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OBJECTIVE: This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein. METHODS: A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6 months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36). RESULTS: Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences. CONCLUSION: This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.
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Procedimientos Endovasculares , Várices , Insuficiencia Venosa , Humanos , Polidocanol , Vena Safena/diagnóstico por imagen , Resultado del Tratamiento , Várices/terapia , Medición de Resultados Informados por el Paciente , Insuficiencia Venosa/terapia , Calidad de VidaRESUMEN
INTRODUCTION: In this multicenter, randomized controlled trial, endovenous laser ablation (EVLA) is compared with conventional surgery for the treatment of varicose veins based on incompetence of the small saphenous vein and the saphenopopliteal junction (SPJ). METHODS: In two Dutch hospitals, 189 patients were enrolled and randomized to receive EVLA (810-nm laser) or ligation of the SPJ. End points were success rate measured with duplex ultrasound (6 weeks post-treatment), perioperative pain, quality of life, duration of surgery, difficulty of surgery, complications, cosmetic results, and number of days to resume work and normal activities. Pain was measured on a visual analog scale (VAS). Quality of life was assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ) and Euro Qol-5D. The follow-up duration in this article is 6 weeks. RESULTS: One hundred seventy-five patients have been treated and analyzed. One hundred eighteen patients (67%) underwent EVLA, and 57 patients (33%) underwent ligation of the SPJ. The patient characteristics were similar in both groups. In the surgery group, 21% residual incompetence of the SPJ was seen after 6 weeks, compared with 0.9% in the laser group. Both treatment modalities reduced pain after 6 weeks. One week post-treatment, patients in the EVLA group temporarily experienced more pain compared with the surgery group (31 vs 18 on a VAS from 0 to 100). There were no significant differences between the two groups with respect to quality of life. Both treatments did show improvement in quality of life. Also with regard to the cosmetics, there were no differences, aside from the fact that patients rated their scar as more beautiful after EVLA. After EVLA, patients could return to work more quickly. The operation time was longer in the surgery group. After 2 weeks, there were significantly more neurological complications in the surgery group: 18 (31%) vs 16 (17%) patients in the EVLA group. Ten percent of patients in the surgery group developed a surgical site infection vs 0% in the EVLA group. CONCLUSIONS: EVLA provides an excellent alternative to conventional surgery in the treatment of symptomatic varicose veins due to an incompetent small saphenous vein with SPJ. EVLA has a superior immediate success rate, is easier and faster, and has fewer complications.