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How the Newly FDA Approved Abbott Heart Valve is Saving Newborn Lives

Heart-shaped cloud in the blue sky

The FDA just approved the world’s smallest mechanical heart valve for newborns and infants. Prior to the approval of the Abbott heart valve, the lives of approximately 40,000 babies a year were in grave jeopardy due to congenital heart defects (CHD). The Abbott heart valve is a mere 15 millimeters in size, approximately the circumference of a dime.


Hope was dim indeed for these newborns, but the Abbott heart valve is now offering these babies a second chance at life. Such was the case for Sadie Rutenburg, now a bubbly, energetic three-year-old, whose bouncing blonde ringlets give no indication of the fact that she struggled to survive soon after being born.

Three years ago, Sadie became the first patient to receive a pediatric heart valve as part of a clinical trial for pediatric patients five years old or younger with a diseased, damaged, or malfunctioning heart valve. In Sadie’s words, she has a sparkle in her heart.

Sadie’s parents firmly believe that the Abbott heart valve saved their daughter’s life. I had the honor of conducting an interview with Dr. Jonathan Chen, who performed Sadie’s surgery, and her father, Lee’or Rutenburg.

Kaitlin: Dr. Chen, please tell us more about the FDA approval of the mechanical heart valve and why it’s significant for pediatric patients?

Dr. Chen: Well, the Abbot 15-millimeter valve, was available to us before, but it was on protocol. It would take several days, like several days, to get the valve to you because you’d have to get it through your institutional review board, and then get the valve from the company. Now with the FDA approval, it means that it’s on the shelf which is a big advance as you can imagine. For emergency operations, for example, it was just not an option before. For the kids for whom we were intending to replace their valve, it does mean we don’t have to wait those several days before the valve is available which is not insubstantial in terms of risk. Then I think there’s another group of patients that we probably are underestimating that are kids who we need to do high-risk, micro-valve repairs on and most often we wouldn’t undertake those operations without knowing that we had a backup. We would have to wait for those kids to get bigger also and so having this valve available to us really kind of changed the game in how we take care of kids with micro-valve problems.

Kaitlin: Oh, that’s amazing! It’s so exciting to see this breakthrough in medical technology. Are there specific qualifications for babies and children that make them candidates for valve replacement, and what does this new treatment offer to patients and their families facing this issue?

Dr. Chen: Every child, for the most part, should be a candidate for the valve. You just have to have what we call an annulus or a diameter because the valve has to be at least 15 millimeters or else you won’t be able to fit the valve in. You know the impact of having what you call mitral valve competence (which means the valve works, it doesn’t leak, and it’s not too small). To have it perfect, which is really what the prosthetic valves are, it can have a huge impact on a kid. You’ll take a baby who is on a ventilator and on multiple medications in the ICU, who has been there for weeks, and after you put in a perfectly competent valve they’re a completely different kid the next day. They’re ultimately out of the ICU and feeding and growing normally. It’s a major, major advance.

Kaitlin: Oh, that’s just wonderful. What is the prognosis for pediatric patients who have undergone surgery for the mechanical heart valve?

Dr. Chen: Oh, the prognosis is great. We expect, and we want the kids to outgrow the valve because the valve obviously doesn’t grow with you so most kids who get this valve are looking to have at least two more operations in their lifetime depending on how big they get as adults just to upsize the valve. Those operations, the upsize valve operations, are neither particularly long nor complicated so the prognosis is very good.

Kaitlin: And before was the prognosis quite bad?

Dr. Chen: Well, if you were too small to get an adult prosthesis which is really what we had available to us, the choices at that point were to make it through the ICU for weeks to months to get big enough, have a transplant, or just get palliative care. I mean it was really a significant problem.

Kaitlin: Thank you so much, Dr. Chen. I have some questions for Sadie’s father, Lee’or, now. You and your wife were aware that Sadie would be born with heart problems. What were some of the symptoms following her birth that led to her receiving Abbot’s pediatric valve?

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Lee’or Rutenburg: When she came home from the hospital she was feeding, but she was feeding a lot more then we were expecting. She was feeding basically around the clock, but she wasn’t putting on any weight. She was having difficulty sleeping at night, she was fussy, and she was sweating a lot. She was working really hard to do all of the things that a baby does. Her skin didn’t look great, it looked a little mottled, and she just didn’t look very healthy come about two months after we brought her home from the hospital.

Kaitlin: That must have been so stressful as a parent to recognize that, especially compared to other newborns.

Lee’or Rutenburg: Yeah, it was scary, and as a new parent we didn’t know what was good and what wasn’t good. Children are fussy, babies can be fussy, and it was hard for us to kind of pick up on whether or not this was her just being fussy. Eventually, it was around two months later, we realized that something just wasn’t right, and that we needed to get it checked out.

Kaitlin: Can you share with us how Sadie is doing today and what that means for your family?

Lee’or Rutenburg: Absolutely, she’s a little firecracker! You wouldn’t even know that she’d been through the numerous procedures and operations that she’s had. She’s doing all the things that you would expect a three- year-old to do. She’s going to the zoo and going to the playground. She’s keeping us on our toes! She has more energy than we do! She’s just the happiest little girl, and the impact of this is that we get to share this with not only the world, but also other parents who are going through the same thing. They get to see a vibrant and young little girl who overcame the odds and is doing, you know, far better than anyone could have expected.

Kaitlin: Oh, that’s just so exciting for all of us to see that, and it’s so nice to see such hope for situations like this. Where can our viewers/listeners go to hear more information about the Abbott heart valve?

Dr. Chen: I think the most comprehensive site is Abbott.com to get information about the valve. For those parents who have kids with either mitral valve problems or other congenital heart disease, there is wealth of other parent groups, chat rooms, and Facebook sites. They should really avail themselves of those communities because they can find out a lot of information… much more than any doctor or nurse can tell them about what it’s like to have a child who has a mechanical valve and needs to undergo surgery, etc.

Kaitlin: Oh, that’s very, very exciting! Well, I personally really enjoyed looking at the videos I was sent and just seeing the complete turnaround for Sadie. That is just such a marvelous medical intervention on her behalf.

Lee’or Rutenburg: Thanks!

Kaitlin: That concludes our interview for today. Mr. Rutenburg and Dr. Chen, thank you so much for all of your time and your answers. We look forward to hearing more about Sadie's progress in the future and all of her wonderful, thriving opportunities due to the Abbott heart valve.

Dr. Chen and Lee’or Rutenburg: Thank you!

Sadie's miraculous story of renewed health and vitality is one of many, thanks to the Abbott heart valve. The lives of 40,000 newborns a year will be dramatically affected now that the FDA has approved the valve. To read more heart-warming stories about how the Abbott heart valve is saving lives, please visit Mended Hearts.

Disclosure: While Abbott's PR company is one of eMaxHealth's occasional sponsors, the reporter had complete editorial freedom covering this story.