Presented as part of the Department of Cardiovascular Surgery Grand Rounds on January 21, 2019, by Samin K. Sharma, MD, at the end of this video, viewers will be able to:
So dr Sharma needs no introduction. And he's the director of the of intervention for the whole health system. And has been for at least since I've been here maybe for the last 25 or 30 years, I don't know. But anyway, he's going to talk to us about trans catheter advances and transported the therapy in the last year. And as you know, Transcanada's therapy has become integral in everything we do and it's an alternative to almost all the surgical procedures that we do. So it's something that comes up every day in our discussions with patients. I thought it's good if he just brings us brings us brings us up to speed with what's been going on In the last 12 months. Dr Sharma. Okay honey, thank you very much. Uh this is uh 20 years for the first time I'm coming here to give the lecture. And of course uh Honey and Dr Adams finally made it, you know, let's say 20 years. Uh the goal will be to just give you update, you know, this field is evolving. Uh trans catheter of al therapy. We did our first new york val meeting was very successful for it's a once a first of its kind on december 6th, about 225 people. So uh and I put together and I updated since then. Actually almost 30 slides have been interchange since then. An idea is just to take you through what Dr anne started. The statement that most of the valves are being tackled are being investigated to be tackled by transcultural therapy is starting, you know, first data actually, if you see what with a polyphonic valve which was very easy with the melody valve and then went to the aortic, then the mitral and the tricastin, all four valves, which is surgical, which of course uh you guys are expert in. But appropriate cases are being evaluated and being treated in clinically or in the trial format by using the transcript rebels Now where the history history started 1989 where this guy Anderson thought that why can't we put the valve future to the pericardium and put in the sheep? That is how this whole field started in 1989. There are the first time everybody thought about the extent. You know, I actually stand before the standard rather balloon that was done by Andreas grunge in Zurich. So the key is that it really has a long history of international cardiology and now for the Transkei travel by Anderson uh and this was called lenders instead extent. Well, there are a lot of sheep experiment that is a valve going to fit how is going to open and close so many issues which comes. So they have a many uh, Ellen crib here is another very uh I would say uh forthcoming interventional cardiologist from France at that time made many designs early stages that how the valve is going to make. And so and I call him as a father of transcultural therapy because he is the one who started, he made the company executives valve technology and They're the first in men case on April 16 2002. So after 89 to 12, 13 years took from the sheep to the human being. 13 years. So basically after the first case he had non surgical implantation of a prosthetic heart valve can be successfully achieved with immediate and mid term human enemy and clinical improvement. And mid term because they published the paper, they had a six month data. But this was right there apparently half hour later after the valve replaced uh translator valve replacement. And you know at that time, early days they were being done as a transept. So you see here very complex issue coming through the trans septal ready to end the retrograde and then go to the vow, see it. So it was transected very complicated procedure many times the system fire caused a severe mitral regurgitation. So valve is working good but patient is in shock because the wire cut off the cold because very severe. So this uh technique was very rapidly abandoned within two years by 2 2000 kind of four. And everything was done then retro greatly by transfer, Meral or other approaches but going back not to the transept, but this was the first case uh in was done in april 2012 by the trans septal approach. With that note. So what we're going to do is go through some of the data in 2018. And that actually has been um and when I started my uh C. C. C. Live C. C. C. Complex coronary symposium. So always put that top 10 advances of international cardiology. Uh Now I have collected 2018, maybe one or two slides will be older than 2018. All will be of 2018 just to give you latest what is going on. And selection is through the change because there's some obligation which has led to the change in clinical practice. And these are from numerous generals presentations abstracts and so and so forth. The first one is the trickiest part value intervention with the tri illuminate trial. So the data from the sts that if you see here the isolated tvr and replacement or repair that mortality uh kind of remain constant. So we all know and I'm sure you know better than anybody on the track has been. So while other valves are good, everybody wants to do it with the troika spit, everyone takes a back seat. Uh whether it's a heart fair doctor, cardiologist or uh Sergent. So because the results are not great with the trigger spitball, then there has been a lot done now. Trust on the trans catheter tracker spitball. And this is a very nice review article uh and basically takes into the various mechanism that how can you tackle the tracker spit. So basically the earliest first stages were hetero tropic cable valve implant that you put a val into the superior inferior vena cava. So you're not working on the track Casper directly but indirectly by decreasing the regurgitation. So this was the first of its kind started then second was cooperation device and one of them called Formiga basically kind of a balloon on the tri casted valve so it is space occupying nothing with a vow just decreasing the regard it and orifice. And then led to the various clip which I'll briefly discuss then of course the future just like we do for the for the middle valve and replacement of the valve uh and annual plasticky followed by the trans catheter tractors with valve replacement. So field is evolving in all, starting with the Vienna cable implant. I would say it has gone into this clockwise direction. There are very scanty report of the t t v. R. But it's there. So what has been maximum data is as to as repair rival registry. It basically same what we use for the metal clip that clip used for that trikus without. And basically based on the cooperation that where is because we know that if the gap is more than seven millimeter, it's it's difficult to get a good results, but if less than seven you can grasp that bicuspid valve. And overall the data have shown satisfactory results, particularly if it is less than seven millimeter gap For more than seven. Your success rate really goes down. Sochi is some cases of the tractor spit valve can be grasped by the, by your regular Mitel clip. And this is a part of the tri while registry then you say, well, why don't you make a clip two suitable for the trackers Federal, which has a bigger pranks compared to the regular mitral clip. And that is a trial illuminate trial with a try clip. And this is a trial has started for 85 patients. 15 centers, uh Foreign Us. Uh uh The Gilbert is the P. I. Here with primary and point being a tr reduction say government, right timing. Uh more than one grade at 30 days. And of course mortality file about 233 years. So we are done four cases so far for the trial illuminate. And this is again uh easier way, very low complications and uh appropriate cases can be done. So a lot of data are coming into the trial attack has been field which I mentioned that which where it will should fit primary or secondary. All these devices have come up uh is kind of indication by first in men data for based on the path of an army of the track as regards where these devices need to be used. So Trackers Whitfield has started central cerebral protection device. So basically we know when we do the tower the embolism takes place just like even surgery uh because the two regions one the calcified valve and secondly we advance the device to a very disease in order Because it was done for the elderly patient. And if you put a filter into the Karate, the data have shown almost 100 time you'll get some symbolic material. And that material could be no calcium Could be a tissue, Trauma's the clot. So many factors, many uh the factors could give rise to this uh embolism during tower you and the oral stroke created about 4%. So once you have a good neurologic assessment of course, once you have a more rigorous assessment Maybe higher but about four with the deficit if you take a micro only with the MRI. That happens in 60 70 of cases. My MRI deficits. But for the gross deficit uh cursing about four of cases. So that led to a trial uh using the central device and look at this very fancy. It goes from the right radio, the one party state in the right and nominate and then goes and to the left side and basically left karate. Uh so idea is there any embolism comes? It can can be captured, then there's a whole technique and the catheter, you can close it and take it out. The only thing is you don't basically take care of the vertebral, particularly the left side. And what trial data showed Because was a trial about 200 patients That there was 42 reduction but did not make AP value. More importantly, that basically the gross or the euro deficit decreased from 6 to 4%. So clearly about 33 reduction. 30 days for identical. That led to approval of the device. And since then we actually have multiple papers in 2018, a few of them actually showing even reduction in mortality by using the device. So overall 5% has become 1 to 2%. So as since it was approved last year in june and there's an added cost of 3500. We went through the process that how do you add the cost of this device to already expensive $30,000 Tower val. So it seems to be the appropriate cases. You cannot use sentinel everybody but about 30% are excluded because of their not me because the way to Catherine uh this Catherine has to fit in about 70% if you make it a routine used particularly patients were if multiple cV age in the past. And so those are appropriate. So that is where we started routinely. Edge of september last year, september and so so now every case if you're not using sentinels making the report that why sentiment was not used. So we make it a default therapy and then you can see many centers like zero sina. And so once they started using routinely 5% became 1%. So we still have to collect data at our center uh because we will show you the our uh that our comparison with the sts were a little higher uh stroke rate, maybe whatever the regions are. But I can tell you in the last four or five months has done tremendously well when you're making it a routine use of the central device and of course and really document why you're not using it. So question also comes that various devices have different types of uh, CVS incidents. So there is some one paper came out last year about really analyzing this debris which is captured in the sentinel dual filter and it shows that you can see everything the vessel valve calcification, myocardial, me one uh necrotic core. So all can be captured in this uh debris uh in the in the And the filter approximately the still filter as you can see now. 2nd point important was the size of the particular size. Now you see here the basically the three types the self expanding uh and uh the SAPIEN valve and Edward. And you know those when boston scientific lotus that seems to be that in Edwards SAPIEN the particle size is a little bigger. So does it mean that it cost me a little more CVA compared to the smaller one. This will show some data, they're very conflicting but some studies did show slightly higher severe rate with the center with the SAPIEN valve compared to self expanding well. Although it's again it's not inconsistent, but it shows that many times in the SAPIEN when we deploy, based on the study that you have a bigger particulate size with the SAPIEN. But then anti traumatic therapy post our just like for any that you want to give more, you're putting a foreign material. You want to give more anti traumatic therapy because you think that it is going to create less embolism. And so, so anti traumatic plus more bleeding risk. Maybe in terms of mortality if you don't have anti traumatic, the trump, shambolic risk and structural val deterioration. So single anti platelet therapy to the duel to the and the empty by anti coagulant. So basically what has happened without any clear cut randomized trial when the process started off the top, both actually for michael clip as well as for tower. So we made aspirin plus clopidogrel, aspirin 81 mg lifelong and copy girl girl 75 mg, 3- six months. It was routine for But some cases have been done with a single anti platelet therapy also. So that whole question was knowing that back many years ago when aortic valve by prosthetic needs to be done. They used to use a short term three months. Nt probiotic therapy. So question is should you use antique robotic therapy routinely? Not because it was indicated for ff another region but routinely. And so. So what has shown that bio prosthetic valve dysfunction which is defined has been graded more than 10 or new mean gradient of more than 20. And prevalence occurs in about 5% of that our patients and it basically cause there's a rhombus and you have moved decreased movement of the leaflet to leaflet uh with thickened and decreased movement caused gradient and its associated with some C. B. A. So a lot of data actually have supported the use of anticoagulants because they found that if you are on anti coagulation the chances of val deterioration is less. So this was the old concept. To me it makes sense that maybe we should be using oral anti coagulants whether it's a warfarin or no access in this patient to reduce this uh stroke rate. So there are uh And the two piece of information in 2018 to really answer this case France to the registry. This was the data of again no randomization. But the patients who were on uh same. There were many protocols they were using anti calculations and then uh they were compared the patients who were getting anti coagulant versus not anti coagulant for two purposes. One follow up at 3 to 4 years and secondly, valve dysfunction. Guess what happened? You use anti calculation your higher mortality, not for every patient valve in the registry. Use anti coagulation. Higher mortality. Second, yes, if you use it, you have a better in terms of your valve dysfunction is less. So now you're dichotomy, you're better val where patients are dead. Not a good thing. So it seems to be saying, well, you know what it's about non randomized data. So people like, you know, uh brushed it off. You know, it's a registry. There were a lot of editorial on that issue. So, well, again, uh this is basically the two dichotomy. As I mentioned, there are actually six trials our on going to answer that question in uh if patients or non if patients using anti coagulation routinely uh in these patients. Uh and comparing with the single or dual anti platelet therapy, the most important was that Galileo Uh Initiative River rocks even 10 mg with aspirin Or three months, adapt and after 30 days remains only river Ex Urban up to one year. And then aspirin. You take the clopidogrel out after 30 days. So basically what we're comparing patients not in ff giving routinely 10 mg. River Ex Urban instead of clopidogrel. Simple makes sense. That's what you want to do. Right? That's what in the Sergey I'm sure. I don't know whether uh used to use a doctor soldier entered from body therapy. I know back in 1992 dr grip used to given by a prosthetic three months. But I think after a few years that was even taken off. But they used to give antibiotic therapy. So that was the whole concept to give it for three months and the trial was eliminated because of the higher mortality. And guess what happened? Do you have a all costs that are bleeding by giving routine anti coagulation? But this field, so for the time being everybody has taken a back seat giving routine antibiotic therapy is not approach not a good thing. Then we have envy says this is a trial is still ongoing. The patients who are on indication for oral anti coagulation, warfarin versus uh no X. Because there's no data that should be warfarin or no X. Because women know X. For the prosthetic aortic valve, mitral valve so is not indicated. So question is, can you use no X at least in the try and scattered of all. And this is what trial ongoing. We are part of it is still ongoing at present. This will be the very interesting when Atlantis is still ongoing and that is the two types of patients who needs oral anti coagulation will be randomized to Warfarin plus epics about five mg twice a day. We're not early anti coagulation apex, even five versus single or dual anti platelet therapy, 1500 patients. So we'll give us answer in next few years. So this actually has come up with some of the guidelines already. But if you want to give in, I'm sure this is earlier at present. Everybody will say don't give any anti coagulation to these patients. And single anti platelet therapy is good enough in many of these patients tower for periodic regurgitation. So problem with the aortic regurgitation is pure S calcification gives a vow if your periodic regurgitation, you are in trouble because what anchors the val, the no calcium, so therefore chances of a parallel or league val embolization is significantly higher. And this actually lead to a registry of a religion nation versus newer generation. Transport travel in and all types of AL has been used predominantly in the past. Used to be the self expanding. But now even the balloon expandable valves are used and overall showing that the outcome of the newer generation valve for pure aortic regurgitation are okay. Uh And this actually put into a nice against central figure that overall regeneration was the newer generation having a better outcome. But again, these are the patients who are extreme risk or high risk not going for surgery. But yes, for there are data now that native aortic valve regurgitation you can use uh uh these current vales but at the same time studies are ongoing and few of them general actually already have some publications like five cases. They are a little more. So basically the new valve, there's some hook see that. So basically go into biotic wall. So keeps it there in this pure aortic regurgitation where there's no calcium so it does not symbolize. So then there's a new Tower indications so few of them. The one is the patients with moderate to severe ears, bicuspid aortic stenosis valve in val moderate aortic stenosis with chf low flow low gradient and early tower in asymptomatic patients. So I'll take you quickly through the low flow low gradient disease. Basically E. F. Is less than 50% The low flow low gradient. We always believe that you do. Do you mean your gradient increases? The stroke volume goes up by 20%. Those are the ideal cases is a true severe ears. And those patients then should be uh undergo tower based on their ex tree in the in the intermediate higher extreme risk. So question comes that if the patient the gradient did not increase but value area increased because of a stroke volume increased. So this is a siro uh Yes should this patient be treated? And there is a trial called tower and load and I'll show you that later. So then the question comes that what about if you did not have a change in the stroke volume which we do the vitamin stress routinely. So this actually is answered by a study called Topas Tavi Registry which are registry cases two year follow up and now you'll say that overall death rate of 1339%. These patients probably acceptable if you don't do the valve probably it will be 6070%. And these are the other individual and point the COPD low hemoglobin value moderate to severe our post or the individual predictor of uh the subsequent bad outcome. So now very interesting we learn from this that when you give w to me stress echo for these patients with low flow, low gradient, half of them will have a contract. I'll reserve the other half did not. So what I also learned, what were the common teaching because surgery, surgical data work. That if you don't have contract will resolve this. Go for surgery. They do bad. And what about the tower you see here, your contractor result or not? A two year outcome were identical. 2nd. That increasing ejection fraction but not determined based on the contact I'll reserve. So it seems to be that patients are low flow, low gradient symptomatic. It's appropriate to just go and do the tower. And that was the editorial that tower in Wt min stress echo out. But I'm a little extreme. But just to say that our decision based on the DSc and this is a non randomised large number of patients that opens registry showed that good outcome for these patients, irrespective of the a stroke volume augmentation. Now, what they also found that in this registry of this to pass that if you're paranoid paradoxical low flow low gradient, the E. F. Is more than 50% but low flow low gradient, they do very badly with the dollar. So for that matter anything, those patients don't cover surgery. Their treatment is aggressive reduction of their diastolic of more management of diastolic dysfunction so that they all because of left ventricular hypertrophy, high blood pressure and so and so forth. So then uh the question had been that the low flow low gradient. I think everybody believes that there is a cd. You try to uh do pc. I also because many of these patients are ischemic uh and sour tower compared to medical therapy. do better. So now what about the field by process? But the drought. So this I'm sure everybody will agree that you have bio prosthetic and so far we have the data. This is the value in. Well that's actually the SAPIEN. Usually we use the core value uh in these patients. And uh with immediate very good human dynamic regions, some gradient always It remains about 10-25 mm Mercury. But no regurgitation. And studies have shown when you compare this is a valve invalid data. And this is a native valve. That valve in valve does very good actually better then. Uh your native valve. So overall so valve in valve like women. Again I may be biased in this. I'm sure many of you will also agree that this kind patient already have a surgery. Probably valve in valve should be class one irrespective of the uh there uh the sts risk score. But right now we still have to go through the same and it's approved only for high risk patient. But just the data are very clear that decrease hospitalization, decreased stroke and mortality of valve in valve compared to Native will only she remains higher the coronary obstruction in this case is uh whether it's a less than 80 or more than 80. Clearly the valve in Valve does quite well. Also we learned well on expendable versus self expanding. Their self expanding have a lower Reginald gradient. So clearly that we prefer self expanding val in this situation compared to balloon expandable. Whatever the bicuspid valve. The problem with the biker spirit, it's clearly surgical disease, partly because of the anatomy of the valve associated errors, apathy. And there is a lot of calcium can go annual, a rupture, not a good seal. And so and so forth. But again, there are patients which cannot go for surgery. So we actually really generation was the newer generation device with a better seal. So less regurgitation are rightly placed while apparently have a better outcome compared to earlier generation has shown here in terms of parallel or leak and subsequent second Valium plantation. And so then is the one which is very tricky is what you do for a symptomatic several years, which happens in about 4050 of cases. And many patients there followed whether it may have severe ears, but no indication you do stress test negative. We can say I feel fine What to do with this. This is asymptomatic heirs. Now there are data if you follow these patients uh without intervention. Uh let us being from Taniguchi that overall you have a 3-5-fold mortality Compared to your standard surgical valve replacement. So this is a very nice data avia was a conservative that in five years you're almost 11 mortality in favor of injury to wait and watch policy. Why that happened largely because I got explosives causing myocardial fibrosis second. Even if you have created that the cardiac damage, you do have surgery. Though many of these patients because more fibrosis has occurred, the correlate is still with a bad outcome and follow up. And there are many the trigger points are coming particularly uh we'll be checking the brain naturally peptide or serial echoes. Looking for L. V. H. And so maybe those cases you intervene. So that led to the whole issue is should you intervene in this case is symptomatic surgery. We know that this is surgery has 1 to 2% mortality. And uh if you if you don't do it, there is 1 to 2% death rate kind of equipoise. If you can make something better knowing that we have some data that may be short term mortality look better with the tower. These patients led to this trial early tower trial and basically this is patient with the CVS. If they're symptomatic or positive stress test, they get whatever needs to be various trials which were part of it. But if there is symptomatic will are being randomized with a transformer tower versus clinical surveillance. So here is the asymptomatic. So key is that you are low uh complication of the tower. Maybe that's the case. If you have less than 1 30 day mortality, maybe it's a reasonable case uh for tower rather than continued surveillance. So this is a big trial ongoing. And Dr Adams promised me after the good if the low risk trial data comes out good and March, we have been invited. We work very hard to be part of it that they will allow us uh to be part uh 1100 patients. They're having, you know, these are very few patients, they even company itself having a tough time to enroll, but they have done about 300 plus cases so far. But the whole idea is that should you do early tower in these patients. And so so this actually is a very interesting data. 2nd is unload. We know the moderate aortic stenosis patients is coming back with heart failure. What to do with this case is so there is a trial of 600 patients after optimal heart failure therapy versus you combined with the tower with a value area between 1-1.5. So this is the unload our trial. They're actually having a bit of time to enroll these patients and we didn't ask to be part of it. But definitely early tower to me I think makes sense. Then we are going with the various vascular access besides federal or subclavian or director transit. People already abandoned with the two new things which are coming is a transfer cable that you go from the Vienna cuba puncture and then you put up Plug in the end. But she's from Vienna cable to the Aorta and Go Retrograde and 2nd is a Karate. A lot of data coming from the karate. Then of course appropriate patients putting a tower val through the karate. So then the PNVR trials. So basically a lot of just like the uh for the aortic, a lot of devices are being uh the in trials first in men in development for the middle space. A few 10 cases, 20 cases, 50 cases. Many of them then got installed because they had trouble trying to understand. So what really has gone to is the randomization is the first val is the Apollo trial with the intrepid of medtronic dr David Adams with the national P. I. With the surgical P. I. And dr uh marty leon is the international P. So this is the first trial of randomized the my P. M. We are of course they have registry high risk intermediate risk randomization against surgery. And of course we need to see the data for their own so that we do have some data on using that SAPIEN valve or various of this situation. Mac valve in ring or valve in valve. And basically world is making no good plus minus for the valve in ring. Very good for valve in valve that led to the publication in european Heart Journal of this uh large registry of degenerated valve 500 plus cases, valve in valve valve in ring and value in MAC. And look at this one Outform converted into surgery. Very bad in mac 2nd, 30 day outcome. This is Val one, Val Baldwin ring well and and MAC success rate Continue to decrease very high 30 day mortality, all complications. And now you see at one year, almost two third of MAC patients have died. The question is what good it is. We are doing a technique. I'm sure if you don't do, maybe they'll survive over 30 40%. Anyway, so the message here is valve invalid. Mac is no good appropriate case valve in valve is okay. Ring plus miners. But definitely the valve in valve, very good outcome. We are for these cases and they did author try to say well if you survive 30 days then your outcome is not that bad. But I think overall and we actually have at Sinai uh not done any valve in valve for Mac. We have done we do about four. We did in 2017 and six last year. Uh there's 30 m we are uh using the SAPIEN and of course the polar trial ongoing quickly. Few other which type of value should use. We have one old trial called choice which showed that data at one year. Whether your balloon expandable or your self expanding the slightly lower stroke rate with a self expanding well numerically but otherwise identical except higher pacemaker rate. And then we are trial called salt to be presented in T. C. T. Two by two randomized trial. Self expanding versus balloon. Expendable or general anesthesia versus local anesthesia and basically uh very interesting trial to show. So whether you use any val self expanding evaluate recipient similar outcome. Although numerically your lower stroke rate in this study with a valued compared to SAPIEN. Maybe it's because of the larger particular size which we saw in the central device but a pacemaker definitely higher with the evaluate compared to SAPIEN. And these are the individual endpoints. There's not much difference as shown here but safety and point which they made slightly better for the evolution. Then anesthesia basically you do general versus uh local which is what we do in 75 80% of cases. Again no difference except that what they found that medication much user higher in the general anesthesia compared to local anesthesia. So basically we have the correct protocol that's what me ourselves uh myself Kinney and Gilbert we follow we decide every case which one we should use. And these are just some data, particularly high calcium. You want to avoid using sapient and if you are you need to pace the ventricle, you want to avoid using sapient and anytime pacemaker then SAPIEN is preferred or very large. Angeles. SAPIEN is a good val But otherwise we have about 50, 50 both of them are shown here. So korean Geography. Post Tower which is one big issue. Uh There's a lot of papers about it. We did a lot of work because we have published the korean geography one time in the aortic aneurysm cases back in 94. Then we did in 2000 and anomalous coronary arteries, korean geography. So this is our field. So we did, I studied a lot of patients after Tower host our to do the in geography is very, very difficult to engage, particularly with a self expanding while. And we went through all cases literature and came up with a great plan. And this is actually central figure made by Gilbert all night when you are ready to send it. Fantastic just to put it together that how difficult it is to uh to do angiography in this patient. Because sometimes the valve leaflet can come in front of the left main. So we did algorithm based on our experience whether you do a self expanding or and the PC or cat and or same thing for the balloon expandable seems to be balloon expandable is not a problem. Is the self expanding. You really have to work on it. The tower for low surgical risk patients. So basically you remember the partner trial and then our Carvel should benefit of Tower and then we did for that was extreme risk then high risk. Both were identical except higher stroke rate in early stages because of Edwards SAPIEN 24 french while then subsequently the high risk trial dr Adams being pr here, no difference. Then we do partner to weigh and set a V. Two years now we're just about five year data. Both were identical outcomes. No difference between two techniques selected patients. So there are some data to say maybe in the lowest group if your sts in less than three maybe while uh for surgery point of view, your outcomes are identical. But for the tower, your outcomes are much better if your sts is low. So this again, this is just the sub analysis of the soil to be. So basically anyone intermediate high risk, extreme risk. And so uh Tower or of course appropriate cases. Tower cannot be done surgery but this group sergio versus tower less than 3% sts have been is being studied in total four trials. One already published, two already done and then fourth one is ongoing. Called notion to. So basically the notion the original notion trial showed five year data comparing one. Tower 1 45 or six surgery 1 35. And you see that exactly uh identical outcome except higher pace. Now it seems to be an STS was three in these patients. So seems to be that low risk will be identical then. And the latest very, very I was prosecuted data from brand waxman of the Five center. They were actually ask us but we could not participate in this run waxman did ask us to be part, they did permission from FDA or prospectively. Tower randomized Tower enrollment, no randomization, 200 patient with a low risk estimates of less than three. And then compared with the historical control of the surgery surgical valve. So I mean it's not a true apple to apple comparison but this is what they did overall as you can see here. Uh and basically found lower length of stay expected what you'll see with the tower. Uh And so uh and uh the more importantly the leaflet there there are same city Analysis that seven of patients have some wild dysfunction and they put the central figure very nicely. So in these 200 low risk patients, what are the data? 30 the clinical outcome? zero mortality, zero stroke permanent pacemaker in 5% 50.5% mild parallel or leak. And just there's some academic density occurs in about 7% of cases. So we need to be careful what to do about it whether it's appropriate a full expansion and we learn more that which patient developed that believe technique which can give trouble but very, very provocation and encouraging data which will lead to Partner three trial has been done to 100 patients. One year end point of the transformer tower was a surgery all cause mortality stroke or rehospitalization at one year will be presented in March on March 17 2019. Then hours you're part of medtronic evaluate low risk Tower 1200 patient primary endpoint was two years death and stroke. But if they allowed to them present interim data of the one year because field is so hot. One year data will also be presented for the evaluation. So, you know, I don't know however they allowed it but they did. So they'll present veneer data. Uh So so having said that, so as I mentioned that all high surgical prohibitive risk intermediate tower was classed away. But european guideline already have changed it to class one based on that subsequent data. Now of even intermediate group with the Saturn v surgical avia or whether Tower this group is only one needs to be established. Having said that this is pending results of the low risk our trial in a C C f D has allowed direct access to power in low risk s under continuous access registry for both SAPIEN annually trial. Well, so now we actually started doing these patients because we're losing these patients to Colombia Colombia started about three months earlier, september and we started only in november. Now the low risk patient appropriate. They still have to present to the company and then if they're appropriate, can be part of the low risk registry. But they had to sign a consent for that purpose. So, lastly the most important advance, which I'll just go through very quickly because everybody has heard about that is the metal clip or functional mitral regurgitation. Go on trial. Basically. We all know that primary um are is a surgical treatment repair is better than replacement. And of course the clip is used for prohibitive surgical risk cases while secondary AmAR will sign medical therapy. CRT and surgeries only selected patients. What about using the clip in these patients who were recurrent heart failure. The two papers, two studies were presented last year. One is the mitra fr Evaluate the efficacy of the clip and basically short that while success rate is quite good, about 96 half of them get more than two cliffs. That's what the good. I would say the results are so less regurgitation outcomes were neutral. No benefit of the clip in this group of patients. Then uh with 12 months follow up a rehospitalization. Then two months later this was in European Society of Cardiology. Two months later we have the data of the court trial which is mitral clip with guided medical therapy versus uh medical therapy alone patients. The severe um are very strict uh randomization, heart failure. Person has to give okay that we have failed all the therapy and CRT has been done in all those half of them. Now these patients appropriate for randomization. So we basically showed to no music to our ears That the primary efficacy endpoint of repeat hospitalizations decreased from 68 to 36 at second and then overall efficacy point of view. And they're a little better outcomes. Procedural in the coop trial compared to what we saw in the maitre far. And more importantly, look at the mortality 46%. If you didn't use the clip versus 29%. Remember when the tower first came in partner one B. You know, what was the difference 50 versus 30 at one year. Similar data in these patients are particularly the patients who are for heart failure all cause mortality. And so and more importantly, which was very interesting was the need for Albert or heart transplant significantly reduced in the group who received the clip. So very dramatic data. So question always came and they're still trying to analyze why these two trials were so desperate different results. So one of the things which I have to again, I'm not a echocardiogram for but why? What I could learn is that in the might try a far. These are the cases regurgitation was a little less but the LV cavity was too big. So you can call it a burn, the stage burnt and the state's cardiomyopathy. So clip did not make different while in the court, they're still not into their birth stage. And we actually have that data, you know, for hypertension trial simplicity when we did the trial in the four patients would require four drugs. The device failed to do it in the real articulation, reasonable, real narrow ablation. But now when we did it for moderate hypertension, the generation work. So I think it has to be once you go to the extreme group it's not going to make any difference. And so so of course this we're hoping to get to use approved very quickly whether it will happen or not, we do not know and then really will make a big difference. And I think that was the biggest trial which everybody nobody predicted. I can tell you the that our pundits are mean or structural gru's who thought nobody could think that there is a clip will decrease mortality almost in half a besides decreasing the hospitalization in this patient so just put it together very quickly that what we what did we learn in 2018? Changing clinical practice. Tm We are for MAC. Anti coagulation. For Tower. My triumph are no good negative D. M. V. R. T. Tv. Our balloon. Now the tower for bicuspid aortic valve to pass for low flow low gradient Salta. We we got some answers that reasonable then sentinel protection device. Tower for pure ai and korean geography two plus the real data. I would say. The value in Well Tower very promising co opt in F. D. Fmr and power and low risk all seems to have very good good future with the greater gels for better intervention and patient survival. So hopefully in the time to come we'll hear more and more about this field expanding further and I'll stop it here now. Thank you very much. What do you think? Mhm. Any questions? Yeah. Yes. Question that always comes up on both the surgical and the prevention side is durability. And unfortunately we hear so many different answers. I'm not afraid from cardiology is saying stretch the legs valve last six years to 10 years. We know that the average is about 12 to 15 years, maybe 20 years. And why is this such a discrepancy? And that seems to be no one knows that durability of tab are valves and we're moving younger, younger, younger and lower and lower risk. So we surgeons always ask the question is this an appropriate therapy for someone who is 55? If we don't know the durability, we know what the durability and stretches about, but it seems to be such a big dichotomy. Who answers that question? If you hear from a cardio Disease five, the sexiest. Both some of this radical valves which we know it's not true Vehicle. My surgeon was their 15 to 20 years. So that may not be completely true. But no, but that's a very, very important point. Now. You know, all the various trials of the tower, the high risk, extreme risk intermediate. They were randomized so quickly while low risk had a tough time and precisely for this. I know even our cardiologist, he said you know it's a great case what to be part of low risk. But cardiologist said no, no, no, no, no, it's a 65 year old. I don't know what our going to last for 10 years should go for surgery. So key is what is the durability now? What we know for sure based on the data. Because remember the partner trial they have done back in 2000 89 and then follow up the, you know, randomization, that initial data. So we have 5 to 6 year follow up. It seems to be That 5-6 year follow up the both randomized group, the tower as well as surgery, remains identical. They're actually some data. So I'm sure that deterioration is slightly less. If you take the definition of a stretch of wild deterioration of ingredient, including more than 10 Or new 20, you have slightly numerically slightly lower with the tower well compared to surgical valve. So that is one piece of data, but only 5-6 years. We don't have more than that. Now, knowing that 5-6 years, 95 96 do very well. You will say that probably both will be equal. So now coming back to that point. So everything was very concerned. So what they did is in low risk group, In both their studies, they made 200 patients in both surgery as well as uh in the surgical valve as well as tower val to do our follow up for the city For leaflet thickening and durability. So not only those main endpoint, which will be one or two years and decide what values but continues for up to 5 to 10 years. So the answer to your question, simple answer to your question. It seems to be at this time that for a midterm and midterm, I'm defining as 5-6 years that both valves were good. Now, also the data are very clear. That is the hemo dynamics point of view. The gradual ingredient aortic orifice consistently is higher with the tower val compared to surgical valve. You know why? Because we don't have to put their future in the tower group And then the surgical valve because you had to see you and maximum you can get it like 19 or 21 here. Many of them were 31 mm. So 34 evaluate you have a value of 2.8 and the gradient become zero. Sochi is the immediate. The val definitely do a little better aerodynamics. Point of the tower was the surgery and at 5 to 6 years consider to him a dynamic studies in the randomized data that both are identical. So I would not say. And just to come back to I never tell any patient that the surgical valve last 5-6 years. If somebody giving that information is wrong. But I do tell them it last 10-12 years. So is there any low risk patient now that you would say should provincially have surgery? Or would you now consider every low risk patient for talent? So I think that's a very very good point. So I once it get approval probably make an algorithm that way. So somebody that low risk has extensive city. We know that this patient is coming back your engagement with whether it's uh even with the SAPIEN may have a little higher chance of acute occlusion. And so maybe that patient should go for surgery, patients with high calcium. The really Angeles uh and young person. Some people actually, another thing will come when your discussion with the patient about department pacemaker. Clearly permanent pacemaker will be three times higher in the tower group compared to surgery. So many patients actually, a few of the patients when we had discussions during the trial, they said there is a chance for 12% 15 for the pacemaker with the Tower vs 34 with the surgery. They said, you know, we don't I don't want pacemaker at age of 65. I do this exercise that exercise. So there will be some decision making will come. So not that every patient uh will be appropriate. So if you think that patient very high chance of pacemaker and that was a clear cut case patient was sent to me. We admitted we did the cat orders were normal but it was a lot of calcium. And he actually did the consultation and I was in India called that you know this looks like taking all this together. It would be better off with surgery. Yeah, I think that's kind of too much calcium McDaniels young person probably better. And patient you're doing something in the next few weeks on that case. But I think it will go step by step. But I still think that by once it is approved for low risk, that is what has happened in Germany, 80 of patients are getting the tower and 20 getting the surgery at this time. So do you take away that bicuspid group? So if you take the bicuspid group out, so bicuspid actual registry, both we actually we're ready to start. The patients are the intermediate to high risk bicuspid registry is also starting the sapient. Has it, the core will will have it. But if you take the bike has spit out uh Remaining patient, I would say probably it will be about 70, 30 or 8020 just because of preference. Uh and it also depends that how much benefit will come in March. It is like a few negative points on the uh on the tower side, the enthusiasm will go other directions. So I think it's just we have to wait for this. But yes, that what is happening in Germany, I think we probably will happen in the United States also. And that is in Germany at present. The surgical, the tower is done in All the article replacement in 80 of cases. Can I ask about going down your list of sentinel device? So are there any off label uses of this device? So it's obviously gotta labelled use for transporting the valve replacement. Are there other cases you're using it for? But most importantly, our surgeons, could we use that device? Unless I have a patient with a bicuspid valve, a lot of calcium. But I have you put one in in the Cath lab and then I do the surgery and then we take it out. Many surgeons actually are doing it. Some people are doing even for the metal clip if there's for some vegetation and but some densities on the valve to metal also being. But many people can use off label. We use off label all the time. Even you're the first extent when we use for the win draft the usability extend powers, stand put into the vein grafts or crimp on the balloon. So approved was the devices approved off label is very common. And this some case when surgical concern, although you know that there are two data on the this protection devices during surgery, both have been unsuccessful. I mean they did not show the data, you know, positive the same sense. You know, that was also a negative trial. But it was approved on the basis of the, you know, the particular matter and the likelihood that it would be beneficial. And then subsequent data have been very, very positive. So question is, can you use the central device for your highest surgical case? You think hard Chancellor? And I was absolutely yes. As long as an art is correct. Gilbert, what you say on that? I think the issue though, when you're bypass, you don't have positive flow and these filters, you know, there's still a risk of despite adequate weaponization on palm. You just don't know what the flow characteristics is across the the net episodes. But there are other, as you know, other several protection devices coming down the pipeline. One is uh federal approach is like basically the umbrella that shielded entirely arch. So everything is deflected rather than trapping the debris. So that one might be more amenable to open surgery because you just don't know what, you know, cross clamping the heart and putting on my bypass would change the flow characteristics on the neck muscles. But I can tell you that right market from cedar Sinai did mention to me that they had done like this was in september last year that a few cases the sergeants have usually they ask him surgeons to do the claim that there's a very high chance for acknowledge him and he inserted. Uh Also depends on the surgery is we typically during the tower we don't leave the sentinel device in the net truth too long. Once it's engaged with the clock's ticking, we like to just get the well deployed and remove it. We just don't know what, how long we can theoretically leave it in the next best was for, you know, with this little data right? Obviously this device was done in a trance capital world. Not in the surgical world but to your point on the that people have done it off label on Trans Captain Metro cases like bob in mathematics involved where you know obviously the surgical valve, a lot of debris or panic just like the you were talking about and they have done it off label just in case of symbolic risks. So let's say we wanted to do that. That would mean the patient first going to the Cath lab and then yeah, I mean I mean ideally you'll be ideally yeah, but you need a radio access and you need to give some happened already just to make sure that the little clot developing and you would I mean ideally hybrid over will be the best place which you just put it in and you can start the case. But if not then you would you would have to put in the uh in the lab and then you have to keep the device stir up because you have to remove it afterwards. And then you will have to bring the patient to the room. So, logistically it's gonna be a bit complicated because that device has to remain store. Also. You can remove it in a stable manner. And the question is, what's your new are hybrid over 20 room 23. Uh, maybe that will be a little better suited for. This guy should do full surgery. But I don't think we are doing routine surgeon 26 at present. Right now we can't properly. The question is maybe 23 should be put for that 2023. So otherwise logistics will be a little difficult. It has to be done under flora skopje. And even before flores, copy patient has to have a cat's city to see because otherwise you'll be very futile, you'll do more scraping. So just by city will be a part of it, about 20 will be excluded because of their not me. You know, you will not be able to 20 or dawn. So remaining that 80 you'll be inserting about 7-70 75 of them because of same is part of the radio. Can we only go through the right radio? And so so we're just a little still technically little challenging ads in the past. Used to have 10 minutes. But now we get very good at it live. But really, you know, we have we showed it that three minutes. It took only three minutes to deploy the central filter. So he is that yes, you need to have a city beforehand in that particular case. And then it has to require, it will require microscopy and sec. And lastly, the radial artery has to present. So I think it's surgically we can access the axillary artery which is in our field. So even without the radio we could go straight through the axillary artery and you can deploy from there. Yeah the catheter is quite long. So it will be more or less like the old days. We used to transform oral system for like the direct aortic or or subclavian. So you would have to really set up the room such a way you can leave that whole system exposed in a sterile and cover it up during the case. But I think the better device might be the tri guard which is federal approach. You don't need any special access. Most people would have federal access and it's just a deflector in the arch vessel. So you don't need any uh like net vessels manipulation and you don't even technically need a C. T. Scan to look at the net vessel. And that's under trial right now. I think Colombia's is traveling that but if you're interested in that we should talk to their company to possibly do it in in the surgical warm. So I think that's actually safer device that's a shield. Just cover and they are all the great vessels like everything that you don't have to worry about it. Confederal. I don't have to worry about the special cat scan. And so so actually Roxanne american was trying to get it. You know again many of these things are very highly politically assigned so they're getting it. But yes try guard is a bill with another one which will be a new in this field. So but now the center actually now we got some reimbursement Before there was none. It costs about $3,000. So now we're getting about 15-1800. I checked it. So we're getting about 15-1800 reimbursement for the device is still not complete, but about 15-1800. Yes, dr Sharma. What we talked about putting these in younger and lower risk patients that the durability issues. What about valve in valve in terms of Tavern Tavern? Do we have any data at all about people who've had a Tavern in the first place? There's been structural degeneration and another Tavern is put in Years later. What kind of data do we have about that? And what size constraints? But you know, when we put it was like a 29 valve that got a 23 inside it. Now, that seems like a huge drop in size. And you know, what size constraints and what sort of things come to your mind in terms of, how do we rescue a failed surgical valve? How do we rescue a failed tavern valve? That's a very good point. I think we actually have experience about five cases so far where we are done. Tower in tower because of uh, what a region one actually was the recent unfortunate case. Where you will also develop annual a rupture after we're putting a SAPIEN because continues to have parallel or leak after the veloute. But otherwise we actually had done, but there are no formal reports. They're only case reports For this. So no, like series of 12 cases. See what happens. What is the radial gradient? No one knows. So, case by case you study what needs to be done. But you're clearly the second valve will be smaller than the first one. And uh, and that always will be the limitation. But there are cases studies and the first actually was published almost five years ago in Jack intervention. So they had a SAPIEN valve which degenerated and they put a core value inside. Uh, that was the first case ever in the literature in 2014. Uh, but since then even our center, we have five cases uh, so far and they all have done okay. It's nothing not that they have high radial gradient. And so they did. What are the purpose was elevate that the gradient, whether or parallel regurgitation? They've done quite well. But anecdotal case reports, no serious publication to really understand a better long term data or immediate human animal data with these valves that our degenerated our walls. So therefore the question comes At age of 60. Now, the question is, what should be at the start point? Some people will say, why not? We do the tower At age of 70. This degenerate. Maybe they do that by prosthetic surgical vow. Now it degenerates at the age of 80. Now you can put the towers. I'm just saying there's a lot of different camps. If other person safe. If you do one tower, I will start by prosthetic valid age of 60. If we degenerate at age of 70, you put a second our world. So now at the age of 80 now you're in deep trouble. You cannot put a three valves in one patient. The problems of Article one tower and then one tower. The living is to that sort of arbitrarily there's only two that you could possibly do. I guess. So, I mean, I don't know. I mean, maybe it will cause more coronary occlusion. Yeah, the problem is you have all these are young residents at the back and you're taking away all the aortic valves. They used to do so you're going to do all of them with the category. So there will be no surgeons to do this your A. V. R. After a table. So to take out the top of a valve and do a surgical values and hard operators or who's gonna learn how how can we do that? The residents don't see a VR anymore. I mean that definitely is the big, But again, I mean they still will remain. Uh they mentioned 2025 of cases if we just follow the German uh the acceptance uh that still will remain at particularly young age, you know bicuspid Although the experience will still remain. But I think this is the issue of what should be the valve start at age of 60. Once it gets approved for the low risk will be the issue. So I told you that we go to all the meetings and everybody has a little different discussion that what to do. So if you put the idea is you do first maybe. And of course the doctor Adams just arrived that you do a by prosthetic. Now it restores that of 70. You put a one tower val now at age eight 80 what you do. So some people are saying and I'm not making that, I'm just saying that what is the out people talking. So what we do it at age of 60 hour about degenerated 70, get the surgical by prosthetic that get rich diagnosed at age 80. You can that read our, so any time you did not have more than 22 valves to prosthetic valves Did it. The problem is to me is that everybody forgets that you don't live, your normal life expectancy when you're gonna navy are at 60 So you don't, you're not going to fail at 70. When you look at a curve, Half the people fail. A quarter of them are dead. So all this hypothesis is built around a 20 or 30 population. Not 100%. And that's the problem in the way we talked about patients is that we just presume everyone is going to survive to their failure and they're all going to fail. Actually, very few of them come back for re intervention. If you think about all the bio prosthetic valves that were put in this institution The last 20 years, how few of them, we discussed valve in valve or re operations on It's, it's a, it's a tiny fraction of the ones of the, of the ones that went in because they don't come back. And I think that um yeah, mine, two cents worth about that. Is that the screening, it's gonna move away from risk and more towards screening. If you have a straight shot, a good sized femoral artery, no disease in the arch, you know, a perfect size match. Then you can say, well, you know, your durability will have to see, we won't know that for 10 years, but the durability might be a reasonable bet if you're in your 60s and especially then if you are a typical american and You know, have a bmi of 30 and all this other stuff that goes on, then you then I think that's going to be the kind of patient against tower. If you're, you know, a six year old chairman of heart surgery, loves to play golf, very healthy. Never spent a day of his life in a hospital, I might still get the surgical valve, but I think patients are going to make those decisions. Whereas if it was my older brother, one of my brothers who is a giant guy and it's just a much bigger deal to do surgery on him might be lower. It's just anatomy I think is going to be a bigger determination than risk going forward. I think I think those are the important will be that what will be the case? The case appropriate case of the low risk in that age. That's a classical. We're talking about age of 60 has to be that your complications are less than 1%. Just like the investments data That your mortality C. V. A. But all those who were talking about less than one now, pacemaker will still always will be the issue. And that actually for many patients, knowing that no longer enough CV. Issue knowing that both are identical numerically maybe even lower with the tower. This issue in the younger group, many of those patients declined just because they had 3% 3 times more chance of pacemaker with the tower versus surgery. So the opted surgery for that purpose. But nobody wants to a pacemaker at the age of 60 and be a normal functioning. Yeah, But I mean, that's the other question is would you, would you like everybody in this front row? I mean if you're going to get us some like picking on you guys because we're all the older group when I took up the stairs the the basement. How are you? How do you how do you discuss that with patients today? Because I mean, most physicians gloss over the bad things and just talk about all the great things. You know, uh, robotic surgery is not even surgery is just robots is still open heart surgery on a heart lung machine longer than you would be the regular way. But we just talk about, it's something else I can just coming back to the robotic, this guy that envy you with the middle. He's making a big waves. Every patient coming with the mitral that robotic and all they have just done with the big publicity on this robotic. No, it's, yeah, but that's just, that's just the left side of google. If you look at, that's just that's just how much money you want to spend. If you look at robotic, Which I'm interested in everything. But if you look at robotic surgery and the impact of microsurgery is actually declined every year. It's a 17 year old field. There are less sinners doing robotics than ever now, meaning there are a few really high volume center. Is this one included that's interested in looking at everything every year. But the number of centers at the robotics is minuscule. They just closed the program at new york hospital after all this fanfare of bringing someone here two years ago literally in the last month. And so it's again it's one of those things where it's a market it's great if it's done really well and really selected it can work. But For instance that Cleveland where they have the biggest robotic program in the country right now they still screen out 70 of people, 5060 of people. You have to have an absolutely simple valve with absolutely no risk to have a robotic operation in Cleveland which is the model we would follow here. But I think that's the I think the other story about the that was interesting in Coop and we're gonna learn a lot more about that at A. C. C. There are three sub studies being presented about you know further narrowing the selection of who should get it and who shouldn't. But the biggest lesson in co app was the importance of medical therapy. Remember half the patients in the medical arm their M. R. Got better in their heart failure symptoms improved in continued medical therapy. And to get in the trial was three months of G. M. D. T. So you had to have three months. And then in that period a lot of them fell out before they before they got to randomization. That's why it took Three different protocol variations in seven years and 80 centers and who knows what to to uh to enroll a trial where there's supposedly millions of heart failure patients out there. And so the guideline medical therapy is probably the biggest story in the FMR in the waiting, which I say to all of you guys in the front, right. What's changing in practices if you come in with? Yeah, heart failure related M. R. You're not going to start with that. You're gonna get referred the patient like we do in this clinic for surgery or for whatever clip surgery, something, do something. But the first thing you're gonna have to do is get ep to see them and get heart failure to see them. Because three, it's three months away from doing anything. And I can promise you, that's what CMS is gonna say. The inclusion for a clip will be exactly the inclusion for this. Which means you will really have to document guideline medical therapy because of at least half the patients will not require either intervention surgery. are clip with guideline medical therapy. And that's actually exactly what happened in the co op. Uh That what happened is uh dR Adams pointed out with the medical therapy. They feel maybe a little better or not problem. What happened? The M. R. Decreases? And if you have two plus um are they were not part of the trump? I'm sure once the guideline will come to the gatekeeper here will be the heart failure. That heart failure team has to see patients three months. And that is what they did to maximize the therapy. And they are the one, you know just like uh current Michael for degenerative. Um Are it is only the sergeant has to right that it's a prohibitive surgical risk then only they can get the clip. So it's in my opinion with a guideline, it will come if the heart failure person has to write tried therapy for whatever time will be one month or three months and fail. And now it's okay to try clip dr chaman curious as to why you have co opt as the highlight and on the top of your list and Michael fr at the bottom. Is it just because of the results? Like like if the results were flipped and carpet was negative and microphone was positive, would you have now put my tray for? That's the highlight. Because last week looking into I think it was the whole idea of what is your regular student orifice. The M. R. Degree of them are compared to the ventricular size. So what happened is that if you follow the patient too long that cavity became too dilated. So now you're end stage. Uh That was my triumph our case. So that patient clip is not going to work. So this I think there are a lot of one paper actually I just saw uh which I still have to make the slide on that. What is the real eco cartographic message or interpretation of these two trials. So what I could get the conclusion what is the degree of em are based on the cavity size? So he was that in the atrium are looks like that the degree of Hamar was less compared to the ventricular dilatation in the coop degree FmR was more compared to pay for ventricular dilatation means the cavity did not dial it and we know and diastolic volume was tremendously. I won 40 versus 1 15 much higher in the maitre far. So what I said negative here is that we don't let our patient of uh this heart failure uh those and my severe moderate to severe mitral regurgitation get to that stage and catch them. What will be the criteria of the core? Because I think we feel so confident that co opt is real and that the results we see there really is possible. That is the micro fr that's real or that the truth is somewhere in between the two. But I think we're getting carried away to think that you can treat six patients and save one life with mitral device. I think it's too good to be better than beating blockages, inhibitors, better than defibrillators. D. C. T. The you know the hosannas. We're flying interruptions of the crowd. Multiple expert. I went to a crying on the stage presenting and then we went to an investigator meeting that night and several of the people that are involved in the trans catheter Michael trial. We're questioning whether it's ethical to still do anything but co app and anybody now could we still randomized patients. There was a gigantic discussion about how COOP has changed the world and I and and I just excluding a lot of senior people and I was one of the two P. I. So I was making the point that we should just realize remember where we are and sort of remember the heart failure community and remember all the other stuff going on here. And sure enough, there's been I mean, the pulse from from Colombia mike max program that, you know, some of the big players around the country is the collapse didn't really change anything in terms of the heart failure community, there wasn't this gigantic upswing of suddenly everybody getting referred for micro clips and whatever. There's just there's I mean, it's a lot, it's interesting and everybody is interested waiting for more sub studies of who, what's the cut off for left ventricular volume that would look like it will probably fail. And the other big point of my tree fr and collapse is I mean it's dr Sharma mentions is the L. V. Volume. The degree of them are it's actually better to have more and more because of course you have a better target and you have more healthy ventricle. And the third thing is is that your there was no prescriptive prescribed medical therapy in my travel far perry you know procedurally. So without the without better medical you know that's where again the medical therapy side of this is going to become increasingly important both free and post op one of the comment was that if you look at the surgical literature with the data from years ago from robert john was that in the patient with ischemic um are the ventricle is greater than 65 millimeter rate of failure was higher. So I mean 65 is not a huge ventricle. And if you look at the C. T. S. Net trial, when they said putting a ring or medical therapy, we didn't change too much because this frantic electrical on the smaller side than on the larger side. The question is a lot of his heart failure. Patients have large vertical, which is more than seven centimetre. And therefore either you do clip or repair. Not be the right thing because as you said, there are two way out and bear down. But I can tell you Michael clip from the FDA perspective industry perspective has made a lot of people very nervous. You know, with the 10 9. The Abbott wanted to go with a randomized now everybody thinking that maybe if they will mandate you're randomization should be against metal clip, what will happen? So I mean it had made a lot of people never. Yeah, but you know 10 9 the Abbott got out of 10 9 because they just are in the bottom of the Abbott got out of 10 9 because there was changing device. It's not because of you know the randomization part of this, they're changing devices. But I think you know that was another question is in the future what would be the rent? You know what would be the right way to randomize? Because you will have less M. R. With a with a replacement device and you will have you know, certainly you'll have less and more. But remember you just have to put this a couple more things in perspective about this trial. I told you to how many years, six or eight years to enroll 1000. I mean literally just talking about millions of heart failure patients. And it takes eight years and 80 centers and all these things to do it. To have our trials enrolled ahead of schedule every to have our trial. This trial took four times what they thought it would take to enroll because and that shows you one about the medical therapy, how effective it is. And to just how selective this was. Ultra selective. Ultra selective meaning You didn't just go in there and keep your fingers trial. We can try your 80. Let's give it a mango. It was like you have to have perfect anatomy screening committees, this and that and whatever and then you only got in the trial. So the results were predicated on unbelievable disciplines, selecting metro patients. Much like the accord. We could have enrolled me accord in one year. If we didn't want to have discipline about the type of post relief of pro last we were going to treat, that's why that trial is in trouble because if you really want to select patients super carefully, you gotta be willing to do it over seven or eight years in the micro position because it's not one lesion like aortic stenosis. And I think that's something that's lost. And then the second thing is what percent of patients in that coop trial were implanted by the top six in planters. I mean about 70%. So 70% of these patients were implanted by the most, the busiest micro cliff in planters in the United States, they're actually very different than the tab our trials. Edwards was 13 or 18 and Medtronic had like 22. This was like six. So this is again, it's really important data because it was the first evidence that treating them are might affect quality of life and heart failure. That's the first. That's a monumental finding. But this was the best of the best doing the most selected patients with the crispus post op medical therapy in history. And then you got a great results. So that's why I say institutionally we have a real message there. If we have we have a gigantic responsibility to do micro clip and fr patients, that is to get the results that we want to tell the patients about. We're going to have to be very disciplined and preoperative management who we select based on anatomy and postoperative follow up. Otherwise we're just we're never going to be able to even pretend like we could duplicate those results because these are are really good results. And I'm actually really I mean, I'm really happy that they came out and we're talking a lot about it at the age. Yes. This year we have several sessions about Coop and my travel far because it's just an incredibly important data set. And we're gonna learn a lot in new Orleans. Well, actually, two days before the PCT, we're doing a polo case, uh David remember conversation? I said, I don't know. This looks like that Cooper will be very positive. I didn't know. But you know, nobody knew. I said, but everybody they're talking, they're like smiling uh maybe. And he said, well, David, how can it be might try farmers negative. And I said, I don't know. But to me this was clearly a selection. Yeah, it's 23 days before the travel presented in PCT. We had a discussion. I said, I don't know. Everybody is like a smiling those who are involved in this field with and it really what's gonna happen with other trials coming in. Like I said, there's a really interesting dataset and we're gonna and we're going to see a lot more about this over the next month or two. I'm sure. I mean, I think when March comes, we'll learn a lot more about this. And then again, you know, I'm on this round table with with CMS, there's gonna be a guideline guideline committee has been put together um that paddle gear and bob bona or leading and they're going to be about six or eight more representatives on that. And we have a writing committee and working with CMS to sort of come up with how that's gonna lay out. So it'll be really interesting to watch how that evolves. But we're clearly gonna see these in the guidelines and clearly going to have a separate writing. We already have put together a writing committee to start to talk about. That should be fun. All right, thank you very much.
