Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.
Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.
J Vasc Surg Venous Lymphat Disord. 2022 Jan;10(1):75-81.e1. doi: 10.1016/j.jvsv.2021.06.017. Epub 2021 Jul 10.
We compared the safety, need for additional foam sclerotherapy, and 1-year venous clinical severity score (VCSS) improvement in the limbs of patients with chronic venous disease and great saphenous vein (GSV) reflux. These patients had undergone endovenous laser ablation (EVLA) using a 1470-nm diode laser and concurrent foam sclerotherapy (1% polidocanol) through the access sheath (transluminal injection of foam sclerotherapy [TLFS]) or EVLA and concurrent direct-puncture ultrasound-guided foam sclerotherapy (UGFS).
In the present study, we screened 467 patients (577 legs) with symptomatic primary GSV reflux for randomization to either TLFS with EVLA (n = 103 legs; TLFS group) or UGFS with EVLA (n = 94 legs; UGFS group). The exclusion criteria were (1) recurrent varicose veins after previous intervention; (2) hypersensitivity reaction to sclerotherapy; (3) acute deep vein thrombosis; (4) serious lower limb ischemic disease; (5) a coagulation disorder; and (6) simultaneous EVLA of both GSVs and small saphenous veins. The correlations of the VCSS changes with the clinical features, such as age, sex, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, total amount of sclerosant used at the original procedure, multiple punctures (more than two) for sclerotherapy at the original procedure, the use of TLFS, and linear endovenous energy density, were estimated using logistic regression.
No significant differences in the distribution of the CEAP classification were observed between the two groups. After 12 months of follow-up, all truncal veins were occluded. The VCSS had significantly improved in the TLFS group compared with the UGFS group (UGFS, -7.4 ± 1.8; TLFS, -8.7 ± 1.5; P < .0001). Multivariate analysis revealed that TLFS was the only significant factor for an improved VCSS (hazard ratio, 0.63; 95% confidence interval, 0.32-0.96; P < .0001). The need for additional second-stage sclerotherapy was significantly avoided in the TLFS group (n = 10; 10%) compared with the UGFS group (n = 51; 54%; P < .0001).
TLFS combined with EVLA is a safe and feasible procedure that improves the VCSS and reduces the need for additional second-stage interventions compared with UGFS combined with EVLA.
我们比较了伴有慢性静脉疾病和大隐静脉（GSV）反流的患者在接受腔内激光消融术（EVLA）联合泡沫硬化剂治疗（通过输送鞘管进行经腔内注射泡沫硬化剂[TLFS]或直接经皮超声引导下泡沫硬化剂注射[UGFS]）后，其肢体的安全性、对额外泡沫硬化剂治疗的需求以及静脉临床严重程度评分（VCSS）在 1 年时的改善情况。
本研究对 467 例（577 条肢体）有症状的原发性 GSV 反流患者进行筛选，随机分为 TLFS 联合 EVLA 组（103 条肢体；TLFS 组）或 UGFS 联合 EVLA 组（94 条肢体；UGFS 组）。排除标准包括：（1）既往干预后复发静脉曲张；（2）对硬化治疗过敏反应；（3）急性深静脉血栓形成；（4）严重下肢缺血性疾病；（5）凝血障碍；（6）同时行 GSV 和小隐静脉的 EVLA。使用逻辑回归分析评估 VCSS 变化与临床特征（如年龄、性别、CEAP（临床、病因、解剖、病理生理学）分类、初始治疗时使用的硬化剂总量、初始治疗时多次穿刺（两次以上）、TLFS 的使用和线性腔内能量密度）之间的相关性。
两组间 CEAP 分类的分布无显著差异。12 个月随访时，所有主干静脉均闭塞。与 UGFS 组相比，TLFS 组的 VCSS 显著改善（UGFS：-7.4±1.8；TLFS：-8.7±1.5；P<0.0001）。多变量分析显示，TLFS 是 VCSS 改善的唯一显著因素（风险比，0.63；95%置信区间，0.32-0.96；P<0.0001）。与 UGFS 组（n=51；54%）相比，TLFS 组（n=10；10%）显著减少了对额外二期硬化治疗的需求（P<0.0001）。
与 UGFS 联合 EVLA 相比，TLFS 联合 EVLA 是一种安全可行的方法，可改善 VCSS，并减少对额外二期干预的需求。
