Subtitles section Play video Print subtitles I'm going to discuss with you three of my inventions that can have an effect on 10 to a 100 million people, which we will hope to see happen. We discussed, in the prior film, some of the old things that we did, like stents and insulin pumps for the diabetic. And I'd like to talk very briefly about three new inventions that will change the lives of many people. At the present time, it takes an average of three hours after the first symptoms of a heart attack are recognized by the patient, before that patient arrives at an emergency room. And people with silent ischemia -- which, translated into English, means they don't have any symptoms -- it takes even longer for them to get to the hospital. The AMI, Acute Myocardial Infarction, which is a doctor's big word so they can charge you more money -- (Laughter) -- means a heart attack. Annual incidence: 1.2 million Americans. Mortality: 300,000 people dying each year. About half of them, 600,000, have permanent damage to their heart that will cause them to have very bad problems later on. Thus 900,000 people either have died or have significant damage to their heart muscle. Symptoms are often denied by the patient, particularly us men, because we are very brave. We are very brave, and we don't want to admit that I'm having a hell of a chest pain. Then, approximately 25 percent of all patients never have any symptoms. What are we going to do about them? How can we save their lives? It's particularly true of diabetics and elderly women. Well, what is needed for the earliest possible warning of a heart attack? A means to determine if there's a complete blockage of a coronary artery. That, ladies and gentlemen, is a heart attack. The means consist of noting something a little technical, ST segment elevation of the electrogram -- translated into English, that means that if there's an electrical signal in the heart, and one part of the ECG -- which we call the ST segment -- elevates, that is a sure sign of a heart attack. And if we had a computer put into the body of a person who's at risk, we could know, before they even have symptoms, that they're having a heart attack, to save their life. Well, the doctor can program a level of this ST elevation voltage that will trigger an emergency alarm, vibration like your cell phone, but right by your clavicle bone. And when it goes beep, beep, beep, you better do something about it, because if you want to live you have to get to some medical treatment. So we have to try these devices out because the FDA won't just let us use them on people unless we try it out first, and the best model for this happens to be pigs. And what we tried with the pig was external electrodes on the skin, like you see in an emergency room, and I'm going to show you why they don't work very well. And then we put a lead, which is a wire, in the right ventricle inside the heart, which does the electrogram, which is the signal voltage from inside the heart. Well, with the pig, at the baseline, before we blocked the pig's artery to simulate a heart attack, that was the signal. After 43 seconds, even an expert couldn't tell the difference, and after three minutes -- well, if you really studied it, you'd see a difference. But what happened when we looked inside the pig's heart, to the electrogram? There was the baseline -- first of all, a much bigger and more reliable signal. Second of all, I'll bet even you people who are untrained can see the difference, and we see here an ST segment elevation right after this sharp line. Look at the difference there. It doesn't take much -- every layperson could see that difference, and computers can be programmed to easily detect it. Then, look at that after three minutes. We see that the signal that's actually in the heart, we can use it to tell people that they're having a heart attack even before they have symptoms so we can save their life. Then we tried it with my son, Dr. Tim Fischell, we tried it on some human patients who had to have a stent put in. Well, he kept the balloon filled to block the artery, to simulate a blockage, which is what a heart attack is. And it's not hard to see that -- the baseline is the first picture on the upper left. Next to it, at 30 seconds, you see this rise here, then this rise -- that's the ST elevation. And if we had a computer that could detect it, we could tell you you're having a heart attack so early it could save your life and prevent congestive heart failure. And then he did it again. We filled the balloon again a few minutes later and here you see, even after 10 seconds, a great rise in this piece, which we can have computers inside, under your chest like a pacemaker, with a wire into your heart like a pacemaker. And computers don't go to sleep. We have a little battery and on this little battery that computer will run for five years without needing replacement. What does the system look like? Well, on the left is the IMD, which is Implantable Medical Device, and tonight in the tent you can see it -- they've exhibited it. It's about this big, the size of a pacemaker. It's implanted with very conventional techniques. And the EXD is an External Device that you can have on your night table. It'll wake you up and tell you to get your tail to the emergency room when the thing goes off because, if you don't, you're in deep doo-doo. And then, finally, a programmer that will set the level of the stimulation, which is the level which says you are having a heart attack. The FDA says, OK, test this final device after it's built in some animal, which we said is a pig, so we had to get this pig to have a heart attack. And when you go to the farmyard, you can't easily get pigs to have heart attacks, so we said, well, we're experts in stents. Tonight you'll see some of our invented stents. We said, so we'll put in a stent, but we're not going to put in a stent that we'd put in people. We're putting in a copper stent, and this copper stent erodes the artery and causes heart attacks. That's not very nice, but, after all, we had to find out what the answer is. So we took two copper stents and we put it in the artery of this pig, and let me show you the result that's very gratifying as far as people who have heart disease are concerned. So there it was, Thursday morning we stopped the pig's medication and there is his electrogram, the signal from inside the pig's heart coming out by radio telemetry. Then, on Friday at 6:43, he began to get certain signs, which later we had the pig run around -- I'm not going to go into this early stage. But look what happened at 10:06 after we removed this pig's medication that kept him from having a heart attack. Any one of you now is an expert on ST elevation. Can you see it there? Can you see it in the picture after the big rise of the QRS -- you see ST elevation? This pig at 10:06 was having a heart attack. What happens after you have the heart attack, this blockage? Your rhythm becomes irregular, and that's what happened 45 minutes later. Then, ventricular fibrillation, the heart quivers instead of beats -- this is just before death of the pig -- and then the pig died; it went flat-line. But we had a little bit over an hour where we could've saved this pig's life. Well, because of the FDA, we didn't save the pig's life, because we need to do this type of animal research for humans. But when it comes to the sake of a human, we can save their life. We can save the lives of people who are at high risk for a heart attack. What is the response to acute myocardial infarction, a heart attack, today? Well, you feel some chest pain or indigestion. It's not all that bad; you decide not to do anything. Several hours pass and it gets worse, and even the man won't ignore it. Finally, you go to the emergency room. You wait as burns and other critical patients are treated, because 75 percent of the patients who go to an emergency room with chest pains don't have AMI, so you're not taken very seriously. They finally see you. It takes more time to get your electrocardiogram on your skin and diagnose it, and it's hard to do because they don't have the baseline data, which the computer we put in you gets. Finally, if you're lucky, you are treated in three or four hours after the incident, but the heart muscle has died. And that is the typical treatment in the advanced world -- not Africa -- that's the typical treatment in the advanced world today. So we developed the AngelMed Guardian System and we have a device inside this patient, called the Implanted AngelMed Guardian. And when you have a blockage, the alarm goes off and it sends the alarm and the electrogram to an external device, which gets your baseline electrogram from 24 hours ago and the one that caused the alarm, so you can take it to the emergency room and show them, and say, take care of me right away. Then it goes to a network operations center, where they get your data from your patient database that's been put in at some central location, say, in the United States. Then it goes to a diagnostic center, and within one minute of your heart attack, your signal appears on the screen of a computer and the computer analyzes what your problem is. And the person who's there, the medical practitioner, calls you -- this is also a cell phone -- and says, "Mr. Smith, you're in deep doo-doo; you have a problem. We've called the ambulance. The ambulance is on the way. It'll pick you up, and then we're going to call your doctor, tell him about it. We're going to send him the signal that we have, that says you have a heart attack, and we're going to send the signal to the hospital and we're going to have it analyzed there, and there you're going to be with your doctor and you'll be taken care of so you won't die of a heart attack." That's the first invention that I wanted to describe. (Applause) And now I want to talk about something entirely different. At first I didn't think migraine headaches were a big problem because I'd never had a migraine headache, but then I spoke to some people who have three or four every week of their life, and their lives are being totally ruined by it. We have a mission statement for our company doing migraine, which is, "Prevent or ameliorate migraine headaches by the application of a safe, controlled magnetic pulse applied, as needed, by the patient." Now, you're probably very few physicists here. If you're a physicist you'd know there's a certain Faraday's Law, which says if I apply a magnetic pulse on salt water -- that's your brains by the way -- it'll generate electric currents, and the electric current in the brain can erase a migraine headache. That's what we have discovered. So here's a picture of what we're doing. The patients who have a migraine preceded by an aura have a band of excited neurons -- that's shown in red -- that moves at three to five millimeters a minute towards the mid-brain. And when it hits the mid-brain, that's when the headache begins. There's this migraine that is preceded by a visual aura, and this visual aura, by the way -- and I'll show you a picture -- but it sort of begins with little dancing lights, gets bigger and bigger until it fills your whole visual field. And what we tried was this; here is a device called the Cadwell Model MES10. Weighs about 70 pounds, has a wire about an inch in diameter. And here's one of the patients who has an aura and always has a headache, bad one, after the aura. What do we do? This is what an aura looks like. It's sort of funny dancing lights, shown there on the left and right side. And that's a fully developed visual aura, as we see on top. In the middle, our experimentalist, the neurologist, who said, "I'm going to move this down a little and I'm going to erase half your aura." And, by God, the neurologist did erase it, and that's the middle picture: half of the aura erased by a short magnetic pulse. What does that mean? That means that the magnetic pulse is generating an electric current that's interfering with the erroneous electrical activity in the brain. And finally he says, "OK, now I'm going to -- " all of the aura get erased with an appropriately placed magnetic pulse. What is the result? We designed a magnetic depolarizer that looks like this, that you could have -- a lady, in her pocket book -- and when you get an aura you can try it and see how it works. Well, the next thing they have to show is what was on ABC News, Channel 7, last week in New York City, in the 11 o'clock news. Anchor: For anyone who suffers from migraine headaches -- and there are 30 million Americans who do -- tonight: a possible answer. Eyewitness news reporter Stacy Sager tonight, with a small and portable machine that literally zaps your migraines away. Christina Sidebottom: Well, my first reaction was that it was -- looked awfully gun-like, and it was very strange. Stacy Sager: But for Christina Sidebottom, almost anything was worth trying if it could stop a migraine. It may look silly or even frightening as you walk around with it in your purse, but researchers here in Ohio organizing clinical trials for this migraine zapper, say it is scientifically sound -- that, in fact, when the average person gets a migraine, it's caused by something similar to an electrical impulse.