TAVI for pure aortic regurgitation with a dedicated CE-mark device: an underdiagnosed disease

well good morning uh and welcome to this session Tavi for Pure AR with a dedicated C Mark device and underdiagnosed and undertreated uh

disease this session is sponsored by yenal technology the objectives uh here are to learn how to improve the treatment of

aortic regurgitation a disease that is underdiagnosed and undertreated to learn about Tavi for aortic regurgitation and to explore the future

of Tavi for aortic regurgitation particularly exciting objective my name is Andre bber I'm from London I'm going to be the anchor I'm with Dan Blackman from Le who's going to be the

spokesperson he will take your question that you can uh ask through the app but also after the talks if you have a question uh burning you can go come up

to the microphone and ask directly there it is um we've got talks and discussions madalina garby from Cambridge HRI TR

from and Muhammad Abdel vahab the what's in the box three talks aortic reg agitation unmet needs uh second one

performance of a dedicated Tavi device and third Tavi for aortic reg agitation where we are now and what the future

holds and we're going to start with a diagnostic bit uh which I heard is also very very exciting with a lot of new things to learn

madalina thank you very much for inviting me to give this talk on the unmet needs in aortic regurgitation um so the unmet need

starts from conservative guidelines two conservative guidelines which are based on the natural history of bpit valve disease which usually affects and

reaches need of intervention in young individuals and is also based on the fact that um in the Years 90s 80s there

was a very high risk from surgery in these individuals so uh temporizing surgery was quite appropriate in the

time uh the current thresholds for severe aortic regurgitations are based on evidence obtained in younger

population again and in male which will have larger volumes of the ventricles and will dilate the ventricles easier so the current regurgitative volume

threshold of 60 mlit for defining severe aortic regurgitation originates from this type of research even more modern research based on MRI enrolled again

young individuals with basp ortic valve disease particularly male that can die at The ventricle however again from MRI

we have more and more evidence that with age we develop a non distensible left ventricle and a low flow state with a

stroke volume index lower than 35 milliters per square meter um and then it means that we cannot expect the same regurg and volume to be tolerated by the

individual with a smaller non- distensible left ventricle there is clear evidence that with age we lose the adaptation to aortic regurgitation dilatation of the left ventricle is a

form of adaptation of the left ventricle to avoid drop uh increasing pressure So to avoid symptoms the ventricles that don't dilate cause severe symptoms in

those individuals and there is evidence that 38% of patients requiring aortic valve Replacements have non severe aortic

regurgitation based on recommendations of guidelines meaning that we need to change the threshold a new optimal cut off for regurg and volume was thought to

be 38 mm rather than 60 mm which will bring down to the old-fashioned uh thresholds of moderate the aortic regurgitation as being severe there is

this recent beautiful paper published in Jack from Cleland clinic in which they demonstrate that left ventricular enlargement as a result of severe aortic

regurgitation is not to be expected the same in over 60 years olds and in women so if you wait you allow this patient to say stay breathless for

longer and poor study designs continue to mislead the guidelines this is a very recent paper they used again they enrolled the young men dilators um 50

years olds with very few female they used basic echocardiography with 2D Echo MRI was better obviously in assessing the left ventricle when it's compared

with 2D rather than with 3D Echo however MRI was misleading regarding the severity of aortic regurgitation downgrading the severity in a large

percent of patients at you can see and circled in my slide um there is also Progressive evidence coming from Mayo Clinic from Patricia pelica recently

which moves up the threshold of ejection fraction to 60 from the 50 uh in the ESC guidelines currently 55 in the American guidelines and in the nice guidelines

now there is evidence that ejection fraction dropping below 60 is bad enough to require um intervention in aortic regurgitation and even more so uh the

evidence is for moderate to severe rather than purely severe aortic regurgitation based on all thresholds so in order to address uh this unmet need

we need to move with Echo card iography beyond the basics we need to learn to assess the ortic regurgitation better and echocardiography in our our days

with 3D Echo can also assess beautifully the suitability for a trans catheter valve and this has to be incorporated in the followup of patients because if the

patient is suitable for a transcatheter valve which is a low-risk procedure and very effective then maybe the timing of of intervention should be earlier than when you're

just uh able to offer surgery with a higher risk particularly depending on the patient's risk so in conclusion we need to use new thresholds for severe

aortic regurgitation we need to stop unrealistic weight for dilatation and EF drop CMR can underestimate AR even

compared with all thresholds of aortic regurgitation however helps uh at followup assess the left ventricle thank you very much

[Applause] thank you very much so that there's a lot of new information and I I take it none of this is in the guidelines right not yet no none of it so we need to do

studies or do we need to I I I think the studies are there is just about picking on the evidence and being a bit open-minded about the risks of the interventions that were informing the

guidelines um new guidelines coming next year Melina do you think they'll bring in some of these different thresholds for AR Sur it uh timing of intervention or was a bit too early for them to made it it might be a bit too early for the

European guidelines and it might have to be um from the American guidelines that will follow the year after okay hendrik you're aortic

surgeon and what are the criteria to to operate on a patient do you do we wait for the LV to dilate or well this is what we usually do but we learn more and more that this is wrong actually and it

can only you depicting from what what Melina was saying is that the um the burden of the disease is very high but we just don't see it and it's also in the heads of the referring

Interventional or for cardiologist or even uh tary care doctors they just don't send patients with ar unless they have LV dilation it's in the guidelines

it's a it's a it's a rare disease but it is a very common disease that we have to treat much more often yeah Mohamed the

madalina said MRI underestimates yet yesterday we had a talk by a colleague of mine who is an MRI you know

specialist uh and he says MRI is much better at at defining volume so you get the numbers but you still don't get it

right what which modality do you use to to arbitrate to say yes or no yeah I I mean I I think the important thing is to understand that probably we we need to have different cut offs in the different

modalities so we we cannot just extrapolate the cutoffs we know from e to MRI and then probably we'll get the underestimation maybe we just are measuring something different and then we need to redefine our cut offs the

best thing would be to redefine them of course based on prognosis um but I was wondering just one question because it it just came into my mind whether we

should start defining AR not like as a one single disease but maybe there are different phenotypes and they should have also different indications uh or cut offs for intervention yeah there is

phenotype of the young dilator young male dilates by Casp aortic valve congenital aortic valve disease that causes aortic regurgitation and the phenotype of the non dilator which is

the over 60 particularly female but also male with systemic hypertension a degree of stiffness of the left ventricle myocardial fibrosis from systemic hypertension and small ventricles with

low stroke volume index so there is low flow AR as there is low flow as so no but Melina I mean thing that I think when we talk about ortic

regurgitation we're not seeing these patients in the same volumes in our clinics as we are aortic stenosis and we know from primary care studies like ox valve that actually it may be the

frequency of AR is actually greater uh the prevalence in the population how can we fix that do you think it's just there's just lack of awareness in primary secondary maybe even tertiary

care about aortic regurgitation yeah I think we need to move with the education towards the referring Physicians as you say toward secondary care and primary care and particularly education should

be on the methodology of assessing aortic regurgitation even by trans tcic Echo correctly this is a smaller valve adjustment of settings of the machine

are important in order to clearly Define the Vina contractor um it's a smaller valve you cannot expect the same regurgitant area and volume as for mitro

regurgitation it's about just opening Minds uh and uh asking them to refer the patient and if you if they see some aortic regurgitation which they consider insignificant but the patient is

breathless they need to refer to us and maybe now as we're going to hear later on in the session that we have a good trans catheter treatment for atic regurgitation we'll start doing what we've done with otic stenosis mro

regurgitation and reaching out a little bit more saying you know exactly to look for these patients I think that that's exactly I mean we're we're coming to the percutaneous treatment but we have to state that the gold standard according

to the guidelin and practice is still surgical aortic weal replacement and until now many of our colleagues out there that see the patients uh firsthand

if they think they're not for an operation they don't think about an alternative so the uh the pressure to do proper Echo to do uh uh something to

refer to an Interventional cardiologist is not there because the knowledge uh of what we're about to see is not out there and I think we need need to communicate uh that

um Marina I thank you I think we come now to the second part of this session and that is uh the performance

of a dedicated Tav device because there is something now that wasn't there 5 years ago and uh even two years ago with increasing

evidence uh for Success yes fortunately enough and uh interesting thing is since we have now the trilogy valve available in my center for a longer time we see more and more

patients being referred because of course the news are spreading so when you treat those patients all of a sudden you see more patients coming in being referred and the same thing will happen to all of you once you get access to the

device so uh we speak of course about the trilogy Al also called Yen valve system and I just brought a couple of images to remind you how the system

works actually it's a Nal poer cardio valve the specific feature of this valve is that it has three locators that are meant to go into the natural sses of the valve and they have kind of a clipping

mechanism so this valve does not rely on classification it does not rely on radial expansion it relies on a clipping mechanism on the native leaflets and this is the way how it fixes and this is

the way why it can be used in pure AR in the absence of classification you see the deployment sequence I just brought a very short uh sequence from the fluo uh so you make sure your locat is in

perfect position and this is a result that you can achieve in the vast majority of patients so complete relief of AR and uh this is nothing that you can achieve with all the commercial

other devices we have that rely on radial expansion so we can show you the latest data um that we uh achieved by the Align AR trial this is a 2-year

outcomes that has just been presented at TCT by torson F so I I Oham and the other investigators of the trial that we get this data it was a multicenter

non-blind single arm evaluation of patients with symptomatic a regation at high risk of surgery that underwent the implantation of the trilogy valve there were of course a number of clinical

evaluations and echocardiographical and functional and quality of life assessments being done and um the primary end points were looking for uh the uh safety endpoints and efficacy end

points and compare those to the specified performance goal 180 patients were enrolled in the Align AR trial and there was nearly complete followup over

the 2-year run for these patients Baseline characteristics uh now we speak about a typical Tavi populations elderly patients mid-age was 75 years and uh

they came also along with the typical comorbidities that we also see with atic stenosis patients it was quite interesting to see that there was quite a large number of patients showing with

pulmonary hypertension and you should also um mention that 16% around of those patients had pre-existing left bundle branch BL or right bundle branch block

what is important to know when we then discuss pacemaker implants after the device otherwise it has been a I would say more or less typical um population

for implantation of um Tavi device this is the all cost mortality at 2 years you see that the per procedure mortality is very low with

2.2% at 30 days 7.8% at year and 15% at 2 years this is very much on line of what we all know from atic stenosis in these patient groups if you just look

for the cardiovascular mortality it's much lower it's only 1.7% cardiovascular around the index procedure 6.2% at a

year and 7.4% at 2 years so very good outcome data when it comes to mortality stroke rates have been low there pared

stroke is extremely low with 1% and uh nondisabling stroke only 2% at 2 years and uh um excuse me um non- disabling 4.

and disabling 2.3% after 2 years these are the clinical endpoints we mentioning so very good mortality very low stroke rates the one thing that comes to our mind that is not yet

satisfying is the pacemaker rate we see here around 25% pacemaker rate for this uh valve design what we can also tell you now with the experience we have that

the pacemaker rate goes dramatically down with the experience of the center so there are some points um when implanting the valve that you have to consider and acknowledge and that helps

you to bring down the pacemaker rate it has to do also with the degree of oversizing with the implant death and other things so I don't see these values being really transferred into real life

in the long run but yes definitely in an AR population pacemaker rates are higher than in an as population and this we also know from surgery and surgery also

in AR um implants of valves the pacemaker rates are higher than with ortic sinosis we have to keep this in mind otherwise we have not seen severe

uh signs uh of of uh difficult outcome hemodynamic we performance is very good you know these patients naturally start off with a very low mean gradient of

only uh 88.7 but that even goes down to four and stays uh at for for the two years but what is much more striking is the extremely large opening area of the

valve so we end up with opening areas of the valve between 2.7 and 2.8 on the long run it stays like this and this is you know of course much different from what we know from tarv Valves and osis

this particular valve the super valve position ends up with excellent hemodynamics uh due to the excellent um effective orifice

areas we also have seen no sign of of significant parav regation so the vast majority about 90% ended up with non trace pvl and the few patients who had

pvl had mild pvl that was basically not not significant number of patients who had moderate so uh it's a wellworking

device when it comes to reduction of uh AR and reduction of pvl and this is then together with the hemodynamics translating into very good LV remodeling

so the left ventricular and systolic dimensions and and systolic um volumes are dramatically going down I have to say um with very good uh signs for

positive remodeling of the LV also expressed by a nice reduction of the LV Mass over time so this is something the ventricles basically waiting for to get

rid of AR and this then again translates into a nice Improvement of New York Heart Association functional class so a very good reduction of symptoms for the

patients um the vast majority about 90% of them being in New York car station class one and two on the long run after the implantation again also an improve

in quality of life as expressed by the kccq quality of life score dramatic increase in quality of life with a long-standing result over the two years

so alog together um I think we have seen that the implantation of the trilogy valve goes along with a very uh good mortality and Mobility hemic valve

performance is unbeaten with a very low uh gradient and a very high effective orifice area the fal LV remodeling um is very promising when it comes to

long-standing results of that uh valve and the Improvement of nework functional class and of uh quality of life show that patients are really profiting also

on the signs of symptomatics um this is much better than what we know from commercially available devices we use for osis and we we of

course have seen the data on the use of evolute and and sapiens and such uh indications this is the purpose study that Professor Testa from Italy was uh

just recently presenting he compared and his group he they compared um a matched comparison of patients who underwent commercially devices for the indication

of AR with what we know from the trilogy valve in a in a typical tarv patient population at the age of 80 and this is the outcome like in in basically every

endpoint primary endpoints um nonetheless V 3 technical uh success and device success dramatic dramatically better for the um Trilogy valve but also

all the secondary outcome and points are dramatically better for the trilogy valve so once you have access to the Val you will no longer use any of the other devices for the indication of um uh pure

a are so the clinic implication at this stage is that for the first time we now have a valve c Mark and available that you can use for this indication that

comes up with very good long-standing outcome in terms of mortality performance and reduction of symptoms and um yeah with this I want to conclude my talk

thanks hendrik the beautiful overview so what's your practice in Minds at the moment uh obviously patients who are suitable for surgery but are you using

yav valve Trilogy just in inoperable patients or are you starting to move down into high or even intermediate surgical risk patients yeah even low risk I mean I I wouldn't make a difference I think the patient

population is the same as for stenosis it's depending on age and comorbidities in an elderly patient population I would not necessar bring them on the Aur table to implant the valve I would rather take

this valve um unless the I mean there are anatomical exclusion so sometimes we see patients very large annually and then we are at the end where where the trilogy we can work but all the others

at the age of Tara I would say go into this now so it's a pretty big change I mean I think certainly our practice with before we had dedicated devices was they had to be more or less inoperable for us

to consider Tavy uh so I mean I guess that leads on to another question Mo maybe I can come to you on are we ready for a randomized control trial Tavy versus surgery for for AR and if so what

what kind of trial do you think it should be yeah I I think we are um the device seems to be working like really

in the in the if if you select the the correct anatomical um um prerequisites for implanting the device it it works

perfectly um and I don't see like any disadvantage at least in the acute performance compared to surgery if the anatomy is suitable and then the

question would be how it would like both devices or like both approaches compare on the long term and this is I think what's uh what's important to understand

um the the pacemaker thing is may be quite interesting I I I actually wanted to ask hendrik because I thought it's probably related to the Interventional approach I wasn't aware of the data that

pacemaker rates are also higher in patients when doing surgery any explanation for that what sometimes I think the

calcification can be even protective because the calcified anulus uh would also you know um protect the valve of getting too much contact to the

conduction system but in the absence of classfication the valve there's has some radial force of course always gets in contact and then it depends on how your

Anatomy is I mean how long the length of your membranal septum and um what is this degree of oversight that you need to do and and these things then come

together but yeah again it's the same thing in in surgery you're also closer to conduction system and this is why we have higher rates so maybe we cannot completely avoid this um but we also

have to confess we have not completely understood it I guess yeah so Andreas maybe I can turn to you cuz I mean you've been using this device for quite a while two years

what's it like you know for an operator to to come to this device how have you found it in terms of ease of use predictability is it something that should be restricted in terms of centers

using this device or have we got a device here that's uh predictable and can be rolled out quickly yeah so we we started we we did exactly two years ago

just before the London Wes we did our first five cases uh and have seen those now and um what can be replicated in

clinical practice we've we've look at about 50 patients now is this reduction in symptoms uh some patients get immediate reduction in symptoms for some

it takes longer usually to to together with a slow Improvement of their LV function the procedure we've you know we we now think of it as a as as an easy

day if we do three because it is very relaxed uh you very rarely have hemodynamic issues um uh if one W leaflet is kept open for example but

that's rare uh you have to learn the technique you have to think about the three-dimensional thing and um getting the um uh position of the uh locators

right is can be tricky but you know it's a nice challenge because the patient is well uh and um uniformly you get you get the valve to sit where you want it to

sit because it just uh sits there what we haven't discussed uh yet is that um you also of course get natural commital alignment which also means you have

access to the corn uh and that might be a good thing for future uh interventions and not just um com access I mean we as you know emerging data that

commer your alignment may be favorable in terms of um hemodynamics and we see the incredible hemodynamics um um reducing the risk of uh leaflet stress

and strain halt um so may be favorable for durability with this device I guess we'll have to wait and see but there's certainly good reasons to believe it may

be I've got one more actually comment and and may maybe question to Marina we often see patients that have not only aortic regurgitation but also mitro

regurgitation and if they were accepted for surgery they would look at two valves whereas we have now a number of patients

where we put the aortic valve in and with time 6 month 12 month the functional amarus disappears I I I absolutely agree with that I'm a

big believer in sequential treatment with trans catheter approaches rather than concomitant treatment with surgical approaches because we don't need to we don't make a scar we don't have sternotomy we don't need to put a zip we

can go back in and three the other valve it was always a question my surgeons were asking me do I need to do the mital or can I count that it will recover and

we had developed ways of assessing how if the leaflets are tented because the ventricle is dilated and is ventricular secondary Mr that will go away when The

ventricle recovers and give it 6 to 12 months and make sure you give peripheral vasodilators ACE inhibitors um uh to to actually facilitate the

process yeah very very interesting good point Malina I'm going we need to move on but one quick question from the audience hendrik you've had a lot of experience audience member wants to know

what morphologies of aoro regurgitation can we treat with the yav Val so giv the example of leaflet prolapse perforation anulus dilation a more common iology are

there any restrictions to the anatomy that can be targeted with this device um not so many by the way unless for the size of the an there's a certain limit that you cannot overcome because we only

have three size available now then the larger size is under development it will come a certain day um by cpit this is the problem because we need to have the

three locators in the sinus so if you have it true especially if it's a type Zero by cpit I mean don't even try it if it's a type one with a non-classified r we could potentially

try it but we have to say we don't have really uh I don't want to you know on this Symposium don't want to promote uh um use of the valve uh outside the ifus

so it it could potentially be done but we don't have much experience there so this would be the exclusion criteria okay good well I think that leads this very nicely actually in to our next talk

from Muhammad Abdul wahab CU he's going to talk to us about Tavy for AR where we are now and what the future holds yeah thank you

then so um I mean we we've heard some uh very important information on U um how we are proceeding with understanding the

disease and the possibilities we now have with the transc valve so uh where are we now uh with um the transc

treatment for ortic regurgitation I think it's a fact that dedicated devices are now available so on the left hand side you see the uh studies we have for

the inav valve which is the only device that is now commercially available in Europe the Align study that has been uh shown by hendrik we also have another

device which is uh being tested in trials in the United States which is the J valve uh with um some similarities and uh disparities compared to the inal but

there is um um room of course for uh a multiplicity of devices uh to be investigated in this setting so this is maybe important to state that we now

have dedicated devices and and why is it important to State and this has been also shortly mentioned by Henrik because they perform much better than all the

off Lael devices we've been forced to use in the last years um Henrik mentioned the purpose registry this is actually meta analysis that has been just published I think two or 3 days ago

in Jack interventions including more than 2,000 patients including in 34 studies um more than thousand of them has have been treated with dedicated

devices mainly the two I've shown um and um another thousand were treated with off lab device and what what you can see here is what has been also shown in the uh purpose study that

uh periprocedural outcome is much better regarding mortality regarding residual ER regarding valve embolization which is the main problem we had with off Lael devices and which led of course to

reintervention or the use of second devices but interestingly even pacemaker rates were smaller and this led to an overall higher device success rate with the dedicated devices and in this study

which is much more powered than the purpose study mortality at one year was even lower it was 6% versus 24% so uh dedicated devices are here

they perform much better and should be used if we're going to treat these patients interventionally the problem is they're still not available or affordable everywhere so maybe I'll I

cannot see all of you but maybe the ones of you who have access to yav valve just raise your hands okay so I think three four persons

handful so this is true because this is the the absolute number of centers with the yav velf program in Europe it's 25 11 of these are in Germany but even

these 11 in Germany there are only 133% of all implanting or Tavi centers in Germany so still it's not available or maybe it's not affordable everywhere and

this is actually the the main limitation we currently have so what the future holds if you want to just uh make the device available to patients in need we

need mechanisms to improve availability one of these would in my opinion be would be like a specific maybe reimbursement for uh a device like that I mean there's a lot of engineering

effort that is being developed in developing dedicated devices for a new disease entity or a different disease entity and we know from Tavern and this is a very old publication from Darren

melet more than 10 years ago that the uh utilization of the technology at that time for aortic stenosis was largely dependent on uh system reimbursement and

this is natural so I I do believe that if we want to uh spread this the technology across Europe then we need uh to work on

that what the future holds is probably also more dedicated devices that are already on the horizon again yav valve is the only valve that is approved I mentioned J valve but there are a lot of other technologies that are being

developed you see that the majority of them use this anchoring principle which is probably what we need for AR because of the lack of

calcification and because of the loger anatomy so we need to uh anchor the devices properly interestingly there's also one device that is in like still investigational for aortic valve repair

and we may discuss this again with with Henrik as well how important this is in the array of treatments we offer to patients where they are what the future

holds is also and we touched on that that we need randomized evidence against surgery and it's being actually created so this is the artist trial which I

think will start soon uh the study will enroll patients with severe native vvr requiring replacement and then the if the heart team says or defines the patient as being suitable for both

approaches then these patients will be one to un randomized between surgery and uh Tav using the trilogy device more than thousand patients will be enrolled Henrik is part of the study leadership

and the study has a primary non-inferiority endpoint a clinical endpoint at 12 months with followup up to 10 years which is also very important and lastly what the future

holds and madalina touched on that I think like any uh like all theee entities that we as Interventional cardiologist have the feeling that okay

we can help uh somehow it gets into the focus and then we try to better and early and identify patients who need treatment um there are a lot of efforts being done some of them have been mentioned in how

to define AR severity using different modalities but also how to identify patients that need treatment at an earlier stage of disease before the cardiac damage becomes irreversible

you've seen this slide before regarding EF but also other markers of disease progression um so to summarize I think it's the next T indication because we

have an unmet patient need we have dedicated device that do work we need we have some compelling data but definitely we need more and um I'm sure that it it

can only be successful if our clinical pathways to identify and treat these patients also improve thank you very much excellent Dan do we have questions from

the audience there yeah so um we touched on this by cuspid Anatomy um one of our audience members is asking can you use y of valvin by cuspid aty Hendrick so you you referred

to that what about type one by cused where we still have three sinuses do you have any experience of that is there experience of that that you're aware of very limited I mean you have to know the

vien at the time started out as a device for exosis so um from more experience from that perspective than from the AR

perspective and um it was yeah no it's uh it's it's difficult so I would right now I would not go this this way um but we have to gain experience maybe those

non-calcified valves open better I personally don't have experience actually Andreas have you ever implanted in type one no we haven't no what I wanted to say is that there are the

repaired bpit valves which become TripIt and then these are young individuals which a large percent of them fails relatively early and they will not want

a sternotomy again and a mechanical Val particularly women which want to have children so it will be a beautiful application to use this technology as a bridge for 10 years delay uh to allow

for maternity yeah and this we have done actually we have also used it for fail David procedures so this is a beautiful indication yeah yeah and I think we saw in the session yesterday actually cases

of previous atic Valve Repair another great indication stentless bio bioprosthesis which are very conventional T devices and and Ross

sorry and left ventricular assist devices that uh um lead to a AR while we're on that topic though you mentioned aortic stenosis I mean we can see some

good potential strength of this device even in aortic stenosis big valve areas automatic commercial alignment clipping the leaflets have you been applying this device the supply has been limited

that's made it difficult but where do you see us going with aortic stenosis with the trilogy well I'm not getting tired of promoting it in this indication because it's a fantastic

vosis and especially when it comes to Pacemaker rates the lowest ever pacemaker rates you can achieve in tari is with the with the trilogy Val Artic stenosis we've done that and we are in a

very low single- digit numbers of pacemakers because then the the lower radial Force comes into place so I know that for many reasons now the company

was focusing on because this was the open Gap that was the Gap that needed to be filled but we should not forget that the valve is really nicely suitable also for stenosis and especially when it

comes to low chony distance to as you said I mean access to chony arteries um very good valve performance also her dynamically because it's a super anular valve but without the frame you know

without the frame that makes further future intervention more difficult so I think it has many many features that make it a very suitable device for for patients osis we got a question from the audience

Andre if I can come in which is about the issue of aortic dilation so dilation of the asending aort and there's a few questions related to that M Melina the

first is what percentage of patients with isolated aortic regurgitation have or dilation of the ascending aota so we're going to need to factor that into our decision making

Tavy versus surgery in particular byp orves have Associated the orthopathy in a 25 to 30% um which means again that

classically surgery offers repair of the earlier because they don't want to off a sternotomy twice uh I think maybe if you have a transcatheter procedure temporize

that um in the population with aortic regurgitation in the elderly uh it's not actually aortic regation due to um dilatation of the ortic root that is

mainly encountered but is due to retraction of casps aortic regurgitation in the elderly with minimal calcification of the commissure and scaring retraction of

the casps with normal root this is more common so I think probably that that will be okay uh I think the cases that will necessitate considering the aortic

root will be rare or ascending aorta and what about the implications that Andress for the feasibility of the procedure does it make a difference to the ease of procedure and the feasibility if you're

treating patients uh with as dilated ascending atis no I think the the patients we've treated so far they they didn't have a surgical indication for

for the for the uh aortic uh for the ascending aorta but close um and it might be a little bit more tricky because you've got so much room

and you you have to be careful with these with these aorta I'm told by the surgeons they're very fragile and we all have experienced problems there um but

technically it's it's it's it all depends on the roote and the and the angle into the root and uh if that's uh within the normal range then we can put that wve in into the uh yeah I mean

that's certainly been our experience and we treated inoperable patients who had very significantly dilated acna AAS up to 55 mm and it does add some procedural challenges but we still ended up with a

perfect result and those are the cases where with the non-dedicated devices we really really struggled and as you said often end up with aortic injury because

of the fragile nature of the dilated asending so yeah know I just wanted to comment on the aortic stenosis and and and again this looks like a w that that is really

superb for aortic stenosis because of the Fantastic hemodynamics the fact that you Comm align we actually restrained ourself at the moment we've got in England um um we've got fully

commissioned for for that valve but we don't have enough material not enough valves uh in our hands so we can only roll it out slowly and we use it for

those patients that have aortic regurgitation and need it for now but I'm sure we'll in the future we'll see series of iotic stenosis patients being treated with this we as

well time to wrap up bring us home yeah let's do it so well listen I think you know the key message that we've heard today and that's all of our experience on the panel here is that this is a really revolution in Taffy you know the

first of these procedures we did really gave me memories of our very first Tavy procedure when you do something that is a c change a step change in what you're able to offer the patient so we have these devices now we now have the

evidence to support that we've got a great trans catheter treatment for atic regurgitation and we need to look to the future with randomiz trials to see if we can extend this into low intermediate

surgical risk patients we've also heard really importantly from Melina how we need to get better understanding um of the nature of aortic regurgitation and better awareness uh both in primary

secondary and tertiary care that we have a treatment option here but we need to be better at identifying these patients surveilling them appropriately with the Imaging Technologies at our disposal and

knowing when it's time to treat them so I think we look forward to a bright future and an expansion of treatment of aortic regurgitation by Tavy with these dedicated devices and I hope you'll all be able to get your hands on these and

and see the results that we've seen so thanks for your attention and thanks to Muhammad and hendrik Melina Andreas who put this session together and shared it expertly and all those of you who

attended thank you