Department of Vascular Surgery, DIAK Klinikum Schwaebisch Hall, Schwaebisch Hall, Germany.
Division of Vascular and Endovascular Surgery, Department of Vascular Medicine, Klinikum-Darmstadt, Darmstadt, Germany.
Lasers Surg Med. 2022 Apr;54(4):511-522. doi: 10.1002/lsm.23500. Epub 2021 Dec 5.
To evaluate the safety, efficacy and ≥36 months outcomes of endovenous laser ablation (EVLA) by means of 1940 nm laser with radial fiber for the treatment of truncal vein insufficiency and compare the results to a historical cohort, obtained via reviewing the literature.
This prospective, non-randomized, single-center clinical study included 139 consecutive patients with 177 incompetent great saphenous (GSV, n = 135) and short saphenous veins (SSV, n = 42). The maximum laser power (Pmax. 10 W) and pullback velocity were adjusted individually (V = 1 mm/s). The laser fiber was placed at the junction to the deep vein under duplex monitoring. Simultaneous phlebectomies were performed on all the patients. Regular follow up with clinical and duplex ultrasound examination (DUS) were carried out postoperatively at 1 month (1 M), 6 months (6 M), 12 months (12 M), 24 months (24 M), 36 months, and after that (≥36 M). The results were compared with three cohorts (total 616 EVLA procedures with 1470 nm laser and radial fiber) from literature (criteria: >100 procedures, follow-up of ≥2 years).
The follow-up rate was 100%, 91%, 73%, 48%, and 23% of the truncal veins at 1, 6, 12, 24, and ≥36 M, respectively. In comparison to the literature using 1470, a lower average linear endovenous energy density (LEED) (53 vs. 77-82 J/cm) resulted in 100% (6 M) and 96.5% (24 M) occlusion rates, reduced local ecchymosis (2.2% vs. 3.2%-18.7%) and reduced average postoperative pain levels (1.3 vs. 2.18). Regarding adverse events, induration (1.1% vs. 1.8%), skin burns (0% vs. 0.45%), endovenous heat-induced thrombus propagation (EHIT) in the deep veins (2.3% vs. 1.8%) and laser-induced persistent paresthesia (2.2% vs. 0.5%-2.9%) were comparable. Recanalizations observed in this study (GSV 0, SSV 3) were asymptomatic and required no treatment. At ≥36 M reflux in the accessory veins was observed in 5% versus 10.5% of patients. Reintervention was required in none (0% vs. 21%). At >36 M, short average stump lengths of 1 cm (GSV) and 0.3 cm (SSV) were observed.
EVLA with 1940 nm laser with radial emitting fiber is as safe and effective as 1470 nm laser for the treatment of truncal vein insufficiency. Lower postoperative pain, low analgesic requirements, short convalescence add to patients' comfort. EVLA with 1940 nm laser-guided by intraoperative DUS permits reproducible placement of the radial fiber at the saphenofemoral and saphenopopliteal junction, enabling further studies to assess the effect of shorter stump length on patterns and frequency of recurrence without increased risk of EHIT.
评估 1940nm 激光联合径向光纤行静脉内激光消融术（EVLA）治疗主干静脉功能不全的安全性、疗效和≥36 个月的结果，并与通过文献回顾获得的历史队列结果进行比较。
这是一项前瞻性、非随机、单中心的临床研究，纳入了 139 例连续患者的 177 条功能不全的大隐静脉（GSV，n=135）和小隐静脉（SSV，n=42）。最大激光功率（Pmax. 10W）和后退速度根据个体情况进行调整（V=1mm/s）。激光光纤在双功能超声监测下放置在与深静脉的交界处。所有患者均同时行静脉切除术。术后 1 个月（1M）、6 个月（6M）、12 个月（12M）、24 个月（24M）、36 个月和之后（≥36M）进行定期临床和双功能超声检查（DUS）随访。结果与文献中的三个队列（共 616 例采用 1470nm 激光和径向光纤的 EVLA 手术，共 1470nm 激光和径向光纤）进行比较（标准：>100 例手术，随访时间≥2 年）。
主干静脉的随访率分别为 100%、91%、73%、48%和 23%，分别为术后 1、6、12、24 和≥36M。与采用 1470nm 激光的文献相比，平均静脉内能量密度（LEED）较低（53 vs. 77-82J/cm），导致闭塞率达到 100%（6M）和 96.5%（24M），局部瘀斑减少（2.2% vs. 3.2%-18.7%），术后平均疼痛水平降低（1.3 vs. 2.18）。关于不良事件，硬结（1.1% vs. 1.8%）、皮肤烧伤（0% vs. 0.45%）、静脉内热诱导血栓传播（EHIT）在深静脉（2.3% vs. 1.8%）和激光诱导持续性感觉异常（2.2% vs. 0.5%-2.9%）相似。本研究观察到的再通（GSV 0，SSV 3）无症状，无需治疗。≥36M 时，辅助静脉反流在 5%的患者中观察到，在 10.5%的患者中观察到。均无需再次干预（0% vs. 21%）。在>36M 时，观察到 GSV 的短残端长度为 1cm，SSV 的残端长度为 0.3cm。
1940nm 激光联合径向光纤行静脉内激光消融术治疗主干静脉功能不全与 1470nm 激光一样安全有效。术后疼痛减轻，对止痛药的需求降低，恢复期缩短，增加了患者的舒适度。术中 DUS 引导的 1940nm 激光可在隐股和隐腘交界处重复放置径向光纤，进一步研究可评估较短残端长度对复发模式和频率的影响，而不会增加 EHIT 的风险。
