Abdallah El Sabbagh, M.D., an interventional cardiologist with a special interest in structural heart interventions and invasive hemodynamic assessment for comprehensive diagnosis of complex valvular and other structural heart diseases at Mayo Clinic in Florida, presents in the Advanced Heart Failure Grand Rounds series on hemodynamics of valvular disease in heart failure.
stenosis. Um When when angina thing could be in heart failure ah become evident that the survival drops and it's only at the late stages when the ejection fraction drops and of course, you know the spiral of death with your ex stenosis. These patients have chronic severe aortic stenosis and then something triggers them to spiral down and uh and at least it leads to death. So they are pretty a pretty sick population, especially those with low ejection fraction. So we'll start with case one and 92 year old gentleman who presented with cardiogenic shock. This ejection fraction is 20% within your valve area of .5 and mean gradient of 25. Um He was taken to the Cath lab and as you as you all know, he has a distal left me bifurcation stenosis that is also ah significant. So he during this the the the icu admission he had respiratory failure, cardiogenic shock, and renal failure. And we were consulted to see whether or not he would benefit from a per cutaneous procedure. So I wanted to ask the audience what what would what would people do in this situation? I think I would first of all see how functional he was as a 92 year old prior to all this. Just to make sure things are very reasonable. Then call our intervention lists, see whether it be viable to do a left main statin a for cutaneous intervention or not. Obviously get a really close look at that valve as well as he how calcified it is at center to see if it's viable. Those are kind of things. Perfect. Perfect. So as as you parag noted, there's a couple of facets that you're going to see the slide several times during this presentation. Those are the key points that we take into consideration when we're deciding whether or not we're proceeding with the pro cutaneous approach. First of all, what is the procedural feasibility and risk? Is it cost effective? And those are the risks of the procedure. On the other hand, what is the patients one year outlook? Because as a rule of thumb, any per cutaneous, any any patient who does not have a one year ah adequate one year survival does not qualify for per cutaneous structural intervention. And again, last but not least, is what is the data supporting the decision or meaning? What what does the data show regarding the benefit of this intervention? So for this patient will start with the procedure of feasibility and risk ah In this day and age we can almost always push the envelope and come up with a creative weight and challenge the anatomy that's in front of us and succeed in a in a procedure. There's always that the logistics behind the tavern here, including the coronary angiogram. The the question for the not P. C. I. Is needed. The pre tavern ct scans, the surgical consultation and a critically ill patient. Some people would consider balloon Vavilov Classy. But again, there are several ways to approach this. So and this day and age. This is almost always. Um and not not a major issue. We can always find a technical way to to get through things. Aside from a few few ah few few issues that that would prohibit prohibit us from doing things. Second question that arises is it cost effective? The and the main purpose I I say this is because ah some of these per cutaneous procedures are not yet approved or covered. Um Taverna is so the patient will will be covered for it. But just remember that um The way I understand it is they give they give a lump sum of money and then every everything every time we do something it just gets subtracted from that lump sum of money. And so ah either the patient will be left with a bill at some point or and plus the program will lose money. So again it's not not an issue. We always put the patients first, but the main concern for for us is um sometimes we do things um for example, as you as you know later on track despite interventions. Um Those are not covered yet and some patients will be, you know um will not be okay with with having $100,000 bill. So that's something to keep in mind when we when we talk about they're considering structure interventions obviously in this case it's an emergency. So that that doesn't even factor in our decision making. What is the one year outlook? So a 92 year old with cardiogenic shock and all on multi organ failure. Um And you're right, but what is this baseline functionality? He he was frail, he wasn't mobile. Um So his one year outlook was not was not great. What about the data in new york stenosis and heart failure? What is the data? What is the benefit that we extract from doing tavern on these patients? So Just a few things about the literature in this patient population. The first thing is all major trials excluded left ventricular ejection fraction less than 30%. So we're really left with registry data and there's many registry data from the what we call the tv t registry that looked at outcomes of tavern, low flow, low grade and severe aortic stenosis in low flow and paradoxical, low flow, low grade and severe aortic stenosis and all of them show that there's a benefit and and it's safe to do this. So really the envelope again has, has we've really stretched the boundaries of this field. And to the point where honestly, um many, many programs, we don't do it here, but many programs, For example, our approach for paradoxical or for low, low grade in severe aortic stenosis, meaning when the valve areas less than one and the gradient is less than 40, we usually do the Vietnamese, stressed us to to differentiate pseudo severe from through severe, but you you only need one out of the three criteria for whatever meaning you need Either a valve area of less than one or a Or a mean grade more than 40 or a velocity peak velocity of more than four. You don't need the three of those. You need just one of those to qualify for a tavern. So a lot of centers do Tavern on Paradise on just low flow, low grating, severe explosives without even seeing if it's due to severe or through severe. And the and the registry data shows that it is safe and and it's beneficial in these patients. Even in patients with contract I'll with no contract I'll reserve meaning. They have low flow, low gradient, severe or extend Asus. We do the debate. I mean test and the stroke volume doesn't go up because they're left ventricle doesn't have um a reserve from let's say, severe coronary disease. Even the registry data even supports that it's it's okay and it's safe and it's it shows favorable outcomes and doing Tavern these in these patients. So um the safety of Tavern has has really again stretched the boundaries of of what we can do and what we can offer with data showing benefit. Now it's not clinical trial data but it's it's at least some data even to the point where the next set of trials, particularly the Tavern unload trial is looking at actually moderate your extend Asus and doing tavern and moderate your extend Asus plus Ejection fraction less than 50%. So a ventricle that is sick. We know that from recent studies that moderate stenosis, monetary expenses, not a benign entity. So and then an ejection fraction of less than 50%. A pump function that is not adequate. Can can have a a composite poor outcome when it's facing even moderate aortic stenosis. So we were seeing whether or not to cover benefits this patient population. So that's that's on the outlook and ah it's still enrolling patients. So now we have also registry outcomes on patients who underwent urgent and emergent tavern. It is feasible. Again, we can almost always get away and and do things with acceptable outcomes and select patients um With with severe or external service. But in this patient because of what we discussed, we we thought that um the risks outweighed the benefit and he we actually went through a palliative approach. His one year outlook was was them. Um And so I think that that's what swayed the decision because and sometimes I don't know if you've seen this image before, but if we don't, if we if we're not very careful about patient selection, we can inflict more harm. And this is a tavern valve extracted from someone who had CpR. You saw how how it becomes deformed like a D. Shaped. Mhm. So the next case is, and this is this case will highlight again the overlap between structural heart disease and heart failure in a sense. It's not it's not per se valvular heart intervention. But these are techniques that we learned from from your extend Asus from Tavern that we can extrapolate to our heart failure population and use and use in our heart failed population. So this is a 72 year old male with purple heart disease, severe ischemic congestive heart disease who presented with cardiogenic shock on our troops. This is his ct. Now he was destabilized. He had a city luckily and it shows distal Yorick. You're the iliac bifurcation stenosis on both sides. And um what would people choose as a mechanical support device in this patient? Right then we can always try our axillary approach. We have done that for the past couple of years um alone pumps and in palace and in that so far if they an item it's reasonable then we can use the upper extremity approach for this. Perfect. So this patient had uh let's say he had a lima and Arema or he had calcification in the accident artists and there is no access up top. So that this is uh that's perfect because yes axillary is the way to go um in a lot of times. But there's this option that that is nice and we haven't tried it here but at some point we might need it because of the patient that I'm telling you about this. The this is the I. V. C. And this is the aorta. There's ah there's a calcium free window here and and the aorta and the I. V. C. Coming in close proximity. The pressure we know from from bench testing that the pressure in the I. V. C. Is lower than the pressure in the inter station which is lower than the pressure in the um in the aura. So there's always that pressure differential and that that enabled a what we call a trance cable approach where um there's a snare that's put up in the arterial side and then a wire that we connect to a body and cause electric carter you are where we basically burned through the I. V. C. Into the aura snared up and then put the sheath up. And then If if the and then towards the end we pull the sheet and we put in a vascular closure device. This is an 80-0 device. Ah And so if the patient blood around it there are multiple multiple rescue. And we can put a stent here. But just remember because of that pressure the french, it will bleed into the I. V. C. Actually a lot of times. Now if it's a major bleed it'll it'll be uh significantly and then we have to put a coverage then. But just because of the pressure differential that I told you about it will bleed into the I. V. C. But that's called a transcranial approach. And it has we it has been used for impeller placement. Um And so ideally we'd like to have a ct for these beforehand. But just just to show you an example of how we can kind of ah extrapolate the what we learned from from tavern to to alternative access to the Hartfield population. Also remember that uh the data on axillary alternative access right now is getting a little bit under scrutiny because of the stroke risk. Um So that's one thing just to keep in mind. So moving along to secondary mitral regurgitation which is which is a huge topic uh in the in the overlap between heart failure and and structural heart disease. And I'll start with a 70 year old gentleman with non ischemic cardiomyopathy with worsening display. And he had two heart failure admissions over the past one year. Is is this his echocardiogram? Basically? E. F. 16% Left ventricular end diastolic dimension of 72 and an e. r. o. Of 0.6 cm two. This is his mitral valve regurgitation. So um I'd like to ask what would my colleagues do in this situation? Okay. From a heartfelt perspective we like to I always try to optimize and first I think that we have seen in the past couple of years multiple patients that the first approach was to placed symmetrically without even attempting medical management. So we have been able to remodel many of these patients and reduce their um are substantially, but unfortunately sometimes they come already with the metro clip and then you're still optimistic about you wonder if you're lost? Um I went off avoiding a procedure. You're absolutely right. So the first step is to optimize them. This gentleman was on maximally tolerated medications including and I'm going to repeat that including interesting this is um some people call it the the the intervention lists enemy because it gets rid of it gets rid of secondary M. R. And many patients. So it's a it's one of those miracle drugs um that ah that just just work beautifully in these patients. But so this is this gentleman was on maximum tolerated medical therapy. Didn't need a device. His QRS wasn't widened. Um So he presented to us for ah not here, it was, it was when I was in Rochester presented for metro clip consideration. So how do we approach this patient from a procedural feasibility and risk back to our back to our balance here again right now in this day and age we have many permutations of the clip ah so that it gives us technical feasibility for different anatomies. So if there's enough, if there's enough ah if the leaflets you know ah there's not a big gap we can always we can always get in and and do it successfully. Um we have now the new generation called the G. four which is a white clip. It works beautifully for functional M. R. As you know, functional M. R. There's dilatation and there's a crescent shape opening across the mitral valve between the leaflets. And so so what this has wide uh wide gripper which can approximate the mitral valve ah beautifully. The biggest enemy right now. There are two things that I've noticed in in heart failure population that are, that makes mitral valve regurgitation technically challenging the first. The first one is heavy calcium and the leaflets. If we don't have enough healthy tissue, we won't be able to grasp it because it'll evolve the leaflet. Um The second and it will cause mitral stenosis. The second challenges. I've seen one case here where the ejection fraction is was very low and the uh and the end and the left ventricular uh chamber size was humongous that they didn't even see the leaflets on T. E. And that's before we understood more about the trials that I'm about to mention. So those are the two biggest challenges. Now we can get an acute result. But the long term results again, we the field is advancing because what ends up happening and a lot of times is we clip the middle line and that's why I'll show you the trials later on, we clipped down the middle and then um you know, a few few months later, a few years later they come back with severe and more because the the dilatation continues to go on the, on the both sides, particularly in patients with, you know, ongoing ator fibrillation where the annual list continues to dilate or the left ventricle continues to dilate. You know, the field is evolving at some point will have annual plastic rings again, those are all investigational still. Um But does that would be important to stabilize the annual, It's just like the surgeons do. Um And then we have the new court system that ah there's now there's actually now a transept a version of it. Um the attacks on so we'll see what, what the future holds. There are also trans catheter might have replacement devices also um ah in trial so there are many many things going on in the micro field um That that could that could be potentially benefit down the road. So procedure feasibility and risk for the micro clip. Again uh It's we can uh the majority of patients there won't be any issues cost effectiveness in in uh in select patients that are that meet the criteria. That I'm about to mention that that the CMS mandates uh There is a cost effective procedure for the patient and for the for the program again same thing. What about the one year outlook um you know this patient was functional um But he he had a low ejection fraction. He had two heart failure hospitalization but I think it's a reasonable one year outlook and he's not very old. So something can be done to help him. What about the data? This is where I think most of the focus will be understood because this is important to understand the data and how we approach these patients. The two major trials. Again, micro clip is the only FDA approved device format regurgitation right now. And in secondary mitral regurgitation meaning mitral regurgitation. That is due to annular delectation from from left atrial disease, left atrial enlargement or left ventricular enlargement. The two trials were uh that have been published and presented with the mitra fr and the co op trial. So start with the mitra fr trial. It's three. It it was a trial that was done in in France or what we call France. Ah Mayor included 300 about 300 patients randomized 1212 micro clip plus medical therapy versus medical therapy alone Notice the inclusion criteria. The Ejection fraction was 15- 40%. The New York Heart Association was between two and 4 And they had to have hospitalization within the previous 12 months and they're not eligible for microsurgery. They defined mitral regurgitation as severe if the E. R. O. It's 20 or above Or the RV volume was more than 30 and what the way they optimized medical therapy was what we call quote unquote. I I don't like the word, I never use it. I don't believe in something like this, but it's called real world heart failure mats, meaning, you know, it was just whatever they felt like treating the patient and call it optimizing medical therapy. So, um, so what they found was that there was no difference between both arms in terms of freedom from death or heart failure optimization, that was the composite endpoint. And so it was what we call a negative trial around the same time, the coop, wow, sorry, around the same time the COop trial emerged. And um, me just here we go. So the coop trial was a little bit more stricter. Um, it was a multi center trial ah included three plus or some moderate to severe or severe mitral regurgitation who remained symptomatic despite medical therapy. Now, here there was actually, there was a stricter dimensions. I'll show you the exact differences between mitra far and core, but there are stricter selection and an atomic selection And guideline directed medical therapy was very strict, was very strict. They actually were calling the patients to make their were followed different protocols. And then there was a steering committee that looked at whether or not this is a guideline directed medical therapy was implemented. So, um, it was truly ah there was a high level of compliance that that may be challenging to replicate, but that's why these these things have to be done in center of excellence where where there's good collaboration between heart failure And and structural interventions like we have here. And to your .1, this is this is what's not happening in the in the quote unquote real world where they put a clip before this happens, that shouldn't be happening. So, back to the co op trial. What they found in this trial is that There was tremendous response, all hospitalizations for heart failure within 24 months. So it was a two year follow up heart failure hospitals and went down one down all cause mortality ah decreased as well tremendously. And then when they when they compared the the treatment effect of micro clip to guideline directed medical therapy, um just to show you just to show you the scale of how effective micro clip is compared to two guideline directed medical therapy plus other devices. So it really is a remarkable response Now this the scrutiny was. Well why did my triumph? Are you know why why was it negative versus COop was positive? Well there's big there are big differences actually. The trials complement each other and I'll show you why with my tray fr the severe, Remember that they included ah the E. R. O. or the office of the Mitral Valve was 20. Whereas um so they there were some moderate ah mitral regurgitation in these patients. Whereas in the coop trial it included a more moderate to severe based on the E. R. O. Um the L. V. And systolic dimensions. So here I don't see I see the end diastolic dimensions but it's actually the the end systolic dimensions. Ah the mitra far noticed that they included larger chambers compared to the co op trial. So the coop trial included more severe mantra agitation with smaller chamber sizes. Whereas here it included kind of a little moderate range but larger chamber size. In fact the cut off that we use That was used in the coop trial was an end systolic dimension of 70. Anything above that was more or less excluded from the trial. The second point that led to the difference between the two towns was the guideline directed medical therapy protocol. It was loose in the mantra fr was it was very strict in the coop trial including interesting which was um which was initiated in these patients in this trial. Finally the results, the operators to be honest and the operators and coop trial were better than in my to a fair trial. They got less residual severe M. R. They had less procedural complications and then that's why they they had less residual um are down the road. So that's the procedural and experience matters in in my truck club. Again, it shouldn't be done by anyone, especially in these sick patients. Ah So they really need to send these patients have to be attack tackled in a center where there's good heart failure and good structural interventions or otherwise we're going to be in the maitre far territory. So how do we put this together actually? Um the you know para que no Milton packer from the days of Ut Southwestern. You and I have have overlapped. Uh huh. I think he was there when, when you were there too. Right. Yeah. He used to run our research conferences as fellows. Yeah. You know how you know how he is. He's very critical and and and ah he scrutinized but he put together this concept based on the two trials of what we call proportionate or disproportionate mitral regurgitation. So what does that mean? He calls, he calls proportionate M. R. Is that the severity of the mitral regurgitation is proportionate to the left chamber dimension, meaning that the chamber dilates. The M. R. Is um is severe because it's proportionate to the dilatation of the chamber. Whereas disproportionate severe mental agitation is the chamber. Although there is heart failure but the chamber the might regurgitation is more severe than the than what would be expected from the chamber of the annotation and that is usually related to the synchrony ah in the in the ventricle such as what we see in ischemic um are so this is proportionate M. R. Again the the the ventricle is dilated and the M. R. Is is rightfully proportionate to the the politician in the chamber. Whereas disproportionate M. R. The chamber is not that you know it's not extremely dilated. Uh But the M. Are severe and this is where the coop falls. This is cooper is a trial that that showed that mitral clip is effective in disproportionate M. R. Because they excluded anyone with left and with L. V. N. Systolic dimension of more than 70. Whereas proportionate M. R. Was more than half our population. Where there's these large chambers with moderate miter regurgitation that didn't benefit much from for from clipping. So I love this chart. I use it actually in all all patients with ah with mitral valve regurgitation plus uh rejection. You know, low ejection fraction. And to put this in perspective our patient back to our patient and I'm going to go back to the echo just to show you just to give you another ah look at it. Um Here we go. So the the chamber was dilated more than what we expect ah In in the coop trial, The EF was 16% but the E. R. O. was super high .6. So if we if we plot it in the chart, I'll go back to the chart here. If we plotted in the chart, that's gonna be somewhere around here. So he's one of those patients that we don't know how he's going to respond. But you know, he is a little bit under disproportionate side of things. So we decided to do a clip on him. This is the micro clip, this is that the the left atrium left ventricle. And here's the here's the mitral valve and notice the human dynamics. This is the aortic pressure, that's the V. Wave on the left atrial pressure. After clipping the V wave went down and the aortic pressure went up. That this is uh this is a great sign that we we would be very happy to see during these procedures. Um We worry about the abrupt increase in the afterlife and these patients. But um he he did well. Some some of these patients just behave in a funny way. I know I know people have gone to the extreme of putting a balloon pump at the same time of doing is doing a clip. Sometimes some people put in um paella in but I think that's that's kind of stretching the envelope too much. Um So ah but this patient did did well. And so now what what is the data ah what does the data show? So I may I show you the coop trial and the mitra far. But there are two more ongoing trials to kind of add to the concept of whether or not this disproportionate or proportionate amar is is uh you know, it's justifiable and then there are multiple registries looking at now specific patient population is undergoing micro clip and forgive me for the next few slides. They look ugly but literally the data was presented two days ago at T. C. T. And the first one is called the my Trowbridge registry is relevant for the heart failure patients because in this patient population um this they basically took patients on an active heart transplant list ah as a pure bridge with low likelihood to receive a donation shortly for body weight or blood group. And they also included patients waiting for clinical decision bridge the decision and patient patients not enlist for heart transplant. Bridge to candidacy with potentially reversible contraindications such as severe problem hypertension or elevated PVR and they clipped them and they saw the one year outcome. The selected use of micro clip as a bridge to heart transplant was safe, 87.5% of them had procedural success Um and no death at 30 days. But keep that in mind. 2/3 of these patients remained free of development of composite adverse event. At one year 15.5% became eligible for transplantation. And nearly a quarter of these patients were removed from the heart transplant list because they had clinical improvement. However, if we look closely at the at the results 6% of them needed urgent heart transplantation, 18% of them needed Urgent l. v. eight and 4.5% died within a year. And so ah again ah I I immediately got an email from our micro clip rep. Look at look at how effective it is for the heartburn. Well look at this too. So we gotta be very careful about how we interpret this data. Um Again, it's one of those things that we need more data ah And we need to be very very careful about how we select our patients. And again, this is just a testament of how our our program, the synergy between the transplant team and and the structural team um is so important. Um Because of of of how sick this population is All right, moving along to the next case of an 82 year old with isolated severe tr and an enlarged right ventricle with lower extremity edema controlled with diuretics. This is the troika spit valve. There's a prolapse here and their severe tr and it's on symptoms ongoing despite medical therapy. Procedure of feasibility and risk. Uh trickle spit valve is just and previously we all the guidelines said try to spit valve repair or replacement in patients with persistent symptoms despite medical therapy. But now we're looking at the track a spit valve differently. What is the present and future holds to this holds of this valve. We we're now understanding more and more about the natural history because that's important. We need to know when do we interfere. But also it's the field is evolving from a per cutaneous standpoint because it is a very tough valve. It is a very tough valve to treat per cutaneous lee. It is the toughest valve to treat per continuously. From a natural history standpoint. We now know that severe TR ensues. Then there's RV dilatation and dysfunction. Then right sided heart failure begins and then there's end organ damage where there's now deliver gets affected, the reno the kidneys get affected and that becomes irreversible and the patient just spirals down. So really pushing diuretics until they stop responding. And having an organ damage is not is not ideal. So, that's why it's important when we when we make decisions about ah cutaneous options to understand the natural history to know when to went to um ah want to interview, went to intervene for cutaneous options. Again, there are many per cutaneous options that are all experimental. There are the co optation devices, such as the clip, um such as this for my device which I was involved in. And when I was in Rochester as a fellow, ah this was this was put to stop because this had a hook and it had a spacer where the leaf it's co act against. But ah there's a lot of perforations that happened with that because the Rvs then the R. V. The troika spit, the thinness of the troika spit valve leaflets. The difficulty with imaging the troika spit valves, it is truly a very difficult structural intervention. There are annual plasticky rings in the making. Some people ah put in a put in trans catheter aortic valves in the I. V. C. And as we see. But yeah you're protecting um you know the the upstream and the upstream but the right ventricle continues to dilate and you know when it dilates there will be ventricular arrhythmias. There will be it's I don't think it's an effective treatment. Um So same thing ring annual plastic devices and then dedicated practice with valve replacement devices is very tough. I don't think, I mean it's gonna take years before the most successful one so far has been the co optation devices. But again everything is um experimental. The only the only again the only devices that we um that we use off label Now off label are the troika spit clipping using the micro clip device. So um there there will be a device dedicated to clipping the track adjustment valve in the making and end trials. But right now what we what we do usually for the for these patients is any patient who undergoes a micro clip. We can retract the mitral clip device and add a second micro clip and try to clip the track custom valve using that. Now we're clipping a tri casted valve using a device dedicated to the micro valve. So we actually make modifications that are a little bit clumsy sometimes ah in order to to grasp Any leaflets and a lot of times we accept a torrential tr two severity our results as a successful result. So again it's not uh it is a field that is in in a major need of more more advances. Um Now, uh same thing now to talk, a spit valve in valve is a very quick and effective procedure, uh an old failed by prosthesis. Some people also put them in rings. The rings are a little bit tricky because um almost always the darkest valve has an incomplete ring and so anchoring might be an issue ah And so we we always are very careful about doing it in rings but ah and failed by a prosthetic bicuspid valves. Ah it's it's still off label but ah a lot of ah a lot of times it is covered by ah by ah it is covered and so and it's very effective and quick and very safe and so ah we've done a couple here. It's, it's been ah with with a really good successes. The troika spit valve, on the other hand, this is one important caveat to know is if we just do try to spit valve clipping now it's not it's off label and it's not covered so the patient has to pay out of pocket for a for a result of going from torrential tr to severe tr if we're lucky we get moderate er that is if we're lucky we almost always aim to clip two of the three leaflets and we would be celebrating in the Cath lab. Um So from a cost effective standpoint we have to bear that in mind. If we on the other hand, we clip the mitral valve. If there's an indication to clip the mitral valve clipping the track, a spit valve is for free because um the company charges only for the guide and one clip. The remaining clips are actually not charged. So that's why we can clip the mitral valve retracted and clipped the tractor spit valve. Okay, so from a cost effective standpoint for this patient, it might not be an option. He might be left with $100,000 bill that he might not want. Ah And so that's an important thing to discuss with the patient. Um What is the one year outlook? I think? I mean on this gentleman, it's reasonable. But what is the data were limited their their early feasibility trials for these devices. Ah We are limited to registry data showing maybe there's a potential mortality benefit from the strike hospital valve interventions. But again, it's only registry data. So we're going to shift gears now to the role of the cath lab and optimizing heart failure patients. And uh we'll start with the L. VAD patients. This is a 68 year old with an L. VAD presenting with this mia severe M. R. On echocardiogram. Otherwise poor echo windows. So in these patients we can and and this is his echo. So in these patients we can offer a a ramp study based on a to be Fars protocol. In Rochester he uh traditionally a ramp studies done by just doing the right heart cast um or an echocardiogram with increasing the speeds of of the um of ah the L. VAD. But there's a limitation with that because we don't know what's happening on the left side a lot of times. Ah we don't get all the data. So I love this protocol. Ah he does left and right heart catheterization and then increases the speed and looks at this parameter called the tag, Which is the difference between the aortic and the peak and the peak of the left ventricle. And of course looks at the uh and what he found is that a tag of 20 to 40 between 20 to 40 of mercury. Or an L. V. D. P. Of less than 16. Um Optimizes these patients and they feel better and optimizes their human dynamics. And of course we also have simultaneous right sided pressure to see what happens on the right side. We don't want the R. A pressure to shoot up. His dad is not good as well. What about what about the the CRT devices? We can also optimize those in the Cath lab. Ah Again this is also a to be fars genius work um that I learned from him and ah he does a left and right heart catheterization and then he says um and his experience is that the A. V. Delay is actually what does it? Ah And uh and changing that parameter in these patients, for example, for instance, this patient blvd ps drifted a little bit downwards here. But what you notice is that the systolic pressure went up and so with this optimization plus adding after load reduction, you will improve the the forward flow of this patient while and decrease the the the feeling pressure and they'll feel better. So that's that's one option for for some of these patients. Finally, I'll talk about a little bit more about the L. VAD art photographs, diagnosis Now. Outflow graft, especially the HeartMate two. Um They're not the best art photographs out there. Um We've seen outflow graft kinks and we've seen thrombosis or fibrosis. Yeah, so I'll start with this case. This is you can see here this is a patient who has had increased speeds in his l've. Odd and so a ct scan was done and you can see a 90 degree king here. What we can do for these patients is we can assess the kink actually in human dynamically. So it's not only to treat the kinks but also to assess them using pressure wires, we put to pressure wires across the kink and we can see here we can even change their positions because the king can change with standing or sitting or Laying flat. And so the you know here uh with supine the kink was worse than the gradient was 20. Now what is the optimal gradient? No one really knows yet, but if you if you extrapolate the co optation gradient then 20 is the is your cut off. But if you extract the aortic stenosis gradient and some people use, you know I mean great in the 40. But um that's that's but that shows you that there's a significant ingredient when the patient is superman. Here's another example. This is a patient who presented with significant him mal assis. Um and that's the outflow graft kink. We were able to put in a self expanding valve across the kink. Um This is the ideal valve to to use, we, I don't like to use balloon balloon meaning that the, the stent comes in a sheath and when we pull the sheath the stent expands and gets deployed as opposed to inflating it with a balloon and deploying it. Because what happens is you're gonna, if you use a balloon you're gonna obstruct flow to the Alvin and they can crash. It happened, it happened with me. So uh so that was the lesson learned. I'll show you that case. So what happened with this patient? The speeds went down immediately after we put the stent and then the hemoglobin stabilized. So it was effective on the other hand, um fibrosis of strong bosses. Um This is an L. VAD fibrosis that's why a cT scan is very important to get in these patients with suspected obstruction to understand what the mechanism is. Um Melissa. You've ah you have experienced at Emory, tell us about your experience with these. Yes. Yeah. So we would see it quite frequently actually and then they would come in with low flows and once we did the C. T. Scan identified that there was outflow graft obstruction. And then we would end up having our structuralist basically stint the entire outflow graft and that was typically very effective in terms of restoring appropriate flow. Perfect. How many stents did you use? So this one, it would vary but dr bagley eros would typically do at least six 6/10. So um to melissa's point we used one stand here and ah thrombosis and the fibrosis shifted downwards and what we learned from this case is one using balloon expandable. This was this was one of the rockiest cases I've ever been to to be honest, been through balloon expandable, stents can lead to a human dynamic. Now this guy tolerated it just fine. But we, you know we almost ah we almost had a situation here um because you're obstructing flew against the L. VAD lesson number two is when we when we plan these these cases, we have to make sure that we have enough reach to send the stent all the way from the year from the access site down to the graph because we engage it in a retrograde fashion. So a lot of times we have to use the axillary artery to to get to have enough reach. So for this patient we didn't have enough reach. Um and so, and we didn't, we were initially in that early learning curve and we noticed that the like melissa said that the ah cloth shifted um distantly when we, when we sent it, just that very proximal portion that, that I was significantly still. No. So I do agree with Melissa's uh you know, input in terms of, we need to probably spend the whole thing because the whole thing as you can see here, it just layers out with uh with cloth other issues, you know, aortic regurgitation with Al Vod. We don't have good practice therapies for native. They are now. But some people are trying to put a stent in the aortic root and then deploying atop a valve in it. Other page. Other people and some people who have and patients who have a park stage, we can deploy a vascular closure device across it so there again uh we can get creative and uh but again we always try and uh you know to to in order to provide the best care for our patients. Severe tr is tricky again because of the the matters that I mentioned to you, I know we had a recent case. The tricky part of it is we can we can always handle severe M. R. With an L. VAD by increasing the speeds. But if there is concomitant severe tr what ends up happening is it unloads the left ventricle When we increase the speeds it pulls the troika spit analysts further and can worsen the tr. So um not an eye, you know not an ideal situation but but that's that's definitely a challenge on between in these patients.