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A Journal on Phlebology
Acta Phlebologica 2002 August;3(2):101-6
External valve-support (EVS) for saphenofemoral junction incompetence. Randomized trial at 3 years follow-up
Agus G. B., Bavera P. M., Mondani P., Santuari D.
Chair of Vascular Surgery, Igea Clinic, University of Milan, Milan, Italy
BACKGROUND: Times for use of saphenofemoral junction valvuloplasty in the treatment of varicose veins, after a long experimental period developed in Italy, are now ready. By the end of 1998, an international multicenter trial started: the IMES (international multicenter EVS Study). The aim of this trial was to evaluate the effects of a new surgical device, external valve support (EVS), and technique for external valvuloplasty of the long saphenous vein (LSV). The purpose of the current brief study carried out within the IMES was to examine our results of EVP procedure versus standard surgery at 3 years follow-up with clinical, haemodynamic and quality of life assessment as outcomes.
METHODS: Our group enrolled 24 selected patients, 18 females and 6 males, between January and December 1999 affected by incompetence of the sapheno-femoral junction (SFJ) and consequent uncomplicated venous disease. The age of the patients was between 26 and 57 years (mean age 48). All the patients underwent operation with the same surgeon so to receive the nearest possible surgical uniformity. Patients with superficial venous disease and venous incompetence were randomized into 2 treatment groups. According to CEAP classification all patients were Cs2,3 – Ep – A2,3p17, 18 – Pr. The first group (Group 1) was cured with a standard treatment (simple ligaton or stripping, according to the different patterns of reflux) plus stab-avulsions, when necessary. The other group (Group 2) was treated with external valvuloplasty with the EVS. For each patient identified as a candidate for venous repair surgery, color flow duplex imaging, air-pletismography (APG) or ambulatory venous pressure (AVP), and Trendelemburg testing were performed preoperatively to assess the number, condition and orientation of the valve leaflets and the diameter of the LSV. The effect of varicose veins surgery to affect quality of life (QoL) was examined. In this study we used the Italian version disease-specific Aberdeen Varicose Vein Questionnaire (AVVQ).
RESULTS: Twelve patients had a “tailored” PTFE patch chosen from 1 of the 3 available sizes, placed around the preterminal SFJ so to correct the caliper and vein cusp function. The remaining 12 were submitted to a “classic” SFL ligation. One month, 6 months, 1-year, 2-years and finally 42 months follow-ups have been conducted after surgical procedures. The check had been subjective and objective, considering the resolution of the primary varicose veins disease and recurrence of varicosity. In all that times, there were no evidence of device related complications and above all the repaired valves remained competent at the duplex scan controls: only 1 patient showed a reflux in the site of valve repair. All the patients reached very good results almost comparable in each of the 2 groups, either if treated with external valvuloplasty (Group 2) or with classical procedures (Group 1).
CONCLUSIONS: If nowadays some excellent 5 to 10 years follow-up studies are available, we consider our small randomized group to be of certain interest. Our study, despite its imperfections primarly because the series is too small for statistical analysis expected for the complete multicenter RCT, clearly shows the beneficial effect for the patients in terms of QoL even if there was no difference in this outcome between the two groups. In our opinion, at this point, the external valvuloplasty is a useful method of restoring form and function to the incompetent LSV in a highly selected group of patients (about 5-8%).