Russ: Hi, I’m Russ Capper and my guest today: Dr. Billy Cohn, renowned Cardiac Surgeon, Director of the Center for Device Innovation, holder of 90 patents, leader in the development of the Continuous Flow Implantable Artificial Heart, occasional trombone player and magician.  Billy, welcome to the show.

Billy: Thanks. Thanks for having me.

Russ: I would also want to say a champion of innovation, big time. Would you accept that?

Billy: Yeah, I think so. I’m passionate about my own innovative efforts and do everything I can to help others.

Russ: It’s really cool that you’re the director now of the Device Center at JLABS. It made me want to go back and look when you first started really getting interested in innovation. I saw you speak recently and you showed your first innovation that involved a spoon. Share that with us.

Billy: I was very fortunate. You know, to become a heart surgeon, you train year, after year, after year, after year. I did that in Houston, Texas, which is sort of the epicenter of heart surgeons in the era that I trained. I was surrounded by giants in heart surgery who were very innovative, who developed a lot of the technology that we take for granted today. It was so inspiring for me, and I admired them so much, of course, I wanted to be like them. Especially because there were some real great examples of these monumentally impactful innovations that had such humble beginnings. When you actually backed it to it’s origins, to it’s headwaters, if you will, the first thing they did was so simple. It was within the abilities of all of us. I thought I could perhaps be like that, I could do that kind of work, and so I aspired to.

Billy: The spoon thing was just the first stabilizers to hold the heart still so you didn’t have to stop it during bypass surgery. I went and watched one, I immediately recognized some of the shortcomings of the current technology, as did everybody in the room. It wasn’t a strike of brilliance, but everybody else said, yeah, this is challenging. Where I said, I bet there’s ways where I can make it less challenging. And that became a successful product, and that sort of forged the rails on which my life has traveled for the last 25 years.

Russ: Describe the innovation of that spoon that you used to hold the heart.

Billy: One of the operations that I was doing a lot of was coronary bypass. In coronary bypass we take veins from the legs, or an artery from the back of the breastbone and use it as plumbing to bypass blockage in the arteries on the surface of the heart.  Since the heart is doing this, it’s moving all the time, your heart is beating 80 times a minute, 42 million times a year, and these arteries are about as big as the handle of a lollipop, they’re really small and the walls are very thin. To put precise stitches in them, everything has got to be very motionless and there can’t be a lot of blood around. For example, we’ll make a slit in the artery about a quarter of an inch long, and around that slit we will put sixteen little stitches. The thread we use is almost so small that you can’t see it with your naked eyes. We wear big telescopes on our eyes.

Billy: So, historically, we would put tubes and hoses into the different chambers of the heart, suck blood out of the patient, put it through a machine that pressurized it, added oxygen, took out the carbon dioxide, filtered it, and then pumped it back to the patient through a second tube. That allowed us to clamp off the heart, pack it in ice so that everything was nice and motionless. It’s like operating on something from your grocer’s freezer, it just sat there.  That was great, but we realized that the risk of putting the tubes and hoses in, and more importantly the risk of having your blood go through all those plastic hoses and machines was considerable, especially in old, sick patients. For example, you’re healthy. If I put you on the heart-lung machine for an hour and did an operation on you, at the end of that hour you’d weigh 20 pounds more than you do right now. It would all be water. All of your blood vessels start to leak, the water goes in your muscles, in your face, in your arms and legs. That’s ok, you’re healthy. Over the next two days, you would urinate it out. But if you’re really sick, if your liver was just hanging in there, if you had some early, organic brain disease, if your lungs were just hanging in there, your kidneys, that swelling, that water can finish them off. So, we started realizing there’s an opportunity to come up with a way to do bypass surgery with a heart still beating that might be safer.

People had started doing it any my Chief said, ‘Billy, why don’t you go down and check out how they do this? This could be very interesting.’ I thought, great, my first innovative effort. I went to Johns Hopkins and watched this guy doing the operation. He had a second heart surgeon there and that heart surgeon had a two-pronged fork, and he mashed down on the surface of the heart to hold it still. The rest of the heart is lurching around, but right between the two prongs of his fork it was pretty still. If he mashed down too hard, the heart couldn’t fill between beats and the anesthesiologist would say, ‘let up, let up, let up,’ because the blood pressure would start going down. If he let up too much the heart would slip out and the surgeon had to stop operating, reposition and say, ‘You ok? Alright, let’s go.’

So, it took three times as long to do the sewing, his assistant was working even harder than he was, it was very stressful. At the end of the operation I said, ‘Congratulations, that’s really amazing, but it looks like your assistant has a really hard job. He goes, ‘Yeah, I’m glad I’ve got Duke here.’ He was a famous heart surgeon that was assisting him that day, and he said, ‘I’m glad I’ve got Duke here to help me.’ And I said, ‘Why don’t they make it so the spoon just sort of, the stabilizer, the little fork thing, locks into position so that you can get it just right and it’ll be, it’ll hold stiller than your assistant could.’ He said, ‘I’m sure somebody is working on that.’ I said, ‘I guess it’s me.’

So, I’d never made anything, I’d never even done any animal work at that point; I was just launching my career. I found out we had an animal facility at the Beth Israel Deaconess. I didn’t have a machine shop, we were living in the North End in an apartment building (Russ: In Boston.), in Boston, yeah, I was on the faculty at Harvard Medical School. And so, I envisioned something that sort of looked like a flattened spoon. So, I thought, that’s a good place to start. I went and bought spoons, I would draw on them with a sharpie marker with the pattern I had in my head with different features that would conspire to make the thing work, and then cut them out with a Dremel, a little motor tool, or a hacksaw and file them, and take them down to the first floor of our apartment building where there was a concrete floor, so I could bash them with a hammer and then I would bring them into work the next day.

There was an animal lab where researchers were doing animal work where at the end of the experiment the animals were euthanized. I’d say, ‘Can I try this on them before you do that?’ They said sure. Sometimes the device would fail miserably, and I’d be sprayed with blood, or it would cut through the tapes, or it wouldn’t work for one reason or another. Sometimes it would sort of work, and then with iterations I got it working very well. I finally got up my nerve and went to the Chief of our division and said, “I’ve got a new technology I’d like you to see.’ I took him down to the animal lab and showed him an animal operation with a cut up soup spoon. He said, ‘When is your first patient?’ I said, ‘What do you mean?’ He said, ‘Billy, there is a long, rich history of physicians and surgeons using homemade stuff in the operating room. You can’t leave it in the patient, you certainly can’t sell it, but if you think it helps you achieve the desired result in a patient, you’re free to use whatever you want.’ So, we scheduled a patient, I told him that I was going to be using a cut-up soup spoon. He said, ‘Are you confident?’ I go, ‘Very confident,’ he said, ‘Let’s go.’ And it worked beautifully.

Russ: That was your first innovation?

Billy: That was my first successful innovation.  And it was trivially easy, it had about as much mechanical complexity as a McDonald’s Happy Meal toy. There’s a little thing with some places where rubber bands could be, and I realized there, and it had a real impact on me then and over, and over again, how simple some of the most important innovations in our world are.

Russ: So, is it true that your interest in innovation in doing these things had led to your participation in this artificial heart that seems to be growing big time now?

Billy: Yeah, this is the holy grail of medical technology, and people have been trying to do this since the 1960’s. Houston was sort of the epicenter of that kind of work when I was training. People have been trying to make artificial hearts to treat heart failure and cardiac death. The number one cause of death across every demographic, statistically, either you or I will die of heart failure.  There’s half a million people that die every year in the United States alone of heart failure, which is a slow, progressive decline in heart function. And then another million that die of cardiovascular death. So, huge opportunity. We can transplant patients, we can cut your heart out and sew a new heart in. Last year, we did three thousand heart transplants in the United States. Usually, it’s about twenty-two hundred, twenty-five hundred. Last year was the busiest year we’ve ever had.

Three thousand (heart transplants) with a half a million-people dying of heart failure that we can see happening over months and months and have plenty of time to react, and then another million that die of cardiac-you know, three thousand, counting on heart transplantation to cure heart failure is like counting on the lottery to cure poverty. So, we need an artificial heart.  No eureka, everybody knows that.  People have been trying for decades to make one. It turns out, as I mentioned earlier, if your heart is beating 80 times a minute, that’s 132,000 times a day, that’s 42 million times a year.  No man-made device can do that. Flexible membranes, valves opening and closing, whatever the mechanism that’s driving that, wears out. How far can you drive a car before you open up the hood and work on it? You can’t get to this to work on it. So, people have spent billions of dollars trying to make an artificial heart and right now everybody has given up.

Our group tried to leverage continuous flow pumps. Everybody said you can’t do that, because you need a pulse. Well, do you need a pulse? Has anybody done that experiment? We’ve now done 90 cows and I can tell you with great authority you don’t need a pulse.  Just like in aviation, all the original efforts at making heavier than air fly machines had flapping wings; that was way too challenging. The materials weren’t strong enough, took too much power. It was only once they abandoned flapping wings, made fixed wings and a rapidly spinning propeller that heavier than air flight became a practical reality. Name a bird or flying insect that uses a propeller; there aren’t any.  So, when we made the intellectual shift and started using a pair of turbines, and did animal after animal, and saw these animals eat, sleep, poop, grow, we would shave them and their hair would grow back quickly. We said, God you don’t need a pulse. And people said, ‘What about this? What about that? What about this? What about that? They’re all tangential issues that don’t address that question.

Russ: Who came up with the first thing?

Billy: My partner, Bud Frazier, was the first person to embrace it. He would submit papers for publication and they would say, ‘Well this may be of some scientific interest but no practical importance.’ Now 50,000 of these pumps have been implanted to assist a failing heart. We’re the first group to say, ‘Look, we’re going to make a continuous flow artificial heart.’ And this device, we were working on our twin turbine pump, because your heart is two pumps, right? One pump takes blood from your veins and pumps to the lungs, the other pump takes the red blood returning from your lungs and pumps to the body. That’s how your heart works. We said we’ll emulate that with two rapidly spinning pumps. It worked well but it had some challenges. We met a group in Brisbane, Australia who figured out a way so that there’s only one moving part; a double-sided turbine, if you will. It’s a double-sided disk with rotors on it that can move so it can autonomously balance the two circulations. The moving part is floating in an electromagnetic field, so there’s no mechanical wear, so it will never wear out. It will out pump your heart by a factor of four. It’s smaller than a heart.

Russ: So, what’s this, are we putting it in replace?

Billy: What we’ll first do, we haven’t put it in a human yet, although we did put our twin turbine heart in a patient and it ended up on the cover of Popular Science and National Geographic, got a lot of lay press. But the good thing about that is it got us on the radar of this group in Brisbane, Australia, that came down and said, ‘Listen, we think we can address your shortcomings.’ We looked at it and said, yep. We completely pivoted, brought them to Houston, and now I’m Chief Medical Officer of that organization.  This, we think, will be the first practical artificial heart in the world.  So now, how sick do you need to be before heart failure, I mean, if you couldn’t walk from here to that door without stopping and catching your breath, we could do an elective operation in the morning, with a fresh team, because transplants are always in the middle of the night. You never know when a heart is going to become available, and you have to have a jet to go get it, and multiple teams from multiple hospitals to harvest all the organs. It’s maximally inconvenient in figuring out who you’re going to use this precious heart in.  If we had a whole shelf with fifty of them on it, and we’d say, ‘Let’s see, you’re about a 36 long.’ And we could do it in the morning, before they were gasping for their last breath and were a really high operative risk, but just when they were starting to fail. Maybe this will be the cure for heart failure.

Russ: Fantastic. Billy, I really appreciate you sharing your perspective with us. I encourage you to continue to keep doing what you’re doing, and we want to visit you at the JLABS institute so that you can go through the whole,

Billy: Yeah, come out. The new Center for Device and Innovation will blow you away.

Russ: That’s fantastic.

Billy: I am the Tony Stark of medical device innovation.

Russ: There you go. Thank you so much. And that wraps up my interview with Dr. Billy Cohn.