Is Transillumination as Predictive as
CT Image Guidance at
Confirming Device Access of the Frontal Sinus?
Frank Robert Glatz III, MD
The Center for Sinus, Allergy, and Sleep Wellness • Email: bobg38514@hotmail.com
ABSTRACT
BACKGROUND
Transillumination of the frontal sinus to confirm transnasal
balloon device position prior to sinus dilation is commonly
used. This study measured the accuracy of using
transillumination and of CT Image Guidance (IGS)
probes to confirm device tip location in the frontal sinus.
METHODS
Sixteen cadaveric specimens (32 frontal sinuses) were
prepared by cutting a window through the posterolateral
wall of the frontal sinus for transfrontal endoscopic
visualization of the ostium. Frontal sinus access was
randomized to a malleable balloon device with
transillumination or rigid probe with IGS. Physicians
blinded to transfrontal views used endoscopic visualization
during transnasal access to the frontal sinus and reported
their confidence (0=none, 4=very) at entering the sinus.
Two observers, using the transfrontal view of the frontal
sinus ostium, recorded ostial cannulation success/failure.
RESULTS
Access to the frontal sinus was successful in 30 of 32
attempts (94%) using the balloon device with transillumi-
nation and in 29 of 32 attempts (91%) using IGS. When
physician confidence at entering the frontal sinus was rated
a 4, this correctly predicted frontal cannulation in 29 of 29
instances with transillumination and in 27 of 28 instances
with IGS. When physicians were not “very confident,”
transillumination correctly indicated device placement
was not in the frontal sinus in 2 of 3 cannulation attempts
and IGS was correct in 2 of 4 attempts.
CONCLUSION
Access to the frontal sinus using transillumination is as effec-
tive as IGS. With both technologies, the positive predictive
value of device placement in the frontal sinus is very high.
–1–
INTRODUCTION
CT based image guidance (IGS) is commonly used to locate
and identify key sinus anatomy during sinus interventions.1-3
Sinus transillumination is also becoming more commonly
utilized as a positioning means for sinus balloon dilation
procedures.4-6 Transillumination and IGS can be particularly
helpful for interventional device placement in the frontal
sinus. Physician confidence in accurate placement of the
device can depend on several factors, depending on the
technology. IGS relies primarily on sophisticated triangulation
algorithms that project the device location on a CT image but
additional factors can also influence the “confidence” of the
position to the physician, such as the endoscopic image and
the “tactile feel”. Transillumination does not project the
device position on the CT scan but does provide visual
transillumination through the forehead to provide feedback
on device placement, and thus physician confidence on
device placement.
Figure 1. Fusion IGS Probe
A
Figure 2. XprESS LoProfile with LED Light Fiber. A) Balloon dilation
catheter in retracted position. B) XprESS in frontal recess/ostium.
C) XprESS balloon inflated.
A
B C
We compared the abilities of an IGS probe (Fusion™ ENT
Navigation System, Figure 1) to transillumination balloon
dilation technology (XprESS™ LoProfile with LED Light Fiber,
Figure 2) to access the frontal sinus and to compare the
accuracy of placement of each technology, based on the
confidence of placement, in a cadaver model.
While it is important for a frontal sinus positioning
technology to have a high rate of success, it is also important
that a positioning technology can give the user an indication
of confidence of the device position, which can be used
to inform decision making such as where or whether to
surgically intervene with dissection or balloon dilation
on a particular frontal sinus.
METHODS
Cadaver Model
Adult cadaveric specimens (unpreserved) were CT scanned
utilizing an IGS scanning protocol. Specimens were required
to exhibit frontal sinuses on both sides and were excluded
if they had an extremely deviated septum or severe concha
bullosa. Anatomic features considered challenging for frontal
sinus access (e.g., moderate concha bullosa, frontal septal cell)
were NOT excluded. A total of 16 cadaver specimens with
32 frontal sinuses were selected and prepared for the study.
To assess the proper placement of the test devices in the
frontal sinuses, the specimens were prepared to allow for
direct visualization of the frontal sinuses from a superiorly
based position. To facilitate this, the calvarium and brain
tissue were removed, exposing the interior of the brain cavity
adjacent the posterior walls of the frontal sinuses. An access
port was then made with a bur into the posterior wall of each
frontal sinus near the superior aspect. An angled endoscope
could then be positioned through the access port during the
device placement step to allow an independent observer to
view the device entering the frontal sinus. The nasal and sinus
anatomy were otherwise left completely intact.
Sinus Access Procedure
Two physicians (MK, FG), each trained and experienced
with both the XprESS™ and Fusion™ technologies, performed
the study.
Prior to accessing the sinuses, the IGS sensor was positioned
on the specimen forehead and the IGS probe was registered
per standard protocol. Access to each sinus was made in
conjunction with standard endoscopic imaging and the
CT scan was available for review.
Each sinus (n=32) was attempted utilizing both technologies.
The sequence of device used in each sinus was determined
using a randomization table.
IGS Probe
When attempting to access the frontal sinus with the IGS
probe, the physician made multiple attempts as needed to
try to position the tip of the device into the frontal sinus.
During placement of the IGS probe, the physician utilized
the feedback provided from the CT image, as well as tactile
feel and endoscopic cues.
–2–
XprESS Transillumination
When attempting to access the frontal sinus with the
XprESS LoProfile with LED Light Fiber device, the light was
activated and multiple attempts were performed as needed
to try to position the tip of the device in the frontal sinus. If
desired, the physician was also allowed to utilize the Light
Seeker (Entellus Medical) tool and then follow-up with the
XprESS/LED Light Fiber device. With transillumination the
physician relied on observation of the light pattern on the
forehead, as well as tactile feel, endoscope cues, and baseline
CT observations.
Confidence Assessment
Once the physician felt that the device was in the sinus, he
graded his confidence level of device placement on a scale of
0 (no confidence) to 4 (very confident). For the IGS probe,
confidence was based primarily on feedback from the CT
image guidance but also included tactile feedback cues and
endoscopic image cues. For the transillumination device,
confidence was based primarily on feedback from the
light illumination pattern on the forehead but could also
incorporate tactile feel, endoscope cues, and baseline CT
observations. Results were analyzed to determine if high
confidence could be used as a predictor of successful
placement for each of the technologies.
Placement Observation
The frontal sinus was then viewed endoscopically via the
superior access port to assess whether the device was in
the frontal sinus. This was performed by two independent
observers familiar with frontal sinus anatomy. The physician
was shielded from this observational endoscopic image and
was blinded to the result of this observation. In addition to
recording the physician’s trans-nasal endoscopic image,
cameras also recorded the IGS screen, the surgical field,
and the observer’s frontal sinus access port endoscope.
R E S U LT S A N D D I S C U S S I O N
Placement Success
• IGS
When the IGS probe was utilized as the first device in the
sinus, it was correctly placed in 15 of the 17 frontal sinuses
attempted (88.2% placement rate). See Figure 3 for an
example showing a correctly placed IGS probe. In 2
instances, the IGS probe was not located in the frontal sinus.
See Figure 4 for an example of a mispositioned IGS probe.
When the IGS probe was utilized as the second device in the
sinus, it was correctly placed in 14 out of 15 attempts (93.3%
placement rate) for an overall placement rate of 90.6%.
Figure 3. IGS correctly placed. A) IGS image with probe tip in sinus. Confidence and Placement Prediction
B) Surgical view. C) Transnasal view. D) Intrasinus view from
superior aspect.
• IGS
A B
The treating physician indicated they were “very confident”
(confidence score of 4) in the positioning of the IGS probe
in the frontal sinus in 28 of 32 cannulation attempts, and
in 27 of the 28 times the doctor was very confident their
assessment of frontal sinus access was accurate (Table 1).
There was one instance in which the doctor was very
confident the probe was in the frontal sinus when in fact it
C D
was not. In the 4 instances in which the doctor was not very
confident (confidence score 0-3), the IGS probe was in the
frontal sinus 2 of the 4 times.

Figure 4. Example of mispositioned IGS. A) Tip of probe is not within
ostium but behind cell wall (arrow). B) Corresponding IGS image.
A B
• Transillumination
The treating physician indicated they were very confident
(rating of 4) in the positioning of the balloon device in the
frontal sinus in 29 of 32 cannulation attempts, and in all 29
attempts with a very confident rating this was an accurate
assessment by the physician (Table 1). In the 3 instances
where the confidence was below a 4 rating level, the balloon
device accessed the frontal sinus in 1 of the 3 times.

Table 1. Confidence rating vs. placement success

Transillumination IGS
• Transillumination Confidence Not in Confidence Not in
Rating In Frontal Frontal Rating In Frontal Frontal
When the XprESS/LED Light Fiber was used as the first 4 14+15 = 29 0+0 = 0 4 13+14 = 27 0+1 = 1
device, it was correctly placed in 15 of 15 sinuses attempted 0-3 1+0 = 1 0+2 = 2 0-3 2+0 = 2 2+0 = 2
(100% success rate). See Figure 5 for an example of a
correctly placed XprESS balloon catheter.
Analysis of Sensitivity,
Confidence Rating Specificity,
In Frontal Positive Predictive Value,
Not in Frontal
When transillumination using the XprESS/LED Light Fiber and Negative
4 Predictive Value from a Physician
True Positive Confidence
False Positive

was utilized as the second device in the sinus, it was correctly Level of 40-3for Each of Transillumination
False Negative True Negative
and IGS
Positive predictive value = TP/(TP+FP)
placed in 15 of 17 sinuses (88.2% success rate), for an overall Negative predictive value = TN/(TN+FN)
Sensitivity = TP/(TP+FN)
placement rate of 93.8%. In 2 instances, the XprESS device When the placement confidence levels for each technol-
Specificity = TN/(TN+FP)
Transillumination IGS
was not positioned in the frontal sinus. See Figure 6 for an ogy are grouped between
Confidence
those with
Not in
“very high confidence”
Confidence Not in
example of a mispositioned XprESS device. Note that in (rating
Rating 4) and less confidence
In Frontal Frontal (rating
Rating0-3), the results of
In Frontal Frontal
4 14+15 = 29can0+0 Transillumination IGS0+1 = 1
this example, when the medial cell was retrospectively placement success be =analyzed
0 4 determine
to 13+14 = 27if placement
Positive
0-3 predictive
1+0 =value
1 0+2 = 229/29 = 100%0-3 2+0 =27/28
2 = 2+0
96%= 2
appreciated, the XprESS was subsequently placed correctly. confidence
Sensitivity can be a predictor
Transillumination ofIGSplacement
29/30 = 97% success = 93% 2).
27/29(Table
Specificity
Confidence Not in 2/2 =Confidence
100% 2/3 = 67%Not in
Table 2. Prediction
Rating
value definitions
In Frontal Frontal Rating In Frontal Frontal
Figure 5. XprESS LoProfile with LED Light Fiber correctly placed. Negative predictive value 2/3 = 67% 2/4 = 50%
4
Confidence 14+15
Rating= 29 0+0 =In0 Frontal 4 13+14Not
= 27 0+1 = 1
in Frontal
A) Light illuminating the sinus cavity. B) XprESS tip in sinus.
0-3 4 1+0 = 1 0+2 True
= 2 Positive 0-3 2+0False
= 2 Positive
2+0 = 2
A B 0-3 False Negative True Negative
Positive predictive value = TP/(TP+FP)
Negative predictive value = TN/(TN+FN)
Sensitivity = TP/(TP+FN)
Confidence Rating In Frontal Not in Frontal
Specificity = TN/(TN+FP)
4 True Positive False Positive
0-3 False Negative True Negative
Positive predictive value = TP/(TP+FP)
The results of using the confidence measure as a positive
Negative predictive value = TN/(TN+FN) Transillumination IGS
Figure 6. Example of mispositioned XprESS and then repositioned predictor
Sensitivity of placement
Positive=predictive
TP/(TP+FN)
Specificity = TN/(TN+FP)
value success
29/29are shown
= 100% in Table
27/283.
= 96%
correctly. A) Transillumination of medial frontal cell. B) Transnasal view. Sensitivity 29/30 = 97% 27/29 = 93%
C) XprESS tip seen in medial cell (arrow). D) CT scan showing medial Table 3. Prediction value results 2/2 = 100%
Specificity 2/3 = 67%
frontal cell. E) XprESS repositioned in frontal sinus. F) XprESS tip Negative predictive value 2/3 = 67% 2/4 = 50%
correctly positioned in frontal sinus. Transillumination IGS

A B C Positive predictive value 29/29 = 100% 27/28 = 96%

Sensitivity 29/30 = 97% 27/29 = 93%
Specificity 2/2 = 100% 2/3 = 67%
Negative predictive value 2/3 = 67% 2/4 = 50%

D E
F
Due to a small number of instances (seven) in which the
doctor was not “very confident” in device access of the frontal
sinus, and due to the low incidence of failing to cannulate the
frontal sinus (five), it isn’t appropriate to measure the
–3–
specificity or negative predictive value of the two
technologies. The most important function of IGS and
transillumination as used in this study was to indicate to
the treating physician if the device was correctly located in
the frontal sinus. There was only one instance in which a
technology provided information to the doctor that
incorrectly indicated the probe/device was in the frontal
sinus and this was with IGS. Overall, this study suggests that
transillumination is as sensitive and predictive as IGS in
confirming device location in the frontal sinus. The results
indicate that when the study device was not accurately
positioned within the frontal sinus, the treating physician
was not very confident based on light confirmation/IGS.
Study Limitations
The study was set up to allow both treatment devices (IGS
Probe and XprESS with LED Light Fiber) to access each
frontal sinus. A limitation of this study is that the second
access of a sinus may have been influenced by the accuracy
of the initial access.
866-620-7615
www.EntellusMedical.com
–4–
CONCLUSIONS
Using appropriate procedural techniques and a malleable-
tipped lighted balloon device, cannulation of the frontal
recess/frontal ostium can be achieved successfully and
repeatedly. In a head-to-head comparison, light confirmation
was as accurate as IGS confirmation when used to position
the device tip in the frontal sinus.
With both technologies, the positive predictive value of
device placement in the frontal sinus is very high.
REFERENCES
1
Sindwani R, Metson R. Image-guided frontal sinus surgery. Otolaryngol
Clin North Am. 2005 Jun; 38(3): 461-71.
2
Citardi MJ, Batra PS. Intraoperative surgical navigation for endoscopic
sinus surgery: rationale and indications. Curr Opin Otolaryngol Head
Neck Surg. 2007 Feb; 15(1): 23-7.
3
Leventhal D, Heffelfinger R, Rosen M. Using image guidance tracking
during balloon catheter dilation of sinus ostia. Otolaryngol Head Neck
Surg. 2007 Aug; 137(2): 341-2.
4
Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon
dilation: 1-year outcomes from a prospective, multicenter, open label
trial. Am J Rhinol Allergy. 2014 Mar-Apr; 28 (2): 156-163.
5
Brodner D, Alexander I, Chandler S, Cutler J, Saigal K. Accuracy of
transnasal cannulation and dilation of the maxillary ostium in cadavers
with intact uncinates. Am J Rhinol Allergy. 2013; 27(1): 58-61.
6
Friedman M, Wilson M. Illumination guided balloon sinuplasty.
Laryngoscope. 2009 Jul; 119(7): 1399-402.