Background
Deep venous insufficiency is a problem in the veins of the legs that can lead to leg ulcers (sores), pain and swelling. It may be caused by a problem with the valves of the vein, by a blockage of the veins or a combination of these events. For most people, wearing special compression stockings and treating the ulcers is enough. When this does not ease the problem, surgery is sometimes tried. It is unclear how much benefit there is from surgery.
Study characteristics and key results
We looked for studies treating deep venous insufficiency with surgery (searched 23 June 2020). We found four studies that randomised 273 participants to treatment or control interventions. All included studies reported on outcomes following surgical repair of venous valves (valvuloplasty). All included studies investigated primary valve incompetence (when valves do not close properly). We found no studies investigating other surgical procedures for treatment or the results of surgery for secondary valvular incompetence (for example, when valves are damaged as a result of deep vein thrombosis and do not close properly), or for venous obstruction. As different outcomes were reported, we could not combine the results of these studies. No studies reported ulcer healing and ulcer recurrence. One study did not investigate this, and the remaining three studies did not include people with ulcers or active ulceration. Three studies reported no major complications of surgery or no incidence of deep vein thrombosis (a blood clot that forms in a deep vein, usually in the leg or pelvis) during follow-up.
We assessed clinical changes using the 'clinical, aetiological, anatomical and pathophysiological' (CEAP) classification score. One study reported an improved CEAP score three years after surgery in both groups, and a greater improvement from before surgery in limbs that had undergone valvuloplasty plus ligation (where a vein is tied off) compared with ligation alone. In another study, participants with worsening deep vein incompetence over the five years before surgery had higher rates of improvement in clinical condition with valvuloplasty plus ligation compared with ligation only after seven years, but in participants with stable deep vein incompetence, there was no additional benefit from the valvuloplasty.
One study reported improvement in patient-reported quality of life (including pain) in both groups and a greater improvement compared to before surgery in people who had undergone external valvuloplasty using a technique called limited anterior plication at 10 years' follow-up. A second study reported that leg heaviness and pain was resolved completely in 36/40 limbs treated with valvuloplasty plus ligation and 22/40 limbs treated with ligation alone at three years' follow-up.
Reliability of the evidence
The reliability of the evidence was very low or low because there were only four studies with small numbers of participants, and there was a high risk of bias (information regarding how it was decided what treatment a participant received and who knew this was missing in three of the four studies).
Conclusion
There is not enough evidence to determine the effectiveness of surgery on the treatment of people with deep venous insufficiency. The included studies did not include people with severe deep venous insufficiency (venous obstruction). Trials investigating the effects of other surgical procedures on the deep veins are needed.
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.
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.
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.
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.
We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency.
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.
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).