An RCT of clinical and cost effectiveness of endovenous laser therapy in the treatment of varicose veins secondary to isolated saphenopopliteal incompetence and small saphenous reflux
Thesis or dissertation
- © 2014 Nehemiah Samuel. All rights reserved. No part of this publication may be reproduced without the written permission of the copyright holder.
Lower limb varicosities are common and cause significant impairment of quality of life to the sufferers. Patients with small saphenous incompetence form a small but significant part of this group who have traditionally been treated by surgical ligation with or without stripping of small saphenous vein (SSV). Within the last decade however, this has been challenged by endovenous thermal and chemical ablation interventions. No randomized clinical trial comparing treatment options for SSV incompetence exists, and there is no clear evidence that this axis behaves the same as the great saphenous vein (GSV) following treatment. This means that the existing literature base, centred on the treatment of GSV incompetence cannot simply be extrapolated to inform the management of SSV insufficiency.
This trial aimed to compare the technical efficacy, safety and clinical effectiveness of minimally invasive endovenous laser ablation (EVLA) with the gold standard treatment of conventional surgery (CS) in the management of SSV incompetence.
Costs and utilities of EVLA and CS were compared to establish the most cost-effective treatment.
The risks and benefits of stripping SSV in the surgical treatment; and efficacy of EVLA in relation to the site of SSV access was also evaluated to establish best practice in both these interventions.
Patients with unilateral, primary saphenopopliteal junction (SPJ) incompetence and SSV reflux were randomized equally into parallel groups receiving either Surgery or EVLA, with concomitant phlebectomies of tributary veins. Patients were assessed at baseline and weeks 1, 6, 12 & 52. Outcomes included: successful abolition of axial reflux on duplex scan (Primary outcome); Visual analogue pain scores; recovery time; complication rates; Venous Clinical Severity Score (VCSS) and Quality of life (QoL) profiling.
For cost-effectiveness analysis, the hospital, general practice, patient costs incurred until full recovery and the indirect cost to society due to sickness leave after treatment, were calculated to indicate mean cost per patient under each treatment category. EQ-5D health utility index was calculated from EuroQol generic QoL questionnaire, and quality adjusted life years (QALYs) were generated by calculating the area under curve. Cost/QALY and incremental cost effective ratio (ICER) was calculated for both treatment groups to determine the more cost-effective treatment.
For patients undergoing surgical treatment, the aim was for SPJ ligation (SPL) and stripping of SSV in each case, but in a proportion this was not possible. Hence, patients were retrospectively sub grouped into SPL with short segment excision ≤ 5 cm and SPL with extended stripping > 5 cm. Clinical and QoL outcomes including recurrence and complications were compared between these surgical subgroups.
Patients undergoing EVLA (810 nm, 14 W diode laser) for small saphenous incompetence were retrospectively divided into two subgroups: access gained at or above mid-calf (AMC) and below mid-calf (BMC), based on the level of endovenous access gained at the lowest site of truncal reflux. Similar clinical and QoL outcomes including recanalization and sensory disturbance were compared between the EVLA subgroups.
106 patients were recruited and randomized to Surgery (n=53) or EVLA (n=53). The primary outcome of abolition of SSV reflux was significantly higher following EVLA 96.2% vs. Surgery 71.7% (P<0.001). Postoperative pain was significantly lower after EVLA (P<0.05), allowing an earlier return to work and normal function (P<0.001). Minor sensory disturbance was significantly lower in the EVLA group 7.5% vs. Surgery 26.4% (P=0.009). Both groups demonstrated similar improvements in VCSS and quality of life measures.
The hospital costs for EVLA was less expensive compared to Surgery, mean (s.d.) £690.31 (121.66) vs £730.77 (304.82) per patient (P=0.390); and enabled patients to return to work 9.6 days (95% CI 4.9-14.3) earlier than after surgery. Based on the Annual Survey of Hours and Earnings 2012 for full time employees, the cost per working hour gained after EVLA was 13.96 pounds (95% CI 7.41 - 20.50). There was no significant difference in mean QALYs gained between the two treatments (P=0.101); however the mean (s.d.) Cost/QALY was significantly lower for EVLA £1652.58 (966.20) as compared to surgery £2123.48 (1084.54) (P=0.032).
Of the 53 surgical patients, inversion stripping was possible in 35 (66%) and in the rest 18 (34%), a short segment of SSV was excised following SPL. Recurrence rates were higher in the short excision subgroup at 44.4% versus 2.9% in the inversion stripping subgroup causing a decline in patient satisfaction with treatment and cosmetic outcomes at the end of follow-up period (P<0.05). There was no significant difference in sensory disturbance or complications between the two subgroups (P>0.05).
Of the 53 EVLA patients, access was gained above mid-calf in 30 (57%) and below mid-calf in 23 (43%). SSV occlusion was equally high in both subgroups with no significant difference in complications or recurrence rates (P>0.05). Patient satisfaction with overall treatment declined in the AMC subgroup (P=0.011). Both EVLA subgroups demonstrated significant improvement in venous severity and QoL measures over the follow-up period (P>0.05).
EVLA produced the same clinical benefits as conventional surgery, but was more effective in addressing the underlying pathophysiology and was associated with less peri-procedural morbidity, allowing a faster recovery for patients. Of the two interventions, EVLA is the more cost-effective option in the short-term, feasible in an outpatient setting under tumescent local anaesthesia. These findings support the adoption of EVLA with concomitant phlebectomy as the standard treatment for primary small saphenous insufficiency.
- Hull York Medical School, The University of Hull and the University of York
- Chetter, Ian; Hartley, John Edward; Renwick, Paul
- Sponsor (Organisation)
- University of Hull; Diomed (Firm)
- Qualification level
- Qualification name
- 3 MB