Transcript No Slide Title

COOLTOUCH
™
CTEV
Endovenous Procedure
Clinical Slide Set
 2006 CoolTouch Inc.
7075-0083 Rev A
Venous Insufficiency Numbers
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80 million have venous insufficiency1
50 – 55% of women2
40 – 45% of men2
50% of patients seek treatment for
cosmetic reasons only
1.
American College of Phlebology Website
2.
RT Image, March 8, 2004
 2006 CoolTouch Inc.
Common Symptoms of
Vascular Insufficiency
 Most common in 70-80% of patients:*
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Aching
Itching
Burning sensation
Heaviness
Restless limbs
 Left untreated, these symptoms may progress to:
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Skin changes
Edema
Skin ulcerations
* Venous Digest, July 2005. Nicos Labropoulos, MD
 2006 CoolTouch Inc.
Patient Selection
 History of varicose veins caused by
incompetent valves and documented reflux
 Confirmed with duplex ultrasound
 CEAP Classification
C = Clinical severity
E = Etiology or cause
A = Anatomy
P = Pathophysiology
 2006 CoolTouch Inc.
CEAP Classification
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C0
C1
C2
C3
C4
C5
C6
No signs of venous disease
Telangiectatic / reticular spider veins only
Simple varicose veins only
Ankle edema of venous origin
Skin pigment changes, no ulcerations
Healed venous ulcers
Open venous ulcers
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Contraindications for Endovenous
Treatment
 Coagulopathy
 Ongoing deep vein thrombosis
 Arteriovenous malformation in the vein segment
being treated
 Non-palpable pedal pulses
 Peripheral artery disease indicated by anklebrachial index of < 0.70
 Pregnancy
 Inability to ambulate
 Active localized or systemic infection or
immunocompromised
 2006 CoolTouch Inc.
Treatment Options
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Compression stockings
Sclerotherapy
Phlebectomy
Vein stripping and ligation
Endovenous radiofrequency
Diode endovenous lasers
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810 nm, 940 nm, 980 nm
1320 nm Nd:YAG endovenous laser
 2006 CoolTouch Inc.
CoolTouch CTEV
 Nd:YAG solid state laser
 Mid-infrared wavelength at 1320 nm
 Fiber optic delivery
Single-use sterile disposable
 Non-sterile reusable
 Multiple fiber sizes
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 Chromophore for absorption is water not
hemoglobin
 FDA cleared for treatment of the GSV, SSV
and tributary veins
 2006 CoolTouch Inc.
Why CoolTouch 1320 nm ?
 1320 nm energy is absorbed by vessel wall
 NOT a hemoglobin-absorption dependent
wavelength
 Does not perforate vessel wall
 Energy is confined to vessel
 Less traumatic for patient
 Mechanized fiber pull back provides precision
 Reusable laser fiber = cost effective treatment
 SaphFire™ fiber provides easiest access for the
even the most difficult veins
 2006 CoolTouch Inc.
Light Absorption in Tissue
1320 Nd:YAG
810-940-980
1 µm
1320 nm
wavelength
absorbed by
water, NOT
hemoglobin
Melanin
10 µm
100 µm
Hemoglobin
1 mm
10 mm
100 mm
1m
Water
10 m
100 m
0.1
0.2
0.3
0.4 0.5
1
Wavelength
 2006 CoolTouch Inc.
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3
1320 nm vs. Diodes
1320 nm
Diodes
(810 nm – 980 nm)
• 1320 nm absorbed by water and
collagen in vein wall
• Without blood, Diode energy
penetrates through vein wall
• Gentle heating contracts vein
leading to closure
• With blood present, high blood
absorption by Diodes can cause
extremely high temperatures and
vein rupture
• Minimal to no post-op pain and
bruising
•Can cause pain, bruising and postop complications
 2006 CoolTouch Inc.
Clot Formation 1320nm vs.
Diode
 After 60 seconds, porcine blood, in vitro:
Diode
 2006 CoolTouch Inc.
1320nm
Endovenous Equipment
 CoolTouch CTEV Laser System
 1320 nm laser
 600 µm or SaphFire laser
fibers
 Pull-Back Device
 Ancillary Supplies Needed
 Vascular access kit
 Duplex ultrasound
 Tumescent anesthesia for
comfort and thermal
protection
 2006 CoolTouch Inc.
Pull-Back Device
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Consistent speed
Reusable
Powered by laser
Two pull-back
speeds
0.5 mm/sec
 1.0 mm/sec
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 2006 CoolTouch Inc.
Pre-Treatment
 Review medical history and sign consent
for treatment
 Blood thinner medications may or may not
be held at the discretion of the physician
 Patient should wear comfortable clothing
and warm socks
 Arrange for transportation home
 Obtain proper size compression hose
 2006 CoolTouch Inc.
Pre-Treatment
 Examine vein using duplex ultrasound
with patient standing and/or lying down
 Scan from the pertinent junction to access
point
 Measure and document
 Pertinent
junction (SFJ, SPJ, other)
 Minimum and maximum vein diameter
 Any aneurysmal or tortuous segments
 Vein depths
 Potential access sites
 2006 CoolTouch Inc.
Pre-Treatment
 Complete final vein marking with patient in
treatment position
 Prep the skin from groin to toes
 Use skin prep that won’t wash off the vein
markings
 Drape affected leg with sterile drapes
 Identify access site
 2006 CoolTouch Inc.
Vein Access
 Access the vein utilizing standard
percutaneous (Seldinger) technique
 A 5 FR, 45 cm long sheath with a side port
should be used with blunt-tip style fiber
(600µm)
 A 4 FR, short sheath with a side port may
be used with a protected-tip fiber
(SaphFire)
 Assemble and flush access devices as
needed
 2006 CoolTouch Inc.
Vein Access
 Inject vein access site with local
anesthesia using 30g needle
 Insert percutaneous access needle in vein
under ultrasound guidance
 Insert guide wire through needle into the
vein and then remove needle
 Make small nick in skin to allow for easier
passage of the introducer sheath
 2006 CoolTouch Inc.
Vein Access
 Thread the introducer sheath over the
guide wire and confirm position
 Remove guide wire
 Remove the dilator from the sheath
 Insert laser fiber and position 1-2 cm
below the pertinent junction
 2006 CoolTouch Inc.
Removing Blood from the Vein
 1320 nm does not require blood to work
 Removing blood allows for more efficient
heating of vein tissue
 Position
patient in 20º- 30º Trendelenburg
 Elevate the extremity being treated
 Encourage vein spasm
 External compression of the vein
 Use the sheath side-arm port to apply
suction to the vein
 2006 CoolTouch Inc.
Tumescent Anesthesia
 Used to provide a heat sink to prevent thermal
skin injury and local anesthesia along the vein
pathway
 Not promoted as a method of vein compression
due to patent infringement issues*
 Infiltrate under ultrasound guidance on top and
around vein wall from the pertinent junction to
the access site
 Create a 10 mm space between the vein and the
skin surface
 Do not leave any segment unprotected
* See CTEV Treatment Guidelines for patent information related to
tumescent anesthesia.
 2006 CoolTouch Inc.
Tumescent Anesthesia
 A combination of local anesthetic (1% lidocaine
1:100,000) diluted with normal (Isotonic) saline to
concentration of 0.1 - 0.2%
 Optional addition of sodium bicarbonate to
prevent stinging
 Use straight local with 30g needle to numb needle
entry sites for the 20g or 22g - 3 ½ needle used to
administer the tumescent anesthesia
 250cc or less (depending on the length of the
vein) should be enough to provide thermal
protection and adequate patient comfort
 2006 CoolTouch Inc.
Sheath Removal
 Pull the sheath out of the vein until only a
few mm is left at the skin access site
 DO NOT BEGIN LASER TREATMENT WITH THE
FIBER IN THE SHEATH
 Verify final position of the laser fiber at 12 cm below the junction
 Place laser fiber in the Pull-back device
 2006 CoolTouch Inc.
Laser Treatment
Starting Parameters
 6 Watts and 50 Hz
 ALWAYS VERIFY AIMING BEAM BEFORE BEGINNING
LASER TREATMENT
 Initiate laser treatment for 2-3 seconds without
fiber movement
 Observe laser tissue effect on ultrasound
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Slowing or stopping of forward movement of flow
Contraction of the vein
Thickened appearance of vein wall
 Adjust watts if needed
 2006 CoolTouch Inc.
Laser Treatment
Pull-Back Technique:
 Start pull-back at 0.5 mm / sec for first 4-5 cm
when treating the GSV or larger diameter veins
 Switch pull-back to the 1.0 mm / sec speed where
the vein narrows or when treating smaller veins
 2006 CoolTouch Inc.
Laser Treatment
Pull-Back Technique:
 Pull-back speed may be slowed or stopped for a
few seconds when treating a large, dilated
segment of the vein or when the fiber moves past
a large perforating or tributary vein
 Observe fiber movement by ultrasound and by
following the red aiming beam
 Stop the pull-back device if laser treatment
delivery is interrupted to avoid creating untreated
segments
 2006 CoolTouch Inc.
Laser Treatment
Double-pass Technique
 May be used to confirm closure of the vein
near the junction
 Treat the beginning segment of the vein and
stop laser and pull-back
 Use the fiber to gently probe the treated
portion of the vein
 Resistance indicates complete closure-resume
laser treatment
 No resistance- re-treat that segment
 2006 CoolTouch Inc.
Laser Treatment
 Examine the treated vein with ultrasound at
completion of the procedure for the
following:
 Vein
appears more dense and thickened
(echogenic)
 Vein is less compressible
 Vein lumen noticeably smaller in size
 Vein does not demonstrate spontaneous flow
 Record treatment data
 2006 CoolTouch Inc.
Immediate Post-Treatment
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Apply Steri-Strip® over access site
Large bulky dressing to absorb tumescent
Medi-Rip or similar type of wrap
Compression hose 30-40 mmHg
Immediate ambulation of the patient is
encouraged
 2006 CoolTouch Inc.
Post-Treatment Instructions
 Frequent ambulation is encouraged
 Avoid heavy lifting / strenuous exercise
for a few days
 Avoid prolonged sitting or standing
 Compression stockings for 3 days to
several weeks
 Return for duplex ultrasound within 1 to
six weeks (1 week until experienced)
 2006 CoolTouch Inc.
Patient Follow-Up
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72 hours
1 to six weeks to evaluate for vein closure
3 to 6 months for repeat ultrasound
1 year
 2006 CoolTouch Inc.
1320 nm Results
 Single treatment
 Low rate of recurrent reflux (greater than 95%
success rate)
 No morbidity
 Minimal to no post-op pain and bruising
 Cosmetically pleasing – one access puncture site
 No downtime
 Less expensive per procedure and easier
technique than RF
 Fewer complications and less pain and bruising
than Diode lasers
 2006 CoolTouch Inc.
Porcine Greater Saphenous Vein
(GSV)
Courtesy of Mitchel P. Goldman, MD
 2006 CoolTouch Inc.
Patient Histology
Courtesy of Mitchel P. Goldman, MD
Full thickness thermal damage affecting endothelium, smooth muscle and
adventitia 1.3-1.5 mm.
 2006 CoolTouch Inc.
CoolTouch CTEV Patient Results
Before
2-week follow up
Photos courtesy of Robert A. Weiss, MD
 2006 CoolTouch Inc.
CoolTouch CTEV Patient Results
Before
1-year follow up
Photos courtesy of Robert A. Weiss, MD
 2006 CoolTouch Inc.
CoolTouch CTEV Patient Results
Before
6-month follow up
Photos courtesy of John R. Kingsley, MD
Adjuvant treatments also performed.
 2006 CoolTouch Inc.
CoolTouch CTEV Patient Results
Before
6-month follow up
Photos courtesy of John R. Kingsley, MD
Adjuvant treatments also performed.
 2006 CoolTouch Inc.
CoolTouch CTEV Patient Results
Before
6-week follow up
Photos courtesy of Rick K. Wilson, MD
Adjuvant treatments also performed.
 2006 CoolTouch Inc.