1. Management of Varicose Vein Introduction of new technology
Wong Wing-Fu Ivan
Tuen Mun Hospital

2. Content Current treatment options of Varicose Vein
Introduction of two new methods
Mechanism
Clinical Trial
Conclusion of future treatment approach

3. Background
Dilated, tortuous, palpable superficial vein with reversed blood flow
~30%population
More in Female
Symptoms
Pain, itching, skin pigmentation
Bleeding
Venous ulcer

4. Treatment According to NICE guideline 2014 Intervention therapy
Compression
Surgery
Endovenous ablation
What news

5. Endovenous therapy Thermal Tumescent (TT)
Endovenous RadioFrequency ablation (RFA)
Endovenous laser ablation (EVLA)
Endovenous steam ablation (EVSA)
Non-Thermal Non-Tumescent (NTNT)
Chemical ablation
Mechanochemical ablation

6. Thermal tumescent (TT)
Duplex USG localization and greater saphaneous vein (GSV) identified
Catheter introduced
Injection of Tumescent solution (diluted local anesthesia)
Mixture of normal saline + lignocaine with adrenaline + sodium bicarbonate
Heat sink
Separate GSV from saphenous nerve
Contraction of vein

7. Mechanism RFA EVLA Denaturation of collagen matrix
Causing injury to vein wall
Fibrotic sealing of vessel lumen
EVLA
Direct causing carbonization of vein wall
Formation of steam bubbles and transmit heat energy to endothelium
Thrombosis and occlusion of vein

8. Compare to surgery Similar success rate to surgery
Less post-operative pain
Less complication
Early return of work
Better quality of life

9. Endovenous steam ablation (EVSA)
First report in 2011
Steam vein sclerosis (SVS) system
Apply thermal energy (steam micro-impulse)
Sterile water was heated up and transferred into vessel lumen via catheter
Endothelial damage, result in lumen obliteration and fibrosis
60J/ cm/ pulse

11. EVSA - Procedure
Steam ablation catheter (diameter 1.2mm) cannula into vein
Positioned 2-3cm distal to SFJ
Tumescent anesthesia administered
Steam pulses was delivered according to vein diameter and withdrawn by 1cm each time
2pulses/cm <7mm, 3pulses/cm 7-10mm, 4pulses/cm >10mm

12. Phase II study
Safety analysis: No major complication
Obliteration rate: 96% at 6 months and 12 months

13. Compare EVSA vs EVLA Primary outcome
Treatment success at 12 weeks and 52weeks (obliteration of GSV segment and absence of reflux)
Change in Venous Clinical Severity Score (VCSS) at 12 weeks

14. Relatively similar successful rate
Primary Outcome
EVSA not inferior to EVLA

15. Better pain control and less limit in daily life
Secondary Outcome

16. EVSA Benefits Limitations
Using sterile water not inducing harm by generating exogenous substance
Stable, constant and relatively low peak temperature
Fewer temperature-related symptoms (pain and bruising)
More thin and flexible fiber
no need guidewire
Feasible to more tortuous vein
Limitations
Lack of large scale high quality study
Still need further study compare EVSA to RFA/ surgery

17. Limitation of TT Need for tumescence multiple injection
Risk for thermal injury
Post-operative pain
Need of generator (cost of money)

18. Non-Thermal, Non Tumescent (NTNT)
US guided foam injection (USGF)
Chemical ablation
Sodium tetradecyl sulphate (STS)/ Polidocanol
Induce fibrosis and inflammation
Result in lumen obliteration
Limitations
2.4 folds of primary failure compare to surgery group

20. USGF More adverse events Risk of neurological events
Skin staining/ pigmentation
Persistent lumpiness
Cough
Chest tightness
Myocardic infarction
Risk of neurological events
Headache
Transient visual disturbance
Stroke
PE and DVT: less than 1 per cent
median rate ofmvisual disturbance: 1.4 per cent
Headache 4.2 per cent
Thrombophlebitis 4.7 per cent
matting/skin staining/pigmentation: 17.8 per cent
Pain: 25.6 per cent
The median rate of complete occlusion of treated veins: 87.0 per cent
recurrence or development of new veins: 8.1 per cent

21. Compare current treatments
RFA/ EVLA
USGF
Surgery
Higher Success rate
Lower Recurrent rate
Better Pain control
Lesser adverse events
Improvement in QoL
Lower Cost
Cost-effectiveness

22. Non-Thermal Non-Tumescent (NTNT)
Mechanochemical ablation (MOCA)
First reported in 2012
Hybrid system
Infusing liquid sclerosant
Rotating a wire within lumen at 3500rpm
Abrade the intima allow better efficacy of sclerosant
Mix sclerosant in vein and onto vessel wall
Catheter tip at 2cm distal SFJ
Pull down rate 1-2mm/second C

24. Mechanochemical tumescentless endovenous ablation: final result of initial clinical trial
Primary outcome
Safety, follow-up to 6 months
No severe adverse events
No neurological events
Primary closure rate
96.7% (29/30)
Secondary Outcome
Pain control
No complaint of pain during procedure and follow-up
Use of analgesia
Only Local anesthesia given during procedure
Presence of ecchymosis
10% (3/30)

25. Prospective observation study
Less post-op pain 100-mm visual analog scale (14 days)
4.8 vs 18.6 (p<0.01)

26. Mechanochemical ablation (MOCA)
Earlier return normal daily activities and work resumption
Similar improvement in quality of life questionnaires

27. Mechanochemical ablation (MOCA)
Benefits
No thermal related injury
No need of multiple tumescent injection
Simple and faster procedure
Limitations
Lack of high quality clinical trial
Ongoing study
MOCA Versus RFA in the Treatment of Primary GSV incompetence (NCT )

28. Conclusion - Meantime
New treatment options still need more high quality clinical trial
Current treatments are improving
Endovenous treatments achieve similar efficacy as surgery with less adverse events
NICE recommend endothermal ablation as first choice if patient is suitable

29. Conclusion - Future development
More use of minimal invasive procedure
Efficacy relative similar among them (>90%)
Focus on cost-effectiveness, improve in quality of life
Surgery is still important
patient not suitable for endovenous treatment
Office-based procedure
Procedure done in clinic
No hospital stay
Short procedure time
More patient being treated, less waiting time

30. Thank You

31. Reference
A Systematic Review and Meta-analysis of Randomised Controlled Trials Comparing Endovenous Ablation and Surgical Intervention in Patients with Varicose Vein, B. Siribumrungwong, European Journal of Vascular and Endovascular Surgery 44 (2012)
Systematic review of foam sclerotherapy for varicose veins, X. Jia , British Journal of Surgery 2007
A Randomized Trial Comparing Treatments for Varicose Veins, Julie Brittenden, M.D., The new england journal of medicine 2014
Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins, R. R. van den Bos, British Journal of Surgery 2014
Endovenous therapies of lower extremity varicosities: A meta-analysis, Renate van den Bos, JOURNAL OF VASCULAR SURGERY January 2009
Great Saphenous Vein Ablation with Steam Injection: Results of a Multicentre Study, R. Milleret, European Journal of Vascular and Endovascular Surgery 2013
Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial, S Elias, Phlebology 2012
Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins, Ramon R. J. P. van Eekeren, JOURNAL OF VASCULAR SURGERY February 2013
Proof-of-principle study of steam ablation as novel thermal therapy for saphenous varicose veins, Renate R. van den Bos, JOURNAL OF VASCULAR SURGERY January 2011
Ultrasound-guided foam sclerotherapy is a safe and clinically effective treatment for superficial venous reflux, Andrew W. Bradbury, JOURNAL OF VASCULAR SURGERY October 2010
Temperature profiles of 980- and nm endovenous laser ablation, endovenous radiofrequency ablation and endovenous steam ablation , Lasers Med Sci (2014)
National Institutefor Health and Care Excellenc guideline 2014

32. Q&A