Toddler Becomes Youngest in World Implanted with Artificial Lung

— August 26, 2010 -- Justin and Tonya Stark of Eldon, MO., thought their toddler Owen's fever and fussiness were just signs of a mid-June cold -- until Owen collapsed while on a family shopping trip to Toys 'R Us.

Owen was airlifted from a local hospital to St. Louis Children's Hospital, near death from heart and lung failure.

"We put Owen on a heart-lung machine, also called an ECMO," said Dr. Mark Grady, pediatric cardiologist at St. Louis Children's Hospital. "But it [was] not a long term answer."

Doctors diagnosed Owen, who was one-year-old at the time, with pulmonary arterial hypertension -- a disease where vessels from the lung to the heart are so constricted that blood flow grows more difficult. If left untreated, high blood pressure in the arteries of the lungs can eventually lead to heart failure. Lung infections may be one trigger for hypertension, but for many like Owen, the cause is unknown.

Pulmonary arterial hypertension among children is relatively rare, affecting about 10 out of every one million children in the U.S., according to the Pulmonary Hypertension Association. The disease is more commonly found in adult women.

"[Doctors] told us Owen was in the worst condition they'd ever seen from hypertension and that night they said his outcome was not good," said Owen's father.

Doctors thought that medications may not work as a long-term solution at Owen's stage of the disease, Grady said. And with time waning on ECMO, they decided Owen needed a new lung. But that was also problematic.

"In the past we saw that children on the heart-lung machine who receive lung transplants do terribly," said Grady.

"We were told to keep in mind when enough is enough – and we thought about that a lot," said Stark. "We had to discuss when we thought we had done enough [for Owen]."

Device, Not FDA Approved, Showed the Most Promise

Members of the transplant team knew that a device not yet approved by the U.S. Food and Drug Administration but used outside of the U.S. in cases like Owen's, may provide the same benefits as ECMO, but with fewer potential complications. The device, called the NovaLung, uses tubes implanted in the chest to circulate blood, while a box outside of the body acts as a replacment lung. Doctors at St. Louis Children's Hospital petitioned the FDA to use NovaLung to maintain Owen until the hospital could identify a new lung to transplant.

The FDA agreed to conditional use of the NovaLung, and Owen became the first pediatric patient in the U.S. and the youngest patient in the world to be kept alive on the device.

"When he was on NovaLung we saw immediate results," said Grady. "Over 3 weeks he was able to come off the medications."

The NovaLung is used as a bridge to transplant in older patients in countries like Canada and Europe. It is also used to help trauma victims recover from lung infections or potential damage.

"It's exciting in that there's a relatively simple device that may prove beneficial in saving childrens lives, because it certainly did that for Owen," said Grady. "If they design a lung machine like this that's smaller, it can be used for many infants who develop lung disease or [are] born prematurely."

Slow but Sure Recovery for the First and Youngest

For the first time in nearly a month, Owen's father said his son, though still on bed rest, was alert and able to move.

He said having Owen be the first in the U.S. to get the NovaLung is not what's important. "We would rather be the second or thousandth to do it if it meant saving Owen," said Stark.

But, in late July, just one week shy of his second birthday, there was a dramatic, and surprising turn of events. It began when Owen kicked off a connector to the NovaLung. While doctors worked to replace the connector, Owen suffered a stroke.

When doctors worked to replace the NovaLung with a ventilator to keep Owen breathing, they noticed that Owen's lungs were able to function on their own.

"There's no question that [the NovaLung] gave him the opportunity for his medicines to work and chance for his lungs to recover," said Grady. "I didn't anticipate his lungs would recover as much as it did."

Owen is now undergoing physical therapy to recover from his stroke. He is still on medications for his hypertension, but is able to breathe on his own and no longer needs an immediate lung transplant, according to Grady. Stark said Owen will move to the rehabilitation floor of the hospital next week, and afterwards may be able to go home.

Doctors found Owen's recovery extraordinary as the youngest patient to thrive on a NovaLung. The Starks, who have not left Owen's hospital room since his collapse in mid-June, said it's "more than luck" that has kept Owen alive.

"I think there's been a little more involved in his journey than medicine," said Stark.