The World’s Smallest Mechanical Heart Valve Saves Lives [transcript] [audio]

Guests: Dr. Jonathan Michael Chen and Richard Olson   

Presenter: Neal Howard

Guest Bio:  

Richard Olson is Divisional Vice President of Product Development for Abbott Structural Heart. Richard is based in Plymouth, MN and has more than 20 years of experience in the cardiovascular field with product development focused on minimally invasive products for Interventional Cardiology and Cardiac Surgery. Previous to joining Abbott, Richard held management positions at Boston Scientific leading the R&D groups responsible for balloon catheters and stent delivery systems that were used to deliver both bare metal and drug eluting stents.

Jonathan Michael Chen, MD is 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. He is the author of more than 120 papers and 25 book chapters. His research interests lie in developing ventricular assist devices for infants and children suffering from heart failure. He has been a co-investigator in several research trials with the goal of improving the systems that act as a bridge to transplant, including a National Institutes of Health grant evaluating long-term mechanical ventricular assistance.

Segment Overview: Dr. Jonathan Michael Chen and Richard Olson discuss the newly FDA approved (March 2018) Abbott Masters HP™ 15mm rotatable mechanical heart valve, the world’s smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement.

Neal Howard: Thank you so much for joining us here on the program today. I’m your host Neal Howard here on Health Professional Radio. Our guests today are Dr. Jonathan Michael Chen, Chief of Pediatric Cardiovascular Surgery and Co-director of the Seattle Children’s Heart Center and Richard Olson, Divisional Vice President and Product Development for Abbott Structural Heart and they’re joining us here on the program to talk about the newly FDA-approved, Mechanical Heart Valve. Thank you both for joining us today. Let’s jump right in. Give us a little bit of background about yourself Dr. Chen.

Dr. Jonathan Michael Chen: I’m one of the co-directors as you said of the Heart Center at Seattle Children’s. I’m a congenital cardiac surgeon and the Chief of the congenital group at both the University of Washington and Seattle Children’s.

N: And Mr. Olson, yourself other than the Divisional Vice President there at Abbott?

Richard Olson: I’ve been with Abbott for 8 years focusing primarily on the structural heart business and so that mainly our valvular technologies as well as products that we have to treat congenital defects as well and I head up the product development group or a lot of people referred to as R&D as well.

N: Now this newly approved heart valve, I said it is the smallest of its kind.

R: Today, it is the world’s smallest mechanical heart valve that’s available and definitely had a pediatric indication but please Dr. Chen, fill in the gaps from your perspective.

C: I just want to say it is the smallest in terms of designated for children. There are other things, other valves you can use but you really kind of jury-rigging valve. You can take a valve out of conduit that’s not meant to be taken out of that and use them but it’s not recommended to someone. This is the first one that is this small where the indication is for pediatric application.

N: What about when a problem arises, is this something that can easily be addressed based on that size as opposed to using as you said kind of jury-rigged valves in the past in pediatrics?

C: So there are sort of two aspects in mechanical valve prosthesis for kids. One is there are some kids for whom we know before we do the operation on their mitral valve in this case, that the valve itself does not have the integrity to withstand really a very viable repair in which case we are going in specifically with the notion that we’re going to replace the valve. That is a very straightforward operation but you need to have a valve that’s the right size, meaning small enough for intent. The other indication which is probably, it’s sort of it’s more broad impact on our field is that there are lots of times we intend to do high risk or unpredictable mitral valve repairs in newborns and infants. And if we have a reasonable amount of uncertainty about how the valve repair will go, we often will not undertake them until the baby is big enough to have a backup, meaning that we know that should all things not go the right way and the valve repair is not adequate that we can backup and replace the valve. And currently, we wouldn’t undertake these kind of high-risk repairs unless we knew we had that backup and so without having a valve small enough like this, 15 millimeter master valve, we wouldn’t even undertake of our repair. So then kids will be sitting around in the ICU waiting to get there, going to get big enough for a bigger prosthesis. So that impact I think is pretty significant on our population.

N: How many kids would you say on average are going to benefit from this new valve? Are we talking a rare, a small amount or is this something that is going to benefit so many children who’s going to make a huge impact on this type of surgery overall?

C: Well I think, it’s a little hard, I don’t mean to be evasive. It’s so hard to estimate, I mean there are certainly that first camp of kids who need valve replacements just out of the gates. That number is, it’s modest, it’s not a huge epidemiologic impact but there are two other sort of moving parts to the denominator – one is what I was talking about which are kids for whom we would not currently undertake or previously undertake a high-risk repair, where now we would do that and some subset of them will end up with a valve replacement for sure. And the other moving part of the denominator is that if you compare the sort of cohort of kids who we’re operating on today versus those who operated on even say 15 years ago, the kids today, the newborns in particular tend to have more complex heart disease and tend to be smaller than the ones we are operating on 15 years ago. And that’s really just the advancement of technology and better newborn care to get the kids through where sometimes they wouldn’t survive in the past. And particularly, we see more and more kids these days who have what we say is “Borderline Valve Sizes” of both mitral valve and the aortic valve and all the other valves on the heart. And so increasingly, I think we’ll see that we’re going to be in a situation where we need to address mitral valve problems and kids who are small and that impact is going to be pretty significant.

R: From my perspective and Dr. Chen already hit on it, this is in a high volume product first. But in case, from our early estimates and things are very vulnerable, we’re talking about maybe 200 cases a year where they might use the 15 millimeter. It’s more about providing the access to a device of which we already had the technology from an adult perspective and really scaling it so that we can apply it for the children and even infants in this case to have this technology available to them which really can be life-saving and get them past it for the first few years and give them a chance at making it to adulthood.

N: Now this is the masters HP 15 millimeter rotatable mechanical heart valve. Where can we go online and learn some more about this?

R: Yes, you can go online to abbott.com and search for mechanical heart valves and this will show up within the website.

N: I thank both of you for chatting with us today Dr. Chen and Richard Olson. It’s been a pleasure.

C: Okay, great.

R: Thank You Neal.

N: Alright, thank you. You’ve been listening to Health Professional Radio. Transcripts and audio of the program are available at hpr.fm and healthprofessionalradio.com.au.

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