Superficial vein valve repair with a new External Valve Support (EVS)

The aim of this international multicenter trial was to evaluate the effects of a new surgical device (Gore External Valve Support-EVS) and technique f or external valvuloplasty of the long saphenous vein (LSV). Patients with s uperficial venous disease and venous hypertension due to pure superficial v enous incompetence were randomized into two treatment groups, the first tre ated with "conventional treatment" (ligation or stripping) and the second w ith external valvuloplasty with the EVS. Patients with uncomplicated varico se veins within the age range of 35-65 years were included. Incompetence wi th presence of functional cusps at the saphenofemoral junction (SFJ), with vein dilatation were the main inclusion criteria. The EVS comprised of a GO RE-TEX(R) patch material (including a nitinol frame) that is placed around the vein, producing a reduction in the caliber of the vein. Also the vein s ection becomes elliptical. These combined actions are aimed to reduce incom petence, allowing a better closure of the cusps. The EVS was placed at the SFJ after limited dissection of the vein and ligation of collaterals. The p rocedure was randomized as an alternative to simple ligation or stripping ( according with the procedure commonly used in the center). The associated l igation of distal incompetent veins was allowed. The main outcome measures of the study were evaluated by color-duplex (morphologic findings and evalu ation of reflux) and with ambulatory venous pressure (AVP) or air-plethysmo graphy (APG). Main endpoints of the first year of the study and main subjec t of this report (mainly concerning safety within the first year of follow- up) were considered presence/absence of reflux; patency of the veins; mobil ity/function of vein cusps; occurrence of thrombosis; tolerability of the d evice; and increased complexity and operating time needed for the EVS. At 1 year 30 patients had been randomized (14 EVS implanted, 16 controls). Refl ux was absent in all EVS patients, all treated veins were patent, and all c usps were mobile. No thrombosis had been observed and the tolerability of t he device was very good. The increased complexity required by placing the E VS was limited (5-12 minutes more). In conclusion results of the first year show efficacy and tolerability of the EVS. In selected patients (superfici al LSV incompetence, reflux-dilatation, functional SFJ cusps, incompetence mainly due to enlargement of the vein), the EVS could be an effective alter native to "destructive" ligation and/or stripping of the vein. Prolonged fo llow-up will indicate the clinical potentials of the EVS.