1. Thermocoagulation as a treatment of the great saphenous vein Dr. S
Thermocoagulation as a treatment of the great saphenous vein Dr. S. Thomis, vascular surgeon UZ Leuven Belgium

2. Introduction
Working principle
Indication/contra-indication
Procedure
Postoperative care
Results pilot study

3. Introduction
Varicose veins and chronic venous disease are a very common pathology, around 20-40% of the population
The last decade a lot of new therapy modalities
Since 1999:endovenous treatment
Minimal invasive
Less complications
Nysten T, van den Bos R, Goldman M et al. Minimally invasive techniques in the treatment of saphenous varices veins. J Am Acad Dermatol 2008;60(1):

4. Introduction: endovenous treatment
RFA
EVLA
Foam
Steam sclerosis
Chemical ablation: Clarivein, Sapheon

5. Thermocoagulation: EVRF
Heating of the vein wall
Endothelial destruction:
Vein contraction
Fibrotic sealing of the vessel

6. Disposable catheter or needle
EVRF by Fcare systems
Working Principle
RF signal generation
Disposable catheter or needle
Non-insulated tip
Central unit

7. Choice of different disposables adjusted to size of the vein
EVRF
Small varicose veins and couperose
Varicose veins
from 1 to 4 mm
Small varicose veins and couperose
Saphenous veins
Varicose veins
from 1 to 4 mm
Saphenous veins
Choice of different disposables adjusted to size of the vein

8. Indications EVRF CR45i
GSV and SSV reflux with a diameter of 3 to 12 mm
Not too tortuous or too superficial
Recurrence GSV: after crossectomie, a hunterperfo,…
Big tributaries (vena accessoria)

9. Contra-indications Absolute CI: acute thrombosis
Relatieve CI:diameter smaller than 3mm and greater than 15mm, too superficial

10. Procedure Local, spinal or general anaesthesia
Anti-trendelenburg position
US guided puncture of the vein at the lowest point of reflux, usually about 10 cm below the knee/at least 15 cm above the foot for SSV
19 gauge needle
6Fr sheath

13. Procedure
Positioning of the catheter at the groin/knee pit 1.5 tot 2 cm from the SFJ/SPJ, in the groin behind the ostium of the epigastric vein
Very flexible catheter
Injection of tumescent liquid around the vein, approximately 10cc/cm (for a long GSV around 500cc)
The area between the skin and the catheter needs to be around 1 cm!

16. Catheter connecting to the generator.
Selecting GSV treatment

17. Positioning

18. Positioning
Position of the catheter in a incompetent GSV from a Hunterperfo

19. Tumescence

20. Procedure
Recheck the position of the catheter after applying tumescent
Start treatment: retract catheter 0.5 cm every three beeps, you can adjust the watt according to the diameter of the vein (normally 25W): for a GSV J/cm
A marcation on the catheter shows when you need to retract the sheath

21. Procedure

23. Postoperative care
Compression stockings CCL II for 1 week day and night, and 2 weeks only in the daytime (when combined with muller excisions).
Immediate mobilisation after the treatment
LMWH profylactic dose only if riskfactors for DVT
Clinical check-up at 1 week and then a US check at 1 month FU

24. Postoperative US

25. Single center (UZ Leuven, Belgium) pilot study
EVRF trial
Single center (UZ Leuven, Belgium)
pilot study
40 GSV were included from until
 1 week clinical FU
1 month and 6 month clinical and duplex FU

26. Exclusion criteria - Deep venous insufficiency
- Cross dilatation with more than 2 incompetent side-branches and maximal diameter of the saphenous vein > 15 mm
- Therapeutically anticoagulation or hypocoagulopathy
- Hypercoagulopathy
- Peripheral arterial occlusive disease
- Pregnancy
- Patients younger than 18 years

27. EVRF Trial Primary endpoint:
Occlusion rate at 1 month follow up (GELEV-score) and at 6 month follow up
Secondary endpoints:
Side effects
Ecchymosis
Pain
Paresthesia
Analgetic use
Quality of life
Patient satisfaction

28. Profession: standing/sitting: 22/18
Results
Age: mean 50.1 years (SD 14.9)
Gender: M/V: 12/28
BMI: mean 25.2 (SD 4.5)
Profession: standing/sitting: 22/18
CEAP: mean C: 2.3 (SD 0.9), 34/40 C2

29. General/spinal/local:30/2/8 LMWH: 11/40 Total energy: mean 7365.8 J
Results
General/spinal/local:30/2/8
LMWH: 11/40
Total energy: mean J
Length: mean 37.2 cm
Diameter preop: mean 6.5 mm (SD 1.6)

30. Recorded at 1 week and 1 month Total number analgetics: 0.7 (SD 1.1)
Analgesia
Recorded at 1 week and 1 month
Total number analgetics: 0.7 (SD 1.1)
Days of analgetics: 0.9 days(SD 1.8)
Mostly paracetamol or ibuprofen

31. Ecchymosis score = Area surface of ecchymosis / length of treated vein
Measured at 1 week postoperative
= 0.02 (max of 0.13)

32. Periphlebitis: 1.1 days (SD 2.8) Paresthesia: 1/40
Results
Periphlebitis: 1.1 days (SD 2.8)
Paresthesia: 1/40
Patient satisfaction: 8.9 (SD 1.0)

33. QOL Measured using the CIVIQ2-score
Quality of life score for lower limb venous insufficiency
20 Questions
4 domains: pain, physical, psychological, social
Higher scores -> lower health related quality of life

34. QOL

35. Painscore: VAS scale

36. Occlusion rate at 1M and 6M
Introduced by GELEV
Lev 0: no occlusion, refluxing vein, unchanged vein
Lev 1a: partial occlusion with proximal reflux
Lev 1b: partial occlusion without reflux
Lev 2a: complete occlusion with unchanged or larger diameter
Lev 2b: complete occlusion with diameter reduction >30%
Lev 3: complete occlusion with diameter reduction >50%
Lev 4: fibrotic cord, vein not visible

37. Occlusion rate

38. 3 veins were not occluded (3/40):
Occlusion rate: 92.5%
3 veins were not occluded (3/40):
- 1 with no occlusion and refluxing (score 0)
- 2 with a GELEV score of 1b, with only a narrow lumen remaining without reflux
we expect an occlusion at 12 M

39. Summary of the results Total number of analgetics 0.7
Days of analgetics
0.9 days
Periflebitis
1.1 days
Ecchymosis score
0.02
Paresthesia

40. Summary of the results Patient satisfaction 8.9 QOL preop 35.1
QOL postop 1w
38.5
QOL postop 1m
27.0
Painscore d2
2.5
Painscore d5
2.0
Painscore d7
1.6
Painscore d10
0.6
occlusion
37/40 (92.5%)

41. EVRF is a safe and efficient treatment
Conclusion
low painscore, no ecchymosis, high quality of life.
Occlusion rate at six month was 92.5%.
EVRF is a safe and efficient treatment

42. Thank you!