External femoral vein valvuloplasty with limited anterior plication (LAP): a 10-year randomized, follow-up study. Femoral vein valve repair with limited anterior plication (LAP). Does surgical correction of the superficial femoral vein valve change the course of varicose disease?
The aim of this study was to evaluate the effects after 10 years of external valvuloplasty of the femoral vein (limited anterior plication or LAP). After informed consent patients with venous hypertension due to deep and superficial venous incompetence were randomized into two treatment groups. Both groups were treated with superficial vein surgery (ligation and section of the major incompetent superficial veins). Group 2 was treated with the same procedure and with LAP. External valvuloplasty of the superficial femoral vein was performed with plication of the anterior vein wall after limited dissection of the vein. Results were evaluated with color-duplex scanning and ambulatory venous pressure (AVP) measurements. Endpoints were AVP, refilling time (RT), presence/absence of reflux at the superficial femoral vein, the variation in the diameter of the vein, and quality of life score (QLS). No complications were observed. All femoral veins treated with LAP were competent after 10 years. Significantly lower AVP and longer RT were observed in the LAP group. Also the average diameter of the vein was smaller in the LAP group. Moreover, QLS was significantly better in the LAP group after 10 years. In conclusion, in selected subjects, with moderate deep venous incompetence, functional cusps, or incompetence mainly due to relative enlargement of the femoral vein, LAP may be an effective alternative to external valvuloplasty. Limited anterior plication (LAP) of the incompetent femoral vein was used in 2 groups of subjects with venous hypertension due to deep and superficial venous incompetence. Group 1 subjects were treated only with superficial veins surgery while groups 2 was treated with external valvuloplasty (LAP) at the level of the incompetent femoral vein. The plication was performed at the anterior side of the vein after limited dissection and manipulation. During a two-year follow-up the results of LAP were evaluated with color-duplex and ambulatory venous pressure (AVP) measurements. Nine of the 11 femoral veins treated with LAP were competent after 2 years (in 2 the incompetence was reduced). A lower AVP and RT was found in subjects treated with LAP in comparison with those in Group 1. Also the number of recurrent varicose veins (incompetent venous sites) and the average diameter of the femoral vein were higher in Group 2 (superficial surgery only). As no complications were observed LAP can be considered an alternative to the standard external valvuloplasty in cases of moderate incompetence when valve cusps are present and functional and incompetence is mainly due to relative enlargement of the vein diameter. We tested the hypothesis that the course of primary chronic venous insufficiency can be changed by correction of the incompetent valve in the superficial femoral vein.
                This was a prospective, randomized, controlled study. A total of 125 extremities with reflux in greater saphenous and superficial femoral veins and belonging to clinical classes C2-C4 were analyzed. During the first 5 years, the type of clinical dynamics and changes in valvular function were determined in each patient. Patients were stratified according to the type of clinical dynamics and randomly assigned to treatment groups. Phlebectomy was performed in all extremities. In each of 64 extremities (the study group), the proximal incompetent superficial femoral vein valve was corrected as a part of the primary intervention. Patients were followed up for 7 to 8 years after surgery.
                The clinical dynamics of the extremity significantly depended on reflux changes. Increase in superficial femoral vein reflux was found in 74% of the extremities with progressive clinical dynamics but in only 47% of extremities with stable clinical dynamics (chi(2) = 9.71; P <.01). After surgical treatment, 65% of the extremities in the control group showed stable improvement; in 11%, recurrent varicosity was found; in 24%, the disease was aggravated. Of the extremities in the study group, 86% had stable improvement, 5% had recurrent varicosity, and 10% were aggravated (P <.05). Extremities with the progressive type of clinical dynamics were main contributors to this difference (chi(2) = 7.86; P <.05). In 92% of the extremities with corrected valves and in 50% of the extremities with increase in reflux after valvuloplasty, clinical improvement was observed (chi(2) = 11.5; P <.01). Extremities with corrected valvular function demonstrated superior results in comparison with extremities with stable valvular function in the control group (clinical improvement in 92% and 66% of extremities, respectively; P <.005).
                In patients with chronic venous insufficiency, two types of clinical dynamics, stable and progressive, can be identified. The progressive type is associated with the presence of superficial femoral vein reflux and increasing greater saphenous vein reflux. Superficial vein surgery neither corrects superficial femoral vein reflux nor prevents it from progressing further. Correction of a single superficial femoral vein valve during primary intervention significantly improves the long-term results of superficial venous surgery. This improvement is associated with the prevention of reflux progression. Surgical correction of the incompetent superficial femoral vein valve changes the course of primary chronic venous insufficiency.
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.