PURPOSE: This study assessed clinical outcomes of two catheter-based endovenous procedures to eliminate or greatly mitigate saphenous vein reflux. MATERIALS AND METHODS: A computer-controlled, dedicated generator and two catheter designs were used to treat 210 patients at 16 private clinic and university centers in Europe. The Closure catheter applied resistive heating over long vein lengths to cause maximum wall contraction for permanent obliteration; the Restore catheter induced a short subvalvular constriction to improve the competence of mobile but nonmeeting leaflets. RESULTS: Closure treatment caused acute obliteration in 141 (93%) of 151 limbs; Restore treatment, shrinking one or more valves, acutely reduced reflux to less than 1 second in 41 (60%) of 68 limbs. Closure treatments were associated with early recanalization (6%), paresthesias (thigh, 9%; leg, 51%; P <.001), 3 skin burns, and 3 deep-vein thrombus extensions, with 1 embolism. Restore treatments were thrombogenic (16%) despite prophylactic anticoagulation, and treated valves enlarged over 6 weeks, becoming less competent. Clinical Efficacy Assessment Project clinical class was significantly improved after both treatments, up to 1 year. At 6 months, 87% of 53 Closure patients were class 0 or 1, 75% were symptom-free, and 96% of 55 treated limbs were completely free of reflux. Fourteen of 31 Restore patients (45%) had no symptoms, but 55% were class 2 or lower and only 19% had less than 1-second reflux. CONCLUSION: Closure treatment is clinically effective, albeit with offsetting complications and early failures; these are being addressed through four procedural modifications. Restore valve shrinking, although conceptually attractive, is too problematic to be competitive with Closure treatment or saphenectomy.
PURPOSE: This study assessed clinical outcomes of two catheter-based endovenous procedures to eliminate or greatly mitigate saphenous vein reflux. MATERIALS AND METHODS: A computer-controlled, dedicated generator and two catheter designs were used to treat 210 patients at 16 private clinic and university centers in Europe. The Closure catheter applied resistive heating over long vein lengths to cause maximum wall contraction for permanent obliteration; the Restore catheter induced a short subvalvular constriction to improve the competence of mobile but nonmeeting leaflets. RESULTS: Closure treatment caused acute obliteration in 141 (93%) of 151 limbs; Restore treatment, shrinking one or more valves, acutely reduced reflux to less than 1 second in 41 (60%) of 68 limbs. Closure treatments were associated with early recanalization (6%), paresthesias (thigh, 9%; leg, 51%; P <.001), 3 skin burns, and 3 deep-vein thrombus extensions, with 1 embolism. Restore treatments were thrombogenic (16%) despite prophylactic anticoagulation, and treated valves enlarged over 6 weeks, becoming less competent. Clinical Efficacy Assessment Project clinical class was significantly improved after both treatments, up to 1 year. At 6 months, 87% of 53 Closure patients were class 0 or 1, 75% were symptom-free, and 96% of 55 treated limbs were completely free of reflux. Fourteen of 31 Restore patients (45%) had no symptoms, but 55% were class 2 or lower and only 19% had less than 1-second reflux. CONCLUSION: Closure treatment is clinically effective, albeit with offsetting complications and early failures; these are being addressed through four procedural modifications. Restore valve shrinking, although conceptually attractive, is too problematic to be competitive with Closure treatment or saphenectomy.