BACKGROUND: Endovascular radiofrequency obliteration has been used as an alternative to conventional vein-stripping surgery for elimination of saphenous vein insufficiency. A clinical registry was established in 1998, and its mid-term results have been reported previously. This study is to demonstrate the long-term treatment outcomes and to determine the risk factors that affect treatment efficacy. METHODS: Data were collected in an ongoing multicenter, prospective registry. Patients were treated before October 2004. Clinical and duplex ultrasound follow-up was performed 1 week, 6 months, 1 year, and yearly thereafter to 5 years. Treatment efficacy and clinical improvement after the procedure were analyzed. Three types of anatomical failure were identified. Logistic regression analysis was performed to determine the existence of any significant risk factors associated with anatomical failure. Risk factors considered were age, gender, body mass index, vein diameter, and pullback speed. The impact of anatomical failure on clinical symptoms and varicose vein recurrence was also analyzed. RESULTS: There were 1,006 patients (1,222 limbs) treated, their mean age was 47.4 +/- 12.1 years, and 78.1% were female. Veins treated included 89.1% great saphenous vein above-knee segments, 1.2% great saphenous vein below-knee segments, 4.1% great saphenous vein groin-to-ankle, 4.3% small saphenous veins, and 1.3% accessory saphenous veins. Mean vein diameter was 7.5 mm, with a maximum of 24 mm. Vein occlusion rates were 87.1%, 88.2%, 83.5%, 84.9%, and 87.2%, and reflux-free rates were 88.2%, 88.2%, 88.0%, 86.6%, and 83.8% at each annual follow-up. Clinical symptom improvement was seen in 70% to 80% of limbs with anatomical failures and in 85% to 94% of limbs with anatomical success from 6 months to 5 years after the radiofrequency obliteration. Logistic regression analysis showed that catheter pullback speed (P < .0001) and body mass index (P < .0333) were risk factors for anatomical failure. Limbs that had type II and type III anatomical failures were found to be more prone to varicose vein recurrence. CONCLUSIONS: Endovascular radiofrequency obliteration of saphenous vein reflux exhibits enduring efficacy. Adequate pullback speed during the procedure should be emphasized to ensure the proper thermal dose delivery. A whole treatment strategy to address hemodynamically significant tributaries and perforators can further improve treatment outcomes. Body mass index is a risk factor for anatomical failure, indicating the impact of hemodynamic factors on disease progression and recurrence.
BACKGROUND: Endovascular radiofrequency obliteration has been used as an alternative to conventional vein-stripping surgery for elimination of saphenous vein insufficiency. A clinical registry was established in 1998, and its mid-term results have been reported previously. This study is to demonstrate the long-term treatment outcomes and to determine the risk factors that affect treatment efficacy. METHODS: Data were collected in an ongoing multicenter, prospective registry. Patients were treated before October 2004. Clinical and duplex ultrasound follow-up was performed 1 week, 6 months, 1 year, and yearly thereafter to 5 years. Treatment efficacy and clinical improvement after the procedure were analyzed. Three types of anatomical failure were identified. Logistic regression analysis was performed to determine the existence of any significant risk factors associated with anatomical failure. Risk factors considered were age, gender, body mass index, vein diameter, and pullback speed. The impact of anatomical failure on clinical symptoms and varicose vein recurrence was also analyzed. RESULTS: There were 1,006 patients (1,222 limbs) treated, their mean age was 47.4 +/- 12.1 years, and 78.1% were female. Veins treated included 89.1% great saphenous vein above-knee segments, 1.2% great saphenous vein below-knee segments, 4.1% great saphenous vein groin-to-ankle, 4.3% small saphenous veins, and 1.3% accessory saphenous veins. Mean vein diameter was 7.5 mm, with a maximum of 24 mm. Vein occlusion rates were 87.1%, 88.2%, 83.5%, 84.9%, and 87.2%, and reflux-free rates were 88.2%, 88.2%, 88.0%, 86.6%, and 83.8% at each annual follow-up. Clinical symptom improvement was seen in 70% to 80% of limbs with anatomical failures and in 85% to 94% of limbs with anatomical success from 6 months to 5 years after the radiofrequency obliteration. Logistic regression analysis showed that catheter pullback speed (P < .0001) and body mass index (P < .0333) were risk factors for anatomical failure. Limbs that had type II and type III anatomical failures were found to be more prone to varicose vein recurrence. CONCLUSIONS: Endovascular radiofrequency obliteration of saphenous vein reflux exhibits enduring efficacy. Adequate pullback speed during the procedure should be emphasized to ensure the proper thermal dose delivery. A whole treatment strategy to address hemodynamically significant tributaries and perforators can further improve treatment outcomes. Body mass index is a risk factor for anatomical failure, indicating the impact of hemodynamic factors on disease progression and recurrence.