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D. Hui et al.
Dosing, Timing, andRoute ofAdministration
For angiography and assessment of tissue perfusion, ICG can be
given immediately intraoperatively as an intravenous bolus injection of 1.25 to 5mg. ICG can be injected directly into the skin for
reconstructive surgeries in a dose of 3.75 to 10mg. Maximum
dose is 2mg/kg.
For visualization of extrahepatic biliary duct for use in patients
ages 12 and older, ICG should be administered at least 45min
prior to surgery as an intravenous bolus injection of 2.5mg.
For lymphangiography, visualization of lymph nodes, and
lymphatic mapping, ICG can be injected directly into target tissue
as a direct injection of 5mg or divided into four 1.25mg injections around target tissue.
As the rst clinically available FGS system, the SPY System
established the clinical utility of FGS but has largely been replaced
by handheld devices and other newer systems. The FDA has
determined the SPY Elite System was substantially equivalent to
the predicate SPY System device as a uorescence imaging system for use in imaging blood ow in plastic surgery (microscopic
and reconstructive), gastrointestinal surgery, transplant surgery,
cardiovascular surgery, and vascular surgery [20].
The SPY Elite System is able to provide real-time monochromatic images of uorescent tagged structures (Fig.2.1b) for the
assessment of perfusion. SPY Elite contains updated processing
and image acquisition software (CINEVAQ) that is able to overlay a color intensity gradient to the grayscale NIR image. This
color intensity image can be recorded and reviewed to assess
perfusion via SPY mode (Fig.2.1c). SPY mode analyzes differences in near-infrared color intensities to offer objective values
on estimated perfusion in the form of absolute perfusion units
(APUs) to assess how well-perfused structures are during surgery [18–20].
The cart-based SPY Systems have been used across many surgical specialties since its clinical debut in 2005. Within the eld of
plastic surgery, it is used to assess tissue perfusion in reconstruction. SPY Elite laser angiography can help predict tissue necrosis
following microvascular and reconstructive procedures such as
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facial reconstruction and nipple-sparing mastectomies [21–23].
Using the SPY proprietary software, absolute perfusion units
(APUs) offer objective data on tissue perfusion with studies showing APUs of less than 24 associated with increased risk of tissue
necrosis [24, 25]. A randomized double-blinded controlled study
on complex abdominal wall reconstruction using the SPY Elite
System displayed that real-time perfusion assessment could predict intraoperatively which patients were at increased risk for
wound complications [26].
The SPY Elite System has been used for laser angiography of
gastrointestinal anastomosis. SPY Elite angiography has displayed utility in assessing bowel perfusion when creating gastrointestinal anastomoses, but there have been no randomized
controlled studies to assess whether its use decreases anastomotic
failure [27–31]. The system has been used as an adjunct to assess
graft patency following bypass in open heart surgery [32].
Recently, lymphangiography during sentinel lymph node biopsies
has shown a non-inferior capability to identify lymph nodes compared to traditional approaches (radiofrequency labeling and
application of dyes) [33, 34].
Pearls and Pitfalls
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• SPY mode relies heavily on the quality of near-infrared images.
Tissue should be in plane with the imager at an ideal distance
of 30cm.
• SPY perfusion assessment can be used in real time or saved for
later review.
Handheld Devices
SPY Portable Handheld Imaging (PHI): HH9000—Stryker,
Kalamazoo, Michigan, USA
SPY PHI (Fig. 2.2a) was initially developed by Novadaq
Technologies as a handheld system approved for uorescenceguided surgery in open surgical procedures. SPY PHI is the handheld version of the rst clinically available uorescence-guided
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D. Hui et al.
a b
Fig. 2.2 (a) SPY PHI handheld device—Photo courtesy of Stryker. (b) SPY
PHI in SPY mode—Photo courtesy of Stryker. (c) SPY PHI in colorsegmented mode—Photo courtesy of Stryker. (d) SPY PHI in overlay
mode—Photo courtesy of Stryker
surgical system, the SPY System. The system consists of a handheld imager that is directly manipulated by the surgeon at target
anatomy in order to obtain NIR images.
SPY PHI System Components
The system includes the following: SPY PHI imager with integrated light cable, video processor/illuminator (VPI), display
(1080p resolution), SPY PHI Fluorescence Assessment Software
(SPY-QP), sterile drape, and SPY AGENT GREEN (ICG)—
25mg vials.
During use, SPY PHI platform is positioned for optimal visualization of the monitor. The handheld imager is connected to the
video processor/illuminator with a light cable and camera cable.
The imager is then sterilely draped, using the included clear
drapes, and is now free to position sterilely in the operative eld.
The working distance of the imager is 10–40cm. The green illumination button on the handheld device activates the light source
and NIR laser for uorescence excitation. The camera is able to
detect full-color visible light and NIR images with the default
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image in overlay mode. The preferred uorophore with SPY PHI
System is SPY AGENT GREEN (ICG) with identical dosing and
timing as with the SPY Elite System [35, 36].
Novadaq (now part of Stryker) developed its handheld uorescence imaging system in 2017 with model HH9000. The currently
available system is the SPY PHI model HH9000 now with SPY- QP
Fluorescence Assessment Software. The FDA has determined the
current system was substantially equivalent to the predicate SPY
Elite System for use in imaging blood ow in plastic surgery
(microscopic and reconstructive), gastrointestinal surgery, transplant surgery, cardiovascular surgery, and vascular surgery. SPY
PHI provides real-time visible and NIR imaging with multiple
modes. SPY mode (Fig.2.2b), color-segmented uorescence (CSF)
mode (Fig. 2.2c), and overlay mode (Fig. 2.2d) can be toggled
using button “A” on the handheld device. SPY mode is a pure uorescence image, displayed in monochromatic format to detect only
NIR images. Color-segmented uorescence (CSF) mode displays
visible light in grayscale with uorescence overlay in different
color intensities to display uorescence ranges (blue being the lowest to yellow and then red as the highest). Overlay mode allows for
real-time visualization in the visible and NIR spectrum simultaneously, with uorescence overlaid in green. SPY-QP software can be
accessed from the handheld device via button “B” or through the
VPI console. SPY-QP provides uorescence assessment via relative
percentage values (Fig.2.2e) compared to a user set reference point
and by color mapping similar to CSF mode [35–37].
Much like the SPY Elite System, the SPY PHI System has
shown utility in a variety of clinical situations, including ap
reconstruction, bowel anastomosis creation, and sentinel lymph
node tracing [38, 39]. Because it is a handheld device, it has a
more compact design that is user friendly in the operating room.
Pearls and Pitfalls
• Plug in device to the VPI prior to turning the system on to pre-
vent “camera cable not detected” error.
• Easy-to-use handheld controls to toggle uorescence on and
off (green button) and adjust focus of captured image (up and
down blue buttons).
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• The VPI menu accessed from button “B” allows users to access
SPY-QP and make adjustments such as ipping the image and
capturing stills or video. Additionally, the reference point for
SPY-QP assessment can be changed via this menu.
• The device has a wide range working distance (10–40cm). It
is recommended that the user starts further away for better
clarity in perfusion assessment.
• SPY-QP should be activated prior to administration of ICG
with recommendation to not change uorescence mode during
the timed perfusion assessment window (indicated by a red
arrow and timer on the bottom right of the monitor).
Photodynamic Eye (PDE)-neo II infrared uorescence
imager: C10935-400—Hamamatsu Photonics K.K, Higashi-ku,
Hamamatsu City, Japan
PDE-neo II (Fig.2.3a) was developed by Hamamatsu Photonics
as a handheld system approved for uorescence-guided surgery in
open surgical procedures. PDE-neo II is a handheld system
designed to visualize ICG in the blood or lymph systems in real
time. The system utilizes a handheld imager that can be directly
held or mounted to a exible arm to manipulate over the desired
anatomy.
D. Hui et al.
PDE-Neo II System Components
The system includes the following: camera unit with attachable
camera cable, controller box, remote controller, TEAC recording
box, monitor, sterile drape, ICG dye, and PDE FlexArm.
During use, the PDE-neo II platform is positioned for optimal
visualization of the monitor located on the cart. The controller
box is turned on and the camera unit is plugged directly into the
input access on the far right. The TEAC recording box can be
turned on to allow for video and image capturing but is not essential for use of the device. The camera unit is then sterilely draped
and locked into the foam lens cover attached to the drape. An
optional rail or clamp attachment for the exible arm mount can
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a
b
c
Fig. 2.3 (a) PDE-neo-II handheld device—Photo courtesy of Hamamatsu.
(b) PDE-neo-II in uorescence mode—Photo courtesy of Hamamatsu. (c)
PDE-neo-II in uorescence mapping mode—Photo courtesy of Hamamatsu
be secured to allow for hands-free operation of the camera unit.
The working distance of the camera unit is 5–30cm and image
clarity can be obtained using the adjustable focus ring. A nonsterile assistant can then turn on the white light and uorescence
mode using the remote controller. The handheld camera unit can
then toggle between color and uorescence at the discretion of the
surgeon. Fluorescence excitation is achieved using a class 1M
LED that produces infrared emissions at a wavelength of 820nm.
These infrared images can be captured via the camera unit with
ambient room lights on but may scatter and produce poorer
images if direct sunlight is present in the room. The timing and
dose administration of a 2.5mg/mL concentration of ICG varies
depending on indications for use [29–37].
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D. Hui et al.
Dosing, Timing, andRoute ofAdministration
For angiography and assessment of tissue perfusion, ICG can be
given immediately intraoperatively as an intravenous bolus injection of 3.3mL to 10mL.For lymphangiography, visualization of
lymph nodes, and lymphatic mapping, ICG can be injected into
target tissue as a direct subcutaneous or intradermal injection of
0.5mL around target tissue.
PDE-neo II was originally developed by Hamamatsu
Photonics with distribution within the United States via Mitaka
USA Inc. Hamamatsu initially developed its handheld uorescence imaging system in 2014 with the Hamamatsu PDE and
subsequent PDE- neo. The currently available system distributed by Mitaka since 2016 is the PDE-neo II.The FDA determined that the system was substantially equivalent to the
predicate PDE-neo device for use in viewing uorescence
images of blood ow. PDE-neo II has two video channel outputs that can toggle between color mode and uorescence mode
(Fig.2.3b). The uorescence mapping mode (Fig. 2.3c) digitally enhances NIR images with green color which can dene
structures containing uorescence compared to surrounding
structures. The resulting image quality can be adjusted by using
the brightness, contrast, and infrared intensity dials located on
the remote controller [40–42].
PDE-neo II was designed as a uorescent angiographic system
for use in assessing tissue perfusion. It is commonly used in
reconstructive surgery for ap assessment and has been found to
assist clinical judgment when determining whether to resect additional tissue [43–45]. PDE-neo II can also assist in identifying
resection margins in pulmonary and hepatic wedge resections
[46]. PDE-neo II was able to successfully identify tumor margins
during lung segmentectomy to maximize tissue preservation.
PDE-neo II provides enhanced visualization of the thoracic duct
during mediastinal lymphadenectomy to prevent chyle leak in
thoracic surgery [47]. The device can also be utilized to evaluate
patients with lymphedema for lymphaticovenous anastomosis and
postoperatively to evaluate for anastomosis patency [48].
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Pearls and Pitfalls
• Simple, lightweight handheld device with adjustable focus
ring with surgeon control over infrared intensity and image
toggling.
• Remote controller separate from handheld device can adjust
contrast and brightness to enhance visualization.
• With initial use, recommend that the contrast, brightness, and
infrared intensity dials are placed in their default locations
marked on the remote controller..
• Visualization of halos during uorescence mode may indicate
infrared intensity is too high.
Fluobeam LX—Fluoptics, Grenoble, France
The Fluobeam LX (Fig.2.4a) was developed by Fluoptics as a
handheld system approved for FGS in open surgical procedures.
Fluobeam LX is Fluoptics’ newest handheld system designed to
visualize ICG uorescence in blood vessels and tissue perfusion
as well as autouorescence from parathyroid tissue.
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Fluobeam LX System Components
The system includes the following: optical head with light cord, control box, touchscreen display, Fluosoft software, and sterile drape.
For use, the Fluobeam LX is positioned with the touchscreen
monitor in view of the surgeon. The controller box is turned on
and the optical head with light cord is plugged directly into the
input access on the far left. The optical head is sterilely draped
with the optical window of the sterile drape attaching directly to
the lens of the optical head. The uorescence imaging system is
now free to use with control of uorescence imaging via the
power button on the touchscreen display or accessed from the
handheld joystick control. The system offers a high depth of eld
>5cm with variable working distances with autofocus and up to
10× zoom. Fluorescence is achieved via class 1M laser which
excites uorophores with emissions in the range of 800–900nm.
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D. Hui et al.
a
b
Fig. 2.4 (a) Fluobeam LX system—Photo Courtesy of Fluoptics. (b) Fluosoft
quantication analysis—Photo Courtesy of Fluoptics. (c) Fluobeam LX image
of parathyroid autouorescence—Photo Courtesy of Dr. Marco DeMarchi
100 %
c
70 %
50 %
30 %
10 %
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Infrared images can be captured via the camera unit with ambient
room lights on. There are no device-specic recommendations for
ICG dosing or timing with use of this device. Autouorescence
from parathyroid tissue does not require ICG [49, 50].
Fluoptics developed its handheld uorescence imaging system
in 2014 with the Fluobeam 800 Clinic Imaging Device. Although
the Fluobeam 800 remains clinically available, the Fluobeam LX
is the most recent system created by Fluoptics with emphasis on
parathyroid surgery. The FDA has determined the current system
is substantially equivalent to the predicate Fluobeam device as a
uorescence imaging system for use as an adjunctive method to
evaluate tissue and organ perfusion used in plastic surgery (microscopic and reconstructive) and transplant surgery [51–53].
Additionally, it has been FDA approved to observe autouorescence of parathyroid glands without the injection of ICG.Fluobeam
provides real-time NIR imaging with uorescence mode with
Fluosoft optimization of images. Fluosoft available on Fluobeam
800 provides quantication analysis that overlays color representation of relative tissue perfusion (Fig.2.4b). The relative tissue
perfusion shows maximal reference perfusion in red and lower
relative perfusion in black/blue. Perfusion assessment has been
shown to be effective even with angulation of the optical head
from 60 to 90° to the tissue (#). Image quality is automatically
optimized by Fluosoft software and contrast of images can be
adjusted by the surgeon via joystick controls [50].
Fluobeam LX was designed as a uorescence system for use as
an adjunctive visual assessment in parathyroid surgery. Fluobeam
is commonly used in endocrine surgery during parathyroid and
thyroid surgery with its ability to detect parathyroid autouorescence without the use of ICG [50, 54]. Fluobeam LX has been
successful in the uorescence visualization of parathyroid adenomas (Fig.2.4c) for resection and parathyroid tissue for preservation during thyroidectomy [55, 56]. With ICG, Fluobeam LX is
able to intraoperatively identify lymphatics and sentinel lymph
nodes for biopsies and is equivalent in accuracy to radioactive
tracing [53]. Perfusion assessment using Fluobeam with associated Fluosoft quantication analysis during reconstructive surgery
has shown that relative perfusion of less than 30% to likely be
nonviable tissue [52].
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