Lee’or and Wendy Rutenberg knew that their baby daughter, Sadie, was going to be born with heart problems. Ultrasounds showed that the walls between her heart’s atria and ventricles were not forming correctly. But they didn’t think it would be a problem for Sadie right away.
“Most children with conditions like Sadie’s don’t need surgery until they are 2 or 3 years old. We thought we’d have two or three years of relatively normal life before we’d have to do all of this,” Lee’or Rutenberg said as he gestured toward his daughter’s bed at Seattle Children’s Hospital.
Unfortunately for the Rutenbergs, Sadie’s heart problems were more complex than expected. The only option for her was a type of pediatric heart valve that is currently in clinical trial. Sadie would become the first child in the U.S. to receive the valve as part of the HALO U.S. IDE Trial, which is testing the safety and efficiency of the St. Jude Medical Masters HPTM Series 15mm mechanical heart valve.
“We are so grateful that this option was available to Sadie,” said Wendy Rutenberg. “She needed something that was really going to make a difference. She couldn’t continue the way she was.”
Dealing with the “unexpected”
Sadie’s journey to becoming a pioneer among pediatric heart surgery patients started just two months after she was born. She was home, but she was not doing well.
“She was breathing fast, had stopped gaining weight and was not eating well at all,” said Wendy Rutenberg. “She was having a really rough time.”
It became apparent that Sadie’s heart problems were much worse than expected. The prenatal ultrasounds didn’t catch that the valves in Sadie’s heart were also deformed and were leaking. With each passing day, the tiny baby was getting sicker and weaker.
The Rutenbergs were referred to Dr. Jonathan Chen, chief of pediatric cardiovascular surgery and co-director of the Seattle Children’s Heart Center, who broke the news that Sadie would need surgery right away.
“She was three months old and only three kilos (about seven pounds),” Chen said. “We needed to get her to a point where she could feed and grow and her heart could grow and get strong enough to endure more extensive surgery.”
The Rutenbergs were shocked – and nervous. “We thought we knew how all of this was going to happen for Sadie, and then everything changed,” said Lee’or Rutenberg. “We’re looking down the road, at Sadie’s future, and we’re scared. But after a few minutes of digesting, we were ready to talk next steps. We said, ‘What’s the game plan?’”
Stabilization, then big surgery
The initial surgery helped. Sadie “sat and fed and grew for six weeks,” said Chen, but then started showing signs of worsening heart failure. Chen started talking to the Rutenbergs about the St. Jude Medical heart valve (Seattle Children’s is one of 40 sites nationwide that are participating in the HALO trial).
Because of her size, Sadie was a good candidate for the valve, which is the smallest pediatric mechanical heart valve in the world, said Dr. Lester Permut, an attending surgeon in pediatric cardiothoracic surgery who is also the lead investigator for the HALO trial at Seattle Children’s.
“Most medical device companies don’t have the incentive to develop devices that are appropriate for small babies because so few of these devices are used,” said Permut, a member of the Center for Developmental Therapeutics at Seattle Children’s Research Institute. “That’s a problem because adult-sized valves won’t fit small children. The St. Jude valve is currently approved by the FDA for investigational use and is available for emergency/compassionate use, but it’s an onerous process. This trial will hopefully demonstrate that this valve is safe for general use.”
Lee’or Rutenberg said the choice to try the valve on Sadie was not easy, but “there really was no other option.”
“We were starting to realize just how fine a line we were walking,” he said. “She was very sick. There really wasn’t a choice to make.”
Chen and team embarked on Sadie’s third open heart surgery on May 7, a date that Wendy Rutenberg has noted on Sadie’s baby milestones calendar. Implantation of a pacemaker shortly after the valve surgery was the last piece of Sadie’s complicated heart puzzle.
“She still has a long road ahead” and will need replacement valves as she grows, Chen said, “but there’s no reason to think she won’t be running and playing and acting like a normal kid.”
Finally going home
After getting her new heart valve and pacemaker, Sadie began rapidly gaining weight and becoming more alert and active. She smiles when her parents and visitors talk to her, reaches for toys and other objects and looks at herself in the mirror. In other words, she’s acting much like any other baby her age.
When the Rutenbergs got the news that they could finally take their baby home from the hospital earlier this month, their reaction was bittersweet.
“It’s overwhelming,” said Lee’or Rutenberg. “We want her home so badly but there’s also a feeling of safety here. The doctors and nurses and staff here are the most amazing people we have ever met. They’ve given me a whole new perspective on health care. There were times that we were visibly upset about everything we were going through and they constantly reassured us that we were going to get out of here; that we were going to get through this.”
Added Wendy Rutenberg: “This place and Dr. Chen saved Sadie’s life. No one (prior to Sadie’s birth) had any idea how sick she really was. There was the very real possibility that she could have died or needed a heart transplant. To come here and have such a positive outcome; it’s just amazing. We are just so grateful.”