Endovascular obliteration of saphenous reflux: a multicenter study.

OBJECTIVE The objective of this study was to assess the differences in clinical outcomes in patients treated with endovenous saphenous vein obliteration with technical outcome of either complete occlusion (CO), near complete occlusion (NCO), defined as < or =5-cm segment of flow in treated vein, or recanalization, defined as >5-cm segment of flow in treated vein. STUDY DESIGN The study was designed as a prospective registry with follow-up at intervals through 24 months. The subjects were 286 patients from 30 clinical sites with saphenous vein reflux as measured with duplex scanning. A total of 319 limb treatments were performed. Intervention included endovenous catheter obliteration of insufficient saphenous veins with temperature controlled radiofrequency heat, without high ligation of the saphenofemoral junction. The main outcome measures were status of occlusion of treated vein segments, presence of varicose veins and reflux, clinical symptoms scores, physician evaluation of procedure success, and patient satisfaction. RESULTS At 12 months, 83.6% of treated limbs were classified as CO, 5.6% were categorized as NCO, and 10.8% were recanalized. At 24 months, 85.2% of treated veins were CO, 3.5% were NCO, and 11.3% were recanalized. Varicose veins were present in 95% of limbs before treatment. The presence of varicose veins in limbs with CO was 10.5%, 7.3%, 5.7%, and 8.3% at 1 week, 6 months, 12 months, and 24 months, respectively. The presence of varicose veins in NCO limbs was similar at each interval. Overall, 91.4% of 232 limbs followed to 12 months and 90.1% of 142 limbs at 24 months were free of saphenous vein reflux, regardless of technical outcome. Paresthesia was reported in 3.9% of limbs at 1 year and in 5.6% at 2 years. The pretreatment mean symptom severity score was 2.0. Mean posttreatment symptom scores decreased to 0.07, 0.0, and 0.50 for CO, NCO, and recanalized limbs, respectively, at 6 months. At 12 months, the mean scores were 0.06, 0.0, and 0.32 for CO, NCO, and recanalized limbs, respectively; at 24 months, the scores were at 0.10, 0.40, and 0.63. Patient satisfaction was achieved in 195 of 212 patients (92%) at 1 year and in 121 of 128 (94.5%) at 2 years. CONCLUSION Endovenous vein obliteration without high ligation dramatically reduces the presence of varicosities and reflux and, when performed with the prescribed pull-back methodology, is comparable with vein stripping at 1 and 2 years. Patient satisfaction with the procedure is high at 2 years, regardless of technical outcome. At 2 years, the closure procedure is a viable alternative to stripping.