Endovenous evidence talk

Endovenous therapy: is it the new gold standard ?

Whats the evidence ?JK Wicks

Varicose veins affects up to 25 % of population

Conventional surgery : SFJ ligation , GSV stripping has been standard of care

Last decade endovenous techniques have developed and been widely practiced (EVRF,EVLT,UGFS) and now are challenging conventional surgery

introduction

Callum MJ.Epidemiology of varicose veins.BR J Surg 1994 Nicolaides AN et al. management of lower limbs guidelines according to scientific evidence. Int Angiol 2008Biemanns AA et al. Endovenous therapies of varicose veins. G ital Derm Ven 2010

Review the evidence Primary failure Recurrence Recovery and Complications Quality of life post treatment Short term v longterm data

Show that endovenous therapy can be considered the new gold standard for treatment of primary varicose veins

introduction

≥30 RCTs comparing endovenous v conventional surgery (CS)

EVLT v CS(11), RFA v CS(9), UGFS v CS(5), 5 EVLT v RFA

previous metanalyses prior to 2009 combined RCTS and non RCT data but latest data looks at purely RCTs

Evidence

Metanalysis of RCTs only from 2000-2011 comparing EVLT, RFA, UGFS and surgery

28 RCTs were included Primary outcomes: failure to completely abolish reflux in

treatment axial vein MIEPS defined as recanalisation on duplex scan Surgery defined as recanalisation, incomplete stripping or

removal of intended vein Secondary outcomes

Clinical recurrence (assessed by examination as visible or papable veins)

Venous clinical severity scores ComplicationsSiribumrungwong B et al: Systematic review

and metaanalysis of RCTS comparing endovenous ablation and surgical intervention in patients with VV.EJVES 44(2012)

Primary failure No difference between EVLT v CS (RR 1.5: 95% CI 0.7-

3.0) No difference between RFA v CS (RR 1.3: 95% CI 0.7-2.4) UGFS v CS twofold risk of primary failure

Clinical recurrence No difference between EVLT v CS (RR 0.6 :95% CI 0.3-

1.1) No difference between RFA v CS (RR 0.9 :95% CI 0.6-1.4)

Siribumrungwong B et al: Systematic review and metaanalysis of RCTS comparing endovenous ablation and surgical intervention in patients with VV.EJVES 44(2012)

Wound infection RR 0.3(95% CI 0.1-0.7) Paraesthesiae NSD however RR 0.8 (95% CI 0.6-1.1) Haematoma EVLT RR 0.5 (CI 0.4-0.8), RFA 0.4(CI 0.1-0.8) Postoperative pain EVLT RR -0.6(CI -1.1- -0.2), RFA -1.6(95%CI -

2.0- -1.1) RFA greater pain reduction than EVLT At all time points immediately post, day 1-6


Return to normal activities/work Significantly shorter for RFA -4.9 (95% CI -7.1,-

2.7) but did not reach significance for EVLT v surgery

?1470nm radial fibre laser causes less pain QOL

EVLT v surgery showed no difference at 2-14 mths (AVVSS)


Conclusions Primary failure and recurrence in EVLT and RFA

not significantly different to surgery Lower haematoma, wound infection, pain and

quicker return to normal activities and work (RFA)

QOL scores comparable EVLT v surgery


RCT looking at five hundred consecutive patients (580 legs) comparing four treatments for GSV reflux

EVLT (980 and 1470nm, bare fibre) v RFA v UGFS v surgical stripping

All treatments done with light sedation , tumescent anaesthesia, combined with miniphlebectomiesRasmussen LH et al. Randomized clinical trial comparing

endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug

Primary outcomes GSV recanalisation GSV patency

Secondary outcomes Pain Return to normal activities/work Venous clinical severity score/ aberdeen varicose

veins symptom severity score SF36 costs

Rasmussen LH et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug


Primary outcomes There was no statistically significant difference

in patent GSVs in the three other groups (EVLT v RFA v CS P = 0·543). Within 3 days 4 patients in open surgery group

had refluxing GSV due to vein breakage Significantly more GSVs were open and

refluxing at 1 year in the UGFS group than in the other groups (P<0·001).


Primary outcomes Recurrence : 14 EVLT (11·6 per cent), 9 RFA

(7·3 per cent), 17 UGFS (13·8 per cent) and 16 CS (14·8 per cent) legs had recurrent varicose veins at 1-year follow-up (P = 0·155).


Secondary outcomes Pain scores

Patients in the RFA and UGFS groups reported significantly less postoperative pain than those in the EVLT and stripping groups (P <0·001).

Mean(s.d.) pain scores during the first 10 days were EVLT 2·58(2·41), RFA 1·21(1·72), UGFS 1·60(2·04) and CS 2·25(2·23)


Return to normal activities/work resumption of normal activities and work was shorter in the

groups treated with RFA and UGFS than in the EVLT and stripping groups (P <0·001 fo rboth RFA and UGFS)

Venous severity score /Aberdeen varicose vein symptom severity score The mean scores improved significantly after the procedure

in all groups, with no significant difference between them Short form 36 results

there was a statistically significant improvement in most scores from pretreatment to 1 year

radiofrequency and foam had significantly better scores than the other two groups, indicating that patients in the stripping and EVLA groups had more pain and discomfort at 3 days


Costs Procedure-related costs were highest in the RFA

group because of the higher cost of the catheter, and lowest in the UGFS group

When the cost of lost work was included in the total costs, UGFS and RFA was the cheapest.


Complications DVT in surgery and UGFS group only major

complication Phlebitis significantly greater in RFA and UGFS

group (p =0.006) but no definition whether branch or axial phlebitis


Conclusions EVLT, RFA, and CS were efficacious both radiofrequency ablation and foam were

associated with a faster recovery and less postoperative pain than endovenous laser ablation and stripping


Primary outcomes Open refluxing segment of GSV >5 cm

Secondary outcomes Recurrent varicose veins VCSS, AVVSS, SF-36 (QOL)

Rasmussen L et al: Randomized clinical trial comparing endovenous ablation and stripping of GSV abd duplex outcome after 5 yrs J Vasc Surg 2013;58:421-6.





Conclusions Five-year follow-up of our randomized

controlled trial comparing EVLA with open surgery in patients with GSV incompetence did not show any significant difference between the two groups in primary or secondary end points


“for treatment of incompetent GSV, endovenous thermal ablation (RFA or EVLT) is recommended over high ligation and stripping of the saphenous vein : Grade I evidence (strong)”

North american joint committee on venous guidelines, Society of vascular surgery (SVS) American venous forum (AVF): Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53(Suppl):2S–48SVenous forum of royal college of medicine: Berridge D, Bradbury AW, Davies AH, et al. Recommen- dations for the referral and treatment of patients with lower limb chronic venous insufficiency (including varicose veins). Phlebology 2011;26:91–3

:

the evidence is good quality and does address key area

Primary failure Recurrence Recovery and Complications Quality of life post treatment Short term v longterm data

endovenous therapy can be considered the new gold standard for treatment of primary varicose veins

My practice is of endovenous first approach RFA for truncal incompetence and UGFS for tributaries

(rather than miniphlebectomies)

conclusion

Healthcare

Endovenous evidence talk