German pump helps baby awaiting heart transplant
FDA gives Packard special permission to use the device
Five-month-old Miles Coulson, blue-eyed and chubby-cheeked, sits in his bouncy seat in the cardiovascular intensive care unit at Lucile Packard Children’s Hospital, eagerly tracking the plastic fish swimming on a play toy before his eyes. His father, Adrian Coulson, is attentive to the baby’s every movement and expression, for the slightest change could signify some complicating factor. The father periodically suctions fluid from the baby’s mouth, the remains of Miles’ tube-fed lunch.
Miles is a bit of a technological wonder, for he would not be alive today without the benefit of a German heart pump that’s been used only three times before in this country. The pump, a fist-sized piece of polyurethane shaped like a diaphragm, thumps quietly at the baby’s side, collecting the blood from the left side of Miles’ failing heart and directing it back to the body via the aorta.
Miles was born healthy on March 30 but went into heart failure a few weeks after birth, most likely as the result of a virus, said David Rosenthal, MD, chief of the pediatric heart failure program at Packard Children’s Hospital and associate professor of pediatrics. The boy, born in the Sacramento area, was put on extracorporeal membrane oxygenation (an artificial heart-lung machine) for more than a week to support the heart, but he didn’t fully recover. It became clear that his heart wouldn’t hold up over time and that he would need a transplant, Rosenthal said.
But infant heart transplants are hard to come by and the wait can be a long one. Of the three babies who’ve received transplants at Packard, the wait has ranged from 10 to 200 days, Rosenthal said. So he and his colleagues began looking at options to keep Miles alive until a heart small enough for the 15-pound infant might come through.
None of the heart pumps available in this country is small enough to serve an infant population. So Miles’ doctors looked to a device known as the Berlin Heart, named for its city of origin, which has been used in 50 to 100 children worldwide. Getting it here – and in short order – was something else again.
It required a special evening meeting of the Institutional Review Board, which oversees research involving human subjects at Stanford, and special dispensation from the U.S. Food and Drug Administration to bring it into the country. And it took a massive organizational effort at Packard to ensure everything was in place – from skilled nursing care to customs’ release forms to the proper electrical adaptors for the device, Rosenthal said.
The pump arrived July 12, accompanied by a cardiac surgeon from the company who came to assist in its implantation. Miles by then was grey and cold, on a ventilator and failing fast, his doctors said.
“He was desperately in need of more cardiac support. He needed some additional therapy to survive,” said Stephen Roth, MD, director of the cardiovascular ICU and associate professor of pediatrics.
The pump, similar to a larger adult pump in use at Stanford, was installed the next morning by a team led by Robert Robbins, MD, associate professor of cardiac surgery, and Bruce Reitz, MD, professor and chair of cardiothoracic surgery.
“There were some technical challenges, not the least of which was that this is the smallest and youngest baby to ever receive the pump,” Robbins said. “But the operation proceeded without any complications.”
Miles emerged pink and robust-looking. “It was a pretty amazing transformation,” Rosenthal said.
Miles has two tubes that emanate from his chest, ferrying blood in and out of his body 100 times a minute. The pump is basically a “fancy air compressor,” Roth said, powered by a console about the size of a filing cabinet and controlled by a laptop computer.
Since the surgery, Miles has had his ups and downs. He experienced bleeding problems and had to have excess blood removed from his chest. And he developed a few temporary neurologic problems, probably the result of some very small strokes that are not believed to have left any lasting damage, Roth said. And, like many artificially supported patients, he has suffered from an infection and received antibiotics.
Today, Miles looks and acts like any other normal infant. He smiles, gestures, moves around within the limits of his little territory, responds to his parents and follows the activities of his caregivers. He is mildly sedated and doesn’t appear to be in any pain.
“This is not a long wait in agony. It’s a tolerable wait for him,” Roth said.
His mother, Leigh Bills, is on leave from her job as an emergency services coordinator in Sacramento and spends much of her days by Miles’ side. His father, a public school music teacher, visits the hospital on weekends and frequently on weeknights along with the couple’s other son, 2-year-old Matthew.
The parents, Roth said, are “hopeful but realistic. They are willing, within reason, to do anything possible to try to help their son. It’s important to them that he’s comfortable and has a reasonable quality of life.”
And so they wait.