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hello everyone my name is Tomas Medina
I'm a consultant cardiac surgeon and
it's my pleasure today with Professor
Lassonde guards to record this video in
which we are going to discuss the
current and very dynamic landscape of
transcatheter mitral valve treatments
and briefly discuss early experience in
mitral clinical trials with intrepid
system we will be also debating on
transcatheter mitral valve replacement
versus repair solutions in my
presentation we're going to discuss who
are not optimal candidates for optimal
mitral valve transcatheter repair these
are my conflicts of interest we will be
covering which patients are not
appropriate candidates for transcatheter
mitral valve repair systems based on
clinical factors and anatomical factors
I extracted this sentence from Joseph
Bhuvana who is a DVT STS registry
president chairman in which he says
science tells us what we can do
guidelines what we should do and the
registries we doing and reflects the
reality the gold standard today for
matter interventions is mitral valve
repair and we should repair whenever
it's possible and if it's not possible
we should replace should also be able to
replace if we have a bad quality of
repair and if you have a failure of the
repair itself we should replace also
which means that whatever the trap you
are choosing you should be able to
reduce my to regurge as well as surgery
and you should take advantage of
improving durability of bio prosthetic
leaflets treatments and we should also
keep in mind that full valve is wearing
is as good as repair if it comes to
choose transcatheter mitral valve
replacement in opposition to repair so
the clinical practice I would like to
develop with you are the following what
we have learned from surgery although
there are some differences technical
differences it comes to compare much of
what replacement to repair for ischemic
mitral regurg we know that on follow-up
mitral regurg recurrence much more often
in the repair group versus the
replacement group and there although
there is no significant differences in
left ventricle reverse remodeling or in
in this if you look at the studies from
the transcript automotive repair we
learned that we from magic might try for
and co-opt these studies are completely
different but also they showed
completely different reasons so there is
a missing part and we should understand
really what drives the success of the
failure of this or that therapy if we go
to the registries themselves we know
that for example for Everest to realism
study it shows that despite the the
possibility to achieve almost 98% 98% of
success but what is success means it
means reduction of the a mitral regurg
but not the elimination of the my
triggers as you can see it here you
still have in 40 to 65 percent of the
patients some of them who are above
mitral regurg and if you look the magic
clip is successful whenever you treat
for example a p2 collapse where it shows
the best mitral regurg reduction that
means this solution is not able to
provide a perfect result in all patients
if you look at the magic clip TV tears
history it shows clearly that when it
comes to analyze the impact of mitral
regurg of 0 or 1 in comparison or 3 & 4
in comparison or great to you it shows
clearly that it unfavored mitral clip
treatment itself so there's the unmet
need that we have to address this slide
shows also clearly that if you compare
the death and the death with because of
heart
in the postal period whatever you are
treating these degenerative mitral
disease or functional mitral disease
there is a huge number of patients that
can we cannot get the benefit we would
like to have from this it's a it's it's
it ranges between 24 to 49 percent of
patients who will not get the clinical
benefits we would like it to have so if
we try to go and understand a bit more
further why is this happening it leads
us to discuss the anatomical factors so
I think we all agree at that the issue
also the pathology and the anatomy of
these patients having mitral regurge
are so different that could explain also
why there is a wide range of
transcatheter mitral repair solutions
that are offered it were eyes from edge
to edge with of course the gold standard
today to annuloplasty to a caudal repair
and so on and so on
and this is why surgeons use many
different techniques to individualize
treatment as many as anatomies in the
nature and this is also why if you look
at the surgeons have been always able to
combine different techniques in one
procedure in order to achieve an optimal
reason which percutaneous repair can not
or is unlikely to achieve and to
eliminate and only be able to reduce
mitral regurg and surgery so if we go
back to the discussion related to
co-opted and and my try for there are
some specific questions in second area
mark which are not only addressed by the
gap between the anterior and the
posterior leaflet which are not only
addressed by the volume of the left
ventricle and so on I think there are
some specific questions that should be
addressed in the in the future which are
the tenting area the co-optation
distance that surgeons are able
sometimes to address and despite this
fact the studies showed no major impact
of repair in comparison
- replacement so I think this is one
anatomical factor that has not been
addressed it should be addressed
I took the liberty to add the last color
in this slide extracted from the expand
steering committee presented a couple of
months ago by stefan von bad 11 compare
an TRX dr clip and how to make the
selection of the appropriate patient for
these two two clips and i have allowed
myself based on their what we know so
far
to add the column which could frame 40
MV i so if you have whatever the length
of the leaflet whatever the anatomy of
ATP to whatever if you have a flair or
not redundant leaflets very strictly
leaflet calcifications a smaller margin
valve area or a problem that comes at
the level of the cultures these patients
could get a TM vr with the replacement i
mean of course if they pass the other
eligibility criteria so that we can
discuss later on but the clip is not
always optimal on all of them and
sometimes you have to combine not only
two kinds of clips but clips and some
other procedures I also built this based
on what with swatches acceptable in the
great majority of sentence and not only
excellent because we're talking about
the therapy that is global so we cannot
imagine a solution that cannot be global
and only dedicated to big volume centers
and and and only skilled the doctors so
we know that there are some specific
patients in whom the clip the
edge-to-edge repair can achieve perfect
results but we know also that many of
these patients are not sent to
transcatheter mitral valve replacement
today because the the solutions that
they offered are mainly TransAm people
and this is something that's going to
change in the future for example we
consider that not suitable for
transcatheter mitral valve replacement
patients are those who have COPD
respiratory dysfunction hostile chest
tribal ventricle tissue
a tourism location in their history some
additional valve disease I think in the
future going to the transept and
solutions the TMV I will be able to do
to offer a perfect solution for these
patients even those and especially those
in whom we know that there is a low
tolerance for residual Ammar and we you
know we know that residual Ammar if we
have the patient with the nagas
expectancy of life could be a
game-changer on which we have to we have
to put a lot of attention hard team if
we how team discussion predicts residual
Ammar equal or superior to - I think TM
VR is and should be much better than
repair itself and we know that some
anatomical echocardiography for factors
like such like annular dilatation
restricted posterior leaflet short
posterior leaflet eccentric jets are one
of the game the changer is that could
make transcatheter mitral valve
replacement a better solution in
comparison to transcatheter mitral valve
repair so putting together all these
fractures and discussing within the
heart team confines we are able to say
that we could achieve we should be able
to achieve the same rules as with mitral
valve surgery and always favor repair
when is it when it's possible but there
are many many scenarios where a prayer
is not possible and replacement should
be considered I would say privileged and
this is especially in case when
transcatheter mitral valve replacement
is going to be able to be observed using
the transformer on approach and in that
case I think
transcatheter mitral valve replacement
will be a winner or a clear winner
so Thomas
was a great overview so as you said
quite a few of these patient who's put
forward for transcatheter micelle
intervention will not have an an optimal
outcome after repair so so what patient
do you think would be better served with
a transcatheter micelle about
replacement this is an excellent
question so let me answer it partially
please so if we put away the safety of
edge to edge intervention and focus only
on the optimal result you want to
achieve at the level of the mitral
regurge
with the patient who has good expectancy
of life if you look at the landscape of
the current practice today we know that
more or around 50% of the patients are
having surgical replacement and not
repair and if you look at the data
together that are merging from the real
world with the mitral clip edge to edge
repair we know that at least 25 to 40
percent it depends on under the disease
you are treating are not a good
candidate for for edge to edge repair I
think putting this together the patients
who have much record in the future will
be offered would be offered if we move
from early the transcatheter mitral
valve replacement over the repair in my
point of view so maybe we should move on
to to try to talk a little bit about
transcatheter mitral valve replacement
so I'm going to talk about the Medtronic
sin TripIt system for myself LP
placement and talk about the initial
experience from the pilot and from the
Apollo role in data so just to start
looking at the valve itself so it's
actually consisting of a dual stent you
have an instant at the same size with a
three leaflet valve and an outer
strength of different sizes so you can
tailor that to the patient's anatomy so
the augustine is going to anchor on
their might so leave it and the inner
state of course is going to be the valve
function it's a trans apical system for
the time being and the last latest
iteration actually allow you to
recapture the valve onto its fully
deployed so it's of course a
a good safety issue that you have a
second chance to replace to really
position the valve if you're not happy
about it so look at the pilot study 50
patient was enrolled back in 2005 to
2017 and these patient need to have
severe mitral regurgitation and if you
look at the data characteristics you can
see it's the typical Mitel candidate
younger than what you see for tabi early
70s most of the patient was mailed quite
a lot of comorbidity and also in this
study very interesting far the majority
of the patient had secondary mitral
regurgitation we know this patient are
not offered surgery as we would seen
only if it has a concomitant procedure
to cabbage if you look at the outcome
here the 30 days outcome this was the
very first experience a7 patient
actually died so giving a quite high
mortality rate of of 14 percent stroke
rate was very low and otherwise there
was some complication but not too much
and if you look at the efficacy of this
you see most the patient came in with
severe mitral regurgitation and all the
patient built at 30 days and the latest
follow-up had Alan done it was 3 out of
4 patient or only a mild mitral
regurgitation so very efficient
treatment so they started design for the
Apollo trial is that it's going to
randomize patient with severe
symptomatic my severe irritation either
primary secondary the high team is going
to discuss where the patient is suitable
or not suitable for cardiac surgery if
the patients are suitable for cardiac
surgery they're going to be randomized
to once a warrant between transcatheter
mitral valve replacement using the
introvert system or cardiac surgery
for the patient not suitable for surgery
they'll be a single arm study looking at
this and also a subgroup of the patient
with severe mitral annulus calcification
intensification is going to be recorded
the outcome here and as you see there
will be a rolling over between 100 and
150 patient before the randomization
exodus starts and if you look here at
the rolling data from the apollo trial
the first 51 patient again same profile
as you saw in the pilot study age early
70s
most of these are male far the majority
have severe symptoms function class
three and four and again 2/3 of these
patient have secondary might so we get
attention and very important now you see
here after the initial learning
experience
third base modality is down to 2% the
only one patient died within the first
one months and again we are against it's
2x prepare which we all considered as a
very safe procedure but 2% is actually
in the same range for the 30 days
mortality within Tribute system as from
the edge to edge repair so we can now
say we have a very efficient but also
for these a very safe procedure I'm just
going to end up here to say that the
current system is a transdermal system
but we expect in the very near future
it's going to be a transferrin system
where you do it as a transexual
procedure and of course if you want to
address these patient where most of them
have secondary myself regurgitation with
impaired LV function it's important not
to have ex-friends apical approach but a
transexual approach is probably going to
be more minimal invasive and also more
general procedures to these patients so
tomorrow we have seen quite impressive
results here with the Brodin phase from
the Polish study but again we have to
remember these patients are quite
selected so how do you see a
transcatheter mitral valve replacement
in a kind of all coma patients will my
sub accreditation us this is a very very
good question that we should address
following what you have presented I
think we are dealing today with the
first catheter mitral valve replacement
systems and we we know that's going to
change in the future
we have two major limitations today one
is clinical because the patients are
referred very late to be treated and
they have a very large anatomies and
dilated analyst and with with very
difficult prosthesis to manufacture
actually and also the attend so
hopefully in the future by by getting
earlier interventions we could control
much better this factor and the other
factor that is responsive responsible
for high rate of rejection of these
patients is is that the risk of LD ot
obstruction and I think is also with the
new iterations that are going to come
with having low profile prosthesis that
have less interference with the LV ot
this rate also projection will be
reduced so I think and also the
experience that we are accumulating
better like selection of the anatomical
factors that could lead to failure or
success the the place of replacement is
going to grow slowly slowly I mean we
must not forget that we are really in
the very beginning of the replacement
experience where the magic have started
back to 2003 so I think we should be
very careful with this with any
statements that goes against a
replacement itself and one of the major
important also elements that could favor
a replacement in addition to what you
have said whether the elimination of
regurge is that it doesn't close the
door necessarily to a second
intervention in the future and we will
be able to put the valve involved which
not which is not the edge-to-edge
systems so we saw that in their polish
story there's a single arm registry on
entry
in patient with severe micelle endless
calcification if we know these patient
are not very well served with cardiac
surgery and also transcatheter mice
about repairs not the optimal solution
for these patients so how do you see
that transcatheter mites about replacing
this is going to fit into the treatment
of these patients China so the the
interpret system is interesting in that
it has this out in this key I've
mentioned to alluded to and internal
list it's the outer disk with with its
ability to confirm to the surrounding
Anatomy could a behaved and spouses I
would say the Mac area which actually
underestimated in in the patients
without treat we know that in elderly
patients in addition to mitral regurg
that is their big number of patients
with a different percentage of
calcifications at the level of the
animals but also at the level of the
leaflets and with this regard I think
trans care too much about replacement
will be a better option and a better
solution if you want to achieve mid and
long term efficacy of eliminating the
mitral regurge
so we have not discussed the role of
transcatheter Maya intervention in
patient with primary and secondary
mitral regurgitation and we know from
the last decade that transcatheter
repair once again it's - it is a very
safe procedure but it's struggle that
it's not going to give an optimal
outcome in quite a subset of the patient
who's left with a quite significant
degree of mitral regurgitation and
that's why we're now looking where is
the the place for the space for
transcatheter mitral valve replacement
and instruments as you have seen here in
the role in face have shown that it's
not only a very efficient treatment
leaving almost no my so regurgitation
behind it's also now becoming a very
safe procedure with the same mortality
rate as for the it's - it's repair and
again as we
it does not close the door so if it's
going to fail there's still an
opportunity to a reinvention maybe a
transcatheter about in these patients so
with this I want to thank you for
attending this session here I want to
thank Chama for the discussion and from
Medtronic
to spawn say goodbye
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