Radiofrequency-Powered Segmental Thermal Obliteration Carried out with the ClosureFast Procedure: Results at 1 Year
published online 28 January 2010.
This prospective and multicenter study shows the results at 1 year of radiofrequency-powered segmental thermal obliteration (RSTO) carried out with the ClosureFast® procedure. The RSTO clinical and duplex ultrasound imaging results were evaluated at 3 days, 3 months, 6 months, and 1 year. All procedures were carried out on outpatients under tumescent local anesthesia. Among the 295 members who were treated, 289 were reexamined at 3 days, 290 at 3 months, 289 at 6 months, and 220 at 1 year. Occlusion scores were 99.7%, 99.3%, 98.6%, and 96.9% at, respectively, 3 days, 3 months, 6 months, and 1 year. At 3cm below the saphenofemoral junction, before the procedure, the greater saphenous vein (GSV) diameter was 5.4±2mm (range 2-18). It decreased to 4.5±1.7mm at 3 days, 2.4±1.5mm at 6 months, and 1.3±0.9mm at 1 year. In members reexamined at 1 year, the decrease in diameter of the treated vein compared with the preprocedural measurement was 79% (p<0.001, t-test). At 1 year, in 58% of the cases, duplex ultrasound imaging at mid-thigh level could not show the GSV trunk. Preprocedural pain that was present in 57.5% of the cases decreased to 10.8% of the cases at 3 days and 2% of the cases at 1 year (p<0.001, χ2 test). Among the treated limbs, 70.1% did not present with any postprocedural pain at any time of the follow-up. On the third day, the patients evaluated the mean pain intensity at 0.7±1.6 on a visual analog scale of 0–10. During the follow-up, no painful indurations were noticed in 67.7% of the legs. No thromboembolic complications were reported. Paresthesias were observed in 3.4% of the cases. Invalidity clinical score, evaluated at 3.9±2 before the procedure, decreased to 3.5±1.2 on the third day, 0.9±1.5 at 3 months, 0.7±1.2 at 6 months, and 0.5±1.1 at 1 year. This study confirms the efficacy of RSTO when using ClosureFast, which allows obliteration of the GSV trunk in 97% of cases at 1 year with few side effects and almost no postprocedural pain.
1Department of Vascular Surgery, Clinique Ambroise Paré, Nancy, France
2Department of Vascular Surgery, CHU de Grenoble, France
3Department of Dermatologie, University of Heidelberg, Heidelberg, Germany. List of the members of the ClosureFast Group: D. Creton, Clinique Ambroise Paré, Nancy, France; O. Pichot, C. Sessa, CHU Service de Chirurgie Vasculaire, Grenoble, France; C. Lebard, Hôpital St. Michel, Paris, France; T.M. Proebstle, B. Vago, Department of Dermatology, University of Heidelberg, Heidelberg, Germany; J. Alm, Department of Dermatology, Hamburg, Germany; O. Göckeritz, C, Wenzel, Venenzentrum, Elsterpark, Leipzig, Germany; C.G. Schmedt, University Ludwig-Maximilian, Munich, Germany; T. Noppeney, Gemeinschaftspraxis, Nuremberg, Germany
Correspondence to: Denis Creton, Clinique Ambroise Paré, rue Ambroise Paré, 54100 Nancy, France.