Lurie F, Creton D, Eklof B, Kabnick L S, Kistner R L, Pichot O, Sessa C, Schuller-Petrovic S
Straub Foundation, Straub Clinic and Hospital, University of Hawaii John A. Burns School of Medicine, Honolulu, HI, USA.
Eur J Vasc Endovasc Surg. 2005 Jan;29(1):67-73. doi: 10.1016/j.ejvs.2004.09.019.
To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial.
Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire.
The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment.
The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.
研究EVOLVeS试验中患者的中期临床结果、静脉曲张复发率和新生血管形成情况、大隐静脉的超声变化以及生活质量变化。
45例患者在治疗后1年接受复查，65例在治疗后2年接受复查。随访检查包括采用CEAP分类进行临床检查并计算静脉临床严重程度评分（VCSS）、超声检查以及生活质量问卷调查。
两个治疗组的疾病临床进程（CEAP、VCSS）相似。射频消融闭塞的大隐静脉主干中有51%逐渐萎缩，外径从治疗后72小时的6.3±1.4毫米降至2年时的2.9±1.5毫米。在2年随访时，另外41%的大隐静脉超声检查无法探及。在2例患者中，我们观察到最初闭塞的大隐静脉管腔重新开放。在1例射频消融病例和4例手术结扎病例中发现有新生血管形成。在1年和2年联合随访时，射频消融组的静脉曲张复发累积率为14%，手术结扎组为21%（无统计学差异）。支持射频消融的总体生活质量评分差异在治疗后1年再次出现，并在2年时仍具有显著意义。
射频消融的2年临床结果至少与大隐静脉高位结扎剥脱术相当。在绝大多数射频消融患者中，大隐静脉保持永久闭塞，并逐渐萎缩直至最终超声检查消失。尽管患者数量有限，无法进行可靠的统计学分析，但两组的复发率和新生血管形成率相似。与手术结扎组相比，射频消融组在2年观察期内生活质量评分持续改善。
