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Otolaryngol Clin N Am

40 (2007) 611–624

Image-Guided Technique in Neurotology


Robert F. Labadie, MD, PhDa,*, Omid Majdani, MDb,
J. Michael Fitzpatrick, PhDc
a
Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University
Medical Center, 7209 Medical Center East, South Tower, 1215 21st Avenue
South, Nashville, TN 37232, USA
b
Department of Otorhinolaryngology, Medical University of Hannover, Hannover,
Germany, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
c
Vanderbilt University, 363 Jacobs Hall, 400 24th Avenue South,
Nashville, TN 37212, USA

If they haven’t already, systems for image-guided surgery (IGS) are com-
ing to an operating room near you. IGS systems are already commonplace
for sinus surgery and neurosurgery. The appeal of IGS systems is that they
allow real-time tracking of current anatomic position on preoperative CT or
MRI scans. (Note: IGS systems differ from real-time intraoperative imag-
ing, such as CT/OR or MRI/OR suites, where surgically induced anatomic
changes are visible.) Although IGS systems do not replace detailed anatomic
knowledge, they have been shown to improve outcomes with inexperienced
[1] and experienced surgeons [2,3].
The transition of IGS from sinus surgery and neurosurgery to otology/
neurotology has been stalled by the need for a compact system that has ac-
curacy at a level suitable for the skull basedon the order of %1 mm. Com-
mercially available systems do not achieve this level of accuracy without
bone-implanted fiducial markers. Once this level of accuracy is achieved,
however, the use of IGS in skull base surgery will have profound implica-
tions, including safety control (eg, turning off the drill when a critical
boundary is reached), robotic surgery (eg, robotic milling of the mastoid),
and minimally invasive surgery (eg, percutaneous cochlear implantation).
Before presenting these exciting applications of IGS in otology/neurotol-
ogy, we first must understand the basics of IGS systems. This understanding
is crucial in being able to appreciate the strengths and weaknesses of IGS.
Contained herein is (1) a description of IGS systems focusing on the

* Corresponding author.
E-mail address: robert.labadie@vanderbilt.edu (R.F. Labadie).

0030-6665/07/$ - see front matter Ó 2007 Elsevier Inc. All rights reserved.
doi:10.1016/j.otc.2007.03.006 oto.theclinics.com
612 LABADIE et al

‘‘accuracy’’ of such systems, (2) a review of the current commercially avail-


able systems, and (3) an overview of future applications of IGS in otology/
neurotology.

How image-guided surgery systems work


IGS systems are analogous to global positioning systems but on a much
smaller, local scale. The typical set-up is depicted schematically in Fig. 1.
The systems consist of (1) a set of markers on a patient (called ‘‘fiducial
markers’’ or simply ‘‘fiducials’’), which are present during preoperative
CT or MRI scanning, (2) a computer tracking system used in the operating
room that aligns the markers in the CT or MRI to the current anatomy and
tracks a patient’s fiducial markers within the operating room. For tracking,
most systems (eg, BrainLAB, Feldkirchen, Germany; Medtronic, Minneap-
olis, Minnesota; and Stryker, Stryker Leibinger, Inc., Kalamazoo, Michi-
gan) use infrared technology, whereas one system (GE Medical Systems,
Lawrence, Massachusetts) uses electromagnetic field distortion technology.
Infrared systems are limited by line of sight, whereas electromagnetic sys-
tems are distorted by metal instruments within the surgical field.

Fig. 1. Typical IGS set-up.


IMAGE-GUIDED TECHNIQUE IN NEUROTOLOGY 613

Fiducial markers
The key to IGS systems are the fiducial markers. The familiar computer
axiom that holds that ‘‘garbage in equals garbage out’’ is applicable to IGS
systems because the only items visible to the IGS system are the fiducials.
Tracking of unknown anatomy depends on actively matching fiducial
markers in the preoperative scan to those within the operating room. This
matching requires an accurate determination of the position of each fiducial,
a process that is termed fiducial ‘‘localization.’’ Without excellent fiducial
localization, all anatomic point localization is compromised. Fiducial markers
range from neurosurgical N-frames (rarely used given less cumbersome
choices), bone-implanted screws, proprietary head-frames (eg, GE Instatrack
head frame), skin-affixed adhesive markers, contours of surfaces obtained by
laser scanning, and dental-affixed mouthpieces. The requirements for excel-
lent fiducials are that (1) they are repeatedly positioned in exactly the same
location relative to patient anatomy during radiographic imaging and in the
operating room (a flaw for all non–bone-affixed systems), (2) they surround
the anatomic region of interest, (3) a sizeable number of markers is used,
and (4) they can be accurately localized.
Why are fiducial markers the key? Fiducial markers are the only things vis-
ible to the IGS system. Everything else depends on them. Once a CT or MRI
scan is loaded into the IGS computer, the operator finds the same fiducial
markers on the patient in the operating room, and the computer’s job is to
align/superimpose the fiducial markers from the CT or MRI scan to those
found in the operating room. To the extent that the anatomy is rigid, fiducial
alignment ensures that the anatomy, including surgical targets, is also aligned.
This process is called ‘‘registration.’’ This important process deserves a precise
definition: Registration is the alignment of anatomic points from the radio-
graphic scan (eg, CT or MRI) with their true positions in the operating
room. This process is schematically illustrated in Figs. 2–4.

Error within image-guided surgery systems


As one can imagine, error is inherent to the process. Although not often dis-
cussed in brochures or advertisements, an engineering standard does exist in
analysis of IGS. This analysis assigns error to each step of the process, as
shown in Fig. 4. First is ‘‘fiducial localization error’’ (FLE), which is the error
in identifying the positions of the fiducial markers in the radiographic images
(FLErad) and in the operating room (FLEOR). Contributions to FLErad
include the resolution of the CT or MRI scan, image distortion of the scan,
and noise in the scan. Components of FLEOR include human error in identi-
fying the fiducial markers and error inherent in the tracking system. Overall,
FLE represents the error in finding the fiducial markers. In an ideal world, the
location of fiducial markers could be determined perfectly; given the imperfec-
tions of the real world, however, this rarely happens. Thus FLE is rarely zero.
When fiducial locations are imperfectly determined, alignment of the markers
614 LABADIE et al

Corresponding
fiducial markers

surgical target
Radiographic Operating
Image Room
Fig. 2. Fiducial markers (rectangles) can be seen on the surface of the patient in the radio-
graphic image (left) and in the operating room (right). Also shown is the surgical target (small
oval in the midst of the larger oval), which we are interested in identifying with IGS.

from the radiographic study to the operating room is also imperfect. The
resultant error in aligning fiducial markers is termed ‘‘fiducial registration er-
ror’’ (FRE) and is graphically depicted in Fig. 4. To minimize this error,
a mathematical best-fit algorithm is used to minimize the differences between
the corresponding image and patient fiducials. (Most systems use a strategy
that minimizes the sum of the squares of the distances between fiducial
markers). The FRE or a derivative of it is the number typically displayed
on IGS systems after registration as an indication of the goodness of fit.
Only after registration is done can IGS tracking begin. Once tracking is
initiated, the surgeon identifies a point of anatomic interest. The difference

REGISTRATION:
align corresponding
fiducials

Radiographic Operating
Image Room

Fig. 3. Registration. Corresponding fiducial markers are actively aligned in registering the ra-
diographic image of the patient to the actual patient in the operating room. The active aligning
of the fiducials is paramount in passively aligning all other tissue, including the surgical target
(small oval within larger oval).
IMAGE-GUIDED TECHNIQUE IN NEUROTOLOGY 615

Fiducial Localization Error


(FLErad)

Fiducial Localization Error


(FLEOR)

Radiographic Operating
Image Room

Fiducial Registration Error


(FRE)
Target Registration Error (TRE)
(a.k.a. ACCURACY)

Fig. 4. Error analysis for IGS. Error occurs when identifying fiducials in the radiographic im-
age (FLErad) and when identifying fiducials in the operating room (FLEOR). Error also occurs
when aligning the fiducials (FRE). The accuracy of the system is the error in finding surgical
targets (TRE). TRE and FRE depend on FLE. The keys to IGS are the fiducial markers.

between where the IGS system says the anatomy is located and its true
position is termed ‘‘target registration error’’ (TRE)dthe accuracy of the
system. TRE and FRE each statistically depend on FLE via relationships
that are beyond the scope of this article. (The interested reader is directed
to Fitzpatrick and colleagues [4].) An important point to remember is that
TRE for a system is not well described by a single number but rather a sta-
tistical distribution. When one states that the accuracy of a system is 1 mm,
what is actually being implied is that the average accuracy of the system is 1
mm, but the accuracy may in fact be higher or lower at any particular time.
(The statistical distribution is a chi-squared distribution with 3 degrees of
freedom [Fig. 5]). When comparing systems, the TRE within the anatomic
region of interest should be compared.
A common misconception is that lower FRE means a more accurate reg-
istration, which is not necessarily true. Although most systems have a thresh-
old below which FRE must fall to proceed with IGS, lowering FRE further
below this threshold does not mean higher registration accuracy. Some au-
thors have called for removal of fiducial points from the registration to
lower FRE [5]. This approach is dangerously flawed. Although FRE tends
statistically to decrease with fewer fiducials, error in target alignment
(TRE) tends to increase [6]. Because FRE can be observed directly, it is
tempting to removal fiducials to see a reassuringly smaller error value dis-
played on the IGS screen, but the chances are great that removing them
will increase the error that countsdthe error in hitting the target (ie,
TRE). Many examples can be given to illustrate this effect, but the simplest
is the case of one fiducial. When only one fiducial is used, FRE may be easily
reduced to zero, but as is depicted in Fig. 6, a zero fiducial registration error
616 LABADIE et al

Fig. 5. Statistical distribution of accuracy (TRE). Although a single number is usually reported,
it must be kept in mind that it represents a probability distribution (chi-squared with 3 degrees
of freedom). Thus, the true value can be much higher or lower. (From Labadie RF, Davis BM,
Fitzpatrick JM. Image-guided surgery: what is the accuracy? Curr Opin Otolaryngol Head
Neck Surg 2005;13:29; with permission.)

clearly does not mean a more accurate registration. When more markers are
used, because of the uncertainty in their localization (FLE), FRE tends to
rise but TRE likely decreases, which results in better accuracy. For clinical
use, more fiducial markers are better, even if it means a larger FRE.
For laser scanning systems, the analysis described in the preceding para-
graphs is as follows:
 A three-dimensional surface model is constructed from the radiographic
data, and multiple points are captured from the surface of the patient in
the operating room using a scanning laser.
 The collection of these anatomic points (fiducials) is compared with the
surface generated from the radiographic data and aligned such that the
distance from the collection of points to the surface is minimized. This
concept is similar to using multiple fiducial markers.
 A larger FRE may result from more anatomic points captured during
laser scanning. This larger FRE does not mean that the TRE would
be higher; rather the TRE would be expected to be lower. More laser
scans are better even if it means a larger FRE.

Commercially available image-guided surgery systems


Although no IGS systems are marketed for lateral skull base surgery,
many are approved by the US Food and Drug Administration (FDA)
and currently are used for sinus surgery and neurosurgery. An in-depth
IMAGE-GUIDED TECHNIQUE IN NEUROTOLOGY 617

A B

Registration with Registration with


1 fiducial multiple fiducials

Small FRE

Small TRE Large FRE


(good accuracy)
Large TRE
(poor accuracy)

Fig. 6. Registration examples. (A) A single fiducial marker allows excellent registration (small
FRE), but TRE (accuracy) may be poor. (B) Multiple markers make registration more error
prone (large FRE), but TRE (accuracy) is excellent.

review of the accuracy of such systems was performed for a prior publica-
tion [7] and is repeated in this article with permission from the publisher.
The four leading commercial IGS systems used for sinus surgery are (in
alphabetical order):
BrainLAB system (BrainLAB, Feldkirchen, Germany)
InstaTrak System (GE Medical Systems, Lawrence, Massachusetts)
LandmarX and StealthStation system (Medtronic, Minneapolis,
Minnesota)
StrykerImage Guidance System (Stryker Leibinger, Kalamazoo,
Michigan)
For each of these systems, the literature was reviewed to find the most
relevant article reporting accuracy of the system. Each company was con-
tacted to determine whether the cited study was the most up-to-date regard-
ing error analysis.

BrainLAB
For the BrainLAB system, no error studies could be identified specifically for
sinus surgery, but such work has been done for neurosurgical applications,
which use similar fiducials and registration methods. In a study performed at
the University of Regensburg, Germany, error analysis for 36 patients undergo-
ing intracranial surgery was performed [8]. FRE using skin-affixed fiducial
618 LABADIE et al

markers was reported as 1.10  0.53 mm; using laser skin contouring, FRE was
reported as 1.36  0.34 mm. TRE was calculated by comparing a skin-affixed
marker on the patient with that location in the corresponding radiographic im-
age; for the skin-affixed marker registration, TRE was reported as 1.31  0.87,
and for laser skin contouring, TRE was reported as 2.77  1.64 mm.

InstaTrak
For the InstaTrak System, a multicenter, multisurgeon study was per-
formed and published in Laryngoscope in 1997 [9]. In this study, registration
was performed either with six skin-affixed markers or a proprietary headset.
TRE was measured using two skin-affixed targets placed on the lateral right
and left supraorbital rims. FRE was not reported. For the skin-affixed fidu-
cial registration, a TRE of 1.97 mm with a 95% CI, of 1.75 to 2.23 and
a maximum value of 6.09 mm was reported. For the headset registration,
a TRE of 2.28 mm with a 95% CI, of 2.02 to 2.53 and a maximum value
of 5.08 mm was reported.

LandmarX
For the LandmarX system, Metson and colleagues [10] performed a pro-
spective study of 34 physicians performing 754 sinus cases over a 2.5-year
period. Using five anatomic key points as fiducials (these points are unde-
fined), they reported ‘‘mean accuracy of anatomical localization at the start
of surgery was 1.69  0.38 mm (range, 1.53  0.41 mm to 1.79  0.53 mm).’’
Although the specific methods are not given, this study seems to report
FLEdthe error associated with repeated identification of the fiducialsd
and not TRE. Hence the question mark in Table 1.

Stryker
The Stryker Image Guidance System was evaluated prospectively on 50 pa-
tients undergoing anterior cranial base surgery by Snyderman and colleagues
[5]. Each patient had ten skin-affixed fiducials placed over the scalp, lateral
face, and mastoid. TRE was not measured in this study. Rather, the authors
reported the error within zone of accuracy, which is an estimate of TRE based
on FRE performed by an algorithm proprietary to Stryker. They reported for
their clinical applications that the Stryker system estimates that in a zone of
accuracy, which it demarcates in image space, it has achieved a TRE !2
mm. The authors visually validated the registrations, but they reported no
independent error measurements to check these estimates.

Applications of image-guided surgery in otology/neurotology


Within our literature there are limited references to the clinical use of IGS.
(Excluded from the current discussion is the use of IGS for virtual training; eg,
virtual temporal bone trainers.) Use of IGS clinically has been limited to
IMAGE-GUIDED TECHNIQUE IN NEUROTOLOGY 619

Table 1
TRE for commercially available otolaryngologic IGS systems
IGS system Manufacturer TRE (mm) Fiducial Author/reference
BrainLAB BrainLAB, 1.31  0.87 Skin-affixed Schlaier, 2002 [8]
Feldkirchen, markers
Germany 2.77  1.64 Laser skin
contour
InstaTrak GE Medical 2.28  0.91 Proprietary Fried, 1997 [9]
Systems, headset
Lawrence,
MA
LandmarX Medtronic, 1.69  0.38 (?) Skin-affixed Metson, 2000
Minneapolis, markers [10]
MN
Stryker Stryker !2 mm Skin-affixed Snyderman, 2004
Navigational Leibinger, ‘‘zone of markers [5]
System Inc., accuracy’’
Kalamazoo,
MI
Data from Labadie RF, Davis BM, Fitzpatrick JM Image-guided surgery: what is the
accuracy? Curr Opin Otolaryngol Head Neck Surg 2005;13:27–31

confirmation of anatomic identity during surgery. The first published clinical


reference was in 1997, when Sargent and Buccholz [11] reported on the use of
IGS for middle cranial fossa surgery. In 2003, Caversaccio and colleagues [12]
reported on the use of IGS during aural atresia drill-outs, stating that it
reduced operative time and potentially could reduce morbidity. Also in
2003, Raine and colleagues [13] reported on the use of IGS in guiding deep
drilling during split electrode cochlear implant placement.
It is surprising to the authors that IGS has not been exploited more by
otologists/neurotologists given (1) the extensive use by neurosurgeons that
shows more complete disease resection in less operative time [2,3] and min-
imally invasive surgery for placement of deep brain stimulators [14], (2) the
large numbersdupwards of 100,000 mastoidectomies per yeardof otologic
procedures performed annually in the United States [15], (3) projections that
IGS will be a part of operating rooms of the future [16], and (4) predictions
that IGS offers an area of advancement of our field [17]. Areas in which IGS
may have large impact on otology/neurotology include (1) safety constraints
regarding surgical tool control, (2) robotic surgery, and (3) minimally in-
vasive surgery, such as percutaneous cochlear implantation.

Safety controls
Perhaps the most practical application of IGS is increased safety control.
In otology/neurotology, in which the surgical field is encased in rigid bone,
the use of IGS to define boundaries and prevent transgressions has great
appeal. Two groups have been working on this, including the authors [18]
and a group from Germany [19].
620 LABADIE et al

The concept is simple: define the boundaries of the surgical field (eg, teg-
men, sigmoid, external auditory canal, facial nerve, labyrinth), track the po-
sition of the drill, and turn it off when the drill approaches vital anatomy.
Although both groups have limited experimentation in nonhuman models,
volumetric speed of drilling is increased using such IGS-controlled drill
cut-off, especially for inexperienced surgeons.

Robotic mastoidectomy
Robots have been used in operating theaters for more than 20 years.
Their advantages are many, including reliability, repeatability, and lack of
tremor. Probably best known is the da Vinci Surgical System (Intuitive
Surgical, Sunnyvale, California), which has been cleared by the US FDA
for laparoscopic procedures [20]. The daVinci system is considered a ‘‘mas-
ter–slave’’ system, meaning that the robot mimics the surgeon’s motions,
eliminating tremor and miniaturizing motions. It acts as an extension of
the surgeon and depends on the surgeon performing the procedure. In con-
trast to master–slave robots, autonomously acting robots offer the potential
of replacing the surgeon for at least portions of surgical procedures. Auton-
omous robots have use in several surgical applications in which the proce-
dure can be planned a priori. The FDA-approved ROBODOC (Integrated
Surgical Systems, Davis, California) is an example of an autonomous robot
used to perform a component of total hip replacement surgery [21,22].
(Note: Novatrix Biomedical Inc., San Clemente, California, has an agree-
ment of purchase for Integrated Surgical Systems at the time of this writing.)
To use this system, the surgeon first locates fiducial markers attached to the
femur and visible in the CT scan. The ROBODOC system then registers the
preoperative CT scan with the surgical anatomy and plans an optimal
milling of the femur for placement of a prosthetic shaft. The robot aligns
itself to the optimal trajectory and drills a cylinder of specified diameter
and depth.
In otologic surgery, autonomous robots have been used to surface mill
the temporal bone to a depth of 4.5 mm to create a receiving well for the
internal processor of a cochlear implant device [23]. Recently, our group ex-
tended this work with the goal of performing a robotic mastoidectomy. To
accomplish such a task we have built an open-architecture, autonomous ro-
bot and incorporated it with an IGS system. Preliminary studies with this
system show that it can drill the volume of a mastoid cavity repeatedly in
approximately 4 minutes. Given the ‘‘x-ray vision’’ afforded by IGS, the
typical strategy of visual identification of mastoid boundaries may be re-
placeable by more effective edge routing techniques, which remove the mas-
toid en bloc. Note that such a system is not intended to replace the surgeon.
Rather it is intended to carry out low-level milling and allow the surgeon to
concentrate on the high-level tasks of fine drilling on vital structures (eg,
facial nerve, internal auditory canal).
IMAGE-GUIDED TECHNIQUE IN NEUROTOLOGY 621

Minimally invasive surgery: percutaneous cochlear implantation


Perhaps the most powerful aspect of IGS applied to otology/neurotology
is the concept of truly minimally invasive surgery. The authors from Van-
derbilt have been working on the concept of minimally invasive surgery as
applied to cochlear implantation for the past 5 years [24,25]. The author
from the University of Hanover also has been performing similar work [26].
The concept (Fig. 7) is to use radiographic guidance to drill directly from
the surface of the skull to the cochlea without injuring vital structures. To
achieve the necessary accuracy in avoiding the facial nerve, bone-implanted
fiducials are placed around the temporal bone. Initial efforts were performed
free-hand, analogous to the way functional endoscopic sinus surgery is cur-
rently performed [24]. Majdani and colleagues [26] reported a similar ap-
proach using robots. Extensions of this work include automated paths
constrained by drill guides [25]. After CT scanning, a proposed drill path
is predicted using a computer program. If the surgeon accepts the proposed
path, an electronic plan is sent for rapid prototyping of a drill guide, which
mounts on the bone-implanted fiducials and constricts the motion of the
drill to pass through the facial recess and intersect the basal turn of the

Fig. 7. The concept of percutaneous cochlear implant. With IGS, a path from the lateral cortex
of the mastoid to the cochlea avoiding vital structures (eg, the facial nerve) can be planned.
(From Labadie RF, Choudhury P, Cetinkaya E, et al. Minimally-invasive, image-guided, facial
recess approach to the middle ear. Otology Neurotology 2005;26:560; with permission.)
622 LABADIE et al

cochlea. We recently completed our first validation on a human patient


(Fig. 8) via funding from the Triological Society and are embarking on
a multicenter trial funded by the National Institutes of Health. This concept
is not limited to cochlear access; it includes access to any structure within the
temporal bone (eg, endolymphatic sac, semicircular canals).

Summary
IGS systems enhance surgical navigation by linking preoperative radio-
graphic scans to intraoperative scans, and they are coming to otology/neu-
rotology. The keys to IGS systems are fiducials markers (also known as
‘‘fiducials’’ or ‘‘markers’’). The positions of these markers, which are at-
tached to the patient before imaging, are determined in the image and on
the intraoperative scan and are used to align the two. Determination of
fiducial position is never perfect, which results in FLE. Ideal fiducial
markers are repeatedly mounted around the anatomy of interest, with the
most accurate being bone-implanted markers. Alignment is never perfect,
and as a result there is inevitable error in the alignment of the fiducials,
termed FRE, and in the alignment of surgical targets, termed TRE. The lat-
ter alignment represents the accuracy of the guidance system.
Typical IGS systems display FRE intraoperatively and specify that it fall
below a set threshold for reliable navigation. Using more fiducial markers
results in a higher FRE but is likely to provide better guidance accuracy

Fig. 8. Clinical validation of percutaneous cochlear implantation. The drill guide attached after
traditional right cochlear implant surgery (top left). A magnified view showing the drill bit pass-
ing through the facial recess (bottom right).
IMAGE-GUIDED TECHNIQUE IN NEUROTOLOGY 623

(lower TRE). Current FDA-approved IGS systems for otolaryngology-head


and neck surgery have accuracies (TREs) on the order of 2 mm with nonin-
vasive fiducials (ie, skin-affixed markers, proprietary headsets, laser scan-
ning of facial features).
To date, clinical application of IGS otology/neurotology has been lim-
ited, but a large potential market and numerous applications support its
use. Such applications include control of surgical instruments (eg, turning
off a drill when close to an anatomic boundary), robotic surgery (eg, robotic
mastoidectomy), and minimally invasive surgery (eg, percutaneous cochlear
implantation).

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