O'Banion Leigh Ann, Reynolds Kyle B, Kochubey Mariya, Cutler Bianca, Tefera Eshetu A, Dirks Rachel, Kiguchi Misaki M
Division of Vascular Surgery, Department of Surgery, University of California San Francisco-Fresno, Fresno, Calif. Electronic address: leighann.o'
Department of Vascular Surgery, MedStar Washington Hospital Center, Washington, D.C.
J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1215-1221. doi: 10.1016/j.jvsv.2020.12.082. Epub 2021 Jan 13.
Venous leg ulcers (CEAP [clinical, etiologic, anatomic, pathophysiologic] class 6) represent the most severe form of chronic venous insufficiency. As closure techniques for superficial venous reflux evolve, direct outcome comparisons of treatments are integral, because many studies have already demonstrated that early endovenous intervention improves wound healing. The present study compared the rates of venous wound healing between two techniques of superficial vein closure: ClosureFast radiofrequency ablation (RFA) and adhesive closure (VenaSeal; both Medtronic, Inc, Minneapolis, Minn).
We performed a multi-institutional retrospective review of all patients with CEAP class 6 who had undergone closure of their truncal veins from 2015 to 2020. Patients undergoing ClosureFast RFA were compared with those undergoing VenaSeal adhesive closure. The primary endpoint was the interval to wound healing from initial vein closure. The secondary endpoints included ulcer recurrence and infection rates. Bivariate analysis involved the χ, Fisher exact, t, and Wilcoxon rank sum tests. Multivariate linear regression analysis was used to examine the factors affecting the time to wound healing in the most predictive model. Statistical significance was defined as P < .05.
A total of 119 patients with CEAP 6 were included, with a median follow-up of 105 days (interquartile range, 44-208 days). Of the 119 limbs, 68 were treated with RFA and 51 with VenaSeal. Significantly more patients undergoing RFA had had a history of deep vein thrombosis (29% vs 10%; P = .01) and deep venous reflux (82% vs 51%; P = .003). The VenaSeal patients were older (72 years vs 65 years; P = .02) with a greater rate of coronary artery disease (16% vs 37%; P = .01). The median time to wound healing after the procedure was significantly shorter for VenaSeal than for RFA (43 vs 104 days; P = .001). Two RFA patients developed a postprocedure infection. The ulcer recurrence rate was 19.3% (22.1% for RFA vs 13.7% for VenaSeal; P = .25). On multivariate analysis, the treatment modality was the only significant predictor of the time to wound healing. When stratified by ulcer size as small (<3 cm) vs large (>3 cm), VenaSeal closure healed the wounds significantly faster for all ulcers.
ClosureFast and VenaSeal are both safe and effective treatments to eliminate truncal venous insufficiency. VenaSeal showed a superior time to wound healing compared with ClosureFast in both large and small ulcers.
下肢静脉溃疡（CEAP[临床、病因、解剖、病理生理]6级）是慢性静脉功能不全最严重的形式。随着浅表静脉反流闭合技术的发展，对各种治疗方法进行直接的疗效比较至关重要，因为许多研究已表明早期静脉内干预可促进伤口愈合。本研究比较了两种浅表静脉闭合技术（ClosureFast射频消融术[RFA]和黏合闭合术[VenaSeal；均由美敦力公司生产，明尼阿波利斯，明尼苏达州]）治疗后静脉性伤口愈合的发生率。
我们对2015年至2020年期间接受主干静脉闭合术的所有CEAP 6级患者进行了多机构回顾性研究。将接受ClosureFast RFA治疗的患者与接受VenaSeal黏合闭合术治疗的患者进行比较。主要终点是从初次静脉闭合到伤口愈合的时间间隔。次要终点包括溃疡复发率和感染率。双变量分析采用χ²检验、Fisher精确检验、t检验和Wilcoxon秩和检验。多变量线性回归分析用于在预测性最强的模型中检验影响伤口愈合时间的因素。统计学显著性定义为P < 0.05。
共纳入119例CEAP 6级患者，中位随访时间为105天（四分位间距，44 - 208天）。在这119条肢体中，68条接受了RFA治疗，51条接受了VenaSeal治疗。接受RFA治疗的患者中，有深静脉血栓形成病史的患者明显更多（29%对10%；P = 0.01），深静脉反流的患者也更多（82%对51%；P = 0.003）。接受VenaSeal治疗的患者年龄更大（72岁对6岁；P = 0.02），冠状动脉疾病发生率更高（16%对37%；P = 0.）。VenaSeal治疗后伤口愈合的中位时间显著短于RFA（43天对104天；P = 0.001）。2例接受RFA治疗患者术后发生感染。溃疡复发率为19.3%（RFA为22.1%，VenaSeal为13.7%；P = 0.25）。多变量分析显示，治疗方式是伤口愈合时间的唯一显著预测因素。按溃疡大小分为小溃疡（<3 cm）和大溃疡（>3 cm）进行分层分析时，VenaSeal闭合术使所有溃疡的伤口愈合速度均明显更快。
ClosureFast和VenaSeal都是消除主干静脉功能不全的安全有效治疗方法。在大小溃疡的治疗中，VenaSeal的伤口愈合时间均优于ClosureFast。
