the Milton S. Hershey Medical Center took out Too Close's heart and replaced it with a machine.

Now, a computer-controlled titanium-and-wax contraption pumps the blood through his body.

"He'll look exactly like a normal calf and he'll feel exactly like a normal calf" once he recovers from surgery, said Allen Prophet, a research associate at the medical center.

Too Close -- who was supposed to be named after the winner of the presidential candidate -- isn't unique.

Researchers at Hershey have been using calves to test artificial heart devices for years.

Hershey doctors hope they will soon be able to implant a battery-powered heart assist pump inside a human.

And soon after that, perhaps as early as within the next two years, a patient at Hershey could become the first person to receive a totally implanted artificial heart like the one keeping Too Close alive.

It has taken more than 30 years of research to even get this far.

Penn State's efforts reach all over the state and also around the world and use the most cutting-edge technologies available. They draw millions of dollars from the federal government and private companies.

Doctors hope artificial heart devices could help thousands of people every year who suffer from serious heart disease.

-The Lion Heart-

In Germany, a heart assist pump beats away inside a man who, without it, would probably have died months ago.

He has a disease called end-stage congestive heart failure and, like thousands of people with heart trouble, also has a condition that makes him ineligible for a heart transplant.

Now, a device called the LionHeart has taken over some of the blood-pumping work for his heart.

It's not a full artificial heart; it's just a device that sits below the heart and assists some of the blood pumping. But it's a forerunner to the fully implanted heart that researchers are testing in calves.

Penn State developed the LionHeart and Arrow International, a Reading, Pa. Company, bought the rights to manufacture and market it.

Ten patients in Europe have agreed to be test subjects for the LionHeart, which hasn't been approved yet for use in the United States.

All of the patients were near the end of their lives when they had the device implanted, and six have already died from ailments unrelated to the heart pump, said Jim Thompson, Arrow's manager of strategic planning for artificial heart development.

But the first patient, who had the pump installed on Oct. 26, 1999, is still alive.

The patients' names are confidential, but Arrow and Penn State are using data from their experiences to help persuade the U.S. government to allow them to test the LionHeart in their research.

"It's not unusual to submit 10,000 pages of documentation to the Food and Drug Administration," said Gus Rosenberg, the bioengineering professor who heads the artificial heart project at Hershey.

Rosenberg has been part of the artificial heart team since it began in 1970. His lab employs 18 full-time staff and operates with a budget of $2.5 million a year.

The team's work could amount to a miracle for people with certain kinds of heart disease with devices such as the LionHeart.

"It's remarkable," Rosenberg said. "You'll have somebody who can't get out of bed, can't brush their teeth, and in three weeks, they're on an exercise bike doing a couple of miles."

In Hershey, the signs in the hallway point to "Artificial Organs," but the lab is chiefly concerned with only one organ: the heart.

Researchers have passed a few milestones through 30 years of experience.

"It's an exciting project," said John Brighton, who directs a teaching and learning consortium at University Park after stepping down as Penn State's executive vice president and provost in 1998.

As an assistant professor of mechanical engineering in 1970, Brighton was one of the first people recruited for the artificial heart team.

When the project started, some people predicted that artificial hearts would be ready for use within five years, Brighton said.

"We started from scratch to implant them in calves," Brighton said. "The first few implants, as you might guess, were failures. Disappointing. But they stuck it out."

The team developed Hershey's first pneumatic assist pump in 1976, which doctors temporarily implanted in a patient after open-heart surgery.

In the 1980s, they pioneered the use of electric motor-driven devices, keeping a calf alive for 222 days with an artificial heart.

In 1985, they installed the first air-driven artificial heart, one that left the patient tethered to a 700-pound machine.

That machine is still in the lab at Hershey, a blue cart about the size of a home water heater. Covered with dials and lights, it could pass for a B-movie time machine.

More recently, researchers have focused on creating artificial pumps that give patients a higher standard of living -- self-contained pumps that require little maintenance and no refrigerator-sized carts to drag around.

Researchers at Hershey began testing wireless, self-contained heart pumps, leading up to the LionHeart in the 1990s.

Other labs, both public and private, have also taken on the task of developing artificial hearts.

One of the most famous was the Jarvik-7, first used in 1985 to keep a patient alive while awaiting a heart transplant. The Jarvik-7 heart never saw widespread use.

But the LionHeart is unique for several reasons.

For one thing, it's designed to be permanent, perhaps lasting several years inside a patient. Other heart pumps are used to keep a patient alive in a hospital while awaiting a donor heart for a transplant.

In addition, the LionHeart has no wires or hoses passing through the skin. It is powered by a six-pound battery pack that a patient carries outside of the body, which actually transmits power through the skin using flat coils of wire.

The total artificial heart, like the one inside Too Close, runs using the same type of power source.

A small backup battery inside the body keeps the heart running if the patient needs to take off battery pack to take a shower, for example.

The power source alone is a major innovation. But it was only one in a series of engineering challenges.

-Building the heart-

Click. Pssh. Click. Pssh.

Right now, five artificial hearts are pumping away inside five glass tanks in a lab in Hershey.

It's an endurance test. Today will be day 146 in the latest round. Machines feed 98.6-degree salt water through the hearts, with valves simulating blood pressure inside the body.

"The idea here is to have the same load that you would have in a patient," Rosenberg explained.

Computer screens mounted above each water tank show data on how the hearts are performing.

The first durability test started in March 1999, with the hope of letting the hearts run for two years.

But during the testing even the tiniest problem in the heart -- in one case, a screw that didn't hold up properly -- can be cause to tweak the devices and restart the experiment.

A heart beats 50 million times a year, Rosenberg said. The design of the artificial heart requires some parts to make 400 million revolutions a year.

For obvious reasons, the parts have to work right every time.

Researchers at Hershey have help from the Applied Research Laboratory at University Park in developing materials that will last a long time while pumping blood -- a thick, warm, corrosive liquid.

The whole project has required the help of professors, researchers and graduate students from many fields.

"The LionHeart system has over 20 post-graduate theses built into it," Thompson said.

By itself, outside of the body, the total artificial heart feels heavy.

The pump assembly is about the same size as a real heart, but made of titanium. Wires and hoses attach it to three other components: a power coil, a small computer and a circular bag that regulates the pressure of the pump.

Within the computer processor is an FM transmitter that sends data from the heart to a computer.

In the case of Too Close, his attendants hold an antenna up to his side and a graph of his heartbeat appears on a computer screen.

In the case of the patients in Europe, they monitor their own statistics on personal computers at home. If something seems wrong, the Arrow team in Pennsylvania can connect to the patients' computers by modem and help doctors in Europe solve the problem.

-Into the future-

Medical miracles, unfortunately, don't always come cheap.

Years of artificial heart research at Penn State has survived off grants from the National Heart, Lung and Blood Institute, part of the National Institutes of Health, and private contributions.

Recently, Penn State received a pledge of millions of dollars in stock from ABIOMED Inc., a biotechnology company in Danvers, Mass.

In exchange, ABIOMED bought the exclusive rights to manufacture and market the Penn State total heart whenever it's ready. The purchase -- for 55,000 shares of stock to start and the prospect of 200,000 more in the future -- was worth $15.3 million when the company made the offer in September.

ABIOMED's researchers are also developing an artificial fully implanted heart. The company claims their heart and Penn State's heart are the two most successful artificial heart devices so far.

The alliances with for-profit companies don't hamper the university's research, Rosenberg said.

"I don't think I've seen the safety of the patients compromised at all with Arrow because of those pressures," he said.

Thompson said Arrow's interest in profit causes the company to be selective about the projects it funds.

"Arrow, being a for-profit business, is not necessarily interested in doing every research project that comes down the pike," Thompson said. Instead, the company focuses on projects that will help them win FDA approval, and consider others on a case-by-case basis.

With approval for real-world trials seemingly within reach for both new Penn State devices -- the LionHeart assist pump and the totally implanted heart -- there's a focus on who it will help.

The Institute of Medicine, part of the National Academy of Sciences, estimated in 1991 that these devices could benefit between 35,000 and 70,000 people a year.

Only a few thousand donor hearts are available each year for transplants, and many patients cannot accept a donor heart because of other illnesses.

Different estimates place the cost of an artificial heart between $100,000 and $200,000 -- for devices the IOM says can add about five years to a person's life.

But Rosenberg points out the cost for an artificial heart is about the same as the cost of a heart transplant -- or the alternatives.

"The amount that's spent on someone dying is also a lot of money," he said, referring to efforts to keep patients hospitalized for a long time at the end of their lives.

And, with the U.S. population aging, heart disease is still the leading cause of death.

But for now, the artificial devices are limited to calves like Too Close, who only live for a few months. They're killed before they grow too big to survive on the human-sized artificial heart.

For the purposes of the research, the FDA orders that the calves live no longer than 91 days, Prophet said.

Researchers will examine Too Close after he dies, Prophet explained, to get information about how well his body held up with the artificial heart at work.

"It never ceases to amaze you just how complex the heart in itself is," he said.

© Copyright 2000 The Daily Collegian

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