Venous function after restoring valve competence of the great saphenous vein

To measure changes in venous function after elimination of great saphenous vein reflux using endovenously-applied heat with a specially designed catheter.

In a prospective clinical study, 13 patients (8 women; mean age 39 years, range 25-59) with symptomatic chronic venous insufficiency were treated for reflux at the saphenofemoral junction. A radiofrequency catheter (Restore) with expandable electrodes that shrinks the vein by controlled constriction of subendothelial collagen was used to restore valve competence. Extirpation of local varicosities was performed simultaneously. Main outcome was change in venous function as measured by plethysmography (foot volumetry) and change in diameter and reflux time at the saphenofemoral junction after 6 and 12 months.

Reflux in the greater saphenous vein was eliminated or reduced to below 0.5 seconds in all patients. The venous function was significantly improved after 6 months' follow-up, with decreased refilling rate/expelled volume related to foot volume (p=0.019). The patients were clinically improved, although only 7 (54%) were entirely free from reflux. Three (21%) patients had thrombus in the vein the day after the treatment, 2 at the treatment site and 1 at the entry site of the introducer. After 1 year, the patients are still satisfied with the results, although venous function is no longer significantly improved compared to baseline.

It is possible to safely restore valvular competence by means of internally shrinking the vein diameter. The venous function is improved, although the vein has a tendency to increase in width with time; limited reflux reappears, with deterioration of venous function.