2011 - Karthikeyan Ponnusamy - ClinicalOutcomesWithRoboticSurgery (Retrieved-2014!05!25)

Clinical Outcomes With Robotic
Surgery
For the last 60 years, robots have captured peoples imagination as the
embodiment of the technological promises of the future. Considering the
rst denition for robot in the Merriam-Websters Dictionary is a
machine that looks like a human being and performs various complex acts
(as walking or talking) of a human being; also: a similar but ctional
machine whose lack of capacity for human emotions is often empha-
sized,
1
it is no surprise that robots permeate science ction literature and
lms. Robots, such as Hondas ASIMO with its humanoid appearance
and ability to walk and run, have the highest public prole, but relatively
simpler robots are in more widespread industrial use. These robots meet
the easier standard set by the second and third denitions for robots in
Merriam-Websters Dictionary: a device that automatically performs
complicated often repetitive tasks and a mechanism guided by auto-
matic controls.
1
The second denition partly arose from the origin of the
word robot, which was created by Karel Capek for his play 1921
Rossums Universal Robots.
2
Capek derived robot from the Czech word
for slave labor, robota, because his play robots, built from chemical and
biological materials, are created to replace humans at mundane repetitive
labor, to provide humans more time for intellectual endeavors. With time
the robots eventually become superior to humans both physically and
mentally and endeavor to destroy humanity. Audiences became quite
upset by the play and feared for their jobs and lives. Later science ction
stories, such as the Terminator and the Matrix trilogies, struck this same
chord with their themes of robot rebellion.
In the robotics community, a more general and more commonly used
denition for robot was established by the Robot Institute of America in
1979: a reprogrammable, multifunctional manipulator designed to move
material, parts, tools, or specialized devices through various programmed
motions for the performance of a variety of tasks. The rst programma-
ble manipulators were developed in the 1940s, and the technology was
further advanced by George Devol with inventions, such as a magnetic
Curr Probl Surg 2011;48:577-656.
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Curr Probl Surg, September 2011 577
process controller that allowed manipulators to have a play back memory.
Joseph Engelberger licensed Devols robot patents and created the
company Unimation in 1961, which was the rst to commercially
manufacture industrial robots.
3
Unimations rst robots went to the
automobile industry and helped with automating repetitive tasks. Since
then, the use of robots in industry has expanded and includes performing
dangerous jobs (ie, handling radioactive material, exploring space) and
precision machining, among others. These tasks generally fall under the
three As of robotics research, which are automation, autonomy, and
augmentation.
4
The rst Unimation robots were in the automation
category, where they performed repetitive tasks, and the majority of
industrial robots to this day are still classied as such. Autonomous robots
are starting to gain more use with advances in articial intelligence (AI),
and their use includes space exploration and even cleaning, as demon-
strated by the Roomba robot.
4
The third category, augmentation, is
focused on humans and robots working together to become capable of
feats neither could perform alone. Human-controlled robots that perform
both macroscopic and microscopic tasks fall under this category. The
most commercially successful surgical robot, Intuitive Surgicals da Vinci
Surgical System, also falls under this category.
The rst reports of robots being used in the operating room are from the
mid-1980s, and multiple engineers and clinicians are responsible for the
initial robotic surgery studies conducted across a range of surgical
disciplines. One of these pioneers in robotic surgery, Brian Davies, had
developed a denition of robotic surgery based on the Robot Institute of
Americas denition that has come to be accepted within the eld. In his
2000 review, he dened a surgical robot as a powered computer
controlled manipulator with articial sensing that can be reprogrammed
to move and position tools to carry out a range of surgical tasks.
5
Davies
goes on to distinguish robotic surgery from computer-assisted surgery
(CAS) based on the fact that robots have their own motors to move,
whereas CAS requires the surgeon to provide motive energy. Nonethe-
less, robots by their very nature of using computers to assess their
environment and control their actions are a subset of CAS.
3
Davies also
writes that robots should not replace the surgeon, but that the robot
should assist the surgeon while under his/her supervision.
5
Although
in the foreseeable future AI will not have advanced enough for robots to
operate independent from surgeon supervision, perhaps the time may
come when AI enables a robot to independently perform surgeries.
Consequently, for the purposes of our review of the eld, we consider
robotic surgery to be a subset of CAS with the distinguishing aspect that
578 Curr Probl Surg, September 2011
it possesses independent motive abilities. With this clarication, we use
Davies denition of robotic surgery without the qualication that the
robot must operate under a surgeons supervision.
Robotic Surgery Classication
The eld of robotic surgery has expanded since the 1980s to include
various systems, and classication systems for them are important in
facilitating communication among all involved parties. Because robotic
surgery research brings together engineers and clinicians, the different
initial classication schemes tended to appeal to 1 or the other. Engineers
tended to develop technology-based classication schemes similar to the
schemes used in the broader eld of robotics (ie, imaging, control
systems, etc), whereas clinicians were more apt to look toward clinical
application-based classication (ie, general surgery, neurosurgery, etc).
Several classication schemas have been proposed to provide utility to
both the engineers and the surgeons, but none of these has become the
standard for the eld. Below we discuss the commonly cited classication
systems, but for the purposes of our review of the eld, we use the
surgical subspecialty categorization of robots for the discussion of clinical
applications since our target audience is clinicians.
Davies in his seminal review in 2000 focused on robot movement, which
had been used as a key distinguishing feature from CAS, and whether it was
passive or active.
5
Passive robots move to get in the appropriate position and
then can be powered off for the duration of the surgery. This is commonly
seen in robots used for stereotactic biopsy purposes where the robot aligns
itself with the target and then does not move until the surgeon completes the
biopsy. Active robots by contrast have manipulators with tools that directly
interact with the patient to perform the surgery, and the da Vinci Surgical
System is an example of this.
Taylor proposed using the role of the robot as the basis for classica-
tion. His classications were intern replacement, telesurgical systems,
navigational aids, precise positioning systems, and precise path systems.
4
Intern replacement robots, as the name implies, replace some of the roles
of surgical interns, such as holding laparoscopic cameras (Automated
Endoscopic System for Optimal Positioning [AESOP] robot). In telesur-
gical systems, the surgeon directly controls the robot that performs the
surgery, as is the case with the da Vinci robot. This interaction with the
robot provides additional benets, such as tremor ltering and the ability
to operate at a distance. According to Taylor, navigational aids encom-
pass CAS systems that provide 3-dimensional (3D) localization tools
integrated with patient-specic imaging. However, these navigational aid
systems would not qualify as robotic surgery per Davies
5
denition. In
the case of systems that serve as navigational aids and have their own
motive power, they would be classied as precise positioning systems in
the Taylor categorization scheme. The last category is precise path
systems, which go beyond the precise positioning systems in that they
move a surgical tool through a predetermined path. The classic example
is in stereotactic radiosurgery, where the robot moves the radiation beam
through a predetermined path targeting the tumor.
Camarillo and colleagues
3
proposed an alternate role-based categoriza-
tion scheme focusing on the robots role in the surgery and labeled them
as passive, restricted, or active. The key aspects for a passive robot are
that its role has a limited scope or its use is low risk. Restricted robots
have a greater role and are involved in more invasive and higher risk
tasks, but are still limited from core aspects of the surgery. Active robots
have an even greater involvement and are intimately involved in the
procedure and carry high responsibility and risk.
3
This system can be
viewed on a continuous scale rather than a simple discrete classication;
even robots within the same category can carry relatively different levels
of invasiveness and risk. Camarillo and colleagues
3
plotted autonomy vs
the robots procedural role for currently available robots and identied an
indirect trend (Fig 1). The robots with the least risk and invasiveness tend
to have the greatest autonomy, and the inverse is true as well.
Bann and colleagues
6
proposed using a 2-group classication scheme
with the rst based on function (similar to the role focus used by Taylors
4
and Camarillo and colleagues
3
classications) and the second based on
technology. Their function-based classication (dexterity enhancement,
precision localization, and precision manipulation) is analogous to Tay-
lors
4
role-based system categories (telesurgical systems, precise posi-
tioning systems, and precise path systems). The second group of tech-
nology classication focuses on the interaction between the surgeon and
robot, and the categories are autonomous, supervisory, and teleoperated.
Autonomous robots execute a preoperative plan programmed by the
surgeon. Supervisory robots work together with the surgeon to guide
him/her through the procedure. Teleoperated systems are similar to
Taylors
4
telesurgical systems. Bann and colleagues
6
brought a unique
perspective to categorization by considering 2 groups for each classi-
cation, but as can be seen from their scheme, the 2 groups do not assess
independent characteristics since dexterity enhancement systems by
denition will always be teleoperated systems as well.
Nathoo and colleagues
7
proposed another 2-group classication system
based on technical and interaction classications. The technical classi-
cation is divided into active and passive similar to Davies
5
active and
passive classication. The 1 difference is that Nathoo and colleagues
7
dene a passive system as 1 where the surgeon provides the motive force
to position the robot and then the robot is powered-off instead of the robot
causing the motion. The interaction classication is based on how the
surgeon interacts with the robot; the categories were divided into
supervisory-controlled, telesurgical, and shared-control systems. This
classication is comparable to Bann and colleagues
6
technology
group. Supervisory-controlled systems are like Bann and colleagues
6
autonomous robots in that the surgeon programs the robot before the
procedure. Shared-controlled systems are called such because control
of the surgical tools are shared with the surgeon and would fall under
Bann and colleagues
6
supervisory category. Last, telesurgical sys-
tems are similar to Taylors
4
telesurgical and Bann and colleagues
6
teleoperated systems.
Surgical Robot Characteristics
Based on Davies
5
denition of surgical robots, the essential compo-
nents of a robot can be broken down to a computer, articial sensors, and
FIG 1. Plot of surgical robot autonomy versus robots procedural role (passive, restricted, or active).
The robots with the least risk and invasiveness tend to have the greatest autonomy, and the inverse is
true as well. (Reprinted with permission from Camarillo et al.
3
)
manipulators. The various available robots each have different capabili-
ties in each of these aspects.
Computer
Teleoperation/Telerobotics/Telepresence. One important feature that
some systems offer is remote control. Satava and Simon
8
described the
different kinds of remote control and they are teleoperation (direct robot
control via master-slave system), telerobotic (the robot has the intelli-
gence to perform the procedure on its own and the surgeons supervises),
and telepresence (similar to teleoperation with additional sensory input
that would allow the master and slave to be physically separated by long
distances yet feel as though they are not separated). As a word of
clarication regarding the categories discussed in the prior section, Bann
and colleagues
6
teleoperated and both Taylors
4
and Nathoo and col-
leagues
7
telesurgical systems would only include robots that Satava and
Simon
8
would classify as telepresence. Satava
9
later reported that
telesurgery was equivalent to telepresence. For the rest of this review,
Satava and Simons
8
denitions will be used.
Teleproctor. Another feature that some robots may have included is
teleproctoring, where an experienced surgeon can remotely follow and
guide another surgeon through an operation. This can be quite useful for
clinicians located in isolated areas who may not have the experience
treating certain diseases. Teleproctoring can be used locally as well for
resident education. Surgical residents and fellows can train to use the
robotic system with guidance from the attending surgeon provided
through the systems interface.
Articial Sensing
Sensor Types. Robotic surgery systems can study their environment
with a variety of sensors. Some, such as propioceptive sensors at joints,
can help the robot to identify its location within 3D space. Other sensors,
such as cameras and ultrasound, can relay information to the surgeon to
provide them with the necessary sensory information to perform the
procedure. These sensors can convey the sensory information to the
surgeon by the same means it was gathered (ie, transmit visual informa-
tion visually) or via synesthesia through another sensory modality. An
example of synesthesia would be a robot that emits an auditory warning
for when instruments are at risk of colliding.
Haptics. Haptics qualify as a type of robotic sensor, but since surgeons
place a unique value on this set of sensation, we discuss it separately. The
nature of surgery before robotics was to work directly with ones hands,
and that provides the advantages of using the evolutionary advanced
human hands natural haptic sensor system. These sensors provide a range
of sensations, including force, pressure, texture, and temperature that
surgeons have integrated into the art of medicine. Okamura
10
reports that
both cutaneous (tactile, ie, texture) and kinesthetic (ie, force) sensations
are necessary to simulate haptics felt by the human hand. In certain
robotic systems, such as Nathoo and colleagues
7
shared-controlled
systems, the surgeon shares control of the surgical tools with the robot
and depending on the design of the system the surgeon can use their
natural haptic system as usual. However, with other robotic systems (ie,
teleoperated systems), the surgeon interacts with the robot controls and
not directly with the tissue and will miss the haptic sensations. These
robots can integrate haptics into the operative experience in multiple
ways, including directly through the controls or with synesthesia. The
most natural interaction for surgeons would be for haptics to be integrated
directly into the controls. As Okamura
10
discusses in her article, there are
multiple technical challenges that arise in integrating haptics into the
controls because reliability and stability of the controls must be ex-
changed for greater haptic feedback. Consequently, Okamura
10
suggests
using synesthesia, such as with auditory and visual signaling as a
workaround for these challenges. Her laboratory has conducted initial
studies focusing on conveying force feedback, and Okamura
10
reports
that in the systems they tested visual feedback played a more dominant
role than auditory feedback.
Preoperative Image Registration. Robotic surgery systems have the
potential to integrate preoperative imaging, such as computed tomogra-
phy (CT) and magnetic resonance imaging (MRI) scans with their sensor
systems to provide targeted guidance for the procedure. The key to these
systems is to register the preoperative images with the operating room
setup. In other words, the robot needs to calibrate the images to reference
points on the patient. Some systems require that ducials, physical
reference points, such as stereotactic frames or radiographic markers, be
attached to the patient either before preoperative imaging or after in order
for the robot to calibrate its position with respect to the imaging. Certain
registration programs demand that ducials must be physically embedded
on patient landmarks, such as on bone. These ducials can be painful and
may even require general anesthesia if used on children.
11
Noninvasive
ducials include dental molds but have the concern that accuracy may be
compromised. The CyberKnife system uses regular high-precision x-ray
images to register the patient and does not require the use of ducials, yet
is able to provide highly accurate positioning.
11
Adoption is likely to be
greater with systems that do not require invasive ducials.
Another important consideration for image registration depends on the
tissue consistency. Hard tissues, such as bone, once rigidly xed will
generally not deform or move with the forces applied during a procedure.
By contrast, soft tissues will tend to deform and move with manipulation,
and the preoperative image registration would likely become invalid as
soon as the procedure begins. Two approaches to address this problem
have been to use intraoperative imaging or modeling soft tissue defor-
mation.
12
Depending on the tissue and the manipulation involved, regular
or real-time updates can be used to adjust the image registration
throughout the procedure. Some intraoperative imaging techniques that
can be used include uoroscopy, CT, MRI, and ultrasound. Modeling of
soft tissue deformation with manipulation has been a more challenging
method to address this problem due to the number of variables involved
in accurately predicting the biomechanical properties of different
tissues.
12
Manipulators
Degrees of Freedom. The manipulators degrees of freedom (d.f.)
represent the number of independent motions that the manipulator can
execute. For the robot manipulator to navigate in 3D space, it will need
at least 3 d.f., 1 each for the x-, y-, and z-axis. In order for the robot to
conduct certain surgical tasks, such as suturing, an additional 3 d.f. with
pitch, yaw, and roll are needed to greatly facilitate surgical ease.
Sometimes grip is considered a seventh d.f. Manual laparoscopic instru-
ments generally have 4 d.f. (roll, x-, y-, and z-axis) and grip can be
considered as a fth d.f.
End-Effectors. The end-effectors are the surgical tools that the manip-
ulator is using. These tools include standard surgical instruments (grasp-
ers, needle drivers, scalpels, etc), energy-based instruments (electrocoag-
ulation, laser, ultrasonic scalpel, etc), and linear accelerators for
radiosurgery. End-effectors can be diagnostic tools like ultrasound probes
and microscopy equipment.
13
The d.f. for each instrument can be limited
by the nature of the tool; a scalpel will not have grip or an ultrasonic
scalpel will have limited pitch and yaw.
Footprint. Depending on the footprint of the robotic systems equip-
ment and manipulators or in other words the space they need to function,
a larger operating room facility may be necessary. In addition, the use of
other equipment, such as uoroscopy or intraoperative CT or MRI, may
be limited or impossible if the robotic system has a large footprint
requirement. Depending on the amount of space the robot occupies near
the patient, patient-side surgeons may be limited in their ability to work
with the robot.
Workspace. The robots workspace is dened as the volume of space
where the robot can reach with its manipulator.
3
The constraining factors
for workspace are the manipulator arm lengths, joint bending limits,
collisions between arms, and anatomy. At the edges of the workspace, the
manipulator may not have its full d.f. available for use since it is at an
extreme position. Consequently, the target anatomy of a surgical proce-
dure should be kept in the center of the workspace to avoid limiting the
manipulators effectiveness.
Limiting the workspace can be used by some robots as a safety
mechanism to prevent accidental injury to the patient. A system where the
workspace is limited such that all possible motion within that volume is
safe is called an intrinsically safe design.
7
The limits can be due to either
hardware (difcult to design a robot useful for patients of all shapes
and sizes) or software. Hardware limits cannot be overcome inadver-
tently, but software limits (although more exible across patients) can
have its intrinsically safe design circumvented by software errors or
improper use.
Resolution. The robots resolution is dened as the smallest unit of
motion that the manipulator can move or measure.
3
The necessary
minimum resolution for a robot depends on its clinical applications and is
commonly assessed in units of length. For example, to perform a
cholecystectomy, a robot would need a resolution of at most 2 mm
3
.
However, some ophthalmologic microsurgeries require resolutions 2
orders of magnitude smaller (less than 25 m).
13,14
As a comparison, the
limits of human performance are around 200 m.
13
Inertia, Force, and Speed. A robots inertia depends on the mass,
shape, and size of the manipulator. The greater the inertia, the stronger the
driving motors need to be to achieve a given speed or force. The motors
are connected to the manipulators via a transmission that takes advantage
of mechanical advantage principles to scale-down the speed to scale-up
force. In order for the speed to be increased, the mechanical advantage
needs to be decreased, resulting in a decreased force. Both speed and
force can be increased with even stronger motors and an appropriate
transmission.
Force Dynamic Range. A robots force dynamic range is dened as the
ratio between the greatest and smallest force that it can control.
3
Creating
a vessel anastomosis, such as a coronary bypass, requires a robot capable
of both high-resolution and small force control, whereas for bone drilling
for orthopedic, neurosurgical, or ear, nose and throat applications, the
robot needs a high force control to use drills and saws. Similar to the case
with resolution, robots need to match their force dynamic range with the
clinical application demands.
Stiffness. The stiffness of the manipulator depends on the materials it is
composed of and its design. A stiff manipulator will allow greater control
and accuracy because it is less likely to be deformed away from its
expected location.
3
However, a less stiff manipulator is less likely to
impart damage to soft tissue structures if the manipulator inadvertently
hits it.
Backdrivability. Backdrivability is the ability for the surgeon to
manually move the manipulator out of the way. Because of the potentially
high mechanical advantage used in the transmission, it could be very
difcult to manually move the manipulator out of the way without using
the controls. In emergency situations where the procedure must be
converted from robotic to traditional approaches, backdrivability is
essential to move the robot out of the way to quickly provide the surgeon
the space and access needed to stabilize the patient. A solution used by
some robots is to use a clutch to disengage the manipulators from the
transmission and allow the surgeon to both easily and quickly move the
robot.
Position Control and Force Control. The robot manipulators can be
manipulated with multiple control schemes. One is position control where
the manipulator is moved through a specic path. In force control, the
robots interactions with specic surfaces are limited to a predetermined
range of forces. Too much force can result in tissue damage, but too little
force with certain instruments, such as a bone drill, can cause the drill bit
to jump, causing injury elsewhere. It is thought that human surgeons use
an innate combination of position and force control when operating.
3
Depending on the application, robots can have better control using a
similar combined position and force control.
Bandwidth of Motion and in Force. Bandwidth of motion is dened as
the highest frequency the controls can be oscillated such that the
manipulator can continue to track the controls. At any higher frequency,
the manipulator would fall behind the controls and would not accurately
follow the input commands. The manipulators inertia, speed, and
stiffness all play a role in determining the bandwidth. Bandwidth of
motion is a very important consideration in teleoperated systems where
master movements are expected to temporally correlate with the slave. In
any procedure, the bandwidth of motion must be higher than the
frequency at which the surgeon controls the master. Bandwidth of motion
is directly correlated with the position control, in that this bandwidth
determines the delity with which the position control commands are
executed by the manipulator.
Similarly, bandwidth in force is related to the force control and is the
highest frequency at which the manipulator can track force commands
from the controls. In this case, the manipulators force, force dynamic
range, and stiffness all affect bandwidth in force. In manipulators with
bone drills as end-effectors, force controls must recognize sudden
changes in force that may signal a possible bone fracture or shift in the
drills position and require sufcient bandwidth in force to quickly adjust
the manipulator to avoid injuring the patient.
Mechanism Type. Another feature of the manipulators is how the
end-effector is attached to the rest of the robot or the mechanism type.
The traditional mechanisms are by serial or parallel linkages. One of the
major advantages of a serial linkage is that the manipulator will have a
larger workspace with smaller footprint than a similarly designed system
with parallel linkage. A movable desk lamp is an example of a serial
linkage that takes advantage of this system to provide lighting for the
entire desk.
3
Parallel linkages have multiple connections between joints
that make the joint stiffer, allowing it to carry heavier loads and have
improved accuracy, with the cost that there is a smaller workspace and
larger footprint. An example of a parallel linkage is a scissor jack used for
lifting a car; it demonstrates the advantages of a stiff joint in holding up
a car.
3
Some current robotics systems may not even have a direct
mechanical link and cannot be classied into these 2 categories. For
example, the Niobe robotic catheter system produced by stereotaxis
controls the catheter with magnets.
History of Robotic Surgery
Robotic surgery came into existence during the 1980s, with multiple
researchers around the world both adapting industrial robots and creating
novel systems for use in surgical procedures across a range of specialities.
The rst reported use of a robot for surgery was for a stereotactic
neurosurgical biopsy in April, 1985.
15
Neuromate, Probot, ROBODOC,
Acrobot, precursors to da Vinci, and AESOP/HERMES are robots that
were developed in the late 1980s and early 1990s. We discuss the
development of these robotic systems because of their prominence in
the history of robotic surgery. Other robotic systems developed during
the late 1980s through the 1990s include Artemis, Minerva, CASPAR,
and EndoAssist.
13
Kwoh and colleagues Neurosurgical Biopsy Robot
Kwoh and colleagues
15
noted that the problems of traditional manual
stereotactic biopsies were that they were time-intensive and manual frame
adjustments led to potential inaccuracies. They wanted to develop a
means to automate the process to increase precision and speed, and they
decided that a robot could achieve these goals. They adapted a commer-
cially available Unimation Programmable Universal Machine for Assem-
bly (PUMA) 200 robot for their biopsy system. The procedure started by
attaching a stereotactic frame to the patients skull to take the necessary
CT images. Once the target is identied on the images relative to the
frame, the robot is attached to the frame for registration and then it swings
its manipulator to direct the probe toward the target. Surgeons are able to
reposition the manipulator trajectory to avoid critical neurological struc-
tures, while the robot maintains alignment with the target. As the rst use
of a robot for surgery, Kwoh and colleagues
15
conducted numerous tests
(including experiments simulating a patients head with a watermelon and
a lesion with a lead BB) to insure safety and accuracy before proceeding
with human tests. These studies indicated that with calibration the robot
could direct a needle tip within 1 mm of the target. Kwoh and colleagues
proceeded to test the robot in a patient in April, 1985, and successfully
biopsied a suspicious brain lesion on the rst attempt.
15
Neuromate
A couple years after Kwoh and colleagues
15
performed their rst
robotic biopsy, researchers at Grenoble University in France published
their initial report of developing a stereotactic robot using a Unimation
PUMA 200 Robot.
16
Their system has been improved over the years and
is used for tumor biopsies, stereoelectroencephalographic investigations
for epilepsy, and functional neurosurgery electrode placement. The initial
system design required that the patient have preoperative CT or MRI
imaging while wearing a stereotactic frame with built-in ducials. The
images are incorporated into the planning software and the surgeon then
programs the target and trajectory that is sent to the robot. In the operating
room, Neuromate is registered by taking 2 x-rays of the patient with a
stereotactic frame and a calibration cage around their head and attached
to the end-effector. The calibration cage is shaped like a cube and has 9
precisely positioned x-ray beads in each of the 4 sides to help the software
register the position of the robot relative to the preoperative imaging; the
robot is locked in this position to maintain the registration. Then, the
end-effector is switched to a guide and the 6-axis passive manipulator
positions the guide with the preoperatively determined starting point and
trajectory. The surgeon can proceed with the surgery using the guide to
perform the procedure.
14
Probot
In 1988, Sir John Wickham, MD, a urologist, and Brian Davies, PhD,
at Imperial College London in London, adapted a PUMA 560 industrial
robot for use in transurethral resection of the prostate (TURP) and named
it Probot.
5
They had recognized that the traditional means of performing
TURPs took nearly an hour to perform and required the surgeon to be in
an awkward position for the entire procedure. More importantly, the
conical section removed in a TURP could be relatively easily pro-
grammed for an autonomous cutting robot.
17
In their initial studies
simulating a prostate with a potato, once the robot was positioned in the
initial position it was able to perform the necessary cuts in approximately
5 minutes.
17
Probot needed 8 d.f. to perform these cuts and this
exibility added additional safety concerns for using this industrial
robot. Consequently, this research group developed and validated a
circular ring that limited the movement of the cutting tool and would
make the system intrinsically safe to prevent inadvertent patient injury
by cutting tissues beyond the prostate. With the establishment of these
safety mechanisms, the Probot performed its rst surgery on a patient
in April, 1991 (Fig 2).
5
ROBODOC
During the early 1990s, Howard Paul, DVM, and William Bargar, MD,
were both interested in total hip replacement/arthroplasty (THA) surgery;
Paul was involved with dog THA, while Bargar was involved with human
THA.
13
At the time the trend in THA was toward cementless femur
components, with the goal of having bony ingrowth into the implant.
There was concern that the manual technique of using reamers and
broaches resulted in gaps between the implant and bone that inhibited
ingrowth.
18
Consequently, Paul and Bargar teamed up with Russell
Taylor (mentioned previously for his classication scheme) and adapted
a Sankyo-Seiki industrial robot for their purposes. For safety, they added
redundant force, torque, and position sensors for a combination of force
and position control.
18
Their robot is able to provide accuracy within 0.1
mm and, depending on the resolution of the CT scan, the overall accuracy
for preparing the femur is within 0.4 mm.
18
Additional tests showed that
manual broaches resulted in 75% accuracy, but ROBODOC could prepare
femurs with 96% precision.
13
The procedure starts with the placement of 3 percutaneous titanium pins
(ducials) in the medial and lateral condyles and greater trochanter. A CT
scan of the femur is taken and imported into the ORTHODOC software
that they developed to help identify the appropriate implant and program
the ROBODOC. Then, the patient is brought into surgery and a traditional
posterior approach to the hip is used to position the acetabular compo-
nents and expose the femoral neck. The neck is cut 2 to 3 mm proximal
to the desired cut, because ROBODOC will adjust for the difference.
Next, the femur is attached to an external xator via a clamp at the lesser
trochanter and 2 halo pins are placed immediately proximal to the
condylar ducials. The external xator is directly connected with the
robot, and then the robot registers its position as the surgeon moves
FIG 2. Probot with intrinsically safe circular ring to prevent inadvertent cutting beyond the prostate.
This was the rst time that a robot was used clinically to remove tissue from a patient in April, 1991
and shows the urologist, Mr Wickham, operating. (Courtesy of Professor Brian Davies, Imperial
College London of London and copyright Stanmore Implants Worldwide Ltd.)
the manipulator with a ball probe at the end to identify each of the 3
ducials. After the software calculates the necessary paths, a standard
surgical burr is switched for the ball probe and the robot executes the
preoperative plan. After the femoral cavity is prepared, the robot is moved
out of the way and the surgeon implants the femoral component. The
incision is closed with traditional means.
18
Paul and colleagues
18
reported their initial success in 25 dogs and did
not have any intraoperative complications or postoperative infections.
This led to the rst human trial in 1992
19
and completion of a successful
10 patient human feasibility trial that demonstrated safety. To determine
efcacy, a Food and Drug Administration (FDA) trial was conducted in
the United States (65 ROBODOC THAs) and a postmarket study was
conducted in Germany (900 ROBODOC THAs) starting in 1994.
20
Advantages associated with using ROBODOC included no intraoperative
femur fractures and the various measures of implant t were signicantly
improved with the robot. It is theorized that implant t is correlated with
long-term outcome, but that remains to be seen. These studies had at most
2-years follow-up that did not show any statistically signicant difference
in functional outcome. The disadvantages of ROBODOC were signicant
increases in blood loss (EBL) (1189 mL vs 644 mL) and operative time
(OT) (258 minutes vs 134 minutes). The EBL was directly correlated with
OT. Bargar and colleagues
20
reported that with experience the additional
OT of using ROBODOC decreased to an extra 30 minutes compared to
manual techniques.
Acrobot
Acrobot, named for being an active constraint robot, was developed at
the Imperial College London by Davies (who was involved with the
Probot) and Justin Cobb, MD.
21,22
Instead of adapting an industrial robot,
they developed their own device for the purpose of making the cuts
needed for a total knee replacement/arthroplasty (TKA). Unlike
ROBODOC with its autonomous execution, Acrobots manipulator is
moved by the surgeon throughout the procedure and offers the surgeons
natural haptic feedback for cutting while actively constraining the range
of motion as a software-based intrinsically safe system. Preoperatively a
CT scan of the patients affected leg (1-mm slices at the knee and 5 mm
for the rest of the leg) is acquired, and the surgeon uses the Acrobot
software to plan the appropriate cuts for the desired implant. During the
surgery, the traditional medial parapatellar approach to the knee is
used to acquire the necessary exposure. The femur and tibia are
immobilized at the knee to the operating table via clamps. The distal tibia
is rigidly held with a foot support, while the patients weight is sufcient
to hold the proximal femur. The robot is brought in and locked to the
operating table to put it in rigid continuity with the femur and tibia.
Acrobot uses an anatomical registration method (iterative closest point
algorithm) that does not require ducials. The surgeon moves the
manipulator with a ball probe at the end to 4 landmarks on the patient, and
from that the robot creates an initial registration. Then, the surgeon
randomly tests 20 to 30 points on the bone to check accuracy, and if
insufcient, registration is redone. Once suitable registration accuracy is
achieved, the surgeon proceeds with the femoral and tibial cuts using the
Acrobot manipulator programmed with the predetermined constraints,
while the patella cut is performed manually due to its simplicity. Initial
clinical trials demonstrated promise, although the OT were longer than for
traditional techniques.
22
Stanmore Implants Worldwide Ltd. currently
produces the most recent iteration of the Acrobot system (Fig 3).
Precursors to the da Vinci Surgical System
The origins of the da Vinci robotic surgery system are rooted in research
conducted at the Stanford Research Institute (later renamed to SRI
International), National Aeronautics and Space Administration (NASA),
and the Defense Advanced Research Projects Agency (DARPA, previ-
ously known as ARPA). During the late 1980s, Joseph Rosen, MD,
completed the Stanford University plastic surgery residency and then
joined the faculty there. He was interested in the potential for robotics to
be used in hand surgery specically for nerve and vessel microsurgery.
Together with Philip Green, PhD, an engineer at SRI, they worked on
developing a dexterity enhancement robot with a telesurgery system.
During this time, they met Scott Fisher, PhD, who was in the laboratory
of Michael McGreevey, PhD, and Stephen Ellis, PhD, at the NASA Ames
Research Center where they were working on virtual reality environ-
ments. They teamed up with the vision to create a virtual reality
environment through a head-mounted display to simulate being at the
operating table and the surgeon controlled the robot with gloves that
recorded hand movements. Because of technology limitations on the
resolution of head-mounted displays and gloves, the team decided to use
a monitor and controllers for the surgeon console. The slave in this system
was a 2-armed robot that was equipped with switchable instruments.
23
Richard Satava, MD, a general surgeon with the Army in Monterey,
CA, heard about and became interested in the telesurgery project, and he
subsequently joined the team as an additional researcher. Soon thereafter,
Satava was at the 1989 Society of American Gastrointestinal Endoscopic
Surgeons, where he saw Jacques Perrisats video of the rst laparoscopic
cholecystectomy. Satava brought this insight to the group and they added
laparoscopic general surgery as another clinical application to explore,
but they devoted most of their energies to hand and open general surgery
procedures. One of the demonstration tests they conducted with their
robotic system was for bowel anastomosis with an open technique. Word
of this spread through the military, and Satava was promoted to program
manager for Advance Biomedical Technologies at DARPA in 1992.
From analysis of soldier injuries, it was determined that 90% of
battleeld deaths occur before the patient can be transported, oftentimes
due to major vessel hemorrhage from delayed surgical intervention.
13,23
FIG 3. Most recent iteration of the Acrobot robot. (Courtesy of Stanmore Implants Worldwide Ltd,
United Kingdom).
Satava oversaw a project to further develop this robotic system for use in
an armored vehicle called the Medical Forward Area Surgical Team
(MEDFAST) to stabilize the injured soldier with open surgery while they
are being transported to the Mobile Advanced Surgical Hospital (MASH)
located 10 km to 35 km behind the line of active combat. The surgeon
would operate from the console based at the MASH and continue to take
care of the patient once they were brought in by the MEDFAST. In trials
of this system in 1994, the rst remote telesurgical procedure was
conducted via a microwave connection between a MASH and a
MEDFAST up to 5 km away. The surgery in this case was the ex vivo
anastomosis of porcine intestine. This DARPA project was eventually
discontinued before implementation because the battleeld was changing
from open areas that a MEDFAST vehicle could quickly navigate to the
urban environments of current wars. For more details about these
developments and the researchers involved, see the articles on the history
of robotic surgery by Satava.
9,13
In 1995, Frederic Moll, MD, cofounded Intuitive Surgical and licensed
the telesurgery system from SRI together with patents from International
Business Machines and the Massachusetts Institute of Technology.
9,23
Their robot was named the da Vinci Surgical System and focused on
minimally invasive surgery. Intuitive wanted to overcome the limitations
of laparoscopic instruments, including the fulcrum effect, limited dexter-
ity, and loss of 3D vision with robotics.
13,23
The key goals of the Intuitive
system were to develop a master-slave system with intuitive control,
stereoscopic vision, a design with redundant sensors to maximize safety,
and laparoscopic instruments with 7 d.f.
23
The system was used in March,
1997, for the rst cholecystectomy telesurgery in a human.
24
After a 200
patient randomized clinical trial to test safety and efcacy in cholecys-
tectomy and Nissen fundoplication, the da Vinci robot received FDA
approval in July 2000.
23
The initial clinical focus for the robot was for
endoscopic coronary artery bypass grafts (CABGs), but the da Vinci
system has gained signicantly greater adoption in other subspecialties,
such as urology and gynecology.
13
Computer Motion
Yulan Wang, PhD, was an entrepreneur interested in medical applica-
tions for robotics and founded Dynamic Microsystems in 1989 (later
renamed Computer Motion in 1990) with grants from NASA and the
National Science Foundations Small Business Innovation Research
Program.
25
Computer Motion focused its efforts on developing a robotic
laparoscopic camera holder called the AESOP and received DARPA
support for it in 1993.
9,25
In the original version of AESOP, the surgeon
controlled the camera direction with either hand or foot controllers that
moved the view relative to the current camera position. The views could
be saved and returned to with a press of a button.
26
Later, voice
recognition and control was added as another option. AESOP was the rst
surgical robot to receive FDA approval, in 1993, 1 month after its rst use
in a laparoscopic cholecystectomy.
25
After its success with AESOP, Computer Motion solicited and acquired
additional nancing from the private sector to produce a complete robotic
system with surgical manipulators.
9
In 1995, they began development of
a new robot that was based on 3 AESOP arms, 1 for the camera and 2 for
surgical instruments. This system was called ZEUS and was a master-
slave system that offered motion scaling and tremor reduction for
laparoscopic and other minimally invasive surgeries.
25
Highlights of
ZEUS include the rst robotically assisted CABG in September, 1998,
and the rst transatlantic telerobotic surgery (a cholecystectomy) by
Jacques Marescaux, MD, in September, 2001. Around this time, ZEUS
received limited FDA approval for abdominal procedures.
25
Intuitive
Surgical acquired Computer Motion in 2003 due to a variety of nancial
and legal disputes, and since then, the AESOP and ZEUS systems have
been discontinued.
9,25
Commercially Available or Near Market Surgical
Robots
Since these early robotic surgery endeavors, numerous research labo-
ratories around the world have embarked on developing new robotic
systems for use in various clinical applications. Many of these projects are
still in the early stages of development and are years away from
widespread clinical use. The focus of our review is on the clinical value
of currently available systems, and, consequently, for this section we
discuss commercially available or near market systems. For a summary of
the cutting-edge research developments in robotic surgery, see the
reviews by Dogangil and colleagues
12
and Pott and colleagues.
27
Neuromate
Since its development, Neuromate has gone on to commercial produc-
tion initially by Integrated Surgical Systems with FDA and European
approval.
14
Commercialization rights were later transferred to Schaerer
Mayeld Neuromate AG,
28
which was later acquired by Renishaw PLC,
which currently manages production and sale of Neuromate.
29
They
advertise that the Neuromate system can currently be used for electrode
placement for epilepsy monitoring, therapeutic neuroendoscopy, deep
brain stimulation, biopsy, neuro-oncology drug delivery, transcranial
magnetic stimulation, and radiosurgery (with miniature radiation source
end-effectors).
29
One of the major updates in the last decade to the
Neuromate system is the incorporation of frameless registration, although
this process still has an invasive component. This new registration process
starts with attachment of a base plate with a 4-spoked ducial system to
the patients skull under local anesthesia. Accuracy of the registration can
be measured by afxing 3 ducials to the skull. Preoperative imaging is
then acquired with CT or magnetic resonance modalities. To register the
robot, in the operating room, a 4-spoked ultrasound microphone system
(identical in shape as the spoked ducial system) is attached to the base
plate. A similar system of ultrasound emitters is placed on the Neuromate
end-effector and the robot registers the preoperative imaging based on the
microphone readings. From laboratory and clinical studies, the mean error
was less than 2 mm, which was similar to results when using the
frame.
28,30
The current system sold by Renishaw can be used with a
commercially available stereotactic frame or with the frameless system.
29
Neuroarm
Garnette Sutherland, MD, a neurosurgeon at the University of Calgary,
conceived the idea of performing surgery while an MRI machine is taking
its images. To achieve this goal, he and his colleagues developed the
NeuroArm, an MRI compatible robot. This system ts inside the MRI
bore and can be controlled while imaging is acquired without degrading
the quality of the images. Neuroarm is composed of a workstation
(master) and 2 manipulators (slaves) and can function in either a
stereotactic or a microsurgery mode. The stereotactic mode uses 1
manipulator positioned in the MRI bore and uses almost real-time
imaging for stereotactic surgeries. For microsurgery, the procedure is
performed outside of the MRI with both manipulators and uses a
registration system to overlay the intraoperative MRI images on the
workstation monitors. Although the manipulators are capable of 50-m
resolution, the visualization is not at a high enough magnication for
surgeons to take advantage of this capability. Each slave has 7 d.f., moves
using ultrasonic piezoelectric motors, and has 2 strain gauges to provide
haptics information through the controls.
31,32
Early clinical tests using the
NeuroArm in a series of 5 patients have been published.
33
CyberKnife
John Adler, MD, recognized that frame-based stereotactic radiosurgery
could only be applied for intracranial pathologies and that the frame led
to pain due to its invasiveness. His goal was to develop a system to
accurately deliver radiation to lesions anywhere in the body with
noninvasive image registration. Adler led a team that successfully
developed the rst iteration of such a robot, CyberKnife, to achieve these
goals in 1987.
11,34
CyberKnife has a 6 d.f. linear accelerator end-effector
that moves through a hundred positions for each patient to concentrate a
lethal dose of radiation at the target while only minimally affecting
healthy tissue (Fig 4). Accuray was founded to commercialize this robot
in 1990, and since then, the system has received FDA approval for use in
the head, neck, and upper spine in 1999 and for the whole body (treatment
is referred to as stereotactic body radiation therapy [SBRT]) in 2001.
34
Before treatment, a CT scan (or MRI) is taken from above the top of the
head to below the chin (for intracranial lesions). The surgeon or radiation
oncologist then plans the treatment in conjunction with the CyberKnife
software to target the lesion and avoid/minimize radiation trajectories
through sensitive tissue. During treatment, the patient lies on a bed as they
did for the CT scan. Beside the patients head are 2 x-ray uoroscopes
that take images of the patients skull and are registered with digitally
reconstructed radiographs from the CT. This allows the robot to identify
the lesion in 3D space and moves to 1 of a hundred nodes (beam
FIG 4. CyberKnife procedure room with robot and linear accelerator. Fluoroscopic images are taken
with the ceiling-mounted sources and detectors embedded in the oor. The Synchrony Respiratory
Tracking System is attached to the ceiling on the left side of the room. (Courtesy of Accuray, Inc,
Sunnyvale, CA.)
origination positions) and delivers the appropriate radiation dose to the
target. Before the robot delivers the next dose from a different node, the
uoroscopes repeat imaging to update the registration to adjust for patient
movement. The registration is typically updated every 20 to 40 seconds.
From the study by Adler and his colleagues, the precision of this
registration system is similar to that offered by a stereotactic frame.
11
Variations to this general setup are used to accommodate treatment of
lesions elsewhere in the body, such as deformable organs. Spinal lesions
are tracked with Xsight tracking; this system uses the preoperative CT
scan to construct digitally reconstructed radiographs and uses software to
identify key spinal landmarks to register the image with the images taken
from the uoroscopes in the procedure room.
35
Thoracic, abdominal, and
pelvic targets movements with respiration can be followed with the
Synchrony system that tracks respiration by following chest-mounted
light-emitting diodes and ducials placed in the tumor. Using the
uoroscopic imaging, the movement of the 2 is used to build a model of
movement such that radiation therapy can be delivered throughout
respiration.
36
For lung lesions, the robot uses the Xsight Lung (also
referred to as Lung Optimized Treatment) system, which was recently
approved by the FDA in December, 2010.
37
The CyberKnife system is
being investigated for use in tumors throughout the body, chronic back
pain, obsessive compulsive disorder and other psychological diseases,
and cardiac ablation. Hara and colleagues
36
thoroughly review the use of
the CyberKnife for tumor treatment throughout the body from a radiation
oncologists perspective.
MAKO Robotic Arm Interactive Orthopedic System
MAKO Surgical Corporation was founded as a spin-off from Z-KAT,
Inc in 2004 to focus on the orthopedic robotics market.
38
They focused on
improving unicompartmental knee arthroplasty (UKA) with robotics,
because research suggested that inaccurate component positioning led to
early failure and manual approaches led to signicant positioning vari-
ability.
39,40
Consequently, MAKO developed its initial robot the Tactile
Guidance System (TGS) to improve component positioning for medial
UKA. TGS is a shared-control system where the surgeon controls a burr
that is actively constrained to preoperatively determined safe zones,
similar to Acrobot. A preoperative CT scan from the hip to the ankle with
ner 1-mm cuts through the knee is used with the software to determine
the necessary boundaries for appropriate implant positioning. Intraoper-
atively, the system registers the imaging initially with an optical infrared
camera to recognize navigation markers placed in the femur, in the tibia,
and on the robotic arm. Key landmarks are then identied, such as the hip
center (by circumducting the hip), ankle malleoli, femoral epicondyles,
and base of the anterior cruciate ligament. Based on this, a virtual knee
model is built and the camera can move the virtual model in real-time
with knee movements. As a result, the leg does not need to be rigidly
xed (unlike the original Acrobot) and can move while burring. For
safety, the burr is stopped if the knee moves too quickly.
40
The surgeon
uses the active constraint robotic burr to prepare the femur and tibia, and
the cuts can be veried using a probe end-effector on the cavity or on top
of the articular surface of trials positioned in the cavity.
39,40
The camera
can be used to provide the surgeon additional information regarding
alignment and knee kinematics, and once proper positioning is conrmed,
the implants are cemented in position.
40
Since the commercialization of TGS, MAKO has developed an updated
version that is named Robotic Arm Interactive Orthopedic System (RIO)
that received FDA approval in 2008. This system is able to prepare both
the medial and the patellofemoral knee compartments unlike the TGS
system that could only prepare the medial compartment. MAKO also
developed the RESTORIS muscle creatine kinase implant system for
bicompartmental knee resurfacing, which also received FDA approval in
2008. MAKO is conducting initial studies of using the RIO system to
prepare the acetabulum for hip replacements and is planning a commer-
cial rollout in the second half of 2011. As of September, 2010, there were
54 RIO systems in use in the United States.
38
MAZOR SpineAssist
MAZOR Robotics developed the SpineAssist due to high rates of spinal
surgery pedicle screw misplacement that was more pronounced with
severe deformities such as scoliosis. The rates of misplacement decreased
with percutaneous uoroscopic guidance and CT-guidance but result in a
considerable increase in radiation exposure. Another approach was to use
computer assisted surgery and it has improved screw placement, but it can
be difcult to use and is highly dependent on registration with a tracking
camera that can be negatively affected by numerous factors such as
camera angle and environment. As a result, MAZOR developed the
SpineAssist robotic system that addresses these registration issues by
being physically mounted onto bony landmarks and then registered with
intraoperative uoroscopic images. Once registered, the six degree of
freedom manipulator has a drill guide as an end-effector and can be
programmed to position its manipulator to provide trajectories per the
preoperative plan for vertebroplasties, biopsies, excisions, and other
procedures directed around the spine from a posterior approach (personal
communication from Mazor Robotics).
41
Preoperatively the patient receives a CT scan per the SpineAssist
protocol with parallel slices 0.41.0 mm apart. The SpineAssist software
generates a three-dimensional model that the surgeon can use to plan
optimal implant dimensions, (pedicle or translaminar facet screws)
starting position, and trajectory. Immediately prior to the procedure, both
the SpineAssist robot and uoroscope need to be calibrated which can be
completed within 10 minutes. The robot is calibrated by placing it on a
mount with three holes and then positioning the drill guide towards the
holes with a K-wire, resulting in a system with an overall maximum error
(after accounting for errors from CT, uoroscopy, registration, and
others) of 1 mm from the preoperative plan. The uoroscope is calibrated
by placing a ducial array with specically arranged metal beads on the
image intensier and then taking an anteroposterior (AP) and lateral x-ray
with no objects. These two blank pictures account for local magnetic eld
distortions and calibrate the images. The patient can then be brought in
and positioned for the procedure. Depending on the levels that will be
operated on, the robot can be rigidly attached to the patient by several
mounts: a spinous process clamp mount, a bed-mount or Hover-T mount
(Fig 5). For the clamp mount, a single spinous process is exposed and the
clamp is physically attached to it, as a platform for the robot which
FIG 5. MAZOR SpineAssist robot mounted on the patients spine with guide attached. A surgeon is
passing a tool through the guide toward the desired target with appropriate trajectory. (Courtesy of
MAZOR Robotics, Inc, Norcross, GA).
connects it directly and rigidly to the patients skeleton. From that
position, the robot can guide implant placement from one vertebra above
to one below. The bed mount and bilateral bed mount are attached directly
to the OR table with a horizontal bar running across the patients lower
back and at the midline a longitudinal bar connects to it and lies above the
patients spine. At its cephalad tip a 2.5 mm k-wire is attached to a single
spinous process above the vertebras which are operated on. The Hover-T
frame can access many more levels, and requires attachment to one
spinous process with a K-wire and the posterior superior iliac spines with
Steinmann pins, thus, forming an upside down T on the patients back
with central longitudinal bar in alignment with the spine and the
horizontal bar attached to the pelvis. Next the system is registered by
taking 2 x-rays: AP and oblique of the target levels with the ducial array
connected to the mount. Only 2 images are needed to register the
SpineAssist system (personal communication from Mazor Robotics).
41
In order to access the different parts of the spine, the robot has
different attachment points on each mount (three for the spinous
process mount and nineteen with the Hover-T frame), three different
drill guide lengths, and two extension bridges. The software can be
used in conjunction with the preoperative plan and informs the
surgeon about which position, drill guide, and if an extension bridge
will be needed to place the implant. Once the surgeon positions the
robot with appropriate guides and extension bridges, the robot moves
the guide to aim at the targeted entry point with the appropriate
trajectory. This system can be used for both percutaneous and open
procedures. For percutaneous approaches, the drill bit is guided to the
bone with a stab incision and blunt dissection, and a starting hole is
created through which a K-wire is passed to the vertebral body (in the
case of pedicle screws). Over the K-wire a screw hole is drilled, and
the walls of the pedicle are tested with a probe to ensure the side walls
are not breached. The preoperatively planned screw can be implanted
into this prepared hole, and this procedure is repeated for all
subsequent screws (personal communication from Mazor Robotics).
41
The SpineAssist received initial FDA clearance in 2004 for use
throughout the spine and MAZOR is currently seeking approval for
applications in brain surgery. There are 25 hospitals in Israel, Germany,
Switzerland, Russia, Netherlands and the US where SpineAssist is in
regular use.
42
To date it has been used in more than 2,000 spinal surgeries
around the world. In June 2011, Mazor Robotics launched a new
generation of SpineAssist named Renaissance that is capable of perform-
ing osteotomies, transfacet and translaminar-facet implant placements,
and the spinal procedures that SpineAssist is capable of performing.
Renaissance has a new design and interface that has received FDA
clearance and CE-mark. The proposed advantages of the system are
reduced patient radiation exposure for preoperative CT scans by up to
50% together with other safety improvements.
43
ROBODOC
ROBODOCs development was discussed above in the history section,
and since then improvements to the system have been made to reduce the
number of ducials needed to 2: speed the milling process, and modify
cutting paths to decrease invasiveness (Fig 6).
44
The commercialization
of the ROBODOC system has only been international in Europe, Japan,
Korea, and India, where the robot has been used for more than 24,000
joint replacements. It received FDA approval in 2008. Integrated Surgical
Systems was responsible for the early business endeavors, but currently
the system is being sold by ROBODOC, a Curexo Technology Com-
pany.
19
Acrobot
The original Acrobot has been updated to be smaller and cheaper and is
being produced with the name Acrobot Sculptor. Other changes include
the addition of a navigation arm that tracks the knee without rigid xation
of the limb. This navigation arm can follow the knee as it moves, which
makes it easier for the surgeon to assess knee range of motion and laxity
during the procedure. Another feature is the addition of a passive
orientation device that lets the cutter end-effector be oriented for better
access while not changing the tip position. This entire system is now
mounted on a trolley.
45
The Acrobot Sculptor is produced by the Acrobot
Company Limited and its use is being targeted for UKAs because of the
time-consuming nature of doing the bony resections needed for a TKA.
45
Stanmore Implants Limited recently acquired the Acrobot Company
Limited (personal communication from Professor Davies). This system is
not approved in either Europe or the United States, but is in clinical trials
to gain European approval.
21
Endoassist/FreeHand
Endoassist was rst developed by Armstrong Healthcare Ltd to serve as
a robotic laparoscopic camera holder. They wanted to address the issues
of shortage of health care personnel and difculty of human assistants in
positioning the camera to the surgeons preferences. The key differences
between it and the AESOP robot are that it was freestanding and had a
head-mounted control system.
46
Because it is a freestanding robot, it must
be calibrated to the point where the laparoscope enters the patient body.
If the position of the operating room table is moved relative to the robot
or if the laparoscope entry site is changed, it takes 1 to 2 minutes to
recalibrate the system.
47
The surgeons head movements control the
robot. An infrared sensor mounted on top of the laparoscope monitor
detects movements of the infrared emitter attached to the surgeons head.
The direction that is recognized by the sensor is displayed above the
monitor, and the surgeon controls the duration of movement by pressing
the foot pedal. To zoom in and out, the surgeon switches modes by
tapping the foot pedal and moves his head down or up, respectively.
46
FIG 6. Current ROBODOC surgical system for preparing femoral cavity for total hip replacement/
arthroplasty. (Courtesy of ROBODOC, a Curexo Technology Company, Fremont, CA.)
In the early 2000s when both systems were on the market, the AESOP
and EndoAssist systems were directly compared in 2 studies. One in vitro
study comparing their use in various tasks found that using EndoAssist
resulted in faster times. This was attributed to issues with under- and
overshooting with AESOP and inaccuracies with the voice control.
48
Another study compared their use in laparoscopic radical prostatectomies
and found that AESOP had faster setup time by 3.3 minutes and
EndoAssist was faster with 1 of the operative steps by 10 minutes. No
statistical difference was found in the remaining 11 operative steps.
However, these results cannot be compared to the prior study because
AESOP was controlled in this study by an assistant with the hand-control
because of the poor voice recognition. One of the purported advantages of
these robots is that the surgeon is in control of the camera, but in this
study AESOP was controlled by the assistant while EndoAssist was
controlled by the surgeon.
47
Endoassist was approved by the FDA,
25
and production of the robot was
transferred to Prosurgics Ltd, which replaced EndoAssist with the
FreeHand system.
49
FreeHand received FDA approval in 2009 and
currently is marketed by FreeHand Surgical PLC.
49
The control system
remains the same as for EndoAssist, but it is not a freestanding robot. It
can be mounted anywhere on the operating table rails depending on the
needs of the laparoscopic procedure (Fig 7).
50
da Vinci Surgical System
The development of the da Vinci Surgical System is discussed above in
the History section. It is manufactured by Intuitive Surgical. This system
is a telesurgery system composed of 3 components: a surgeons computer
console, a video cart, and a robotic tower (Fig 8). The surgeons computer
console is where the surgeon sits and can look into the binoculars to
perceive a 3D view of the surgical eld with stereoscopic 0, 30, or 45
endoscopes.
23
More recent versions of the robot (the da Vinci S HD and
da Vinci Si models) offer high-denition 3D vision. The surgeon controls
the robot with the masters, which read the surgeons hand movements
more than 1300 times per second and converts them to robotic instrument
movement.
3
In addition, the surgeon can change the scaling of the masters
to 1:1, 3:1, or 5:1. Through the masters some haptic feedback is delivered
but the level of sensation is dependent on the position of the instruments
and is most consistent when the instruments hit rigid bodies. The surgeon
also has foot controls for energy instruments, camera position, clutch for
the masters, and switching robotic arm control.
3,23
The video cart is the storage center for the light sources, camera control
boxes, insufators, and other equipment. At the top of the cart is a
touch-screen monitor that can be used to adjust the instrument settings (ie,
brightness) and for local teleproctoring. The original da Vinci system had
a robotic tower with 3 robotic arms (1 camera and 2 instrument), and in
FIG 7. FreeHand robotic laparoscopic camera holder mounted on the operating table. (Courtesy of
FreeHand Surgical Plc, Bracknell, UK.) (Color version of gure is available online.)
FIG 8. Intuitive Surgical da Vinci Si Surgical System with surgeons console on the left, robotic tower
in the middle, and video cart on the right. The individual standing at the video cart is demonstrating
the teleproctoring system and has drawn a circle on the touch screen monitor. (Courtesy of Intuitive
Surgical, Inc, Sunnyvale, CA.)
2002 the FDA approved a new system with 4 arms (1 camera and 3
instrument). The third instrument arm can be used as a retractor that
stays locked in its last position whenever the surgeon is controlling the
other 2 instruments. Modular reusable end-effectors, which can be
used for 10 operations, can be switched throughout a surgery by the
patient-side surgeon.
23
The da Vinci system received expanded FDA
approval in December 2009 for use in transoral otolaryngology
procedures.
51
Currently, there are more than 1600 Da Vinci systems in
use worldwide.
52
CardioARM
CardioARM was rst conceived by cardiac surgeon Marco Zenati, MD,
Howie Choset, PhD, and Alon Wolf, PhD, through a collaboration
between the University of Pittsburgh and Carnegie-Mellon University.
These 3 went on to found Innovention Technologies in 2005, later
renamed as Cardiorobotics, to further develop and commercialize their
system.
53
The problem they were seeking to address was the difculty
that rigid shaft instruments had in reaching the posterior side of the heart
for epicardial interventions.
54
Their system was based on a snake-like
design of sequential rigid cylindrical links that allows it to bend at various
joints along its length; its distinction from simple endoscopes is that it can
maintain its prior shape as it moves forward and backward (Fig 9). Thus,
this system is able to go around anatomical obstacles without risk of
inadvertently hitting them on advancement. For cardiac applications, this
system is designed to be inserted through a subxiphoid port and then
use its maneuverability to access any part of the epicardium. Cardio-
ARM works using cables, controlled by motors outside the patient,
which run through all cylindrical links to control their motion. The
distal end is 10 mm in diameter and has a ber optic endoscope that
displays vision from the distal tip on a monitor and also has a working
port through which off-the-shelf 8-French catheter devices can be used
for interventions.
54,55
Newer versions allow the simultaneous use of
multiple tools, such as an ablation catheter with an irrigation/suction
device.
56
The surgeon controls the distal link with 2 d.f. via a joystick,
while another button controls the amount of insertion. As the robot is
advanced, it follows the prior path and at the distal end it follows the
direction that the tip is facing. As a safety mechanism, the system can
become limp for easy removal.
54
The cardiac applications that the system is being considered for are
ablation, injection (for stem cell or other therapeutics), mapping,
pacemaker lead placement, biopsy, and ligation of the left atrial
appendage. For ablation, endocardial catheter techniques traditionally
have been predominantly used because of the invasiveness of tradi-
tional epicardial approaches that require a sternotomy or thoracotomy.
Using a simpler subxiphoid approach instead, Cardiorobotics is
hoping to open up alternative and possibly more efcacious treatment
options for cardiac patients.
54
Reports of using the system in multiple
live porcine and cadaveric studies have reported that it can be used for
all these cardiac applications.
54-56
Published human clinical trials are
still pending, and Cardiorobotics is hoping to commercialize their
system by 2012.
53
Cardiorobotics is also exploring potential uses of the CardioARM
system for gastrointestinal and intravascular procedures. The system
could be adapted for natural orice translumenal endoscopic surgery
(NOTES) via transoral or transrectal access to the small intestine or other
abdominal organs. For intravascular procedures, the CardioARM system
could provide more controlled maneuvering for percutaneous coronary
interventions.
54
FIG 9. CardioARM robot demonstrating its snake-like design and exibility at each of its numerous
joints. (Reprinted from Ota T, Degani A, Schwartzman D, et al. A highly articulated robotic surgical
system for minimally invasive surgery. Ann Thorac Surg 2009;87:1253-6.)
Sensei
Hansen developed the Sensei master-slave robotic system to control
catheters with a focus on use in cardiac electrophysiology procedures,
such as ablation. Currently, these procedures require precise control of the
catheter tip to deliver appropriate ablation to the cardiac conduction
pathways while exposing cardiac electrophysiologists to high levels of
uoroscopic radiation needed for visualization. The Sensei system was
designed to address both of these issues by providing physicians better
control and decrease their radiation exposure.
The slave is a robotic arm positioned at the foot of the procedure table
and controlled via pull wires through an external and internal sheath that
can carry traditional ablation catheters. The external sheath has 1 pull
wire that allows it to be deected, rotated, and inserted/withdrawn. The
internal sheath has more control with a pull wire in each quadrant
providing it the capability to move 360 and also be inserted or
withdrawn. Ablation catheters are positioned just past the internal sheath
and the physician can control its motion via the masters 3D joystick. The
physician can view the procedure with traditional uoroscopic images
and can also integrate real-time electroanatomic mapping (EAM) and 3D
CT imaging with the robotic catheter positioning. A preoperative 3D CT
image of the heart can be registered with EAM information. This
integrated image can be registered with the robot in 5 minutes as the
robotic catheter advances retrograde through the aorta as it maps the
aortas endoluminal surface. An initial registration is developed from this
information and can be rened by having the catheter collect data in the
left atrium. The integrated image with EAM, 3D CT, and robotic catheter
positioning is presented in an integrated fashion to the physician who can
change perspectives. The joystick moves the catheter with respect to the
view that the physician is using (Fig 10), meaning that regardless of
which perspective the physician is viewing the heart, moving the joystick
to the right results in the catheter moving to the right on the image.
Similar to the da Vinci Surgical System, the controls can also be scaled
with 1:1 or 4:1 ratios. Since the masters do not provide haptic feedback
through the controls, the IntelliSense system detects forces at the catheter
tip and uses synesthesia with a visual warning when the tip forces are
concerning for risk of perforation.
57
Niobe
Stereotaxis developed the Niobe magnetic guidance system for cathe-
ters because of the difculties in accurately directing manually guided
catheters for cardiac electrophysiology, interventional cardiology, and
interventional neuroradiology.
58,59
Based on prior work using magnetic
catheter guidance since 1951, the Niobe system addresses this problem
using 2 permanent magnets to similarly guide a catheter. These 2 magnets
are each kept in a casing located on both sides of the patients procedure
table, and they are used to create a 15-cm spherical 0.08 T magnetic eld
centered on the heart or other target organ (Fig 11). A computer system
is able to manipulate the magnets to create a magnetic eld vector in any
direction in 3D space.
58
Depending on the amount of vector directional
change, the time to change the eld can take 5-20 seconds.
60
Wires with
magnets at their tip will align themselves in line with the magnetic eld,
but will not be advanced or withdrawn due to the magnetic eld.
Magnetic wires of varying stiffness and other properties are produced to
provide the physician exibility in performing the desired procedure.
58
The physician controls the direction of the magnetic eld through the
control software to direct the wire collinearly with the target and then can
advance the wire toward it. Advancing/withdrawing the wire can be
manually controlled or performed with an additional robotic wire ad-
vancer (Cardiodrive Catheter Advancement System).
61
In the case of
manual control, a sterile touch-screen magnetic eld control system can
be placed by the physician as he/she performs the procedure. If a robotic
FIG 10. Hansen Sensei robots physicians console with the physician directing the catheter with the
joystick below the monitors. (Courtesy of Hansen Medical, Mountain View, CA.)
advancer is used, the wire and magnetic eld controls can be used on an
integrated control station located remotely from the procedure table. In
this case, the physician is protected from radiation exposure during the
procedure and can track the position of the wire on the imaging since the
robot can measure the degree of advancement.
58
The magnetic eld control software can integrate live uoroscopy
images, biplane and rotational angiography, CT, and EAM.
58
The
software can also construct 3D coronary vessel models based on 2
angiographic images that are at least 30 apart.
62
These images are
registered to the patient using uoroscopic landmarks, including spinous
processes and the catheter. Since the heart is continuously beating, the
software can gate the imaging to the electrocardiograms phase. The
physician-software interface (Navigant Software User Interface) is criti-
cal for the physician to use all the available imaging to determine the
subsequent 3D magnetic eld direction.
61
Stereotaxis has developed both
2D and 3D view interfaces to simplify drawing magnetic eld vectors. In
addition, endoluminal, bulls-eye views, and various other multiplanar
reconstructed cross-sections can be used to simplify navigating through
lumens narrowed by atherosclerosis.
58,62
Magnetic eld vectors appro-
priateness can be veried by checking the vectors on the orthogonal views
presented by the software.
60
Another tool used to simplify navigation is
the inclusion of preset magnetic elds based on expected directions for
the coronary vasculature based on averages from numerous patients. The
physician is given the ability to create their own frequently used preset
elds as well.
58
FIG 11. Stereotaxis Niobe system in the procedure room with both magnet systems adjacent to the
table and a uoroscopy unit at the head of the table. The physicians control system is accessible
through the touch screen monitors mounted from the ceiling. (Courtesy of Stereotaxis, St. Louis, MO.)
One problem that was noted in early studies was that the use of a strong
external magnetic eld can distort electrocardiograms used for electro-
physiology procedures. However, they reported that analysis of the
rhythm or morphologies of P-wave and QRS complexes were not
affected, and that intracardiac readings were qualitatively not affected.
59
Stereotaxis is looking to apply the more than 150 globally available
Niobe systems
63
for improved accuracy in cardiac electrophysiology
ablation, percutaneous coronary interventions in difcult anatomy and
chronic total occlusions, and possibly in the future for stem cell
implantation.
62
Niobe has been FDA approved for cardiac electrophysi-
ology and interventional neuroradiology since 2000 and interventional
cardiology since 2003.
58
Clinical Outcomes
Neurosurgery
Neuromate. No studies directly comparing traditional stereotactic
biopsy techniques with robotic techniques have been published. Multiple
case series have been published reporting on the accuracy of the
Neuromate in the literature, and the ones that will be discussed involve
the frameless Neuromate technique.
28,30,64
One series looking at mass
lesion biopsies reported that 18 of 19 were diagnostic, while the
nondiagnostic biopsy was from the abnormal region as indicated by
postoperative imaging.
28
Neuromate has been used for transcerebellar
biopsies in the delicate brainstem where 13 of 15 were diagnostic, and 1
of the remaining 2 was diagnostic on the second procedure. Despite the
high risk of operating in the brainstem, there was no operative mortality
and 1 case of permanent and 2 cases of transient morbidity.
64
In a review
of deep brain stimulation electrode placement in 111 patients, the mean
error from planned position was 1.7 mm and the error was greater than 3
mm in 3 cases.
28,30
This accuracy is comparable to procedures performed
with frame-based surgery per literature reports.
28
The theorized advan-
tages include speed and accuracy, and comparison studies are needed to
determine how Neuromate compares with traditional techniques.
CyberKnife. Below we discuss the highlighted articles of using the
CyberKnife for neurosurgical pathologies. For a more extensive review of
the clinical outcomes of treating various intracranial and spinal lesions,
see the review by Naff.
65
Glioblastoma multiforme is a primary brain cancer notorious for its
poor prognosis. Patients treated with the current standard of care of total
resection and multifractionated focal external beam radiation therapy
(EBRT) have a median survival of 12 to 15 months. Lipani and
colleagues
66
conducted a retrospective study of 20 patients treated with
CyberKnife instead of EBRT to determine if CyberKnife is an effective
alternative. Their patient pool included 11 total resections and 9 subtotal
resections or biopsy, and the pools overall survival was 16 months.
Looking only at the total resection patients, the median survival was 36
months, while the subtotal resection or biopsy patients had a median
survival of 8 months.
66
Even patients with malignant tumors that are
progressing despite radiation therapy and chemotherapy may benet from
CyberKnife treatment as suggested by Giller and colleagues.
67
They used
hypofractionated treatment on 18 progressive malignant lesions (6 primary
and 12 metastatic) in 15 patients and found 72% of them have a decrease in
volume. Six-month follow-up was available in 9 tumors, of which 78% had
local control. A hypofractionated dosing was used to minimize toxicity, and
1 patient in this study experienced toxicity symptoms that improved with
steroids.
67
Wowra and colleagues
68
performed a matched-pair analysis of
Gamma Knife (n 63) vs CyberKnife (n 73) for the treatment of single
brain metastases and found comparable clinical results between the 2 groups.
The CyberKnife group did have signicantly longer overall survival but the
authors attribute that to the more recent treatment for them compared to the
historical Gamma Knife control.
68
CyberKnife in these studies shows strong
promise in the treatment of primary and metastatic cancers.
For certain brain metastasis, the standard of care has been resection
followed by whole brain irradiation (WBI). Local control after resection
and observation is 54% and with WBI is 80% to 90%. WBI is associated
with acute toxicities and long-term neurocognitive dysfunction, and to
avoid that Soltys and colleagues
69
did a retrospective study of 72 patients
who had resections and then had CyberKnife treatment to the cavities.
This approach still left WBI as a later option in case the clinical course
worsened. These researchers found that local control at 6 months was
88% and at 12 months was 79%. In terms of side effects, 7 patients
needed steroids for edema, and 3 patients needed surgical resection due to
the mass effect of the necrosed tissue. CyberKnife treatment to maintain
local control after resection is promising, but it is important that these
patients have frequent surveillance imaging because of the risk for new
metastases.
69
Due to the precision of CyberKnife treatment, researchers have studied
its use for patients with lesions adjacent to the optic pathways. The
retrospective study of 49 patients by Adler and colleagues
70
reported that
vision was unchanged or improved in 94% of patients. These patients had
stable or smaller tumors with magnetic resonance follow-up at an average
of 46 months. Of the 6% (3 patients) who had worsened vision, 2 were
due to tumor progression.
70
Cerebral arteriovenous malformations
(AVMs) have become another target of CyberKnife, and Colombo and
colleagues
71
developed software to coregister CT and 3D rotational
angiography images to automate the targeting process. They treated 279
patients and greater than 3-year angiographic follow-up was obtained in
80 patients of whom 81.2% had total AVM obliteration. Side effects
included 1 transitory radiation adverse effect and 8 bleeding cases.
71
Researchers at Stanford have studied the use of CyberKnife for use in
trigeminal neuralgia, and in their rst study
72
used it to treat 29 patients
who had failed prior medical therapy. Their results indicated that, with
follow-up at 10 months, 90% of patients had excellent pain control, while
10% had no improvement. The median time for patients to see an
improvement was 6 days. In terms of side effects, facial numbness was a
major issue, with 76% of patients reporting no or minor progression, 14%
with worsening, and 10% with severe numbness.
72
Because of this high
incidence and severity of ipsilateral facial numbness, these researchers
changed the CyberKnife protocol for dose and volume de-escalation. In
this new study,
73
46 patients with intractable idiopathic trigeminal
neuralgia were recruited and treated. Pain relief came quickly as in the
prior study, with patients experiencing relief within the rst week. By 5.2
weeks, 85% of patients had all symptoms resolved. One patient did have
recurrence at 7 months, but symptoms resolved with a second treatment.
Overall results were excellent in 72%, good in 24%, and poor or no
improvement in 4%. Compared to the prior study, only 15% of patients
had signicant facial numbness.
73
A cost-effectiveness study comparing
CyberKnife with microvascular decompression with 20 patients in each
group found similar effectiveness at 6 months but the CyberKnife
treatment cost 34% less for each patient.
74
Stanford researchers also investigated treating acoustic neuromas,
which usually are treated with single-stage frame-based radiosurgery and
have an associated 50% to 73% chance of maintaining pretreatment
hearing levels. This research group had previously demonstrated that
staged radiosurgery can improve hearing preservation to 77% at 2 years.
Chang and colleagues
75
hypothesized that staging with the CyberKnife
system would be an easier procedure and would result in greater
preservation of hearing. They retrospectively examined 270 patients with
acoustic neuroma treated with CyberKnife and found 61 patients for
whom they had a minimum of 3 years of follow-up. Seventy-four percent
of these patients had serviceable hearing and no patient completely lost
hearing if they had some preoperative hearing. In terms of effectiveness,
tumor size decreased in 48%, stayed the same in 50%, and grew in 2%.
No major side effects in terms of new trigeminal dysfunction or
permanent facial nerve palsy occurred, although 2 patients had transient
facial twitching for 3 to 5 months.
75
Metastases are the most common malignancy to the spine, and
CyberKnife has been used in its treatment. One prospective study
76
of
500 patients with spinal metastases treated with single fraction Cy-
berKnife found that patients generally responded well. For patients with
primary CyberKnife treatment, the long-term tumor control was 90% and
for patients treated for radiographic tumor progression, it was 88%.
Symptomatically, long-term pain improvement was achieved in 86% (290
of 336 patients) and 84% (27 of 32 patients) of those with neurological
decits before treatment improved. Another study
77
of 18 patients with
breast cancer spinal metastases treated with CyberKnife was compared to
a matched control who was treated with EBRT. The results were similar
between the 2 groups in terms of ambulation, performance status, and
pain. The CyberKnife patients tended to have improved survival and
decreased complications but was not statistically signicant.
77
One
cost-utility analysis study determined that the CyberKnife treatment for
spinal metastases added 0.08 quality-adjust life years when compared to
EBRT and was $1933 cheaper than comparable EBRT effectiveness.
78
CyberKnife use for spinal metastases appears to be promising in terms of
both treatment effectiveness and side effects.
Gagnon and colleagues
79
achieved similar success with their prospec-
tive treatment of both primary and metastatic spinal tumors in 200
patients with 4-year follow-up. Using the CyberKnife system, they were
able to signicantly decrease pain scores compared to preoperative levels
and improve SF-12 Mental Component scores. There was no difference in
SF-12 Physical Component scores compared to preoperative levels; early
toxicity was usually mild, and there were no reports of late toxicity.
79
Use
in intradural extramedullary spinal tumors was also promising as reported
by Dodd and colleagues.
80
They followed 51 patients with 55 benign
spinal tumors and reported that 3 of the 51 required surgical resection
within the rst year posttherapy due to persisting or worsening symptoms.
For the 28 patients who had follow-up longer than 2 years, 61% of these
lesions were stable, while the remaining 39% were smaller.
80
Treatment
of primary spinal tumors with CyberKnife is promising.
Spinal cord AVMs are generally very difcult to treat with the
traditional techniques of embolization and surgery due to their size,
location, angioarchitecture, and risk of hemorrhage or spinal cord
ischemia. One retrospective study
81
of 15 patients used CyberKnife to
irradiate the spinal cord AVMs with escalating doses (to minimize spinal
cord radiation exposure) and were followed with MRI annually and spinal
angiography every 3 years. One patient had complete obliteration of the
AVM 26 months after treatment, while 4 of 5 patients with spinal
angiography had a decreased AVM size and 6 of 7 patients with longer
than 3-year follow-up had signicantly decreased AVM sizes on MRI.
81
Additional studies will be needed to determine the ideal treatment
protocols for spinal cord AVMs, but the use of CyberKnife is very
promising considering the poor therapeutic potential of current
treatments.
Orthopedics
MAKO RIO. The MAKO TGS system was developed to improve UKA
component placement and consequently long-term implant survival.
Lonner and colleagues
39
published a level III therapeutic study that
followed the immediate postoperative outcomes of 1 surgeon performing
31 UKAs with the TGS system and the preceding 27 consecutive UKAs
performed manually. The results indicated that the TGS system produced
statistically signicant improvement in positioning of the components
than manual techniques in terms of tibial slope, variance, tibial alignment,
and varus/valgus error.
39
Sinha,
82
in his review of early clinical reports
from 6 scientic presentations, reported similar improvement in position-
ing with less variance in robotic groups when compared with manual
UKAs. Clinical outcomes as measured by the Knee Society Score were
not statistically different between robotic (n 36) and manual (n 45)
UKA groups at 3, 6, and 12 weeks postoperative. In Sinhas
82
review, he
reports that a 223-case robotic UKA registry had 6 reoperations within 1
year. One of these revisions was unique to TGS because it was a femoral
fracture through a navigation marker site.
These early results with the MAKO system indicate that there is better
UKA implant positioning with decreased variance with the robotic than
manual techniques. The clinical signicance of this improved implant
positioning remains to be seen in long-term follow-up of these patients.
Another factor is that the ideal position and tolerable levels of error are
unknown as of yet. In terms of outcomes measured by patient question-
naires, there are no differences through 12 weeks after operation. These
studies were conducted with the TGS system, and as of now, no studies
have been published regarding the effectiveness of the MAKO RIO
system for UKA or bicompartmental knee resurfacing. Published studies
do not yet have the evidence to determine the clinical value of the MAKO
robotic systems for the long term.
MAZOR SpineAssist. One recent retrospective study by Devito and
colleagues
83
reported the outcomes from all SpineAssist cases between
June 2005 and June 2009 and compared the results with outcomes with
manual techniques reported in the literature. This study included 673
cases in which the robot was used for treatment, of which 88% had
pedicle screws implanted, 10% for vertebroplasty, and 2% for excision of
osteoid osteoma and biopsy. A total of 3271 pedicle screws or guide wires
placed with the SpineAssist robot were included in the study. Assessment
of the accuracy of screw or guide wire placement was performed in 635
cases with intraoperative uoroscopy and for 139 cases with postopera-
tive CT scans. Based on intraoperative uoroscopy, 98% of 3271 screws
or guide wires were placed in a clinically acceptable position according to
the operating surgeons judgment. A more quantitative assessment was
conducted on the 646 screws in the 139 patients with postoperative CT
scans. Accuracy was measured by comparing 6 locations on each screw
to the preoperatively planned position. Differences from the preoperative
planned location were classied using the Gertzbein and Robbins crite-
rion: A, perfectly within the pedicle; B, breaching less than 2 mm; C,
breaching 2-4 mm; D, breaching 4-6 mm; and E, breaching more than 6
mm. The results indicated that 89.3% of these 646 screws were classied
as group A, which was signicantly more than the 81.9% reported in the
literature for FreeHand techniques. This improved placement persisted for
percutaneous procedures as well, where 2.4% of 292 robotic-placed
screws breached greater than 2 mm, whereas literature reports indicate
that 8.3% of free-hand percutaneous screws breached greater than 3 mm.
The clinical signicance of this improved placement can be seen in the
0.7% of reversible neurologic decits seen with robotic screw place-
ment, while the literature indicates a 2% to 5% frequency of
permanent neurologic decits with free-hand techniques. Some addi-
tional advantages promoted by the authors include easier implant
placement in severe deformity and percutaneous procedures, and
decreased uoroscopy use corresponding a 50-fold decrease in radia-
tion exposure. The OT needed to use the robot once surgeons and staff
became experienced with the system was an average of 10.6 minutes
per screw when operating at 1 level and 2 minutes per screw when
operating at multiple levels.
83
The use of the SpineAssist seems to indicate better screw placement
corresponding to decrease in neurological decits. An unpublished report
from Gttingen, Germany compared robotic and manual screw placement
and reported lower uoroscopy usage, complication rates (20.9% vs
41.2%), and reoperation rates (14.3% vs 26.55%), while OT was no
different (unpublished communication, MAZOR). However, the signi-
cance of the results is limited since the 2 groups were heterogeneous.
These results show promise for the SpineAssist robot but to accurately
assess its clinical value a direct comparison study between comparable
free-hand and robotic groups is needed.
ROBODOC. Three major studies have been conducted directly com-
paring ROBODOC to manual techniques of femoral component prepara-
tion in THA. All were randomized and followed patients for 2 years in the
cases of Honl and colleagues
84
and Nishihara and colleagues
85
and 5
years for Nakamura and colleagues.
44
Honl and colleagues
84
performed
a prospective trial with 74 THAs performed robotically (13 of these
were converted to manual techniques because of robotic failure to
complete reaming and were removed from subsequent analysis) and 80
were performed manually. The trial by Nishihara and colleagues
85
used the newer 2 ducial system and used the ORTHODOC preoperative
planning software for both treatment arms, unlike Honl and colleagues
84
study. They randomized 78 THAs to the robotic group and 78 THAs to
hand-rasping. Nakamura and colleagues
44
conducted a level II therapeutic
study where 146 primary THAs were randomized with 75 in the robotic
group and 71 in the hand-rasping group.
Clinical outcomes in all 3 studies were assessed using various patient
questionnaires, including the Harris, Merle dAubigne, Mayo, and Japa-
nese Orthopedic Association (JOA) scoring systems. Honl and col-
leagues
84
used the Harris, Merle dAubigne, and Mayo clinical scoring
systems and found no signicant differences at 3 or 24 months in any
system. However, there was a transient interim statistical signicance at
6 months in the Mayo and Merle dAubigne systems and at 12 months in
Harris and Mayo systems. The Merle dAubigne system was used by
Nishihara and colleagues
85
and they found no differences at 3 months
postoperatively but there was a statistically signicant outcome improve-
ment in the robotic group 2 years postoperatively. Although statistically
signicant, the magnitude of the scoring difference was small: 17.4 in the
robotic group vs 17.1 in the manual group. They also assessed the number
of patients who could walk more than 6 blocks without a cane within 13
days postoperatively, and there were signicantly more in the robotic
group (41 vs 28, while for the greater than 14-day category it was 37 vs
50).
85
Nakamura and colleagues
44
used the unvalidated JOA score that
assesses pain, range of motion, walking ability, and activities of living on
a 100-point scale. They found in short-term follow-up that there was no
difference between the robotic and hand-rasping groups. By the 2- and
3-year time points, the robotic group had a statistically signicant greater
JOA score, although the absolute magnitude was only 2 points. However,
this difference was unnoticeable by the 5-year follow-up. Overall, these 3
studies found minimal to no difference in clinical outcome questionnaires
between the robotic and manual treatment groups.
OT was consistently longer with the robotic technique than manual
methods. With the older ROBODOC system, Honl and colleagues
84
reported that procedures took 25 minutes longer with the robot than
manually. Nishihara and colleagues
85
and Nakamura and colleagues,
44
who were using a newer ROBODOC system, reported that their
robotic OT was 19 and 12 minutes, respectively, greater than manual
methods. This longer OT was not associated with increased EBL or
infection.
44,84
Results from Honl and colleagues
84
and Nakamura and colleagues
44
indicate that dislocations may be a problem with the robotic approach. For
Honl and colleagues,
84
dislocation rates were signicantly higher in the
robotic group at 18% vs the 4% in the manual group, and there were 5
hips with recurrent dislocation while none in the manual group. The
authors attributed this to insufciency of the abductor muscles due to the
reamer cutting into the tendon. These 5 recurrent dislocators required
revision and contributed to the 9 cases (15%) of revisions in the robotic
group, while only 2 cases (3%) needed revision in the manual group. The
other 4 causes for revision in the robotic group were 1 case of heterotopic
ossication and 3 cases of limp with pronounced Trendelenburg sign,
while the 2 cases for the manual group were due to infection. Nakamura
and colleagues
44
reported a higher dislocation rate of 5.3% in the robotic
group, while the hand-rasping group was 1.4%, but this difference was
not statistically signicant. Nakamura and colleagues
44
suggested the
decreased dislocations compared to Honl and colleagues
84
could be due
to their posterolateral instead of anterolateral approach or improved
preoperative planning with appropriate implants.
The robotic approach may be a safer means of press-tting the femoral
component than manual techniques. Honl and colleagues
84
did not have
any problems with intraoperative fracture in either treatment arm, but
Nishihara and colleagues
85
reported a 6% rate of femoral fracture and
Nakamura and colleagues
44
reported 7% rate of femoral fracture with
manual techniques. Both Nishihara and colleagues
85
and Nakamura and
colleagues
44
did not have any fractures occur in the robotic treatment
group.
Another complication that was reported was pain at the ducial
placement site for the robotic treatment group. Honl and colleagues
84
did
not report the number of patients who had this issue, but stated that there
were several reports of knee pain that could be attributable to pin
placement. This pain was reported to resolve within 1 month for the
2.7% of cases of knee pain in Nakamura and colleagues
44
robotic
group. Partial palsy of the peroneal division of the sciatic nerve
occurred in 7% of the robotic group and partial femoral nerve palsy in
1% of the manual group for Honl and colleagues.
84
This was
theorized to be due to the rigid femoral xation needed for the robot.
However, Nakamura and colleagues
44
did not have any problems with
nerve palsy in either treatment group, or any problems with deep vein
thrombosis or infection.
All 3 studies followed radiographic assessment of implant positioning
and alignment and all consistently showed signicantly better results with
the robotic group. Honl and colleagues
84
reported that their radiograph
assessment showed signicantly better t immediately postoperatively
and limb lengths at 6 months had less inequality and variance. Despite
this improved positioning, there was no radiographic difference in terms
of ingrowth, migration, or loosening. Nishihara and colleagues
85
exam-
ined plain radiographs and a 1-month postoperative CT and reported
better t and alignment with the robotic group. Nakamura and col-
leagues
44
found similar radiographic evidence of better positioning,
although varus/valgus alignment was not statistically different. This
difference in positioning between the 2 treatments may have led to the
greater stress shielding in the hand-rasping than robotic group that was
found on 2 years postoperative radiographs and increased by 5 years
postoperatively.
Overall, the studies to date report that, according to clinical question-
naires, there is little difference between robotic- and manual-treated
groups. Advantages of robotics treatment include better radiographic
positioning and decreased intraoperative femoral fractures. The clinical
signicance of improved positioning remains to be seen, and longer term
studies will be needed to identify potential benets. A clear disadvantage
for the robot is its increased OT, although the most recent study suggested
it is 12 more minutes.
44
Another potential disadvantage is the increased
reports of dislocation in robotic treatment groups, although Honl and
colleagues
84
study may be an outlier. Since THAs are generally known
for their high success rate that lasts for 2 decades, studies with follow-up
on that time scale will likely be needed to determine whether the
ORTHODOC robot delivers longer implant life or other patient care
improvements.
Acrobot
A prospective, randomized, double-blind trial of the original Acrobot
system vs manual techniques for UKA was conducted by Cobb and
colleagues.
86
Fourteen patients were assigned to the manual treatment
group, while 13 were treated with the Acrobot system. The primary
outcome of interest was in the positioning of the implant measured by the
tibiofemoral angle and whether it was within 2 of the planned location.
Acrobot positioned all its implants within the 2 goal, whereas only 40%
of the manual treatment group achieved this level of accuracy. This result
was statistically signicant. Cobb and colleagues
86
measured the Amer-
ican Knee Society (AKS) and Western Ontario and McMaster Universi-
ties Osteoarthritis (WOMAC) scores preoperatively and at 6 and 18
weeks after surgery. Although the WOMAC scores did not nd any
differences in the 2 groups, there was a signicant increase in AKS score
in the Acrobot groups compared to manual treatment.
86
A 5-year
follow-up of these patients after unblinding reported that there was still a
statistically signicant AKS improvement with the robot compared to
manual techniques.
45
The utility of these results is brought into question
because of the considerable interobserver and intraobserver errors asso-
ciated with the AKS score.
86
Another nding at 5 years follow-up was
that 2 revisions were necessary for the manual group and none for the
robotic group.
45
However, it is uncertain whether poor initial placement
of the implant was the cause of the revisions. The Acrobot system may
have promise, but due to the small nature of this study and the
questionable reliability of the AKS scores, little stock can be placed on
the results. New studies will be needed to test whether the new nonrigid
registration system used in the Acrobot Sculptor can deliver similar levels
of accuracy and long-term clinical outcomes will need to be tracked.
General Surgery
CyberKnife. Treatment of pancreatic cancer has not had signicant
improvements over the last couple of decades with a median survival of
8 to 14 months and 5-year overall survival at less than 5%. Although
surgery is the treatment with best long-term survival, 38% to 55% of
patients present too late for it to be an option.
87
Local control is 1 problem
with progression rates of 40% to 60% with conventional radiotherapy
fractionation.
88
With the view that CyberKnife SBRT can reduce local
recurrence, Koong and colleagues conducted both phase I
89
and phase
II
90
studies of using single-fraction CyberKnife treatments for pancreatic
cancer. The initial phase I study only used SBRT with CyberKnife
treatment and did not reach dose-limiting toxicity with the highest dose of
25 Gy, while all signs of progression were found to be metastases and not
locally.
89
The phase II study added single-fraction CyberKnife treatment
after 5-uorouracil and intensity-modulated radiotherapy treatments
(IMRT) and continued to have good local control of 94% (15 of 16
patients), although overall survival did not improve due to the progression
of metastasis. In addition, there was greater gastrointestinal (GI) toxic-
ity.
90
Because of the toxicity and metastasis issues, in their next trial,
these researchers decided to test gemcitabine chemotherapy treatment
with CyberKnife between cycles 1 and 2.
88
The results continued to show
good local control with 19% (3 of 16 patients) developing local disease
progression only after at least 14 months after SBRT treatment, but
median survival was still only 11.4 months and comparable to traditional
chemoradiotherapy. Acute GI toxicity with SBRT was not of major
concern as in the phase I and II trials, but late GI toxicity in the form of
duodenal ulcers was a larger concern at 47% (7 of 15 patients).
88
Mahadevan and colleagues
87
changed treatment with the goal of
improving long-term survival by initiating treatment with CyberKnife
SBRT fractionated over 3 days and then using gemcitabine chemother-
apy. This treatment strategy avoids adding a delay between chemotherapy
cycles. In addition, to minimize late GI toxicities, they fractionated SBRT
treatment and gave smaller total doses if the tumor was close to the
duodenal wall. Their results in 36 patients demonstrated good local
control at 78% and a slightly increased median survival of 14.3 months.
Late GI toxicity was much less, with only 2 of 36 patients developing GI
bleeds. To test the value of SBRT plus chemotherapy, a randomized trial
to compare it with conventional chemoradiotherapy is necessary.
87
Overall, CyberKnife treatment has evidence to support its use for local
control, but additional studies are needed to determine if and how it can
be incorporated to result in increased overall survival of pancreatic cancer
with minimal side effects.
Hepatocellular carcinoma (HCC) can be treated by numerous tech-
niques, such as surgical resection, percutaneous ethanol injection, radio-
frequency ablation, external radiation therapy, and transarterial chemo-
embolization. Surgery is not an option by the time of diagnosis in more
than 80% of patients, and for the other treatments none have been shown
to be clearly superior.
91
Radiation therapy is limited because of the
radiation dose tolerated by healthy liver tissue. One retrospective study
91
reported on using CyberKnife without the Synchrony targeting system for
HCC (n 23) and advanced HCC with portal vein tumor thrombosis
(also received transarterial chemoembolization) (n 9). For treatment,
patients had gold ducials placed around the tumor. Instead of the
Synchrony system, this study had patients hold their breath in exhalation
for both preoperative imaging and for each radiation node. Treatments
were delivered in 3 fractions over consecutive days. Results indicated that
82.6% of HCC patients and 44.4% of patients with advanced HCC with
portal vein tumor thrombosis responded to treatment, which is similar to
traditional more invasive treatments. Because similar results were
achieved noninvasively and with decreased morbidity (no grade 4
toxicity), the authors suggest that CyberKnife treatment for HCCs can be
benecial for patients.
91
Goodman and colleagues
92
conducted a phase I
dose-escalation study for using CyberKnife with single-fraction treatment
for primary and metastatic liver tumors. They treated 40 lesions in 26
patients and used CyberKnife with the Synchrony targeting system. The
researchers were concerned for potential toxicity using high single-
fraction dose, but the dose-limiting toxicity was not reached in any of the
patients as measured by radiation-induced liver disease. The results
indicated that 9 patients had acute grade 1, 1 patient had acute grade 2,
and 2 patients had late grade 2 GI toxicities. These are the early studies
of using CyberKnife for liver malignancies and the appropriate dosing
and fractionation protocols have not been determined yet.
92
EndoAssist/FreeHand. Studies with the newer FreeHand system have
not been reported as of yet for general surgery applications. There has
been 1 prospective randomized trial using the EndoAssist system to
compare robotic with human assistants for laparoscopic cholecystec-
tomy.
46
Forty patients were in the robotic group, while 46 were in the
human assistant group. Operating time from port placement to removal
was statistically signicantly decreased in the EndoAssist group with
mean OT of 66 minutes vs 74 minutes. This study also reported that the
EndoAssist learning curve was quick; within 3 robotic operations, OT
was similar to the human assistant group.
46
da Vinci Surgical System. The da Vinci Surgical System has numerous
studies and case reports of its use for various general surgery procedures.
Maeso and colleagues
93
published a recent meta-analysis of the literature
comparing the use of the da Vinci system with laparoscopic techniques in
the case of fundoplication, Heller myotomy, gastric bypass, gastric
banding, gastrectomy, cholecystectomy, splenectomy, colectomy, and
rectopexy. Wilson
94
published a review of many of the same procedures
and also looked at thyroidectomy, pancreatectomy, and adrenelectomy.
Low anterior resections are a newer application being explored with the
da Vinci system. Below we integrate and summarize the ndings from
93
and Wilson
94
with more recent publications.
Fundoplication was 1 of the procedures that helped the da Vinci system
win its initial FDA approval. Albassam and colleagues
95
published a
study in a pediatric population comparing Nissen fundoplication in 25
patients treated robotically and another 25 treated laparoscopically. No
deaths or complications affected either group, and there was no difference
in terms of OT, postoperative analgesia requirements, length of hospital
stay (LOS), or gastroesophageal reux symptoms at 14 months. Similar
results were found in a meta-analysis of 6 randomized trials by Markar
and colleagues,
96
except that there were signicantly longer OT for the
robotic treatment. Maeso and colleagues
93
looked at the results from both
Nissen and Dor fundoplications in their meta-analysis and concurred with
Albassam and colleagues
95
ndings of similar OT, LOS, and complica-
tions. These studies suggest that robotic fundoplication does not offer any
benet over traditional laparoscopic techniques.
No newer comparative studies of robotic Heller myotomy were found
than the 3 studies already included by Maeso and colleagues.
93
They
reported that these 3 studies they analyzed were not of the highest quality,
including that their baseline characteristics either were not compared or
were different. With these data, they concluded that robotic Heller
myotomies seemed to have a signicantly decreased risk of perforation
and increased patient quality of life (QoL). It remains to be seen whether
these robotic advantages hold true in more rigorous studies.
One of the rst large series using the da Vinci system for Roux-en-Y
gastric bypasses was by Yu and colleagues,
97
who reported on their rst
100 robotic cases. They reported that the robotic learning curve was faster
than the 100-patients curve for laparoscopy as supported by the zero
robotic anastomotic leaks compared to the literatures 7% rate for the
initial 100 laparoscopy procedures. Additionally, the stricture rate was
2% compared to the 5% rate found with hand-sewn anastomosis. Since
then, Scozzari and colleagues
98
reported their comparison of 110 roboti-
cally treated patients with 423 laparoscopically concurrently treated
patients. They found that the robotic procedures took signicantly longer
OT (247.5 minutes vs 187 minutes). No conversions were needed in the
robotic group. There were no differences in complications, LOS, or need
for revision surgery.
98
93
analysis differed; they
reported similar OT between the robot and laparoscopic techniques and
greater conversion rates with the robot. They agreed in that there was no
difference in complications or LOS. These results do not support an
advantage to using robotic surgery for Roux-en-Y gastric bypasses.
Newer studies using robotic gastric banding were not found, and Maeso and
colleagues
93
only report 1 comparative robotic gastric banding study. The
robotic approach took signicantly longer with 40 more minutes of OT and
no difference in complications or LOS. Similarly, evidence demonstrating a
clinical advantage of robotic gastric banding is lacking.
In the case of robotic gastrectomies, Clark and colleagues
99
published
a systematic review and reported nding 8 articles about gastrectomy of
which few were comparative trials and of these they were unmatched or
had weakly matched controls. Oncologic outcome is unknown because
these were not long-term studies. They report a signicantly longer
robotic OT vs open or laparoscopic approach. Overall mortality was 0.5%
and morbidity of 14.9%, with an anastomotic leak rate of 1.4%. Maeso
and colleagues
93
found a similar dearth of quality studies and looked at 2
comparative studies with different baseline characteristics in each treat-
ment arm. Their analysis found signicantly longer robotic OT as well,
but with shorter LOS by 1.4 days in the robotic treatment group. No
difference in complications or EBL was found. These literature analyses
are based on lower quality studies, and utility of robotic gastrectomies
cannot be reliably assessed with them.
No recent studies on robotic cholecystectomy beyond those included in
93
review have been published as this is not a
common robotic operation yet. Maeso and colleagues
93
found that robotic
cholecystectomies take signicantly more OT by 17 minutes but signif-
icantly shorter LOS by 0.7 days. Newer comparative studies of splenec-
tomies were not identied, and Maeso and colleagues
93
only reported
nding 1 study that reported no statistically signicant difference in terms
of OT, complications, LOS, or EBL. Although OT was 30 minutes greater
with the robotic group, it did not reach statistical signicance. Colecto-
mies were another operation for which more recent reports were not
found. Maeso and colleagues
93
based their analysis on 7 controlled and
nonrandomized studies. They found signicantly longer OT by 39
minutes. No statistical difference in complications, LOS, EBL, or
conversion rates was found.
Robotic rectopexy, used to treat rectal prolapse, was examined by de
Hoog and colleagues
100
in a case-control study of 82 patients of whom 47
were treated with open techniques, 15 laparoscopically, and 20 roboti-
cally. They found signicantly different OT among the 3, with open
technique the least at 77 minutes, laparoscopic next with 119 minutes, and
robotic last with 154 minutes. LOS had the opposite trend and was
statistically signicant with robotic at 2.6 days, laparoscopic at 3.5 days,
and open at 5.7 days. Recurrence rates were 2% with open, 27% with
laparoscopic, and 20% with robotic. After controlling for age and
follow-up time, robotic recurrence rates were signicantly higher than in
the open group, while laparoscopic recurrence rates were near signicant
compared to open rates. As assessed by 2 functional scores, there were
similar levels of improvement among the 3 treatments.
100
Maeso and
colleagues
93
found only 1 study that had a similar increase in OT with robotic
procedures lasting 39 minutes longer than laparoscopic. Unlike de Hoog and
colleagues
100
there was no difference in LOS. Maeso and colleagues
93
also
reported no difference in time to defecation, postoperative constipation, and
incontinence. de Hoog and colleagues
100
did not report any conversions of
the robotic procedure, and Maeso and colleagues
93
said 5% of robotic
procedures required conversion. These results suggest that robotic procedures
have longer OT and may have decreased LOS, but recurrence rates are much
higher than with open procedures.
Adrenalectomies are usually performed laparoscopically, and recently
studies have been performed to determine if there is an advantage to
robotic techniques. Brunaud and colleagues
101
conducted a prospective
trial comparing 50 patients treated robotically and 59 patients treated
laparoscopically for unilateral adrenalectomy. They found signicantly
longer OT with the robot, but report that after a learning curve of 20 cases,
there was no statistic difference in OT. In fact, they report for certain
patients (body mass index 30 or tumors larger than 55 mm) robotic
procedures are signicantly shorter. They did not nd a difference in
LOS, morbidity, or conversion rates.
101
Wilson
94
from his review, based
on one randomized study, suggests that robotic adrenalectomies have
longer OT but that may be attributable to inexperience of the surgical
team in using the robotic system. That study had also reported increased
morbidity, unlike with Brunaud and colleagues.
101
Additional study with
experienced robotic surgical teams to determine whether robotic tech-
niques may be advantageous in adrenalectomies or in a subset of that
patient population.
Pancreatectomies are traditionally performed with open approaches,
although some groups use laparoscopy. No comparison studies have been
conducted comparing open or laparoscopy with robotics. Guilianotti and
colleagues
102
have published the largest series of robotic pancreas
procedures composed of 134 retrospectively reviewed cases. They re-
ported OT averaging 331 minutes, LOS of 9.3 days, and postoperative
mortality of 2.23%. Wilson
94
reports in his review a longer OT of 399
minutes and mortality of 3.6%. The main complication of the procedure
is the high pancreas stula rate, with Guilianotti and colleagues
102
reporting 31.6% and Wilsons
94
review noting 22%. Open surgery stula
rates in the literature range from 4% to 35% with more studies at the
lower end of the range.
102
The remaining operative parameters of EBL,
conversion rates, LOS, and transfusion quantities were similar to pub-
lished values for laparoscopic and open pancreatectomies.
102
To summa-
rize, the use of the da Vinci system for pancreas procedures has promise,
but the high rates of pancreas stulas are disconcerting. New techniques
to address this issue need to be developed and subsequent study can
determine if robotics provides a clinical advantage.
Woong Youn Chung, MD, a South Korean surgeon, and his colleagues
have published multiple reports of a gasless transaxillary da Vinci
Surgical System approach for thyroidectomies. They have recently
published the results
103
of their 1043-patient database of robotic thyroid-
ectomies (366 total and 677 subtotal) for low-risk differentiated thyroid
carcinomas. Average OT was 132.4 minutes for total and 63.9 minutes for
subtotal thyroidectomies with LOS of 2.9 days. None of these procedures
were converted to any other technique and were all successful with only
1% major postoperative morbidity.
103
This same group published a
prospective comparison of 41 robotic and 43 open thyroidectomies with
3 months follow-up.
104
OT was longer in the robotic group with 128.6
minutes vs 98.0 minutes for total thyroidectomies and 99.3 minutes vs
87.0 minutes for partial thyroidectomies. There was no difference in LOS
or postoperative pain, but neck discomfort and swallowing disturbances
were signicantly greater with open surgery at both follow-up times of 1
week and 3 months. In addition, cosmetic satisfaction scores were
signicantly increased with the robotic treatment.
104
In summary, the
robotic transaxillary thyroidectomy approach is safe and effective with
longer OT but having the advantage of improved cosmesis.
Robotics has recently shown promise in improving low anterior
resection procedures. Baik and colleagues
105
published a prospective
comparative nonrandomized trial looking at robotic (n 56) and
laparoscopic (n 57) low anterior resection. They had originally planned
to perform a randomized trial, but due to differences in cost and patient
choice, randomization was abandoned. The robotic treatment involved a
hybrid laparoscopic-robotic approach, since the robot did not have
sufcient workspace to complete the entire procedure without moving the
operating table or robotic cart. They found comparable OT and EBL
between the 2 groups. There were no conversions with the robot, while
10.5% were converted with laparoscopy. Major complications were
signicantly more common in the laparoscopy group (19.3%) than the
robotics group (5.4%). LOS was shortened with the robot (5.7 days vs 7.6
days). Furthermore, the macroscopic pathology grading was signicantly
better with the robotic system, and the authors theorize that this may lead
to improved long-term survival.
105
Because of the hybrid nature studied
by Baik and colleagues,
105
newer techniques have been developed to
perform the procedure totally robotically using either the newer da Vinci
S or Si systems
106
or the standard da Vinci with a fourth arm.
107
Urology
CyberKnife. Multiple radiation treatments have been used for prostate
cancer, including high-dose rate (HDR) brachytherapy, EBRT, IMRT,
and 3D-conformational radiation therapy.
108
In the past couple of years,
trials using fractionated CyberKnife SBRT with ducial prostate tracking
have been explored for similar efcacy with decreased treatment
toxicity.
108-111
In a phase II clinical trial, 41 patients were treated and
reported to have 5% grade 3 late urinary toxicity and no grade 4 urinary
toxicity. They did not have any grade 3 or 4 late rectal toxicities.
111
Another study of 100 patients treated with a median follow-up of 24
months reported that no patients had grade 3 or 4 urinary toxicity and only
1 patient had grade 3 rectal toxicity. A retrospective chart review of 50
patients by Townsend and colleagues
108
reported 6% grade 3 urinary
toxicity and no grade 2 or higher GI toxicity. Katz and colleagues
110
in
their study of 304 patients (254 patients with 5 fractions of 7.25 Gy and
50 patients with 7 Gy fractions) report even lower rates of toxicity. The
lower dose treated patients had 1 grade 2 late urinary toxicity and none at
high grades. Those patients treated at the higher dose had 5.8% grade 2
late urinary and 2.9% grade 2 late rectal toxicities. In terms of grade 3 late
toxicity, only 1 patient of 206 had urinary toxicity and no reports of rectal
toxicity, and none of either kind of grade 4 toxicity.
110
From comparing
the results of these studies with the literature for HDR brachytherapy,
IMRT, and 3D-conformational radiation therapy, the toxicities are lower
or the same with CyberKnife SBRT for grade 2 or higher urinary or GI
toxicities. Similar levels of grade 1 toxicities were found.
108-111
In terms
of tumor control as assessed by prostate-specic antigen (PSA), the phase
II trial
111
had a nadir of 0.32 ng/mL at 33 months and Friedland and
colleagues
109
had a nadir of 0.5 ng/mL at 24 months. Katz and
colleagues
110
had 1 of the larger studies and reported no biochemical
failures from the lower dose treatment (median follow-up of 30 months)
and 4 failures of the 254 higher dose patients (median follow-up of 17
months). Overall, the CyberKnife SBRT treatment for prostate cancer
seems to have lower levels of toxicity, and further study will be needed
to determine long-term cancer control and quantify the difference with
other radiation treatment modalities.
Endoassist/FreeHand. A recent study compared the use of the newer
FreeHand system vs human assistant for endoscopic extraperitoneal
radical prostatectomy.
50
The prospective study randomized 25 patients to
each group and evaluated OT (total and for each step), number of camera
movements, number of lens cleanings, EBL, and margin status. There was
no difference in total time or in the individual steps, except for the
additional average of 1.9 minutes needed for robotic setup. The robotic
system had signicantly fewer horizontal and zoom camera movements,
lens cleanings, and camera errors. Human assistants had signicantly
fewer vertical movements. No statistical difference existed for EBL or
margin status. Overall, the results seem to indicate that the robotic system
was generally more efcient with its movements but this did not translate
into shorter OT or clinically noticeable improvements.
da Vinci Surgical System. Urology has become the largest clinical area
for the da Vinci system, with prostatectomies the most common robotic
procedure in 2009. Other urological procedures frequently performed
robotically include cystectomies, pyeloplasties, and partial nephrecto-
mies. Below we review the clinical evidence for these procedures.
Robotic prostatectomy has become the dominant approach, accounting
for 60% of 2007 US radical prostatectomies, and undoubtedly this
percentage is currently higher.
112
Nonetheless, the gold standard treat-
ment is considered open radical prostatectomy.
112
One possible explana-
tion for the high adoption of robotics is that performing a laparoscopic
prostatectomy requires signicant technical skill because of laparoscopys
inherent limitations and the robotic technique helps overcome these
burdens. Despite the fact that robotic prostatectomies have been per-
formed since 2000, no randomized controlled trials have been performed
comparing open vs laparoscopic vs robotic approaches. Recent reviews of
the literature by Finkelstein and colleagues
112
and Coelho and col-
leagues
113
have waded through the numerous studies that at times
reported conicting results. We also incorporate the recent results by Di
Pierro and colleagues
114
and Carlsson and colleagues.
115
Di Pierro and
colleagues
114
conducted a prospective comparison of consecutive robotic
(n 75) and open (n 75) prostatectomies, while Carlsson and
colleagues
115
prospectively compared the complications in a series of
1253 robotic and 485 open prostatectomies. In terms of EBL, both
reviews and Carlsson and colleagues
115
concluded that the robotic
approach led to less EBL and transfusions than open procedures. Coelho
and colleagues
113
reported that robotics had a smaller transfusion rate
than laparoscopy, reporting 20.1% for open, 3.5% for laparoscopy, and
1.4% for robotics. Coelho and colleagues
113
found that OT were
signicantly longer in a surgeons early series of robotic patients than for
open surgeries, but with increased experience there was no difference
between the 2. Laparoscopy took signicantly longer than either robotic
or open. Both reviews found some studies report shorter LOS with the
robot, while others had similar LOS depending on the postoperative
protocol, but generally patients treated robotically spent less time in the
hospital. When comparing robotics with laparoscopy, da Vinci prostatec-
tomy was associated with a lower conversion rate (0%-1% vs 2%-8%).
Coelho and colleagues
113
noted no difference in weighted mean compli-
cation rates among the 3 treatment options, but Finkelstein and col-
leagues
112
reported that with experienced surgeons laparoscopy and
robotics have a slight decrease in major complications compared to open.
In their large series, Carlsson and colleagues
115
reported signicantly
higher Clavien grade (IIIb-V) complications with open (12.9%) than
robotic (3.7%). The reviews reported conicting results in urinary
continence between laparoscopy and open groups, but robotics tended to
be better than either. Carlsson and colleagues
115
reported that signi-
cantly more open patients needed additional surgery for incontinence than
robotic (2.2% vs 0.5%). Finkelstein and colleagues
112
suggest that
robotics may theoretically have advantages in preserving potency, but did
not nd a major difference among the 3 treatments. Coelho and col-
leagues
113
and Di Pierro and colleagues
114
reported that potency rates
were higher with robotics than open, which was better than laparoscopy.
Robotics was signicantly better than open in terms of infections (1% vs
9%) and bladder neck contractures (0.2% vs 4.5%).
115
For oncologic
results, Finkelstein and colleagues
112
suggest that laparoscopic proce-
dures may have higher incidence of positive margins than open and
robotic approaches, which are comparable. According to Coelho and
colleagues,
113
positive margins were signicantly less with robotic
procedures (13.6%) than either open (24%) or laparoscopy (21.3%). Di
Pierro and colleagues
114
concurred that positive margins were better with
robotics than open, and they found no difference in percentage of patients
with PSA values less than 0.2 ng/mL up to 1 year after surgery. Longer
term studies of robotic treatment is limited, but 1 report of 5-year PSA
follow-up suggested that the robotic treatment may have decreased failure
compared to open, and both are better than laparoscopic.
112
Finkelstein
and colleagues
112
argued that the approach with robotics, laparoscopy, or
open may not be as important as the surgical technique in affecting patient
outcomes. Nonetheless, trials to date strongly suggest fewer major
complications, less EBL, decreased blood transfusions, and improved
margins with robotics than open procedures. Laparoscopy tended to have
comparable or worse outcomes than robotics and open. Prospective
randomized controlled trials are considered necessary to truly demon-
strate these differences, but this may be hard to accomplish given that
many patients and surgeons consider da Vinci prostatectomy the standard
of care and will not agree to randomization to a nonrobotic arm.
The rapid adoption of robotic prostatectomies has spread to other
urological procedures, including radical cystectomy, which is the stan-
dard surgical treatment for bladder cancer. Nix and colleagues
116
per-
formed a prospective randomized trial comparing open and robotic
radical cystectomies. Their study was relatively small with only 21
patients in the robotic and 20 patients in the open group. The goal of the
study was to demonstrate noninferiority of the robotic approach in terms
of lymph node yield and they concluded that robotics is noninferior.
116
In
terms of other operative parameters, Mansour and colleagues
117
pub-
lished a systematic review of the literature and reported that the robotic
technique has decreased EBL and LOS. They also suggest that robotic-
treated patients have a better QoL after their procedure.
117
In terms of
oncologic outcome, Chade and colleagues
118
performed a systematic
review of the literature and were able to nd up to 2-year follow-up with
robotic treatment. They found 1- to 2-year recurrence-free survival rates
with robotics of 86% to 91%, which was comparable to results with
laparoscopy (83% to 85%).
118
Longer term oncologic results will be
necessary to insure that robotics offers comparable outcomes with
laparoscopy and open procedures.
Either open or laparoscopic partial nephrectomy is the standard treat-
ment for localized renal cell carcinoma. Robotics has been reported to be
technically easier than the laparoscopic procedure. Haber and col-
leagues
61
compared 75 robotic partial nephrectomies with a matched
control of 75 laparoscopic approaches. They found no difference in OT,
warm ischemia time, LOS, or complications. Both treatment groups had
negative margins. The robotic group had signicantly more EBL by 101
mL.
61
A systematic review by Van Haute and colleagues
119
reported that
OT is generally the same as in Haber and colleagues
61
study or shorter
with the robotic approach. Similarly, Van Haute and colleagues
119
reported that more studies reported shorter warm ischemia time with
robotic treatment, and that the EBL is comparable to laparoscopic
procedures. Oncologic outcomes are similar among robotic, laparoscopic,
and open approaches and positive margins are rare in both robotics and
laparoscopy. Complication rates averaged 9.7% across multiple stud-
ies.
119
As with other oncologic procedures, it will be necessary to
determine long-term outcomes.
Surgical treatment of ureteropelvic junction obstruction is pyeloplasty,
which urologists have traditionally performed with open approaches, but
laparoscopy has gained more prominence. More recently, urologists have
been examining the advantages of robotic techniques. Bird and col-
leagues
120
compared their prospective database of 98 robotic and 74
laparoscopic pyeloplasties. They found no difference in OT, complica-
tions, and long-term success (radiographic success at a minimum 6
months).
120
Braga and colleagues
121
performed a meta-analysis of the
results for robotic vs laparoscopic procedures and found statistically
signicant decreases in LOS by 0.5 days. OT, complications, and success
rates were similar between the 2 groups.
121
Robotic pyeloplasty appears
to be just as efcacious as laparoscopy, but the clinical advantages
beyond a slightly shorter LOS remain to be seen.
Gynecology
da Vinci Surgical System. The da Vinci system is gaining wider usage
in the eld of gynecology for hysterectomies (for benign and malignant
disease), myomectomies, and sacrocolpopexy. It is the most rapidly
growing area of robotic surgery currently. Frick and Falcone
122
have
published a thorough review of the use of robotics for gynecology,
including the history and development, techniques, and outcomes. A more
detailed meta-analysis of published outcomes was recently published by
Reza and colleagues.
123
As in the general surgery section, we integrate
more recent studies with this meta-analysis to assess the effectiveness of
robotics for gynecology.
Hysterectomies are 1 of the most common gynecologic procedures, with
greater than 600,000 performed annually in the United States. The
indications for hysterectomies include benign and malignant processes,
but benign causes, such as broids, endometriosis, and prolapse, are the
most common indications.
122
The surgery can be performed vaginally or
via an abdominal approach, where the technique can be laparotomy,
laparoscopic, or robotic. Due to the range of indications and possible
approaches, it is important to take these into account to determine which
patients would benet with robotics.
Lim and colleagues
124
compared robotic (n 56), laparoscopic (n
56), and laparotomy (n 36) hysterectomies for endometrial cancer.
Gaia and colleagues
125
performed a meta-analysis comparing that same 3.
Both studies reported that robotic procedures took longer than laparot-
omy, but Lim and colleagues
124
report that robotics is faster than
laparoscopy and Gaia and colleagues
125
did not nd a difference. Lim and
colleagues
124
noted these differences, although they were assessing the
learning curve of robotics and saw improvements in OT with each
chronological group, but no improvements in laparoscopy or laparotomy.
Both studies found the least EBL with robotics (89.3 mL), then laparos-
copy (209.1 mL), and greatest with laparotomy (266 mL).
124
Lim and
colleagues
124
noted that LOS with robotics (1.6 days) was shorter than
laparoscopy (2.6 days) and laparotomy (4.9 days), but Gaia and col-
leagues
125
report no statistical difference between robotic and laparo-
scopic LOS. Laparoscopic cases tended to be converted to laparotomies
more frequently than robotic cases (9.9% vs 4.9%) but that difference did
not reach statistical signicance.
125
Complication rates were comparable
across all the groups in Gaia and colleagues
125
study, but robotics tended
to have less complications with Lim and colleagues.
124
Lim and col-
leagues
124
reported that fewer lymph nodes were resected with the robot,
but Gaia and colleagues
125
noted no difference. Transfusions were less
common with robotics than laparotomy but not statistically signicant
(1.7% vs 7.2%).
125
Reza and colleagues
123
results are similar when
comparing laparotomy and robotics in that there are decreased LOS and
EBL with a longer OT. They also reported lower complication and
transfusion rates. When comparing laparoscopy and robotics, they had
similar results as Gaia and colleagues.
125
They did a further subgroup
analysis of obese patients and found the robot signicantly decreased OT
and EBL, while resecting more lymph nodes.
123
Results for hysterectomy for cervical cancer were similar in Reza and
colleagues
123
meta-analysis and Halliday and colleagues
126
study com-
paring 16 prospective robotic cases with a historic cohort of 24 laparot-
omies. Robotic compared to laparotomy had signicantly decreased LOS
by 2.05 days, EBL by 334.17 mL, and transfusion rates.
123
Halliday and
colleagues
126
found similar results but the magnitude of difference was
greater for LOS (1.9 days vs 7.2 days) and EBL (106 mL vs 546 mL). OT
and complications were similar with Reza and colleagues
123
study but
longer robotic operations and fewer robotic complications were reported
by Halliday and colleagues.
126
Both studies reported no difference in
number of lymph nodes resected with robotics or laparotomy. When
comparing robotics with laparoscopy, EBL was signicantly less by
63.52 mL, while there was no difference in terms of OT, LOS, lymph
nodes resected, complication rates, or conversion rates.
123
Cantrell and
colleagues
127
performed a retrospective study of 63 patients with a
median follow-up of 12.2 months and reported that the 3-year progres-
sion-free survival and overall survival were both 94% and comparable to
a historical laparotomy cohort. In hysterectomies for malignancy, robotics
tended to show decreased EBL and LOS compared to both laparotomy
and laparoscopy, but long-term oncologic outcomes need to be assessed
in studies.
In the case of benign diseases, Reza and colleagues
123
found 1 study
reporting longer OT than laparoscopy. After accounting for the learning
curve and only including the last 25 procedures, the robotics cases were
signicantly shorter. Additional advantages were signicant decreased in
LOS by 0.5 days and EBL by 52 mL.
123
Robotic hysterectomies for
benign cases appear to have similar advantages as those for malignant
cases.
Myomectomies for broids are usually performed with laparotomy or
laparoscopy. Bedient and colleagues
128
performed a retrospective chart
review of 40 robotic and 41 laparoscopic myomectomies. The baseline
characteristics were different in the 2 patient populations, and after
controlling for broid size and number and uterine size, there was no
signicant difference in OT, EBL, complication rates, LOS greater than
2 days, and resolution of symptoms.
128
When comparing robotic and
laparotomy, Reza and colleagues
123
found signicantly longer OT by 80
minutes, while there was a decrease in EBL by 170 mL and LOS by 2
days. Robotic cases compared to laparoscopy had decreased EBL of
72.36 mL but conicting results on OT. No other difference between
these 2 groups was found.
123
Sacrocolpopexy is usually performed with an open or laparoscopic
approach for vaginal vault prolapse. Our search of the literature identied
1 comparative robotic study by Geller and colleagues.
129
They performed
a retrospective cohort study with 73 robotic and 105 open sacrocol-
popexies and found increased OT (328 minutes vs 225 minutes),
decreased EBL (103 mL vs 255 mL), and more frequent postoperative
fever (4.1% vs 0%).
129
It remains to be studied whether there is an
advantage to robotic vs laparoscopic techniques.
Otorhinolaryngology
CyberKnife. Initial studies of using CyberKnife for various head
and neck cancers have been recently published. Heron and col-
leagues
130
reported their phase I study of using CyberKnife for
squamous cell carcinoma (SCC) of the head and neck in previously
irradiated patients. They treated 25 patients in a dose-escalation trial
and did not have any grade 3 or 4 or dose-limiting toxicities. Grade 1
or 2 acute toxicities were suffered by 4 patients. QoL surveys did not
nd any signicant changes with treatment.
130
These results suggest
that use of CyberKnife is safe and additional studies can assess clinical
effectiveness.
The standard treatment for nasopharyngeal carcinoma (NPC) is den-
itive radiotherapy, because of its dose-sensitive radiation response that
improves local control. Hara and colleagues
131
found that giving 82 NPC
patients a SBRT boost 2 to 6 weeks after EBRT resulted in 5-year
freedom from local relapse rates of 98%. Additionally, the 5-year
statistics for freedom from nodal relapse was 83%, from distant metas-
tasis was 68%, and from any relapse was 67%. Their overall survival at
5 years was 69%. The late toxicities that they observed were 3 cases of
radiation-related retinopathy, 1 case of carotid aneurysm, and 10 cases of
radiographic temporal lobe necrosis (2 of these had symptomatic sei-
zures).
131
Another study
132
looked at dysphagia side effects in NPC when
treated with radiation therapy, boosted with IMRT, and administered a
second boost with either brachytherapy or SBRT. These investigations
found that the rst boost with IMRT had an increase in dysphagia, but the
second boost with either brachytherapy or SBRT did not result in
additional dysphagia.
132
This same study looked at oropharyngeal cancer
(OPC) and found similar results in that IMRT boosting increased
dysphagia more than brachytherapy or SBRT.
Nijdam and colleagues
133
compared the use of brachytherapy vs
CyberKnife boosts after EBRT for tonsillar fossa and soft palate tumors
in terms of costs and QoL. With 1-year follow-up in the CyberKnife
patients, these researchers could nd no difference between the 2 boosting
treatments. However, the cost with CyberKnife was less because a
hospital admission and operating room were not needed. To summarize,
CyberKnife has evidence to support its safety in use for head and neck
cancers, and long-term studies will be needed to assess efcacy of
treatment.
da Vinci Surgical System. Gregory Weinstein, MD, an otorhinolaryn-
gologist at the University of Pennsylvania, and his colleagues developed,
conducted technical and feasibility trials, and performed early clinical
studies using the da Vinci system for transoral procedures (transoral
robotic surgery [TORS]). They saw the difculties of traditional transoral
surgery as being the limited functionality of long instruments, poor
visualization from a microscope external to the oral cavity, and difculty
using lasers far from the target. Using a robotic approach, they hoped to
overcome these challenges. Weinstein and colleagues
134
published a
review of the development, feasibility, safety, efcacy, teachability,
functional and oncologic outcomes, and costs of TORS. Below we review
some of the newer studies on the functional and oncologic results of this
approach, but due to the recent FDA approval 1 year ago,
51
high-quality
comparison studies with traditional techniques are lacking.
Standard of care for OPC is surgical excision and adjuvant radiation,
which results in good local control but high rates of morbidity, especially
with speech and swallowing difculties. Weinstein and colleagues
135
performed a prospective phase I study on the use of TORS with selective
neck dissection and adjuvant radiation/chemotherapy for OPC. There
were 31 patients included in the study that reached the minimum 18
months of follow-up and had a median of 24 months. The primary
outcome for their study was regional recurrence rate, and their results
found only 1 regional recurrence on the contralateral nonoperated side
and another case of distant recurrence. They concluded that their local
control rate was 100% and no patients needed a percutaneous endoscopic
gastrostomy (PEG) at 2 years, which is required in 9% to 14% of patients
treated with chemoradiation treatments.
135
Moore and colleagues
136
provided further evidence for the decreased morbidity in their prospective
series of 45 patients with oropharyngeal SCC treated with TORS with
selective neck dissection and adjuvant therapy as needed. These patients
had all their supportive tubes removed, including tracheostomy (mean use
of 7.0 days), nasogastric feeding tube (mean use of 12.5 days), and PEG
(mean use of 140.3 days).
136
Another study by Weinstein and col-
leagues
137
looked at the oncologic outcome after treating 47 patients with
advanced OPC (stages III to IV) with TORS and adjuvant treatment as
indicated. All patients had a minimum of 18 months follow-up and the
mean was 26.6 months. One (2%) patient had a local recurrence, while
another 2 (4%) had regional and 4 (9%) distant recurrences. Only 1
patient needed a PEG tube in this study at 1-year follow-up. These 2
studies support Weinstein and colleagues
137
contention that TORS can
result in oncologic care similar to current standards, while having lower
morbidity as demonstrated by only 1 patient who needed a gastrostomy
tube. These case series suggest that TORS provides similar short-term
outcomes but decreased speech and swallowing morbidity.
White and colleagues
138
published the longest follow-up study after
TORS for SCC. They prospectively followed 89 patients with cancers of
all stages in the oral cavity, oropharynx, hypopharynx, or larynx and had
a median follow-up of 26 months. Their 2-year recurrence-free survival
for primary treatment was 89.3%, which is comparable to traditional
treatments. After including the patients with recurrent disease, the entire
groups survival was 86.5% at 2 years. All these patients were free of
feeding tubes at the 2-year follow-up, indicating the decreased swallow-
ing morbidity noted in prior studies. White and colleagues
138
attributed
this decreased morbidity to the decreased radiation doses that their TORS
patients received since they all had negative margins. Other advantages
that they refer to based on prior studies are that TORS has decreased OT,
shorter LOS, and quicker return to activities. One of the important points
that White and colleagues
138
make is that not every patient is a good
TORS candidate. It will be important that future studies fully elucidate the
key factors for a good TORS outcome, and additional data regarding
longer term and comparative results should be gathered. Nonetheless,
these studies indicate that TORS may be of signicant benet to patients
in terms of decreased morbidity.
Thoracic Surgery
CyberKnife. Non-small-cell lung cancer (NSCLC) is a difcult to treat
disease because surgery is generally not an option even for many stage I
patients. Conventional radiation treatment for inoperable patients has
generally not produced good local control. Consequently, CyberKnife
treatment has been considered an option to better target NSCLC. Before
the FDA approval of the Xsight Lung system, ducials needed to be
placed in the patient for tumor targeting with the Synchrony system.
Fiducial placement complications, such as pneumothorax, have been
reported to range from 5% to 25%.
139,140
The studies that will be
subsequently mentioned used the older Synchrony system with ducials,
and future studies will need to insure that similar clinical outcomes can be
achieved with Xsight Lung targeting without the use of ducials.
Collins and colleagues
139
treated 20 patients with the CyberKnife
system for inoperable small peripheral stage I NSCLC and had 2-year
KaplanMeier overall survival estimates at 87%. They did not have any
problems with recurrence either locally or at the regional lymph nodes,
and there were no distant metastases that developed.
139
Another study
141
followed 70 patients with inoperable stage I NSCLC who were treated
with 45-Gy (n 11) or 60-Gy (n 59) 3 fraction CyberKnife treatments.
Those treated at the higher dose had 2-year local control of 96%, whereas
the lower dose had 78% local control. Overall survival at 2 years was
62%. They reported a 10% rate of grade 3 treatment-related toxicity, and
no grade 4 toxicity. Octogenarians with NSCLC are less likely to be
surgical candidates than younger patients, and 1 study
140
looked at the use
of CyberKnife for the treatment of 39 octogenarians with stage I NSCLC.
These patients had a 1-year overall survival of 65% and 2-year survival
of 44%. Local control was 100% at 2 years in those surviving. In terms
of side effects, these patients did relatively well with 5% acute grade 3
and 16% late grade 3 toxicities, and no reports of higher grades.
In addition to having promise in NSCLC treatment, 1 study
142
reported
the use of CyberKnife for NSCLC (n 26), recurrent lung cancer (n
12), and solitary lung metastases (n 13). One-year overall survival of
81% and local control of 85% in the NSCLC patients was lower than
reported in the prior studies. Patients with recurrent lung cancers had a
1-year survival of 67% and local control of 92%, whereas patients with
solitary lung metastases had a 1-year survival of 62% and local control of
85%.
142
The CyberKnife system has shown encouraging results in these
early studies for the treatment of inoperable lung cancers. Additional
studies with the Xsight Lung system will likely have lower complication
rates since ducials will not be needed and hopefully will have compa-
rable clinical efcacy.
da Vinci Surgical System. The use of the da Vinci Surgical System has
been explored for use in thoracic surgery procedures, such as lobecto-
mies, mediastinal mass resections, and esophageal procedures. Many of
the published reports in this eld are case reports or noncomparative case
series. We review the larger of these reports and the comparative studies.
Veronesi and colleagues
143
and Park and colleagues
144
have conducted
comparison studies, with the rst being a matched control of 54 robotic
and 54 thoracotomies, while the second was a retrospective review of all
robotic, thoracoscopic, and thoracotomies performed at a single institu-
tion in a year. Robotics was associated with a longer OT with Veronesi
and colleagues,
143
while no difference was found among the 3 groups
with Park and colleagues.
144
Both studies found shorter LOS with the
robot (approximately 4 days), while thoracotomy patients stayed for 6
days
144
; thoracoscopy LOS was similar to the robot.
144
The robot and
thoracotomies had similar complication rates and number of lymph nodes
resected.
143
Due to the cumbersomeness of using the robot for the nal
lung removal steps, Gharagozloo and colleagues
145
performed a study
using the robot for the initial dissection phase and then using traditional
thoracoscopic techniques for the last steps. They reported on their rst
100 consecutive patients and their mean OT was 216 minutes with an
average LOS of 4 days. Their complication rate was of 21%, of which
atrial brillation composed more than half the complications. The patients
were followed for a median of 32 months and there were no reports of
local recurrence, although 6% had distant metastases, 2% a second lung
primary cancer, and 1% died of cancer.
145
Newer techniques using a
subcostal incision for lobe extraction are being explored to decrease
morbidity,
146
and additional study is needed to determine the clinical
advantages of robotic lobectomy.
Various masses and pathologies in the mediastinum can be removed
robotically, and Weissenbacher and Bodner
147
reviewed the multiple case
series and reports of these. Here we discuss more recent and larger
studies. One prospective study
148
of 14 robotic and 22 open sternotomy
resections of anterior mediastinal tumors found that the open procedures
had a signicant decrease in general functioning at 1 month postoperatively,
whereas the patients with robotic procedures had returned to preoperative
levels by the same time point. Augustin and colleagues
149
reviewed the
literature for use of the robotic, thoracoscopic, and open sternotomy ap-
proaches for thymectomies. Thoracoscopic compared to sternotomies had
decreased EBL, shorter LOS, decreased pain, improved cosmesis, and faster
recovery. Comparisons between robotic and thoracoscopic approaches were
lacking, but the authors suggest that OT may be shorter with the robot.
149
Clark and colleagues
99
examined the literature for use of the robot for
esophagectomies and found only 1 comparative trial, while the other articles
were cohort studies and case reports. They integrated the results and reported
that 90% of the cases achieved R0 resections and, with follow-up ranging
from3 to 29 months, the recurrence rate was 14%. Longer termdata were not
available. The mean LOS was 15 days. A 30-day mortality rate of 2.4% was
reported. Complication rates were reported to be high with 18% anastomotic
leak, 25% pulmonary complications, 11% cardiac complications, and 8%
thoracic duct injury.
99
Overall, high-quality study data are lacking to
determine the effectiveness of robotic vs thoracoscopic approaches for
mediastinal resections.
Cardiac Surgery/Cardiology
da Vinci Surgical System. W. Randolph Chitwood, MD, has been 1 of
the major leaders in using the da Vinci Surgical System for use in various
cardiac surgery procedures. He and colleagues published a recent re-
view
150
that offers a thorough summary of the clinical evidence to date
regarding the use of robotics for mitral valve repair, CABGs, atrial
brillation surgeries, left ventricular epicardial lead placement, intracar-
diac tumor resection, aortic valve surgery, and congenital surgery.
Folliguet and colleagues
151
were among the rst to perform a compar-
ative study between mitral valve repairs performed robotically and
traditional sternotomy. They prospectively followed 25 patients who were
treated robotically and compared them with a matched control of 25
retrospectively chosen patients. They found signicantly longer aortic
cross-clamp and cardiopulmonary bypass times in the robotic group, but
the LOS (7 days vs 9 days) was signicantly less. With the short 2- to
3-month echocardiography follow-up, there was no difference in the
competency of the mitral valve repair.
151
Murphy and colleagues
152
reported a longer mean follow-up of 8.4 months for 98 patients and
reported regurgitation grades of zero for 88.8%, 1for 8.2%, and 2 for
3.1%. The number of patients in Folliguet and colleagues
151
study was
small, and Chitwood and colleagues
153
later published a report of the 300
patients that they had treated at their center, which is the largest published
report. The complication rate was 0.7% strokes, 0.7% transient ischemic
attacks, 1.0% myocardial infarctions, and 2.3% reoperations due to
bleeding. They reported a mean LOS of 5.2 days, which is shorter than
published by Folliguet and colleagues.
151
The procedures were generally
quite successful, with immediate postoperative echocardiograms indicat-
ing mitral regurgitation of none/trivial in 98%, mild in 1.0%, moderate in
1.0%, and severe in none. With follow-up averaging 815 days, the mitral
regurgitation results were none/trivial in 68.8%, mild in 23.6%, moderate
in 5.4%, and severe in 2.2%. They also reported a 5.3% reoperation rate
within 2 years, and the authors noted that it is similar to the early repair
rates published in the literature for traditional sternotomy approaches.
Chitwood and colleagues
153
noted that they had a higher early failure rate
of 7% in their rst 100 patients, and that it dropped to 4.5% for the last
200 patients. KaplanMeier survival at 5 years was 96.6% and freedom
from reoperation was 93.8%.
153
Kam and colleagues
154
performed a
recent retrospective comparative analysis of all their mitral valve repairs
in a span of 3 years and reported on 107 robotic and 40 traditional
procedures. Postoperative success in repairing the mitral valve was
similar, but had signicantly longer OT with the robotic group (239
minutes vs 202 minutes). Similar to Folliguet and colleagues,
151
the
robotic group had signicantly shorter LOS (6.47 days vs 8.76 days) and
intensive care unit stays (37 hours vs 45 hours).
151
Overall, the robotic
group has similar success at the short and mid term with shorter LOS,
albeit longer OT.
There have been multiple variations of robotic CABGs, including
partial robotic/open vs totally endoscopic robotic and off vs on the pump.
Poston and colleagues
155
conducted a recent prospective study of 100
consecutive off-the-pump robotic internal mammary artery CABGs with
or without stenting compared to a 100 patient-matched control of
conventional sternotomy internal mammary artery and saphenous vein
CABGs patients. For the robotic group, they found signicantly de-
creased LOS (3.77 days vs 6.38 days) and transfusion needs (0.16 U vs
1.37 U). Major adverse cardiac/cerebrovascular events at 1 year were
signicantly less with robotics as well (4% vs 26%). Patients were more
satised with the robotic procedure (76.5% vs 42.9%) and were able to
return to work quicker (44.2 days vs 93.0 days).
155
Another endoscopic
and off-the-pump study was performed by Srivastava and colleagues.
156
They focused on the 3-month patency of the graft in 214 patients after
robotic treatment. The patients were treated somewhat heterogeneously,
with patients receiving single- to triple-vessel bypasses and others having
stenting as well. Eighty percent of patients had 3-month angiographic
follow-up and all of them had grossly patent grafts. However, reinterven-
tion was required in 3 patients (1.4%), and Srivastava and colleagues
156
concluded that overall clinical freedom from graft failure was 98.6%.
Longer 5-year follow-up was obtained by Kappert and colleagues
157
in 41
of their patients treated with both on and off pump robotic techniques. A
word of caution is that these patients were treated between 1999 and 2001
and were treated using older technologies and techniques. They found that
5-year overall survival was 92.7% and that the 3 patients who had died
had noncardiac causes. With a median follow-up of 69 months, the
freedom from reintervention rate was 87.2%, while freedom from major
adverse effects was 75.7%.
157
Robotic CABGs show promise in terms of
decreasing LOS, transfusion needs, and time to return to activity, but
more comparative data are needed to determine long-term effectiveness.
Sensei. Although comparison trials between the Sensei and Niobe
systems have not been conducted, there have been comparison studies
between each to conventional manual techniques. Steven and col-
leagues
158
conducted a prospective trial of 50 atrial utter patients and
randomized them to treatment with either Sensei or conventional manual
ablation. This study did not use 3D mapping for either treatment arm, and,
thus, the study more directly compares the difference in control with and
without robotics. All patients in both groups had complete block without
any complications, and this study did not follow patients long term. Total
OT was signicantly more with Sensei (79.2 minutes vs 58.4 minutes).
An important consideration is that the robotic OT signicantly decreased
from the rst 10 case average of 105.3 minutes to 60.6 minutes for the last
10 cases.
158
Another study had suggested that the learning curve for using
the Sensei system is 75 patients, which is much more than was treated in
this study.
159
With robotic treatment, total uoroscopy time was signif-
icantly less (8.2 minutes vs 5.8 minutes) and physician radiation exposure
was even less (8.2 minutes vs 4.6 minutes).
Sensei has been used for atrial brillation as well, and Di Biase and
colleagues
160
conducted a prospective nonrandomized study of 390
consecutive atrial brillation patients with 197 with manual and 193 with
robotic ablation. There was no statistically signicant difference in
success between the 2 groups at an average of 14.1 months of follow-up
(85% for robotic vs 81% for manual). Di Biase and colleagues
160
found
no statistical difference in OT between the 2 groups, with an average 3.09
hours for robotic ablation and 3.05 hours for manual ablation. Similar to
Steven and colleagues
158
study, Di Biase and colleagues
160
had signif-
icantly less uoroscopic time with the robot (48.9 minutes vs 58.4
minutes). Complication rates were comparable between the 2 groups.
160
A prospective trial of atrial brillation patients was conducted in a
different study by Steven and colleagues.
161
They randomized 30 patients
each for robotic and manual treatment, and in this study they used EAM
for both treatment arms. Successful ablation was reached in all patients,
and no difference in 6-month freedom from atrial brillation was found.
The robotic procedure tended to take longer but was not statistically
signicant (156 minutes vs 134 minutes). As with the other trials, overall
uoroscopy time was signicantly decreased in the robotic group (9
minutes vs 22 minutes), and the same was true for physician exposure (7
minutes vs 22 minutes).
161
Overall, Sensei has shown similar clinical
effectiveness with decreased physician radiation exposure compared to
manual techniques, but it tends to take longer than manual techniques.
Niobe. Stereotaxis maintains an extensive list of all the publications in
the literature related to their Niobe robotic system.
61
A large percentage
of them involve in vitro studies and in vivo case reports or case series.
Due to the novelty of the technology, few direct comparison studies
between Niobe and manual techniques have been reported.
Patterson and colleagues
162
examined the use of Niobe for the treatment
of 44 patients with simple coronary blockages (elective single discrete
stenosis) and compared the results in a matched control study of another
44 patients who were treated with conventional manual techniques. They
found that both groups could achieve a high 90% success rate in
positioning the wire distal to the stenosis, and there was no statistical
difference between the 2. No difference in OT or uoroscopy time was
found in the treatment of these blockages. However, they did nd a
signicant reduction in the contrast used with a median of 60 mL in the
robotic group and 100 mL in the manual treatment group.
162
In another
study, Patterson and colleagues
163
looked at using the Niobe system for
more difcult percutaneous interventions in the case of acute myocardial
infarction. This study had 65 sequentially treated patients in the Niobe
group, while the conventional group was a historical control of 405
patients. Both groups had high 90% success rates and were not statisti-
cally different. The robotic group had a distal embolization complication
rate of 7.7%, but the historical control did not have these data available
and the authors compared this to the 15.2% rate reported in the literature
for manual techniques. There was no difference between the 2 OT, but
there was signicantly less uoroscopy time (median of 7.4 minutes vs 9
minutes) and contrast usage (median of 170 mL vs 200 mL) with the
robot. Niobe has been studied in a prospective randomized trial for use in
even more difcult interventions, treating bifurcations. Ramcharitar and
colleagues
63
randomized 31 consecutive patients who had bifurcating
lesions to have a rst attempt with either magnetic or conventional wires
to place wires in both bifurcating limbs. Once the data for 1 wire were
gathered, the data for placing the other wire were gathered before
treatment. Thus, each patient was able to serve as their own control and
a success was dened as placing the crossed wires within 6 minutes. The
success rate for positioning the magnetic wires was 96.8% (30/31) vs
90.0% (28/31) for conventional wires. In 2 cases the manual technique
could not position the wire at all, but the Niobe system was able to
position the wire. The 2 wires took similar times for procedure and
uoroscopy for positioning. There was a tendency toward decreased
contrast usage with the magnetic wires, but due to the small amount of
contrast generally used (10 mL), it was not statistically signicant.
63
In
the treatment of blocked coronary vasculature, the Niobe system tends to
use less contrast than conventional techniques. Additional studies using
Niobe for difcult to treat patients may be able to elucidate an advantage
for uoroscopy or procedure time.
Niobe has been tested for various cardiac electrophysiology procedures
as well, with comparison studies published for supraventricular tachycar-
dias. Kerzner and colleagues
60
published a retrospective study with 28
atrioventricular nodal reentry tachycardia patients treated with Niobe
compared with 28 matched control cases treated conventionally. Both
groups had similar success rates in eliminating slow pathway conduction;
neither group had recurrence at the 3-month follow-up. There were no
differences in procedure or uoroscopy time. Their study supported that
the Niobe treatment was not inferior, but did not have evidence to support
it being superior to conventional treatment, although the nature of the
study has many limitations.
60
Stereotaxis had sponsored the HEART
(Helios Electrophysiology Ablation Remote Treatment) prospective,
multicenter, randomized trial to compare magnetic with conventional
catheters. This study had used the Helios II catheter (at the time not FDA
approved), but the trial was ended early due to decreased subject
recruitment after an FDA approved magnetic ablation catheter came to
market. The results from the 56 patients treated with Niobe and 15
patients with manual techniques were published by Wood and col-
leagues.
164
Both techniques had similar acute and chronic (80 days after
ablation) success rates, and major adverse complications. There was no
difference in OT, but uoroscopy time was signicantly less in the Niobe
group (17.8 minutes vs 27.1 minutes).
164
Larger studies will be needed to
determine if the more precise navigation with Niobe translates into
improved ablation outcomes. These studies suggest that there may be a
decreased uoroscopy advantage to using Niobe, but further research is
warranted.
Future Advances
Since the initial forays into surgical robotics by Kwoh and colleagues
15
in 1985, many clinicians and engineers have created various new robotic
systems. We have reviewed the systems that are at or near-commercial
availability, but many more incorporating newer technologies and ap-
proaches are under development. Dogangil and colleagues
12
review many
of these research endeavors from around the world, and below we discuss
the broader trends in robotic surgery.
Surgical robots can be divided into 3 major components according to
Davies
5
denition: articial sensors, computer, and manipulators. The
coming years will see advancements in each of these components. In the
arena of articial sensors, new imaging modalities are being developed
and incorporated into surgical practice. Some of these modalities involve
the use of near-infrared imaging, confocal microscopy, intraoperative
ultrasound, Raman spectroscopy, biomarkers, dyes, and autouorescence
to improve identication of tissues, such as nerves, blood and lymphatic
vessels, and cancers. Researchers at Rice University have developed
silica-gold nanoparticles that specically target breast cancer with the
hopes that they can be used for intraoperative detection of tumor
margins.
165
With robotic systems, these additional imaging modalities
can be integrated with the surgeons display, similar to a heads-up display
used in military planes. These imaging modalities are being developed
with the goal of making surgeries safer and more effective with decreased
patient morbidity and improved cancer resections. Additionally, imaging
can play an important role in enhanced imaging registration with
preoperative scans. As mentioned above, registration can be difcult in
the case of soft tissues that are easily deformed. CyberKnife uses
uoroscopy and chest-mounted light-emitting diodes to account for tissue
movement. Similarly, the imaging modalities discussed above, including
intraoperative ultrasound, can play an important role in maintaining
accurate registration of preoperative scans for soft tissues. The NeuroArm
uses almost live intraoperative MRI to account for deformation of the
brain with stereotactic manipulation.
32
A third use of these new imaging
techniques is to guide both semi- and fully autonomous robots to perform
procedures. Researchers at Duke University are exploring the use of 3D
ultrasound to guide autonomous robotic biopsies.
166
Another arena for advancing sensors is for haptics. One frequent
complaint from surgeons regarding some robotic systems is their lack of
haptics feedback. It is difcult to integrate haptics into the controls while
maintaining a stable and reliable telesurgery system. In the near term,
engineers have been developing alternate solutions to this problem, such
as synesthesia, as used in Hansens Sensei robot to visually indicate
whether too much force is being exerted at the catheter tip. For the longer
term, researchers are working toward developing natural haptic controls.
One solution to the difculty of embedding sensors in the end-effectors
has been developed by researchers in Germany who have been able to
accurately estimate forces without the use of sensors at the end-
effector.
167
Manipulators and the end-effectors are another area where technology is
being advanced. New tools, such as harmonic scalpels, lasers, and high
intensity focused ultrasound, are starting to enter surgical use. Robotics
may offer better control and use of some of these tools, such as lasers. For
example, in TORS, robotics offers more precise laser manipulation since
there is better line of sight and better control.
168
Another development in
end-effectors are intelligent instruments that have embedded sensors that
can detect cancer cells or blood vessels.
169
These tools can enhance the
surgeons perception of the surgical eld and hopefully offer better
outcomes. Last, these manipulators are gaining more capabilities in
smaller packages. Some current systems have limited workspaces due to
the bulkiness of the manipulator motors, and miniaturization of these
components can expand the workspace. For example, the newer and
slimmer da Vinci systems are more easily used in low anterior resections
than the original system.
The computers running robot systems and the networks they are
working on are also advancing. Telesurgery has been performed at a
distance in early feasibility case reports using specialized networks that
provided the surgically necessary latency of 200 ms.
13
With improving
global Internet networks, it may be feasible to perform operations at a
distance with commonly available broadband and wireless Internet
connections. Additional new software and training techniques are being
developed to better train residents in the use of robotics using teleproc-
toring systems. Robotic training simulators are also being developed for
practice by residents and experienced surgeons. Satava
9,13
advocated the
development and use of simulators for surgeons because surgery is unique
among technically challenging professions, such as athletes and musi-
cians, because surgeons typically do not practice before performing. He
advocated the creation of simulators that use preoperative imaging to
mimic the actual procedure that the surgeon is about to perform. This
strategy could even be extended to the point that the surgeon can
repeatedly practice and modify the procedure until they determine the
optimal approach. This ideal procedure can be programmed into a robot
for autonomous execution. Other features can include robots that learn
from a database of expert surgeons motions and use that knowledge to
provide other surgeons suggestions and warnings throughout a sur-
gery.
9,13
Satava
8,9,13
has been 1 of the major visionaries in the eld of robotic
surgery since its beginnings, and another of his visions is the creation of
fully robotic and integrated operating rooms. He envisions the future
operating room to be a clean room, similar to microprocessor assembly
facilities, to minimize the risk of infections. The patients are sterilely
prepared before entering the room where robots replace the anesthesiol-
ogist, surgeon, scrub technician, and circulator nurse. Physicians can
control these robots from a control room. In addition, these robots can be
integrated into the hospital supply network. When an instrument is pulled
from the shelf, the robots notify the supply center to order another
one.
8,9,13
This may seem farfetched, but early steps have already been
taken in that direction. In October, 2010, McGill University reported the
rst all-robotic surgery for prostatectomy where a da Vinci system
performed the surgery and a robot nicknamed McSleepy provided
anesthesia.
170
Robotics opens up the possibility of treating patients with completely
novel surgical approaches. The CardioARM robot opens up the possibil-
ity of performing epicardial procedures with a single, small subxiphoid
incision vs sternotomy, thoracotomy, or multiple thoracoscopy ports.
Minimally invasive surgery is progressing from multiple small incisions
to a single small incision called laparoendoscopic single site (LESS)
surgery. There have been multiple reports of adapting the da Vinci
Surgical System for LESS in urology and general surgery applica-
tions.
171,172
The da Vinci system was designed for traditional multiple
port endoscopic procedures, and when they converge around a single port
for LESS, their workspace is limited due to manipulator collisions. One
solution has been to have the robotic instruments cross at the abdominal
wall such that the right robotic arm controls the left instrument and vice
versa in what has been dubbed chopstick surgery.
173
The ideal solution
would be to design a surgical robot specically for this application, and
many researchers are heading in that direction for what is called scarless
surgery or NOTES. Shah and colleagues
174
and Forgione
175
have
written recent reviews of novel robots that are being developed for
NOTES, including endoscopic, pill, and specialized cooperative robots.
The stereotaxis Niobe system is being investigated for use in controlling
wireless robots through the GI tract,
176
while the CardioARM robot is
being explored for transoral and transrectal procedures. In the future,
other approaches yet to be conceived may become feasible because of
robotics broad capabilities.
Other avenues of research that are farther on the horizon are biosurgery
and automation with AI. Satava
9
discusses that in the future cellular level
functions will be manipulated in what is called biosurgery. This level of
manipulation is currently being used in the case of in vitro fertilization,
and perhaps robotics may play a role in improving care in this or other
applications. AI is still in the very basic research stages for use in surgical
applications. Due to the high-risk environment and the relatively simple
currently available AI, it will be many years before robots will be both
capable of and trusted to independently execute surgical procedures.
Conclusions
Robotics made its rst appearance in surgery 25 years ago for a
neurosurgery biopsy and has since captivated the imagination of clini-
cians as a possible solution to various clinical problems. Numerous
surgical robots have been developed to address a myriad of issues across
a broad spectrum of clinical specialities. They have generally been quite
successful in achieving their desired goal and often improving clinical
parameters, such as blood loss, LOS, and complications. However, some
applications have not been as successful in demonstrating substantial
clinical gains. With the increasing emphasis on comparative effectiveness
research in US health care, clinicians will need to justify the use of robots
with more extensive trials. The future of surgical robotics will depend on
better understanding of clinical problems such that appropriate solutions
are developed to signicantly improve patient care.
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