When Leonor Childers' heart quit, it wasn't without reason.
Childers, 46, a mother of four, was pregnant with her second set of twins when she was diagnosed with breast cancer. What followed would tax any heart, she says: "A mastectomy, chemotherapy, an emergency C-section, more chemotherapy and six weeks of radiation."
Two weeks later, Childers suffered cardiac arrest. "It's hard to pinpoint what caused it," she says. "My body just started shutting down, saying enough is enough. My liver blew out, my kidneys blew out. It was a life-or-death situation."
Fortunately for Childers, of Durham, N.C., her doctors had on hand the technology she needed to tip the scales back toward life: a heart pump called the HeartMate II, which won government approval Jan. 20 for patients who can't tolerate a transplant.
The HeartMate II is the second in a series of pumps designed to sustain heart-failure patients until a donor heart becomes available. A souped-up successor to the HeartMate I, which offered patients only a short-lived reprieve, the HeartMate II has revived a dream that a mechanical device may serve effectively as a "destination" therapy for patients who can't find a donor heart or may not survive a transplant.
Childers won't be eligible for a transplant until she has been cancer-free for five years, in 2012, because the anti-rejection drugs may suppress her immune system and allow the cancer to return. Without her HeartMate, she would have died. "It has given me 453 days that I wouldn't have had with my family," she says. "Days mean a lot to me. Hours mean a lot to me."
Evolution of the technology
Even a good candidate is unlikely to find a donor heart, with just 2,100 available for the 150,000 people who develop heart failure every year. Totally implantable artificial hearts have failed to live up to the high expectations generated when doctors swapped dentist Barney Clark's heart for the Jarvik-7 in 1982.
The Jarvik-7 doomed patients to live tethered to a console, prone to hemorrhages and strokes. But it ultimately led to smaller pumps like the HeartMate II, which is battery-powered, portable and frees patients to golf, travel and care for kids.
"It's now a practical approach," says Clyde Yancy, director of heart and lung transplantation at the Baylor Health Care System in Dallas. But at about $80,000 for the pump and $45,000 for the surgery and hospital stay, it's a pricey one, he says.
A study presented at an American Heart Association meeting in November shows that the device doubles two-year survival to 58%, up from 24% for the HeartMate I. One hundred thirty-four patients were given the HeartMate II; 66 got the older version.
"We now have outcomes with these pumps at one year that are very close to what we're seeing with heart transplant patients," says Roberta Bogaev, medical director of heart failure and transplantation at the Texas Heart Institute.
The next generation of heart pumps may be even smaller. The experimental CircuLite pump, the size of one AA battery, could make providing mechanical heart support as simple as implanting a pacemaker. Doctors in Europe have begun testing the CircuLite. A trial also is beginning in the USA, says Joseph Rogers of Duke University, lead author of the study released at the November heart meeting. "We've come a long way," he says.
'A lot of hurdles to leap'
Earlier devices were designed to pulse like the native heart, but that made them large and noisy. The HeartMate II, a continuous-flow pump, is about one-third the size of its predecessor. With just one moving part, it's much quieter and leaves patients without a pulse. "It's there, but it's difficult to find. Even the nurses have a hard time," Childers says.
Her children have listened to her heart through a stethoscope, which amplifies the pump's whirring sound. "That's really neat. Mommy sounds like a train," one said. Living with the HeartMate required a big adjustment, though, Childers says: "I have a lot of hurdles to leap every day. I can't do certain things."
Childers, formerly a trial lawyer, says she no longer has the energy or resilience she needs to represent clients in court. Everywhere she goes, she says, she brings a suitcase with "everything I might need in an emergency to get the pump back up before I lose consciousness."
Water terrifies her, because she fears it will short out the two batteries that send power through a cable into her chest. The pump's maker, Thoratec, makes a shower kit to protect the batteries and digital controller, which she ordinarily wears on a belt. "You can hang the bag on your shoulder, strap it across your body or hang it in the shower," she says. "It took me eight months to get over my fear of taking a shower."
When she was socked in by a recent snowstorm, Childers says, doctors decided to hospitalize her for a few days to clear an infection that occurred when the tube that exits her abdomen became dislodged from her skin while she was caring for her four active children.
"It's the first time I've had to be hospitalized since they put (the pump) in," Childers says.
Grateful as she is for her HeartMate, Childers is still marking time until December 2012. That's when she'll be considered cancer-free: "Then I can be listed and wait hopefully for a new heart."
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