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 (R) (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 (O-2/CO2) and increasing volumes of 1% foam increase the risk of AEs.