Photograph courtesy of St. Louis Children's Hospital
A Missouri toddler will return home today from St. Louis Children’s Hospital weeks after emergency surgery that made him the youngest person in the world and the first in the U.S. to be fitted with an artificial lung.
“I don’t think there’s any question, he wouldn’t be alive without it,“ says Dr. Mark Grady, a pediatric cardiologist at St. Louis Children's Hospital, referring to the German-made Novalung®sLA which sustained 2-year-old Owen Stark for over three weeks in July.
Justin and Tonya Stark, Owen’s parents, were out shopping for toys with their son early this June when he suddenly collapsed. Driven to a Columbia, Mo., hospital then airlifted to St. Louis, Owen was repeatedly revived from total heart failure.
Grady and his team made a diagnosis of pulmonary arterial hypertension—a progressive disease that causes arteries in the lungs to tighten, impeding blood flow and stressing the heart. Although common in the elderly, the condition is extremely rare in children, affecting only about 1 in 100,000.
“The disease this little boy has, if the medications fail, transplant is the next step,” Grady says.
Owen’s case was especially dire. Grady saw that Owen needed a lung transplant immediately, but no suitable organs were available on short notice (patients often wait months before an acceptable donor can be found). Placed on a temporary heart-lung bypass machine called an ECMO, physicians had just two weeks to find a solution—after that, the ECMO begins to damage organs, which can even leave patients ineligible for the transplants they need.
“At that point, we really had no other options,” Grady says, and so the team petitioned the Food and Drug Administration to allow for a novel use of new “bridge-to-transplant” technology, the Novalung artificial lung.
The Novalung consists of a small red and white box connected to a pair of tubes—one for an artery, to carry blood from the heart, and the other for a vein, bringing it back in. A membrane in the device filters carbon dioxide from the blood and adds oxygen, just like a real lung. But while the device is used throughout Europe and Canada, the FDA has approved only limited use within the U.S.—only by adults and only for the duration of surgery, about six hours at most. Owen’s doctors wanted to place a pediatric patient on the device, and for as long as possible.
Ultimately, the FDA granted a “compassionate release use,” and Owen would spend a total of 23 days on the Novalung. Although the move was only intended to buy time, doctors and family began observing an immediate improvement in Owen’s condition.
“There was a huge difference,” Stark says in an interview with KSDK. “He wasn’t sedated anymore, he could actually sit up in a little chair in his bed and play and interact with people and talk to us. Huge difference.”
Grady says the Novalung is also “remarkably cheap for a medical device,” at only about $5,000. Compared to other bridge-to-transplant technologies—like the Berlin Heart, which comes in at over $100,000—that’s a pretty good deal, Grady explains.
Despite being set back by a stroke and being taken off the Novalung, Owen’s natural lung function had improved so much while on the machine that doctors removed him from the active organ transplant list altogether. Grady says his team decided last week that Owen could return home today while continuing his rehab and medication regimens.
Although Owen’s disease is a progressive one and he may eventually require a lung transplant, Grady believes the risks taken on by Owen and his family could aid in saving the lives of more kids down the road.
“If we came across a similar situation, we could use it again,” says Grady. “It really shows that it can be successful, and it really opens the door, I think, to lots of other sick children that might have other kinds of lung disease where this device may be utilized.”
