Radio Cade

Detecting Heart Disease and Reducing Invasive Procedures

September 16, 2020 Russell Medford Season 1 Episode 95
Radio Cade
Detecting Heart Disease and Reducing Invasive Procedures
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Radio Cade
Detecting Heart Disease and Reducing Invasive Procedures
Sep 16, 2020 Season 1 Episode 95
Russell Medford

When is a heart attack not a heart attack? Current diagnostic tools are surprisingly inaccurate. 2020 Cade Prize finalist Dr. Russell Medford and his team have developed a “virtual cardiac catheterization” that takes existing CAT scan images and analyzes them using advanced mathematics and computational fluid dynamics. Heart doctors can quickly run this analysis on a desktop and determine whether someone has a blockage and how serious it is. This could eliminate up to 1.5 million unnecessary invasive procedures annually in the United States and Europe.  

Show Notes Transcript

When is a heart attack not a heart attack? Current diagnostic tools are surprisingly inaccurate. 2020 Cade Prize finalist Dr. Russell Medford and his team have developed a “virtual cardiac catheterization” that takes existing CAT scan images and analyzes them using advanced mathematics and computational fluid dynamics. Heart doctors can quickly run this analysis on a desktop and determine whether someone has a blockage and how serious it is. This could eliminate up to 1.5 million unnecessary invasive procedures annually in the United States and Europe.  

Intro:

Inventors and they're inventions. Welcome to Radio Cade a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade , who invented Gatorade in 1965. My name is Richard Miles. We'll introduce you to inventors and the things that motivate them, we'll learn about their personal stories, how their inventions work, and how their ideas get from the laboratory to the marketplace.

Richard Miles:

When is a heart attack, not a heart attack, and how do we know? Welcome to Radio Cade, I'm your host Richard Miles. Today my guest is Dr. Russell Medford, CEO of Covanos, a company that is working on solutions to the diagnosis and treatment of cardiac and vascular disease. Dr. Medford is also a finalist for the 2020 Cade Prize for Innovation. Congratulations and welcome to Radio Cade Russell .

Dr. Russell Medford:

Thank you, Richard. It's a pleasure being here.

Richard Miles:

So I should note from the beginning that you are one of our first Cade Prize finalists from outside the state of Florida, specifically from Emory University in Atlanta, and now normally Floridians don't congratulate Georgians for anything, but today is a new day. So Russell, tell us a little bit about yourself. You're originally from Brooklyn. How did you end up in Georgia?

Dr. Russell Medford:

Well, first of all, thank you for having me on your show Richard and we at Covanos are honored to be a Cade Fibonacci finalist . We understand this is the first year that the award is now outside of Florida and I'll speak for many Georgians, if not all, that we view our Floridian brothers and sisters with a great deal of affection and we're part of a Southeast region that has a great deal to be proud of in many areas. So we love Florida. I love Florida. My background, I'm a Brooklyn born son of Brooklyn, but was raised in Northern New Jersey, went to Cornell University for my undergraduate training and then to the Albert Einstein College of Medicine in the Bronx, in New York City for both my medical degree training and I also have a PhD in molecular and cellular biology. I then traveled as a professional student as one to do, to Harvard and became a resident in medicine and a fellow in cardiology. And my first faculty position at the Harvard hospitals, the Beth Israel and the Brigham and Women's hospitals. My career has been characterized by basic science research on the basis for heart disease and vascular diseases and was recruited in 1989 from Boston to head up the molecular cardiology group at Emory University School of Medicine in 1989, where we began to apply new fields in our understanding of genes and molecular biology to the treatment and understanding of heart disease and other vascular diseases such as stroke. In the course of that work, I became introduced to the process by which we take ideas in the laboratory, as a basic scientist, and translate those ideas eventually into therapies that we, as doctors can use at the bedside to treat patients with disease. And in my laboratory, we had come up back in the nineties with a hypothesis that heart disease, the disease that leads to blockages and the vessels that feed the heart with blood, the coronary arteries, a process called atherosclerosis was an inflammatory disease. Any irritation, shall we say that the immune system never quite resolves and chronically manifests itself, kind of like a cut the redness and swelling that you see on your skin when you get a cut is an inflammatory response designed to resolve the infection and the irritation. Well in heart disease that irritation never goes away, it is chronic. And instead of protecting the blood vessel, it contributes to damage to the blood vessel. And that's how we began a journey of looking at heart disease and applying advanced technologies and science to the most common killer in the United States and the rest of the world, which is cardiovascular disease and coronary artery disease. So this is a journey, shall we say of innovation, of using science and technology and medicine together, which I began throughout my training, and this will be a theme as we go through our discussion today of how did we get to Covanos in which we're using a combination of advanced technologies that haven't been put together before to really change the way in which we view heart disease, it's diagnosis and it's therapy.

Richard Miles:

So let's go right into that. And as you said, heart disease and vascular disease remains one of the leading killers of Americans . So it's one of those studies, actually that your average American has a fair amount about simply because almost everyone has had some sort of experience with it either personally or a family member. So a lot of the terminology and a lot of the treatments are fairly well known to Americans. But if you could just give us a little bit of context in terms of maybe some statistics, how many people for instance, need to go in for some sort of intervention or testing. And then what is the standard of care now, if you present at a hospital and you think you may be undergoing a heart attack or symptoms of that, what happens now today, if I were to go to the emergency room an hour from now, what would happen? And then again, give us that context. How often is this happening across, let's just take the United States as an example.

Dr. Russell Medford:

Well, Richard, I'm glad you asked that. Heart disease is the leading cause of death and disability in the United States and throughout the world. Cancer is actually number two and my wife is a molecular oncologist so sometimes we have this argument as to which is the more important disease on the human condition. But for us, for your listeners, a coronary disease is by far the most important issue that we'll be dealing with. Certainly as we age and in your listeners that are over the age of 55, for example, the statistics in the United States are daunting for heart disease. Over 18 million Americans have blockages in their coronary arteries already, walking around. And these blockages are what to the heart attack that destroys heart muscle and causes cell death, death of the heart muscle and kills people on a regular basis. I think the heart attack rate is enormous. We have over 360,000 deaths from heart attacks every year in the United States, alone, 360,000, which means every 40 seconds during this interview, an American will have a heart attack. So just add up those minutes as we go forward in this conversation. Importantly, along those 18 million Americans, with heart disease , almost half of us, half of all, adult Americans, 120 million of us walk around with risk factors that lead to coronary artery disease. We have some combination of high blood pressure, high cholesterol, diabetes, all of which are important risk factors that predispose us to heart disease. So, this is a huge problem that is on a daily basis. Your question was, well, what do we do with this? How does it manifest itself? Well, not infrequently. You develop what's called chest pain. When the blockage in the coronary arteries reaches a certain point, the blood flow to the distal part of the heart muscle, that's fed by that coronary isn't sufficient for the activity. You climb a flight of stairs and your heart starts to be quicker. Well, that means the muscle is working harder and it needs more blood and more oxygen to continue beating the faster. If the blockage prevents that increased blood flow from occurring, the heart begins to develop. What's called aschemia . It sends out pain signals that are saying, I need more blood. I need more blood. And therefore you wind up with what's called angina. Well, this is a very common diagnosis. This is probably the most common presenting symptom to an emergency room, for example. And if any of your listeners develop that kind of pain, especially on exertion or even at rest, they should go see a doctor. And what does the doctor do at that point? Well, whether it's an internist, an emergency room physician, or a cardiologist, we would be asking questions first. Have you ever had a heart attack in the past? Are you predisposed to this disease? Has anybody in your family ever had a heart attack? Do you smoke cigarettes? Do you have diabetes? Do you have high blood pressure? Do you have high cholesterol? What we're trying to do is ascertain now by history, what is your likelihood that the chest pain that you're presenting with may be due to blockages in your coronary artery? We're also very concerned under the circumstances, is that chest pain, a heart attack and evolution. Are you actually having a heart attack right now? Or is this just angina in which there's no permanent damage? Our tools available to us though, as physicians are indirect and not very accurate unfortunately, assuming that you're coming in with what's called stable angina, stable angina means, doc, I'm not having any, Hey now, but when I climb a flight of stairs, I develop this heaviness in my chest and it goes away when I sit down and rest. Well, that is exertional angina, which could be chronic, may not represent a medical emergency, but our challenge is, is that due to blockages in your coronary artery? And what do we do about that? Well, what your doctor currently does is they say, you know, I'll examine you, I'll take an EKG, do the history and do some blood tests. But what I'm going to do next is what's called an exercise tolerance test. I'm going to try to repeat the symptoms that you had on the outside, under controlled circumstances. And I'm going to hook up an EKG to you, or I'm going to do a nuclear medicine scan or look at your heart's ability to pump using an echocardiogram and try to get a sense of whether or not when you develop those symptoms that I can see objectively that the heart muscle is not functioning properly because of a lack of blood flow. Well, we performed 16 million of those tests every year in this country. And our goal is if it's positive, if it turns out to be some abnormality, the next step is I'm going to take you to a cardiac catheterization laboratory. An operating room like Sweden, which under sterile conditions, a team of doctors and nurses and technicians thread, a catheter into the coronary blood vessels, themselves inject dye, and in an X-ray, we can visualize whether or not you have blockages in your heart. And if those are significant blockages, then we can correct that by putting in a stent, which is a metal lattice that opens up the coronary artery permanently, or if it's too complex to send you to bypass surgery. The problem with our technology Richard now, and this is where Covanos comes in is this industry of diagnostic exercise tests and nuclear medicine test is old technology. I was trained on this when I was a cardiology fellow at the Brigham and Women's Hospital. And we know that the diagnostic accuracy of these tests are about 50%. It's a coin toss, whether or not you actually have disease that when I take you to the cath lab, which is the gold standard that the interventional cardiologist and the cath lab said, well, we had a positive stress test. Something is wrong based on that test, but I don't see anything here. Well, over 50% of the time, that's the answer. I don't see anything, that I'm going to do anything about, so over half of these invasive very expensive procedures are unnecessary. What we need is a tool that allows us to diagnose rapidly and definitively whether the chest pain that you're presenting to your doctor is due to blockages in your heart and whether or not those blockages are functionally significant so that you can justify going into an invasive procedure to have a stent put in or to go to bypass surgery. So this is where Covanos comes in. The technology for imaging. The heart has advanced so dramatically that we can take very accurate pictures of blockages in the heart, in your street clothes, get a CAT scan. You've heard of cat scans in which you lie down in your street clothes, and you go through a donut-like device. And we take concentric pictures of slices through the heart, and we can reconstruct the entire heart and look at the coronary arteries. It's a coronary CT angiography. It's outpatient. It's done quickly, it's in your street clothes and you get the results quickly. What we need is one more element on top of that, just seeing blockages in the cath lab or by CAT scan is not enough. If we see the picture and we often say a picture's worth a thousand words, that's not the case in cardiology or medical imaging, simply seeing a blockage doesn't tell us how serious it is. There's a huge number of patients that I can see some blockage there, but I don't know if it's significant or not. This is where Covanos comes in. We take that image on a PC workstation, that's attached to the CAT scanner and we use advanced mathematics, our technology and our scientific founders are leaders in the world in an area called bioengineering and computational fluid dynamics. And through that single picture, that picture of the coronary artery from the CAT scan, we can compute and reconstruct the blood flow through the coronary artery to determine if that blockage that we see on the picture is impeding or blocking 70% of blood flow or 80% of blood flow. This is what your cardiologist does in the cath lab itself. The gold standard. When they see a blockage they'll thread, a catheter, pressure catheter, across that blockage physically, and measure the pressure drop across that blockage. And then we'll get the same answer they'll saying , well , those pressure drops calculate to be an 80% reduction in blood flow. Why is that important? Because if you just use your eye, you over-diagnosed disease tremendously. It becomes cost prohibited. We get too many false positives by knowing the physiology. We eliminate the false positives and the false negatives for that matter and create a definitive diagnosis, noninvasively that tells your cardiologist or internist in their office whether I have disease, here's a picture. You can actually put it up on your refrigerator wall if you want next to the ultrasound of your new child. But also I can overlay this mathematical analysis that says, well, in fact, that lesion, which looks pretty bad actually by eye, really isn't blocking blood flow significantly. And we know through extensive clinical trials, that there is a cutoff on the reduction in blood flow that tells us whether we should take you to the cath lab and do a procedure and put a stent in, or do bypass surgery, or we'll just increase your medication. We'll increase your lipid lowering therapies, antihypertensives and control your diabetes better. This is where Covanos comes in. It provides for the first time a definitive tool that within minutes of that CAT scan, we now know not just the structure of the lesion a picture, but the significance of it, functional significance. And it allows the doctor to use an evidence based approach to effectively determine what the next course of action is and tell you what your diagnosis is. So, if it's significant and I tell you, you have to go to a catheterization ] procedure, Richard, you know that you're going for a definitive procedure, not for a diagnosis. We have the diagnosis you're going in, your doctors preparing to put a stent in, and we're going to fix the problem instead of taking you to a cath lab in invasive procedure, not knowing over 50% of the time, that there was no reason for you to go to the cath lab in the first place.

Richard Miles:

So I just want to underscore for our listeners , what you all have done is not developing a new piece of hardware or a new machine that gets wheeled into the room. And somebody gets hooked up. You're really using existing machines, existing scanning technologies, right? Primarily CAT scan. But I imagine other scanners like MRIs, or I don't know if the other scan technologies would help, but then you're taking that data that it already exists. Or there are machines already for that. You're taking that. You're running that through what some sort of algorithm, right? You can see, we know exactly where it is. So I'm guessing then that the cost factor must be a lot lower than if you'd come up with a brand new machine for instance.

Dr. Russell Medford:

Exactly. We're adding a dramatic extension of the capability of already a , uh , installed base of CAT scanning machines that are all over this country, whether it's Atlanta, Georgia, Macon, Georgia, a rural hospital, anywhere in the country. In Florida, for example, all of these hospitals have CAT scanners. It is a basic tool now of American medicine. What we've done is taken that install base, and now magnified its capability, extended its capability, using very sophisticated advances in mathematics and engineering principles to draw new information from those images to help make definitive diagnosis and the treatment of heart disease. So what we're doing is adding on a cost. That is true. There is a bit of a cost to add that on that's the business model, but it has such a dramatic impact on patient outcomes. You do better when you make a decision. Based on that data, we have extensive what are called outcome and pharmaco economic studies that look at patients who underwent traditional methodologies for intervention versus this new approach. They do better. They have less events, it is less expensive, and we can cost justify this extremely well. So our job is to improve clinical outcomes for patients. That's what Covanos is in the business for . We want to make the diagnosis and treatment of cardiac disease, much more efficient and effective. And we reduce costs to the patient and to the medical system by billions of dollars by eliminating unnecessary invasive, cardiac catheterizations. So, in an era we're facing now, in which we have to re-evaluate our priorities in terms of medical expenses and expenses in the healthcare , each of us as consumers and as patients and our doctors want the most efficient, effective way of advancing of diagnosing and treating the most common cause of death and disability in the United States, heart disease.

Richard Miles:

So just to clarify, Russell , it sounds like the two major benefits or outcomes for the health care system is one, you're identifying people who really don't need invasive procedures to determine whether they have a serious problem or not. And you can confidently look at those people who look you're okay, you know, we can send you home. And it sounds you can take people who are at high risk and take some of the guests where it can maybe speed them into treatment that they might've not had before. Is that an accurate way of looking at it?

Dr. Russell Medford:

It works both ways. Exactly. We're giving a powerful new tool to the noninvasive cardiologist , to the internist, potentially even the family practitioner. So in the community they have now we call it a virtual cardiac catheterization lab . So they don't have to send their patients to a specialized center. One of our scientific founders is Dr. Habib Samady. He's the head of interventional cardiology at Emory University School of Medicine at Emory Hospital. He's thrilled by this saying, if we can diffuse decentralize the decision making, patients will only come to me as the head of the cath lab when they need a procedure done, and we can make these sophisticated diagnoses in the community, locally. We don't have to send patients into Atlanta or central facilities in New York City for example, all this becomes all the more important Richard in a post Covid environment, in which we only want essential travel to medical centers, sophisticated medical centers for definitive procedures. If we can make those diagnoses out in the community, then the costs go down. The clinical outcomes go up for the individual and the risk of centralizing diagnosis in very crowded and stress hospital facilities goes down dramatically.

Richard Miles:

So we are going to switch now and talk on the business end of this now Russell , an entrepreneurial side of it and great ideas don't sell themselves. They have to make it to market. And sometimes particularly in the health field, that includes a lot of different obstacles and capital regulation, et cetera, et cetera. So, two part question here. One is what are the origin stories of the idea itself? Did somebody come up with this and a flash of insight, or was this something that got iterated to a solution where people sort of tinkered and then tell us a little bit about the road that Covanos faces in terms of getting, not just regulatory approval, but convincing, I presume doctors and hospitals that they should use this because a lot of people in this field report that it's not enough to say it works. You've got to prove that it works by a factor of two or three in order for hospitals and doctors say, okay, fine, I'll go ahead and add this to my arsenal of tests. And so on that I use, it's not good enough to be just 5% better, 10% better in most cases. So tell us a little bit first origin story of the idea and then path to market. What has it been like so far and what do you face ?

Dr. Russell Medford:

Well, I think Richard, you put your finger on it. You made several good points. Let's take them one at a time. Outstanding science and outstanding technology is absolutely necessary, but absolutely not sufficient to translate new discoveries into products and services that will have an impact on people's lives. I've been in the biotech industry for 25 years. I've had the privilege of bringing two major clinical trials, drugs that are new ways of treating heart disease and infectious disease. It is not sufficient to be able to have a new approach or outstanding science, the steps that we to take from a financing regulatory clinical standpoint, and to address a true need that's in the marketplace all have to be addressed on top of outstanding science that's extremely exciting. So there are four founders of Covanos. I have the privilege of being one of those four, but the three core scientific founders, Dr. Habib Samady at Emory University, Dr. Don Giddens, who was the former Dean of the School of Engineering at the Georgia Institute of Technology and Dr. Alessandro Veneziani is a professor of mathematics at Emory University, have worked together for the last 15 years in this interface of mathematics and engineering and coranary physiology and medicine, to understand the details of how blood flows through obstructed coranaries, the physiology of it, doing careful measurements with advanced technologies and with an eye towards taking images that are easily derived and creating this type of computational solution that creates the virtual cardiac cath lab. So this is something 10 years in the making of collaborative research and $6 million in research funding even before they came to me and said, this sounds like a pretty good idea. What do you think? And this was only three years ago, they've been working on this and , and put this idea together. So it didn't come over a weekend or a cup of coffee. This is years of work together in publications. What I brought to the table was as a cardiologist and as a molecular biologist, but more importantly, with 25 years experience in the biotech industry, as a CEOs of public and private biotech companies, what is the business model? The regulatory pathway are we addressing the proper clinical marketplace here? How do we align multiple interest groups together to move this forward from a legal and regulatory and financial standpoint? And do we have a technology with a series of clear milestone accomplishments that reduce the risks that we all know are inherent in any new science or technology as you advance it towards the marketplace, there are new requirements on that science and technology at each step, a significant fraction of ideas fail. They can't be advanced. So how do we plan that out, bringing all these interest groups together and skill sets to create basically a product that we are now within one year of launching for Covanos the C-HEART program. That's what got me excited about the science and technology that had been developed as interdisciplinary, multidisciplinary effort with people who I had known by reputation for many years, I was on the faculty at Emory as well, but an opportunity to work with people that have broken down barriers, broken down silos that I think are critical for us to advance science in general, but medicine in particular, to bring engineers and mathematicians and clinicians together in one room is something that we do on a routine basis in industry. But in academia, that's not so common necessarily. So it was my privilege to say, well, I've been there, done that. I understand what the problem is. I think you have a major solution. Let's put our work together and see, what are we going to try to address? It's not enough Richard to solve a technical problem in medicine. It has to be a solution that will be used by physicians, be used by hospitals so that patients can have access to them. And it has to be in such a way that we have universal access. There has to be broad access. It can't be something specific for a unique group. How can we make sure that everyone who needs a C-HEART gets a C-HEART analysis and so pricing and access to care. And these are the issues that we had to bring on, not just outstanding scientists and mathematicians and engineers, but business people, our head of commercial development and Brian Walsh , somebody who may be well known to some of your listeners is a Senior Medical Technology Industry Executive with vast experience in major and large and small companies and bringing medical technologies into the workplace, through the regulatory pathways. And by putting that package together, you then have to engage with the financial communities which we're doing now to say, well, you know, this costs a fair amount of money to get into the marketplace. What is in your best interest as investors? How do we reconcile the return on investment requirements for different groups, financial returns, the societal returns technology returns. And when you create that mix and solve that you're able to pull it all together and you can see that the science is a big part, but it's only the first part of the journey. Then we've got many other steps that we have to succeed and to get here. And it's exciting for me to relate to that through this journey, we are very close to launching this product and making a difference. Now, the last point that I'd like to say is this has to be used by doctors. If we have a technological solution, as great as it may be, if it's never used by doctors, it means you've got patients that won't benefit from it. So we've been very careful that we've advanced our technology in a way that enables us to be used easily and readily in the workflow and decision making process for cardiologists and radiologists and hospitals so that they can order this, get the result quickly and in their workflow, be able to make decisions and then move on to the next patient. All of this requires in depth analysis and integration, but it's more than just the science. And I think that's what the Cade Prize is all about, actually. It's how do you bring these elements together? What type of people with backgrounds, diverse backgrounds can come together in some sort of effective collaboration to create a company and a company being probably a group of people with very different backgrounds and skillsets that somehow now share a common vision, even though their backgrounds are different and their skill sets are different. Well, that's what Covanos says. And every company that I've been involved with and helped start in advance has had that same mix of diversity and a common purpose among people with very different backgrounds, but essential skill sets to make a difference in people's lives.

Richard Miles:

Hey Russell, one more question you, usually we ask almost every interview, a version of what do you wish you knew then that you know now, or ask people to think of your 25 or 30 year old self? What advice would you give now? And a lot of times people say something like, well, you know, work hard, don't give up. And I want to know, are there things that aren't as obvious? Are there insights that you gained say 10, 20 years into your career as a doctor and the medical industry that you didn't really figure out until later and go like, wow, that would've been really useful to know 20 years ago, but I had to figure out, is there anything that falls in that category, nuggative wisdom? If you think of somebody wanting to emulate something that you've done, start companies, take ideas to market, lot of pitfalls in there. What are some of the do's and don'ts that you would give to somebody wanting to do that?

Dr. Russell Medford:

So, Richard, thank you for asking that question. That's a good question. And there are some takeaways that putting myself as a 30 year old, you have to build trusted relationships with people of diverse backgrounds. You cannot accomplish any of these things on your own. You build it through teams. It doesn't mean that there aren't leaders. It doesn't mean that there are inspirational components to this, that people bring unique skills and capabilities, but unless you can build a team around you, of people who are experts beyond your expertise, a multidisciplinary approach like changing the face of cardiology is impossible for the individual. So I think one thing I learned that I guess I evolved that over time was you need to recognize that you are building a group to share a common vision and you need multiple skill sets to move forward on that. So I think that's the first thing nothing is done in isolation, no matter how talented you are. And the last point is you have to have the confidence in your own abilities to work with people who are much smarter than you, hopefully in the areas, in which you lack expertise. And if you're prepared to do that, then I think your chances of advancing are dramatic. If you, as most of us are concerned and perhaps intimidated by very smart people, especially in different fields, we tend to shy away from that and try to protect ourselves. I think that's the advice I would give. You have to have confidence in your own capabilities to work with and potentially lead a group of people who are much smarter than you. And if you can do that, the sky's the limit. I think.

Richard Miles:

One of the best things I ever heard early on is, you know, you never ever want to be the smartest guy in the room. And fortunately, that was never a problem for me. Thank you for being on the show. I want to congratulate you again and you and your team for making the finals of the Cade Prize wish you the best of luck. And I hope at some point when your book comes out, Russell, we'll have you back on the show.

Dr. Russell Medford:

Richard, it was a pleasure call on me anytime.

Richard Miles:

Thank you.

Outro:

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida . Richard Miles is the podcast host and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood, Soundstage and edited and mixed by Bob McPeak . The Radio Cade theme song was produced and performed by Tracy Collins and features violinist, Jacob Lawson.