Endovenous management of saphenous vein reflux

Purpose: This study assessed clinical outcomes of two catheter-based endove nous procedures to eliminate or greatly mitigate saphenous vein reflux. Materials and Methods: A computer-controlled, dedicated generator and two c atheter designs were used to treat 210 patients at 16 private clinic and un iversity centers in Europe. The Closure catheter applied resistive heating over long vein lengths to cause maximum wall contraction for permanent obli teration; 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 li mbs; Restore treatment, shrinking one or more valves, acutely reduced reflu x to less than 1 second in 41 (60%) of 68 limbs. Closure treatments were as sociated with early recanalization (6%), paresthesias (thigh, 9%; leg, 51%; P < .001), 3 skin burns, and 3 deep-vein thrombus extensions, with 1 embol ism. Restore treatments were thrombogenic (16%) despite prophylactic antico agulation, and treated valves enlarged over 6 weeks, becoming less competen t. Clinical Efficacy Assessment Project clinical class was significantly im proved after both treatments, up to 1 year At 6 months, 87% of 53 Closure p atients were class 0 or 1, 75% were symptom-free, and 96% of 55 treated lim bs were completely free of reflux. Fourteen of 31 Restore patients (45%) ha d no symptoms, but 55% were class 2 or lower and only 19% had less than 1-s econd reflux. Conclusion: Closure treatment is clinically effective, albeit with offsetti ng complications and early failures; these are being addressed through four procedural modifications. Restore valve shrinking, although conceptually a ttractive, is too problematic to be competitive with Closure treatment or s aphenectomy. (J Vasc Surg 2000;32:330-42.).