D. CARRADICE, J. EL-SHEIKHA, S. NANDHRA, T. WALLACE, N. SAMUEL, G. SMITH, I. CHETTER
Hull York Medical School, United Kingdom
Key words: EVLA, phlebectomy
Superficial venous insufficiency of the leg (SVI) affects 40% of adults, causing symptoms impacting upon
quality of life (QoL); and causes damage to the soft tissues of the leg, culminating in ulceration. There
has been a revolution in the understanding and management of SVI. Recent UK guidelines recommend
endothermal axial ablation as the first line treatment, but the management of the varicose tributaries
themselves remains under debate. Some consider the tributaries to be an insignificant aspect of the
disease and think that they will resolve once the axis is treated, whereas others feel that they are an
important aspect of the disease which need to be addressed.
The study aim was to compare the outcomes from endovenous laser ablation with concomitant
phlebectomy of all tributaries as a single procedure (EVLAP group) and EVLA alone with phlebectomy if
required, after a delay of at least 6 weeks (EVLA group).
Consenting patients were randomised to one of the two groups. Clinical, patient reported and economic
outcomes were recorded until 5 years. A cost-effectiveness analysis was performed with costs calculated
based upon prospective data reflecting the actual resource requirements. A sensitivity analysis explored
differing assumptions and fi nally a Monte Carlo simulation of 10,000 patients explored the uncertainty
associated with the estimates and the effect of variation in the re-intervention rate.
Fifty patients were randomised equally into two parallel groups. The EVLAP group had lower (better)
venous clinical severity scores at 12 weeks (0(0–1) versus 2(0–2); P<0.001), leading to lower (better) QoL
scores (AVVQ) at 6 weeks (7.9(4.1–10.7) versus 13.5(10.9–18.1); P<0.001) and 12 weeks (2.0 (0.4–7.7)
versus 9.6 (2.2–13.8); P=0.015). These became equivalent by 1 year, but only after 67% in the EVLA
group, compared with 4% in the EVLAP group (P<0.001), had received a secondary intervention.
From 1 to 5 years both groups were equally effective. EVLAP took longer to perform (65min(50-70)
versus 45min(40-55), P=0.002) leading to higher initial treatment costs (£1157(94) versus £1093(95),
P=0.005). However, the increased number of secondary interventions required to achieve equivalent
effectiveness in the EVLA group infl ated the costs, making the EVLAP group more cost-effective by
1 year (P=0.001) and this was maintained until 5 years. These findings were robust during sensitivity
analysis and there was a probability of 0.75 that EVLAP was most cost-effective. Re-intervention rates
would have to be less than 30% (less than half of that observed) to restore this to equipoise.
EVLA with either concomitant or delayed management of tributaries is a clinically effective treatment for
SVI, however delayed treatment is associated with significantly higher expenditure to obtain the same
health benefit and therefore concomitant phlebectomy is the more cost-effective strategy.