World’s smallest mechanical heart valve approved for use in infants

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It’s a game of millimeters. Working inside an infant’s tiny heart is complex. Now, access to a newly FDA-approved device is changing the outcome for some of the tiniest patients with abnormal heart valves.

Before Avery Molina was born in December 2016, she was diagnosed with several heart defects – one was a malformed mitral valve.

Dr Carl Backer, Lurie Children’s heart surgeon: “She was born with insufficient valve tissue.”

With each squeeze of the heart muscle, the mitral valve opens and closes to regulate blood flow. In Avery’s case, it was leaking -- allowing blood to back up and pool inside the chambers of her heart.

Dr Carl Backer, Lurie Children’s heart surgeon: “If the valve leaks, then the child doesn’t have good blood flow going up to their body, and sometimes they can’t support their own circulation.”

Aisha Custodio, Avery’s mom: “She just wasn’t herself during this whole thing. She was depressed, she wasn’t eating. They did physical therapy with her, they did music therapy, anything to uplift her spirits, which wasn’t helping.”

A surgical repair using her own tissue didn’t work. The next option was replacing the valve with a mechanical version. But at the time, the standard device available on the open market -- at 16 millimeters – was too bulky for the infant. Surgeons did their best to make the larger valves work in babies – but if the device didn’t fit right, it often led to complications, like blood clots and obstructed blood flow.

Dr Backer: “This is the 15. The smallest valve we used to have was 16.”

What a difference a millimeter makes. At 15 mm, one less than standard valves, it’s the smallest in the world, developed for the smallest patients, like Avery.

Dr Backer: “It’s a beautiful little valve. It’s like a little jewel. That’s where the valve is opening and closing right there. The valve is sitting just like that.”

The FDA officially approved the device last week, but Lurie Childen’s heart surgeon Dr Carl Backer has been using it since 2011 as part of what’s called an investigational device exemption. In other words, surgeons could request the valve in emergency situations -- that’s how Avery was able to get one. It’s called compassionate use. Hospitals placed a special order with the manufacturer, but the wait was 48 hours or more, which, at times, was too long for some infants to wait.

Dr Backer: “I think it’s an important step forward for our patients, and it’s nice to have it on the shelf and not have to go through any channels or any time constraints to get the valve.”

It’s a game of millimeters. Working inside an infant’s tiny heart is complex. Now, access to a newly FDA-approved device is changing the outcome for some of the tiniest patients with abnormal heart valves.

Before Avery Molina was born in December 2016, she was diagnosed with several heart defects – one was a malformed mitral valve.

Dr Carl Backer, Lurie Children’s heart surgeon: “She was born with insufficient valve tissue.”

With each squeeze of the heart muscle, the mitral valve opens and closes to regulate blood flow. In Avery’s case, it was leaking -- allowing blood to back up and pool inside the chambers of her heart.

Dr Carl Backer, Lurie Children’s heart surgeon: “If the valve leaks, then the child doesn’t have good blood flow going up to their body, and sometimes they can’t support their own circulation.”

Aisha Custodio, Avery’s mom: “She just wasn’t herself during this whole thing. She was depressed, she wasn’t eating. They did physical therapy with her, they did music therapy, anything to uplift her spirits, which wasn’t helping.”

A surgical repair using her own tissue didn’t work. The next option was replacing the valve with a mechanical version. But at the time, the standard device available on the open market -- at 16 millimeters – was too bulky for the infant. Surgeons did their best to make the larger valves work in babies – but if the device didn’t fit right, it often led to complications, like blood clots and obstructed blood flow.

Dr Backer: “This is the 15. The smallest valve we used to have was 16.”

What a difference a millimeter makes. At 15 mm, one less than standard valves, it’s the smallest in the world, developed for the smallest patients, like Avery.

Dr Backer: “It’s a beautiful little valve. It’s like a little jewel. That’s where the valve is opening and closing right there. The valve is sitting just like that.”

The FDA officially approved the device last week, but Lurie Childen’s heart surgeon Dr Carl Backer has been using it since 2011 as part of what’s called an investigational device exemption. In other words, surgeons could request the valve in emergency situations -- that’s how Avery was able to get one. It’s called compassionate use. Hospitals placed a special order with the manufacturer, but the wait was 48 hours or more, which, at times, was too long for some infants to wait.

Dr Backer: “I think it’s an important step forward for our patients, and it’s nice to have it on the shelf and not have to go through any channels or any time constraints to get the valve.”

Aisha Custodio, Avery’s mom: “The valve fit her perfectly. It was the best thing for her.”

The valve should last until a child is about 3 or 4 years old, then patients can get a larger version. There isn’t great demand for the tiny device – that’s because it’s not common to do valve replacement on infants. Dr Backer has done eight with the new device, which is now manufactured by Abbott Labs based nearby in North Chicago.

Aisha Custodio, Avery’s mom: “The valve fit her perfectly. It was the best thing for her.”

The valve should last until a child is about 3 or 4 years old, then patients can get a larger version. There isn’t great demand for the tiny device – that’s because it’s not common to do valve replacement on infants. Dr Backer has done eight with the new device, which is now manufactured by Abbott Labs based nearby in North Chicago.