Morrison Vein Institute, Scottsdale, Ariz.
Lake Washington Vascular, Bellevue, Wash.
J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
Endovenous cyanoacrylate closure (CAC) is a new U.S. Food and Drug Administration-approved therapy for treatment of clinically symptomatic venous reflux in saphenous veins. The device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV). Early results from a randomized trial of CAC have been reported previously. Herein we report 1-year outcomes.
There were 222 subjects with symptomatic GSV incompetence randomly assigned to receive either CAC (n = 108) or radiofrequency ablation (RFA; n = 114). After the month 3 visit, subjects could receive adjunctive therapies aimed at treating visible varicosities and incompetent tributaries. Vein closure was assessed at day 3 and months 1, 3, 6, and 12 using duplex ultrasound. Additional study visit assessments included the Venous Clinical Severity Score; Clinical, Etiology, Anatomy, and Pathophysiology classification; EuroQol-5 Dimension; and Aberdeen Varicose Vein Questionnaire. Both time to closure and time to first reopening of the target vein were evaluated using survival curve analysis. Adverse events were evaluated at each visit.
Of 222 enrolled and randomized subjects, a 12-month follow-up was obtained for 192 (95 CAC and 97 RFA; total follow-up rate, 192/222 [86.5%]). By month 1, 100% of CAC subjects and 87% of RFA subjects demonstrated complete occlusion of the target vein. By month 12, the complete occlusion rate was nearly identical in both groups (97.2% in the CAC group and 97.0% in the RFA group). Twelve-month freedom from recanalization was similar in the CAC and RFA groups, although there was a trend toward greater freedom from recanalization in the CAC group (P = .08). Symptoms and quality of life improved equally in both groups. Most adverse events were mild to moderate and not related to the device or procedure.
In patients with incompetent GSVs, treatment with both CAC and RFA results in high occlusion rates. Time to complete occlusion was faster with CAC, and freedom from reopening was higher after CAC. Quality of life scores improved equally with both therapies.
静脉内氰基丙烯酸酯闭合术（CAC）是一种新的美国食品和药物管理局批准的治疗下肢大隐静脉（GSV）等浅表主干静脉临床症状性反流的疗法。该设备用于永久性闭合下肢浅静脉，如大隐静脉（GSV）。之前已经报道了一项 CAC 随机试验的早期结果。在此，我们报告 1 年的结果。
222 例有症状性 GSV 功能不全的患者被随机分为 CAC（n=108）或射频消融（RFA；n=114）组。在第 3 个月就诊后，患者可接受旨在治疗可见静脉曲张和功能不全属支的辅助治疗。术后第 3 天及 1、3、6 和 12 个月使用双功能超声评估静脉闭合情况。额外的研究就诊评估包括静脉临床严重程度评分；临床、病因、解剖和病理生理学分类；EuroQol-5 维度；和阿伯丁静脉曲张问卷。使用生存曲线分析评估静脉闭合时间和目标静脉首次再通时间。在每次就诊时评估不良事件。
在 222 名入组和随机分组的患者中，192 名（95 名 CAC 和 97 名 RFA；总随访率，192/222[86.5%]）获得了 12 个月的随访。术后第 1 个月，100%的 CAC 患者和 87%的 RFA 患者的目标静脉完全闭塞。术后第 12 个月，两组的完全闭塞率几乎相同（CAC 组为 97.2%，RFA 组为 97.0%）。12 个月无再通率在 CAC 和 RFA 组相似，尽管 CAC 组有更高的无再通率趋势（P=0.08）。两组的症状和生活质量均同等改善。大多数不良事件为轻度至中度，与设备或手术无关。
在有功能不全的 GSV 的患者中，CAC 和 RFA 治疗均可导致较高的闭塞率。CAC 组的完全闭塞时间更快，CAC 组的再通率更高。两种治疗方法的生活质量评分均同等提高。
