Endovenous laser ablation (EVLA) for vein insufficiency: two-year results of a multicenter experience with 1940-nm laser diode and a novel optical fiber.

Thermoablative techniques currently represent, in accordance with international guidelines, the most used methods in the treatment of varicose veins. From some years, lasers with a wavelength greater than 1900 nm have been introduced for EndoVenous Laser Ablation (EVLA) treatment. However, currently, few clinical studies regarding this new technology are reported in the medical literature. The aim of this study is to evaluate outcomes at a 2-year follow-up (mid-term) of EVLA of varicose veins of the lower limbs using a 1940-nm laser and a new cylindric monoring fiber. This clinical trial was conducted as a multicenter, retrospective, non-randomized, non-blind clinical study. Ninety-three patients were enrolled for a total of one hundred consecutive procedures performed in the period between January 2021 and May 2021 in two Italian facilities. The primary efficacy endpoint was the occlusion rate of the treated vein immediately after surgery and at the follow-up (24 months). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power and linear energy density or LEED). The primary safety endpoints were the incidence of pain (1 day and 7 days after surgery) and the rate of intraoperative and postoperative complications. The precepted pain was evaluated with the visual analog scale (VAS). The secondary safety endpoint was the evaluation of the improvement of the patient's symptoms related to venous disease. This evaluation was conducted by recording the changes in clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification. All procedures were carried out regularly on an outpatient basis, and no intraoperative complications occurred. The occlusion rate of the target veins was 100% at 7- and 30-day controls. At follow-up controls, performed at 6 months, 1 and 2 years carried out showed an occlusion rate respectively of 99% (97 to 100), 96.9% (93.6 to 100), and 95.9% (92.1 to 99.9). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power watt and linear energy density): As regards the power parameters, we report an average of watts of 4.5 ± 0.8 [2.5 to 6] and linear energy density delivered (LEED) of 41.2 ± 8.6 [(21.1 to 66.7)]. The pain reported (with VAS scale) on 1 day of the procedure was 2 [1; 3] and 1 [0 to 4] at 7 days. All patients showed improved symptoms related to venous disease, with reduction of the individual CEAP class to which they belong. This study demonstrates that EndoVascular Laser Ablation (EVLA) treatment of varicose veins with a wavelength > 1900 nm is safe and effective. The overall occlusion rate was high. The reported results suggest that using lower parameters, such as output power (watts) and LEED (linear energy density), do not reduce the success rate of the treatment when used over 35 J/cm.

980 nm laser endo-perivenous treatment of lower limb reticular veins and telangiectasias. Technical notes.

INTRODUCTION: For several years, the venous aesthetic problem has been tackled mainly with sclerotherapy techniques. In recent years, laser techniques have been added, both surface (transdermal) and endo-perivenous, performed with small optical fibers (100-200 µm) and low intensities in terms of LEED and Watt. The endo-perivenous technique has extended the possibilities of laser treatment also to the nourishing veins, to telangiectasias resistant to therapies with sclerosing agents and/or transdermal lasers and to vessels with larger diameters (1-3 mm) and depths >1.3 mm. MATERIALS AND METHODS: We report a series of 20 patients affected by reticular veins and telangiectasias of the lower limbs (CEAP C1-2) treated with endo-perivenous technique. The most used setting was: 3 W (range: 2-4 W) with a mean fluence delivered of 11.25 J/cm (range: 6-18) in pulse mode with 980 nm laser, 200 µm fiber after a preventive skin cooling. Scheduled follow-up occurred 20 and 60 days after treatment. RESULTS: Total technical success, understood as complete obliteration of all treated vessels, was achieved in 70% of cases (14/20) after just one treatment. The most observed early local complications were erythema, vesicles, and small cutaneous eschars that regressed in 3 weeks. At 60-day follow-up, just one complication was observed: a small area of hyperpigmentation (5%). In this case, chemical peel procedures was performed with good clinical results. CONCLUSIONS: Endoperivenous laser treatment represents an effective and valid tool for the treatment of teleangectasias and reticular varicose veins.

Endovascular laser treatment. Comparison of lasers and fibers of different generations: study of temperatures and tissue damage produced on a porcine liver model.

The current international guidelines identify tumescent ablative techniques such as laser thermal ablation (EVLA) and radiofrequency (RFA) to be the gold standard in varicose vein surgery. New-generation lasers have been introduced, which have high wavelengths (1940 and 2000 nm) and therefore with a greater affinity for water than the old generation (980- and 1470-nm lasers). The purpose of the study was to evaluate the biological effect and the temperatures produced during the use of lasers with different wavelengths (980, 1470, and 1940 nm) and with optical fibers with different emission (radial diverging at 60° and radial with cylindrical mono-ring) on in vitro model. Porcine liver was used as an in vitro model. The laser control units used had 3 different wavelengths: 980, 1470, and 1940 nm. The optical fibers used were 2: the Corona 360 fiber (mono-ring radial fiber) and the infinite fiber (cylindrical mono-ring fiber). The laser operating parameters used included the delivery of 6 W in continuous wave (CW) mode with a standard 10 s/cm pull-back. Eleven measurements were made for each fiber and for each laser, for a total of 66 measurements. We performed measurements of the maximum transverse diameter produced with laser irradiation to evaluate the biological effectiveness of the treatment. During laser irradiation, we performed measurements of both of the temperatures reached on the external surface of the porcine tissue, near the tip of the laser catheter, and the temperatures reached inside the irradiated tissue by using a digital laser infrared thermometer with apposite probe. The calculation of the statistical significance (p-value) was obtained with the ANOVA method with two between factors. The comparison study of the maximum transverse diameter (DTM) of the lesion produced on the target tissue demonstrated the absence of statistically significant differences between the 1470-nm laser and the 1940-nm laser regardless of the type of fiber used. It was not possible to perform measurements of the maximum transverse diameter produced with the 980-nm laser as this produced no visible effect on the model. The comparison study of the temperatures developed during and immediately after the treatment instead showed higher maximum surface temperatures (TSM) and a higher thermal increase (IT) regardless of the type of fiber used in a statistically significant way (respectively, p 0.002 and 0.012) when using the 980-nm laser versus the 1940-nm laser. Comparing instead the 980-nm laser with 1470 nm, there were no differences in TI recorded during the procedure but a significantly higher VTI (p 0.029). The experiment conducted with the new generation laser, compared with those of the first and second generation, shows how this works overall at lower temperatures with the same effectiveness.

Third generation of laser (>1900) for endovenous thermoablation (EVLA) of varicose veins: A systematic review and meta-analysis.

OBJECTIVES: Third generation lasers with longer wavelengths (>1900 nm) have been introduced, in recent years, for the treatment of varicose veins. The possible advantage of the new generation lasers is that they allow complete damage to the vein wall using a lower Power in Watts (W: J/sec) and a lower linear energy density (LEED: J/cm). The aim of this work is to evaluate the results present in the literature regarding efficacy and safeness of the new generation lasers for the treatment of varicose veins. METHODS: Published articles were searched on PubMed database and on Cochrane Library, entering the keywords "1940 nm or 1920 nm laser AND varicose veins laser thermoablation (EVLA)." The primary endpoint of the study was to value rate of occlusion and adverse events at the short term follow-up. The search yielded a total of 14 studies. In the end, only six studies were judge eligibility. RESULTS: The studies were heterogenous in their documentation, EVLA, duplex ultrasound protocol and result reporting. A total of 540 limbs of 377 patients were treated with endovenous laser ablation (EVLA) with laser 1920-1940 nm. The treated veins had a mean diameter of 0.74 ± 0.17 cm and a mean length of 27.87 ± 20.63 cm. The pooled estimates of immediate occlusion rate was of 99.8% (95% CI: 97.9% to 100.0) with high heterogeneity (I2 = 60%; 95% PI: 89.7% to 100%), while at short-term follow-up was of 98.2% (95% CI: 94.0% to 100.0%) with higher heterogeneity (I2:79%; 95% PI: 77.1% to 100.0%). EHIT occurred in 7 cases (pooled estimate: 0.7%). The other adverse events rate reported were 1% of hyperpigmentation, 2.8% of neurological complications, 0.6% thrombophlebitis and 1.9% of bruising/hematoma. The pooled mean estimates of LEED was equal to 38.2 J/cm (95% CI: 26.3 to 50.1 J/cm) although with a very large heterogeneity (I2 = 100%). CONCLUSIONS: The overall success rate of EVLA was high. The analysis of these studies suggests that using lower parameters (Power and linear administered energy) may have no effect on the treatment success rate. Short-term results demonstrate comparable occlusion rates respect the second-generation lasers. Instead, data suggest a low complication rates. Short-term results demonstrate comparable complications rates respect the second-generation lasers (1300-1470 nm). Randomized studies with longer follow-up are required to evaluate the EVLA 1900 nm procedure further.

The evolution of endovenous laser ablation (EVLA). A single-center experience with a 1470 nm versus a 1940 nm diode laser.

AIM: To evalue the short-term results obtained in endovenous laser ablation (EVLA) procedure of the varicose insufficiency of the lower limbs with Diode 1470 nm laser compared to Diode 1940 nm laser. MATERIALS OF STUDY: A total of 55 patients were enrolled in the study. The patients were divided into two groups: those subjected to 1470 nm laser treatment in group A and those with 1940 nm laser treatment in group B. The endpoints were: Closure of the target vessel, complications and post-operative pain. RESULTS: There are no intra-and post-operative complications. The occlusion rate of the target veins was 100% at 7- and 60-day controls. The pain perceived in the immediate post-operative and at the controls showed no statistically significant differences between the two groups. However in group B it was necessary to apply lower values of Power (W) and Linear Energy Density (LEED) with a statistically significant difference compared to group A. DISCUSSION: Short-term results demonstrate closure rates comparable to those obtained with 1470 nm lasers. There were no statistically significant differences in the two groups in terms of primary and secondary endpoints. The advantage of using 1940 nm laser technology is that it is possible to dispense a lower linear energy density (LEED) at a lower power (Watt). CONCLUSIONS: Endovenous laser ablation with Diode 1940 nm is particularly suitable and advantageous in the treatment of superficial and small vessels, as well as venous segment adjacent to nerve structures. KEY WORDS: Diode laser, Intravenous ablation, Varicose, Venous insufficiency, Veins.

Conservative treatment of non-healing plantar skin ulcer complicated by infection and fistula in congenital clubfoot. A case report.

INTRODUCTION: Congenital changes related to Spina Bifida (SB) include congenital clubfoot (PTC), also known as equinovarus congenital clubfoot. Skin pressure ulcers represent a frequent complication associated with SB and PTC, determined by both sensitivity deficits and skeletal alterations of plantar support. This conditions can lead to the onset of frequent neurotrophic skin ulcers. CASE REPORT: 72-year-old female patient suffering from spina bifida with congenital clubfoot condition, complicated by ulcerative lesion in the plantar region with fistula and infection (Proteus Mirabilis). An infectious disease evaluation with monitoring of the inflammatory-infectious hematochemical values and targeted antibiothic-therapy was performed. The patient performed a scintigraphic examination in order to exclude the osteomyelitis process. The dressing protocol set up was: Disinfection with disinfectant based on Poliesanide and Betaine, with the use of Nelaton 6 Fr catheter (and subsequent dressings with 18 G needle cannula), inside the fistulous channel. Subsequent abundant washing with 0.9% saline solution. Application of oily phyto-product Mix of Neem Oil and Hypericum Perforatum (1-Primary Wound Dressing), inoculating it with the catheter inside the medium and checking its leakage from both sides and cover with sterile gauze and bandage with cohesive bandage. After 4 weeks there was a reduction in the size of the fistula and the disappearance of serum-corpuscular secretions. At 7 weeks, complete re-epithelialization of the skin ulcerative lesion was observed. DISCUSSION: This case report refers to the conservative medical treatment of a complex case of non-healing pressure skin ulcer with distant fistulization. The main difficulty in managing this lesion was identifying the right dressing that could reach and spread within the fistulous channel, favoring the reduction of the inflammatory-infectious process. The dressing used, as it was in an oily formulation, therefore had the right characteristics as it was easy to inoculate. The oily mix of Neem and Hypericum Perforatum (1-Primary Wound Dressing) has in fact performed a prolonged antiseptic function while maintaining the right degree of local hydration, essential for the correct carrying out of the reparative processes. CONCLUSIONS: In undermined or fistulous ulcers, the use of oil-based dressings, such as the oily mix of Neem and Hypericum Perforatum (1-Primary Wound Dressing), can represent a valid local therapeutic choice. KEY WORDS: Congenital clubfoot, Neurotrophic skin ulcer, Wound Care.