Objectives: The purpose of this prospective study was to evaluate the occlusion rate, clinical severity, disease specific health related quality of life (HRQoL), and safety in patients with great saphenous vein (GSV) reflux 3 years after a single treatment session of catheter directed foam sclerotherapy (CDFS) combined with peri-saphenous infiltration of tumescent local anaesthesia (TLA).
Methods: A total of 249 patients with symptomatic unilateral GSV incompetence underwent CDFS combined with TLA and were followed up for 3 years. The primary outcome was complete obliteration of the treated segment of the GSV. Secondary outcomes were changes in Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) score, absence of above knee GSV reflux, and safety of treatment.
Results: Three years after CDFS, the estimated cumulative proportion of persistently obliterated above knee GSV was 81.5%. Freedom from above knee GSV reflux was demonstrated in 89.6% of patients. Both the VCSS and CIVIQ score improved significantly (p < .0001 and <.0001, respectively). No major adverse events were encountered. Thrombophlebitis, skin pigmentation/matting, and transient scotomata were reported in 2%, 7.8%, and 0.8% of cases, respectively.
Conclusion: CDFS combined with TLA for treatment of GSV incompetence yields good mid-term results in terms of occlusion rate, clinical severity, patients' QoL, and safety.
Keywords: Catheter directed; Foam sclerotherapy; GSV incompetence; Tumescent anaesthesia.
Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.