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). Comparison of endoscopic ligation and propranolol for the primary prevention of variceal bleeding.
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 compared propranolol therapy and endoscopic ligation for the primary prevention of bleeding from esophageal varices. This prospective, controlled trial included consecutive eligible patients who had large varices (>5 mm in diameter) that were at high risk for bleeding. The patients were assigned to either propranolol therapy, at a dose sufficient to decrease the base-line heart rate by 25 percent, or variceal ligation, to be performed weekly until the varices were obliterated or so reduced in size that it was not possible to continue treatment.
                Of the 89 patients, 82 of whom had cirrhosis of the liver, 44 received propranolol and 45 underwent variceal ligation. The mean (+/-SD) duration of follow-up in each group was 14+/-9 and 13+/-10 months, respectively. The mean time required to achieve an adequate reduction in the heart rate was 2.5+/-1.7 days; the mean number of sessions needed to complete variceal ligation was 3.2+/-1.1. After 18 months, the actuarial probability of bleeding was 43 percent in the propranolol group and 15 percent in the ligation group (P=0.04). Twelve patients in the propranolol group and four in the ligation group had bleeding. Three of the four in the ligation group had bleeding before their varices had been obliterated. Nine patients in the ligation group had recurrent varices, a mean of 3.7 months after the initial treatment. Five patients in each group died; bleeding from the varices was the cause of death of four patients in the propranolol group and of three in the ligation group. There were no serious complications of variceal ligation; in the propranolol group, treatment was stopped in two patients because of side effects.
                In patients with high-risk esophageal varices, endoscopic ligation of the varices is safe and more effective than propranolol for the primary prevention of variceal bleeding.
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.