Looking through the Loupes: An End User's Perspective

Scott Pantel  0:01  

All right, I'm really excited about our next presentation and all the incredible presentations this morning, really terrific. Our next guest is going to do something really special for us and give us a unique perspective. And it's, I believe, totally appropriate that we do it at this stage of the event. We talked, we've talked a lot over the last three days about finance and technology. And we've heard from all these incredible innovators. And often we don't get the clinical perspective on how we see things actually translating into the front lines. And I think that it's one of the areas that we need to spend more time unpacking. And so today, it's a pleasure to have somebody that's out there on the frontlines who understands technology is working with some very innovative companies and also has a really unique perspective. So it's my pleasure to bring up Dr. David Joyce, David, please join us. David is associate professor at the Medical College of Wisconsin has a background with mayo, Stanford, Johns Hopkins. He was born and raised in the Twin Cities, and I think Welcome, welcome the weather a bit. But we'll probably be happy to go home to his hometown. He is his father was a cardiac surgeon at the Minneapolis Heart Institute. He graduated from the United States Air Force Academy, Harvard Medical School, and then went on to complete his residency at Johns Hopkins and fellowship at Stanford. Let's really get dialed in here today, we're looking forward to having you unpack things, and maybe tell us what we're missing and where some unmet needs are David?

David Joyce  1:39  

Well, I'd really like to thank Scott and Rebecca and the entire LSI family for inviting me to the party today. And this week, it it feels a little bit like when I was a kid, and I got to go over to my best friend's house to play, except that it's 800 of my new best friends, and they've got a better backyard than anything we had growing up in Minnesota. So later today, if you know, when my parents have to come pick me up, if you see a meltdown over in the lobby, you'll know what that's all about. So let's see here. There we go. Make sure this clicker is working.

David Joyce (2:13)

Oh, sorry, there we go. So I really just have one goal today. And that is to, I mean, everybody that is in this room, is working inside of one of the most complicated and difficult ecosystems that that there is when it comes to developing new products. And I think for all of us, there, there are some very difficult days that we go through there's, there's challenges that are unique to this industry. And it can become very discouraging. And I think what I really hope to accomplish today is to just remind everyone of what it's all about, and the lives that are changed on the other end of this. And I've had a very unique experience as a cardiac surgeon, to be able to have a patient come and visit me with a problem that probably many people wouldn't be able to solve. But if I've had the opportunity to work with early stage companies like the ones we've seen here, sometimes I can find an answer to a problem that nobody else could think of. And it's I have to tell you, it's so exciting to be able to do that and save someone's life. And so in addition to that part of my unlike a lot of people who specialize in one small little area of cardiac surgery, I've been blessed with opportunities to go and treat a whole range of diseases. So we're going to talk a little bit about technologies that I've personally used in lots of different things that can go wrong with the heart, and some of the things that can go wrong or heart rhythm disorders and the electrical system that allows the heart to contract regularly. Some of the problems that I've had to face have to do with structural problems with the heart most commonly valvular disease. And obviously, heart failure when the when the muscle doesn't work anymore, we've we've had to wrestle with that problem, too. Along the years. Even when the hearts working well, the blood vessels that supply, the blood of the body sometimes can fail. And so we've had a lot of challenges over the years in managing that problem. And then of course, the biggest problem of all the blood supply to the heart is the failure mode for just about everybody who gets into trouble. And so that has been quite a journey in terms of understanding how to manage that. So let's start by going back to the very beginning of my specialty of cardiac surgery, march 26 1954, at the Variety Club hospital at the University of Minnesota in Minneapolis. And there was a baby that had just been born, had a hole in his heart called a ventricular septal defect. And at that time, we didn't have anything to be able to treat that problem. So this this baby was not going to be able to make it to his next birthday. And so, at that time, one of the most innovative and disruptive individuals and our entire really our founder as as cardiac surgeons was a man by the name of Walt Lilla high and Lulu high came up with one of the most brilliant and creative solutions to this problem. 

David Joyce (5:00)

The heart lung machine technology hadn't really quite picked up at that point it was getting there. But it wasn't quite ready for primetime. And we didn't have a lot of the other technologies that kind of go along with that to be able to be successful. So what little I came up with was the idea that we could use this baby's father, to provide the heart the oxygenated blood to the patient, while Lilla hai worked inside the heart and fix the hole inside the heart. And for 19 minutes, Dr. Lulu Hi sewed that whole shut and save that patient's life. And he actually went on to do that 45 more times over the next year, with very impressive results. And so you can just imagine that this ushered in a brand new era, by 1955, actually, now the heart lung machine was starting to take the improvements that we were seeing in that technology were allowing this to be done and more and more patients. And another element started to come into play, which you know, sometimes we don't like to think about, but let's face it, it's a really important part of, of our success is that there was a competitor down in Rochester, Minnesota, there was a guy named John Kirkland, who wanted to get in on this game. And for a brief period, the only two places in the world that you could have open heart surgery were about 90 miles apart in Minnesota. And so they those two programs went head to head. And really, I think the rest is history. But one of the big problems and the biggest reason that they had mortality in the early days of open heart surgery had to do with this problem of rhythm and losing the conduction system. When we fix a defect inside the heart, the electrical conduction system sits right next to where we have to put those sutures. And so it's very common that you can end up with heart block. And those days, that was a that was a life threatening problem. And so early on everyone recognize this, but it really really became a crisis on Halloween night of all things in 1957, when there was a power outage at the hospital. And unfortunately, one of the babies died because they couldn't get the electrical impulse delivered to their heart. So this obviously, accelerated the need for a wearable pacemaker. And so what Lulu hai did was he went to his good friend, the electrical engineer, Earl Bakken, and he asked her Obachan to, you know, see what you can come up with. So Bakken goes to his garage, 800 square foot garage, and Minneapolis, sits down with sketches, some things down on the back of an envelope, and on some grocery bags, picks up a pop, Popular Electronics Magazine that he had. And he finds a circuit diagram for a metronome. And he starts working on it. Four weeks later, he brings the first prototype to Lilla, high and he says, I just want you to look at this, you know, I just want to see what you think about this is this something that might solve our problem. And then I'll go back, and I'll keep working on it. And I'll bring you something a little better. The next day, Bocking came back to the hospital. And there's already a patient on the first device. And so I think we all kind of know the rest of the story when Medtronic was born. But what we what we may not know about the Medtronic story is that it wasn't always, it just being the first mover in this market didn't result in immediate success. In fact, their first year, they made a total of $8 in revenue. And so by 1967, they'd already been through two bankruptcy filings. And it was at that point that Bakken made probably one of the most important decisions in his entire tenure at Medtronic, which is that he hired an individual by the name of Manny villafana, to direct the sales in the international markets. And so Manny then went down to mostly in Latin America, and did what he has now. And I can tell you from personal experience, he continues to even do this 55 years later. And this is so critical, because whatever product you're working on whatever company you're focused on, you have to remember this key element of success. Man, he would go into the operating room, he would spend time with the surgeons spend time with the cardiologists, understanding all the challenges that everyone was going through. He's part of the operating room team. And it was just the same way back in Argentina 55 years ago as it is today. And of course, when he did that, one of the first things he figured out was that they had some problems with the technology. Most importantly, these pacemakers weren't lasting very long. And that was a huge problem. So he started thinking about it and came up with the idea for a lithium battery, which was completely I mean, now it just seems obvious, everybody's using lithium batteries for everything. But at that time, nobody, nobody thought that would work. Well, he founded CPI in 1971. And it obviously worked pretty well. And at that point, we had a complete new way of approaching this problem in the in the heart rhythm industry. Well, obviously pacemakers have come a long way. When you look at the evolution that's happened over the past several decades, it's remarkable to think about where we've come from those very early days. But what I find the most interesting about today's technology is not the electrical impulse that's being delivered to the heart to allow it to contract in a coordinated way. But it's actually the information that's coming back in the other direction. 

David Joyce (9:55)

Our modern version of pacemakers can give us a new window into the heart in terms of how The rhythm is coordinated how it's working. Even things like activity levels, we can monitor now on our patients. And I think that the ability when we think about modern computing and artificial intelligence, I think that that information that we're getting back is going to be really important in the next 10 years in terms of new devices and new approaches to monitoring people's hearts. But it's not just pacemakers, that are bringing all that new data into our world as clinicians. Most of us today are wearing on our wrist a device that in the Apple Heart Study was found to be 84% accurate when your watch said that you had an irregular rhythm 84% of the time, it was atrial fibrillation when we went and checked it out on an EKG. So to think about the fact that this is just a object that we've taken for granted all these years, and now all of a sudden, we're starting to get these amazing new insights. But it doesn't really help us to be able to know that you have atrial fibrillation, unless we have a way to treat it. And that actually has proved to be a very difficult challenge. All these people walking around with atrial fibrillation, and the options for treating it historically haven't been that great relative to other things that we've we've been able to solve very effectively. Well, about five years ago, at the Medical College of Wisconsin, I had the opportunity to lead a team with a very new approach to to how we tackle atrial fibrillation. And again, I think this is really important to remember, because as you're thinking about new products, and you're thinking about who the end users are, don't forget about the fact that the end user isn't a person anymore. It's a team. And so what we've done at the Medical College is we've put together a team of actually two different surgical specialties. We've got a robotic thoracic surgeon who does nothing but sit at the console all day, a cardiac surgeon who can handle anything that you have to deal with going on with a heart, and then an electrophysiology team that can do the mapping and figure out you know, where things are going wrong. And they're kind of the brains behind the operation in terms of how to fix it. So what we do is you can see here, the, the surgical team will come in, and basically carpet bomb the backside of the left atrium, take out all those electrical aberrant currents. And then later on, we'll use the robot to put a clip around, that's the left atrial appendage you see there in that video, and we're getting ready to occlude that, because that's where all the clots form and cause strokes. And then later on, we'll bring them over to the cath lab and the EP doctors will go in and kind of precision bomb all the areas if there's anything that we missed in the operating room. And we've been very, very effective and very safe to when you do it that way, because you've got all the experts there. Now, you guys are gonna think I'm making this up. But I didn't come up with a name for this procedure, but it is literally called the convergent procedure. So I think that kind of really helps us appreciate how convergence occurs even in even in the operating room. Well, if rhythm disorders were the first wave of disruptive device technologies, there's no question that the second wave occurred with the treatment of valvular heart disease. And so if we take it back all the way to 1952, with the early Hufnagel valve, we had people tinkering around with some very intriguing ideas and designs. Those then evolved into these ball and cage valves that we had in the 1960s. And eventually, people developed a tilting disc valve like the Bjork Shiley valve that became kind of the industry standard. Meanwhile, there was this other idea that maybe we should try to use tissue valves and try to avoid the anticoagulation. So we had some of the early porcine valves and then bovine pericardial tissue valves, and of course in 1977, that I think was really the moment where the whole field sort of went into high gear with the introduction of the St. Jude valve the by leaflet prosthesis. And then of course, we had the pericardial valves, the open pivot design, which is now kind of the standard for, for mechanical valves. And then with the tissue side of the equation, we started trying to figure out ways to be basically not even have to put sutures in and so I think we're all familiar with, with where that took us in terms of the transcatheter market. And I can just tell you, as a clinician, the significance of this is not just not just the growth and the potential of the market and things like that, but it's in the past, I mean, aortic stenosis, if you have severe aortic stenosis, and you're short of breath, you've got two years to live. And so that I mean, that's worse than having some some of the worst cancers. But it used to be that to treat that you had to have your chest cracked open, and you had to go on the heart lung machine, and it was five days in the hospital. So with these new technologies, in the past, you would have had to basically exclude anybody, I mean, maybe 85, you might think about going to the operating room, but after that, you know, it's probably just too high risk and not enough benefit for an older patient. Well, I can tell you that my grandmother is about to celebrate her 100th birthday this September, and two years ago, she had one of these valves put in and I'll tell you, it's not just about making your heart better, she can eat a little more salt in her diet. Now she can get around and exercise a little more and it actually really improves your quality of life for people that in the past would have just been left To You know, left to die, basically. But when we think about all that progress that's been made in the valve industry, I want you to take a step back and think what would have happened in 1976? If Manny had just said, You know what everybody's saying, it's never gonna work. You know, they're probably right, let's it's too much. It's too new, let's let's, let's not go that direction. We're doing great with the pacemakers. Let's let's not even approach that market. I mean, if he just said that, not only would we I don't think we would have any of the current devices, we wouldn't have had the field of valvular disease evolve the way that it has. But even St. Jude Medical, I mean, think about all the things that have happened, just because St. St. Jude Medical existed, I mean, through a series of acquisitions of some really important companies that have done treatments for things like heart failure, and other other even beyond cardiovascular, you know, we've been able to advance multiple different fields just just because of the fact that there was a St. Jude and of course, in 2017, even St. Jude was acquired for $30 billion by Abbott. So let's talk for just a minute now about what happens when you know, maybe we've tried a few of these other things. We've tried valvular surgery, we've tried some of these rhythm treatments. And maybe despite that somebody has gone into heart failure, and their muscle just doesn't squeeze anymore. 

David Joyce (16:15)

Well, when we look at the history of innovation in the treatment of heart failure, to me, that story starts on December 2 of 1982. And in 1982, there was a dentist from Seattle by the name of Barney Clark. And he was suffering from a really severe case of heart failure. He had all these a arrhythmias that were impossible to treat. And it's 61 years old, he was actually too old for a heart transplant. And you know, we did a 74 year old about a year ago. And actually, we've transplanted a patient off of a total artificial heart over the age of 70. And our practice, but in 1982, I mean, Barney had been turned down by three programs, including Stanford, and it just was not an option at that point. So he came over to the University of Utah where they had this new device that you see here that called the Jarvik seven, it was actually invented by the same person who came up with the idea for dialysis willing cough. And at that point, they had a bunch of cows running around in the barn with these devices. And so Barney went to check out the the animals and see how they were doing. And he thought about it, went back home, because he thought, you know, this isn't, I'm not sure I'm quite ready for this yet. But by Thanksgiving weekend, he was really at the end of his life. And then it was to the point where they couldn't do anything to stop as a rhythm is and he had to go emergently to the operating room. At that time, he had to sign an 11 Page consent form. And it had to be signed two days apart, just to make sure that he knew what he was getting himself in for. And so on that day, the two surgeons you see here on the on the right is Dr. William degrees, and on the left is actually my father, Dr. Lyle Joyce. So they performed the very first permanent implant of a total artificial heart. And that was a very exciting time. I mean, it was, it was really a big, big move for the entire field of cardiac surgery. And one thing I do want to point out is that that pump, actually, you know, just in case, you're worried that the new technology we're working on might not have a lot of staying power, we say that is the only approved pump, and it's a great pump, we still use it today, I've gotten to implant a whole bunch of those working together with my father and a bunch of patients saved a bunch of lives. So and actually, we have Honeywell here with us today who is now acquired SynCardia. And they're working on some cool new drivers for us to use, it'll get even better outcomes with that device. So it's kind of exciting to think about the fact that even something that's been around for that long is still a real big part of our armament armamentarium. Well, this shows you, we went to visit Barney, that's me in the bowl cut there on the right, we went to visit him over over the Christmas holiday and and he lived for 112 days. Ultimately, he ended up dying from an infection that we didn't have a name for back then. But we call it C Diff colitis now, and it's usually a complication of being on a lot of antibiotics. And so you know, it was maybe not the super success story that we all dreamed of. But what it did do is it launched an entire field of mechanical circulatory support. And the reason that's so important is because if you have end stage heart failure, again, it's one of these diagnoses that you need to be able to make it out to two years is a huge long shot. And so even with the earliest generation, the Model T of left ventricular assist devices, the HeartMate x v was the first one that we studied in a randomized trial in 2001. And there's a 48% reduction in mortality over two years just by putting in one of these clunkers? Well, of course, you better believe that device technology improved over the years. And by the time we have the HeartMate two now all of a sudden, we could keep people out 10 years or more on one of these. And then in the most recent randomized study that compared the HeartMate two with the current generation of technology, the HeartMate three we actually have two years survival now with a met with a mechanical pump that is as good or maybe even a little better than a heart transplant. So that's that's how far we've come in and just you know, a few a few decades so So we do still have problems with these devices. And one of the challenges that we have is that they can form clots inside the blood pump. And one of the advantages of working in an academic medical center is that I get to try to help solve these problems in the in the research lab, in addition to as a clinician on the front lines. And so here you can see a device that we came up with that it's a catheter system, where we can use a percutaneous access from the groins, to deploy these balloons inside the LVAD itself through the outflow graft in the inflow chamber. And once we inflate those balloons, now we've basically isolated the pump chamber of the LVAD from the rest of the circulation. And so by doing that, now, we can blast it with as much lytic therapy as you want to use without having to worry that those drugs are going to go to the brain where we know, if we try to just inject it into an IV, we're going to have a fatal stroke. So that has given us a new way to try to approach this short of a device Exchange, which is a really invasive, really risky and expensive procedure that is currently the only standard that we have for managing LVAD thrombosis. One of the other things that's kind of interesting about this, we had a competitor when we first started working with this product, and this design you see here is really his design. But in the meantime, we were trying to think about well, what about all that stuff that's getting flushed out of there. 

David Joyce (21:15)

So we were at the Mayo Clinic, we were working on this embolic protection net. And so we had we were developing that were out while our engineer competitor was developing the balloon system. And you know, we get along with each other really well. So at one point, we just kind of sat down and it was kind of like the you know, you put your chocolate in my peanut butter moment where we said, Why are we competing with each other, let's just form our own company. And we'll build all this stuff on the same catheter, and then we'll we'll be in great shape. So obviously, transcatheter approaches are disrupting this field. And a lot of other ways to actually this is the impella five five device, which is a, it's the smallest heart pump that exists. And as you can see, this thing goes in just through a tiny little incision on your collarbone, and we can advance a wire down into the left ventricle, where this device can suck the blood out and pump it to the rest of the circulation. And that's a big deal. Because this is p this is for people that are basically at the end of the rope. I mean, they're in cardiogenic shock, they're not going to be able to survive minutes without some solution. And this device can even recover their heart function. Well transplantation has been sort of I mean that we've had that for over 50 years. And it kind of took a long time before we really started seeing device technology disrupt that field. But even in the last couple of years, we've even seen how that has happened where here you can see the trans medics device, this is the organ care system, it's just like a heart in the box. But what this thing does is it allows the heart to be perfused with oxygenated blood. During the critical period, when you have procured the organ out of the donor hospital, we've gone as far as Hawaii for lungs on these devices, and then brought it back to wherever your transplanting center is. And during that entire interval, you're not starving the heart of oxygen, which is the biggest risk factor for a heart transplant patient. So these these kinds of technologies are absolutely changing our ability and expanding the donor pool for people that are in the end stages of heart failure. Well, let's pivot for a moment and talk a little bit about you know, even when the hearts working well, there's still a lot of big problems that we run into as cardiac surgeons that have to do with the great vessels and particularly the aorta. And one of the we can't talk about aortic disease without talking about the ultimate pioneer in this field, the father of vascular surgery. And one of the big leaders in early cardiac surgery is a guy by the name of Michael DeBakey. DeBakey has obviously been an influential figure in our family. My dad, this is my dad on the on the left graduating from medical school is even as an undergraduate, he was sneaking into Debakey his lab to see what was going on with the latest blood pumps that Debakey was working on. And then when I was in residency, I had an opportunity to go down and spend two years with Debakey down in Houston with the current generation of a blood pump that at that time, which was interestingly a product that they developed jointly with NASA because the the NASA engineers had some some tricks that we hadn't thought of in the medical device industry. So Debakey is probably best known for his classification system of aortic dissection, which is a disease that can basically shred the aorta, if somebody's got high blood pressure, or they've got a genetic mutation that causes their aorta to be weak, that can tear the inner layer of the aorta, and it just rips the entire vessel all the way down, sometimes even into the legs and up into the brain. And if that happens to you, you have a 1% per hour mortality rate. So it's the worst thing that you could have going into the ER, and your only chance of surviving that is for a surgeon to be able to go in and replace that aorta where it's diseased right by the heart. And so, you know, you can imagine in the very early days, we didn't have anything to treat that. And so but if we could replace that aorta if we could come up with some kind of a prosthetic material that we could replace it with that that might actually work pretty well. And so this is where debate He started thinking about, you know, well, gosh, we use, we use nylon a lot. I mean, we use these nylon sutures. So we know that the nylon seems to be pretty well tolerated by the body. What if, what if I literally just go down to the fabric store and buy some nylon and make something on my wife's sewing machine? I mean, let's see if it works, you know, you could do that kind of stuff back then. And so he goes to the fabric store, and sure enough, they're fresh out of nylon. So the person the clerk at the store brings out this other fabric called dacron. And he said, Well, I don't know, try this, what do you think, would this work? And he feels it, and he thinks about it? And he says, Yeah, you know, let's, let's give that a try. And I can tell you guys that there are there are probably more dacron grafts inside of human beings. 

David Joyce (25:41)

You know, if you go to the airport later, probably that you're gonna, you're gonna see a few people there that you know, still to this day, that is kind of the gold standard and how we replace diseased arteries inside the body. And of course, it didn't take long before people figured out that if we could deploy these inside of a stent graft so that we don't have to make a big incision, you know, that that obviously became kind of the next wave of evolution in the treatment of aortic diseases. And here on the right, you can see one of my mentors, interventional radiologists by the name of Mike dake, who performed the very first thoracic endovascular aneurysm repair using this type of technology. And I wanted to mention Dr. dake. Because, you know, even in the cradle of innovation in Silicon Valley, one of the things I remember about him was that he was such a happy warrior when it came to doing new things and coming up with new ideas and implementing new strategies. But, you know, we like to tell the stories about the first Jarvik and the cross circulation, like it was just, Oh, everybody was celebrating them. And there was they never had any pushback. Nobody ever said they were crazy. But I think we all know that that's, that's not the way the real world works. And I mean, just as all of you have, probably have your battle scars to show for what you know, what you've been through in this in the development of these devices. That's, that's true for us too. And I can tell you, as somebody who tends to be a little bit too far on the leading edge, sometimes there's there's a lot of people that are looking to take shots at you. And I always remember how Dr. dake really modeled, you know how to how to handle that with with poise and confidence. And, and I think for each of us, as we're interacting with our our physician colleagues, you know, don't forget that your encouragement actually makes a big difference in terms of them being on the frontlines and trying to help patients that don't have any other options. All right, well, we can't end this talk without talking about the big elephant in the room, which is the disease that affects more people than any other problem that we see in medicine. And that's ischemic heart disease, when the blood supply to the heart is affected by coronary artery disease. Now, I'm sure that for a lot of us, maybe you're working on some new product, and it feels like, gosh, it's been five years and we haven't really made as much progress as we were expecting, we thought we're gonna go to market by 2023. And that's not going to happen. Well, let me just remind everyone that solving this problem of coronary artery disease goes back to about 1818, when we first came up with the diagnosis of angina pectoris, to describe people with chest pain. And it was actually all the way back in 1844, that we were already talking about the idea of a cath lab. So just kind of get your mind around how long it has taken us to make any progress in the field of managing coronary disease, we first recognize that you could actually have a heart attack and have a cardiac infarct in 1876. 

David Joyce (28:32)

As early as 1910, you already had Carell starting to think about doing a coronary bypass operation. So that mean, just think how long it took for any of this stuff to really come into the real world. 1929 Forsman was a surgeon who performed the very first human cardiac catheterization on himself. And then by the time we got to 1950, now we've got, you know, surgeons getting a little bit more aggressive with things like rerouting the internal mammary artery. Of course, given bringing out the heart lung machine in 1953, was a game changer for everything in cardiac surgery, including coronary artery disease. And of course, by 57, we were now coming up with all kinds of clever ways as surgeons to fix this. But just as on the top, I'm going to show you what was going on in the operating room, it became an arms race. And so then on the on the bottom side of the screen, you're gonna start seeing some of the things that were going on in the cath lab. And we were really, again, that idea that, you know, competition is not necessarily a bad thing, it really helps us to get there a little faster, I think, because, because by the 50s, now, things are really starting to accelerate. We've now got diagnostic coronary angiograms, we've got the first real saphenous vein graft used in the coronary circulation and 62. We've got angioplasty and 64, which is now being perfected as a transfemoral approach. And then we all recognize kind of 1968 as the big year where we had kind of the first successful bypass surgery at the Cleveland Clinic. And then by 77, we're doing PTC A's We have our first coronary stent in 1986. And then by 1994, we have our first FDA approved stent, I'm just going to stop and let you insert your own regulatory joke there, that's fine. And then by 1996, we've got all kinds of new crazy surgical techniques that are being introduced. And some of them work. Some of them don't. We're doing minimally invasive type approaches. But despite the fact that this disease has been studied more exclusively than any other medical condition, and you can just see the number of patients here that have been enrolled, and really well conducted multicenter randomized trials, we have more questions than we have answers about how to fix this problem. I mean, just on the on the basis of bypass surgery alone, we as surgeons can't even decide which side of the table you should stand on, or which incision, you should make sure to be a sternotomy or some less invasive thing. Should we use the heart lung machine or not? That seems like a big question. We're still arguing about that. When you go to our meetings, if we're going to position the heart, I mean, do we use one of these fancy devices? Or should we just get a human hand to hold it? If we're going to arrest the heart? Because we know we got to protect the heart? If we're going to if we're going to stop the heart? You know, how are we going to do that? We're going to go antegrade retrograde, what solution are we going to use? Should it be warm? Should it be cold should be kept Good? Are we going to give down the graphs? Or is that going to injure the graphs? I don't know nobody can agree. How are we going to so those those graphs onto the heart? Should we use a continuous suture and interrupted suture? Are we going to shut the coronary if we're going to do it off pumper? So we just like it it and see what happens. What about when we're doing this proximal? Should I mean, is it gonna increase the risk of stroke? If we if we use a side bite or clamp? I don't know, nobody can decide. How many grafts should we do? I mean, we know that it's three vessel disease. But what about that little diagonal? In the second om? I mean, do we need to graph those? I mean, can anybody decide like, that's a lot of extra surgery? Who knows? Okay, now let's talk about conduit, you really want to get people going, we can even argue over whether artery or vein, we can't even decide on that. 

David Joyce (32:00)

And if we're going to take an artery, we don't know whether the radio is better or the internal manner. And we know there's risks with both of those. So we can agree on that. Let's just say we've agreed finally that we are going to take some vein, we can't even agree on whether you should take the vein out with a scope or whether you should fillet open the leg, there's people that are very bitterly divided on both sides of those debates, and how you take the artery down if you're going to use an artery, how you how you close the chest. I mean, this is kind of one of my favorites, because I pretty open about sharing the fact that a whole lot of what I learned came from having the incredible privilege of, of being mentored by a guy named Lyle Joyce all these years. But you know, there are a few things that we do disagree on. So even even surgeons in the same family don't agree on what how you should put your wires into close to the chest. So that just goes to show you how hard this can be. So anyway, as we as we look at all these unanswered questions, one of the reasons that I think that even when we do really well conducted randomized trials that we can't figure it out, is because it's not like given a red pill and a blue pill to 1000 patients in each arm. There's huge variability in a surgical technique, especially a coronary bypass grafting technique. And so to be able to try to standardize that, with one group getting one treatment, and another group getting another treatment is I just don't think you can do it. Or at least I don't think it's been easy to do in the past. Now, when we talk about conduit especially, you know, I've already mentioned kind of the different approaches that people are using. But one thing that I do think is going to be a game changer for us is that I think for the first time, and you guys have already heard about it this week, we are now going to have one type of conduit that is a standard across the entire industry. So I think for the first time, we're going to actually have a very reasonable chance to be able to definitively say that this, this approach is going to work better than whatever our other strategy is that we want to argue over. Because it's coming out of the same box, there's no, there's not a lot of variability and how you kind of peel the the sterile packaging off. 

David Joyce (33:58)

So I'm really excited as an advisor, medical 21, to see for the first time that we can take this great science that's being done and really apply it to a surgical setting. Well, I started our conversation today, defining myself as an end user. And I think it just goes to show you how complex this ecosystem is, when even the labels we use to try to talk about ourselves are very confusing. I mean, who really is the payer? Who's the customer? Am I the champion? Or am I the end user? Or am I the What am I I mean, it's very hard to even answered those basic questions about the market. Sometimes we might look at it and say that will the real end user is the patient. And so just in case you were worried that that I was providing a perspective that is maybe one sided as a health care provider, I just wanted to also show share a personal story is that even as a patient I have greatly benefited from these incredible technologies that have come down the pipeline. When I was a cadet at the Air Force Academy and my senior year, I was diagnosed with type one diabetes So at that time, the technology that we had for treating that was called a syringe. And it evolved, of course, over when I became a medical student, we had our first insulin pumps. When I became a resident, we had continuous glucose monitoring. And of course, when I got out into practice, now we have a closed loop system with artificial intelligence that can do a better job than I've ever been able to do at regulating blood sugar. And you know that that is obviously it's made a huge difference in my life. But it's also allowed me to be more confident and able to do things in my life and treating other patients that would have been very difficult and potentially at risk to me if I didn't have if I weren't able to stand on the shoulders of the people who developed these amazing technologies. So I'm going to stop there. I'd be more than happy to chat with everyone offline. You've got my email here. If you want to call me later on. I'd love to hear more about all the exciting things that you guys are doing and look forward to coming back next year. Thanks, guys.