Transcript No Slide Title
COOLTOUCH CTEV
™
Endovenous Procedure Clinical Slide Set
2006 CoolTouch Inc.
7075-0083 Rev A
Venous Insufficiency Numbers
80 million have venous insufficiency 1 50 – 55% of women 2 40 – 45% of men 2 50% of patients seek treatment for cosmetic reasons only 1.
2.
American College of Phlebology Website RT Image, March 8, 2004
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Common Symptoms of Vascular Insufficiency
Most common in 70-80% of patients:*
Aching Itching Burning sensation Heaviness Restless limbs
Left untreated, these symptoms may progress to:
Skin changes Edema Skin ulcerations * Venous Digest, July 2005. Nicos Labropoulos, MD
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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
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C0 C1 C2 C3 C4 C5 C6
CEAP Classification
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 ankle brachial index of < 0.70
Pregnancy Inability to ambulate Active localized or systemic infection or immunocompromised
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Treatment Options
Compression stockings Sclerotherapy Phlebectomy Vein stripping and ligation Endovenous radiofrequency Diode endovenous lasers
810 nm, 940 nm, 980 nm
1320 nm Nd:YAG endovenous laser
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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
Chromophore for absorption is water not hemoglobin FDA cleared for treatment of the GSV, SSV and tributary veins
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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
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Light Absorption in Tissue
1320 nm wavelength absorbed by water, NOT hemoglobin 810-940-980 1 µm Melanin 10 µm 100 µm 1 mm 10 mm Hemoglobin 100 mm 1 m Water 10 m 100 m 0.1
0.2
0.3
0.4
0.5
1 Wavelength 1320 Nd:YAG 2 3
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1320 nm vs. Diodes
1320 nm Diodes (810 nm – 980 nm)
•
1320 nm absorbed by water and collagen in vein wall
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Gentle heating contracts vein leading to closure
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Minimal to no post-op pain and bruising
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Without blood, Diode energy penetrates through vein wall
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With blood present, high blood absorption by Diodes can cause extremely high temperatures and vein rupture
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Can cause pain, bruising and post op complications
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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
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Pull-Back Device
Consistent speed Reusable Powered by laser Two pull-back speeds
0.5 mm/sec
1.0 mm/sec
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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
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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
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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
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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 (600 µm) 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
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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
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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
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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 20 º- 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
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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.
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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
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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 1 2 cm below the junction
Place laser fiber in the Pull-back device
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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
Slowing or stopping of forward movement of flow
Contraction of the vein
Thickened appearance of vein wall
Adjust watts if needed
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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
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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
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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
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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
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Immediate Post-Treatment
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
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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)
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Patient Follow-Up
72 hours 1 to six weeks to evaluate for vein closure 3 to 6 months for repeat ultrasound 1 year
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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
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Porcine Greater Saphenous (GSV) Vein
Courtesy of Mitchel P. Goldman, MD
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Patient Histology
Courtesy of Mitchel P. Goldman, MD Full thickness thermal damage affecting endothelium, smooth muscle and adventitia 1.3-1.5 mm.
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CoolTouch CTEV Patient Results
Before
2006 CoolTouch Inc. Photos courtesy of Robert A. Weiss, MD 2-week follow up
CoolTouch CTEV Patient Results
Before
2006 CoolTouch Inc. Photos courtesy of Robert A. Weiss, MD 1-year follow up
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
2006 CoolTouch Inc. 6-month follow up Photos courtesy of John R. Kingsley, MD Adjuvant treatments also performed.
CoolTouch CTEV Patient Results
Before 6-week follow up Photos courtesy of Rick K. Wilson, MD Adjuvant treatments also performed.
2006 CoolTouch Inc.