PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.