Department of Vascular Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Department of Vascular Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
J Vasc Surg Venous Lymphat Disord. 2023 Jul;11(4):854-865.e5. doi: 10.1016/j.jvsv.2023.03.011. Epub 2023 Apr 6.
We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency.
We performed a systematic review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and a Bayesian network meta-analysis. The primary end points were great saphenous vein (GSV) closure and venous clinical severity score (VCSS) improvement. A meta-regression using GSV diameter as a covariate was undertaken for the two primary end points.
We included 14 studies and 4177 patients, with a mean follow-up of 25.7 months. Radiofrequency ablation (RFA; odds ratio [OR], 3.99; 95% confidence interval [CI], 1.82-10.53), cyanoacrylate ablation (CAC; OR, 3.09; 95% CI, 1.35-8.37), and endovenous laser ablation (EVLA; OR, 2.72; 95% CI, 1.23-7.38) displayed increased odds for GSV closure compared with mechanochemical ablation (MOCA). MOCA inferiority compared with RFA (mean difference [MD], 0.96; 95% CI, 0.71-1.20), EVLA (MD, 0.94; 95% CI, 0.61-1.24), and CAC (MD, 0.89; 95% CI, 0.65-1.15) was also depicted regarding VCSS improvement. EVLA resulted in an increased risk of postoperative paresthesia compared with MOCA (risk ratio [RR], 9.61; 95% CI, 2.32-62.29), CAC (RR, 7.90; 95% CI, 2.44-38.16), and RFA (RR, 6.96; 95% CI, 2.31-28.04). Although the overall analysis identified nonstatistically significant differences for Aberdeen varicose vein questionnaire score improvement, thrombophlebitis, ecchymosis, and pain, further investigation revealed an increase pain profile for EVLA at 1470 nm compared with RFA (MD, 3.22; 95% CI, 0.93-5.47) and CAC (MD, 3.04; 95% CI, 1.05-4.97). A sensitivity analysis displayed a persistent underperformance of MOCA compared with RFA (OR, 4.33; 95% CI, 1.15-55.54) for GSV closure and both RFA (MD, 0.99; 95% CI, 0.22-1.77) and CAC (MD, 0.84; 95% CI, 0.08-1.65) regarding VCCS improvement. Although no regression model reached statistical significance, the GSV closure regression model revealed a trend for considerably decreased efficacy for both CAC and MOCA with larger GSV diameters compared with RFA and EVLA.
Although our analysis has produced skepticism regarding the efficacy of MOCA in the mid-term period for VCSS improvement and GSV closure rates, CAC showed equivalent results compared with both RFA and EVLA. Additionally, CAC displayed a decreased risk of postprocedural paresthesia and pigmentation and induration compared with EVLA. Also, both RFA and CAC had an improved pain profile compared with EVLA 1470 nm. The potential underperformance of nonthermal, nontumescent ablation modalities in ablating large GSVs necessitates further research.
评估热消融和非热消融治疗下肢浅静脉功能不全的中期疗效和安全性。
我们根据 PRISMA(系统评价和荟萃分析的首选报告项目)声明和贝叶斯网络荟萃分析进行了系统评价。主要终点是大隐静脉(GSV)闭塞和静脉临床严重程度评分(VCSS)改善。对两个主要终点进行了使用 GSV 直径作为协变量的元回归分析。
我们纳入了 14 项研究和 4177 例患者,平均随访 25.7 个月。射频消融(RFA;优势比[OR],3.99;95%置信区间[CI],1.82-10.53)、氰基丙烯酸酯消融(CAC;OR,3.09;95%CI,1.35-8.37)和静脉内激光消融(EVLA;OR,2.72;95%CI,1.23-7.38)与机械化学消融(MOCA)相比,GSV 闭塞的优势比更高。与 RFA(平均差值[MD],0.96;95%CI,0.71-1.20)、EVLA(MD,0.94;95%CI,0.61-1.24)和 CAC(MD,0.89;95%CI,0.65-1.15)相比,MOCA 对 VCSS 改善的劣势也得到了描绘。与 MOCA 相比,EVLA 术后出现感觉异常的风险增加(风险比[RR],9.61;95%CI,2.32-62.29)、CAC(RR,7.90;95%CI,2.44-38.16)和 RFA(RR,6.96;95%CI,2.31-28.04)。尽管总体分析显示 Aberdeen 静脉曲张问卷评分改善、血栓性静脉炎、瘀斑和疼痛无统计学差异,但进一步调查显示,与 RFA 和 CAC 相比,1470nm 的 EVLA 疼痛程度更高(MD,3.22;95%CI,0.93-5.47)和 CAC(MD,3.04;95%CI,1.05-4.97)。敏感性分析显示,与 RFA 相比,MOCA 的 GSV 闭塞和 VCCS 改善(OR,4.33;95%CI,1.15-55.54)以及 RFA(MD,0.99;95%CI,0.22-1.77)和 CAC(MD,0.84;95%CI,0.08-1.65)相比,MOCA 的中期表现仍不理想。尽管没有回归模型达到统计学意义,但 GSV 闭塞的回归模型显示,与 RFA 和 EVLA 相比,CAC 和 MOCA 的疗效明显降低,GSV 直径较大。
尽管我们的分析对 MOCA 在 VCSS 改善和 GSV 闭塞率的中期疗效产生了怀疑,但 CAC 与 RFA 和 EVLA 相比显示出等效的结果。此外,与 EVLA 相比,CAC 显示出较低的术后感觉异常和色素沉着及硬结风险。此外,与 EVLA 1470nm 相比,RFA 和 CAC 的疼痛状况都有所改善。需要进一步研究非热、非肿胀消融模式在消融大 GSV 方面的潜在表现不佳。