Ancient Principle Fuels Modern Heart Device

Aug. 25, 2008— -- Kim Zeoli suffered her first heart attack shortly after turning 50 in 1991 and was hospitalized several times during the next 17 years -- including a quadruple bypass after a heart attack just a few months after her first -- to deal with various heart ailments that arose.

In the years since, Zeoli has had stents inserted to facilitate blood flow after hospital visits for heart problems, steps that relieved her problems for a time. But in recent months, she found she was having difficulties again.

"All of a sudden a year ago, starting in January, December, I started getting worse," Zeoli said.

Her doctors told her that she had congestive heart failure and that she was too high a risk and that surgery was not an option.

But Zeoli was being cared for at St. Elizabeth's Medical Center in Boston, which was planning to participate in a trial for a new heart device.

Recently, ABC News affiliate WCVB reported that Zeoli became the first patient at the hospital to be treated with the new apparatus, which operates on a similar principle to technologies used to irrigate the Third World.

Zeoli, whose heart was running at 35 percent of capacity, has had much of her heart function restored since then.

"I've already started noticing the difference in my health as far as being able to exert myself more and not being fatigued," said Zeoli. "They said it would take six months, but I'm starting to feel it now."

Zeoli is among the patients who were involved in a trial of a heart-assistance device known as Impella, which helps double the flow of blood from the heart to the body and can be inserted without major surgery.

The device is typically used during medical procedures that might require physicians to restrict blood flow in patients who already have reduced levels of it. In Zeoli's case, the device was used to maintain her blood pressure so that doctors could insert a stent to promote blood flow.

Current recommendations say the device should be removed within six hours after treatments.

The Impella device has been in use in Europe for several years, but the pharmaceutical company ABIOMED, along with cardiologist Dr. William O'Neill of the University of Miami, is hoping to bring it to the United States to help patients in need of heart operations.

"It's going to be superior to other kinds of support," said O'Neill. "This device itself is better at taking blood out of the heart and pushing it forward as the heart naturally would."

The Impella is threaded through the widest artery in the leg, known as the femoral artery. This artery gives access through the heart valve into the left ventricle -- the part of the heart responsible for pumping blood throughout the body.

Once the catheter of the Impella has been inserted, a needle, which looks much like a mosquito tongue, curls around and a small screw inside the device begins churning blood, helping to propel the blood out of the left ventricle and push it through the body.

The churning component is known as Archimedes' screw, after the ancient Syracusian inventor who used it to bring water from a deep well, and is a technique that may even have been around before the third century B.C. It is commonly used in irrigation, as it can help water to flow uphill.

The Impella can pump roughly 2 to 2.5 liters of blood from the heart in a minute.

"It's enough to augment the failing heart and keep blood pressure maintained," said O'Neill. "It really can provide very effective support in people that have almost no heart function."

Dr. Faisal Khan, Zeoli's heart surgeon at St. Elizabeth's, likens use of the device to regulating traffic; by pushing some of the blood through itself, Khan explains, the Impella is enabling the heart to maintain blood flow while pumping less.

"When it's pumping against less traffic, or less pressure, it can get blood around easier," he said, noting that by allowing the heart to work less temporarily, it may hasten recovery.

Khan said the device can do roughly half of the heart's work.

So far, he has used the device on two patients, Zeoli and another patient who needed it after a heart attack.

"We're excited about the potential they will provide to us to extend the care of patients who are very sick," said Khan.

In June, the Impella was cleared for marketing by the Food and Drug Administration, according to agency spokeswoman Karen Riley.

She said the current trial is not part of the regulatory process, which the Impella has already cleared. She explained that some companies run further trials for other purposes, such as insurance clearances or marketing.

Researchers involved hope that the Impella will replace the two main devices currently in use. The first and more common device, known as a balloon pump, displaces blood by its expansion and contraction, while the other, known as a TandemHeart, involves making a hole from one side of the heart to the other.

While he remains optimistic that the device will ultimately replace others, O'Neill said that the current trial will likely take another year and that only then will most consider adopting use of the Impella.

"Most American cardiologists want to wait to see some proof that it's actually better than a balloon pump," he said. "I think that people are going to wait for a while to see what happens with this trial before they decide if they're going to use it or not."

For Zeoli, the Impella was beneficial, although she still requires more treatment. She has chosen to be optimistic about where she is now.

"I'm fine and I'm blessed," she said.

In September or October, Zeoli will need to return to have more stents put in; ultimately she will have 15 of them in her body.

"I'll be bionic," she said.