High-tech pump does what her heart can't

Leonor Ortiz Childers' heart is too weak to keep her alive.

A recent cancer survivor, she cannot even get on the heart transplant list until 2012, when she would be cancer-free for five years.

What has kept the 46-year-old Durham mother of four alive for the past year is a small pump implanted in her upper abdomen that does the work her heart cannot. Without it, she would die.

The pumping device, only conditionally approved by the U.S. Food and Drug Administration, is supposed to buy time before a heart transplant, but it has worked so well that some think it might be an alternative to transplant.

Although mechanical heart systems are not new - a fully implantable heart was approved by the FDA five years ago, and left ventricular assist devices similar to Ortiz Childers' have been around for more than a decade - the technology is growing more sophisticated. Results are improving enough to keep people alive indefinitely.

In a study published last week in the New England Journal of Medicine, Ortiz Childers' doctors at Duke University reported that the survival rate of patients getting a newer model pump was more than twice the rate using an older model.

Dr. Joseph Rogers, one of Ortiz Childers' doctors and a member of the Duke team that participated in the study, said the smaller, quieter device circulates blood continuously, so the machine doesn't wear out as quickly as the old device, which mimicked the heart's distinctive pulsing rhythm.

Improving durability means less trauma: "It's heart surgery, so it's not a trivial thing to replace pumps," Rogers said.

For people with heart failure - there are more than 5 million in the United States, and asmany as 100,000 develop late-stage disease that puts them in need of a heart transplant - the mechanical alternatives are becoming increasingly attractive.

Thousands die each year hoping to receive one of about 2,100 heart transplants annually in the United States.

Ortiz Childers said she is so pleased with her pump, she would now think long and hard before considering a transplant.

"Do I want to risk another heart surgery?" she asked. "Once they take your native heart out, there's no turning back."

Abrupt, mysterious illness

For most people, heart failure develops over time, but it arose inexplicably and suddenly for Ortiz Childers in 2008, after she gave birth to her second pair of twins.

A criminal defense lawyer, Ortiz Childers said she and her husband, Jeff, began their family late after changing careers as scientists to become lawyers. Their first set of twins was born in 2006, and the second set was due at the end of July 2008.

"Twins run in my family," she said.

A former college tennis player, Ortiz Childers said she never felt better when she learned she was pregnant in November 2007. But a month after that good news, she was diagnosed with breastcancer.

It was late stage and aggressive, requiring a mastectomy and chemotherapy.

In June, eight weeks before her due date, she went into labor, prompting an emergency Caesarean section. Despite their early arrival, the babies were healthy.

Ortiz Childers, however, suffered heart failure - a complication that can arise after pregnancy, often for unknown reasons. Ortiz Childers' doctors had run tests on her heart during chemotherapy to make sure she was healthy and found no evidence of weakness.

"Maybe it was a combination of mybody going through breast cancer, chemotherapy, pregnancy with twins, the emergency C-section," Ortiz Childers said. "Who knows how much a woman's body can take?"

For most women with post-pregnancy heart failure, the problem mends with drugs and close attention.

"We felt like if I got the rest I needed and took my medicine, I would recover like thousands of other women," Ortiz Childers said.

And she did for awhile. But as the summer turned to fall, Ortiz Childers began having shortness of breath and periods of exhaustion that were uncharacteristic of the athletic, hard-charging mom.

One day last November, she became so weak she couldn't hold up her baby's bottle. She arranged for someone to look after her brood and phoned her husband that she was driving herself to the emergency room at Duke.

She was admitted for observation. Three days later, Ortiz Childers' heart stopped.

"There are different stories of how long it took to revive her," Jeff Childers said.

Doctors stabilized her heart, but her liver and kidneys were failing. Ortiz Childers was going to die.

One of the nurses in the intensive care unit approached Jeff Childers and told him a team of doctors wanted to talk with him.

"So we went into the consultation room," Jeff Childers said, "and in walks I don't know how many people, all in lab coats, and they introduced themselves as the device team."

Pump was only option

The doctors, led by Dr. Carmelo Milano, explained that Ortiz Childers' heart was unlikely to recover and that her only hope was for them to implant a mechanical pump called a left ventricular assist device, or LVAD.

The pump pushes blood through the left ventricle - the large, muscular chamber of the heart - into the aorta to circulate throughout the body. Implanted in the abdomen with tubes that run into the heart, the device is powered by a battery or regular household electrical current from a cord extending through a small surgical opening.

Original models of the devices are the size of two fists, ruling them out as an option for smaller patients such as Ortiz Childers.

But amid a sequence of horrible circumstances, Ortiz Childers had a bit of good luck. It happened that the Duke team had on hand a new model of the device, as one of 38 sites in the country testing it for expanded regulatory approval.

The smaller LVAD, about the size of two thumbs, circulates blood through the ventricle in a constant, efficient whirl, eliminating the big pumping mechanisms of old.

Approved as an intermediate measure to keep patients alive while they wait for a heart transplant, the new device has not been proven as a permanent fix.

As a result, the Duke team needed to get special permission from the FDA, the device maker and Duke administrators to use the pump for Ortiz Childers, who was far too sick to be considered for transplant, or to participate in the clinical trial. All quickly agreed.

"There really wasn't another option for her," Milano said.

Tethered to a machine

A week after the implant surgery, Ortiz Childers awoke, foggy and in pain. She had no idea how she wound up with a huge zipper-like scar down her chest, and why there were cords snaking out of her abdomen.

"I was mad," she said. "It took two weeks to appreciate what had happened. It was almost like being paralyzed. My brain was very active, but I couldn't express my thoughts. I felt terrible. I hated people having to take care of me. I was as dependent on them as my infant children were dependent on me."

Thanksgiving and Christmas passed in the hospital - she only saw her babies twice and her older twins four times - but just before New Year's Day, she went home. It was at least a month earlier than doctors had forecast.

Initially, Ortiz Childers considered the LVAD temporary and hoped for a transplant. Now, she says, she isn't so sure she'd want one, even if she were to qualify.

Instead, she has adjusted to being tethered to a machine and doesn't feel hampered by the control device she straps to her waist, like a handyman's belt.

Still, life with a mechanical heart device is far from carefree.

Ortiz Childers worries constantly about the machine failing, creating a situation where she has just enough time to switch out the system controller, the external computer that keeps the pump on pace, before she falls unconscious, or worse.

That's happened twice.

And she must never lose power. The pump plugs in to a battery pack by day and a wall system at night.

The family retrofitted their home in North Durham with a generator that kicks on during power outages, and Ortiz Childers has overcome fears of electrocution in the shower by carefully sealing the device in a waterproof bag.

Her doctors say she could live for years with the machine.

"It's not normal, but it's a pretty good life," Milano said, noting that more technological advances may soon make the pumps a better solution than transplant, extending life for thousands of people with heart failure.

And although Ortiz Childers cannot yet play golf with her husband or practice law, she is grateful for what she can do each day.

"It's been a wonderful year," she said. "I wake up every morning, and I can kiss and hug my children. I have reduced life down to a very few important things that I make sure I do every day."

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