In diesem Review werden 24 Studien zur Behandlung der insuffizienten V. saphena magna mit Mündungsklappeninsuffizienz ausgewertet. Sie wurden nach „Reflux“ und „Rezidiv“ hinsichtlich Therapietechnik, Patientenzahl, Länge des Follow-up sowie der Angabe primärer und sekundärer Endpunkte ausgewertet. Die Studienlage ist unklar, deshalb sollte ein verbindliches Studiendesign definiert werden, um zukünftige Studienergebnisse vergleichbarer zu machen.
Abstract
The results of studies on treatment of the great saphenous vein (GSV) with sapheno-femoral-junction (SFJ) insufficiency are unclear. Guidelines, however, recommend endovenous laser ablation (EVLA) and ultrasound-guided-foamsclerotherapy (UGFS) for symptomatic varicose large saphenous vein. There are numerous studies on GSV treatment but only a few randomized studies with a follow-up of two years and more. Meta-analyses in most instances included all studies and do not focus on studies with a follow-up of two years and longer.
Methods: A literature research in Pubmed used the keyword „great saphenous vein treatment“, „large saphenous vein treatment“, „varicose therapy“ in conjunction with „randomized controlled trial“, „meta-analysis“ and „systematic review“. Of 128 studies only 24 randomized controlled studies investigated the effect of High Ligation and Continuous Stripping (HL + CS), Endovenous Laser Ablation (EVLA), Radiofrequency Ablation (RFA), Liquid Sclerotherapy (LS), and Ultrasound-Guided-Foam-Sclerotherapy (UGFS) and a follow-up of two and more years. Study evaluation included „reflux“, „recurrence“, „therapy technique“, numbers of patients/legs treated, length of follow-up, and primary/secondary study endpoints.
Results: Most of these studies investigated surgical High Ligation and Continuous Stripping (HL + CS) with a follow-up of two years and more. This technique served a reference technique for other techniques in randomized controlled studies. However, there are major differences in techniques, mode of treatment, definitions, criteria for exclusion and inclusion, and study endpoints. The surgery study group included 1915 legs in 19 studies, the EVLA group 1047 legs in 12 studies and 240 legs in 3 studies with combined HL + EVLA treatment. RFA was used in 299 legs in 4 studies, UGFS in 661 legs in 5 studies, combined UGFS + HL in 39 legs and LS + HL in 92 legs in one study each. EVLA is associated with more reflux and recurrence when compared to HL + CS. RFA shows similar reflux and recurrence rates as surgery. In most studies UGFS and LS is followed by more reflux and recurrence when compared to surgery.
Conclusion: Due to heterogeneity of studies comparing study results of HL + CS, EVLA, RFA, LS and UGFS is not reliable. UIP or ECOP may form a commission to establish uniform, reliable and accepted study designs for varicose vein treatment to improve comparability of further randomized studies.
Schlüsselwörter
Vena saphena magna - Crossektomie mit Stripping - endovenöse Laserablation - Radiofrequenzablation - Schaumsklerosierung
Keywords
great saphenous vein - high ligation and continuous stripping - endovenous laser ablation - radiofrequency ablation - foam sclerotherapy
