Early Results (3 months) of an Asian Prospective Multi-Centre VenaSeal™ Real World Post-Market Evaluation to Investigate the Efficacy and Safety of Cyanoacrylate Endovenous Ablation for Varicose Veins (ASVS Study).

OBJECTIVES: The aim of the A Singapore VenaSeal™ real world post-market evaluation Study (ASVS), is to evaluate the performance of cyanoacrylate closure (CAC) for varicose veins in a prospective multi-racial Singaporean Asian cohort. We report early clinical and patient satisfaction outcomes at 3 months post intervention. METHODS: 100 patients (151 legs; 156 truncal veins) underwent CAC between April - December 2018. 49 (32.5%) legs were treated for great saphenous vein (GSV) incompetence, 96/151 (63.6%) bilateral GSV, 1/151 (0.7%) small saphenous vein (SSV) and 5 (3.3%) combined unilateral GSV and SSV reflux. At baseline, 68/151 legs (45.0%) had C4-C6 disease and 67/151 (44.4%) legs had concomitant multiple stab avulsions. Patients were reviewed at 2 - and 12 weeks using Duplex ultrasound to check for venous recanalization (defined ≥ 5cm in length), pain score, revised Venous Clinical Severity Score (rVCSS), EuroQol-5 Dimension questionnaire (EQ-5D), Aberdeen Varicose Vein Questionnaire (AVVQ), Chronic Venous Insufficiency quality life Questionnaire-14 (CIVIQ-14) for quality of life (QoL) measures and a patient satisfaction survey. Time to return to work and normal activities were also recorded. RESULTS: There were 59 females and mean age was 60.1± 12.7 years. There was 100% technical success. Patients tolerated the procedure well and reported low peri-procedural pain (mean pain score = 2.9 (range: 0-9)). Patient surveys at the 3-month interval showed high satisfaction rates with 72/91 (79.1%) being extremely/very satisfied. By day 10, 93/100 (93%) resumed their daily activities while 36/100 (36%) had returned to work. At two-weeks, GSV and SSV were completely occluded in 150/150 (100%) and 6/6 (100%) veins respectively. At 3 months, GSV and SSV occlusion rates were 140/141 (99.3%) and 6/6 (100%) respectively. Transient superficial phlebitis was reported in 27/151 (18 %) legs, which were all self-limiting. At 3 months, rVCSS improved from 5.00 (range 1.00-18.00) to 1.00 (0.00-10.00) (p < 0.001), EQ-5D from 0.686 (-0.382-1.00) to 1.00 (0.12-1.00) (p < 0.001), AVVQ from 17.14 (1.29-61.15) to 4.83 (0.00-57.12) (p < 0.001) and CIVIQ-14 from 19.64 (1.79-73.21) to 7.14 (0.00-51.79) (p < 0.001). CONCLUSIONS: CAC has a high safety profile and is an effective way to block refluxing truncal veins in Asian patients at early follow-up. Patients are highly satisfied and report low post-operative pain. There is significant continued QoL improvement at 3 months. Early results are encouraging but we await further prospective long-term follow-up from the study.