Thermocoagulation as a

treatment of the great

saphenous vein

Dr. S. Thomis, vascular surgeon UZ Leuven Belgium

• Introduction

• Working principle

• Indication/contra-indication

• Procedure

• Postoperative care

• Results pilot study

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):110-119

Introduction: endovenous treatment

• RFA

• EVLA

• Foam

• Steam sclerosis

• Chemical ablation: Clarivein, Sapheon

Thermocoagulation: EVRF

Heating of the vein wall

Endothelial destruction:

• Vein contraction

• Fibrotic sealing of the vessel

EVRF by Fcare systems

6

RF signal generation

Disposable catheter or needle

Working Principle

Non-insulated tip

Central unit

EVRF

7 Choice of different disposables adjusted to size of the vein

Small varicose veins and couperose

Varicose veins from 1 to 4 mm

Saphenous veins

Varicose veins from 1 to 4 mm

Small varicose veins and couperose

Saphenous veins

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)

Contra-indications

• Absolute CI: acute thrombosis

• Relatieve CI:diameter smaller than 3mm and

greater than 15mm, too superficial

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

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!

•Catheter

connecting to the

generator.

•Selecting GSV

treatment

Positioning

Positioning

Position of the catheter in a incompetent GSV from a Hunterperfo

Tumescence

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 250-

300 J/cm

• A marcation on the catheter shows when you need

to retract the sheath

Procedure

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

Postoperative US

EVRF trial

• Single center (UZ Leuven, Belgium)

• pilot study

• 40 GSV were included from 11-2011

until 3-2012

• 1 week clinical FU

• 1 month and 6 month clinical and

duplex FU

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

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

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

Results

• General/spinal/local:30/2/8

• LMWH: 11/40

• Total energy: mean 7365.8 J

• Length: mean 37.2 cm

• Diameter preop: mean 6.5 mm (SD

1.6)

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

Ecchymosis

• Ecchymosis score = Area surface of

ecchymosis / length of treated vein

• Measured at 1 week postoperative

• = 0.02 (max of 0.13)

Results

• Periphlebitis: 1.1 days (SD 2.8)

• Paresthesia: 1/40

• Patient satisfaction: 8.9 (SD 1.0)

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

QOL

20

30

40

50

60

70

80

90

100

preop

postop 1W

postop 1M

Painscore: VAS scale

0

1

2

3

4

5

6

7

8

9

10

2 5 7 10

mean

mean

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

Occlusion rate

0

5

10

15

20

25

30

35

40

1m 6m

0

1b

2a

2b

3

4

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

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 0

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%)

Conclusion

• low painscore, no ecchymosis, high

quality of life.

• Occlusion rate at six month was

92.5%.

EVRF is a safe and efficient treatment

Thank you!