Radiofrequency-powered segmental thermal obliteration carried out with the ClosureFast procedure: results at 1 year.
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 3 cm below the saphenofemoral junction, before the procedure, the greater saphenous vein (GSV) diameter was 5.4+/-2 mm (range 2-18). It decreased to 4.5+/-1.7 mm at 3 days, 2.4+/-1.5 mm at 6 months, and 1.3+/-0.9 mm 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, chi2 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.
Creton
Denis
D
Department of Vascular Surgery, Clinique Ambroise Paré, Nancy, France. dcreton@veinsurg.com
Pichot
Olivier
O
Sessa
Carmine
C
Proebstle
T M
TM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation; D016009:Chi-Square Distribution; D002908:Chronic Disease; D004867:Equipment Design; D005260:Female; D005602:France; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D010292:Paresthesia / Q000209:etiology; D011446:Prospective Studies; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014648:Varicose Veins / Q000000981:diagnostic imaging / Q000601:surgery*; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation; D014689:Venous Insufficiency / Q000000981:diagnostic imaging / Q000601:surgery*; D055815:Young Adult