Special pump gives child time to wait for new heart

Robert Dicks/Lucile Packard ChildrenÂ’s Hospital

Suzanne Akard kisses daughter Serafina after she received a Berlin Heart device at Packard Children’s Hospital.

Two-year-old Serafina Akard earlier this month became the second child to receive the Berlin Heart device at Lucile Packard Children's Hospital.

The device is an external pump that fills in for the job that Serafina's damaged heart can't do—circulating blood throughout her body and rallying her for a heart transplant—while she waits for a donor heart to be found.

Serafina suffers from cardiomyopathy, which was first detected last November. Although she had previously seemed like a normal toddler, her health had begun to fail. Cardiologists at the hospital watched her closely for several months, and she was admitted to the hospital's cardiovascular intensive care unit on April 28. That night she had a heart attack and was placed on an artificial heart-lung machine as she awaited a heart transplant.

But doctors worried that the toddler would not live until a new organ became available. The heart-lung machine can usually only support a child for a few days or weeks, and so her doctors realized that they had to turn to the last viable alternative: the Berlin Heart.

Even though the device has not been approved by the U.S. Food and Drug Administration, the agency had given special permission for it to be used once before for a patient at the children's hospital—on young Miles Coulson last summer. The compact pump kept 5-month-old Miles alive for more than six weeks until his successful heart transplant on Sept. 4, 2004.

Bridge-to-transplant, or ventricular-assist, devices are becoming more common for adults in this country, but small versions suitable for infants and toddlers are hard to come by. Although the Berlin Heart is widely used in Europe, the potential market here has not been large enough to spur the company to seek FDA approval. The children's hospital is the only hospital on the West Coast that has used the device in infants.

So a few weeks ago, doctors again asked the FDA for "compassionate care" permission to import the Berlin Heart. After the FDA quickly granted approval, it was flown in from Germany, and Marc Pelletier, MD, an assistant professor of cardiothoracic surgery, implanted it on May 3.

So far, it seems to be working.

"Serafina was very fragile and her organs were shutting down," said pediatric cardiologist David Rosenthal, MD. "She's now much better. In general she is making very good progress." Rosenthal, who is an associate professor of pediatrics at the School of Medicine, directs the hospital's pediatric heart failure program.

Parents Suzanne and Michael—both instructors at Modesto Junior College—are thrilled their little girl, who loves cats and teddy bears, is now doing better. Although the device is only a temporary fix, barring complications like blood clotting or infection, it may have bought Serafina months of time to await a new heart.