Adverse neurological events after sodium tetradecyl sulfate foam sclerotherapy – A prospective, observational study of 8056 treatments

Background Ultrasound guided foam sclerotherapy (UGFS) is a flexible and highly utilised tool in the treatment of varicose veins (VVs), both as a primary treatment and as an adjunct to other treatments. Concern remains regarding the risk of neurological adverse events (AEs) such as migraine, visual disturbance and serious adverse events (SAEs) such as cerebrovascular accident that have been reported after UGFS treatments. Aim To determine the incidence of neurological AEs and SAEs after UGFS. Methods A prospective, multicentre, post-authorisation safety study across Europe (both private and government) was performed between January 2015–2020. Neurological adverse events after UGFS with Fibrovein® (Sodium Tetradecyl Sulfate) 1 and 3% physician generated foam. Results 8056 patients underwent treatment. There were 46 AE (including 5 SAEs), 30 (65%) SAEs were in female patients. Mean age was 55 years with mean body mass index (BMI) of 27. Univariable logistic regression demonstrate that UGFS only treatment (i.e. no adjunctive treatment), liquid-to-gas ratio, gas type and total foam volume (1% sodium tetradecyl sulfate, STS) were significantly associated with the odds of experiencing the outcome. Multivariable logistic regression model exhibits that migraine and total foam volume (1% STS) maintained statistical significance thus associated with the odds of adverse events. Conclusions This study demonstrates that UGFS with Fibrovein is safe with a very low incidence of neurological AEs and SAEs. Past history of migraine, use of physiological gas (O2/CO2) and increasing volumes of 1% foam increase the risk of AEs.

LIPIODOL reduces the lytic activity of detergent sclerosants in vitro

Objectives Contrast agents are used widely in the interventional setting and in particularly in the management of vascular anomalies and have also been used in combination with sclero-embolic agents. There is limited information on the interaction of contrast agents with sclerosant agents when used as mixtures. The aim of this study was to determine the effect of mixing radiological contrast agents with detergent sclerosants and measuring the effect on change in lytic activity of detergent sclerosants in vitro and by proxy the change in potency. Methods Red blood cell lysis was assessed following the incubation of two commonly used contrast agents, LIPIODOL® and ULTRAVIST®, mixed with detergent sclerosants, FIBROVEIN®, sodium tetradecyl sulfate (STS), and AETHOXYSKLEROL®, polidocanol (POL). Results The density of both contrast agents was higher than STS and POL and neither of the detergent sclerosants were miscible in LIPIODOL. LIPIODOL on its own caused cell lysis (1.01%, p < 0.05) whereas ULTRAVIST did not. Fifty per cent cell lysis for sclerosant and LIPIODOL mix occurred at concentrations of: 0.041% (2.4 times greater than the control, p < 0.05) and 0.08% (3.6 times greater than the control, p = 0.06) for STS and POL, respectively. Conclusions LIPIODOL, when mixed with sclerosant detergents (ratio 1:1) causes a reduction in the lytic activity of sclerosants and this effect was statistically significant and most prominent in lower sclerosant concentration mixtures.

Sclerotherapy of telangiectasias: A prospective, randomized, comparative clinical trial of hypertonic glucose versus sodium tetradecyl sulfate

To compare the disappearance of the telangiectasias after sclerotherapy with 75% glucose (HG) versus 0.2% sodium tetradecyl sulfate (STS). This prospective, randomized clinical trial compared the results of sclerotherapy of the telangiectasias with HG and STS. The primary efficacy end point was telangiectasia disappearance within 14, 28, 42, and 56 days following treatment. The clearing of the vessels was assessed using a six-point scale (from 0 to 5). A total of 159 women were treated (81 in the STS group; 78 in the HG group). The median score of the vessels clearing (IQR) was significantly lower in the STS group than in the HG group: 3 (2–4) versus 4 (3–5) after 56 days, p < 0.001. Pigmentation was frequently observed in the STS group (38.3% vs 2.6%; p < 0.001). In conclusion, throughout the entire follow-up period, sclerotherapy of telangiectasias with glucose was significantly superior to that with STS. Moreover, pigmentation and intravascular clots frequently occurred with STS treatment. Registered at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD); ID: VRCVD 1.005.

Sclerotherapy

Sclerotherapy involves the injection of a caustic solution into an abnormal vein so as to cause localized destruction of the venous intima and obliteration of the vessel. Over the past 50 years, improvements in the technology have greatly enhanced the results achievable with sclerotherapy. To ensure optimal results, it is essential to have a thorough knowledge not only of the technique but also of the indications, expected outcomes, and possible complications associated with the procedure. This review covers preoperative evaluation, operative planning, technique and complications associated with sclerotherapy. Figures show a 63-year-old woman before and after two treatments with 0.2% sodium tetradecyl sulfate, a 52-year-old woman before and after two treatments with 0.5% sodium tetradecyl sulfate, a 36-year-old woman before and after four treatments with a combination of 0.5% and 0.2% sodium tetradecyl sulfate, the standard hand position for sclerotherapy, skin necrosis on the left posterior calf of a 48-year-old woman after ultrasound-guided sclerotherapy, a 56-year-old woman before treatment and with residual hyperpigmentation after treatment with 0.2% sodium tetradecyl sulfate, and telangiectatic matting in a 43-year-old woman after treatment with 0.2% sodium tetradecyl sulfate. Tables list complications of sclerotherapy, suggested polidocanol (POL) and sodium tetradecyl sulfate (STS) concentrations for liquid and foam sclerotherapy, materials needed for sclerotherapy, and absolute and relative contraindications for sclerotherapy for varicose veins. Key Words: Varicose veins, Chronic venous insuffiency, sclerotherapy, foam sclerotherapy, reticular veins, venous disorders This review contains 7 highly rendered figures, 4 tables, and 29 references.

Sclerotherapy

Sclerotherapy involves the injection of a caustic solution into an abnormal vein so as to cause localized destruction of the venous intima and obliteration of the vessel. Over the past 50 years, improvements in the technology have greatly enhanced the results achievable with sclerotherapy. To ensure optimal results, it is essential to have a thorough knowledge not only of the technique but also of the indications, expected outcomes, and possible complications associated with the procedure. This review covers preoperative evaluation, operative planning, technique and complications associated with sclerotherapy. Figures show a 63-year-old woman before and after two treatments with 0.2% sodium tetradecyl sulfate, a 52-year-old woman before and after two treatments with 0.5% sodium tetradecyl sulfate, a 36-year-old woman before and after four treatments with a combination of 0.5% and 0.2% sodium tetradecyl sulfate, the standard hand position for sclerotherapy, skin necrosis on the left posterior calf of a 48-year-old woman after ultrasound-guided sclerotherapy, a 56-year-old woman before treatment and with residual hyperpigmentation after treatment with 0.2% sodium tetradecyl sulfate, and telangiectatic matting in a 43-year-old woman after treatment with 0.2% sodium tetradecyl sulfate. Tables list complications of sclerotherapy, suggested polidocanol (POL) and sodium tetradecyl sulfate (STS) concentrations for liquid and foam sclerotherapy, materials needed for sclerotherapy, and absolute and relative contraindications for sclerotherapy for varicose veins. Key Words: Varicose veins, Chronic venous insuffiency, sclerotherapy, foam sclerotherapy, reticular veins, venous disorders This review contains 7 highly rendered figures, 4 tables, and 29 references.

The effect of the calibre and length of needle on the stability of sclerosing foam

Objectives Little is known how calibre and length of needles affect the stability of sclerosing foam. Methods Foams were made of 0.5%, 1%, 2% and 3% polidocanol, and 0.2%, 0.5%, 1% and 3% sodium tetradecyl sulfate (STS), which were mixed with air in the proportion of 4:1. These foams were ejected through needles with the length of: 4 mm, 6 mm and 13 mm, and diameter of: 0.26 mm, 0.3 mm and 0.4 mm. Results Foams made of more concentrated polidocanol were more stable. Regarding STS an opposite relationship was revealed. Foams made of polidocanol were more stable if ejected through a longer needle, while the length of needle did not significantly affect stability of STS foams. Foams ejected through 0.26 mm diameter needles were very unstable. In the case of 0.5% polidocanol, 0.3x6mm needle provided atypically stable foam. Conclusion In order to inject maximally stable foam, calibre and length of needle should be taken into account.