Kolluri Raghu, Gibson Kathleen, Cher Daniel, Madsen Monte, Weiss Robert, Morrison Nick
OhioHealth, Riverside Methodist Hospital, Columbus, Ohio.
The Lake Washington Vascular, Bellevue, Wash.
J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.
Cyanoacrylate closure (CAC) was shown in the recently published VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) randomized clinical study to be an effective and noninferior option (in terms of both safety and effectiveness) to radiofrequency ablation (RFA) in the treatment of incompetent great saphenous veins. The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose roll-in (training) group treated with CAC by physicians who had received device use training but had no prior treatment experience with the technique and to compare the outcomes with those from the randomized RFA and CAC groups.
The first two subjects at each participating site (n = 20) were roll-in cases (ie, not randomized but instead treated with CAC) to ensure the physician's familiarity with the procedure. Subsequent eligible subjects were randomized to either CAC or RFA. After treatment, all subjects returned for assessment on day 3 and months 1, 3, 6, and 12. The study's primary end point was complete closure of the target vein at month 3. Secondary analyses included patient-reported intraprocedural pain and investigator-rated ecchymosis at day 3. Additional assessments included procedure time, quality of life surveys, and adverse events.
Mean procedure time was longer in the roll-in group (31 minutes) compared with the randomized groups (24 minutes for CAC and 19 minutes for RFA; P < .0001). Procedure time decreased in both the CAC and RFA groups over time, plateauing at about 22 minutes for CAC and 15 minutes for RFA. In the roll-in group, the 3-month complete occlusion rate was 100%. Reported intraprocedural pain ratings were similar between the roll-in and randomized groups. Other clinical assessments, including quality of life improvement and adverse events, were similar between the roll-in and randomized groups. Increasing procedure number did not affect clinical outcomes.
The results from the VeClose study roll-in group demonstrate that despite the physician's lack of prior experience, initial treatment with CAC leads to comparable efficacy and safety results to RFA and is associated with a relatively short learning period.
在最近发表的关于大隐静脉功能不全的VenaSeal Sapheon闭合系统与射频消融术对比研究（VeClose）的随机临床试验中，氰基丙烯酸酯闭合术（CAC）被证明是治疗大隐静脉功能不全的一种有效且非劣效的选择（在安全性和有效性方面），与射频消融术（RFA）相当。本分析的目的是报告由接受过设备使用培训但此前无该技术治疗经验的医生对VeClose纳入（培训）组进行CAC治疗的疗效和安全性结果，并将结果与随机分组的RFA组和CAC组进行比较。
每个参与研究的站点的前两名受试者（n = 20）为纳入病例（即不进行随机分组，而是接受CAC治疗），以确保医生熟悉该操作流程。随后符合条件的受试者被随机分为CAC组或RFA组。治疗后，所有受试者在第3天以及第1、3、6和12个月返回进行评估。该研究的主要终点是在第3个月时目标静脉完全闭合。次要分析包括患者报告的术中疼痛以及研究人员在第3天评估的瘀斑情况。其他评估包括手术时间、生活质量调查和不良事件。
纳入组的平均手术时间（31分钟）比随机分组的两组更长（CAC组为24分钟，RFA组为19分钟；P <.0001）。随着时间推移，CAC组和RFA组的手术时间均有所下降，CAC组稳定在约22分钟，RFA组稳定在15分钟左右。在纳入组中，3个月时的完全闭塞率为100%。纳入组和随机分组的两组报告的术中疼痛评分相似。其他临床评估，包括生活质量改善情况和不良事件，在纳入组和随机分组的两组之间也相似。手术例数增加并未影响临床结果。
VeClose研究纳入组的结果表明，尽管医生缺乏先前经验，但使用CAC进行初始治疗可产生与RFA相当的疗效和安全性结果，且学习期相对较短。
