Randomised Trial of Mechanochemical or Thermal Ablation for Great Saphenous Vein Insufficiency: 7 Year Follow Up.

Abstract

Treatment of superficial venous insufficiency has been associated with high rates of recurrent symptoms and/or recurrent varicose veins; therefore, there is a need for new treatment options associated with longlasting outcomes. This study reports the 7 year durability of mechanochemical ablation (MOCA) and thermal ablation (TA) in treatment of great saphenous vein (GSV) insufficiency in patients with Clinical Etiological Anatomical Pathophysiological (CEAP) class 2-4 (C2-C4) venous insufficiency in the GSV in a single leg. After recruitment in 2014 - 2015 at Helsinki University Hospital, patients were randomised 2 : 1 : 1 for MOCA, EVLA, and RFA. The GSV was evaluated with a duplex Doppler ultrasound examination, and disease specific quality of life (QoL) was assessed with the Aberdeen Varicose Vein Questionnaire (AVVQ). The primary outcome measures were patency and reflux of the GSV at 1 month, 1 year, 3 years, and, instead of the pre-specified 5 years, at 7 years due to the COVID-19 pandemic. The secondary outcome was the need for further interventions in the treated GSV. Originally, 125 patients received the allocated treatment. The 7 year follow up visits were attended by 89 of 125 (71.2%) patients. In the proximal part of the treated GSV (upper 20 cm), reflux was detected in 10 of 44 (23%) / 3 of 42 (7%) patients in the MOCA / TA groups (p = .032). Between the 3 year and 7 year follow up visits, two patients in the MOCA group had reoperations on the previously treated GSV segment, while no reoperations were required in the TA group. No QoL differences as measured by the AVVQ were shown between MOCA and TA. Seven years after the treatment of GSV insufficiency, MOCA is more often associated with vein recanalisation, recurrent reflux, and additional treatments than is TA.