In this Grand rounds presentation, Dr. Robert Smith discusses the Modern Mitral Surgeon. He reviews the role of minimally invasive surgery techniques for managing mitral valve disease, transcatheter options including MAC and finally reviewing the heart team.
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Ok. That, oh, a lot of different every year. Yeah. Hi. That thanks. Bye bye. I, yeah. Oh, God. Ok. Yeah. Oh, I know. I know. Well, yeah. Yeah. Yeah. Yeah. Yeah. All right. Good morning. Um, can they hear us online now? You should be able to hear me now? Ok. I think we got a quarter of people online as well. So we'll get started. Um, so, um, good morning everybody. DJ DJ Diamond. This is, uh, Rob Smith. You guys get to know each other for a while. Um, good morning. It's a great pleasure to introduce my friend and mentor Dr Rob Smith. Uh, this morning as some of, you know, I was lucky to spend a few months with Doctor Smith. Um, after my train here at Penn, learning robotic repair and trans cap of micro thera. Um, Doctor Smith is the chair of cardiac surgery at the heart hospital in Plano, which is one of the largest valve centers in the country. Um, he's a native son of Texas and attended Texas Christian University where he played football for the horn frogs and, uh, graduated medical school from the University of Texas Medical School. At uh San Antonio. Doctor Smith went on to complete general and cardiac surgical training at um University of Virginia. And following that, um Doctor Smith went to Leipzig Germany, um which is an internationally renowned center for minimally invasive mitral valve surgery um where he learned uh the full gamut of minimal invasive surgery and trying to get the valve procedures. Ultimately, Doctor Smith um went to uh Dallas Texas where he's where he's been focusing on treating valve or heart disease and expanding access to uh minimally invasive cardiac surgery. He is a nationally and internationally recognized leader in MIT valve disease, um and robotic cardiac surgery and he serves as the primary investigator of numerous national and international trials. Um and he's certainly one of the most highly regarded robotic metro valve surgeons in the world. Um Today, we're excited to have him speak to us on his insights on the future microvalve surgeon. Thank you. I keep my clock up here so I, I can get long winded because we're talking about minor surgery. And this is, this is my passion. This is my sweet spot. So I appreciate the invitation and I loved having Mike Abraham come up or come down to Dallas. It was a, it was a joy to, to work with him and I'm excited for all the things that he's doing here. This has been really great. So my name is Rob Smith. I'm from uh Plano Texas payment. We're gonna gonna figure this out. Uh Here the objectives today. Uh We're gonna talk about the role of invasive surgery techniques and managing microvalve disease. We'll review transcatheter options for microvalve disease including ran your cal and then we'll do a quick review of the heart team. Uh But first, as Mike was talking about mentorship and, and you guys here are blessed to have mentors all around you uh from the resident standpoint for me. Uh My, my kind of senior mentor was I was a guy who really got me interested in cardiac surgery, uh helped train me along the way. Uh And really got my passion up for doing my uh microvalve surgery. In fact, when I was a general surgery resident, this paper came out and this is a simplified approach to treating degenerative bowel disease. And this was a triangular reception paper where the real goal of the paper was not to describe some new technique. This is already being done, but was really to try to provide a framework for doing a reproducible repair, which at the time is not something that was routinely done, something with complete reproducibility in this paper though a small series, uh they had actually done a really good job and it really kind of got me thinking about what is it? That's so tough about microvalve repair. Why aren't more people doing a good repair? Because at the time, the average microvalve surgeon was doing five microvalve repairs at the time, uh along the way and while I was there, and I'm sure with you guys too, you get an opportunity to meet a lot of different personalities, uh came down one time and, and I took away from his entire discussion, a really important phrase and he said, you've got to own the disease. And while he was talking about aortic disease, this is really true about mit disease, at least kind of from where I'm at. I am a micro specialist and I assume that's kind of the way that most programs are going. You've got to own the disease, not just from being a technician in the operating room, but you've got to understand why the disease is there. What are the different options for treating the disease? And how do you work with your colleagues on making sure that a patient in front of you is receiving the best optimal treatment along the way. I also met Mike Mack. And between these two guys, I got a lot of really good lessons uh on developing practice. Uh But Mike actually is the one who offered me a job. Uh He taught me about the hard team and how it's really important. Uh and that the sum uh or rather the uh uh the some of the uh uh the team is greater than the individual parts. Um He then brought me down to Dallas where I met Will Ryan, who is one of in my mind one of the master surgeons that most people don't really know of. Uh This guy has been doing ross procedures and microvalve repairs for years and years and years. He's kind of an unsung hero of structural heart disease. Uh but has been a phenomenal mentor. Uh But uh both Mike and will wanted me to go to where I learned from Fred Moore and I think it's really important that you go and watch other people operate. You go and you get in their operating rooms, you get underneath their skin and you try to figure out what it is that they're seeing that maybe you're not. And that's a really important piece of this. And while I was there, Fred had been uh really optimizing uh the port access approach and using loops and he had really honed this up and it was just kind of a matter of routine. They would do 3 to 4. He would do 3 to 4 of these a day. Their hospital would do probably eight of them a day. It was ridiculous at the time they were doing about 4000 heart surgeries a year. So what I wanna do is now talk about the role of minimally invasive approaches for treating uh or managing microvalve disease. And I wanna start out with this. So a lot of you guys are young, so probably don't even remember what one of these things is, but this is a Blockbuster video store. Where they used to give you V H S S OK. And then what happened to Blockbuster was Netflix. And so Netflix completely changed the way that we actually see videos and this is what happens. And so this is actually kind of what I think that if you're in the market that has minimally invasive, minimally invasive microvalve surgery, this is what starts to happen to those folks who don't offer minimally invasive options to those patients is a lot of times the referral volume start going towards m invasive surgery. So in the Dallas Fort Worth Metroplex, there are two programs that offer minimally routinely, minimally invasive uh surgery. So 90 about 90% of the microvalve surgery goes to those two programs, right? Not because every one of those cases is done normally basically, but they draw in those patients. So embrace change, do not be a victim of it. So primary M R is definitely a surgeon's disease repair remains the gold standard and this is what we need to be doing for patients. But why is the prevalence up here? But the intervention ratio down here? Well, one, there's not enough surgeons who do a good job with repair. That's not really true. We've seen in the S T S data that that surgeons are doing a better and better job with repair. Cardiologists used to do a very poor job of referring on time. Now they do a much better job of referring on time. But what our big hold up is, is patients really fierce anatomy and it's not that they really want a micro glyph either. What they really want is a MIT pill, right? They don't want anything. We're offering them the worst of things in astronomy, which we all know is not the important part of the case. It's what you do to the heart, but it is a major obstacle, a fear factor that they have to get over. So how do we get these patients to come see us? How do we get our referring cardiologists to see value in our work? And how do we get these patients done before they get too sick? And it's to provide good durable repairs with no mortality and minimal morbidity so that patients can get back to living. So what's the difference in an approach? So here we have sternotomy mini thoro where you spread the ribs sum and then a robotic approach. These are less invasive but are we sacrificing outcomes for smaller incisions? So really to figure out what you know, what is the the good outcome that you should benchmark yourself to? This is Tyrone David's Lifetime Series here where we see freedom from severe M R and moderate to severe M R and over the course of 20 years, your freedom from that 3 to 4 plus is about 80% in a master surgeon's hand. And honestly, if you're offering microvalve repairs to patients, this should be your goal. And why patients died was largely related to their comorbidities to heart failure. And it turns out that patients who came in class for heart failure, uh they were oftentimes not able to achieve the full lifetime span that they should have gotten back with a microvalve repair, had they come in sooner. So the idea is how do we attract these folks in so that, that they can actually get that full lifetime benefit. So honestly, in my opinion, me, invasive surgery helps with that. So how does it stack up? So, looking back at the Cleveland Clinic experience, this came out in 2011 but was presented at the A T SI believe in 2009, which was a big or 2010, excuse me, was a big impetus for us to get really involved in uh micro repair surgery with the robot. Um They basically did like 700 P two uh prolapses and files with excellent results, 100% repairs, uh and excellent recoveries with minimal morbidity. Uh shortly after the uh minimum invasive experience for the Virginia uh Cardiac surgery quality Initiative uh was reported where they propensity matched over 300 patients and found that there's no difference in the outcome of mortality or stroke. But really what they were seeing is less of the morbidity associated with that we see with sternotomy. So shorter ic times hospital stays, fewer transfusions and no cost difference. So now, we've got kind of an equivalent and outcome, the heart outcomes but less of resources utilized and certainly from a patient standpoint, they're feeling better. So uh Rakesh took a look at his entire surgical volume of patients who came into not just P two files but complex disease. Bi lethal disease, anterior lethal disease, poster lethal disease, P one through P three, et cetera. 487 patients, um 100% repair rate. A one year survival of 99.5% which is what we want at a, at a center of is less than 1% risk of mortality. Um His one year freedom of two plus or greater M R was 99.5%. And that's what I quote to patients because that's what our data is. Is it's a less than 0.5% of patients will have significant F M R that we have to consider Following them to do something about it in the future. Uh 5% freedom from two plus or greater uh 94.6%. So again, at five years out, we're starting to see some patients who may have something at 20 years out. Now, if you go to Tyrone David's data, you're gonna have about 80% of patients. So, so really, you're not gonna be perfect man. You can get really close to this and this is just as good as Tyrone David's data. It's just short. So we have great intermediate durability for now, a minimally invasive approach. So it can be done. It has some indications of less per operative morbidity, the repairs look durable. Well, what about quality of life? Well, in this same series, what they did is they looked at the Duke activity status index which goes over household chores, tasks of personal care and recreation. Uh And they found that the robot did better than conventional sternotomy for the same kind of disease. They looked at the S F 12 physical function study uh test and in that questionnaire, robot statistically better. Uh they look at quality of life assessments, um chest pain uh assessments and then fatigue. And then each one of those cases, the robot performed better than those patients who had had stony. Uh And then when we look at getting back to work, uh the dotted line is the um uh the robot case. Uh the solid line here is the uh open trey cases and the exact same kind of operations and robot patients went to work and got back to work much quicker at the one month, two months and three month time period. And it's not really out to a year that they really those those lines completely converge. And I would say that in my practice right now, I'm routinely getting patients who are young out of the hospital about two days after micro surgery. And most patients nowadays, a lot of them work from home. So that's easy. Right? And those who don't work from home are often times back to work within a couple of weeks. So it can be done. It had some indications of less per operative morbidity, uh repairs look durable, reasonable quality improvement. And now is it scalable? So who can do it? So, number one surgeon volume is very important. Hospital volume is also important, but surgeon volume is important. And the and the reason is is that surgeons who have high volumes of microvalve surgery uh actually have better outcomes. So there's a very good volume outcome uh relationship. And I think that's really important. So surgeons to do a lot of microvalve surgery through all different techniques, they they have a feedback loop of how they're doing. So they they tinker with and alter their techniques for repairing the valve. So I think it's important now that you're adding new access that you're gonna have an opportunity opportunity to have a big practice. And the reason I say this is I think it's really important for older surgeons to help uh really cultivate younger surgeons to have big practices so that they can be aggressive in developing these new techniques. Um it turns out when you look at port access surgery that this is very safe in training. So uh in Europe, he has a a very large uh training program and there was no difference when a consultant did a minimum basic case by themselves compared to when they took a residence for a case. Uh When you look at how many cases you really need though. It's a fair number. This is for port access. So again, in Germany, at the time, this is 3895 operations from a single high volume center. Uh it turned out it took about 75 to 85 100 and five cases to really learn. This is many. So for robotics, it usually takes once you're a good m invasive search, it usually takes 40 to 60 cases to really feel like you've covered your curve on learning. So, really important things to remember is that it's invasive surgery. A market differentiator many will try sometimes when they're not really ready. Minimum invasive surgery is uh only good for our specialty if we can really train people uh to do this so that we can improve access. It is not great if we have four or five folks who are out there just kind of touting their own practices. This has gotta be something scalable so we can deliver it to the community. Um And as surgeons, uh we must continually challenge ourselves to improve um is a significant morbidity. I've had a sternotomy. It sucked. I totally will tell you. It sucks. All right. So we have to be thinking about better ways to do things I got over it. It's not the end of the world. The most important thing was having good heart surgery, right? But there are better ways to do things and we need to continue to work through these. So we have some challenges ahead of us. But the outcomes can be very comparable to astronomy approaches. Astronomy are safe. Um Teaching is possible but good, safe for care is what really makes patients live longer and better, minimally invasive approaches. They really get patients home faster and back to work quicker so they can go back to living their better lives now. So here's an example of a robot case. Uh This is a 60 year old female that we saw with a history of PV CS who have an inflation. Um had a lot of recurrent PV CS uh uh had minimal symptoms though uh bile disease um complicated by mit calcification and no significant comorbidity. And I've put up here a more complex case, not because I'm trying to tout what I can do, but really to show that there have been, there have been reports out there that the only thing you can do with a robot is a two and that is not the case, right? So I don't want you to think that this is some super niche practice. Um This patient had multi scalp disease with my chain or disjunction being a contractor at a 20.5 centimeter squared uh volume of 56 millimeters. And the E F is uh just over 50 with a dilated L V. Here's her that goes. So you can see nitrate or disjunction over here on the right, a significant elevation of both leaflets. Uh This is the 3D contractor and what they did is they went and looked at each one of these jets. Uh And they measure those. Paul is excellent that he's one of, he's kind of one of the Echo standards. Um Then we get ac T A of everybody take a look at their coronary arteries. But it also helps give us a good look at the my trainer calcification. If it's there not the worst in the world doing this through an open case, I would have complete comfort in, in doing that good core, uh good purple uh vessels for UL. This is our set up. We use uh J S C C 15 French can a 25 French, uh multiple Venus Canon for most cases. And then we can the order with either a 21 or 23 through can so that we can use an and if they're not a good candidate for, we use a clamp, uh we cool the 32 degrees 30. If it's gonna be a really long case, we can usually use del cardio SIA. And then here is that valve. So this valve, what I do first and most of these mac cases now um in particular cases that are associated with my chain or disjunction, uh what I'll do is I'll lift the leaflet off and I'll just push it down into the ventricle. And oftentimes what I'll start doing then is, uh, you'll have some little calcium spicules that'll grow up into the leaflets. I'll take those out as well. Uh I'll divide a number of the tertiary cords to the post to your leaflets. So this is just getting this down. I'll move to the next one here and then we take the calcium out. Once we get that uh leaflet all down, usually what you gotta do is just get through this first layer. But it particularly these disjunction patients, it almost in kind of a fibrous capsule. This is we're finally about to break through this bar. So I try to break through the bar so that I can lift one side and then come back and lift the other side. You see it peeling out of the capsule And this is not a straight two p 2 flail. Here. There you go. You see that capsule peeling out and now we get it on the run. You can see how that starts and stuff starts lifted out. Now, if they don't have mitan or disjunction, usually the calcium is far more deeply penetrated into the, into the muscles. So you have to be a lot more careful about that. And then we reattach the leaflet here, I use a double layered running tex from the sides to bring it down in the middle. And the reason I've divided those tertiary cords is the case. I don't slide it. Exactly right. There's good ability there. So we put this guy back on and we test the valve and we look for residual prolapsing segments here. So just by doing that, I've shortened the poster leaflet to a large degree, but there's still a fair amount of uh prolapse there. So we're gonna fix that at the same time. What I'll do is I'll size this valve. I size this up to a 40 millimeter band. I usually size it by the, on T E E. Um We use a lot of uh multi planner reconstruction for doing the sizing here and then we'll go ahead and start putting the band in after we put in some NEAC cords. So I put all the neo cords in first. I basically, God gives a, a great plan here. He's got cords coming from all the different path muscles and I just follow that. So here I'm putting in a cord here at the uh post your head of the lateral mule. I tend to put it between the muscle heads uh because the blood supply comes up right through the center of those. Um I anchor it down onto the path head first, which is what I'm doing right now. And then I'm gonna put it up into the leaflet so we can slide it down. Uh And I end up supporting P one P two and P three as well as that A two P three or excuse me, a two, a three junction in this case. And then once we get this done, here's it down over there. I gotta put it into the leaflet. Don't worry, I'm not gonna make you watch all of the chords, but this is pretty much how I'll do all my courts kind of through, uh, one of these cases just set up all the way around. The largest number of cords I've put in is 24 um where it looks kind of like vortex vomit coming out of the side of the chest. Fortunately, No 1's come in with the technology yet. That's great. They're not. All right. So that's, that's our accords and we can adjust those, they slide down pretty nicely. Then what we need to do is get the band secured in here. So we've already measured it up and I take really deep bites, particularly in patients who have mito destruction because there is a separation here from the leaflet down to where the true is. And you gotta, you've gotta get that gap squished out a nice big deep bit that this is not where the crux of M ad is up here by the tri. So, uh but you have to be very thoughtful about the coronary and we mark that out every time on echo to make sure we know exactly what our distance is to the coronary artery which slide the band down around all those cords. This is the importance of having excellent bedside assistant. Uh We have uh a great team uh of folks who help out at the bedside. You can see how that goes. And then what I'm gonna do is get you kind of the band as it's coming in here. And this is some of the way we test or, uh put the, the neo cords out after we tested on the right. And this is the remainder of the band. You can see how deeply I'm going down in there to get bites. This is uh it's no joke that, that, I mean, they, these can be displaced up to 12-plus mm and then we're securing down the cord on the right. We've already put in all the knots and we're gonna take a look at what this looks like right when we're done. So we've got good poster displacement as opposed to your leaflet Cooptation line is now very poster. We have a long line of Coaptation as well. Uh And we've got good ventri function and more importantly, we have no M R Here's our 0D image, the bands all the way up from the Triones. In summary, this patient, uh we placed 10 neo cords um supported with a 40 band. She was discharged on post day four and one year out. She's doing well. She's on no anti rhythmic medications and no longer is on any not agents. And she has no PV CS residual. And that's actually one of the things that I find in the randy junction patients has been quite interesting is the amount of PV cs we get rid of by just fixing the valve. So this is her now one year out, this is her post op. Uh and that I think it's very important that we follow our own patients. Uh So she continues to have no micro regurgitation. So I'll follow patients out for about three years. I'll follow them with the, with the cardiologist getting echoes on a yearly basis. So I know exactly what's going on in my practice. And so with these, it's really important because we get great cosmetic results. This is a 60 year old female who had been recently divorced, very worried about her cosmetic appearance. She had my disjunction and this is how things look And not just cosmetic results. We get workable results. This is a 52 year old guy who works in IT whose job threatened to fire him if he was out of work for more than two weeks. So this guy was back to work sitting at a desk in an office two weeks after his micro voucher. So as much as that's important, transcatheter, therapies are coming in and we need to really embrace this. So here's another example and I bring up all these kind of examples because I'm in business school now. So I'm kind of following this up, you've gotta have an eye on really what's gonna make you change? All right. So I bring up this example. I don't know if you guys remember Barnes and Nobles and mortars, but these are bookstores, right? And Amazon came in. So what was Amazon at first? Amazon sold used books online, Right? And pretty simple model and that model destroyed bookstores. This is what Amazon's stock portfolio looks like, right? So they started out really slow and it took a long time to amp up. But this is now about 2018. Look where they're at. So I don't know if you guys know what this is. This is Sears, this is Sears and robot. Sears and Roebuck in 1906 was the first retail company that was publicly traded, right? They were on the NASDAQ. All right. So they bobbed and weaved for over a century, maintaining a, a pretty reasonable uh reputation, right? So what, what ended up happened is Amazon came along and they destroyed the classic brick and mortar store, right? This is now what happened to robot. They went bankrupt. They are often as a so the important part here is know what is happening out there, go to cardiology meetings, be involved and this is where we get into being a complete microvalve surgeon. Uh So this is a 68 year old female has a history of a 26 mit, an uh an ring with a future band. Uh, it was placed in 2006 and she's been having markedly increased shortness of breath. Uh, for the last six months, she takes pictures at the, uh, rodeos. She's pretty amazing, but she gets down there in the dirt. She's taking a picture of all the rodeo folks, particularly the clowns. Uh, and this is, this is her gig. Um, but she's B M I, she's also got now chronic hepatitis and some liver dysfunction. Uh She's got permanent fib and depression, hypothyroidism and a significant amount of heart failure is good. A lot of diastolic dysfunction. Um She's got a pretty badly his um and so now she's got severe M R and some moderate T R and it's very difficult to manage her heart failure symptoms. So we could either do a redo or given all of her morbidity, consider a trans cathode therapy. So this is what our valve looks like. Now, this is one of the worst deists I've seen for trying to treat with a uh a club. This is a really bad one. So we put a lot of time and effort into thinking about this as a team. This is what a regurgitation looks like, But this is what we typically see. This would be like an 85 year old gentleman who has multiple comorbidities and has Fibroplastic disease and just a couple of cord. These, we do phenomenal with the other ones. It's hard to know, but that person was a pretty high risk. So, you know, really where transcatheter therapy indicated microvalve surgery is really what's most commonly indicated for degenerative disease. But after the Everest trial, uh, although percutaneous repair was less effective in reducing M R than conventional surgery, it was really found to be a safe procedure. And after evaluating their high risk group, they, they ended up approving it, they mean the FDA ended up approving this device. And so it has an indication of primary R uh primary M R when high, when surgery is too high risk or prohibitive uh uh to perform. And that's what we do is when we perform tea therapy. Uh Here's kind of some typical leaflet pathology, that's that it's best for, but we definitely have, have worked our way around this and getting to uh more significant complex uh anatomy. Um And then the setting of functional M R where the ventricle, that's the issue. Uh We look at trans cat therapies actually have a two, a indication after the co op trial for surgery, except in the setting of concomitant surgery is actually a two B indication. So the trial was a 1-1 randomization of patients who are in guideline directed medical therapy, who received a clip uh or just guideline directed medical therapy alone. And the results of that showed that there was a significant uh reduction in heart failure and uh mortal heart failure, hospitalizations and mortality. Um at two years. Uh the population had a mortality of 29%. So it's still really high. These, these are sick patients. Um we're the, the uh guideline direct medical therapy group had a mortality of 46%. Uh so almost a half production. Um the hospitalizations were reduced even more significantly. So it was only 30, it was 36% hos heart fire hospitalization in the treatment group. 68% in the un in the untreated group. So a mark reduction in heart fire uh hospitalizations. So that eventually led to its approval. So now um you have class one recommendations, guideline, direct medical therapy and C RT gotta be done in the in this population two a indication for tier therapy when patients have an E F of 20 to 50% and are on uh fully managed guideline, directed medical therapy and remain symptomatic. So, indications for use, we've got it here, go through this here. But Co op has recently been updated. Uh There was a presentation at AC C by Greg Stone who showed that the cumulative mortality and ho heart failure hospitalization of this group at five years was 91 5. I mean 91.5 Percent of the control group and 73.6% in the group. And what's important about that is this is a sick population, this is a population that honestly we don't really wanna operate on unless we know we can really make a bigger impact than what has done. These folks are sick. All right. The disappointing part is that very few patients really advanced their medical therapy to include some of the newer heart failure medications. So this is a really important part about the heart team is we've got to continue to work with the whole group to keep everybody honest. Right. Are we just doing procedures? Are we really optimizing patients before we do a procedure? So that's why I'm a big fan of the heart team. This is clip you guys have seen this. This is what we're using nowadays. It's the G four. Um So it of improvements in these devices make it possible for us to treat more and more complex disease. This is not gonna stay the same. Remember, Amazon started out slow but it grew all right. So this is that case that we talked about. So here we are, we're doing our trans puncture. Uh We're crossing underneath the annual plastic band here and you can see us lining this thing up. Um And is this is difficult. We had to, we had very little room to maneuver. Uh We're putting our first device on here. You see that on the right? We got a marked reduction in the M R but we have a of four. So we figured, hey, let's try to put another device on. Uh We came across and put that device on. Here's our second device. We have trace residual M R Radiate six. Now, the heart rate is up in the 70s. This patient feels awesome. All right. So that patient left uh did well and after years continued to do well. So trans therapies, they're here to stay uh replacements kind of what's next to come. Uh This is what I consider the holy grail of trans therapies. That is something we continue to strive for but continue to not achieve yet. Um uh I guess first year I got the expansion on tier, sorry. So expansion on the pascal device is now um achieved approval through the FDA. Uh we had a uh a study where um at the uh EFS trials after two years, it showed sustainable and favorable outcomes in both E M R and F M R. Uh Essentially the, the trial results showed that it, it was essentially the same effectiveness as Micro Club. Uh And here we can see our uh this is a post pascal implantation uh also very effective. Uh The two D, two F trial, uh the two D trial finished. This is the uh degenerative M R trial. Um where Scott and I and Linda were the uh uh P I s of this trial. It was non inferior in safety and efficacy to micro uh functional and quality of life outcomes were the same and the M R outcome was durable after six months. So this received a approval and, and I think what's really important here is I was involved in this trial as a surgical investigator, but I'm an implant. Ok. And I think that it is very important. I, I, we do this as a team. Our team is very different to a lot of places. But in our uh our tier therapy uh uh procedures, it is our structural intervention, echo person at the head of the bed. It is a surgeon and an individual cardiologist who do all those procedures together. There is no one of us who makes all the decisions during those cases, we all work together as a team. Um What's really important is that uh these, these therapies are gonna try to work to continue to challenge us from a surgical standpoint. The repair M R trial is looking at patients who are older than age 75 or 65 with multiple comorbidities. Uh what we would consider a moderate risk for surgery and they're trying to see does micro clip have and is it non inferior to surgery so that it may become first line therapy for individual or for intermediate risk patients who have severe degenerative M R. The primary trial is actually looking at low intermediate and high risk patients uh who are 65 or older. This is the C T S N trial. Um and this is gonna be a 1 to 1 randomization for superiority. So surgery has to prove that it's actually better. Uh then tier therapy in this group and it's looking at uh primary outcome of uh recurrence of M R three plus uh or greater at three years. The good thing is it's a longer follow up. The other important thing here is we're actually gonna have 10 year follow up on the entire cohort, but also looking at a number of secondary end points. Um The primary end point is always one of uh considerable contention and one that continues to be hotly debated. Um Moving into now replacement therapies. Uh The really fun part about my job is I get to do a lot of surgery, but really investigating new devices is a lot of fun as well. Um Because I think we're getting closer and closer to really getting to some of these breakthroughs, but we're not there yet. Uh The 10 device uh is a um trans delivered uh micro valve replacement. It's something that kind of globally we have the most experience with it's actually approved in Europe. Uh The summit trial is the ID and they actually have a Mac arm. Uh that's uh that's been significantly used. Uh And it's pretty interesting some of these outcomes, uh successful implants and 97% of patients and at two years, they all cause mortality with 39%. And a relatively thick group of patients who are not candidates for surgery. Um Player, hospitalizations were reduced by half uh compared to what were historic. Um and an improvement in symptoms were sustained at two years. This is a pretty good device. It's a, it's a morbid approach for delivery, but it's a, it's a pretty good device. Uh The intrepid device is now the centerpiece for the Apollo trial. Uh This is the uh uh the device itself. It's, it's got this kind of unique frame uh that uh with a valve that sits in the middle and this takes a lot of the impact from the away the Apollo trial is ongoing and we look for uh eventual uh results from that. But this is an example of how the device looks, sitting in, sitting in position flows really nicely and in, in the right anatomy can fit well. Um We also have comparisons here at the summit and the Apollo trial. Uh Last we have the evoke device. Um Currently, this uh this trial is, is kind of wrapping up. So we'll um eventually be able to hear how the evoke and eventually turn into the uh the trial or the EOS device, um how those results uh ended up. But the delivery system here is really fantastic. This set of knobs at the end of this allows a number of different maneuvers to be made with the device so that we can really implant uh this system into a perfectly placed uh position. Um And what was really neat about the E OS device uh which you can see right here in position and working and you have complete resolution of micro regurgitation, the device sitting nicely in position and this device is actually um set up so that it could be retrievable and reposition. Uh And here's the example of my um the challenges here, these are high profile uh and uh devices with a significant risk for L V O T obstruction. Um In certainly in 10 9, you have the access management uh man the devices uh when going trans is improving significantly. Um Malposition is definitely a problem. Uh And post operative heart failure is also an issue. So lots to be learned still. Um And what I wanted to do is kind of kind of go over where now minimally invasive techniques and trans therapies cross. Um This is a special case of my trainer calcification. I will say that um there's been a really growing interest in this group of patients. Um And I think it's largely because for so long, they were really hard to do anything for. Uh I know you guys have had a great series of, of really good outcomes. Uh We have now taken on for Bad Mac who we don't feel that there are any options uh for we've taken on using bloom expandable valves and my trainer calcification. Um I do worry that this group of patients has a lot of unknowns about them. Um We don't even know necessarily what happens if we just let natural disease go its course first. What happens when we operate and how do we balance that risk benefit ratio? So I usually will only offer this to patients who are markedly symptomatic. Uh But uh you know, these patients have a lot of complexities that baseline with valves, they come in in all sorts of shapes and sizes, the ventricles do as well. And we're gonna try to put it a balloon expandable valve down there in the calcification. Uh We came up with this concept for uh uh excuse me, other programs have been using it in the open technique uh for surgery. Um What we did though is uh cut out the anterior in the mid portion just at a two. Um actually put in a cup which helps reduce the risk of violation, but put it on the annual instead of on the valve itself. Uh And we do this to reduce PV L and the risk of violation and we do it through a minimally invasive approach. Uh First reporting it was a port access approach and now in the setting of isolated disease, I routinely do it robotically. Uh So this is the result of our felt on the annual technique. We have 51 patients, 90% of them were in threes. Uh Most of them are size 20 nines. We had cases that where we had 12 A V R S 21 myectomy. Uh 15 cases that we had uh custom valve repair or replacement. 75% of these were done minimally invasively. And our 30 day outcome showed uh 13.7% mortality, uh one year outcomes with 33% mortality. This is a sick group of patients, but those are actually some of the best reported results. Um Our ourselves with uh uh Isaac George uh have come up with kind of AAA growing assortment of cases that we're pulling together and been working on publishing that in a uh multi uh multi institutional multinational uh uh data set. So this is a 64 year old gentleman who had mantle radiation for his hodgkin lymphoma. He's a history of cabbage uh at A V R with a Toronto root replacement and it kind of the Toronto root that's still out there. Um He has a pacemaker in his E F is down and severe MS with M R. This is what his C T shows and you can see how bad that calcium is. This is not a traditional surgical patient. So here's our video. Um You know what this is, forgot to ask if there's sound of these. We'll see. OK. So I'll talk you through it. So here's the C T scan as we go through it, this is the uh distribution of calcium. You can see there's actually no post here. Calcium. In this one, this is when you're doing transcatheter therapies for these, you need to have a pretty robust distribution of calcium. So in this one, we felt it was better addressed robotically. Um So here I'm cutting out uh the mid portion of a two. Uh I can only take out so much because the calcium is, is really thick right there. I put in a uh a semi rigid balloon here just to work on sizing. This is a 28 and I can still see that there's gonna be some difficulty with uh PV L issues. Um So I place felt that goes down and I secure it into the, or even just into the leaflet tissue as I'm able to. And what we do is we just secure this down and we put in about six or eight of these sutures. So I, I, what I've done is I take like a traditional uh micro valve replacement sizer, um usually a size 29 I'll go around that with this and add an extra centimeter and then I divide it in two. So it's just easier to manage. And then I'm basically encapsulating the calcium here with this belt and just creating a better scaffolding uh for placing a, a balloon expandable valve into. Then we secure these down to three knots here on each one of these, we resize it to kind of see what our fit is gonna look like. So it's looking pretty tight. Now. Now, what we're gonna do is we, we've got our uh 29 CP three on the back table that's being prepped. I align those tabs with the uh Triones to make sure that we keep the outflow track open just like we would. If we were doing a traditional valve, I pull it as atrial as possible. The Triones, those little uh tabs at the end of the valve are basically the tabs. And so if we can match that up and pull that all the way back to the felt, we can pull this valve very atrial. You'll be able to really appreciate it on the C T scan when we're done. So here, now I've expanded the valve. Uh I'll pack it into position uh with the sutures that we have there. This will help reduce the risk of and then we secure these down with and we'll go all the way around with that test it. And I see a little PB L over on the left side. Uh I'll re expand it with now about plus four CCS in the balloon. Um There's a lot of recoil once you try to put these into a bunch of calcium. Uh So this really helps to try to get good optation with that. Uh that um there's still gonna be a little PB L over here uh that you'll see when we test over on the left side up in that lateral trigo. So instead of trying to come off and see what happens, I create my own PV L closure device and we'll stuff that in there and secure that into position, lock that in. Alright then this is what it looks like afterwards. So, excellent results uh gradients uh run 4 to 5. I've seen this guy back now for a couple of years uh since having done this, uh This is what it looks like and on and this is what it looks like from the side. Uh And I always get C T scans at six months out to make sure that the leaflets don't have halt. Uh I put everybody on an uh you can see that we have zero output trackt obstruction. Look how far back at this valve sits. It's because we can do it under direct uh surgical supervision and we don't have to have it deeply implanted um because we have that cup that allows us to pull things more at. So our L B O T risks are, are much lower. In fact that new L B O T was uh 3.45 centimeter squared. Uh So concluding here, I wanted to just make a quick mention about the heart team. You know, cross functional teams are really important in business. We see this all the time and it's increasingly becoming important in medicine. Uh heart failure shows this in cardio, in the, in the cardiology world. Uh These are my two mentors, the hard team approach, which has been Mike Mack and David Brown. They did syntax together every ta trial together and realism. Uh This is what our heart team has become. Now, this is just our bet. Uh team, the team is an even bigger heart team. Uh So far right now, we have three surgeons who are active implants in trans cat devices. Uh myself, uh Doctor George and doctor uh all implants from a surgeon side. Uh as well as we have three cardiology implanture. Um heart teams are a class one indication for patients with heart disease, uh who are have complicated, um who have complicated disease. Uh And so what I wanna make mention of from the surgical side is um if we don't put effort into these, into these developments, if we don't put effort in a minimally invasive surgery, if we don't put efforts into being involved in heart teams in trans cat therapies, we should expect nothing out of it. Gotta, you've gotta be present, you've got to go down there and work with your cardiologist, make friends with them, get involved with the transcatheter therapies uh and show them your value with your surgical work as well so that you really have a robust team discussion and then what you do is you wanna take that uh and take what you've learned and then start to share it. So it was our pleasure to have Mike come spend some time with us. Uh It was an absolute joy. I've loved it and I've loved getting texts and emails from him showing all the great work that he's doing and I expect him to be able to do exactly what I've done down in Plano. Um, so good luck to you all up here. Yeah. Um 35. That um strong point. Alright. What, what this robotic uh we want out here? How does robotics? That's a lot of a pretty routine question. I think it's important. So, number one, I think the transition to port access surgery from Strey is an excellent one. It's a great step. If that's, if that's what you do. Awesome. Right. We're making moves in the right direction. The difference is most people who perform port access or, or mini surgery, use a rib spreader, rib spreaders hurts. And I, that's what I did up until I did robotic surgery and I had a pretty reasonable practice of port access surgery. Um, once you start doing robotic surgery and you get fairly fast out with it, you actually find that the instrumentation allows you to do more robotically than you would with a, with a traditional port access approach. And I would say probably tackle larger patient, physical anatomy. So I've got a patient coming up who's over £400 who will be doing a, a minimum basis, micro valve repair. And I did a prior, uh, former offensive lineman who's running about 3 83 96 ft four. Once you get that procedure set up, it's just like doing any other microvalve repair. I would not have done that case for access. In fact, the limitations of those instruments make it very difficult. And I would say that the, particularly now I'm seeing a lot of my trainer, uh, disjunction and the ability for that to get the needles all the way down and really eliminate that space. It's something that I feel much more comfortable doing robotically than I do for. So, it's not just, yeah, it's even less pain. I mean, because the comparability on that are gonna be pretty small. I get patients out faster. Um uh patients routinely, they're back to driving in about a week to a week and a half from robotic surgery which you know from port access is probably two weeks to three weeks. It's not great differences. Um but it's enough over a long patient series to say that it's, it's a big enough difference to me. Yeah. So there is of course a rate of that's small and some people later on my question is how often clinically or on examination or get an on these people? Yeah, so I do, I recommend for patients to get routine. So we fall in our clinic with yearly echoes for three years. Um I wanna find anything that could be off because the the benefit to pay for degenerative disease, the benefit to patients is a good repair and we can, we can return those patients back to their anticipated actuarial survival statistic. So if something's off, I don't wanna just follow up forever. I wanna be aggressive about it. So, three years ago. Mhm. Then, then I, then I, then I quit with their cardiologist. I asked them to see their cardiologist for yearly echoes. That five years we have no change. I'd say, you know, just get, you know, get an echo every once in a while. It's, um, yeah. Yeah. Absolutely. And, I mean, that's part of what goes along with this and have tons of videos on that too. So I'll, I'll do complete mazes. I'll close the appendage. Absolutely. Do a lot of by mazes. Um uh With this uh the approach robotically doesn't prohibit you from doing tricuspid valve repair. I'll do replacements, etcetera. So, yeah, we, we cover the gamut of any of the hr pathologies. Uh But also I think I'd say, I don't know, at least 30% of the cases I do have concomitant ablation done. Hr uh usually with, yeah. Uh And then for those patients at six months, what we do is get ac T A uh to make sure that we have uh A so we, we follow our uh our L A uh uh colleagues. Uh They've kind of given us the protocols that they use and so we follow the same C T guidelines. Thank you very much. Thank you so much. Go ahead. You wrong. Yeah. Yeah. Yeah. So I, no, you've never seen him in before. We call him little kittens. OK. Hey, you look specifically for she has been here. Yeah. Oh, good, good. Ok, great. Oh, the version, I assume. Yeah, Andrew's here. Yeah. Yeah. Yeah. Um, you, oh, yeah, like that I said, man, I, every time I know, I know.
