Hope for Young Patients: World’s Smallest & Mechanical Heart Valve [transcript][audio]

Guests: Dr. Jonathan Chen & Lee’or Rutenberg

Presenter: Tabetha Moreto

Guests Bio: Dr. Jonathan Michael Chen is the Chief of Congenital Cardiac Surgery and Co-Director of the Heart Center and also the Samuel and Althea Stroum Endowed Chair in Pediatric Cardiovascular Surgery. As chief of pediatric cardiovascular surgery and co-director of the Seattle Children’s Heart Center, Dr. Chen oversees a team that performs more than 500 surgeries a year, and is the largest of its kind in the Pacific Northwest. Dr. Chen has performed more than 150 heart transplants and is Chair of the Membership and Professional Standards Committee for the United Network for Organ Sharing (UNOS), the group that oversees all solid organ transplantation in the United States. The author of more than 120 papers and 25 book chapters, Dr. Chen’s research interests lie in developing ventricular assist devices for infants and children suffering from heart failure.

Lee’or Rutenberg is the father of Sadie Rutenberg who was born with heart problems. Sadie became the first patient to receive a pediatric heart valve as part of a HALO clinical trial, which enrolled pediatric patients five years of age or younger with a diseased, damaged,or malfunctioning heart valve across the U.S.

Segment Overview: In today’s interview, Dr. Jonathan Chen and Lee’or Rutenberg come together on the show to talk about FDA approving the world’s smallest and only mechanical heart valve designed for newborns and infants with heart defects. They share their thoughts and experiences with the world’s smallest mechanical heart valve. In the case Lee’or’s daughter Sadie, she the first patient to receive a pediatric heart valve as part of a clinical trial.

Transcript

Tabetha Moreto: Hello everyone. Welcome to Health Professional Radio. I’m your host for today, Tabetha Moreto. Today, we have two guests joining us. They are Dr. Jonathan Chen and Lee’or Rutenberg. Dr. Chen is the Chief of Congenital Cardiac Surgery and Co-director of the Heart Center and Samuel and Althea Stroum Endowed Chair in Pediatric Cardiovascular Surgery. Lee’or is the father of Sadie Rutenberg who was born with heart problems and shares caregiving duties with his wife Wendy. Today, we’re going to talk about the FDA approving the world’s smallest and only mechanical heart valve designed for newborns and infants with heart defects. They are here to share their thoughts and experiences with the world’s smallest mechanical heart valve.

Dr. Jonathan Chen: So I’m here to talk a little bit about the Abbott 15 millimeter mechanical valve – it’s indications for the mitral valve but of course it can be used in aortic position also. And the valve was available to us previously on protocols and so to have it available in the operating room to several days because you’d have to get it through the IRB and then request the valve, etc. And the FDA’s approval of it a couple weeks ago means that we can have it off the shelf which is a big advance for us because this means in particular for emergencies, we have it available right there. Obviously, we have it available for kids on whom we intend to replace their valve and so we can do that operation whenever is indicated as supposed to waiting. And then potentially as important, as a backup for kids who would be undergoing high-risk mitral valve repairs and we’re doing more and more of those repairs recently meaning in the last, I’d say 5 to 10 years probably because we’re operating on more and more kids with complex heart disease these days that we might not have even operated on or who we might have even operated on maybe even 10 years ago. And so for those kids who are going to be on war for a high-risk might repair, you want to have some sort of a backup and so this valve affords us that opportunity. And before this, the only valve that we had were adult sized valve. So you’d have to wait for the kids to get big enough for their mitral annulus to get big enough to accept an adult sized valve and they’re not small. So a 17 valve, you’d probably have to wait until a baby was close to toddler age to accept a 17 valve. And there are other options but they’re all kind of taking adult prosthesis and taking our valve out of a conduit and all these things that are kind of off-label uses and I don’t think there’s either broad adoption of those techniques or endorsement to be honest. So it’s a big advance to have their Abbott valve for all these reasons. Otherwise, the kids and you’ll hear from Sadie’s dad, otherwise kids stay in the ICU for weeks, and weeks and weeks waiting for their annulus, their mitral annulus to get big enough for an adult sized prosthesis. So having us available to us means we can operate more expeditiously and get the kids sort of back on the road to recovery.

Lee’or Rutenberg: I think for Sadie we knew she had a heart defect before she was born but we had no idea that was going to take the kind of limping along in the ICU for that long in order for her just to get this repair. And she was born, we thought we’re gonna take her home and have our operation in a couple years to fix her defect and then would be a different story. And then we found out that we have to have this Abbott valve. It was one of those things where you kind of just focus on, “Alright, what’s the next stage to get her to the point where she can get that valve?”. And I guess what it kind is for most families is you don’t focus on the end, getting her that she’s 12, or 13 or whatever or how old but you focus on what’s the next step. How do we get her to, let’s say it’s seven pounds or how do we get her to eight pounds? And that’s the hard part there is no guideline. We’re breaking into kind of a territory where we make our best guess to see if we can get her the things that are going to help her along.

C: I see that it’s an amazing place in that way, the sort of small incremental steps that you need to make and there’s a time when they changed where I used to work in New York, they revised the floor plan of the neonatal ICU. And the important difference to me was that they put windows and giant windows and I said to the parents, “Some of the importance of that is that you get to see the sun like rise and set every day and you get this sense of time actually progressing because otherwise ICUs, you have no idea what’s going on.”. And you get very focused on these things like, “When is she going to get to be eight pounds?”. But if you take a step back and you have the sort of 30,000 foot view, you can see that she’s really making progress. She’s an example that I will say that progress thing. I use her story a lot to tell parents about the impact of having mitral valve competence and I described Sadie as she was so uncomfortable when her valve weak. I mean she was just inconsolable so much of the time. And almost a minute, she had a confident valve. It was like she was a completely different kid. It was like incredible.

L: It was amazing I mean and we spent those 7 months just trying to keep her comfortable and there wasn’t any recipe for what would one day, one thing would work, the next day, not necessarily so. And she was a moving target all the time but the people had children in the cardiac ICU were amazing. I mean if something stopped working, they were on it in a flash and we moved to something else and those are the things that you don’t necessarily have to worry about as a parent. All you have to worry about is just keeping her happy and you say, “Hey, she’s uncomfortable.” and everybody jumps to it. It’s amazing. You don’t have service like that at the home, that’s for sure.

C: I definitely underestimated. I mean we do the operations and we have the extraordinary satisfaction of watching kids get better. But I underestimated the day-to-day and so often as what I do is I’ll tell parents and you guys have been very kind to sort of say, “You should just talk parent to parent.”, like hear it from somebody who is really managing anticoagulation in infants and a toddler like, “What is it like to have to go to preschool like we’re talking about?” And that’s very important.

L: And I think as we move into a more, the internet age and the ability for people to reach out on Facebook and support groups like Mended Little Hearts and the James’ Foundation, these are all programs where I don’t know necessarily we would have reached out in that fashion 10 to 15 years ago. We would just kind of work for ourselves in a small groups that are in Seattle or locally not necessarily in the national level like we are now.

C: And I think as we get to understand things like what’s anticoagulation like in an infant as more and more kids get this was a much better idea of the sort of the boundaries and what’s appropriate and what’s not. We may look back on this time as the time of a real frameshift for our field in that way because just having a pediatric valve that’s available is really important. There’s obviously tons of questions I’m sure people will have about this. The best place obviously is abbott.com or these other family support groups that can help. I think patients and families understand that the valve itself and its indications for use.

T: And that was Dr. Jonathan Chen and Lee’or Rutenberg. If you like this interview, transcripts and archives are available at www.hpr.fm. We’re on all social media platforms. So don’t forget to follow, like and subscribe. Show us some love by subscribing to our HPR YouTube channel. We’re also available for download on SoundCloud and iTunes. I’m Tabetha Moreto and you’re listening to Health Professional Radio.

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