Endovascular Laser Treatment versus Saphenectomy for the Management of Varicose Veins in Lower Limbs

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPONI, A; REY-ARES, L.

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Varicose veins are abnormally dilated superficial, cylindrical or saccular veins. They may present as telangiectasia to extended dilatation of the main lower limb superficial vein system, following a circumscribed or segmental pattern. They affect 10-15% males and 20-25% women.The pressure varicose veins have on the sensitive nerves results in symptoms, pain, fatigue, heaviness and tension in the legs. Chronic vein insufficiency, the most severe degree of this condition, is accompanied by edema, skin changes and ulceration.Surgical therapy is indicated in patients with symptoms of chronic vein insufficiency affecting the saphenous veins and the perforating veins, varicose veins with few symptoms but very prominent at potential risk of complications (varicose vein phlebitis or varicose vein bleeding), and relapsing varicose veins. Partial or complete ablation of the saphenous vein associated to the incompetent perforating vein ligation is still the most widely used technique. Less invasive techniques include sclerotherapy, effective in the treatment of small and medium veins (up to 5 mm), which is usually used to complement surgery and obliteration procedures using foam, laser or endovascular radiofrequency.Endovenous laser treatment (EVLT) is proposed as a potentially less invasive alternative to the standard surgical therapy for the treatment of varicose veins.TechnologyEVLT consists in inserting a catheter into the internal or external saphenous vein by percutaneous puncture (Seldinger´s technique) or through a small incision at the knee or ankle level. Once the catheter inserted, a laser fiber is advanced until the distal end is located, one or two centimeters below the sapheno-femoral vein junction. Laser pulses are triggered at periodic intervals every 5 millimeters, as the fiber is removed until vein obliteration is achieved.PurposeTo assess the available evidence on the efficacy, safety and coverage policy related aspects on the use of EVLT for the treatment of varicose veins in lower limbs.MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems.ResultsTwo meta-analyses and three RCTs published at a later date compared EVLT ablation with saphenectomy; two technology assessments, seven coverage policies and one clinical practice guideline were found.One 2011 Cochrane meta-analysis which included two RCTs examined two endpoints: rate of recanalization and reinterventions due to technical failures. No statistically significant differences were observed in the rates of recanalization. Reinterventions due to technical failures were lower in the subjects treated with EVLT OR 0.12 (95% CI 0.02 to 0.75). No meta-analysis was conducted on adverse effects; one study showed a higher bruising frequency in the saphenectomy group and the other study showed a higher phlebitis frequency in the EVLT group. One of the studies showed a statistically lower mean comeback to daily activities in the EVLT group.A second meta-analysis published in 2010 which included 7 studies, found a non significant relative risk (RR) of recurrence at 3 months after surgery with EVLT of 2.19 (95% CI 0.99; 4.85) compared with saphenectomy. As regards return to work, the meta-analysis included two studies which showed a quicker return of the EVLT patients treated with a mean difference of -5.2 days (95% CI -6.52; -3.53).Two RCTs did not find significant differences between the groups in terms of clinical recurrences or presented adverse events. Another RCT showed statistically significant differences for EVLT in terms of surgery success (99.3% vs. 92.4%) and recurrence of varicose veins (20.4% vs. 4%).The practice guideline considers that there is Grade IV evidence (expert committee) for EVLT use as an alternative to conventional surgery. Out of two health technology assessments, one considered that EVLT is comparable to saphenectomy in terms of clinical benefits, while the other one carried out in 2003 did not find evidence of its effectiveness or benefits. All the coverage policies consider that EVLT is a safe and effective procedure and a valid alternative to vein removal in patients with surgical treatment indication.ConclusionsThe evidence from the five studies found is solid and of good quality. Four studies, as well as the technology assessments, did not find significant differences between saphenectomy and EVLT obliteration. Both the government agencies from four countries and the private health provider consulted considered that EVLT is a valid alternative to conventional surgery. Both procedures are effective and have similar adverse event profiles therefore the decision making on its use will depend on accessibility and costs.