Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins

Background: The management of residual varicosities following endovenous laser therapy (EVLT) for varicose veins is contentious. Ambulatory phlebectomy may be performed concomitantly with the initial EVLT, or sequentially as a secondary procedure. This randomized trial compared these two approaches. Methods. Fifty patients with great saphenous varicose veins were randomized to EVLT alone or EVLT with concomitant ambulatory phlebectomies (EVLTAP). Principal outcomes were procedure duration, pain scores, requirement for secondary procedures and quality of life after 3 months. Results: EVLTAP took longer, but significantly decreased the requirement for subsequent interventions. There was no impairment in immediate postprocedural pain, Short Form 36 or EuroQol 5D scores with EVLTAP. Median (i.q.r.) Venous Clinical Severity Score (VCSS) at 3 months was lower for EVLTAP than for EVLT alone (0 (0-1) versus 2 (0-2); P < 0.001), with lower Aberdeen Varicose Vein Questionnaire (AVVQ) scores at 6 weeks (7.9 (4.1-10.7) vermis 13.5 (10.9-18.1); P < 0.001) and 3 months (2.0 (0.4-7.7) versus 9.6 (2.2-13.8); P = 0.015). At 1 year, there were no differences in VCSS or AVVQ scores. Conclusion: Concomitant phlebectomy with EVLT prolonged the procedure, but reduced the need for secondary procedures and significantly improved quality of life and the severity of venous disease

Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity

Aim: The durability of occlusion post endovenous laser therapy (EVLT) for varicose veins is linked to the magnitude of energy delivered to the vein and consequently increasing amounts of energy are employed. The aim of this study is to establish whether increasing the energy results in greater periprocedural morbidity or complications. Methods: Linear and logistic regression models were built to study the effect of energy delivery on outcome. The models controlled for age, gender, BMI, pre-operative quality of life and vein dimension. The outcomes were pain and analgesia requirement in week 1, change in disease specific quality of life (Aberdeen varicose vein questionnaire (AVVQ), change in generic quality of life (Short Form-36 (SF-36) and Euroqol (EQ5D)at week 1 and 6 and complication rates. The sample size calculation established that 115 patients would be required to detect any significant relationship. Results: 232 patients were included. The mean (range) age was 50 (18-83) years. 63% were women. The mean (range) energy delivery was 89.8 (44.5-158.4) J/cm. There was no significant effect on any outcome related to increasing energy delivery. Conclusion: Up to 160J/cm, increasing energy delivery has no significant effect upon the morbidity or complications of EVLT for superficial venous insufficiency. © 2010 European Society for Vascular Surgery

Combined endovenous laser therapy and ambulatory phlebectomy: refinement of a new technique

Objective. Sclerotherapy (IS) or ambulatory phlebectomy (AP) are required as subsequent interventions in majority of cases following endovenous laser therapy (EVLT). We assessed whether AP performed concomitantly with EVLT (EVLTAP), is effective, acceptable, and reduces subsequent requirement for interventions. Method. 67 patients (70 limbs) with great saphenous varicosities underwent EVLTAR Pain was assessed on days 1, 4 and 7 using a visual analogue scale (VAS) of 0 to 10. Clinical and ultrasound assessments were done at 1, 6 and 12 weeks (no ultrasound at 6 weeks). Residual varicosities underwent further AP or IS. Patients' satisfaction with the cosmetic outcome and overall treatment was assessed at 12 weeks using a VAS rating. Results. 49 patients (70%) completed follow-up. Median pain scores were 1.6 (IQR 0.2-4.8), 0.3 (0-1.4) and 0.2 (0-1.1) on days 1, 4 and 7 respectively. Ultrasound demonstrated 69 (99%) and 47 (96%) occluded long saphenous veins at 1 and 12 weeks respectively. Subsequent IS or AP was performed on 3 (4%) or 1 (1%) limbs respectively. Cosmetic satisfaction was 9.6 (IQR 8.9-10) and overall satisfaction 9.8 (IQR 9.3-10). Conclusion. EVLTAP produces excellent results, is feasible and acceptable, and obviates need for subsequent procedures in the short-term

Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins

Background: Endovenous laser ablation (EVLA) is a popular minimally invasive treatment for varicose veins. Surgical treatment, featuring junctional ligation and inversion stripping, has shown excellent clinical and cost effectiveness. The clinical effectiveness of both treatments was compared within a randomized trial. Methods: Some 280 patients were randomized equally into groups receiving either surgery or EVLA. Participants had primary, symptomatic, unilateral venous insufficiency, with isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein. Outcomes included: quality of life (QoL), Venous Clinical Severity Score (VCSS), pain scores and time taken to return to normal function. Owing to the nature of the procedures, blinding was not possible. Results: Both groups had significant improvements in VCSS after treatment (P &lt; 0.001), which resulted in improved disease-specific QoL (Aberdeen Varicose Vein Questionnaire, P &lt; 0.001) and quality-adjusted life year (QALY) gain (P &lt; 0.001). The pain and disability following surgery impaired normal function, with a significant decline in five of eight Short Form 36 (SF-36.) domains (P &lt; 0.001 to P = 0.029). Periprocedural QoL was relatively preserved following EVLA, leading to a significant difference between the two treatments in pain scores (P &lt; 0.001), six of eight SF-36. domains (P = 0.004 to P = 0.049) and QALYs (P = 0.003). As a result, surgical patients took longer to return to work and normal activity (14 versus 4 days; P &lt; 0.001). Complications were rare. Conclusion: EVLA was as effective as surgery for varicose veins, but had a less negative impact on early postintervention QoL. Registration number: NCT00759434 (http://www.clinicaltrials.gov)

Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins

Background:This report describes the clinical effectiveness and recurrence rates from a randomized trial of endovenous laser ablation (EVLA) and surgery for varicose veins.Methods:Some 280 patients were randomized equally using sealed opaque envelopes to two parallel groups: surgery and EVLA. Inclusion criteria included symptomatic disease secondary to primary, unilateral, isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein (GSV). Outcomes were: technical success, recurrent varicose veins on clinical examination, patterns of reflux on duplex ultrasound examination, and the effect of recurrence on quality of life, assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ). Assessments were at 1, 6, 12 and 52 weeks after the procedure.Results:Initial technical success was greater following EVLA: 99&middot;3 versus 92&middot;4 per cent (P = 0&middot;005). Surgical failures related mainly to an inability to strip the above-knee GSV. The clinical recurrence rate at 1 year was lower after EVLA: 4&middot;0 versus 20&middot;4 per cent (P &lt; 0&middot;001). The number of patients needed to treat with EVLA rather than surgery to avoid one recurrence at 1 year was 6&middot;3 (95 per cent confidence interval 4&middot;0 to 12&middot;5). Twelve of 23 surgical recurrences were related to an incompetent below-knee GSV and ten to neovascularization. Of five recurrences after EVLA, two were related to neoreflux in the groin tributaries and one to recanalization. Clinical recurrence was associated with worse AVVQ scores (P &lt; 0&middot;001).Conclusion:EVLA treatment had lower rates of clinical recurrence than conventional surgery in the short term. Registration number: NCT00759434 (http://www.clinicaltrials.gov). Copyright &copy; 2011 British Journal of Surgery Society Ltd. Published by John Wiley &amp; Sons, Ltd