This session will focus on innovative techniques and novel approaches to treating vexing clinical problems in adult cardiac surgery.
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Past Notes
So we'll have the cartel come up to
talk about branch and replacement
for Archer and or a small disease
next.
After hearing Dr. King and Dr.
Schultz, thank you for the privilege
of the podium.
My disclosure.
So I didn't come up here as well.
All right. So.
It's not advanced.
Can you run the slides for the
speaker, please?
Good.
Okay. These are my disclosures.
And I think the most important one
is I'm a national spy for
one of the the thoracic
branch devices.
So the good old days are gone.
Again, this this
type of aneurysm rarely seen
on an annual basis at Michigan.
And I just want to focus on the
aortic heart for which we are
describing these branch devices.
So pathology is very varied, as you
know, and it could be the distal
extent of an ascending aortic
aneurysm or dissection,
a proximal extent of the descending
in aneurysm or dissection,
a traumatic aortic injury,
and then an isolated non traumatic
large pathology.
And it's the second and the fourth
one for which this these
devices are more likely
to be used.
And the beta, the anatomic
basis for arch TAVR really rests
on these issues our landing zones
described a few years ago,
and there are significant
differences between treating
in the arch versus in the other
locations in the descending aorta
or in the abdomen, predominantly
relating to significant hemostatic
forces, critical branch vessels,
extreme curvature.
And then, of course, the exaggerated
motion of arch vessels
relative to the aorta and the three
dimensional space, particularly, for
example, if you have aortic valve
insufficiency,
the strategy for treating patients
with branched arch devices
first rests on where you're going to
place the stent graft.
Is it a zone zero or zone one
versus a zone two deployment?
If it's a zone zero or zone one,
should you use a dual or a single
branch device?
And then is proximal or distal
extension necessary?
And I'm going to go through all of
the devices that are out.
And these are all obviously
investigational.
Some are in the midst of clinical
trials that are either early
feasibility or in pivotal
studies.
And you see these five devices, the
three on the top are single
branch devices, the two on the
bottom are dual branch devices.
And again, these are all
investigational devices.
I'll run through each one of them
relatively quickly.
The Medtronic device
is a is a22
piece system.
It has a volcano cuff
to allow for the
exaggerated motion between the
branch vessel and the main body of
the graft.
And it's it has
a tip capture system that is
present on the typical Captiva
device.
And what it does is it allows a
zone to place
and there was a feasibility study
described with this device with
nine patients, there was technical
success in all of these patients
without any major strokes.
Three patients had minor strokes
and there were side branch patency
in all.
At the conclusion of the procedure,
the Gore thoracic branched and the
graft device is also
a modular construction and
again it has off the shelf
components.
The difference between this
particular device and all the others
is that the branches is oriented
retrograde within the aluminum of
the aorta, unlike the other devices.
So the feasibility
study for this in zone
two was described with 22
patients a technical success again
in fall no 30 day mortality,
stroke or paraplegia good
side branch patency at
be in good survival at
six months.
This device is also been used in a
feasibility study described
in Zone zero and one
and this particular device,
the primary endpoint was successful
deployment and primary patency of
this device at
one month.
So this particular early feasibility
study had nine patients.
It is the predominant
type of treatment with secular
aneurysms, the majority of them in
zone zero.
And a lot of this relates to the
the distances between the
branch vessels that allow for
placement of this particular device.
The results in this patient cohort
stroke occurred in two patients who
were absent embolic occurring during
the via T-bar portion.
But all in all,
there were no early deaths, no
branch occlusion as of 12 months.
This this data will shortly be
published in both of these
devices. The single branch devices
are in so that the Gore
device has completed its pivotal
study and
the FDA submission
will likely be at some point this
year. The Medtronic devices
and is in is
in the study as well
the Nexus branch device.
This is a device that's not been out
of clinical trials in the United
States, but likely a pivotal trial
will be starting relatively soon.
This is an interesting concept where
the arteries is calculated
and it's really this is a zone zero
device.
It's calculated in the dominant
artery, a device deployed
straight into the nanometer artery
and then a proximal extension to
to seal off the the aneurysm.
A different. Concept for
delivery and deployment.
Currently, 25 patients have been
treated outside of the US with good
technical success some early
deaths, two early deaths and two
strokes with good side
branch patency.
The predominant three interventions
in this group were four gutter
leaks, usually related to chimney
devices that were placed for the
second branch.
The Cook Ranch device is a
dual French system.
This is also intended for off the
shelf with a
device with two apertures to
simulate using
the, for example, the nanit and
in the left carotid artery.
You use zenith limbs for both of
these for I'm sorry, fluency
for the left carotid.
And this is this will allow for an
integrated perfusion.
The main body sits within the arch
aorta and this device
has actual published results.
This was the first branch device
published in a multicenter
feasibility study with 38 high risk
patients.
You'll note at this point that there
was a significant learning curve
with this, with the first ten
having a high mortality rate of
30%.
But then the centers got used to
this. The mortality rate plummeted.
There were no ruptures in this group
and a 9% incidence of secondary
interventions.
The Bolton device, which is
currently in early feasibility
study, is based
on the relay
device, descending
device that is currently available,
and it's also off the shelf with the
large aperture for ease
of cannulation and two internal
tunnels for a dual branch
system. It's really intended for
Zone Zero deployment
and it's combined with experience
on a bypass graft for the left
hand saving arm, the
worldwide VoLTE and clinical
exposure.
So the original there was a single
branch device and this has been
limited since the initiation of the
double branch device.
There have been over 100 implants
with the double branch device.
And as mentioned earlier, the US
feasibility study, the early
feasibility study is underway
and nearly complete.
So which is better?
Which is better? Can you have a
single branch system or double
branch system, for example, in zone
zero, which is better?
Well, our group did a Computational
Fluid Dynamics study.
And in this in this patient
with a circular aneurysm, we matched
preoperative conditions of
cardiac output,
aortic pressure and cerebral Doppler
blood flow to assess this.
The way that we did this was with
four scenarios.
We utilized three arm and wind
vessel to measure cerebral blood
flow in this group of patients.
And then we assessed for platelet
thrombus potential with
blood shear rate distributions
in this model in four
scenarios.
And what we found was that these
devices all reduced
cerebral blood, blood flow, blood
flow through a varying extent from
1.42% for
the dual branch system and 3.62
4.8% for a single
brain system.
With the with the left side
of the extreme left of
the screen, the cerebral blood flow
being markedly would do that.
Interestingly, the thrombus
potential was increased in all of
the scenarios, and none of this
was none of this accounted
for incomplete circles.
Well, this is where
redistribution of blood flow may
actually be relatively inadequate.
So some of this, either
short or long term results are yet
to be determined. Obviously, with
all of these devices and in
clinical trials, but this is an
important consideration,
particularly if devices are used
in younger patients.
So what is the future?
I'm going to show you a picture of
of a 71 year old female who
presented with a prior history of
coronary bypass surgery.
She was frail. She had poor
ambulation, terrible lungs.
She had no aortic valve
insufficiency.
And as you can see here, a
type dissection with an arch entry
tear.
As noted here, the dissection was
limited down to the mid
descending thoracic aneurysm aorta
and what we ended up doing was
treating this patient with a
combination of a single branch
device into the nominal artery
and then a ascending device to
treat the to treat the dissected
ascending aorta.
This is a CT scan shown at seven
days and it shows
patency of the devices.
This is a retrograde going in and
this was done as part of a study
trial
is in the emergency and
compassionate use
setting.
So in summary,
arch aortic repair remains a
difficult procedure, often best
treated at this point in time with
open surgical approaches.
But this is evolving.
The currently available t bar
technology is really limited by
hostile native anatomy,
and I think these are going to be
promising alternatives, but it's
still early in development.
So thank you again for.
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