Big Ideas: Man and Machine
It looks like something you'd find under the hood of your car. A humble little cylinder, about 4 inches long, 2 1/2 inches around and weighing just more than a pound, sprouting tubes and wires like spider legs.
In an automobile, it would be a trivial chunk of titanium without much to say, dwarfed by more vital gears and rotors. Listen to its story, though, and you'll see that it's tiny but mighty. It has a task much more important than any other bit of crafted metal can boast.
This device is responsible for running a human, not a car. The artificial heart is smaller, lighter and sleeker than any other generation of similar devices. It lives here, in a small third-floor laboratory at Cleveland Clinic's Lerner Research Institute, while it's honed and tested.
Today, its tubes are attached to two jugs of fluid — a mixture of water and glycerol that approximates the viscosity of blood — to demonstrate its abilities. Though the final design will be titanium, this prototype, which is still about five years away from clinical trials, has clear plastic sides. A tiny valve inside bounces from side to side, hustling the faux-blood from one jug to the other, simulating the tasks of our hearts — blood in, blood out. Nearby monitoring equipment shows the jump of a pulse like an electrocardiogram, but is actually tracking the device's flow and pressure readings.
The busy pump inside the device is what makes it so revolutionary. Its one moving part floats back and forth, eliminating friction and reducing opportunities for failure. Plus, it's smaller than its clunkier, heavier competitors, meaning it will fit inside the bodies of nearly all men, women and even teens.
Many artificial hearts just buy time for patients with end-stage heart failure while they wait for a transplant. But this new device, which will eventually be marketed as the SmartHeart Total Artificial Heart by Cleveland Clinic Innovations spinoff Cleveland Heart Inc., has the potential to be a true heart replacement that could last up to 10 years.
At the center of this project is Dr. Leonard Golding, an Australian-born cardiovascular surgeon who has led the Clinic's artificial heart program for almost two decades.
Golding is 71, with an even temperament, a diminishing supply of white hair and grandfatherly eyes. It was his eyes that took him out of the operating room and into the lab back in 1991, when he suffered a cerebral aneurysm that bled into his optic nerve. Surgeons were able to repair the aneurysm, but it left him blind in one eye.
"I have no good depth perception, and that's not good for a cardiac surgeon," says Golding, who admits he was miserable for the first year or two after his illness. "Most people who get into surgery need instant gratification. Maybe it's an ego trip, but to beat the odds, to fix something that used to kill people, that's fun."
He's clearly still wistful for his surgery days. What he's doing today is still fun, he says, even though the victories are fewer and farther between. But conquering death on the operating table for one patient at a time could be dwarfed by the life-saving potential of the SmartHeart, designed for patients with end-stage heart failure whose prospects are grim. By the time they reach this stage, any kind of physical activity is difficult, and most in terminal heart failure will be dead within two years if they don't get a new heart.
Golding says there are about 2,300 heart transplants in the U.S. each year, but another 50,000 patients annually need one, and the average wait for a donor heart is about a year. Insufficient blood supply to other organs such as kidneys can cause those organs to fail as well.
"The potential for this to push forward the health of some patients that aren't doing well otherwise is enormous," he says.
He was skeptical about its prospects when his senior engineer and the device's inventor, David Horvath, pitched the idea. They'd been working on rotary pumps that help the failing left ventricle of the heart, which accounts for about 70 percent of heart failure cases.
Horvath proposed a total artificial heart based on the same technology. He ticked off for Golding the advantages: one moving part, lightweight design and a smaller size to fit more patients.
"I said, 'o-kay.' It was almost science fiction," Golding says. "Fortunately, I listened to him."
Nine years and a $5.7 million National Institutes of Health grant later, Golding and his team are fine-tuning the device. Documentation to request a go-ahead for clinical trials from the Food and Drug Administration will likely take another five years.
Significant hurdles remain in securing the funding that can support the artifical heart on the road toward commercialization. It got a boost last summer in the form of a $30 million infusion from Korean private equity group Power Heart Consortium.
With a domestic investment climate that favors minimal risk and quick returns, Golding still has a long way to go in getting support for a radically new medical device that's years from the market.
"Even though I believe in it and we're seeing the results, it's still a tough sell," he says, adding dryly, "fortunately there are some crazies out there who are listening."
in the cle
12:00 AM EST
March 23, 2013