Abbott’s tiny heart valve offers new options for kids, families

Last week, the FDA approved Abbott’s 15-millimeter Masters HP mechanical heart valve, a tiny device that can be implanted in small babies. The valve gives pediatric cardiac surgeons new opportunities to intervene early, rather than waiting for kids to grow big enough to tolerate a larger device.

“Some children we would keep on medical management – a ventilator and drugs to support the heart – for many months as they grew until we thought they were big enough to put a valve in,” said Carl Backer in a phone interview. Backer heads the Cardiovascular-Thoracic Surgery division at the Children’s Hospital of Chicago, one of several hospitals that participated in the trials. “With this valve, we don’t have to go through that time of managing these patients.”

The valve can help babies born with a variety of valvular conditions, such as congenital mitral valve disease or atrioventricular septal defect (AVSD), which is basically a big hole in the heart. These issues are relatively rare but still produce around 40,000 cases a year. The device itself is made from pyrolytic carbon, which makes it quite durable, and is rotatable, allowing surgeons to give it the optimal orientation.

Affected babies often suffer from upper respiratory infections and can have trouble gaining weight, which presents a Catch-22 as they need to grow bigger to qualify for a larger valve.

Sadie Rutenberg, now three, was the first child to receive the valve. Her 20-week ultrasound showed she had a relatively minor heart defect, but it was only after she was undergoing repair surgery at two months that her medical team realized she had AVSD and her valves were not formed correctly.

“At the time, the options were heart transplant – for which she wasn’t a good candidate – or comfort care,” said Sadie’s father Lee’or Rutenberg in a phone interview.

The third option was the investigational valve, though Sadie would have to wait several months for the surgery. Lee’or and his wife Wendy had to do their best to help Sadie while they waited.

“We were just limping through moment by moment,” said Wendy in a phone interview, “just holding on to what we needed to do to get her to gain one more ounce, what we needed to do to get through one more night.”

The successful valve replacement was conducted at Seattle Children’s Hospital Heart Center when Sadie was nine months and provided almost instant relief.

“When she came out of it, she just looked better,” said Wendy. “Her color was better, her skin used to be mottled and it looked normal. She was breathing better.”

Sadie also had to receive a pacemaker and will need new valves as she grows. This valve should last until she’s around 5 and then she will need another in her teens. In addition, the valve poses a clotting risk, so she must take blood thinners, which put her at increased risk of bleeding.

Still, two years later, Sadie is thriving: taking music classes and swimming lessons, loving the zoo.

“You couldn’t even tell she’s been through any of this, she’s such a resilient little girl,” said Lee’or. “She’s the happiest, toughest girl you’ve ever met.”

Photo: Abbott