Gore external valve support for superficial saphenous vein incompetence: a 10-year, follow-up registry

Aim. This long-term (10-year) study evaluated the safety and efficacy of expanded polytetrafluoroethylene (ePTFE) external valve support (EVS) implants used for external valvuloplasty in the treatment of incompetence of the proximal long saphenous veins. Methods. During a 10-year follow-up, patients with superficial venous disease and venous hypertension due to pure superficial vein incompetence underwent an external valvuloplasty using an EVS with a PTFE suture. Forty-nine patients were included in the EVS group and 47 in the control group. Patients with superficial venous disease and venous hypertension due to pure superficial venous incompetence were randomised into two treatment groups. The first group was treated with what was considered "conventional treatment" (ligation or stripping) and the second with external valvuloplasty with EVS. This report deals with controls treated with ligation as only 6 cases (not mentioned in this report) were treated with stripping. There were no significant differences in the two groups concerning age, sex, or type of venous insufficiency. The procedures focused on only one single limb per patient. Results. 46.9% of limbs treated with EVS developed varices in comparison with 73% in the control group. New surgical procedures (localized ligation) were needed in 32.6% of the EVS patients vs. 55.3% in controls. Sclerotherapy was used in 42% of the EVS patients vs. 72.34% in controls. At 10 years the SFJ was incompetent (reflux) in 2 EVS patients (4%); one after 5 years and one after 7 years. There was no incompetence at the level of the ligated junction in controls. There were 62 incompetent venous sites (1.26 per limb) in the EVS group vs. 96 new incompetent venous sites (2.04 per limb) in controls. In controls 10.63% of the limbs developed minor discolorations and signs due to mild CVI; none was observed in the EVS group. In all ESV implants there was full restoration of competence at 1 year. Conclusion. EVS implants used to correct superficial venous incompetence at 10 years were well tolerated and produced good results on incompetence and on the evolution of varicose veins.