Treatment of primary varicose veins by endovenous obliteration with the VNUS closure system: results of a prospective multicentre study.

BACKGROUND Radio frequency obliteration of the saphenous veins has been introduced as a less invasive alternative to traditional surgery for varicose veins. OBJECTIVE To report the efficacy of obliteration and clinical outcomes following endovenous obliteration of the saphenous vein with limited follow-up to 3 years. MATERIALS AND METHODS Radiofrequency obliteration (Closure system, VNUS Medical Technologies, San Jose, CA) was performed in 330 limbs of 294 patients in a prospective worldwide multicentre study with 31 participating sites. Follow-up duplex ultrasound and clinical examinations were performed at annual intervals. The main outcome measures were the completeness of occlusion of the treated vein segment, presence of reflux and presence of signs and symptoms of venous disease. RESULTS Before treatment 3.9% of limbs were categorised as CEAP clinical class zero or one. This improved to 82.9% at 1 year, 83.1% at 2 years and 86.8% at 3 years following treatment. Varicose vein free rates were 1 year: 90.1%, 2 years: 87.2%, 3 years: 88.2%. Duplex ultrasound demonstrated a reflux-free rate of about 88% over 3 years. Total occlusion (TO) of veins was 1 year: 81%, 2 years: 80.4% and 3 years: 75%. Partial occlusion (PO, <5 cm open segment) was 1 year: 6.3%, 2 years: 7.4% and 3 years: 17.6%. Incomplete occlusion (IO, >5 cm open segment) was 1 year: 12.7%, 2 years: 12.2% and 3 years: 7.4%. Partial occlusion did not result in any differences in the symptom severity score, the number of symptom free limbs, or the varicose vein absence rates at any follow-up time point when compared to the total occlusion group. The varicose vein absence rates were significantly lower in the IO group comparing to the TO and PO groups. CONCLUSIONS Radiofrequency saphenous vein obliteration improves the symptoms of varicose veins. The reflux-free rates in the treated veins remain constant over a 3 year follow-up period. There is no difference in clinical outcomes between the TO and the PO limbs, suggesting clinical effectiveness of the PO category. Greater than a 5 cm open segment in treated veins poses a risk of recurrence.