RESUMO
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.
Assuntos
Terapia a Laser , Varizes , Humanos , Fibras Ópticas , Estudos Retrospectivos , Varizes/cirurgia , DorRESUMO
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.