Perrin M
Clinique du Grand Large, Décines-Charpieu, France. perrin.chir.vasc@wanadoo. fr
Int Angiol. 2010 Aug;29(4):303-7.
Endovenous treatment is progressively supplanting open surgery in treatment of saphenous reflux. Among the emerging techniques the VNUS Closure, procedure with ClosureFast is one of the most promising. The aim of the presente review is to remind the principle of radiofrequency action in varicose vein treatment, to describe the procedure achievement including the devices used generator and catheter and finally to report the published studies on ClosureFast. A research in the published literature identified only two articles reporting the outcome of procedure. The first one, a prospective, non-randomized international multicenter prospective clinical trial includes 296 great saphenous veins treated by radiofrequency with the ClosureFAST catheter under tumescent anesthesia. Occlusion rate at 6 months (62 extremities) was achieved in 99.6% with no recanalisation since the first ultrasound assessment at 3 days. The Venous Clinical Severity Score was significantly improved at 6 months compared with the baseline one. No serious adverse events were reported. The second one RECOVERY trial was a multicenter prospective randomized comparative clinical trial of the ClosureFAST catheter and endovenous 980-nm laser ablation including 69 patients. Final results showed patients treated with the ClosureFAST catheter experienced significantly less post-procedure pain, bruising and tenderness when compared to laser ablation, There were statistically fewer complications in limbs treated with the ClosureFAST catheter compared to laser ablation (P=0.021). In conclusion radiofrequency segmental thermal ablation with ClosureFAST catheter is feasible, safe, and well tolerated. Procedure is shortened and short-term results are better than those provided by the previous Closure catheter. A randomized control trial ClosureFAST versus endovenous laser is in favour of the first one.
在治疗大隐静脉反流方面,腔内治疗正逐渐取代开放手术。在新兴技术中,使用ClosureFast的VNUS闭合术是最有前景的技术之一。本综述的目的是回顾静脉曲张治疗中射频作用的原理,描述该手术的操作过程,包括所使用的设备(发生器和导管),并最终报告关于ClosureFast的已发表研究。对已发表文献的检索仅发现两篇报道该手术结果的文章。第一篇是一项前瞻性、非随机的国际多中心前瞻性临床试验,纳入了296条在肿胀麻醉下使用ClosureFAST导管进行射频治疗的大隐静脉。6个月时(62条肢体)的闭塞率为99.6%,自第3天首次超声评估后未再通。与基线相比,6个月时静脉临床严重程度评分显著改善。未报告严重不良事件。第二篇RECOVERY试验是一项关于ClosureFAST导管与腔内980纳米激光消融术的多中心前瞻性随机对照临床试验,纳入了69例患者。最终结果显示,与激光消融相比,使用ClosureFAST导管治疗的患者术后疼痛、瘀斑和压痛明显减轻。与激光消融相比,使用ClosureFAST导管治疗的肢体并发症在统计学上更少(P = 0.021)。总之,使用ClosureFAST导管进行射频分段热消融是可行、安全且耐受性良好的。手术时间缩短,短期结果优于先前的Closure导管。一项ClosureFAST与腔内激光的随机对照试验支持前者。