Department of Vascular Surgery, MedStar Washington Hospital Center, Washington, DC.
Department of Vascular Surgery, MedStar Washington Hospital Center, Washington, DC.
J Vasc Surg Venous Lymphat Disord. 2021 Nov;9(6):1510-1516. doi: 10.1016/j.jvsv.2021.04.020. Epub 2021 Jun 7.
The authors have previously demonstrated that VenaSeal (Medtronic, Inc, Minneapolis, Minn) adhesive, compared with radiofrequency ablation (RFA, ClosureFast; Medtronic, Inc), in treatment of refluxing saphenous veins in CEAP 6 limbs, results in shorter healing times of venous ulcers. The authors hypothesize that the longer treated length possible with VenaSeal's nonthermal modality may affect the number of critical refluxing perforators contributing to the nonhealing wound. This follow-up study compares the need for follow-up treatment of perforator veins after saphenous vein treatment with either radiofrequency ablation (ClosureFast RFA) or adhesive closure (VenaSeal).
A multi-institutional retrospective review of CEAP 6 patients who had closure of their saphenous veins from 2015 to 2020 was conducted. Patients who underwent follow-up treatment of perforator veins were grouped according to their method of initial management of their saphenous veins. The primary end point was incidence of a perforator procedure after ClosureFast or VenaSeal ablation. Secondary end points included sclerotherapy to facilitate wound healing. Bivariate analysis used the χ test, Fisher exact test, t-test, and Wilcoxon rank sum test. A P value of <.05 defined statistical significance.
There were 119 CEAP 6 patients with saphenous closure: 51 limbs treated with VenaSeal and 68 with RFA. Median follow-up was 105 days (interquartile range: 44, 208). All limbs achieved wound healing during the study period. Mean time to wound healing post index procedure was shorter for VenaSeal than RFA (72 vs 293.8 days, P > .0009), as was median time (43 vs 104 days, P = .001). More limbs treated with RFA had previous known deep vein thrombosis (29% vs 10%, P = .009), deep venous insufficiency (82% vs 51%, P = .0003), and perforator reflux (57% vs 29%, P = .002). Limbs with identified follow-up perforator reflux treated with RFA had a higher prevalence of initially treated saphenous veins with RFA compared with those treated with VenaSeal (49% vs 27%, P = .003). There was no difference between the methods of vein closure and use of concurrent sclerotherapy.
ClosureFast and VenaSeal are both effective and safe modalities of saphenous ablation, but VenaSeal treatment was associated with less perforator RFA intervention.
作者先前的研究表明,与射频消融(ClosureFast;美敦力公司,明尼苏达州明尼阿波利斯)相比,VenaSeal(美敦力公司)黏合剂在治疗 CEAP 6 肢体反流隐静脉时可缩短静脉溃疡的愈合时间。作者假设,VenaSeal 的非热模式可能会增加治疗的静脉长度,从而影响导致未愈合伤口的关键反流穿孔静脉的数量。这项随访研究比较了射频消融(ClosureFast RFA)或黏合闭合(VenaSeal)治疗隐静脉后,需要对穿孔静脉进行后续治疗的情况。
对 2015 年至 2020 年间接受隐静脉闭合治疗的 CEAP 6 期患者进行了多机构回顾性研究。根据初始隐静脉处理方法将接受穿孔静脉后续治疗的患者分组。主要终点是 ClosureFast 或 VenaSeal 消融后发生穿孔手术的发生率。次要终点包括行硬化治疗以促进伤口愈合。使用卡方检验、Fisher 确切检验、t 检验和 Wilcoxon 秩和检验进行双变量分析。P 值<.05 定义为统计学意义。
共有 119 例 CEAP 6 期患者接受了隐静脉闭合治疗:51 条肢体接受了 VenaSeal 治疗,68 条接受了 RFA 治疗。中位随访时间为 105 天(四分位距:44,208)。所有肢体在研究期间均实现了伤口愈合。VenaSeal 组的指数手术后伤口愈合时间短于 RFA 组(72 天 vs 293.8 天,P>.0009),中位时间也短于 RFA 组(43 天 vs 104 天,P=.001)。RFA 治疗的肢体更常见先前已知的深静脉血栓形成(29% vs 10%,P=.009)、深静脉功能不全(82% vs 51%,P=.0003)和穿孔反流(57% vs 29%,P=.002)。接受 RFA 治疗的有随访记录的穿孔反流肢体中,初始治疗时接受 RFA 治疗的隐静脉比例高于接受 VenaSeal 治疗的肢体(49% vs 27%,P=.003)。两种静脉闭合方法之间以及同时行硬化治疗之间没有差异。
ClosureFast 和 VenaSeal 都是有效的隐静脉消融方法,且安全,但 VenaSeal 治疗与较少的穿孔 RFA 干预有关。