Comparative Analysis ofVenous and Paravenous Tissue Damage During Endovascular Laser Ablation with Wavelengths of 1470 and 1940 nm

Endovenous Laser Ablation of Saphenous Veins Larger than 2 cm: a Prospective Study

The relative roles of power, linear endovenous energy density, and pullback velocity in determining short-term success after endovenous laser ablation of the truncal saphenous veins

Background: The aim of this study was to develop and evaluate an exact, pre-defined, reproducible therapy protocol for endovenous Laser Ablation (EVLA) with 1940nm laser system and radial fibre, to optimize EVLA and minimize adverse thermal complications, whilst maintaining high occlusion rates. This study presents the short-term (1-month) and mid-term (12-months) results of EVLA with 1940nm-laser and flush placement of the radial fibre-tip, supported by a 4-Zone, low-energy-application-protocol (LEAP). Materials and methods: The EVLA procedures were performed with a Thulium-Fibre-Laser-System (Vela XL, Starmedtec GmbH, Starnberg, Germany) with radial fibre (Saturn Side Fibre, 600µm/400 µm Radial Fibre, Light Guide Optics, LGO, Meckenheim, Germany) with intraoperative duplex ultrasound monitoring. The preoperative patient’s data, intraoperative parameters and the postoperative follow-up results were documented on the home-made standardized 4-Zone, LEAP protocol. Great saphenous vein (GSV) and small saphenous vein (SSV) were divided in 4 and 2 zones respectively with corresponding set power levels. Zone-1 (4W) extended from the sapheno femoral junction to the level of the perineum, Zone-2 (4W) perineum to the upper border of patella, Zone-3 (3W) patella to tibial tuberosity for the GSV and the sapheno-popliteal junction to tibial tuberosity for the SSV, Zone-4 (2W) from the tibial tuberosity to ankle joint. Power was increased by 1 W for veins >10 mm and decreased by 1W when intraoperative fibre sticking was encountered. Pullback-velocity was max. 1mm/s. Results: A total of 152 consecutive patients (185 procedures) were recruited in this prospective non-randomized study between 01st June 2017 and 30th July 2019. Mean follow-up time was 11.9 Months. Follow-up was 100% at 1M and 85.9% (159/185) at 12M. Average Linear Endovenous Energy Density (LEED), median power for GSV were Zone-1: 42J/cm (4W); Zone-2: 33J/cm (3W); Zone-3: 27J/cm (3W); Zone-4: 22J/cm (2W). The corresponding values for SSV were Zone-3: 34J/cm (3W); Zone-4: 27J/cm (2W). Occlusion rates were 98.9% (1-month) and 93.7% (12-months). Complications at 1M were low; laser-induced paraesthesia (LIP 2.2%) and endovenous heat induced thrombosis (EHIT 1.6%). Persistent LIP at 12M was observed in 0.5% of treated limbs. Conclusion: The proposed 4-Zone, low-energy-application-protocol, an effort to standardize EVLA execution and documentation, supports the operating surgeon to focus on critical elements of EVLA like flush placement of radial fibre and adequate dosimetry, to achieve an effective and durable vein occlusion and to avoid adverse events. This strategy shows good mid-term results with minimal complications. Long-term follow-up and application in further centres are necessary to prove its reproducibility. Such a guiding tool could improve the ability to analyse, compare and review different EVLA wavelengths and fibre types.

A randomized clinical trial to assess the impact of laser power with constant linear endovenous energy density on outcomes of endovenous laser ablation (SLEDGE trial)

Introduction: The immediate success rate of endovenous occlusion of the great saphenous vein (GSV) and its durability after endovenous laser ablation (EVLA) was postulated to be the matter of a dose-response relationship to the amount of laser energy used. Patients and methods: Patients presenting with varicose veins with incompetent GSV scheduled for EVLA were randomized into Group A who received low linear endovenous energy density (low LEED), and group B who received high linear endovenous energy density (High LEED) using the new 1470-nm diode laser. Patients were followed up for 6 months for the durability ofGSV occlusion and the occurrence of unwanted side effects after the procedure. Results: Between April 2011 and May 2012, we treated 63 legs in 58 patients. We had no statistically significant difference between the two groups regarding the occurrence of early post-operative side effects as pain, paraesthesia, and ecchymosis. Regarding ultrasound proven durability ofGSV occlusion after 6 months, data showed total occlusion of the treated GSV segment in 24 out of 32(75%) legs in group A versus 30 out of 31(96.7%) legs in group B. This data indicates a statistically significant difference (P= 0.04) regarding the failure of treatment in the treated GSV segment in group A patients who had the Low LEED 35J/cm in comparison to group B patients who had the High LEED 50J/cm. Conclusion: The use of the 1470-nm diode laser radial fiber (ELVeS-radial kit) with a high laser energy dose (LEED 50J/cm) was optimum in achieving a durable GSVocclusion without a significant increase in unwanted side effects when compared to lower laser energy dose (LEED 35J/ cm).

We sought to investigate the mid-term and long-term efficacy of 1470 nm endovenous laser ablation (EVLA). We conducted a systematic research on PubMed, Scopus, and Web of science for articles published by January 2024. The primary endpoints were truncal vein and great saphenous vein (GSV) occlusion. Fifteen studies, 4 randomized controlled trials (RCTs), 5 prospective, and 6 retrospective case series, including 2064 patients and 2125 truncal veins (1862 GSV) were included. The pooled truncal vein occlusion estimates at 2, 3, and 5 years were 93.51% (95% confidence interval [CI]: 90.01, 95.84), 89.60% (95% CI: 82.75, 93.93), 88.94% (95% CI: 81.59, 93.58). The pooled GSV occlusion at 2, 3, and 5 years were 93.90% (95% CI: 90.30, 96.21), 93.01% (95% CI: 82.80, 97.36), and 89.06% (95% CI: 80.55, 94.12), respectively. The pooled deep vein thrombosis (DVT) and burn estimates were 1.42% (95% CI: 0.87, 2.31) and 2.64% (95% CI: 1.19, 5.75), respectively. The pooled overall and permanent neurologic complication estimates were 4.33% (95% CI: 1.62, 11.12) and 1.70% (95% CI: 0.69, 4.13), respectively. The pooled Venous Clinical Severity Score (VCSS) reduction by the end of follow-up was, mean difference (MD), 4.96 (95% CI: 3.87, 6.05). Meta-regression analysis including linear endovenous energy density (LEED) values ranging from 69 to 101.7 J/cm elucidated a statistically significant positive association between LEED and GSV occlusion at the 2-year (β=0.0977, p=0.02), 3-year (β=0.2021, p<0.01) and 5-year (β=0.0534, p=0.01) follow-up intervals. This review has displayed satisfactory medium and long-term truncal and GSV occlusion outcomes for the 1470 nm device. In addition, a positive association between GSV occlusion and LEED was identified, persisting through the 2-year, 3-year, and 5-year follow-up intervals. Despite these favorable findings further research is imperative, focusing not only on technical aspects, such as vein occlusion but also on critical clinical parameters, including varicose vein recurrence, to comprehensively evaluate the effectiveness and durability of EVLA.Clinical ImpactThis review demonstrated the efficacy and safety of the 1470 nm EVLA device in the treatment of lower limb venous insufficiency over the medium- and long-term periods, further substantiating its continued use. Moreover, the consistent positive association between linear endovenous energy density (LEED) and occlusion outcomes across the five-year follow-up interval highlighted the critical role of LEED in optimizing long-term clinical results, potentially offering valuable insights for practitioners.

Objective: To date, conflicting evidence has been reported regarding the energy settings to use during endovenous laser ablation (EVLA). In the present study, we evaluated the outcomes of EVLA of the great saphenous veins (GSVs) using different power settings with the same linear endovenous energy density (LEED) of ∼70 J/cm. Methods: We performed a single-center, randomized, controlled noninferiority trial with a blinded outcome assessment of patients with varicose veins of the GSV who underwent EVLA with a wavelength of 1470 nm and a radial fiber. The patients were randomly assigned to three groups according to the energy setting: group 1, 5 W power and an automatic fiber traction speed of 0.7 mm/s (LEED, 71.4 J/cm); group 2, 7 W and 1.0 mm/s (LEED, 70 J/cm); and group 3, 10 W and 1.5 mm/s (LEED, 66.7 J/cm). The primary outcome was the rate of GSV occlusion at 6 months. The secondary outcomes were pain intensity along the target vein the next day and at 1 week and 2 months after EVLA, the necessity for analgesics, and the occurrence of significant complications. Results: From February 2017 to June 2020, 245 lower extremities of 203 patients were enrolled. Groups 1, 2, and 3 included 83, 79, and 83 limbs, respectively. At 6 months of follow-up, 214 lower extremities were examined with duplex ultrasound. GSV occlusion was observed in 72 of 72 limbs (100%; 95% confidence interval [CI], 100%-100%) in group 1 and 70 of 71 limbs (98.6%; 95% CI, 97%-100%) in groups 2 and 3 (P < .05 for noninferiority). No difference was found in the pain level, necessity for analgesics, or rate of any other complications.

The 1,470-nm Bare-Fiber Diode Laser Ablation of the Great Saphenous Vein and Small Saphenous Vein at 1-Year Follow-up Using 8–12 W and a Mean Linear Endovenous Energy Density of 72 J/cm

Background and aims: In Japan, stripping under general anesthesia, lumbar anesthesia and tumescent local anesthesia has been used in the treatment of primary varicose veins due to saphenous vein insufficiency. However endovenous laser ablation (EVLA) using a 980 nm diode laser has received National Health Insurance (NHI) coverage in 2011, while EVLA using a 1470 nm diode laser with a radial 2-ring fiber has received coverage in 2014. As a result, the use of EVLA has become widespread in Japan. We herein report on the results of varicose veins treatment at our hospital. Subjects and methods: Two hundred eighty-nine patients with saphenous vein reflux who received treatment between October 2013 and December 2015 were included in the present study. The surgical results (operating time, complications, ablation rate, linear endovenous energy density [LEED], and the incidence of surgical site infections [SSI]) were retrospectively assessed and compared among the patients who underwent stripping (group A) and those who underwent EVLA (group B) according to the Japan Guidelines for EVLA. Results: Group A and group B included 49 patients and 240 patients, respectively. Group B comprised 20 patients who underwent EVLA using a 980 nm laser (group B1) and 240 patients who underwent EVLA using a 1470 nm laser (group B2). The operative time in group A was 48 ± 16 minutes, whereas that in group B was 28 ± 10 minutes. The operative time, the length of the treated vein and LEED in groups B1 and B2 were 40 ± 11 and 27 ± 10 minutes, 36 ± 10 and 33 ± 10 cm and 84 ± 10 and 77 ± 18 J/cm2, respectively. Furthermore, the mean operative time in group B1 (with no phlebectomy) was 31 ± 9 minutes, whereas that in group B2 (with no phlebectomy) was 22 ±7 minutes, which was statistically significant (p<0.05). The level of pain peak was day 1 in group A patients and on days 3-7 in group B1 patients; the group B2 patients felt little pain. Surgical site infection at the phlebectomy site was observed in two group B2 patients. EVLA resulted in an occlusion rate of 99.6% at approximately two years after surgery. Conclusions: This study showed that EVLA using the 1470-nm laser caused less pain and bruising than EVLA using the 980-nm laser. The operative time of EVLA was approximately 9 minutes shorter than that of stripping. Therefore, EVLA using the 1470-nm laser might be the first treatment of choice for patients with saphenous vein reflux. However conventional surgery remains important because EVLA is not suitable in cases in which the diameter of the saphenous veins is >20 mm or in patients with highly tortuous veins.

To estimate the safety and efficacy of using the laser 1560 nm wavelength for treatment of chronic venous disease in patients with wide diameters of the proximal segment of the great saphenous vein. In the study 88 patients with lower limb varicose veins were included. Maximum diameter of the great saphenous vein proximal segment varied from 15 to 34 mm (22 ± 2.3) in all patients. In the 1st group in 34 cases crossektomy and endovenous laser ablation (EVLA) were performed. In the 2nd group in 30 cases EVLA regardless diameter of the great saphenous vein proximal segment was performed. In the 3rd group in 34 cases EVLA taking into account the diameter of the great saphenous vein proximal segment was performed. The laser 1560 nm wavelength was used. Linear endovenous energy density in the 1st and 2nd groups was 90 J/cm for the proximal segment and trunk of great saphenous vein. Linear endovenous energy density in the 3rd group was personalized on the size of the veins: 100 J/cm for diameter of great saphenous vein proximal segment 15-20 mm, 150 J/cm for diameter 20-30 mm, 90 J/cm for middle and distal segments of great saphenous vein. In the 1st group obliteration of the trunk of the great saphenous veins and accessory great saphenous veins in all cases without additional interventions was reached. In the 2nd group at four cases (13.3%) the second procedure EVLA was carried out, after which the obliteration of the trunk was achieved. In the 3rd group the obliteration of the trunk of great saphenous vein was achieved without additional interventions. Our experience of using the laser 1560 nm wavelength for the treatment of the chronic venous disease in patients with wide diameter of the proximal segment of great saphenous vein shows the safety and efficacy of this technique.EVLA has to be personalized on the size of the segments of vein in patients with wide proximal segment of great saphenous vein.

Outcomes Using a 1470-nm Laser for Symptomatic Varicose Veins

Patency of Anterior Accessory Saphenous Vein Following Endovenous Laser Ablation for Varicose Veins: Bare-Tip Versus Radial Fiber

Effect of Transluminal Injection of Foam Sclerotherapy Combined with Endovenous Thermal Ablation of Varicose Veins

Endovenous Laser Ablation with and Without Concomitant Phlebectomy for the Treatment of Varicose Veins: A Retrospective Analysis of 954 Limbs

To provide an evidence-based overview of endovenous laser ablation and describe its role as an effective and durable technique for the management of superficial venous insufficiency. The published literature on the treatment of varicose veins using endovenous laser ablation was reviewed. The literature search focused on the history of endovenous laser ablation, its safety and durability, known complications, and differences in outcomes based on the iterations of fiber type and laser wavelength. Treatment safety and efficacy of endovenous laser ablation appear to be based on the amount of energy administered over a defined distance, or the linear endovenous energy density. The ideal linear endovenous energy density varies with the laser wavelength and fiber-type. Post-operative pain and bruising may be reduced by the use of higher wavelength fibers or the use of radial or jacket-tip fibers as compared to bare-tip fibers. The incidence of endothermal heat-induced thrombosis remains low and has declined with increasing experience. Reports have demonstrated a greater than 90% technical success rate with saphenous endovenous laser ablation, long-term durability of ablation, and commensurate improvement in quality of life. Endovenous laser ablation is a safe and durable treatment option for the management of incompetent superficial and perforator veins of the lower extremities. As an endothermal technology, it remains a key component of the standard of care for the treatment of chronic venous insufficiency.