Chapters Transcript Video History of Interventional Cardiology: The Mavericks and the Rebels Who Made It Happen it's really a great honor and a distinct pleasure for me to introduce our keynote speaker, Dr William O'Neil, we really have a great pleasure to have him here amongst us. He is currently the director of structural heart disease program at Henry Ford and he is really a world renowned cardiologist and you know all the interventionists in United States and in fact all over the world are doing the interventional procedures the way they do because of pioneers like him. So such an honor to have him here. I kind of know dr O'neill since my early days when I was trying to get into residency program in the United States and I would see him in the Cath lab. He would be doing the most complex cases. Many of them may be the cardiology attendings would not know what he's doing. And once he's done with the case and the patient is out of the eye so they will realize what he has done. So that's kind of a leader he is and what a great coincidence today that today is also first day of Diwali, the Festival of lights which all you know is celebrated widely and it symbolizes victory of light over dark, good over evil and knowledge over ignorance. So let's celebrate this day heart of innovation today with Dr O'neill who has tirelessly been working on defeating heart disease over the last several decades. And now he has taken the challenge to defeat the worst kind of heart failure that is cardiogenic shock. And let's hear from him the history of interventional cardiology, The Mavericks and the rebels who made it happen. And he's one of them. Thank you very much. I mean it's very, very kind of you and you know, my career with Vcenter is actually intersected for almost 30 years. It's actually, I think the second time I've been down here and the reason is that you folks have a lot of commonalities to William Beaumont Hospital, which I was in Royal Oak for 17 years. And a lot of the acute studies that we were doing were intertwined. And I've always admired from afar how you started A small community hospital in the early 90s and developed an incredible program. So again, I think we all kind of stand on the shoulders of Giants, but you do to here and the group that has really established has made you a nationally known program, whether it's for quality, for innovation and now for all the interventions you're doing. So, congratulations for me to you. I think it's a wonderful place, wonderful place to practice. A shout out to dr panic Rocky. He was a resident when I he was an intern when I was a resident and I've always tracked his career and has been really happy that he's been down in Norfolk and I've sent him many patients who are trying to leave the north to go to the south and they come into this area. I always try to get them to see him because he was a wonderful wonderful man. I'm sure he's a wonderful cardiologist. Um, I'd like to go over the next 35, 40 minutes with you some observations. It would obviously be ridiculous for me to really go over the entire part of the career. But just sort of give you my own personal journey. I'm kind of like forrest gump. I was at the right place at the right time. So you remember forest landed in Vietnam in the helicopter and then he was in riots and then etcetera. So watching his, he was at the epicenter of, of his life, of the life of America for about 30 years and a lot of it is honestly simplistically just luck or God's plan and I'd like to go over that here. My disclosures, none of which are going to have any impact on today. Um, the other thing that for me I'm celebrating is that, that I've just finished taking the interventional cardiology boards for the third time. So one thing about being old, one of the good thing about being old is that there's something that are called non time limited certificates. I'm board certified in internal Medicine and board certified in general cardiology. Those are going to last forever but interventional now time limited, which a lot of people would say just as a money making ploy from the IBM but regardless, so I'm hoping that this will be the last time and as I was taking these. That was really kind of interesting that a lot of the stuff that I've done over the years would now be considered level of evidence 33 C is like you shouldn't do that. And it's really, really kind of interesting how all of this evolved. If you take the freeway from here to Kitty Hawk, it's about an hour and 20 minutes. So uh kitty Hawk in in december of nine of 1903, the Wright brothers flew the first plane for about 120 ft And then in July of 1969, years later, the first band landed on the moon. And so it's just absolutely dramatic and amazing to see the way that the world changes over a relatively short period of time. And I think one of the main messages I would give you if you're not, if you're not about embracing change, if you're not about innovating you're going to be stuck on earth. And the other thing that's really amazing about this, I clearly remember, I'm old enough to actually remember this moon landing. It was kind of black and white tv and it was in the middle of the night and we were listening and I was like an avid fan of the, of the space race and us getting to the moon and it was kind of like Yankees versus the tigers then to try to see who was going to get to the moon first as far as the Russians. But one of the things that I really clearly remember is that nobody really knew what the surface of the moon was going to be like. It could be a barren rock that'd be hard or it could be a bunch of dust and my fear for these people was that it would be all dusty and the rocket would flip on its side and that be the end of it. And it was just absolutely thrilling to watch as Neil armstrong first stepped foot on the moon. So there's a lot of that stuff that we do in cardiology where some people have to have to have the courage of their conviction and science to take that first step onto the surface without knowing exactly where you're going to land. And I think that's really kind of been one of the joys of my life is to go through that again, right place, right time. I was very fortunate to be at the University of Michigan steve Yacouba was also there to, he's about five years behind me. So University of michigan and the man in the middle of dr burke pit is who I really give credit to. He's an amazing, amazing doctor, He's the one that invented the Muga and actual pioneer knew everybody in cardiology was generous with his time, introduced us to a lot of the important people and had the conviction to let us sort of be innovate. That's me next to him, I was I was 29 at the time when I graduated from from cardiology fellowship. And and three years later I was the director of the cardiac Cath lab. Now one of the things that was one of the things that was absolutely amazing about being there is that dr pitt I knew about inter coronary struck two counties. He'd heard about it and no one in America was doing it. Peter rent was doing at N. Y. U. But other than that and then uh dr peter arranged to have a randomized trial started. I was the cardiology fellow in 1980 May of 1980 when a patient came into the University of michigan emergency room and he was having chest pain. He had a cardiac arrest cpr and so everybody was called down there and we had just gotten approval to start this inter coronary streptokinase trial. And so we took the patient to the Cath lab dr joe Walton, who was the head of the Cath lab. Break your already cut down because we're only doing procedures from the artery and stuck a catheter into the right corner. And this is what we found that the patient was ashen diaphragmatic sweating Braddock Arctic, just a typical right coronary occlusion. And we started infusing the streptokinase about 30 minutes into it. He had a short burst of et and then he looked like he was feeling better. He said doc. I feel better and it's like you could see this, the weight of the world was lifted off of him and we shot this angiogram and this was again the first and the moon. The first time anybody had seen documentation that you could open up a coronary artery with inter coronary streptokinase. And so that was just like a magical moment for me. I couldn't sleep that night. It was so exciting because prior to that time we treated patients with acute myocardial infarction with bedrest. And for the first part of my fellowship, I see all these young people come into the hospital big infarct. There's nothing you could do. You gave them morphine, put him to bed, waited for a while and hope that they would recover. And some did. But a lot of them would just sort of dwindle and die. And it was just sort of the feeling of hopelessness that we had watching these young vital people having these acute infarct. So this is the first study that was done. If you look at the print, I'm in the middle of the I'm in the middle of the pack there. I was a fellow but I was I was a cardiology research coordinator because I had to sign the consent forms and I had to fill out all the forms and and do all that and it gave me the opportunity to see these patients and I was watching the patients, the ones that got stuck to kind of open label. So you could tell who got and who had the arteries open and clearly the patients that had the arteries open. We're doing better, at least in my inexperience estimation, watching these people, I talked to them, they seemed like you felt better. And so uh we had but it had to be scientifically proven. This was the first randomized trial placebo controlled trial of inter corners stepped Aquinas versus placebo. And it was published in 1982. It was actually a quote unquote negative trial. What we're trying to demonstrate is that microbial salvage would occur that if you open up the arctic, you could save heart muscle. The only way that we had to assess that is with a contrast ventricular gram and in the contrast ventricular graffiti, there was no difference in ejection fraction between the people that were treated with streptokinase and those that were treated with control. So again, sometimes you get let off a path by some trials that that may or may not be positive very soon thereafter, the western Washington study was conducted and that was a randomized trial. Again, a placebo controlled trial and there was a mortality advantage to strep to kindness. Over one year inter corner strip resulted in a one year survival. So that looked pretty good. But it really had a lot of problems. We really didn't know honestly. We didn't know what we're doing in the cardiology boards. There was a slight, almost identical this on the boards, I won't tell you what the questions were because I'm obliged not to. But Anyway, it's just like the state of ignorance that we had in the early 80s about actually what was going on in that coronary first of all, was that the clot that caused the infarct or was it not? And there was controversy honestly, in the late 70s about whether the clot was a primary insulting event or whether it just occurred passively after the infarct had already started. That was that was clarified. We didn't know anything about platelet receptors. Glycoprotein receptors. We didn't know that thrombin was an incredibly potent agonist to, to platelets and this ruptured plaque and now we've got sophisticated strategies to open up the artery to keep it open. You got glycoprotein receptor blockers, pY two and 12 inhibitors, etcetera, etcetera. More importantly, Blue Angel plastic was done if you think about it actually, an angioplasty would probably the wrong thing to do because the vessel was already dissected. It was disrupted and dissected. If you blew it, you would cause blue an injury. So conceptually it was really hard to justify that and we had no idea what the anti coagulation strategy was. So there was a controversy when we gave streptokinase as to whether or not the patients needed to have further heparin therapy, the patients were bleeding because they had a systemic fiber analytics state and it was just really, really difficult to know. So the building blocks of all of this occurred over time. And and and we've gotten just dramatically better not only at how to fix the vessels, but also how to keep the vessels open. So in in november of 1982 again, I got the American Journal American Heart Journal and there was this article from this guy nobody ever heard of. His name was Jeffrey Hartzler and he was doing something that was radical. He was taking the patients the Cath lab and rather than giving strep to kindness, he was doing balloon angioplasty and what he saw there was a significant improvement in injection fraction for the patients that were treated with with primary angioplasty. And so that's really the start of demonstration of some other availability of re perfusion therapy. This is dr Hartzler most of you that started practicing after nine, you don't even know who he was, but this is actually a giant in the field who actually is, in my estimation, the father of infarct angioplasty. He was a pioneer, he worked at the mid America Heart Institute in Kansas city and he was a passionate advocate for primary angioplasty. So much so that he really kind of refused to concede the throne politic therapy might have a role because what he was doing in his estimation with his patients, he was going to give them the best possible option when they were in his care. So he didn't really want to think about politic therapy. So we we and and again just going back to the ninth to the eighties. These are the catheters that we had 10 french sheaths, nine french guiding catheters. You can you can kind of take a look on the far right, there's a glass syringe. There was a five CC glass syringe with some metal on the outside. And the reason for that was when glass syringe were started. You had to push so hard. A lot of people broke the syringe and shattered and caused a lot of injury to their hands. And it was really it was really a bear to try to push the contrast through these clunky balloons there was a sidearm distal perfusion ports so you can see contrast and And this is kind of what we had to start with. So I saw Dr. Hart slurs article I thought we were doing we were doing thrown politic therapy. I was very discouraged about the fact we weren't improving a ventricular function and it looked like they did. So we started doing this. This is the first patient we treated in December 23, 1983 was a patient that was transferred from another hospital. He had a calf earlier had a severe stenosis of his approximate lady. And then in the recovery room started S. T segment elevation in the anterior leads. Now this is again the technology, the imaging that has gotten so much far better. So much better now than it was then. We didn't have a very good replace, it was just a cassette recorder that you tried to replay and the image quality was so terrible that very often we had to stop the case and developed the films. They were actually films that need to be developed in a dark room and look at him in a projector to see what we were doing. So this is this is the patient. And now we got a wire across and I venture to ask any of you where the hell this wire is. Okay. So, so now this is, I'm a year and a half into a director of the Cath lab at this very prestigious, incredibly conservative university. Okay. And so I got this wire across and I'm thinking to myself, where the hell is it? And then we fortunately were able to put a balloon across and able to get successful confusion. Now just think about it for a second. If I had been in the pericardium, okay, that would have killed this patient and killed my career. So there's a lot of that, that honestly it's just somewhat plain luck. And and so this was the art of the patient did very well and then we developed an infarct angioplasty program at the University of michigan. And that was the first in the nation, there are a couple in europe, but we're really two or three hospitals in the world that we're doing this on a routine basis. But there was also, there was always an interest in streptokinase therapy. This was the first randomized trial of angioplasty versus throwing politic therapy that was ever done. We conducted this with William Beaumont Hospital and with Henry Ford Hospital and all of those hospitals have had a great part of my career. It was quite interesting because I'd come in on monday while we were doing the trial and had been a month since we had angioplasty at the University of michigan. And I come in and I'd have seven keys report forms over the weekend from from William Beaumont hospital. I knew that this is kind of an epicenter of heart attacks, very similar to very similar to Sentara. So that's kind of where the commonalities happened in any event. More about that later. So, this looks like a great trial. We demonstrated ventricular function was better. That exercise induced ischemia was better. That re infarction was better, but it was not going to be a commonly applied therapy at this time in the state of michigan with about 10 million people. There were three hospitals that could do primary angel plus and so it wasn't going to become available And people thought, well, how do we expand this to the masses in 1985. A huge national study was being done about intravenous streptokinase. It was called the G. C. study that was done in Italy and it looked like mortality was improved. So the idea conceptually it sounds really great. Okay so so give the public therapy in the trenches, the patient to the cath lab. And then if the art is open that's fine. If not you can do rescue angioplasty. And so we did this randomized trial by this time I'd recruited Dr ERIC Topol to join us. Then he and dr rob Caleb, the current FDA commissioner who was at Duke at that time help us develop this trial called the tammy trial and it was thrown valises and angioplasty acute infarction. And at the same time that we were doing this trial there was a european study that was being done in a timi study and they all we all did the same thing. I? Ve thrown politics followed by angioplasty. And and if you take a look at the meta analysis that the mortality was significantly higher when angioplasty was done. And so it's like well if you probably had a cardiology board then this would have been doing primary angioplasty was a three C indication harmful and you shouldn't do it. And that's what a lot of people thought. In fact in the state of Washington and in the state of Ohio there were laws being passed so that the insurers could not reimburse if you did angioplasty during acute myocardial infarction. So that's kind of how how extreme things were and how we were kind of led astray by by these trials And this is kind of what we were talked okay. So you guys think about putting in impel is and how radical you are and how you know, we were we were being told that we were killing patients for a profit, that we the hungry, unwashed, knuckle dragging, interventional ists, we're going out there and we were killing people because we wanted to make money okay. And that was that wasn't, that wasn't by any, thank God there wasn't twitter then, Oh my God, that twitter fiasco. So anyway, so but the thing that bothered me, I mean I was stunned by this, I was depressed. I thought, oh my God, I've been working for five years. The angioplasty were great before now we're doing lyrics and it's terrible. And that actually started an unfortunate controversy that I had with my friend eric Topol that really lasted for decades because he was a strong advocate of therapeutic therapy. And so we had to go back and rebuild the reputation of angioplasty. So we did a study with four hospitals including moses cone, which is down the road and three others. And we found that primary angioplasty actually looked very good in historical comparison. And then this is probably the study that I would think in the field of re perfusion was the one that was the most impactful and what we decided to do is do the study looking at angioplasty alone versus angioplasty plus streptococcus. So this is the one on the right is what we were doing in the randomized trials before. And what we found is when trick your function was not improved by doing giving streptokinase early. But transfusions were dramatically increased and look at the rate of emergency bypass. 10% of the patients that got angioplasty was strapped economies. And then what we finally realized that the throne politic therapy was causing plaque rupture and plaque hemorrhage. And since we didn't have, you would open up the artery and then it would include the patients were treated with Ron politic therapy. So this is really what set the stage to say, okay, now we know it took a decade to get to this point, but now we sort of said we can do the proper trial of angioplasty versus thrown politic therapy and that's what was done. This is the study that I recruited DR Cindy grinds to join me at Beaumont after the tammy trial. I didn't think we were going to be doing any more info arcangel plastics at the University of michigan, but I still felt that the primary angioplasty needed to be properly tested and I had to go to institution that had a lot of heart attacks coming to their emergency room because one of the big critiques about primary angioplasty is if you bring people from far away to do it, then it's really unlikely to be beneficial and michigan was a referral source and we weren't really getting a lot of influx into the emergency room. So one of the big motivations for me to move to William Beaumont was to try to do this trial. And we were able to get 10 centers in the United States, not the Harvard's, not to stanford's, not Georgetown, not the major academic centers. These were all done in places like el camino Hospital where Greg Stone was practicing and mid America Heart Institute and and William Beaumont Hospital places, the accommodations have never heard of. And so that's again, what I would encourage you folks here, you're not a university, but you've got the patience and you've got the skill and you've got the talent and you've got to drive. You guys can lead this, you know, that you guys have the patience. This is really where a lot of the innovations really have to come from. Anyway. This study demonstrated that angioplasty on the right lead to a decrease in death and re infarction. And there were two other studies published in the same issue in the new England Journal that showed the same thing, one from ZOLL and one from the Mayo clinic. But after these studies were published, people still refused doggedly refused to admit that this might be valuable. They're actually had to be 27 studies done of angioplasty versus throwing politic therapy before the throne politic advocates through in the town. And that happened in 2005 with the meta analysis. And so now anywhere in America, practically anywhere in the world. If somebody comes into the emergency room with stc segment elevation within 6 to 12 hours of symptom eyes that they're all going to go to the cath lab, radial approach to a coronary instagram, find the vessel stenting and you're done and that's across the board. But you have to understand that it took a long time to get there. A lot of, a lot of technology had to be developed and a lot of innovation had to occur and also the science had to develop and this is the meta analysis that showed Again the death and re infarction was substantially reduced, immortality was decreased. The rate of stroke was decreased with primary angioplasty. These are the real drivers that have led this to be the dominant therapy. So now cycle forward to December of 2006. I was at the University of Miami at that time and I had a call from the CCU fellow, he said that there was a patient in the emergency room with an acute inferior infarct. I wanted the interventional fellow to go and see the patient because we knew they were going to have to bring in the cath lab and he was tied up with a complex case with one of my partners. So I said, well why don't you go down and get the guy consent, bring him to the cath lab And so the first year cardiology fellow was scrubbing with me. This is the artery on the top was totally occluded. And then balloon and stent later reap refused in perfect therapy. We did it from the radial approach and the fellow happened to be my son brian. So it was really cool that a quarter of a century later, first year cardiology fellow is treating an acute inferior infarct but much, much different than we did 25 years before. Very quickly going forward. One of the things that we did in the 80s is that we found that angioplasty was truly life saving for cardiogenic shock. Again, prior to re perfusion, there's a 90% mortality with shock. We were able to show that angel plans to improve survival and that kind of is where we were for 30 years I think now that things are changing are changing as we're going forward. The reason that I put this back is because you know, there's been a concern about about using impeller mechanical circulatory support for cardiogenic shock or using it in general. And I'm hearing the same themes now in the twittersphere about as dangerous as more likely blah blah blah blah. And we need randomized trials. And that's one of the key messages that I would give you is that you start the science, you develop the concept, you improve the therapy and then you do have to randomize it to something in order for the scientific community to accept it. Well, we love balloon pumps. This was we used balloon pumps, used tons of balloon pumps when I was first in my practice. And we actually did the very first randomized trial that was Greg stone was was the P. Of and we took high risk angioplasty. And after the angioplasty we prophylactically put out in a balloon pump and we saw that there was no advantage. Again in the 90s, about a third of the patients that had anti influx had a balloon pump, putting prophylactically largely because we didn't want the artery to re include in the stent area. That isn't really much of a problem. So there really wasn't any advantage. And similarly, that all the studies of balloon pumping have not really proven to be successful. And so I would say that the advocates of interesting balloon pump really have to do the trials because there really hasn't been any that are shown them to be of value. So, but we needed balloon pumps. We needed some form of mechanical support. In the nineties. We tried to use something called cps, femoral femoral bypass and it worked okay but we didn't have the stents to keep the vessels open. So there was a high risk that after you stop the human dynamic support that the arctic could re occlude. And we did him a pump. I didn't do that. But it was being tested at the texas heart institute. The tandem heart doing a trans catheter puncture putting Catherine the left atrium. I lead the randomized trial that was done here in the United States and shock. And that was probably one of the most difficult studies that we ever did. Imagine with flores coptic guidance. Not with ice or not with tea would do an emergency trans septal puncture and put this big 15 french sheet across the entire atrial septum. And and it was very difficult to do. There wasn't enough interest in the United States. There's just too complex to do. And so then when when in Pella came and abdomen bottom pell and brought it to us. This seemed like a god because now we have something that trans catheter that transform relax is relatively easy to insert and remove and would give you excellent thermodynamic support. So that was kind of how the whole thing developed for me. And we've done we've done this study in cardiogenic shock. I can't see it unfortunately. But on the left you can see the hands of somebody doing cpr on the patient and then the right after the impeller was placed. Um You could see that the artery was occluded but but it was re vascular ized in the N. C. S. I. In the national currency shock initiative. We've had 37 patients who had active mechanical support while the impeller was being placed. So imagine that for a second. And how often you would think that those patients would would benefit. And in fact we found almost a 70% survival. So as we're doing some of these early trials, you can see the, in my estimation, I think the interventional boards are really helpful because you have a combination of science and experience. And when you experience something like I did with primary angioplasty and the trials and stuff are not congress, I think you have to really kind of go back and ask yourself what do they not get because you're getting it. And with the mechanical support, it truly has been lifesaving for many patients. Now. We have, we have a series of studies that have been done. We did the CSC with 400 patients. The nova group has done an excellent trial and have and then the japanese registry and you can see that we're getting consistently. Survivals are consistently greater than 70% which is a significant improvement to primary angioplasty that has been done for 40 years. Again, looking at guidelines the next time the guidelines are written, there should be a to a indication because they do have multiple registries Now that show consistent benefit but that's not a randomized trial. And so now myself and naveen Kapoor are being the leaders of the recover four study which is a randomized trial of primary angioplasty using the C approach versus standard of care and we hope that you guys will be interested. We need centers like you that have patients coming into your institution to do the studies. And this is exactly like angioplasty versus the politic therapy. If we don't prove it to the skeptics or naysayers, it's never going to be a widespread approach. So I really urge you that are in the room that have influence to really consider the recover for study because we're going to be looking for high quality, high volume sites like you to participate. So sometimes you get it wrong, this is the Gianturco Ruben stent. It's not it's not a spiral notebook. Okay. And when I saw that said holy cow, there is no way in hell that I'm gonna take this thing and put it into a human body. It took a nine french sheath, it went over a balloon. This is called the Gianturco Ruben stent. And and it was, it was invented basically to treat coronary occlusion and it did a pretty good job of that. But it was really, really difficult to deploy at the same time Julio palmas and Richard Schatz invented the coronary stent and again a very rigid device hard to deploy, didn't think it would ever work. And I was all interested in D. V. A threat to me and wrote a blade or a threat to me. So again there were two camps of a threat to me versus stenting. And I I got laid on board. I think the thing that drove me to start using standing is that The problem with interventional cardiology, the malignancy of it in the 90s, was that a third of the time the patients would include within the next 24 hours. And because the artists were dissected and we didn't know how to keep them open and stenting, really allowed us to prompt. You really don't understand. Now when when we left the Cath lab after balloon angioplasty, there was always this sort of level of uncertainty. We actually we actually had the patients and the recover room for an hour and a half. That was the occlusion watch. We waited for an hour and a half to make sure that they weren't going to include before they went to the floor and I would go home a few nights. I've done four or five angel plastic and I would think to myself driving home, I know I'm going to get called back in the middle of the night. I don't know which of the patients, but I know one of them is going to call and there it is, three o'clock patient's chest pain segment elevation. You take them back to the cath lab, pound on the artery. Again, you put a strep to kindness and a balloon pump and hope that they would and it was really miserable. The standing has really made things very predictable and very safe. Now we're doing outpatient study. I would have never imagined in 1990 that you could ever send the patient home within 24 hours of an interventional procedure. So I mean and I didn't know, but again, as things developed, you sort of get that right. One of the things that I did know and I guessed earlier was was intervening on the aortic valve. You all know that this is really one of the most dramatic impactful interventions we can have is improving the arctic stenosis. The Mayo Clinic published a control group study demonstrating the patients that were not treated had about a 50% mortality. And it's interesting, it's fascinating that in the original partner one trial, the mortality and the control group was exactly 50% so intervene the valve was enormously impactful. I actually was involved with led the original study of purgatory. This balloon aortic valve replaced the this was the first structural study that was done in America. And it was a study that demonstrated that if you improve the aortic valve gradient in valve area, you couldn't impact on survival. And this led to the approval of Boston, scientific valvular plastic stent that was approved in 1992 because of that. Then people were doing stuff. And again, early on it worked very well. Value plastic was dramatic and life saving but it didn't last very long. We saw within six months that 80% of the patients that reached the nose. And so is there any way that we could keep the valve open And of course, some brilliant guy rude Anderson thought of this in 1992 stowing a calf valve on honest and and putting in a corny artie and I was involved again right place right time. I actually had a lot of hair and it was brown back. Then. This is the, this is the national press conference that we have. The guy to my left is fred j grand Frederick koji grand. He owned grand ford in Southie Michigan. I met him in December of 2003 in our coronary care unit and he was basically crying. He was depressed because he had been to three places and nobody could do anything. He was at heart failure aortic stenosis. I took him to the Cath lab in December. He had a severe lady lesion that we fixed that bought him a little time and we did a value plastic. And then two months later he comes again with recurrent symptoms of valvular stenosis. And by then we had the approval for doing the first So we did the first valid plastic in the US and in North America. And this is myself to the the other white coat gentleman is dr joe Bassett who was the head of cardiac surgery and I had to give joe public credit because he was an ultimate gentleman, very comfortable and incredibly phenomenal surgeon in Southeast michigan. But he had he had, what would I say, the patients, the grace to be able to say okay try it and allowed us because if he if he had said no, there's no way in the world that we would have done aortic valve tavern procedures at Beaumont Hospital. And and to the far right is Larry Wood, who is the senior Vice President of Edwards and in charge of all the Edwards Tavern programs. So anyway, this is how we did it. We went across the septum, the valves were huge. We did a transept of puncture. We created a rail by putting across the septum around the mitral valve up the aorta and down. And then we advanced the valve retrograde and and again, it's a pity I can't get the slide to show. But but we we paste it and then the valve was deployed fred lived for 6.5 years. He was Abbot. He had a car, he had a hot mustang. He wrote me a little note when I was in Miami telling me that he'd taken his mustang out 100 miles an hour on the freeway. And uh and it was really cool. And then by he died of Euro substance in in a small hospital in florida 6.5 years later and we were able to explain the valve and the valve looked fine. It was perfectly normal. So it really kind of tells you how how wonderful and impactful these interventions are. We're going to get his this case report published in the journal of interventional cardiology very shortly. So it's really fun to see 20 years later how the field is advanced. Uh and I want to just tell you a few patient stories. Before I end. This is viola Waller. I met mrs Waller in 2012. She had been referred to us from a hospital up north from a friend. She was a lady that was 63 at the time, but basically was dying in the intensive care unit in northern Michigan. She had had a previous aortic valve replacement in the valve is failing. And it was very severely static overt heart failure and she was desperate and by then we had to have a veil. But there was so the way of approaching and she had very small femoral arteries. So we took our surgeon took her to the operating room and it was starting to do a transit pickle puncture. And when he put the suture and everything just kind of started to fall apart with one, there's no way in the world that I can do this close the chest went up to the intensive care unit. And she was dying. And we had really heard from the NIH group that they had developed a way of crossing the in fear of Enoch Eva and then going across the arctic valve and doing the trans cable puncture again, radical technique. Our vascular surgeon said, There's no way in hell this is going to work. We had a lunch before we did the case and we asked them so can you provide us back up and we'll sit and we'll sit in the control booth. But if you guys rupture the patient's dead so there's nothing we can do basically. And so we were able to successfully do the procedure. I saw her in the office 10 years ago I'm sorry, sorry a month ago and I asked and she was doing fantastic 10 years out and and doing incredibly well. And the thing that will never I will never forget about this lady as we were telling her as she was in the intensive care unit, telling her about this radical thing. Nobody's ever done it. Who knows if it's going to work or not? It's been done in pigs but never in a human. And she said, well you know, I'm hoping that it works but if it doesn't help me it may help someone else. And the degree of altruism of these patients is absolutely unbelievable. One other quick I'm just going to go forward in the interest of time. Just one other quick story. This is mr holly fred holly. He was a patient that came in with against severe heart failure. Refractory. The last patent coronary artery. We brought him to the cath lab Jose enrique from the Netherlands came over and helped me do the angioplasty in support. We did a rotor blade er we did a blue pump angioplasty. His ventricular function significantly improved and two years later he was out playing golf. So again with patient 001. In my experience, I found the power of of the mechanical circulatory support. We did this study, we enrolled patients throughout the United States. This is a randomized trial of impeller versus versus bloom pumping PC and these are the event curves. That study is touted as being negative because the endpoint was done at 30 days and you can see that the event curves really don't change very much, but in 90 days is a significant improvement with people. Still don't believe that this is a seminal trial. And so now Greg Stone is conducting the protect for study. You guys are a big part of it. I hope that you can actively enroll because I think that the therapy dramatically effect fel I just want to kind of conclude here. So, first in man on the left, you've got a skilled skier, well prepared, fantastic skis, knows what he's doing. He's got a backpack. He's probably got something back there in case he gets buried in an avalanche and he's going down this untracked snow, doesn't know anything about what's going on on the other side of that curve, but it it's very likely that he's going to be able to get down there safely on the right, you've got a Jackrabbit and he's on a well groomed, beautiful slope, gorgeous day, he's going to be able to get down that slope very easily and get down there very safely. And you need kind of both. You need the one side of it where the pioneers risk takers are well prepared, incredibly skilled. But don't quite really know, just like you don't know when you step on the moon, what that floor is going to be like and you have to be prepared on the right. You've got people that are now in one A And what we've done is we've developed the field that the slopes are groomed great technique and everybody is going to be able to get down there safely. So that's kind of how the field advances. And then I would finally conclude that the biggest lesson of all of this and what I really try to transmit to you is that at the end of the catheter there's somebody's mom or dad, son or daughter, sister, brother. And the patient always comes first. Thank you very much. Published Created by Related Presenters William O'Neill, M.D. Henry Ford Health
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