Early results of an Asian prospective multicenter VenaSeal real-world postmarket evaluation to investigate the efficacy and safety of cyanoacrylate endovenous ablation for varicose veins

Abstract

ObjectiveThe aim of A Singapore VenaSeal Real-World Post-Market Evaluation Study (ASVS) was to evaluate the performance of cyanoacrylate closure (CAC) for varicose veins in a prospective multiracial Singaporean Asian cohort. We report early clinical and patient satisfaction outcomes at 3 months after intervention. MethodsThere were 100 patients (151 legs; 156 truncal veins) who underwent CAC between April and December 2018. Of the 151 legs, 49 (32.5%) were treated for great saphenous vein (GSV) incompetence, 96 (63.6%) for bilateral GSV incompetence, 1 (0.7%) for small saphenous vein (SSV) incompetence, and 5 (3.3%) for combined unilateral GSV and SSV reflux. At baseline, 68 legs (45.0%) had C4 to C6 disease, and 67 legs (44.4%) had concomitant multiple stab avulsions. Patients were reviewed at 2 and 12 weeks by duplex ultrasound to check for venous recanalization (defined as ≥5 cm in length), pain score, revised Venous Clinical Severity Score, EuroQol-5 Dimension questionnaire score, Aberdeen Varicose Vein Questionnaire score, 14-item Chronic Venous Insufficiency Questionnaire (CIVIQ-14) for quality of life measures, and patient satisfaction. Time to return to work and normal activities were also recorded. ResultsThere were 59 female patients, and mean age was 60.1 ± 12.7 years. There was 100% technical success. Patients tolerated the procedure well and reported low periprocedural pain (mean pain score, 2.9 [range, 0-9]). Patient surveys at the 3-month interval showed high satisfaction rates, with 72 of 91 (79.1%) being extremely or very satisfied. By day 10, of 100 patients, 93 (93%) resumed daily activities, whereas 36 (36%) had returned to work. At 2 weeks, GSV and SSV were completely occluded in 150 of 150 (100%) and 6 of 6 (100%) veins, respectively. At 3 months, GSV and SSV occlusion rates were 140 of 141 (99.3%) and 6 of 6 (100%), respectively. Transient superficial phlebitis was reported in 27 of 151 (18 %) legs, which was self-limited. At 3 months, revised Venous Clinical Severity Score improved from 5.00 (range, 1.00-18.00) to 1.00 (0.00-10.00; P < .001); EuroQol-5 Dimension score, from 0.686 (−0.382 to 1.00) to 1.00 (0.12-1.00; P < .001); Aberdeen Varicose Vein Questionnaire score, from 17.14 (1.29-61.15) to 4.83 (0.00-57.12; P < .001); and 14-item Chronic Venous Insufficiency Questionnaire, from 19.64 (1.79-73.21) to 7.14 (0.00-51.79; P < .001). ConclusionsCAC 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 postoperative pain. There is significant continued quality of life improvement at 3 months. Early results are encouraging, but we await further prospective long-term follow-up from the study.