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Wong Wing-Fu IvanTuen Mun Hospital
Current treatment options of Varicose Vein
Introduction of two new methods Mechanism Clinical Trial
Conclusion of future treatment approach
Dilated, tortuous, palpable superficial vein with reversed blood flow
~30%population More in Female Symptoms
Pain, itching, skin pigmentation Bleeding Venous ulcer
According to NICE guideline 2014 Intervention therapy
Compression Surgery Endovenous ablation
What news
Thermal Tumescent (TT) Endovenous RadioFrequency ablation (RFA) Endovenous laser ablation (EVLA) Endovenous steam ablation (EVSA)
Non-Thermal Non-Tumescent (NTNT) Chemical ablation Mechanochemical ablation
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
EVLA Direct causing
carbonization of vein wall
Formation of steam bubbles and transmit heat energy to endothelium
Thrombosis and occlusion of vein
RFA Denaturation of collagen
matrix Causing injury to vein
wall Fibrotic sealing of vessel
lumen
Similar success rate to surgery Less post-operative pain Less complication Early return of work Better quality of life
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
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vein diameter and withdrawn by 1cm each time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
Phase II study Safety analysis: No major complication Obliteration rate: 96% at 6 months and 12 months
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
Primary Outcome
EVSA not inferior to EVLA
Secondary Outcome
Benefits 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
Need for tumescence multiple injection Risk for thermal injury Post-operative pain Need of generator (cost of money)
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
More adverse events Skin staining/ pigmentation Persistent lumpiness Cough Chest tightness Myocardic infarction
Risk of neurological events Headache Transient visual disturbance Stroke
RFA/ EVLA USGF Surgery
Higher Success rate
Lower Recurrent rate
Better Pain control
Lesser adverse events
Improvement in QoL
Lower Cost
Cost-effectiveness
• 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
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)
Prospective observation study
Less post-op pain 100-mm visual analog scale (14 days) 4.8 vs 18.6
(p<0.01)
Earlier return normal daily activities and work resumption
Similar improvement in quality of life questionnaires
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 (NCT01936168)
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
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
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 1470- nm endovenous laser ablation, endovenous radiofrequency ablation and endovenous steam ablation , Lasers Med Sci (2014)
http://clarivein.com/ https://www.youtube.com/watch?v=hnNMdkUy_0w National Institutefor Health and Care Excellenc guideline 2014
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