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Reshaping Interventional Radiology Webinar: Magellan Robotics

Reshaping Interventional Radiology Webinar: Magellan Robotics


Brian: Here’s our agenda. We have three presenters
today. Dr. Katzen will provide an introduction to intravascular robotics and discuss its
current and future role in interventional procedures. Then, Dr. Sterling will provide
insights from starting off an intravascular robotics program at Inova Alexandria Hospital
in Virginia. And finally, Dr. Bagla will review the current state of prostatic artery embolization
and share how robotics may play a role in the development of this emerging and very
promising procedure. Then, we’ll have the Q&A period at the end with all of our presenters. Our first presenter is Dr. Barry Katzen. Dr.
Katzen is the founder and medical director of Miami Cardio and Vascular Institute in
Miami, FL. Dr. Katzen has been a leader in the development of interventional radiology,
and multi-disciplinary models for delivering cardiovascular care. He was awarded the gold
medal for lifetime achievement by the Society of Interventional Radiology, and was the first
American to receive the gold medal from the Cardiovascular and Interventional Radiological
Society of Europe, or C.I.R.S.E. Throughout his career, Dr. Katzen has been a leader in
the development of new, less invasive procedures for the treatment of vascular disease. He
and his colleagues at MCVI have been pioneers in the clinical use of intravascular robotics.
Dr. Katzen is currently a lead investigator on the Rover Registry, which is a post-market,
multi center study of clinical procedures performed globally with the Magellan Robotic
System. Thanks for joining us today, Dr. Katzen, and I will now turn it over to you. Dr. Katzen: Thank you very much, Brian, and
good afternoon, everyone. It’s a pleasure for me to participate in this panel and share
some of our experience and thoughts about intravascular robotics. If we can go to the
next slide, please. Just by way of disclosure, I think you’ve had a chance to look at that
or… Sorry, thank you. Next, please. So we became interested in vascular robotics
looking at the increasing importance of robotics in health care in general, and looked at the
potential of robotics as being able to reduce radiation exposure to patients, operators,
and staff, perhaps providing improved precision and reducing the degree of vascular trauma
associated with manual catheterization. It’s a possible solution for those of us involved
in medical education in training physicians of multiple disciplines who have less foundational
training experience, and also has the potential to facilitate more complex procedures for
operators who are missing this foundation. As we go to the next slide, we begin to see
some of the components of the Magellan Robotic System. On your left is the robotic arm that
stays on the patient’s table side, and to your right is the actual remote physician
console. These can be coordinated both remotely on the table side. In this animation, you
can see at first the robotic remote animation, and this is the robotic arm on the table involving
the components that allow us to steer the device. We have the ability to controle the
guidewire in multiple directions, including advancement and rotation, as you see here,
as the wire is held within this driving system that exists on the robotic arm. All of this
can be controlled by this remote station. One of the other advantages of robotic catheterization
is our ability to actually manipulate the catheter in three dimensions. We begin to
think this way as we start to use robotics in terms of trying to drive through the center
of the vessel versus tracking against the wall of the vessel as we advance the catheter
and the devices. In the next slide, you’ll see some of the
movements that exist in the 6 French device. You can see here that that involves two points
of motion: a curvilinear change at the distal end. And you can see how we’re actually changing
the shape into a reverse head hunter, a long multi-purpose catheter, or something resembling
a right coronory as we have multiple controls in these two bending sites. The concept with
this 6 French is different than with the 9 French coaxial system becuase of these multiple
bend points and the ability to actually obtain the distal sweep in 360 degrees, as you see
in this table top demonstration. Here you can see the three principal catheters
that exist right now from a commercial point of view: the fundamental 9 French catheter,
which involves a 6 French intraluminal sheath, and a 6 French sheath and a leader catheter,
the 6 French device in the middle, which is the one you just saw the animation of, and
then the next generation product which we should see soon, which also involves the movable
sheath, and the distal leader catheter. This will allow, essentially, the introduction
of any type of therapeutic device that will fit through a 7 French sheath. The 9 French
allows the equivalent of any 6 French IV delivery. One of the reasons we got interested in robotics,
was some of the data that came about from the first generation device where the group
at Imperial College in London looked at procedure time, number of catheter movements, and vessel
access time to accomplish a prescribed number of tasks. They compared this versus manual
technique, and you can see in both of these actions, there was a seemingly dramatic difference
between robotic test accomplishment and manual test accomplishment for the same models. As
we look at the next slide, you’ll see another discovery that came out of those studies here,
and that relates to learning curve issues. If you look at group A, B, and C, they consist
of a fellow’s experience and an attending’s experience, and an experienced attending’s
experience in accomplishing various prescribed catheterization tasks. If you look at the gray column, the one on
the left of the two columns, you’ll see this represents conventional or manual catheterization
as you might expect. As we move from a fellow to the more experienced attendings, the time
to accomplish, the success of the task, the overall performance essentially, improves
with experience. Something that we would naturally expect. However, if we look at the performance
of robotics, it’s almost the same between the inexperienced fellow and the experienced
attending, suggesting what I was alluding to before, the potential of robotics to allow
us to accomplish a task through lesser degrees of training. This, we think, is an exciting
potential opportunity. As we look at the next slide, one of the other
studies that was done by the group at Imperial College, this was Cecilia Riga and Nick Cheshire’s
[SP] group. [inaudible 00:07:44] to look at the actual work done by manual catheterization,
and they developed a very unique catheter tip tracking program, which you can see here
on this fluoroscopic image of an arching carotid with a bovine left carotid. You can see the
amount of wall hits and the amount of catheter movement against the wall of a vessel during
a diagnostic catheterization in this patient who’d had a previous CABG. Most of us don’t
really look at this in a meaningful way, but we began to become concerned once we saw this
data. Here you can see the same operator in a model doing manual catheterization on the
left, and robotic catheterization in the same anatomy on the right. And you begin to see what potential might
be derived by robotic catheterization, reducing vascular trauma and making our task of going
from point A to point B much more efficient. In the case of treatment of carotid disease,
for instance, perhaps reducing the risk of distal embolization. As we look at the next
slide and movie, this will show you what the actual catheter room set up is. This is a
patient who’s actually undergoing a carotid angiography, and you can see where the remote
station is positioned, a number of observers, and so on, both driving and learning from
this. From this remote position now, we can pretty much control everything. Of course
there’s a nurse in the room managing the patient. Here you can see the demonstration of the
robotic images that we monitor. Here’s an example of direction of a catheter
as we go around the arch. And what I want to point your attention to is the fact that
instead of running along the roof of the arch, we’re actually bending the catheter to actually
stay away from the wall. And we could do this with two motions, in this case, the leader
and then the sheath. Here’s some examples of catheterization of
a left carotid artery, and then a right carotid artery in this patient, who obviously is high
risk for surgery with a difficult radio pacification tracheostomy in place, and so on. The wire’s
being driven around, and then we can advance the catheter in the sheath and take advantage
of changing of these shapes as we go along. Here’s an example showing you the quality
of angiogram we can get with hand injections. You don’t need power injections through the
leader catheter. And one of the differences here is if you’re doing a carotid procedure,
by the time you get to this point, the only thing you have to do is deal with the stenting.
One catheter, one wire, one sheath, and you’re fully in this position. Here we begin to do our measurements. Again,
the leader’s been repositioned to a lower position, more optimal for stenting. And we
can, of course, look at the contralateral circulation as well, all using the same catheter,
wire, and sheath. These devices can use almost any wire that
you’re comfortable using, by the way. There’s a variety of wires. You can alter the steerability
[SP] and whatever type of wire you think might be most appropriate. Here’s just a step-wise
sequential deployment of the stent and dilation all the way to the image on the right. As we begin to look at the completion angiogram,
again, you can see what it looks like following completion of the procedure. Moving on to
other applications, you can see for very complex high radiation dose procedures such as this
complex fenestrated graft where you’re worrying about putting devices through multiple fenestrations,
operators very close to the abdomen and the pelvis, subject to a lot of scatter radiation,
that there’s a potential role. We have actually used robotics in Europe, and a number of sites
have used robotic catheterization for the purpose of positioning these various branch
stent graphs as you see here, using image infusion and robotics with the potential to
reduce contrast and reduce x-ray dose, particularly to the operator but hopefully to everybody
by reducing procedure time. As we move on, this is my colleague, Dr. Pannu
[SP], who’s actually doing this fenestrated case. And teams can get involved and there
can be a lot of dialogue while you’re continuing to work. Following fenestration, as you can
see here, as stents are placed, placing multiple stents and devices through these fenestrations.
And then, we finally do a completion angiography. On the next slide, as you can see here, showing
successful performance of the procedure, and then finally 3D reconstructions, as we move
on to the next slide, show what can be done with robotically assisted fenestration. Now I mentioned earlier the 6 French device
which we found very helpful for a number of uses. You’re going to see a lot more of that
from the other speakers. Again, a concept of putting a proximal bend and a distal bend.
The concepts that are in use here are different than manual catheterization. It’s not just
a question of creating a shaped catheter, because we’re driving these catheters through
blood vessels not just using a specific shape to cannulate an ostia and then tracking them
over guidewires. By the way, that 6 French catheter will take coaxial devices for therapy.
And this is an example that my colleague, Dr. Gandi, did in a patient that had very
difficult anatomy, and actually failed during a prior chemo embolization because micro catheter
advancement was not possible. As we look at the next slide, you begin to
see some of the anatomic challenges. As you see here, the iliac artery had a large bend
in it. And of course, any of us could get a catheter through this, but as you do, especially
in a non-calcified artery, you’re going to get restriction on the torquability [SP] of
that catheter and that sheath as a result of straightening out that very large bend. As we look at the next slide, you’ll see the
celiac anatomy, as you can see here, in the robotic catheterization of the celiac axis,
ultimately cannulations of the [inaudible 00:14:14] beginning to drive the guidewire
through the vessel. You can use 3D anatomy and other road map, or go back to the old
fashioned way where we used to catheterize oseo [SP] by knowing where the anatomy is.
And here, you’re going to see an example of the celiac anatomy and some of the challenges
in getting a catheter distally. Of course, any of us look at this anatomy and say, “Of
course we can do this.” I think most of us feel quite comfortable with our manual skills,
but we all know that there’s failures, as well. Here’s an example of a robotic catheter placement
of a wire and how the wire is driven on the left and now on the right. You’ll see the
dynamic imaging of our ability to actually drive the wire and shape it…the catheter,
rather, to a distal location. This is not a tracking process, it’s actually a driving
process over the wire. And now you can see a very distal location,
which in this patient, with a very large hepatic mass that you can see here. As we move on
to the next slide, you’ll see the placement of the microcatheter, and ultimately, primary
therapy. Here’s the position of the microcatheter, and ultimately, properly positioned for embolotherapy. Moving on to our next images, we’ll be able
to see what looks like following embolization and then following treatment. The interventionist
who did this case had several observations, which are demonstrated on the next image,
the follow up thank you, which you can read for yourself here. The ability to get stable positioning and
manipulate the 6 French robotic catheter allows for a very easy selection of celiac access.
And these catheters are very much more stable than conventional sheaths that we use. Microcatheter
placement was facilitated and the robot catheter potentially reduced procedure time and radiation
exposure to the patient, given the fact that it was two procedures, and of course, improved
precision with stability once there has been something we’ve seen in a lot of different
embolization procedures. Moving on to our next image, I just wanted
to share with you briefly the range of types of experiences we’ve been using robotics for
as we try to explore where it may have a sweet spot for clinical application. They include
a diverse group of complex procedures that you see at the top, as well as various types
of angioplasty and stenting. We have made some attempts at using this as a crossing
device, and of course, a considerable amount of embolization including delivery of large
devices like [inaudible 00:16:55] and smaller devices like chemo mobilization and micro
embolization. In our next slide, I just want to briefly
mention the registry that you heard about earlier. And this is an attempt to engage
users that are involved in the trial. It had been retrospective but now it’s pretty much
mostly prospective multicenter non-blinded registry. We’re collecting a lot of data to
try and understand what the impact and clinical applications for robotics might best be used
for. Finally, there is a technology roadmap. What
you’re going to see today is really a little bit about what exists, but we’re looking at
techniques of advanced imaging integration and localization that’s both catheter tracking
using 3D imaging to try and get the flow of these procedures. Both Hansen and some manufacturers
are working on this. The use of simulation with robotics to reduce procedure time, the
potential for telemedicine integration, and then more remote controllabilities [SP], including
microcatheter control therapy delivery and contrast injections, which right now are being
done manually. We’ve also implemented, and this is widely available, a mobility option
which allows you to move the arm, in particular, on and off the table, or even in certain situations,
from room to room. So in summary, I tried to share with you some
really clinical evaluation which demonstrates definite value in anecdotal situations. I’ve
tried to share a couple of these with you. The next step for us, as you hear more, is
to try and look at clinical trials designed with specific endpoints that can possibly
create a tipping point to decide about robotics and the value of robotics. We’re currently
doing a subset analysis on radiation and flouro time. We’re doing a radiation study through
the Rover Registry looking at those to the operator team and patients. And then finally,
looking at success and morbidity related to this device. At this point, we’ve had no device
related morbidity in any patient. So thank you very much for your attention,
and I appreciate the opportunity to share this experience with you. Brian: Well, thank you very much, Dr. Katzen.
And I just want to remind our audience, you may type questions or comments into the questions
area in the control panel as we go, and we’ll try to address as many of those as possible
at the end. Our next presenter is Dr. Keith Sterling. Dr. Sterling is Chief of Cardiovascular
and Interventional Radiology at Inova Alexandria Hospital in Alexandria, Virginia. He is associate
professor also at George Washington University. Dr. Sterling has been the principle investigator
on numerous research trials involving drugs and innovative devices. In addition, he’s
been responsible for pioneering cutting age therapies in the endovascular space for both
embolization and thrombolysis. Thank you for joining us today, Dr. Sterling. I will now
turn it over to you. Dr. Sterling: Great. Thanks, Brian. I totally
appreciate the opportunity to talk and be part of this webinar. I’m going to talk about
robotic embolization and basically real world experiences that we’ve had with the Hansen
Magellan Robotic System. When we were trying to make the decision about why we would want
to integrate robotics into our interventional radiology practice, I think the first premise
was that we know as a practice, we had a philosophy of being involved in cutting age, minimally
invasive therapies. We found this to be a new technology that was very exciting. And
then we thought about the fact that we’d all had complex cases that we did during our career,
which could involve increased procedure time, there’s increased radiation to the patient,
to the staff, and to the physicians, especially when you’re doing multiple, complex procedures
during the course of the day or certainly a career. Then, there were those cases where
multiple catheters and wires were required to either successfuly catheterize an artery,
or when you’ve catheterized that artery, to maintain stable position if you’re going to
deliver therapy via embolization or revascularization. And this could be because of tortuosity in
the vessel or different vessel angles. In addition, we all realized that there’s technical
failures that we had with our primary access and we may need to perform multiple accesses
to accomplish our procedure. Or even as Dr. Katzen mentioned, there’s cases where you
have to bring the patient back and perform a second procedure. And we also realized that
with different people and different training programs and all different specialties, there’s
a lot of discrepancies in training and the skill set of interventional radiologists and
even other endovascular physicians. So again, why we wanted to integrate robotics into our
practice is to reduce this unpredictability. We wanted to keep our cost down of the equipment
going to multiple catheters, wires, and devices sometimes that we opened which we were unable
to deliver. And then we wanted to reduce any inefficiencies or overruns in our labs, and
obviously reduce complications. We knew that we all had cases just like this,
where no matter what you did in this uterine fibroid embolization procedure, you just couldn’t
get your 5 French catheter or any other catheter, despite multiple catheters, or even your microcatheters
and wires to get into this uterine artery when it’s typically very easy to do so. And
no matter what you did, it was a very complex procedure. In addition, you had these aortic
arches which were very complex aortic arches if you’re gonna be doing, as in this case,
a right carotid artery stenting procedure where the angles to achieve what you need
to to get your catheter and then, ultimately, your stent into the artery could be quite
complex. Lastly, we’re very aware that interventional radiologists now who are even busier, receive
high radiation doses. Radiation exposure is both cumulative and the effects are permanent.
We are concerned about radiation induced cataracts. The SIR has had a mission to look at this
among interventional radiologies. And also, we’re worried about occupational malignancy,
and certainly from all these procedures, wearing lead and standing for long periods of time
in complex cases that we’d be at risk for orthopedic complications. So what we did, is we worked with our hospital
administration in Inova and we obtained the Magellan Robotic System at the end of October
2014, so just about six months ago. We decided to set up a week of training and it was important
for us to get all of our technical staff trained on this, our technologists and nurses. And
we have seven interventional radiologists in our practice and we wanted many of them
to get trained because all of us brought different subspecialties, even within the field of interventional
radiology, to the table. And it was important for us to get everyone trained to see where
they might use the robotic system for their individual sub-specialization. So there’s both, as you heard, the 9 French
and the 6 French system. They’re actually two separate trainings for this, and that’s
why we dedicated the week for this and we went through the two discrete training sessions
which included didactics lessons for both the physicians and the staff on prepping and
draping. Then, there’s model training, and I’ll show you that in a little bit. Then,
we set up cases at the end of the week to actually do live cases with patients. We learned
a variety of troubleshooting tips, as with any new technology. And then, Hansen representatives
were there during the whole week to sign off on the physicians who completed the training. And so the next part was to figure out, “Okay,
which room are we gonna put this in?” and “How are we going to orient this in our room?”
And obviously, you have to worry about both the robotic arm itself, which is table-mounted
to the side, usually on the left side of the table from the patient’s side, and then there’s
the work station that’s going to be in the room. And if we’re going to achieve many of
the benefits, we’re going to want to put this away from, obviously, the table, in a good
place. So this is our room; we’ve decided to put
this in one of our interventional radiology rooms. And here’s the robotic system that’s
actually draped for a patient. You can see that there’s your regular monitor system that’s
on the left, and then there’s the one that comes with the Hansen system on the right.
And you can use both, depending on where you’re standing for the procedure. There’s also a
monitor system at the work station. This shows what the robotic system’s set up for one of
our procedures, how it looks at the end of the table. And here, with the catheter system
in place and ready to drive for this fibroid embolization case. Then, this is over in the
corner of the room, the workstation. Here, for this procedure, we’re stepped further
away from the image intensifier from the flat panel that’s on top of the patient and we’re
at the end of the table. So even doing this, we’re eliminating radiation because there’s
a table side control that we can use if we so desire. And in our early experience, we
decided that this was advantageous, so we weren’t taking off our gowns and putting them
back on multiple times during the procedure. But then, as we got more comfortable, we went
over to the work station. And you can see from this perspective, we have a lead shield
wall here. The staff are monitoring everything that all is okay with the robotic arm and
everything is moving as we want to, and the position is further away from the radiation
performing the procedure. And as I mentioned before, sometimes it could
take a variety of catheters to get what you need to accomplish for the procedure. And
really, with either 9 French system with or without the leader catheter, and the 6 French
system, you can achieve, really, any of these shapes, as Dr. Katzen had showed in the earlier
presentation. And so here’s the flow model that is in place which you can see is set
up to handle a variety of catheterizations on the left. And here, we’re using the robotic
arm from the workstation to basically train. And this, we had access to both during the
week and after the week of training if we wanted to perfect our techniques, not on live
patients. And here, you’re seeing an image of catheterizing what would look like a right
renal and a left renal artery. And then here, a superior mesenteric artery and then as we
got more experienced with the 6 French system, into internal iliac artery branches. You’ll see here, I have some examples of fluoroscopic
images of driving the robot in the model. Here, catheterizing from an ipsilateral approach
the internal iliac artery, and you can see we could advance and maintain a stable position
if you’re going to perform any embolization procedures. In this case, we were trying to
simulate also going over the aortic bifurcation into the contralateral iliac artery and really
using the robot to turn, twist, and go over the bifurcation. So what is our current status? We perform
both 9 and 6 French cases. Here’s our list of cases. Usually, the 9 French case, you’re
going to do revascularization procedures as described here: Iliac artery recanalization,
carotid artery stenting, mesenteric arteries stenting. And then, with the 6 French device,
we performed usually a variety of embolizations and one interesting pulmonary artery thrombolysis
case that I’ll show you in a second. So there’s certainly a learning curve, and
that’s what I think the model is very helpful for. Things that you need to think about when
you’re using the device, so 1, for the 9 French system, if you’re performing a lot of iliac
revascularization procedures now or contralateral femoral revascularization procedures, usually,
you’re using 6 French axises. So with the 9 French system, you’re gonna need a 9 or
10 French sheath. We use a 9 French sheath. You’re gonna be using closure devices, and
you need to learn when you’re going to manipulate both the guide catheter and then the leader
catheter and the wire. That’s totally a learning curve that…when do you bend, rotate, and
advance? And what we learned is, I think one of the concerns is with using the robotic
system, is that you would feel that you lose your tactile feel of the vessel but what you
really learn is even when you’re using a manual catheterization, this is mostly a visual feel
when you’re looking at what you’re doing. You’re not necessarily always feeling the
vessel as you’re catheterizing a normal vessel. Certainly, with the 6 French, again, the learning
curve is when to use the leader catheter and when not to use the leader catheter. We find
that we’ll frequently not use the leader catheter and we’ll use the 6 French guide to really
bend into a lot of the positions we need to get to. We can perform roadmapping through
the guide catheter with the wire in place. Then, we’ll figure out when we’re using the
leader and when we’re gonna go right to a micro catheter. So I have a few case examples I’ll show you
from our practice. Here’s a 73 year old woman presenting with mid epigastric pain. She had
a history of cholecystectomy in the past. In her workup, she was found to have a three
and a half centimeter visceral artery aneurysm. Again, with her symptoms of abdominal pain,
here’s her non contrast CAT scan demonstrating what at the time was felt to be a gastric
duodenal artery aneurysm. And here, with the 6 French guide in place, really just rotating
it using your anatomical landmarks pointed right at the junction for the superior mesenteric
and celiac axis, and doing a nice angiogram through that guide catheter. Then, using the
robotic system to drive right into the superior mesenteric. And as you can see in this case,
we’re dealing with a replaced common hepatic artery aneurysm. Then, we used the leader
catheter to go up into the distal portion of the common hepatic artery, perform angiography,
and then, as you can see here, really mapping things out. Then, performing coil embolization
to both the vessel and the aneurysm while maintaining a very stable position with the
guide catheter. This patient went on to a very successful hepatic artery aneurysm embolization. Next is a patient who had a history of pulmonary
embolism and presented with a recurrent submassive pulmonary embolism. The patient was treated
a couple years earlier with ultrasound assisted catheter directed thrombolysis. And what the
operators mentioned was that it was really difficult navigating through the right heart
and that it was very big and boggy, and probably more chronically as the patient had a history
of chronic pulmonary hypertension. But the plan, in this case, with this very symptomatic
patient was to perform repeat ultrasound assisted thrombolysis. And you can see here from the
CT angiogram, a large pulmonary embolism in the right main pulmonary artery. And obviously,
the indication here being that the the RBLB ratio is so significantly increased with a
patient with significant degree of right heart dysfunction. And here, coming up from the femoral vein
approach, driving the robotic arm directly into the right atrium. And then, you’ll see
on the next, really, very easy navigating through the right ventricle and into the pulmonary
outflow tract. You’ll see how easy it is, and these were almost real-time pictures where
we were able to drive directly into the pulmonary artery to ultimately deliver our therapy and
navigate into the branch of the pulmonary artery that we wanted to and then pull the
guide back. Then, we could advance our, in this case, EKOS catheter directly into the
pulmonary artery where we’re going to perform the procedure, and again, have that stability
of the guide in place. And then, this is the 48 hour follow up CT which you see resolution
of the pulmonary embolism and more normalization of the RBLB ratio. Next is a uterine fibroid embolization patient.
This is a patient who had two prior myomectomies. And interestingly enough, one was done robotically
assisted a year prior and the patient was actually referred for our robotic assisted
uterine artery embolization procedure. You can see here, large despite the two myomectomy
surgeries, large uterine fibroids in the coronal and saggital MRI. And then, I’ll take you
right through the procedure where very easily using the 6 French system driving over the
aortic bifurcation into the hypogastric artery where we can do a nice arteriography through
a hand injection and you see this nice sized uterine artery. So this seemed like a great
case to use a leader catheter to perform our target therapy of the embolization through,
which is in fact what we did, so advancing that wire and just navigating that leader
catheter in place and having nice flow into the uterine artery and then performing the
embolization. And that’s a post-embolization run on the left, and then similarly, doing
the same thing with the same catheter to treat the right uterine artery and navigating right
into the right uterine artery as you can see we’re doing here. Then, with the leader catheter
in place, performing successful embolization. And this is the final aortogram which indicated
occlusion of both uterine arteries. So again, one of the reasons to use this is
catheter stability. As you can see here with TACE case, a very complex celiac artery origin
to perform this TACE procedure. And then, with the 6 French system, you can really straighten
things out and still have flow and have a stable catheter position to perform the embolization.
And then, as Dr. Katzen described before, the direct catheterization of the vessel instead
of scraping along the wall. You can see here, with the aortic arch, you really hate to scrape
along the wall of the aortic arch in this place as opposed to just navigating the catheter
directly into the left carotid artery to perform both the arteriography and then ultimately
the stenting procedure. So I want to get to the big issue of radiation
reduction, which I think is something that you’ll be hearing more and more about. This
is actually courtesy of Dr. Sandeep Rao in El Paso, Texas, who performed 10 TACE procedures
and he used the RaySafe i2 active dosimetry system to look at intra-procedural radiation
exposure to both the operator, the technologist, the additional support staff, and at the control
side, at the bedside where the table side controls are. This is an example of the RaySafe.
There’s all these dosimeters which give you direct feedback during the procedure of what
the radiation exposure is to. And what they found was in these 10 cases, the radiation
dose of the operator significantly decreased over time. And you’ll see they worked from
the independent workstation for the last seven cases where you can see the radiation dose
to the physician is markedly reduced down to a 5.2 on that last case. Then, if you look at the bedside control,
what you’re getting – and this is when you’re doing your typical procedure – is you’re standing
by the patient, and in their 10 cases, the average radiation was 220mg. But to the operator
on these cases working from the remote station, it was an average of 8.1. And as I said before,
this is when working from the remote work station, how significantly reduced the radiation
exposure is. So in summary, obviously, you can see there’s
many potential roles for use of the catheter robotic system. There’s a potential for increased
predictability of doing the procedure: increased stabilization, decreased catheter exchanges
in the complex cases, and decreased radiation exposure for the operators. So thank you very
much. Brian, I’ll turn it back to you. Brian: Well, thank you very much, Dr. Sterling.
Another reminder for the audience, you may type questions or comments into the questions
area in the control panel. We’ll address as many of those as possible at the end of the
presentation. Our final presenter is Dr. Sandeep Bagla. Dr. Bagla is an interventional radiologist
at Inova Alexandria Hospital in Alexandria, Virginia. He’s actively involved in conducting
and publishing clinical research on a variety of topics related to interventional radiology,
including pancreatic cancer, pulmonary embolism, and prostatic artery embolization, or PAE.
Dr. Bagla was lead investigator on the first published study from U.S. Cohort on PAE for
the treatment of benign prostatic hyperplasia. Thank you for joining us today, Dr. Bagla,
and I’ll turn it over to you. Dr. Bagla: Brian, thank you very much for
the invitation. I’m excited to speak about the role of robotics in prostatic artery embolization.
A couple things I’m going to cover here. First, is just to review the literature for PAE and
describe a little bit about who’s the candidate for the procedure, then focus on what the
challenges are with the procedure. I think that’s the main obstacle that we face with
PAE. And then, the transition of the Magellan Robot into our current practice with PAE,
and what those actual advantages are over the traditional method. And I’ll show some
case examples. In terms of who’s a candidate, there’s really
a few ways to break this down. The first is looking at what does the data support in terms
of which patient to treat, poor URO candidates, and then let’s talk about who’s not really
a candidate at all for PAE. The data, when we look at a review article from 2014, this
is published in CVIR and it reviewed all the studies done up until mid last year. And as
you’ll see on the next slide, it looked at 562 studies from the PUBMED database study.
They ended up narrowing it down to nine articles in which they reviewed 706 patients that were
actually included in the analysis. There was some possible overlap of data from European
studies and there were no randomized controlled trials at that point published or studied
longer than two years. All patients had moderate to severe symptoms
in terms of their prostate enlargement or BPH. And the mean age of the patient in these
studies is as you would expect, in the mid to late 60’s to early 70’s. What they found
when they took all the data together, and they pooled it all together, they found out
that although these patients started in a moderate to severe category, as you can see
here in the dark blue line, this is an IPSS score which is the severity of symptoms a
man faces from their prostate enlargement. You can see that it reduced by more than 50%
in the first month after the procedure, or PAE, and was durable to at least 12 months
and then out to 36 months. Their quality of life, which is on a different
scale, 0 to 6, did also improve by 50% or more and this is also durable out to 36 months.
So besides this really impressive clinical improvement, they also found that there was
a decrease in prostate volume, PSA decrease, and importantly, there was no deterioration
in sexual function. And they concluded that the overall benefit of PAE is very positive
at 12 months and the procedure does seem safe. Now, subsequent to this, there were two randomized
controlled trials that were published and presented in a national meeting. The first
of this study that was published in the radiology, it was a Chinese study, it was a randomized
control study that looked at 114 patients in which half of the patients were randomized
to get TURP, which is the traditional trans-urethral resection of prostate, or roto-rooter type
procedure. And this procedure, which is performed through the urethra as most people may know,
is associated with a significant complication rate, anywhere from 5 to 15% in terms of things
like incontinence, impotence, bleeding, etc. Other complications such as retrograde ejaculation
occur in up to 75% of patients. So this study, they wanted to randomize patients
to TURP or PAE, and they looked at midsized prostate patients which are 50 to 80 grams
in size and they followed them for two years. What they found is both sets of patients had
significant improvement in symptoms that did not differ. The PAE group, however, did have
twice the failure rate compared to TURP. And that’s important because that difference in
failure rate was really related to the technical success of the procedure, which speaks to
the challenge. Carnevale presented his data from Brazil at
the 2014 American Urologic Association meeting in which they did 15 patients in each arm
when they compared TURP and PAE. And they found also both arms demonstrated significant
improvement, although there were less complications with PAE, there was a better improvement in
terms of quality of life and flow rate associated with the TURP arm compared with PAE. And you’ll
see here that in the Gao study, both red and blue PAE and TURP from 0 months to 2 years
on both left and right, left is the clinical score of IPSS, how do people do. And you can
see that they both have significant clinical improvement and there’s no difference in 24
months. And in their study, there was no difference in flow rate, as you can see on the right,
at two years. In the Carnevale study, you’ll see that they
both improved in terms of symptom improvement. However, there was a greater symptom improvement
in the TURP arm than PAE. And in the subsequent slide, you’ll see that the flow rate did improve
greater in the TURP arm than the PAE group, although the PAE group did return to a normalized
flow rate, which is about 50cc’s per second in an adult male. So further, other studies
have also demonstrated improved quality of life – and I won’t really touch much on this.
But quality of life study that was published by Carnevale also demonstrated that in patients
who were catheter dependent, in 90% of patients, you were able to remove their catheter in
patients who had BPH and complete bladder outlet obstruction. They did have one complication,
and that also speaks to the technical challenges of the procedure, and that was an area of
bladder ischemia in which the catheter was probably placed in an area where the embolic
material was then delivered into the vesicle or intravesicle artery going to the bladder. So are there limitations to other therapies
and give us opportunities with PAE? Well, with large glands, as you can see here on
the left, in the central area of the small prostate or with a big median lobe on the
right, there are different complications associated with those procedures. And those complications
are things that limit the ability of traditional procedures like TURP, microwave laser, and
allow PAE to come to the forefront as a relatively low risk procedure, however technically challenging
to perform. For PAE, does size really matter? And you’ll
see here on the left, with a large prosthetic artery, here in the middle with an average
sized, and on the right with a small prostatic artery, ironically, the large prostatic artery
on the left has the most tortuous course. So even though it may accommodate a catheter
easiest in terms of its size, the tortuosity does limit the ability for the interventionals
to actually catheterize and secure a distal catheter position for embolization. So there
are technical challenges with each size, but in terms of clinical use, as you’ll see here
on the next slide, whether it’s a large volume prostate as you’ll see here on the left or
in the center, whether it’s midsize prostates as we’ve presented recently here at ISAIDS
[SP], in Florida, Dr. Katzen’s. On the right, a small size prostate, mid-size prostate,
large size prostate, all do the same. They all demonstrate significant clinical improvement.
And we also presented this data at the DSIR [SP] meeting just last month. And so are there challenges with PAE, and
why is this not so widely adopted? I just mentioned earlier how tortuous the arteries
can be to navigate, and I think that’s really one of the most primary challenges of the
procedure. The anatomy in elderly men does distort and misdirect pre-shaped catheters,
or as we call “pre-robotic catheters.” There are small distal target arteries which require
proximal support, which sometimes proximal catheters like 5 French catheters cannot offer.
Acutely angled origins, which I’ll get into, the origin of the prostatic artery is off
and acutely angled. Then, there’s some issues with actually recognizing what is the correct
prostatic artery. And then the last is a safety issue. The cases can take a long time if they’re
not consistent and performed in a reproducible manner. This can lead to high radiation doses,
not just to the operator but to the patient, alike. So is there really a role for robotics at
all, and I’ll get into this here with a few examples and what those challenges are. So
in terms of limitations, you can see here on the left. This is a very straightforward
ipsilateral iliac artery selection in which we used a reverse curve catheter, like a 72
catheter, to do our selection. And then where the green arrow is, is a very small prostatic
artery, and I know that may be challenging to place a microcatheter in because of its
size. The angle by which it comes off the enteric divison of the hypergastric artery
is not particularly challenging, and the actual anterior division which here is paralleled
by a red line, is fairly straight. And so placing a catheter into this artery and angling
the tip of that catheter medially is actually fairly easy to do in a patient like this.
However, on the next slide here, you’ll see that we have patients in which we use either
a reverse curve catheter like we did with the previous, or we use a Waltman loop, which
interventionists are familiar with, using a cobra catheter and then trying to direct
or angle that catheter tip medially. Unfortunately, in this patient in particular,
because of common iliac artery tortuosity, torquing that Waltman loop medially can be
very challenging. And no matter how much you torque the catheter, the distal tip still
wants to point laterally and that can limit our ability to select a medially oriented
vessel. On the next slide, we’re also limited by things like a steep aortic bifurcation.
Here, in which the angle is about 15 to 18 degrees, getting a catheter up and over this
bifurcation may not be so challenging, but having the catheter stay there while you perform
distal embolization or subselective catheterization, that can may be more challenging in which
the proximal catheter may back out. On a subsequent slide here, you’ll see ipsilateral
hypogastric artery angulation can offer the same challenge in which we may place a catheter
not just in the Waltman loop but directly into that hypogastric artery, and that angulation
can also limit our proximal support. Here is what I was talking about in terms of acutely
angled origin. This angle, as you can see here on the slide on the left with the red
arrow, is pointing to a vesicle prostatic trunk. So it gives origin to the vesicle artery
which goes to the bladder superiorly, and then that torturous artery which extends inferiorally
is the proper prostatic artery. That acute angle is very challenging to negotiate a micro-catheter,
unless you have good proximal support. And not only that, but support which actually
angles medially so it allows proper selection of that vessel. That angle is very commonly
seen in patients in which there’s a vesicle prostatic origin. In patients in which the
prostatic artery arises from other origins, that’s not often seen, but in this particular
example, it is. On the right slide here, you can see a similar
example with the vesicle prostatic trunk. The straight vessel which arises off that
red arrow, is a branch that goes anterior to the bladder, or that curved arrow that
goes inferiorly in that prostatic artery. And unless you have good proximal support
or proximal angulation, then it’s very different to put that micro-catheter distally into the
prostatic artery. On the subsequent slide here, you’ll see this is a case in which we
failed effective catheterization on the left picture. We failed to select the catheterization
because we could not get our Waltman loop angled medially, and subsequently get our
microcatheter into that first torturous artery that makes a complete reverse curve and then
goes down. Subsequent to that, we brought the patient
back. And you can see here, this is actually a robotic 6 French guide catheter which is
placed in the tip of the angle just to the origin. On the picture on the right, you’ll
see the catheter extends just distal to that radio opaque marker and is seated right at
the origin of that really torturous artery. So then on the subsequent slide, you’ll see
we were able to place our microcatheter distally here, and it was placed using the robotic
catheter as support and angulation so we could basically pick up the origin of that vessel
and then advance our microcatheter distally. You can see on the image on the right, how
hypervascular and large this prostatic gland is. So despite having a massive prostate,
it still was very challenging. And the robotic catheter, in this case, we used very successfully
in a patient who we failed initially in the pre-robotic. Error, if you will, for us. Similarly, here in the case I showed with
ipsilateral hypergastric artery angulation, how do we get over this? You’ll see on the
next slide, we can take that 6 French catheter and perform angulation by angling the proximal
articulation point away from the hypergastric artery origin, then using our distal tip and
angulating it medially, then seating it very well into the hypergastric artery, then driving
that catheter down into the anterior division, as you’ll see, and then performing prostatic
artery embolization from there. So not having to perform a Waltman loop, and then manipulating
this catheter, it’s fairly straightforward. And you can see, without getting too confusing
with some terminology, the actual arc that is performed on the distal tip of that catheter,
or what I like to refer to it, the tightness of the curve, the ability to curve the distal
tip of that catheter, is so acute that it allows you to actually perform a selective
catheterization of a vessel that’s completely 180 degrees from the origin of the parent
vessel. And you can see here from these videos that
advancing that catheter, and in this case, we’re advancing that over a guidewire without
the leader catheter, just the 6 French catheter alone. Over the leader catheter and into the
hypogastric artery, very successfully into the interior division and then subsequently
being able to perform, as you’ll see on the next slide, our prostatic artery embolization.
In this case, we advanced our catheter in. That middle picture is just to demonstrate
how torturous this artery actually is and how well this 6 French guiding catheter, or
robotic catheter, can be advanced over that wire without significant difficulty. I think
that’s important because when performing prostatic artery embolization, what I always tell our
techs is the contralateral side is often not as difficult as the ipsilateral side. This
has really reduced our time in ipsilateral prostatic artery embolization. On the next slide here, you’ll see this is
exactly what I meant by that tight radius. If you look here before we perform our selected
catheterization, this is a complete 180 degree selection of that hypogastric artery, but
on the right in the video here in the [inaudible 00:52:14] image, you can see the distal tip.
We basically curve on itself, then select, then perform a hand injection through that
guided catheter. And it gives us great imaging of the hypogastric artery and subsequent branching.
We don’t even need to use a power injector, at this point, to do our subsequent injection. On the next slide, you’ll see is another example
of us driving that catheter into the hypogastric artery distally without an issue, both on
the ipsilateral side. And you’ll see on the image on the right or the video on the right
on the contralateral side here, we’re driving that catheter all the way into the obturator
artery. So clearly, it can be driven very distally in both examples. This is even without
the leader catheter. I think, initially, it might be nice to use, but we found that actually
with distal embolization for prostatic PAE, we’ve been very successful without it. It’s
actually streamlined our workflow. Here’s an example of where you need to angulate
the distal tip of the catheter to bring your catheter tip to the origin of the prostatic
artery and then perform an easier selected catheterization. Where the red arrow is, is
clearly where the distal tip is of the robotic catheter but the anterior division, as you
can see, right at the origin of that very small prostatic artery is where the green
arrow is. And what we can do here is just use either our bedside control or table side
control, or remote workstation, and articulate that distal tip and then use our microcatheter.
It’s seated now right at the origin of that vessel, or the anterior division. And it allows
us a less frustrating experience at not having to select that superior artery repeatedly
and allows us to advance our microcatheter into that prostatic artery. On the subsequent slide, you’ll see another
example of this. Here, we wanted to bring our distal catheter, 6 French robotic catheter,
into that anterior division where it bifurcates here at the gluteal and pudendal artery. We
brought our 6 French catheter, as you’ll see here, all the way down to that bifurcation
of that prostatic artery and pudendal artery, and then subsequently brought our microcatheter
into the prostatic artery and performed our embolization. It can not only be used in the
hypogastric artery, in the anterior division, but here we brought it down even into the
internal pudendal artery to then perform our subsequent embolization. As you’ll see here on the next slide, this
is another good example of distal angulation. We used our micro-catheter here after getting
that catheter in the hypogastric artery on the left. We used our catheter here, angulated,
again, into the anterior division. You can see how small that vessel is, probably perhaps
five or six millimeters, and able to bring that catheter into that vessel without a problem.
On the subsequent slide here, is an example of us bringing that catheter, or the 6 French
catheter, up to a trifurcation point. So we brought it up to where the inferior vesical
artery then bifurcates into a prostatic artery, which you can see extending all the way to
the left of that leftward image. Once we brought it to that bifurcation or trifurcation point,
in this example, we were easily able to bring our microcatheter down distally, as you can
see on the image on the right. And that’s a great example of prostatic artery profusion,
as you’ll see, and how distal we take that microcatheter, basically into the gland, before
we perform our embolization. So why is proximal support so important? Well,
with small target arteries, it’s obviously important to have proximal support because
as you’re advancing your microcatheter, it’s easy for a 5 French catheter or even an ansel
sheath or proximal sheath to back out. But with this robotic catheter, it takes on a
fixed position. That proximal support is very important and does not back out. In an easier
selected case like this, where the vessels are not very torturous, and you can see they
all sort of take obtuse angles, proximal support may not be as important. But unfortunately,
this is not the typical case in an elderly male. On the next slide, this is actually three
different videos where I wanted to show you an example of what that distal articulation
does. You can see here on the video all the way on the left, as we’re just articulating
the distal tip, we’re directing that distal tip towards the prostatic artery. In the video
in the middle, once we direct that catheter tip medially, now we do a hand injection.
And you’ll see with that hand injection, we now can pacify three different vessels: one
going laterally, one going medially, and then in the middle that really torturous double
S-shaped vessel of the prostatic artery. Here in the video on the right, without even using
the microwire, because of that proximal support, that microcatheter is able to be advanced
into that prostatic artery with very good proximal support, maintaining antegrade flow,
and in a very torturous artery. So this is a perfect example of how that distal navigational
ability really allows us to select a normally difficult vessel to select. Here’s an example of that pushability. So
if we need to get that catheter all the way down into that gland, you need that proximal
support in order to get that distal. And this is just to show how distal we take that microcatheter
before we perform PAE. On the next slide, you’ll see here. This is the next slide where
we can demonstrate even when we need that 6 French catheter, way back here – this is
in the anterior division of the hypogastric artery – that microcatheter can still be advanced
very distally, as you can see here in the slide on the right, into that prostatic artery
and perform our PAE. So the support is still there, even with a proximal placement. And
I think that’s really important with a 5 French catheter, as most people know, when you’re
performing advanced embolizations in the pelvis, especially up and over the bifurcation, that
catheter can easily back out on you if you’re trying to advance your microcatheter very
distally. Last thing I want to talk about really quickly
is this hypogastric artery knuckle. We go to the next slide here, this is basically
where you see here in this orange circle. In elderly men, the hypogastric artery as
it bifurcates, forms this knuckle where it travels from a posterior location to an anterior
location and distorts your 5 French catheter. So although your C2 catheter, robbers catheter,
or any angled catheter you want to direct medially towards that green arrow, where the
prostatic artery is, when you bring it through this knuckle, it tends to direct laterally.
And unfortunately, despite any torquing that you do to the catheter, that knuckle in the
hypogastric artery can malform your catheter. You can see that here, as evidenced by those
white arrows here on the right. So on the next slide, you’ll see that the normal solution
is to take a 6 French sheath which can be fairly painful, however rigid, and use a buddy
wire, as you’ll see here with the blue arrows. And in this case, we use a shorty wire to
straighten out that sheath and try and then redirect our microcatheter into the prostatic
artery. That’s very challenging, and unfortunately, that does not work very well because now you
have to go to a bigger sheath. Because you have to allow it to accommodate both your
buddy wire and micro catheter, and the two do not torque very well together. As you’ll see here, the solution with the
robotic catheter is once you bring it through as you can here – and here’s our target here
with the red arrow – you can see our robotic catheter going through the knuckle here. Once
we bring it through, now we can angulate that distal tip however we want, and it will fix
our position. And in this case, we angled it to the origin of that vesicle prostatic
trunk, and it allows us to then select that target vessel without redirecting a traditional
catheter into the wrong vessel. And so here, we want to get into this white
line or prostatic artery, and this can demonstrate how we can get all the way down to the origin
through the knuckle without a problem. On the next slide, again, same thing to show
here, medial angulation once we bring it past the knuckle. You can see the difference between
the left slide and the right slide, is that the angle of the catheter here, we just directed
it medially, and that’s really important. And so one more example here to show distal
support. You can see here in the video on the left is a senam [SP] image from a hand
injection. That very first branch is a very short trunk or vesicle prostatic trunk, and
this is another example of why you need that proximal support because of that severe acute
angulation. As you can see here on the right, at that first branch, and then the double
s-shaped curved vessel. That is really important and critical here. We can move on here. This
last couple of shots is just to show exactly that last case. We were able to take that
guide wire into that vessel, bring the robotic catheter down to the origin, and then you
can see here on the side on the right, bring our microcatheter into that prostatic artery
and subsequently perform our PAE very successfully. So this has really come to prove advantageous
for us in terms of our PAE procedures. In terms of data for PAE, my personal feeling,
there are issues to work out in terms of reimbursement in future prospective clinical trials, but
PAE definitely is here to stay. The data is very supportive of doing the procedure, and
I think that’s really important. The biggest issue with the procedure besides
clinical trials and prospective clinical trials, will be the technical challenges associated
with the procedure. I think that’s going to limit the widespread adoption. This is where
the Magellan Robotic System really shines. It’s really offering us the potential to improve
the procedure in terms of ease, consistency, reducing our radiation dose because we can
actually stand four feet or more from the patient’s pelvis. Then, in terms of marketability,
there’s an undeniable fact that intervention radiologists have been limited in their ability
to market their procedures and because of the way they get referrals from other physicians.
And I think that this system can offer us a real advantage in terms of marketability.
So besides just making our procedures consistent and allowing us to take advantage of the robot
in terms of difficult procedures in which we wish we had the robot and we didn’t before,
these advantages have really come to fruition for us. And we use it now on every case that
we can in terms of PAE. And it’s really, like I said, improved both our ease and consistency.
In conclusion, that’s how I’d like to end. And Brian, thank you for this invitation to
speak to this audience. Brian: We have all three of our speakers here
for our Q&A period. I’ll ask them to come off mute now, and I’m going to direct the
first question to Dr. Katzen. Dr. Katzen, there’s a question here about tactile feedback.
Dr. Sterling touched on this a little bit, but one of the main concerns for interventionists
in going to robotic navigation, potentially to give up tactile feedback with the hands.
Dr. Katzen, if you’re still with us there, I wonder if you can address that with what
your experience has been. Dr. Katzen: Sure. Thank you, Brian. I think
this is probably one of the common questions that people have when considering robotic
catheterization. I think all of us have grown up on developing unique tactile feedback,
and one of the things we’ve found is that what we interpret as tactile feedback when
you actually start to critically look at it, is actually a very large proportion of visual
feedback. Specifically, if you see a guidewire, you may or may not actually feel the guidewire
bump up against the wall but you’ll see it deflect and will respond to it. So I think
that there’s a surprising amount of what we interpret as tactile feedback that’s actually
visual in nature. Secondly, you have to understand what’s creating
the tactile feedback, and that’s basically, as I think Keith mentioned earlier, Dr. Sterling,
that we’re basically interacting, sliding – whatever word you want to use – a catheter
along a guidewire that’s generally out against a wall of a vessel. Particularly when we’re
probing around an ostium and trying to pick off an ostium, what we’re doing is basically
dragging or pushing a catheter and trying to find an ostium. I think the value of tactile
feedback certainly based on current manual skills is really critical, based on the current
foundation that we have. I think there’s also some both clinical and lab evidence that it
may be more traumatic than we think. Brian: Thanks, Dr. Katzen. Our next question
relates…I’m going to direct this to Dr. Sterling. It’s a question about the different
catheters that are offered, the 6 French versus the 9 French catheter. Dr. Sterling, because
you’ve had some extensive experience with both of those catheters, can you talk about
what your considerations are when choosing to use one versus the other for a particular
case? Dr. Sterling: Sure. I think that most of our
cases have actually ended up being embolization cases. For those cases, we’re using the 6
French catheter system. As I said earlier, we’re using it more often than not without
the leader, because you get, as Dr. Bagla just showed in his prostate talk, your guide
catheter and you can position it in exactly the direction you want to and then advance
your microcatheter with a lot less difficultly. We’re using the 6 French system mostly for
embolization, visceral embolizations, and basically driving to where we want to get
our therapy, if you will, be it the EKOS catheter for the pulmonary embolism, or our microcatheter
for the embolization procedure. I think the 9 French system, we’re using for a lot of
endovascular reconstruction uses, so stenting and angioplasty and such. Because I think
that you need to have that larger device as the main guide, and then you’ll use the leader
catheter with the wire to actually get through the lesion. So we’re using that. I think in
certain anatomies like carotid arteries and endovascular aneurysm repair, that 9 French
device is going to be your device of choice. Brian: Okay, great. Thank you very much. Last
question here for Dr Bagla. Dr. Bagla, in terms of the staff, what has been your experience
with the learning curve for the staff and the training process they’ve gone through?
How have they adopted the setup and utilization of the robotic system? Dr. Bagla: I think like with any new technology,
there’s always a learning curve in terms of the staff learning anything. I think that
they welcomed it warmly. I think from an emotional standpoint, they were excited to adopt a new
technology that would be exciting and something new. As far as the actual technical aspects
of it, I think it’s very straightforward, and they had no real issues. I think just
like with anything, learning how to drape the actual robot, learning how to unwrap the
devices and set them up, probably added about anywhere from five to ten minutes in terms
of case time. That’s about it, in terms of their setup. We don’t really see it; it’s
pretty streamlined. As you know from our experience, we don’t really rely on having anyone else
there, because the staff has become fairly autopilot for the device itself. Brian: Okay. Thank you very much, Dr. Bagla.
Dr. Katzen, anything to add on your end on that topic at all, just about overall integration
into the institution or with your staff? Dr. Katzen: I think the learning curve for
the staff has been very good, fairly simple to do. I think a lot of the training involves
preparation of the device. In the end, most of that goes to our support staff and so on.
I think it’s become relatively easy if we wanted to do something on the fly, let’s say,
in terms of preparation, to be able to do that. I think that’s all quite manageable. Brian: I think those are all the questions
that we have for now. So I guess, at this point, we’re going to bring the meeting to
a close. I did want to thank our presenters: Dr. Katzen, Dr. Sterling, Dr. Bagla. Thank
you very much for your time. I want to thank our participants for joining. And to our attendees,
you will be receiving an email link with a link to the recording of the event. It will
be posted on our website, www.hansenmedical.com. And also, email those out to you by the end
of the week. This concludes today’s webinar. I want to thank you again for attending.

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