Department of Surgery, University of Pittsburgh, Pittsburgh, PA.
Division of Vascular Surgery, University of Pittsburgh, Pittsburgh, PA.
Ann Vasc Surg. 2021 Jan;70:109-115. doi: 10.1016/j.avsg.2020.06.051. Epub 2020 Jun 27.
Venous leg ulceration (VLU) represents the most advanced form of chronic venous insufficiency (CVI). Persistent VLU that fails to respond to noninvasive treatment requires a minimally invasive endovascular treatment, which may include chemical (ultrasound-guided foam sclerotherapy [UGFS]) and thermal ablation (endovenous laser therapy [EVLT] or radiofrequency ablation [RFA]) targeting incompetent veins. Current guidelines suggest ablation of incompetent perforating veins (IPVs) juxtaposed to active or healed VLU; however, the ideal treatment modality is unknown. We hypothesize that similar to incompetent superficial vein treatment options therapies, VLU healing will be equivalent across minimally invasive IPV treatment options.
Using the Vascular Low Frequency Disease Consortium, adults with VLU across 11 medical centers were retrospectively reviewed (2013-2017). We included those who underwent IPV therapies. The primary outcome was complete ulcer healing over time compared with cumulative hazard curves, log-rank testing, and multivariable Cox proportional hazard regression. Secondary outcomes included number of subsequent procedures, which were compared using negative binomial regression.
Of the 832 adults with VLU, 158 (19%) were exclusively treated conservatively, and 232 (28%) underwent index treatment for IPV and constitute the full and final cohort. The mean age was 60 ± 14 years, 57% were men, and the mean ulcer area was 3.0 cm (interquartile range, 1-6 cm). Ninety-one (39%) were treated with EVLT, 127 (55%) RFA, and 14 (6%) UGFS. Patients treated with RFA were older (RFA 62 ± 14 years; EVLT 59 ± 14 years; UGFS 52 ± 9 years; P = 0.01), more likely to be men (RFA 68%, n = 86; EVLT 41%, n = 37; UGFS 64%, n = 9; P < 0.001), with a higher frequency of anticoagulation (RFA 36%, n = 46; EVLT 18%, n = 16; UGFS 14%, n = 2; P = 0.005). VLU did not significantly differ in size between groups (RFA 6.2 ± 8; EVLT 4.2 ± 5.4; UGFS 6.1 ± 8; P < 0.001). There were no differences in 1-year ulcer healing rates between groups (P = 0.18). The number of subsequent procedures did not differ by treatment modality (P = 0.47).
This multi-institutional retrospective study does not demonstrate any association of IPV treatment modality with differing rates of VLU healing or number of subsequent procedures.
静脉性腿部溃疡（VLU）代表慢性静脉功能不全（CVI）的最严重形式。未能对非侵入性治疗作出反应的持续性 VLU 需要进行微创的血管内治疗，其中可能包括针对功能不全静脉的化学（超声引导下泡沫硬化疗法 [UGFS]）和热消融（静脉内激光治疗 [EVLT] 或射频消融 [RFA]）。目前的指南建议对毗邻活动性或愈合性 VLU 的功能不全穿通静脉（IPV）进行消融；然而，理想的治疗方式尚不清楚。我们假设，类似于功能不全的浅表静脉治疗方法，微创 IPV 治疗方法的 VLU 愈合效果相当。
利用血管低频疾病联盟，对 11 家医疗中心的 VLU 成年患者进行回顾性分析（2013-2017 年）。我们纳入了接受 IPV 治疗的患者。主要结局是与累积风险曲线、对数秩检验和多变量 Cox 比例风险回归比较时的溃疡完全愈合随时间的变化。次要结局包括随后的治疗次数，采用负二项回归进行比较。
832 例 VLU 患者中，158 例（19%）仅接受保守治疗，232 例（28%）因 IPV 进行了指数治疗，构成了完整的最终队列。平均年龄为 60±14 岁，57%为男性，平均溃疡面积为 3.0cm（四分位距，1-6cm）。91 例（39%）接受 EVLT 治疗，127 例（55%）接受 RFA 治疗，14 例（6%）接受 UGFS 治疗。接受 RFA 治疗的患者年龄更大（RFA 62±14 岁；EVLT 59±14 岁；UGFS 52±9 岁；P=0.01），更可能为男性（RFA 68%，n=86；EVLT 41%，n=37；UGFS 64%，n=9；P<0.001），抗凝治疗的频率更高（RFA 36%，n=46；EVLT 18%，n=16；UGFS 14%，n=2；P=0.005）。各组之间的 VLU 大小无显著差异（RFA 6.2±8；EVLT 4.2±5.4；UGFS 6.1±8；P<0.001）。各组间 1 年溃疡愈合率无差异（P=0.18）。治疗方式之间的后续治疗次数无差异（P=0.47）。
这项多机构回顾性研究未显示 IPV 治疗方式与 VLU 愈合率或随后治疗次数有任何关联。
