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vein diameter and withdrawn by 1cm each time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