World's Smallest Mechanical Heart Valve Saves 3-Year-Old Sadie Rutenberg's Life

A 3-year-old became the first to get the world's smallest mechanical heart valve that saved her life. The tiny 15-millimeter valve manufactured by Abbott was given to Sadie Rutenberg, who was born with a heart defect.

Despite two open-heart surgeries, the organ still did not work well, and she was too weak for a transplant, doctors said.

“Sadie was born with a complete atrioventricular canal defect and underwent two open heart surgeries in her first few months of life,” according to Seattle Children's Hospital, which offered the toddler’s parents the chance to be in a Food and Drug Administration trial.

Explaining the defect, Dr. Jonathan Chen, chief of pediatric cardiovascular surgery and co-director of Seattle Children's Heart Center, said: “Imagine a giant hole in the upstairs chamber of your heart, and a giant hole in the downstairs chamber, so the middle is essentially missing.”

The mechanical heart valve was first designed for pediatric patients in need of replacements after they are left with no other approved options.

“We replaced the valve and she was off the races. She turned into a different child. She was able to eat and grow,” Chen said, adding that following the valve replacement, Sadie is full of energy.
Lee'or Rutenberg, Sadie's father responded, saying: “Looking at her, you'd have no idea she's been thru 5 heart surgeries... Having an opportunity to try this valve was huge and so exciting.”
Dr. Chen thanked the Rutenbergs for their willingness to try the experimental device, which can in the future save several other children with similar valve defects.
“Without the Sadies of the world, we wouldn't have these valves on the shelf,” Dr. Chen said.

Wendy Rutenberg, Sadie's mom, said the family didn't know if there was any other option to save the child.

“Having the opportunity to try this valve was huge and so exciting,” the mom told KOMO-TV.

“I remember Dr. Chen coming out after the surgery. That initial moment where we’re looking at him and wondering, 'Is he going to give us good news or bad news?' Then he broke into a smile. It was like winning the lottery,” Wendy shared. “I think the future is really bright. She is going to have some limitations, but she has so much opportunity ahead of her now. If that clinical trial hadn't been available, we would have started planning for her death rather than planning for her life, setting up a college fund and all the things that parents typically do.”