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在不使用术后压迫的情况下,使用氰基丙烯酸酯封闭大隐静脉、小隐静脉及副隐静脉功能不全后辅助手术的必要性:来自VenaSeal系统上市后评估(WAVES研究)的三个月数据。

Need for adjunctive procedures following cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of postprocedure compression: Three-month data from a postmarket evaluation of the VenaSeal System (the WAVES Study).

作者信息

Gibson Kathleen, Minjarez Renee, Gunderson Krissa, Ferris Brian

机构信息

Lake Washington Vascular Surgeons, Bellevue, USA.

出版信息

Phlebology. 2019 May;34(4):231-237. doi: 10.1177/0268355518801641. Epub 2018 Sep 18.

DOI:10.1177/0268355518801641
PMID:30227791
Abstract

PURPOSE

Studies examining cyanoacrylate closure of saphenous veins with the VenaSeal™ System have not allowed concomitant procedures for tributaries at the time of the index procedure. Outside of clinical trials, however, concomitant procedures are frequently performed in conjunction with endovenous ablation. We report on the frequency of need for saphenous tributary treatment three months after cyanoacrylate closure of the treatment of great saphenous vein, small saphenous vein, and/or accessory saphenous vein.

METHODS

Fifty subjects with symptomatic great saphenous vein, small saphenous vein, and/or accessory saphenous vein incompetence were treated with no postprocedure compression stockings. Concomitant procedures were not allowed. Treating physicians predicted the type and nature of any concomitant procedures that they would usually perform at the time of ablation, if not limited by the constraints of the study. Evaluations were performed at one week, one and three months and included duplex ultrasound, numeric pain rating scale, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire, and time to return to work and normal activities. At the three-month visit, the need for and type of adjunctive procedures were recorded.

RESULTS

Complete closure at three months was achieved in 70 (99%) of the treated veins (48 great saphenous veins, 14 accessory saphenous veins, eight small saphenous veins). Revised venous clinical severity score improved from 6.4 ± 2.2 to 1.8 ± 1.5 (P < .001) and Aberdeen Varicose Vein Questionnaire from 17.3 ± 7.9 to 6.5 ± 7.2 (P < .0001). Sixty-six percent of patients underwent tributary treatment at three months. The percentage of patients who required adjunctive treatments at three months was lower than had been predicted by the treating physicians (65% versus 96%, p=.0002).

CONCLUSIONS

Closure rates were high in the absence of the use of compression stockings or side branch treatment. Improvement in quality of life was significant, and the need for and extent of concomitant procedures was significantly less than had been predicted by the treating physicians.

摘要

目的

使用VenaSeal™系统对隐静脉进行氰基丙烯酸酯封闭治疗的研究未允许在初次手术时对属支进行联合手术。然而,在临床试验之外,联合手术经常与静脉内消融术同时进行。我们报告了在对大隐静脉、小隐静脉和/或副隐静脉进行氰基丙烯酸酯封闭治疗三个月后,隐静脉属支治疗的需求频率。

方法

50例患有症状性大隐静脉、小隐静脉和/或副隐静脉功能不全的受试者接受治疗,术后未使用加压弹力袜,不允许进行联合手术。治疗医生预测了如果不受研究限制,他们在消融时通常会进行的任何联合手术的类型和性质。在1周、1个月和3个月时进行评估,包括双功超声、数字疼痛评分量表、修订的静脉临床严重程度评分、阿伯丁静脉曲张问卷以及恢复工作和正常活动的时间。在3个月的随访中,记录辅助手术的需求和类型。

结果

70条(99%)治疗的静脉(48条大隐静脉、14条副隐静脉、8条小隐静脉)在3个月时实现了完全闭合。修订的静脉临床严重程度评分从6.4±2.2改善至1.8±1.5(P<0.001),阿伯丁静脉曲张问卷评分从17.3±7.9改善至6.5±7.2(P<0.0001)。66%的患者在3个月时接受了属支治疗。在3个月时需要辅助治疗的患者百分比低于治疗医生的预测(65%对96%,p = 0.0002)。

结论

在不使用加压弹力袜或侧支治疗的情况下,闭合率很高。生活质量有显著改善,联合手术的需求和范围明显低于治疗医生的预测。

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