1. COOLTOUCH CTEV ™ Endovenous Procedure Clinical Slide Set
Rev A

2. Venous Insufficiency Numbers
80 million have venous insufficiency1
50 – 55% of women2
40 – 45% of men2
50% of patients seek treatment for cosmetic reasons only
American College of Phlebology Website
RT Image, March 8, 2004

3. 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 Nicos Labropoulos, MD

4. 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

5. CEAP Classification C0 No signs of venous disease
C1 Telangiectatic / reticular spider veins only
C2 Simple varicose veins only
C3 Ankle edema of venous origin
C4 Skin pigment changes, no ulcerations
C5 Healed venous ulcers
C6 Open venous ulcers

6. 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

7. 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

8. 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

9. 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

10. Light Absorption in Tissue
1320 Nd:YAG
1 µm
Melanin
1320 nm wavelength absorbed by water, NOT hemoglobin
10 µm
Hemoglobin
100 µm
1 mm
10 mm
100 mm
Water
1 m
10 m
100 m
0.1
0.2
0.3
0.4
0.5 1 2 3
Wavelength

11. 1320 nm vs. Diodes
Diodes
(810 nm – 980 nm)
1320 nm
1320 nm absorbed by water and collagen in vein wall
Gentle heating contracts vein leading to closure
Minimal to no post-op pain and bruising
Without blood, Diode energy penetrates through vein wall
With blood present, high blood absorption by Diodes can cause extremely high temperatures and vein rupture
Can cause pain, bruising and post-op complications

12. Clot Formation 1320nm vs. Diode
After 60 seconds, porcine blood, in vitro:
Diode
1320nm

13. 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

14. Pull-Back Device Consistent speed Reusable Powered by laser
Two pull-back speeds
0.5 mm/sec
1.0 mm/sec

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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.

23. Tumescent Anesthesia
A combination of local anesthetic (1% lidocaine 1:100,000) diluted with normal (Isotonic) saline to concentration of %
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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. Immediate Post-Treatment
Apply Steri-Strip® over access site
Large bulky dressing to absorb tumescent
Medi-Rip or similar type of wrap
Compression hose mmHg
Immediate ambulation of the patient is encouraged

31. 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)

32. Patient Follow-Up 72 hours 1 to six weeks to evaluate for vein closure
3 to 6 months for repeat ultrasound
1 year

33. 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

34. Porcine Greater Saphenous Vein (GSV)
Courtesy of Mitchel P. Goldman, MD

35. Patient Histology
Courtesy of Mitchel P. Goldman, MD
Full thickness thermal damage affecting endothelium, smooth muscle and adventitia mm.

36. CoolTouch CTEV Patient Results
Before
2-week follow up
Photos courtesy of Robert A. Weiss, MD

37. CoolTouch CTEV Patient Results
Before
1-year follow up
Photos courtesy of Robert A. Weiss, MD

38. CoolTouch CTEV Patient Results
Before
6-month follow up
Photos courtesy of John R. Kingsley, MD
Adjuvant treatments also performed.

39. CoolTouch CTEV Patient Results
Before
6-month follow up
Photos courtesy of John R. Kingsley, MD
Adjuvant treatments also performed.

40. CoolTouch CTEV Patient Results
Before
6-week follow up
Photos courtesy of Rick K. Wilson, MD
Adjuvant treatments also performed.