Creton Denis, Pichot Olivier, Sessa Carmine, Proebstle T M
Department of Vascular Surgery, Clinique Ambroise Paré, Nancy, France.
Ann Vasc Surg. 2010 Apr;24(3):360-6. doi: 10.1016/j.avsg.2009.09.019. Epub 2010 Jan 29.
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.
这项前瞻性多中心研究展示了采用ClosureFast程序进行射频动力节段性热消融术（RSTO）1年时的结果。在术后3天、3个月、6个月和1年对RSTO的临床及双功超声成像结果进行评估。所有手术均在门诊患者的肿胀局部麻醉下进行。在接受治疗的295名患者中，289名在术后3天接受复查，290名在3个月时复查，289名在6个月时复查，220名在1年时复查。闭塞率在术后3天、3个月、6个月和1年时分别为99.7%、99.3%、98.6%和96.9%。在隐股交界处下方3 cm处，术前大隐静脉（GSV）直径为5.4±2 mm（范围2 - 18）。术后3天时降至4.5±1.7 mm，6个月时为2.4±1.5 mm，1年时为1.3±0.9 mm。在1年时接受复查的患者中，与术前测量相比，治疗静脉直径的减小率为79%（p<0.001，t检验）。在1年时，58%的病例在大腿中部水平的双功超声成像中无法显示GSV主干。术前有疼痛症状的病例占57.5%，术后3天时降至10.8%，1年时降至2%（p<0.001，卡方检验）。在接受治疗的肢体中，70.1%在随访的任何时间均未出现任何术后疼痛。在术后第三天，患者在0 - 10的视觉模拟量表上评估的平均疼痛强度为0.7±1.6。在随访期间，67.7%的腿部未发现疼痛硬结。未报告血栓栓塞并发症。3.4%的病例观察到感觉异常。术前无效临床评分为3.9±2，术后第三天降至3.5±1.2，3个月时为0.9±1.5，6个月时为0.7±1.2，1年时为0.5±1.1。本研究证实了使用ClosureFast进行RSTO的有效性，该方法在1年时可使97%的病例闭塞GSV主干，副作用少且几乎无术后疼痛。
