Endovenous evidence talk
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Transcript of Endovenous evidence talk
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Endovenous therapy: is it the new gold standard ?
Whats the evidence ?JK Wicks
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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
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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
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≥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
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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)
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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)
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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
Siribumrungwong B et al: Systematic review and metaanalysis of RCTS comparing endovenous ablation and surgical intervention in patients with VV.EJVES 44(2012)
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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)
Siribumrungwong B et al: Systematic review and metaanalysis of RCTS comparing endovenous ablation and surgical intervention in patients with VV.EJVES 44(2012)
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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
Siribumrungwong B et al: Systematic review and metaanalysis of RCTS comparing endovenous ablation and surgical intervention in patients with VV.EJVES 44(2012)
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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
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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
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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
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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).
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
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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).
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
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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)
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
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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
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
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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.
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
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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
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
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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
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
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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.
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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.
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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.
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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.
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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.
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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
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.
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“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 var- icose veins). Phlebology 2011;26:91–3
:
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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
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