Surgery for deep venous insufficiency.

Background: Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most people, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000.

Objectives: To assess the effects of surgical management of deep venous insufficiency on ulcer healing and recurrence, complications of surgery, clinical outcomes, quality of life (QoL) and pain.

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov trials registries to 23 June 2020.

Selection Criteria: We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency.

Data Collection And Analysis: Two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias with the Cochrane risk of bias tool. We evaluated the certainty of the evidence using GRADE. We were unable to pool data due to differences in outcomes reported and how these were measured. Outcomes of interest were ulcer healing and recurrence, complications of surgery, clinical changes, QoL and pain.

Main Results: We included four RCTs (273 participants) comparing valvuloplasty plus surgery of the superficial venous system with surgery of the superficial venous system for primary valvular incompetence. Follow-up was two to 10 years. All included studies investigated primary valve incompetence. No studies investigated other surgical procedures for the treatment of people with deep venous insufficiency or surgery for secondary valvular incompetence or venous obstruction. The certainty of the evidence was downgraded for risk of bias concerns and imprecision due to small numbers of included trials, participants and events. None of the studies reported ulcer healing or ulcer recurrence. One study included 27 participants with active venous ulceration at the time of surgery; the other three studies did not include people with ulcers. There were no major complications of surgery, no incidence of deep vein thrombosis and no deaths reported (very low-certainty evidence). All four studies reported clinical changes but the data could not be pooled due to different outcome measures and reporting of the data. Two studies assessed clinical changes using subjective and objective measurements, as specified in the clinical, aetiological, anatomical and pathophysiological (CEAP) classification score (low-certainty evidence). One study reported mean CEAP severity scores and one study reported change in clinical class using CEAP. At baseline, the mean CEAP severity score was 18.1 (standard deviation (SD) 4.4) for limbs undergoing external valvuloplasty with surgery to the superficial venous system and 17.8 (SD 3.4) for limbs undergoing surgery to the superficial venous system only. At three years post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that had undergone external valvuloplasty with surgery to the superficial venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the superficial venous system only (low-certainty evidence). In another study, participants with progressive clinical dynamics over the five years preceding surgery had higher rates of improvement in clinical condition in the treatment group (valvuloplasty plus ligation) compared with the control group (ligation only) (80% versus 51%) after seven years of follow-up. Participants with stable preoperative clinical dynamics demonstrated similar rates of improvement in both groups (95% with valvuloplasty plus ligation versus 90% with ligation only) (low-certainty evidence). One study reported disease-specific QoL using cumulative scores from a 10-item visual analogue scale (VAS) and reported that in the limited anterior plication (LAP) plus superficial venous surgery group the score decreased from 49 to 11 at 10 years, compared to a decrease from 48 to 36 in participants treated with superficial venous surgery only (very low-certainty evidence). Two studies reported pain. Within the QoL VAS scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at 10 years for participants in the LAP plus superficial venous surgery group and increased from 2 to 3 at 10 years in participants treated with superficial venous surgery only. A second study reported that 'leg heaviness and pain' was resolved completely in 36/40 limbs treated with femoral vein external valvuloplasty plus high ligation and stripping of the great saphenous vein (GSV) and percutaneous continuous circumsuture and 22/40 limbs treated with high ligation and stripping of GSV and percutaneous continuous circumsuture alone, at three years' follow-up (very low-certainty evidence).

Authors' Conclusions: We only identified evidence from four RCTs for valvuloplasty plus surgery of the superficial venous system for primary valvular incompetence. We found no studies investigating other surgical procedures for the treatment of people with deep venous insufficiency, or that included participants with secondary valvular incompetence or venous obstruction. None of the studies reported ulcer healing or recurrence, and few studies reported complications of surgery, clinical outcomes, QoL and pain (very low- to low-certainty evidence). Conclusions on the effectiveness of valvuloplasty for deep venous insufficiency cannot be made.