Background: Chronic deep venous incompetence (DVI) is caused by incompetent vein valves and/or the blockage of large calibre leg veins, with a range of symptoms including recurrent ulcers, pain and swelling.
Objectives: To establish the effectiveness of various surgical procedures for treating DVI.
Search strategy: Trials were identified through the Cochrane Peripheral Vascular Diseases Group's trials register, reference lists of relevant studies, and contact with principal investigators of identified trials and world experts in deep venous surgery.
Selection criteria: Randomised controlled trials of surgical treatment for patients with DVI.
Data collection and analysis: Reviewers extracted data independently. Outcome measures included ambulatory venous pressure (AVP) and venous refill time (VRT).
Main results: Three trials were included, one trial was excluded. Two trials compared external valvuloplasty using limited anterior plication (LAP) in combination with ligation (L) of incompetent superficial veins (L+LAP) against ligation only (L). The other trial compared external valvuloplasty and ligation (V+L) of incompetent superficial veins against ligation only (L). Trial participants had primary valvular incompetence with mild to moderate symptoms but no venous ulcers.L+LAP produced significant improvement in AVP: the mean difference between L+LAP and L groups was -15 mm Hg (95% confidence interval (CI) -20.9 to -9.0) at one year and -15 mm Hg (95% CI -21 to -8.9) at ten years.AVP values after surgery remained relatively high. Nine of eleven valves repaired remained competent after two years of follow up. No complications occurred. The overall mean score for clinical outcome was +2 (moderate improvement) in the L+LAP group compared with +1 (mild improvement) in the L group. Patients with deteriorating clinical dynamics over the five years preceding surgery had a significantly higher rate of improvement in clinical condition in V+L compared to L (81% versus 51%; p < 0.05) after seven years follow-up. Patients with stable preoperative clinical dynamics demonstrated a similar rate of improvement in both groups (96% versus 90%; p> 0.1). AVPs were not performed.
Reviewers' conclusions: These results indicate that ligation and valvuloplasty may have produced a moderate and sustained improvement for seven to ten years after surgery, in patients with mild to moderate DVI caused by primary valvular incompetence. However, there is insufficient evidence to recommend the treatment to this subgroup of patients, as the trials were small, used different methods of valvuloplasty and different methods of assessment.