In the third and final part of this deconstructing the mitral valve series, experts from Penn Medicine discuss functional mitral regurgitation and whether not to perform transcatheter edge to edge repair.
Related Links: Deconstructing the Mitral Valve: Part 1 Functional Mitral Regurgitation: Part 2 Twitter @PennMDForum
Good evening everyone. Thank you for joining us this evening for our program deconstructing the mitral valve Session three cases of functional mitral regurgitation, trans catheter, edge to edge, tear or not to tear. I'd like to introduce you to hans. Mata dr hans martin, one of our advanced failure specialists who will be moderating our program this evening. Good evening. Thank you for joining us for our third session. Our first session was degenerative mitral valve. Our last session last week was functional and this is to tear or not to tear Disclosures for Part three. in terms of just to know relationships for the top four attendings and then Dr Wilson Zito has grant research and consulting fees listed below. Penn cardiology has received funding for clinical trials from Abbott animatronic. Any conflicts of interest related to the cmI activity was resolved prior to this activity. This cmi activity has been produced with no commercial support. I want just to display our multidisciplinary mitral valve team at Penn Presbyterian which involves structural imaging, heart failure, cardiac surgery in ep and again, why are we here as we all know that mitral valve disease is a growing epidemic. Um it's about two of our population. And when we're looking at our population in general, in terms of moderate M. R. We'll see it 11 of the male population in 12 of the female population. And we're going to talk about the management of mitral regurgitation. We've already talked about goal directed medical therapy C. R. T. And today we're going to talk a little bit more in terms of other options beyond those two. So I want to introduce ross who will start talking about in terms of heart, the heart failure perspective. Thank you hans. E uh we've discussed in some detail the value potential value of addressing with T. R T. E. R, uh functional metric vegetation and carefully selected subgroup of patients. Yet it's not just medical therapy versus medical therapy and this type of intervention, we also have to take into account a lot of these patients may have better longer term, more definitive options. And we need to navigate through that as we make our decisions up front and down the road and next line the indications for vat and transplant. Uh you all know well um typically class for heart failure uh despite good compliance with good medical regimen, this is often confirmed with a poor Vo two result. Um and these values typically are consistent within uh excuse me, one year survival of under 50 even more clear patients who are home and dependent with low cardiac output state. And in the most extreme cases there in cardiogenic shock requiring on a trope suppressors or even mechanical support. Next slide now to that end, we are limited not just by the realities of other potential contraindications, but a certain set number of potential transplants. And so if you look at the numbers for north America, Uh we're in every decade we've averaged about 2000 transplants a year in this country. Despite the fact there may be 20-50,000 patients who require this lifesaving intervention. Next line, when I say life saving, I mean lifesaving, we're going from a 50% 1 year survival. And if you look at the numbers here, 80 90% survival over the last 20 years. And next slide, you'll see as well five years you have over an 80% 5 year survival. This is clearly in the carefully selected patient, not just something that improves quality of life but improves survival definitively. And for an extended period of time we have patients who survive well over 10 and sometimes up to 20 years, which is something we cannot say about trans catheter and two and repair at this time. Next slide. Now, given the realities of the limitations of transplant, we've turned and have now greater and better and more simple although still a time was clunky and problematic devices known as el. That's next slide. And the numbers here are increasing but have leveled off. And there may be a lot of reasons for that range into contraindications to physician biases, but you do have still a reasonable one year outcome and carefully selected patients of up to 80% and I think reasonably so potentially as high as 40 25 to 40% of 10 years. We don't have a lot of that value those numbers yet because these newer and better devices have really only hit the stage About 10 years ago. Well, no more viable option to transplant. Absolute. Uh typically not as good. And I still think we consider transplant in the best patients. The gold standard next slide to that end as we put these two options side to side. The nice thing about all of that is there's no wait list. Um But you do, it does come with an external drive line which is a risk for infection and there's issues of vanity and comfort with that. It requires anti coagulation with an iron are typically 2-2-8 and for any number of different reasons. High rate of Gi bleeds. Um Well transplant is certainly totally uh enclosed in the body. There's no drive lines. You need to go through a wait list. And Well that's not that big a deal. Even after transplant, you're talking about the risk of rejection which requires frequent biopsies. You're talking about the need for immuno suppression, which comes along with its own acute and sub acute complexities and complications. And long term you develop transplant or terry apathy and other potential cancers. Next slide to that end, what limits some of these options? And some of them are intuitive given the information I've given you to that end. An l that is an L left side of the closest device. And so poor are we function more than moderate is an absolute contraindications. Uh for any number of different reasons, significant renal insufficiency is as well. Let's for argument's sake, call a creating greater than two in many cases, anyone who has intrinsic bleeding or clotting issues. And as you'll see that limits transplant as well. Advanced organ dysfunction, dementia, you know, cirrhosis would be an absolute contraindications as would be poor insight and support with transplant. The RV is not an issue. It's more pulmonary pretension. You're taking a heart out and that right heart is going to be connected to the pulmonary vasculature. Recent malignancies, solid organ malignancies or hard stop, high circulating levels of antibodies oftentimes seen in young patients, young women specifically. Uh and so you have a mixed bag of determining Does someone need an advanced therapy? What is the best option for them given their age and other comorbidities? And what are the contraindications fall into play? This is not in some ways much different than making decisions where we're talking about advanced heart disease with functional metro vegetation. So to that end a final slide, how do we choose? And this is something I put together that there's nothing locked in stone. Here, transplant is our gold standard. And I think if you have a class for patient it was I'm choked dependent and younger. This is the way I would go. I think for uh l've add again be a class for patient on a trip dependent. But maybe older still has a decent RV and no advanced chronic renal insufficiency. Now, by the way, if we look at those numbers were still talking about only 5000 people a year where there's some between 20 and 50,000 people who may need this intervention. And many of those as you guys know, have significant marginalisation and where trans catheter and 10 repair may come into play our class for patients not requiring on china tropes. Typically alder the RV can be off but hopefully not severe. You can have renal insufficiency but hopefully not really advanced a concern as it affects management but not a hard stop. And then you have some other secondary level concerns. I bring something back from the last meeting which would be disproportionate, M R. I think if you have that would support this approach that said. And in summary, no matter the choice, the decision and the best option and the subsequent outcome is going to be greatly dictated by the response and subsequent stability by those meds that are put in place. I think that's what supports the trials. Is supporting the trials and a lot what konzi spoke out at the last meeting. Thank you ross. So, in terms of when we're talking about treatment strategies, in terms of tear and other options, we have edge to edge repair, Kordell and Kordell apparatus, direct angioplasty, indirect angioplasty, trans catheter, micro valve replacement and going into a little deeper into each of those categories jean so other, I just wanted to point out there's there's a newer or another device out there for education repair with its Edwards pascal device, the trial called the clasp to deliver generation to fr functional that that pen has been participating in for a while and we hope to get our first patient here at presbyterian done soon as we've gone through the screening process and spoke to a patient today, there are some potential benefits or advantages to this device but it's still a basically a clip if you will. But it has some larger paddles for maybe better or more grasping of the leaflets unless my trick vegetation there is a independent grippers that the new devices also has, but it also enters the LV in a different way elongates as to opening up. And so that might be better suited for people when they have a lot of coral apparatus and so forth. Especially if you have to maneuver things. But it's exciting to be able to have another edge to edge repair device out there next Well, so can you speak to this section? Sure. Thanks hans. So for patients who have the general michael disease and who are felt to be at lower strata risk of operative assessment, i. E. There are reasonable surgical candidates as opposed to non surgical candidates or high risk. There are new technology that is currently under investigation. We at penn are also fortunate to be part of the harpoon study, which is the device highlighted on the right side of screen. It is essentially an off pump left ventricular approach with artificial Kordell reconstruction targeted at the leaflets. So again off punk Kordell reconstruction. Uh And this is really exciting technology for surgical patients who wish to perhaps avoid car diploma bypass uh and have degenerative much about regurgitation. Mhm. So as we move to the more functional category of functional matrix vegetation, there are other annual plastic, as we mentioned, it's it's sort of uh not just directed at the leaflets but also directed at the LV size analysts and so forth. There's another ideology in this uh pathology or path of physiology. We're excited. We're we had hoped to be um having enrolled uh as part of the Caroline trial or Caroline device was basically a pre cutaneous bandits placed into uh the coronary sinus for cutaneous lee and then synched to try to optimize that Manulis and reduce my trick vegetation for patients with dilated annually. And also I'll be dysfunction from this and metro gravitation from this pathology. There's some direct uh annual plastic as well, but that all of these are currently on hold in terms of the trials, courtesy of the ongoing pandemic for patients um with functional as well as D. M. R. Who are not candidates for a catheter based repair strategy. Um There are also mitral valve replacement. Trans catheter platforms under investigation Current United States you can see here these are just a few uh platforms that are currently available. We at Penn are also fortunate to be part of the folk early feasibility study highlighted here at the bottom of the screen. The Edwards Life Science Evoked received platform. It is a transept oh platform. I hope to show your case later this hour, but it is a trans septal approach for a mitral valve replacement. Uh And certainly we are looking forward to enrollment. Continuing enrollment as this study is ongoing currently at Pat. And they're here are three other platforms with a similar uh concept of a catheter based metro valve replacement. Perfect, thank you. So now on to the cases so case one um we're gonna go through this one and there's gonna be a pole at the end of the case so pay attention and you know decide what you would you would choose. So uh this is a 63 year old man with ischemic cardiomyopathy, an ejection fraction of 20 to 25%. He has a sub Q. I. C. D. In place, severe mitral regurgitation and recurrent heart failure, hospitalizations. His past medical history is notable for coronary disease with prior history of M. I. And P. C. I. Diabetes, peripheral arterial disease. He's had a right BK as well as COPD and active tobacco use pertinent medicines. He's on beta blockers, Arnie and S. T. O. T. Two inhibitor as well as GLP one agonist. Next slide please. Uh in terms of his thermodynamics and right heart catheterization showed evidence of elevated by ventricular filling pressures with a preserved cardiac index. E. K. G. Is shown here showing sinus rhythm with a narrow complex QRS. Next slide, transit salvageable echo showed an eF of 2025% with severe mitral regurgitation E. R. O. A. Of 0.49 centimeters squared. Next life these are his uh trans esophageal echo images. Um And what you will see here is you have a dilated left ventricle with evidence of coral, tethering and leaflet restriction. Um Next slide please. And then this is a zoomed in view of the long accessory of the transits have visual echo showing mitral regurgitation. Excellent. Please. Here on the left hand side you have your by commercial explain view again, delineating leaflet morphology as well as pathology. You can visualize to leave the restriction and on the right hand side is a similar image with color flow. Doppler uh What you can see here on the color images are to regurgitate and jets, there's one jet at the A. Two P. Two co optation as well as a lateral commercial jet that is visualized. Next diapers. Three dimensional views. Again delineating the leaflet restriction as well. As you can see the regurgitation. Jets and colorful doubt their next line next like this. So based on what you've heard so far, what would be your next steps? Medical management, tier, mitral valve surgery, bad or transplant? So as we're as people are voting, um I want to get everyone's thoughts in terms of jean wilson ross, What are your thoughts about this case? So ross. Um did you feel that this patient was optimized? I do. Um He's on all the standard therapies. That good doses. Um Of course I think would be a little bit more d congested but I think uh you know uh looking at the standards given in the trials and given what I see on the meds and the doses, yes I'm comfortable that he is optimized. I am concerned just to close the loop that we don't have many good options independent of this. Given his comorbidities really likely preclude strong consideration for any higher end option. And then Wilson, what are your thoughts in terms of surgery for this patient? I think that's a great question. Um um As many of you know um treatment of functional micro vegetation and surgery have have been challenging scenario over time, surgeons in general um have reservations about operating on patients for functional M. R. For a variety of reasons. Um um And as you know, over the last two decades um it has become less and less desire for many reasons outcomes, quality of life, mortality benefit, which I don't think any studies have shown a mortality benefit with surgery. Uh, so, but having said that, I do think there is a probably a small role or a niche role for surgery uh in the appropriately selected patients with FMR. But that is I think that lane is getting more and more narrow. Especially now with the introduction of these varieties of catheter based therapy. Perfect. And then, so just in terms of to share the audience results. So 14% wanted medical management, 55% tier 27% mitral valve surgery, 5% dead five transplant Jean. What are your thoughts for this case? Since you're the winner? Mm I don't know about the winter, but it's certainly just looking at a review of the case with rick, nash, the echo and the T. E. And so forth. He had some slightly challenging features a little bit a wider jet um little bit the restriction but of the poster leaflet but it certainly looked amenable to being uh having a successful result with tear edged edge repair, pre cutaneous lee especially with the recent introduction of a wider clip. And I think we thought that we could provide significant benefit and reduction in the metro vegetation for this individual, Having been almost about 56 months post his hospitalization and optimized from the heart failure management standpoint. So we felt pretty comfortable that we could provide benefit for him. So uh this patient was seen by a heart failure specialists and medical therapy was optimized due to persistence of shortness of breath and volume overload requiring escalations of escalation of diuretic therapy. We decided to proceed with trans catheter edge to edge repair. Next slide. Now just quickly uh reiterate the new guidelines that came up functional mitral regurgitation class to a indication. And this patient certainly fits the guideline criteria with the Class N. Y. H. A. Class four ejection fraction of 20 to 25% In systolic dimension of 52 and the pressure of 51 next life. Now these are inter procedural imaging. And what you will see here is what we decided to do was we decided to target uh sort of going in between the two records and jets and hoping that we will achieve adequate leaflet co optation that this will reduce the mitral regurgitation. So you see a by commissioner long axis view with the clip arms just above the leaflets. Next slide please. Yeah. And on the left hand side now we're into the left ventricle and this shows the importance of leaflet morphology in terms of uh leaflet calcification as well as the length of the leaflet. Because we basically go into the L. V. And come up and the leaflets fall on onto the leap onto the clip arms themselves and then we subsequently closed the clip. Um So on the right hand side is with the clip closed. And you can see there's been a significant reduction in mitral regurgitation. There's trace residual mitral regurgitation, jean. Feel free to comment on anything if you wish to. Next slide please. Now again, just a couple of imaging highlighting the end result with uh stable clip position, good leaflet grasp and trace residual mitral regurgitation. Next life please. Uh This is our final result with the three D. On fast View the surgeons view of the mitral valve and you can see a nice double orifice with a nice tissue bridge in between an adequate orifice area. Next slide please. So in terms of how the patient did follow up wise so clinical improvement in symptoms, N. Y. H. Class tuna and he's able to walk his dogs two blocks did have one er visit for hippo bulimia and diuretics. For decreased next like please in terms of imaging follow up. So at one month post intervention echo there was slight reduction in his left ventricular end, diastolic dimension uh significant reduction in mitral regurgitation. Next slide please. Now we're gonna move on to our second case. Um And we'll have some discussion after that. Next slide please. So this is a 61 year old woman with non ischemic cardiomyopathy. Ejection fraction of 20 to 25%. She has an I. C. D. In place severe mitral regurgitation with recurrent heart failure. Hospitalizations. Her medical history is notable for a prior history of stroke with aphasia and hand weakness as well as chronic kidney disease. Her pertinent meds, she's on carvedilol. She's on hydrology and and ISIS or bite. Along with the diuretic of note. She's been intolerant to ace are etcetera because of acute kidney injury. And another thing of note during one of the hospitalizations she based on her human dynamics became dependent on anna tropic support and was not able to be weaned off Next life. Please the trans antarctic eco showed a dilated left ventricle severe LV. Dysfunction. She did have right ventricular enlargement that preserved function severe mitral regurgitation as well as moderate to severe try custard regurgitation and her E. K. G. Shows presence of sinus rhythm with a narrow complex QRS Next life. Please, In terms of her chemo dynamics to the pre anna tropic support. She had evidence of bi ventricular filling pressures that were elevated with the depressed cardiac index on anna tropic support. Her filling pressures were lower and she had improvement in her cardiac index. Next slide please. This is her trans esophageal echo. Again you can see the dilated left ventricle here with significant coral tethering and leaflet restriction and a wide jet of mitral regurgitation. Next slide please. Again. three d. images imaging demonstrating the Mitral regurgitation as well as the restriction of the leaflets. Next slide please. So she was evaluated by the heart failure team and felt not to be an optimal candidate for home miller. Known given her history of stroke and associated hand weakness. Of note. Her significant other also had a stroke and has deficits related to that. She was felt not to be L. VAD or transplant candidate due to lack of social support. Her sister lives in Georgia and she really didn't have the social support necessary next life. So for this case, what would you do? Medical management offer her tear? Offer her palliative mill reknown asked her to move to Georgia to live with her sister or hospice as people are voting. Let's get everyone's different perspective. Wilson, what are your thoughts about this case? Thanks han si a tough case. Um I didn't, I guess I could just summarize by saying boy um this is tough. I I certainly think a a surgical mitral valve replacement would be an extremely challenging option for her giving all her comorbidities. Um you know, the the language of quote unquote inoperable patients is often hard to uh sort of defined. Um I think some of the language that we have now prefer to use or extreme risk prohibitive risk, I certainly think that would be the category that I would I would put her in. Um and frankly, you know, these are patients that um you know, surgeons have wondered what mortality benefit of any or even symptomatic relief of any, even if the patient had a successful open heart mitral valve replacement. Um, so these are tough patients. Um I'm not convinced open surgery would be her first option. Ross what are your thoughts about this patient? I wouldn't let Dr Zito touch the patient. No disrespect to Dr Zito. I reading between the lines, I think he feels the same way. I obviously have grave concerns. You have no high end options. She's very debilitated and I think you have to look at this case in a few ways. Certainly can she get through the procedure? I think that the overwhelming likelihood is, yes. Will she have a short term period of stability And she very well made. But I still have pretty significant concerns that an intervention in this patient, given this pathology, given her comorbidities would be one that I have real concerns about having a sustainable and improved quality of life jeanne. What are your thoughts? I think that I would echo what Ross and Wilson have said thus far in the sense of a sustainable benefit. Um it's hard to know and unfortunately you don't know until you try. Um but it seems that her current hospitalizations and her dependency upon member known uh would certainly despite all the intervention that you had placed her on and followed it very closely almost weekly for a short period of time. Um just didn't bode so well um for a long term sustainable benefit. But then on the other hand, I think we were looking at what options could we provide for her, Looking at it in a different light, We had some concerns and reservations because the ignition point out the width of this jet was very wide. A significant amount of restriction or within that restriction. But we thought I thought we could improve at least reduce the amount of micro vegetation and see what that resulted in terms of clinical practice. Perfect. So the polls showed that four would offer medical management 57 tier 17 palliative mill reknown, four said to move to Georgia and 22 hospice. True. I just also wanted to point out a lot of this is not just a discussion amongst the multidisciplinary fields but extensive discussion that you had with the patient on this and there's a significant amount. I don't want to de emphasize how much involvement and understanding the patient has to get in terms of managing expectations and seeing whether they would like to proceed with this type of procedure or not. Okay. This slide just highlights were her various parameters fall and within the current recommended guidelines. Uh next slide please. So after after a thorough discussion we decided to proceed with the intervention and these are inter procedural imaging. So on the left hand side we have grasped the leaflets and uh what we decided to do was go go in the center of the jet and hope to achieve adequate reduction in mitral regurgitation with our first clip. And there was a significant reduction in mitral regurgitation while the leaflets were still grasped and on the right hand side. Um It's an example of what can occur at times when we released the the device. Uh and when the device is still in place and attached to the catheter, there there could be some tension and torque on on the device itself and live on the device itself and on the leaflets. And when you release it, you may distort the leaflets and you can see that we ended up with a little bit more mitral regurgitation. Still in the qualification would be mild to moderate. But now we're ended up with to regurgitate and jets one on the lateral side of the clip and one on the media side of the clip. In light of her clinical situation and the fact that we had achieved adequate reduction or reduction in mitral regurgitation and the fact that there were two separate remaining jets, we elected to not proceed with an additional intervention or additional clip at this time. Next line please. So in terms of her follow up, she had clinical improvement in her symptoms. She's class 2-3, she was able to be weaned off mill renard and in terms of her follow up imaging. So the 2.5 months off in a trope echo showed similar left particular enlargement, some slight change in her ejection fraction that she did have residual moderate mitral regurgitation. There was a significant reduction in her tribe custard regurgitation. Next slide please. So this trial has been talked about before in terms of the coop trial. But I just wanted to highlight truly a landmark trial in terms of what it was able to show in this patient population with regards to heart failure, hospitalization and mortality With regard to number needed to treat to prevent one heart failure, hospitalization in 24 months. They It was 3.1 and number needed to treat to save one life at 24 months of 5.9. So pretty significant results of the coop trial next life does now as you know, both the coop trial and the Maitreya Fire trial came out in the same issue of mainland Journal of Medicine with differing results at the Matri. A fair trial was negative trial with regards to Metro flip intervention for functional mitral regurgitation. Whereas the court trial you just saw the results of however, when you dive deeper into the patient selection selection, the differences of techniques and things of that sort that there's quite a bit of differences and it's really hard to link these two trials together and compare them and specifically some parameters that are highlighted here. The court trial had more mitral regurgitation with larger er away. They had smaller left ventricular size. And then these patients really had more of a heart failure truly refractory to medical therapy that higher levels of anti pro PNP and higher heart failure, heart failure, hospitalization rate And on the bottom of this uh slide here. Our parameters for the two different patients that we discussed are are highlighted here in terms of their er away, their left ventricular size and their anti pro Bmp. And falling more towards the correct criteria as you'll see in the next slide. So this is a graph from paul Gray burns paper and eloquently highlights here the concept of proportionate versus disproportionate mitral regurgitation. So you have your end diastolic volume on the X. Axis and the er away on the Y axis. And as you can see the patient population had more disproportionately severe mitral regurgitation where compared to the Maitreya far patient group was more proportionate mitral regurgitation now incorporating all of this together in terms of their two cases that we talked about, where do they fit along this spectrum? And case one and two both fall within the disproportionate M. R. Certainly case one has more disproportionate. M are based on the knee roo and diastolic volume that's listed. And and it also highlights that this is a continuum in the spectrum and and patients will vary depending on their medical therapy and and the different volume status and the roos status. Uh Next slide please. So this is just kind of an extension of that paper where they looked at the co act and also Metro F. R. And also put L. VADs on this line. In terms of if you have a patient in what's going on, would they be that are served are they more of a micro fr patient or a co op patient? And some of these patients, if we had a little bit more time we could have described another patient that we had a similar situation. And we actually offered them in L. VOD. Because that was the better. Um in terms of long term outcomes for them. But this is also a great paper in terms of outlining how do we do patient selection for these patients? And one of the things before we got on to the next case is that for this patient and for all of these patients remember functional M. R. We also have a dysfunctional left ventricle. So even after we do the clip for these patients you still have to still follow them afterwards. And that patient that we talked about in case to, she was closely followed in terms of increasing her neural homeowners in order to get that result. So in terms of these patients it's not just fixing the you know in terms of doing an intervention it's also continuing pushing the envelope in terms of neuro hormonal. Okay onto case three. Well thank you. I just wanna take the remaining party our before the discussion to share a case. Um Here a pen um with the trans Catherine micro platform. I'll briefly go through the patient demographics and we'll share with you some inter operative videos. This is a patient that was treated a little bit over a year and half ago now, 61 year old man. Bmi of 15. It's obesity. Um The classroom mark failure. He has had previous surgery before previous corner bypass grafting. He's also had a history of Pc in the past atrial fibrillation, hypertension, anemia, hypercholesterolemia and also peripheral vascular or cerebral vascular disease, correct artery stenosis. Thanks line please. As I mentioned he's had previous coronary artery disease history and he had a corner of bypass grafting. It does appear to have a stable river pasteurized corner disease in the sense that he has a patent that led is the pain bank grafted a diagonal. He does have some mild osteo radio marginal disease but nonetheless okay. And included in compensated being grafted A P. D. A. Uh in a native R. C. A. Has LV function on an Eco demonstrated me up around 40 to 45% In that stage three chronic kidney, chronic kidney disease. Next slide please. This is just the summary of the eco finding four plus M. R. Again, ejection fraction between 40 to 45% severely dilated or enlarged left atrium. Um, and you can see here on ATE done in January of 2019, which is around the time of his procedure, it was described. And you'll see the video shortly, moderately restricted interior and severely restrict a poster model belief and mobility with some poster leaflet segment, P. Two and P. Three specifically there was severely severely restricted likely due to its likely due to ischemic LV. Remodeling. Thanks live please. Here is a video you can see here significant my drew regurgitation um characteristic or what you would expect based on this path of physiology. Ie ischemic much vegetation. Next slide please. So as I mentioned earlier, we at penn or fortunate to be part of uh early visible study involving the Edwards ego platform. This is a trans catheter, trans septal approach mitral valve replacement system. The concept is that it utilizes the entire metro apparatus, meeting analysts as well as the leaflets and accords for positioning and deployment as an intra annular ceiling skirt with the concept that it will mitigate or minimize provider leak. Um The profile has been optimized over the last few years so that there is a lower atrial and more importantly a lower ventricle it profile to reduce any complications. And specifically we're talking about L. V. O. T. Or left ventricular outflow tract obstruction. Next slide please. Here's a video of the procedure. Um The artist rendition you can see here a transept will approach so a trans venus transept all approach much like a tier approach would be the devices then under three Rosco P. And Ecuador choreography guidance deployed with a very um deliberate uh mechanism of leaflet captured patient um At this point remain very stable human dynamically they've left ventricular anchors that deployed. The valve is expanded and then the atrial anchors release and the valve is then detached again completely. Transept all for continuous and the patient remained relatively stable. The steering system of the delivering system, you can see our picture on the top of the slide um Similar to a tier apparatus allows you to have multiple planes of flexion to enable optimal co actuality so that the metro apparatus can be lined up appropriately with the prosthesis. There are also independent death control that allows for positioning, so allows the device to go ventricular as well as a true thanks like please. Um because it is a replacement platform, obviously annular measurements are important and a careful um deliberate C. T. Analysis E K G gate. It is required to ensure that the annual our measurements are within the measurements and within the I. F. You of these two sizes that we currently have in this device. Next line, as I mentioned before. L bot analysis is key here. Um It is one of the more common failure modes in terms of screening uh not failure miller device but screening screen fails. You can see you're a careful ct analysis is done in both in systolic um in both an optimal and sub optimal trajectory to ensure that we have adequate ele bot clearance after valve deployment. Newsline here is the procedure um trans septal approach. You can see the sternal wires, there's a pigtail in the left ventricle to assist in positioning. An L. V. Graham is then performed to allow us to see the mitral annular um claim then under very careful flores, coptic guidance. The devices then advanced across the mitral valve. Angelus into the left ventricle. Next slide please. The positioning after introduction in LV is all echo base and it is just like tear. It is a very eco heavy imaging um reliable uh modality of treatment. You absolutely need a strong partner in imaging you can see here the valve is then positioned in a way that there is co actuality and appropriate leaflet captured so that these leaflets are not pinned. Uh and this is obviously to ensure appropriate position in no para barbara legal. We're finished. Next slide. Once we have assurance our eco colleagues at the positioning is appropriate, then the valve is released and deploy as you can see here on the floor. A Skopje, The 11 trickle anchors release followed by the atrial anchor and then complete detachment. And you can see here on the far right completion of ventricular graham demonstrating no montreux gravitation and adequate L V O T clearance. Next line here is the completion or end a procedure. Inter operative transfers out your echo well functioning device, no significant para volver a leak. Um So a very satisfactory outcome. Thanks. Fine. Right, thanks Wilson. So jean kind of in terms of bringing all of the different thoughts, What are your thoughts in terms of degenerative and functional? I just wanted to um say that you know seen from these series of meetings that metric vegetation certainly is comes from a lot of different pathology allowed different ideologies not sort of a one size fits all. One problem to the ideology of this. Um We tried in the way you've organized this to go through a simplification or deconstruction if you will of mitral valve regurgitation, mitral valve pathology separating to generate and functional or primary secondary M. R. But even within those broad categories, um hope that those of you who have shared your time with us gain appreciation of the different variable presentations and technologies ranging from the simple A. Two P. To prolapse. That would be very ideal to trans catheter or Trans am our tier urgent repair. Two other cases that are more complex and may be better suited for surgery and or higher end options or new technologies that are in development um to that and I want to just reiterate some of the points that we've been trying to highlight along the way uh for degenerative M. R. This is really a surgical treatment. It's a surgical illness that should be dealt with surgery unless um there are other features for this um individual patient and that really comes to this sort of patient selection. Looking at the patient, having your conversations with the patient, a multidisciplinary team, tear or trans catheter exchange repair really is a has a two way indication for those patients who are high risk or probably prohibitive risk for surgery. Um And uh appropriate like the patients can get a significant amount of benefit and reduction in the M. R. With this uh technology for function. Um Are without any good surgical options. I think we've run through that tear in the appropriately selected and identified and treated patients is indicated after they've been optimized from a chf standpoint. Um All of these approaches really sort of highlight if you will how much of a truly coordinated multidisciplinary approach um That this is um ranging from administration administrative people, nurses, uh pornographers um and all the various physicians in the different specialties with cardiology and C. D. Surgery. Um So all it takes um you've heard that saying that it takes a village. My wife likes to say that all the time and it truly does take a village to um to basically treat um these patients to tailor to select the best treatment option for these patients. And again just highlighting how crucial and vital it is in terms of patient selection for the appropriate treatment to best treat these patients. And with that I'm very thankful that not necessarily I've spent a lot of a lot of time getting better at echo reading. Thanks to two national and Roy. But to be able to work with all of you guys um in treating our patients before getting the Q. And A. I just I'd be remiss if I didn't thank all of you for joining us for these sessions. I hope you really enjoyed it. I know that we've all enjoyed being a part of it. I want to thank the panelists for spending their time and and sharing their expertise with all of us. But I also want to put out a major shoutout to hans um for putting this incredible effort together. I mean she's really put all these slides together kept us on track um and coordinated each session remarkably well And I really truly enjoyed it myself and also to linda for uh really keeping us on track for scheduling everything for getting us these screens to to look at the backdrops and so forth. So I want to thank all of you all of us. Any one of us are reachable at any time honestly. Um by email, by phone you see up on the screen here um that there is a referral email um that we will get back to you if you'd like to get to us that way instead. But the cartoons truly uh we need to look at these patients appropriately select the um the right strategy for the right individual and really one size despite the cartoon on the right here, one size does not fit all. So to that I want to get to at least some time here. I think we slept about 10 plus minutes here to get through some questions. Perfect. Okay, so some of the questions, So is there any anti coagulation required after tear? No. So I will say that um if you look at the trials for co apt and Everest and so forth, it was mostly doing to play your therapy and it ranged from a month to six months and I think probably because it was driven by interventionists and we're so used to dual anti platelet therapy with stents. A lot of us are doing dual anti platelet therapy with aspirin and Plavix per se for six months pier or shorter, depending on the duration. I think it becomes different for those patients that are on no acts or Coumadin or antique wagon therapy to begin with. And they have another indication. It's not an indication we don't treat patients necessarily if they don't have an indication outside of this illness to use antique wagons but if they're on anticoagulants we varied it to um antique wagon alone. To anti coagulated with aspirin or Plavix Allah akin to what's going on in the stent world as well. Um and the duration it is uh definitely tailored as you can imagine to the bleeding risk of some of these patients. I mean I think it's different for a 60 year old versus an 88 year old but that's the general guideline that our approach that we've taken. Thank you Jack, nash. Can you explain again disproportionate mar and proportionate M. R. Sure. Yeah if you can pull up that slide again. But basically the way I think of it as as you know you're plotting the the left ventricular volume versus the severity of the mitral regurgitation and towards the left of the screen. We have the disproportionate M. R. And more proportionate as you go to the right of the screen. So as the left ventricle enlarges and as you get more mitral regurgitation, that's that's sort of one of you know to be expected and and considered proportionate mitral regurgitation. These patients may be too far along the spectrum of their heart failure whereas disproportionate mitral regurgitation being left particular hasn't enlarged that much but they have more significant mitral regurgitation. So that would suggest more of a valvular contribution to the disproportionate M. R. As opposed to the proportion of them are suggesting more of the left particular contribution being greater and and thus with the disproportionate mitral regurgitation, one is to expect more benefits with intervening on the valve itself as obviously the LV is treated in both conditions but that's that's how I would view it. So uh in terms of plotting the volume versus the severity of mitral regurgitation. Perfect. Thank you. Ross. So how soon after tears should patients be be seen to assess to just diuretics and neural hormonal blockade? I don't think there's any one right answer. After any hospitalization where you have a diagnosis of chronic systolic heart fire. I think patients should be seen within a week. I think that's a Jaco standard and I think it's even more relevant than you've had. Someone who is typically somewhat tenuous realizing that some of these patients are closer to class two or class 23 Uh And quite honestly, I think if there may have been optimized upfront, uh if you've had a cut back a little bit in the peri procedural period, I would quickly go back up. Obviously if there's issues of an Ak I or hypertension, I'd be patient. I think there's no urgency to get them back up to a certain level. So I'd answer it this way. There is no urgency to do things immediately. I think their clinical course specifically their blood pressure and the renal dysfunction will pave the way to tell you when to get either back to the doses that may have been trenchantly reduced or to further build on your medical regimen that you had going into the procedure. Perfect. Thank you. Um are there any risk prediction models or risk scores for mortality for tier patients in the degenerative mitral regurgitation? You guys are aware of Jose? I'm not aware of a formal risk model, but there's certainly several features that are, it may not necessarily mortality, but poorer outcomes. Examples would include the coexistence of significant try customer vegetation, for instance. Um There's certainly some degree of prediction with respect to the proportionate disproportionate mar that's out there, but that hasn't really been validated in terms of a full model, in terms of looking at whether to do it or not as you know, um and so forth. And then obviously the result that you get um has been associated with poor outcomes, not necessarily mortality but poor outcomes and um lisa. Um One of the questions is in terms of for these patients that um are after procedures after they get a tear procedure, what follow up do they get? Um In terms of um do they see the team again? Are they following up with the cardiologist? What assessments do we do? So for the 30 day follow up post terror? Uh They see me, they'll have an echo prior to it. Um And I will also review the questionnaire on their heart failure. With them. A one year follow up would be inclusive. As the baseline. We would do a six minute walk to compare it to the baseline. Six minute walk as well as their heart failure questionnaire and an echo. And that's typically what we would do to uh to have the patients come back to us. The people that did the procedure of course they would see their cardiologist or primary cardiologist in between. Okay perfect. Thank you. Um In terms of that last case it was a great case. Um Are there are patients would you have offered him if he didn't have the favorable anatomy Wilson? What would you have offered him? Um Good question. Um um He was a younger patient. His ejection fraction was still relatively intact at 40 to 45 certainly. There were no trans catheter options. There would have been a real sort of hard to hard discussion about surgery. Um um He has done well with trans character replacement. So I do think that um uh correcting the mijo regurgitation lesion uh would have offered him benefit even if it was so concerned. But it would have been a tough, tough recovery period for him. But um surgery would have been the last resort for sure. Um There's a question about transplant is can skin cancer recurrent skin cancer contra indication to transplant Ross. You don't you don't want to handle that one hand. Uh I don't I can't say for sure. I think your squamous and basal cells are usually non issues patients with the current skin cancer. It becomes a concern because there is a marked increase in skin cancers after transplant. Social heart transplant. I think melanoma is a different animal. Um And depends on the nature of the melanoma. I'd really have to lean on my team uh to tell me where we're at, where we stand now, but I'll stand by that basic assessment. So in terms of, as you said, a lot of the immuno suppression will increase your risk. And so a lot of these patients after transplant, even if they didn't have a history of skin cancer and basil cell will end up being seen by dermatology quite frequently. Jack Nash is if you had one view or in terms of what would be your ideal view in terms of micro records, imaging? Yeah, honestly, I would get the by commercial view um and you know, with and without color with with um explain through that view, giving you the long axis view and that one view can give me a lot of information on leaflet morphology, mitral regurgitation severity location. So that's really the bread and butter. The three dimensional view adds additional information and provides a nice overview of the mitral valve and the various gallops and I think it complements it. But if if I only had one view, that's that's what I would pick. If I had to use then I would do that view and the three D. Zoom view. Um And and then that would be the two most important. And then another question came up in terms of Gene and Wilson. Where do you think if we had this session in three years, where do you think the field is heading, jean? You want to take a stab at it first? I mean I think the field is definitely heading and it I guess you can take a look at and you know the history better than anyone else in terms of just try to make it akin to the eric valve. Um and the prettiness aspects of eric valve development over the past decade. You have to believe that more and more trans catheter based therapies are gonna become prominent in three years. Uh The technology for edged edge repair is going to get better and easier to use and maybe even smaller. Um So less vascular complications. Um but there will be a limit because I do think that the trans uh basically trans septal approach is going to be the preferred modality for all trans Catherine peace therapies. But they're the um aspects are looking at other modalities of treatment, whether it be annular annual plasticky or other tethering types of devices, even from a surgical standpoint, like harpoon for instance, um as that gets mature. Um You have to believe that minimally invasive surgery and trans catheter based surgery up trans catheter based technology is really going to continue to refine treatment and broaden the scope of patients who can get these type of therapies. I would I would agree an echo of those statements. I think a couple of points. one. yes, I do think that feels looking optimistic in that sense because I think technology is always amazing. Look at what's already transformed over the last decade or two. So I do think more and more patients, we'll have trans catheter options in your future because I think technology is just just progressing so rapidly. There are many, many smart engineers out there that's going to help us overcome technical challenges. I think from the physician side. Um, drawing from our open surgical experience, I think what we're going to have to um refined uh it's no different than what we did in surgery. Doesn't matter. You're going to fix something surgically or catheter base. We're gonna have to learn which vows are good to repair, how to repair them. And we're also going to have to understand which vows that we should just replace. Um And we have some of that lessons learned from surgery, especially especially in FMR. Um And I think we can translate a lot of those lessons learnt into the catheter world which vow should we repair and which vow should we replace and a bad repair is not as good as a good replacement. And I think that's my sort of my parting shot. Perfect. So one of the things that I'm just going to highlight again this is our multidisciplinary structural team in terms of the mitral valve team, we have structural cardiology imaging, heart failure, cardiac surgery in E. P. Um I just wanna you know this was the this is a three part series in the evening um To round we're going to do another round table. There's gonna be a roundtable with degenerative M. R. And as part of cardiac surgery. Grand rounds on april 8th. And I want to thank you all again For joining us these past three weeks. In terms of these Thursday three Thursdays I hope you have enjoyed um what you've learned and I hope you have also taken away in terms of deconstructing this um You know the mitral valve, this is the year of the mitral valve. But in terms of you know when we talked about at the beginning of this series that there is a lot more mitral valve disease than even aortic disease. And one of the questions is patient selection. What is goal directed medical therapy getting them plugged in in terms of seeing should they should we intervene? So I want to thank you guys again. I want to thank the panelists for joining us. Um, I think this has been very informative. Um, and um, I want to, if anyone has any other thoughts, um, great. You can add this time an honor to be on the panel. Handsy. Thanks for putting this all together. Congratulations everyone. Fantastic. Great work nancy. Right. Thank you guys. Okay. Have a good night, enjoy. Oh, sorry, go ahead. Have a good night. Everyone enjoy the nice weather. Uh huh.
