The novel minimally invasive mechano-chemical technique of the saphenous vein ablation. Our center experience: results of 24 months follow-up

Abstract

Introduction: The aim of the study was to evaluate the efficacy of the endovascular ablation method of GSV/ /SSV superficial venous insufficiency using Flebogrif® catheter, the safety of the method, expressed in number and quality of observed complications in 24-month observation. Material and methods: Initially, the observed group included 200 patients undergoing ablation of insufficient GSV/SSV. During 24 months of observation, this number decreased to 158, which seems to be a natural process. All patients signed the informed consent form approved by the Bioethics Committee of the Medical University of Lublin. Based on clinical evaluation, including ultrasound assessment, 200 patients, including 170 women and 30 men, were admitted to the study using the adopted criteria of inclusion/exclusion. In the studied group of patients, 172 great saphenous veins (GSV) and 28 short saphenous veins (SSV) were ablated. The treated inefficient veins were punctured at three levels depending on the length of the segment of insufficient GSV/SSV. Each patient was treated with a compression agent in the form of a second compression class elastic stockings (20–30 mm Hg). Control visits on the basis of the accepted protocol were established in 1, 3, 6, 12, 24, 36 months after the procedure. Results: During 24 months of observation, the evaluation of the Flebogrif® catheter method was based on the analysis of results obtained in four categories: effectiveness of the method, expressed as the ratio of the number of successfully closed veins ablated with the Flebogrif® catheter to the number of observed cases of recanalization; clinical improvement of venous insufficiency symptoms, based on the VCSS, CEAP, VAPS scale; safety of the method, expressed in terms of quantity and quality of observed complications; technical characteristics of the method. The obtained results were analyzed statistically using tests for non-parametric variables. The effectiveness of the method based on the obtained results was 92%. A statistically significant decrease in the intensity of clinical symptoms in relation to the preoperative condition was observed. The number and quality of the observed complications allow considering the procedure of vein ablation with the use of Flebogrif® catheter as safe, possible to perform in ambulatory conditions. Conclusions: Effectiveness of the method of 92% in 24-month observation; good cosmetic effect; a statistically significant decrease in the intensity of clinical symptoms in 24-month observation; the low incidence of complications allows to consider the method safe; the method of surgery allows to perform the procedure in ambulatory conditions.