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navigation was employed in thirty-seven target vessels in fteen patients, with a successful cannulation rate of 81%. All
branched and chimney stent target vessels were accessed
successfully by the robotic system. Mean cannulation time
was 4min and 23s and there were no robotic-related intraoperative or post-operative adverse events. This further conrms the feasibility for robotic-controlled systems to perform
safe cannulation of target vessels in complex endovascular
aortic procedures.
Contralateral Gate Cannulation
A multicentre retrospective cohort study has demonstrated the
effectiveness of robotic contralateral gate cannulation in endovascular aortic aneurysm repair (EVAR) [41]. Fourteen robotic
cases were compared to eleven manual cases. Endovascular
catheter path-length was signicantly shorter for robotic techniques, compared to manual techniques. Median cannulation
time was signicantly shorter for manual cannulation compared to robotic. Efciency ratio (path length/aorto-iliac centrelines) was signicantly lower in robotic cases.
ful in all patients, and procedure success rates were 100%.
No intraoperative or post-operative complications were
recorded and all patients reported a signicant improvement
in symptoms at 6kl-month follow-up.
Embolisation of a saccular renal artery aneurysm has also
been performed using the Magellan robot [43]. This case
demonstrated the utility of the Magellan in high- risk procedures with complex vascular anatomy, due to its precision
and stability. Figure13.8 demonstrates intraoperative robotic
sheath and catheter cannulation.
Embolisation
Magellan robot-assisted bilateral uterine embolisation has
been performed in ve female patients [42]. Robotic bilateral internal iliac and uterine artery cannulation was success-
Fig. 13.7 Magellan robot performing cannulation of left renal artery in
fenestrated endovascular aneurysm repair
Fig. 13.8 Magellan sheath and catheter cannulation in renal artery aneurysm [43]
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Developments inExisting Robotic Platforms
In addition to the currently commercially available robotic
systems, a number of systems have been proposed to overcome the decits and shortcomings of existing technologies.
These include: compatibility with conventional materials;
haptic feedback to the operator; autonomous catheter function; and an authentic master–slave interface. These technologies will be reviewed.
Use ofStandard Catheters
Existing robotic systems are mostly incompatible with conventional catheters, guidewires, balloons and stents, and the
requirement for system-specic equipment leads to substantial cost increases. A number of systems have been explored
to incorporate conventional catheters into endovascular
robotic technologies. Robotic systems have traditionally
been compatible with specialised, specic catheters which
have been designed alongside the robotic system to enable
maximum degrees of freedom and stability. It has been recognised that this is costly and impractical, and the use of
standard catheters and wires should be incorporated into new
robotic models. In magnetic robotic endovascular navigation
systems, the need for specialised equipment may be
unavoidable.
System for Endovascular Telerobotic Access (SETA) is a
prototype robot-assisted system compatible with conventional catheters [44, 45]. It has a slave manipulator comprising two translational stages and one steering stage, which
enable simultaneous manipulation of conventional guidewires and catheters. The slave mechanism can both steer and
insert or withdraw both catheters and guidewires. A second
mechanism provides linear drive to the catheters. The actuators were constructed using friction wheels whilst the steering stage was constructed with a gripper-pulley system. The
slave has torque sensors coupled to actuators to provide force
feedback to the surgeon, whilst the controller uses a haptic
device to command the position and velocity of the slave [44,
45]. SETA also possesses technology to remove tremor.
SETA has currently only been evaluated in phantom vasculature. Time taken to complete procedures and amount of contrast uid used during the procedure were comparable to
manual intervention. SETA was rated as easy to use and performance was equivalent to manual intervention. It is low
cost and easy to construct. Drawbacks include lack of natural
twisting action and steering accuracy [44, 45].
Cercenelli and colleagues developed a telerobotic system
(TS) to remotely navigate and reposition standard steerable
catheters with deectable tips, within the heart [46]. The
study was performed in animal subjects. The system has a
driving unit, control unit and remotely controlled user interface. A translation stage acts as an actuator of the distal catheter tip. The controller is via a 2-DoF joystick. Forces at the
proximal tip are displayed graphically at the user interface.
The system does not require a dedicated guide catheter and
does not necessitate bulky machinery. In vivo study demonstrated reduced time for catheter positioning and navigation
compared to manual procedure [46].
Further research in EM technology has included the
development of the CathROB prototype robotic system [27].
It has been effective in cardiac mapping and ablation.
CathROB uses electromagnetic technology to remotely control steerable catheters with 3-DoF.It has force sensing technology which supports both catheter navigation function and
operator haptic feedback. It is compact, has a fast set-up time
and does not require a specialised room. The system is compatible with standard sheaths, catheters and deployment
devices. Further studies are required to demonstrate its safety
and cost effectiveness prior to widespread use.
Force Sensing andHaptic Feedback
Haptic feedback utilises touch to provide information to
users; the lack of haptic feedback with endovascular robotic
technologies potentially poses a safety risk to the patient.
Haptic feedback is not currently embedded within any commercial robotic systems. Commercial haptic interaction
devices are, however, available, including the Geomagic
Touch device (3D Systems Corp, Rock Hill, SC, USA) [47].
These devices, however, are limited by providing haptic
feedback in a single linear direction, delivering unknown
consistency of feedback and having high costs. Haptic feedback requires accurate localisation of catheters, accurate
estimation of catheter tip deformation, and a computerised
system capable of force estimation by integrating catheter
deformation and live x-ray images. The estimated force must
then be translated into a recognisable tactile force to the
operator in order to support accurate and atraumatic navigation and therapy.
Haptic feedback can be either sensor-based (direct) or
model-based (sensorless), and feedback can be either from
the proximal or distal end of the catheter. A number of
sensor- based feedback models have been demonstrated in
endovascular models and virtual reality, using both distal and
proximal feedback [48–56]. Model-based haptic estimation
has also been demonstrated in endovascular models and virtual reality, using both distal and proximal feedback [57–59].
In sensor-based feedback, the distal catheter tip has sensors
and feedback is replicated in a master controller. In modelbased feedback, forces are estimated using a computer
model. Force sensor-based devices include miniaturised
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piezoelectric force sensors and strain gage sensors, or piezo
resistive force sensors [59–61]. These are limited by electromagnetic interference from other devices and electrolytic
environment, and so led to the development of optical
bre- based sensors, and light-intensity modulators (LIM)
which can measure contact forces along the catheter body
and tip [62–68]. Sensor-based catheters provide important,
instant haptic feedback but are limited by size, material exibility and electromagnetic compatibility. Information is limited to a specic point on the catheter tip, which may not be
in contact with tissue at a given time. All such technologies
continue to be limited by high costs, however, and therefore
have not been adopted in routine clinical practice.
Model-based haptic feedback incorporates sensors, a
mechanical model of the catheter/guidewire, live imaging
and the patient’s anatomy. Feedback is constructed using
force/torque sensors and orientation/position coders. Various
models of catheters exist, with no clear model having an
advantage [69]. Additionally, model-based haptic feedback
has largely been investigated in virtual environments. Whilst
sensor-based haptic feedback has been shown to have shorter
response time and less computational cost, model-based haptic feedback is less susceptible to noise, is easy to use and has
lower costs [69]. Model-based haptic feedback necessitates a
compromise between accuracy and computational
efciency.
Autonomous Catheter Positioning
A natural progression from catheter tip sensors is autonomous catheter positioning based on feedback. This technology is still in its infancy. Ganji and colleagues [70] developed
a robotic steerable cardiac catheter, with 3-DoF and autonomous steering properties to navigate the cardiac chambers in
animal models. The distal shaft of the deectable catheter
possessed magnetic sensors which, in conjunction with the
kinematic catheter, could perform semi-autonomous catheter
positioning. Force control-based robotic systems are a further development to improve catheter navigation, independent of the operator. In vitro cardiac studies have demonstrated
the potential for catheters to use information from
3- dimenional ultrasound (3DUS) and tissue interactions, to
either maintain a constant force or follow a predetermined
specic force instruction [71]. These technologies require
further research and invivo studies.
Autonomous positioning is the ultimate goal of robotic
endovascular technologies to remove human error.
Autonomous positioning requires: validated anatomy of the
target area; real-time visualisation of catheter/wire location;
tissue feedback; feedback/alert system to the operators; ability to autonomously plan a new route when obstacles are
encountered; and the ability to switch back to manual con-
trol. Autonomous positioning would be the ultimate amalgamation of current robotic technologies. Renement and
development of steerable catheters with haptic feedback and
3D live imaging are vital to realise this goal. The anatomical
environment of endovascular surgeries remains complex,
however, and rules cannot cover the range of surgical complexities encountered. Robotic reinforcement learning may
overcome this, but more research is required.
Master–Slave Interface
Robotic systems have traditionally been based on a remote
master workstation, controlled by a joystick. Remote control
skills are independent of the traditional manual skills
required for endovascular procedures. This results in operators having to learn two independent skills: manipulation of
conventional catheters as well as manipulation via a joystick.
This could result in increased training times. The use of a
joystick, however, is simple, intuitive and achieves the same
outcome whilst removing some of the complexities of conventional catheter manipulation.
Systems have been developed whereby a master catheter
is manipulated by the surgeon to mimic conventional catheter movements, and these actions are translated to a slave
catheter. Thakur and colleagues [72] designed a model where
the master catheter was manipulated by conventional axial
and radial motion. Although the system demonstrated evidence of motion replication invitro, it lacked force feedback
to the surgeon. Subsequent systems have been developed
with force feedback [49, 60, 73]. The Hapcath system [59]
used this technology, but also measured forces at the guidewire tip using a piezo resistive force sensor and was successfully demonstrated invitro. Force feedback has been shown
to reduce the magnitude and duration of force on vessel wells
invitro [49]. Further research by Yang and colleagues [47]
demonstrated a novel surgical robot controller which mimics
the traditional handling of catheters and guidewires, with
force feedback. This model demonstrated reduced procedure
time and reduced force feedback denoting reduced risk of
vessel wall injury and greater safety invitro.
Remote Control over Signicant Geographical
Distance
Remote control over large geographical distances is an additional area of research. This could overcome the unequal distribution of endovascular surgeons and resources. Guo and
colleagues [74] demonstrated a cloud server which could
effectively be used for remote control endovascular robotic
procedures. Additionally, Madder and colleagues demonstrated that the CorPath GRX could safely perform robotic
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endovascular interventions in invivo animal models when
manipulated from a separate geographical location [75]. The
system was also shown to be effective in performing PCI on
a model between Boston and San Francisco (over 3085miles)
via wired networks and 5G wireless networks [76].
New Technologies inRobotic Surgeries
In addition to improving existing robotic technologies,
research has focused on novel techniques for remote catheter
control and adjunctive technologies, the most important of
which is imaging. These are explored in more detail below.
Electromagnetic Endovascular Navigation
Tracking Systems (EM ENS)
EM ENS use electromagnetic coils in device tips to provide
digital data on coil position within an electromagnetic surgical eld. Voltage data is converted to digital data and visualised on a preoperative 3D CT scan. Preoperative imaging is
combined with intraoperative MRI, CT or uoroscopy. Two
systems are currently available: Aurora (Northern Digital,
Waterloo, Ontario, Canada); and StealthStation TREON
Plus (Medtronic Inc., Minneapolis, MN) [26]. Aurora ENS
has been applied in a range of models, using a range of
devices [77–83], and demonstrated good precision. It was
not, however, associated with reduced procedure time or
radiation exposure [56]. Evidence for StealthStation ENS is
limited to two studies using a rigid model, and nonclinical
wire [81, 82]. It demonstrated good accuracy, improved performance scores and reduced uoroscopy exposure. More
research is required into these systems.
Ultrasound-Based Localisation Tracking
Systems (ULS)
Ultrasound has been postulated as an alternative to magnetic
catheter tips for localisation and tracking [26]. ULS uses a
piezoelectric ultrasound transmitter at the tip of a catheter.
Signals are sent to triangulated sensors on the body’s surface.
Real-time catheter tip position can then be demonstrated on
a preoperative 3D CT image, without real-time imaging.
There are currently two studies demonstrating the use of
ULS invitro, with potential for use in endovascular aortic
procedures [84, 85]. These studies demonstrated feasibility
and also a method for aperture error compensation [85]. This
technology requires further renement, miniaturisation and
extension to other devices beyond a 9F ULS catheter. ULS
could potentially negate the need for intraoperative contrast
use and x-ray. Due to the complex nature of procedures, uo-
roscopy may, however, be required in addition to ULS to
ensure procedure safety. Combining these techniques will
minimise uoroscopy use.
3D Rotational Angiography (3DRA)
Traditional uoroscopy provides the operator with a 2D
image. 3DRA constructs a 3D image prior to intervention,
with the aim of improving diagnostic accuracy and therapeutic intervention [7]. 3DRA reconstruction negates the need
for intraoperative contrast use, and reduces radiation exposure [86]. A prototype navigator has been developed which
calibrates pre-operative 3DRA images with catheters and
guidewires with 5-DoF electromagnetic sensors [87]. Realtime tracking can be performed during the procedure, combining live uoroscopy with 3DRA.Limitations include the
static nature of the 3DRA, which does not account for natural movements of breathing and vessel deformation when in
contact with devices and wires, and continued dependence
on uoroscopy and radiation. Combining robotic technologies with 3DRA, however, may provide a solution to realtime catheter tracking, without the need for uoroscopy.
MR Endovascular Robotic Platform
Robotic platforms depend on uoroscopic-guided intervention. This continues to expose patients and surgeons to ionising radiation, and patients to the risk of contrast-induced
nephropathy. MR has potential advantages. Firstly, MR
endovascular robotic platforms may use real-time data from
either MR or uoroscopy, potentially minimising and eliminating the need for contrast and radiation. It is also superior
in imaging soft tissue, such as vasculature, and providing 3D
imaging. Early studies [88, 89] have demonstrated that time
to complete complex procedures was comparable to manual
techniques. Simple procedures and overall total procedure
time, however, were signicantly longer with the MR endovascular robotic platform, compared with manual techniques. MR scanners are also ergonomically cumbersome
and patients cannot easily be accessed within MR. MR
robotic endovascular intervention is currently only compatible with steerable catheters for cardiac procedures.
An MRI-guided robotic platform was designed for manipulation of standard catheters and guidewires using multimodal imaging (uoroscopy and MRI) [88]. The system
used a master controller which mimicked manual movements, and was guided by haptic and visual feedback. The
platform required conventional manual access of the arterial
system. Following access, instruments were connected to the
robotic slave, and controlled remotely. Preliminary preclinical trials revealed a reduction in forces applied to the phan-
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tom compared with conventional manual techniques.
Maximal forces were also reduced. Complex task navigation
was completed faster.
An early-stage MR robotic prototype has been proposed
[89]. It included an interventional room with an MR safe
slave robot, and a control workstation with a navigation system and master device. Motor control was generated by
pneumatic pressure patterns. Real-time imaging from MR or
uoroscopy guided controller intervention. Master controllers were adapted to mimic conventional manual instrument
handling, and had a 2-DoF motion catheter and guidewire,
which performed linear and rotational movement, and torque
and force feedback. The slave robot mimicked the master
control with 6-DoF. Guidewire and catheter carriers performed linear force transmission, driven by pneumatic clamp
and linear actuator. Rotary platforms performed catheter and
guidewire rotation; however, a signicant limitation was that
catheters and guidewires could not be manipulated simultaneously. The slave robot set-up was fast, intuitive and cost
effective compared to manual techniques. The system was
tested by seven senior surgical registrars or consultants on a
thoracic phantom, using either robotic or manual execution.
Robotic cannulation was successful in 90–100% of cases,
and forces were similar to other experimental data.
Cannulation time was slower but still within an average of
2 min. Technical limitations were related to the catheter
buckling and limited linear operational workspace in the
interventional room. Further research is required to integrate
devices into MRI suites, incorporate MR safe steerable catheters and guidewires, and automate procedural sub-tasks.
Microrobots
ulation. This would enable navigation of difcult anatomy
invivo, and invitro experiments have demonstrated successful
navigation of tortuous and aneurysmal anatomy in a cerebrovascular phantom. These microrobots also released therapeutic agents at specied locations [94]. A self- lubricating
hydrogel skin reduced the risk of vessel wall damage. Other
therapeutic indications of microrobots could be to break down
thrombosis/emboli by mechanically rubbing against them.
This has been demonstrated invitro, using magnetic actuation
of helical robots under ultrasound guidance [95].
Microrobot technology remains in its infancy and there are
obstacles which need to be addressed in its development.
Delivery and retrieval of microrobots needs to be dened, as
well as visualisation invivo. The microrobot will likely enter
the body via injection and migrate to its target site. Device
removal would also ideally be via injection, although limited
device lifespan may also be an option, with microrobots
degrading either naturally or via stimulation after achieving
their therapeutic goal [96]. Microrobots must also be integrated
with a feedback and controller system. Control may be extracorporeal or intrinsic, with intrinsic control affording greater
autonomy and the potential for machine learning. Currently,
the focus of microrobots has been to deliver targeted cell therapies and local drug delivery. Endovascular therapeutics including stenting or angioplasty are yet to be explored.
The design of microrobots also has a number of limitations. Devices may be lost, or controllers may lose navigational control of devices invivo. This could result in vessel
wall injury. Microrobots could also heat fragile tissues.
Manipulation and navigation of atherosclerotic plaques may
result in distal embolisation. Measurement of success of
intervention also needs to be recordable and dened.
The development of microrobots has seen a paradigm shift in
robotic endovascular surgery, with a greater focus on the
potential independent functional capabilities of robots.
Microrobots are mobile robots measuring a few hundred
micrometres [90]. Their autonomous function and small size
may further the scope of endovascular practice and facilitate
access of distant, difcult-access vessels. Their independent
function could help to overcome human error and limitations
in controller dexterity. There are two types of microrobots:
tethered ferromagnetic soft robots which use magnetic steering, and soft polymer screen type which propel by rotation
around a helical axis. Soft robots can deform and therefore
have innite DoFs. Design of microrobots has been challenging. Microrobots are an existing area of research in the
eld of oncology, specically to deliver targeted therapy to
cancerous cells [91].
A new design of microrobot has combined magnetic actuation of ferromagnetic soft robots [92–94]. These robots can
deform and change shape within seconds by magnetic manip-
Advantages andChallenges ofRobotic
Technologies
Benets toPatients
Robotic technology has many potential advantages over standard endovascular techniques. Stability, steerability and accuracy in both catheter positioning and navigation have been
shown to be superior in robotic techniques compared to manual techniques [27, 31, 36]. These advantages mean fewer
catheter movements, fewer catheter exchanges and shorter
navigation times [9]. These improvements may confer fewer
complications and better outcomes for patients, and have
been demonstrated in both simple and complex procedures.
Robotics techniques have been shown to be superior to manual techniques across a range of contexts including in complex anatomy, cannulation and simple therapeutic procedures
[30]. Benets have been demonstrated across a range of endovascular areas, including transcatheter aortic valve implanta-
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tion (TAVI) [97], coronary intervention [33, 98], peripheral
vascular intervention [34] and aortic stent grafting [24, 99,
100]. Patients also benet from reduced radiation exposure
and reduced contrast burden [33, 36].
Benets toSurgeon
Surgeons, as well as the whole theatre team, benet from
reduced radiation exposure [34, 36, 38]. Fluoroscopic- guided
aortic procedures were shown to be associated with an acute
DNA damage response in operators [101]. This may result in
an increased risk of brain and neck tumours, basal cell carcinomas and cataracts amongst operators [102–104]. A reduction in radiation exposure could justify higher costs and
complexities associated with endovascular robotics. Remote
control also creates the potential for a surgeon to perform procedures from a remote location, which may widen accessibility to treatments for patients in different geographical
locations. Surgeon comfort may also be improved as they may
remain seated throughout the procedure, and do not require
lead aprons, resulting in fewer orthopaedic complications,
improved comfort and potentially enhanced performance [24].
Robotic technology has been shown to be intuitive and
easy to learn. This confers a shorter learning curve compared
to manual techniques, and robotic technology has been
shown to improve accuracy and economy of movement [36,
105]. Surgeons benet from the development of new techni-
cal skills. Further advances in robotic technology may also
be associated with greater catheter automation, thereby
reducing the surgeon’s technical workload. Robotic technologies remove human tremor for greater precision and reduce
the risks associated with human error, thus giving rise to
improved surgical outcomes.
Technical Challenges
Robotic technology must be easily integrated into existing
practice and augment existing techniques. It should be compatible with commercial standard catheters in order to minimise costs. Systems must be able to simultaneously
manipulate catheters and guidewires, and be remotely controlled. Catheters must have dexterity to reach their target.
Mechanisms should provide catheter stability, manoeuvrability, safety and practicality. The systems must be safe,
and surgeons should experience the same operative forces
and haptic feedback as in manual procedures. Developments
should also improve the occupational safety of surgeons
[38]. These criteria are not currently satised by existing
technologies. This chapter has highlighted the need for further developments in haptic feedback technology, initial
catheter placement and conventional catheter use. Specialised
robotic catheters are costly, and also incompatible with conventional balloon and stent systems. This means that robotic
target cannulation may be followed by exchange for standard
devices for therapeutic purposes. This negates much of the
advantages conferred by robotic systems.
In spite of reduced radiation exposure, even with robotic
technologies, individual support staff are still required in the
operating room to manage equipment. Alternative approaches
for reducing radiation and contrast may therefore also need
to be considered.
Sustainability
Robotic technologies are expensive, bulky and impractical in
the current clinical setting and thus are not currently widespread. They require a specialised room, and are time consuming to set up. These costs may be offset by faster
procedure time and reduced complications. In order to be
cost effective, further developments should focus on making
robotic technologies compatible with conventional catheters,
guidewires, stents and balloons. In addition, hospitals need
to complement the implementation of robotic technologies
with adequate training facilities. The introduction of training
facilities must be accompanied by clear, transparent and
robust technical assessment. This requires technology capable of assessing catheter performance, and the creation of
clear, unied training standards.
Current cost analysis of endovascular robotic systems is
difcult due to limited application of endovascular robotic
technologies. Cost-benet analysis of widespread surgical
laparoscopic robots may be of value. One study [106] demonstrated that, in the US, once the initial cost of a da Vinci
robot is covered, the prots from high-volume laparoscopic
radical prostatectomies are maintained if switched to roboticassisted surgeries. However, initial costs are high, with one
da Vinci robot costing $1.5 million, with an additional
$112,000 annual service contract and $200 of disposables
per case. The da Vinci has demonstrated that despite initial
high costs, robotic technologies do not signicantly increase
costs once the robot is purchased and in high-volume use.
This data is promising, although dependent on increased efciency and high caseloads. Potential cost benets should also
be considered alongside the potential reduced risk of cancers
for operators.
Training
Advantages have been demonstrated in the acquisition of
robotic technical skills compared to manual skills. It is
important, however, that alongside competency in robotic
technologies, surgeons are also equipped with skills to man-
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age complications of new technologies. Robotic skills should
be developed alongside conventional manual skills. In order
to monitor development of robotic skills, training requirements and objective assessment are required. Currently, certication is industry based. The following parameters need to
be assessed in the training setting: technical success; procedural time; uoroscopy exposure; number of vessel wall
contacts; force of vessel wall contacts; and motion-based
metrics. Assessment is completed by a grading system such
as Objective Structured Assessment of Technical Skills
(OSATS) [9]. These assessments can, however, be too generalised and oversimplied. Language models have also been
employed, such as the Hidden Markov Models (HMMs).
Learning algorithms and learning models are required for
training and clear assessment of skills. Learning algorithms
may also contribute to the development of automation of
catheter function.
Conclusions
Endovascular intervention has revolutionised the management of cardiovascular disease. The eld continues to
develop and evolve with the advent of robotic endovascular
technologies. Robotic- assisted intervention for endovascular surgery may still be in development but is an area of great
potential growth and further innovation. Robotic technologies have been shown to improve accuracy, stability and
steerability compared with manual procedure. These benets
have been demonstrated across a range of procedures.
Existing commercial robotic technologies are limited by lack
of haptic feedback, incompatibility with conventional catheters and a master–slave interface which is based on a different skill set to manual practice. Surgeon skills are not being
fully utilised and costs remain high. Endovascular robotics
has also witnessed a re-evaluation of real-time imaging,
moving away from 2D uoroscopy imaging, to alternatives
including 3DRA and MRI. Alternative technologies have
been explored including electromagnetic coils, ultrasound
and microrobots. Robotic technologies hold great promise
for future development. Technical superiority must, however, be matched by cost effectiveness, accessibility and
thorough training assessment.
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Part II
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Peripheral Occlusive Disease
Соседние файлы в папке Библиотека им академика М.И. Перельмана