A 2-Year-Old Is First in U.S., and Youngest in World to Use Artificial Lung

Doctors at St. Louis Children’s Hospital say Owen Stark, a 2-year-old from Eldon, MO, is alive today because of an artificial lung. St. Louis Children’s Hospital is the first hospital in the country to use the device, the German-made Novalung® sLA Membrane Lung, as an artificial lung. Owen is the youngest person in the world to receive one.

Originally approved to help adults through cardiac surgery for intervals up to six hours, the Washington University physicians on the Children’s Hospital medical team requested permission from the FDA to use the sLA for Owen to oxygenate his blood in place of his failing lungs until donor organs became available. This temporary use is commonly referred to as a “bridge to transplant.”

Surprisingly, Owen rehabilitated so significantly on the Novalung®sLA, that when doctors removed it after 23 days — expecting a need to replace it right away — Owen’s lungs were strong enough to function on their own.

Owen was diagnosed with idiopathic pulmonary hypertension — or high blood pressure in the lungs — earlier this year. This condition can stress the heart, ultimately leading to heart failure. Owen was in full heart failure when he was transferred to St. Louis Children’s Hospital in June. In that critical state, the medical team determined he’d need a transplant to survive.

Owen didn’t have time to wait for donor organs. He was placed immediately on a heart-lung bypass machine called ECMO in order to buy time for his heart and lungs to recover and be evaluated for transplant. ECMO is considered a last resort and only sustainable for 2 weeks before risking organ damage, which would make a child ineligible for a transplant operation.

When Owen reached the safe time limit on ECMO, his heart had recovered, but his lungs had not. He needed a lung transplant. With no organs available, and no other options, the transplant team at St. Louis Children’s Hospital, led by cardio-thoracic surgeon Dr. Charles Huddleston, petitioned the FDA to secure ‘compassionate release use’ of the Novalung®sLA, which is not FDA-approved for use as an artificial lung. Dr. Huddleston recognized that the Novalung® sLA device might provide Owen the same lung benefits as ECMO but with fewer potential complications.

The FDA agreed to the conditional use of the Novalung® sLA because without it, Owen would have faced certain death. The sLA is essentially similar in design and function to the iLA Membrane Ventilator, which Novalung markets outside the U.S.

The Institutional Review Board that oversees St. Louis Children’s Hospital and Washington University School of Medicine also is aware of the exceptional circumstances surrounding this case and approved its use.

Unlike the heart-lung bypass machine, a child on the artificial lung might not need to be sedated or use a ventilator. While using the device, Owen could sit up, eat and communicate.