Novel treatment modalities for varicose veins
Authors:   , Alozai Tamana 
Published: January 2024

This thesis aims to examine the outcomes of various endovenous ablation techniques for treating varicose veins. Part 1 focuses on endovenous thermal ablation, speciﬁcally endovenous laser ablation (EVLA), while Part 2 centers around endovenous non-thermal ablation, particularly mechanochemical ablation (MOCA).
Endovenous thermal ablation has emerged as a minimally invasive alternative to saphenofemoral ligation and stripping (SFL/S) for the treatment of great saphenous vein (GSV) incompetence. In Chapter 1, a single- center, randomized, controlled trial was conducted to compare the 10-years results of SFL/S with EVLA for the treatment of GSV incompetence. This study showed no clear long-term advantage of EVLA with a 980-nm wavelength and bare-tip ﬁber over SFL/S of the GSV under local tumescent anaesthesia.
Despite the favorable outcomes and minimally invasive nature of EVLA, the development of recurrent varicose veins due to reﬂux in the tributaries near the junction is a commonly encountered issue after EVLA. Particularly, the anterior accessory saphenous vein (AASV) is prone to become insufficient because it frequently discharges into the GSV in close proximity to the saphenofemoral junction (SFJ). To prevent AASV reﬂux, laser crossectomy (LC) has been proposed, which involves occluding the GSV up to the SFJ by positioning the laser tip exactly at the junction. Chapter 2 presents the ﬁndings of a randomized, patient- and observer-blinded, controlled trial that compares LC with standard EVLA of the GSV up to 1-2 cm below the SFJ. The study found that LC of the GSV is as safe and effective as standard EVLA, however, it does not reduce AASV reﬂux at 24 months.
Primary AASV reﬂux accounts for approximately 10% of cases of varicose veins, with comparable disease severity and morbidity to those caused by GSV insufficiency. Therefore, treatment of primary AASV reﬂux is necessary. In Chapter 3, a systematic review and meta-analysis was conducted to summarize and compare the outcomes of the currently available treatment modalities for AASV insufficiency. Despite the limited evidence, this study showed that occlusion of the AASV can be achieved with endovenous thermal ablation and cyanoacrylate. Phlebectomy shows promising results if the SFJ is competent. Lower results are seen after sclerotherapy and CHIVA.
MOCA combines mechanical endothelial damage with the infusion of a sclerosant. It does not involve the use of heat and does not require tumescence. As a result, there are fewer complications related to heat, and patients experience less pain and faster recovery. Chapter 4 focuses on a multicenter, randomized, dose-ﬁnding study to determine the optimal dosage of Polidocanol (POL) for MOCA using the Clarivein device in occluding the GSV. The results showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not signiﬁcant. Chapter 5 provides a subanalysis of this study, focusing on the patient-reported outcomes following technical success (TS) and technical failure (TF) using Clarivein. This study indicates no signiﬁcant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.
In addition to Clarivein, a new MOCA device called Flebogrif has entered the market. Chapter 6 presents a systematic review and meta-analysis of Flebogrif showing that it is a safe and well-tolerated procedure for the treatment of saphenous vein insufficiency. However, there is a lack of studies comparing Flebogrif to endovenous thermal ablation. To address this gap, a multicenter, open-label, non-inferiority, observer-blinded, randomized controlled trial was conducted to compare Flebogrif with EVLA in the treatment of GSV incompetence. The protocol of this study is outlined in Chapter 7.