Introduction This is a single-center clinical study for the evaluation of safety, efficacy, and performance of endovenous cyanoacrylate (Sapheon Venaseal Closure System, now Medtronic Medical) for the treatment of great saphenous vein (GSV) reflux. Methods Primary outcome measures included the GSV obliteration, with clinical recurrence on follow up as detected by serial clinical and duplex examinations of patients at 1 week, 1 month, 6 months, and 1 year. Venous clinical severity score (VCSS), Aberdeen varicose vein questionnaire (AVVQ), Short Form Health Survey 36 Item (SF-36) questionnaires were used at clinical follow up. Diameter of the GSV, treatment length of the GSV, and pretreatment clinical severity of the varicose vein were analyzed to predict recanalization using Cox regression analysis. Results Fifty-seven legs in 29 patients with primary varicose veins were included. One week follow-up duplex showed successful obliteration of the GSV in all except one of the legs. Two legs had minimal extension of thrombus to deep vein. None of the patients had deep venous thrombosis. All the patients were discharged the same day of operation. Median time to return to work was 1 day (range 1-16 days). Our VCSS, AVVQ, and the SF-36 physical and mental scores changed from a mean of 6.91, 23.66, 44.24, 54.26 at baseline to 2.43, 6.10, 43.85, 52.50 at 1 month post operation, respectively. Kaplan-Meier analysis showed that the GSV closure rates were 98.2%, 94.3%, 89.7%, and 78.5% at post-op 1 week, 1 month, 6 months, and 1 year, respectively. With median follow-up period of 9 months (range 1-13 months), no clinical recurrence of varicosity was observed. Mean GSV diameter ≥8 mm was a significant predictor for recanalization (hazard ratio 6.92, 95%CI 1.34-35.67, p = 0.021). Conclusion This study showed that the use of endovenous cyanoacrylate in the treatment of the GSV reflux was safe. All patients had symptomatic improvement as shown by the VCSS and AVVQ.
Keywords: Varicose veins; clinical follow up; cyanoacrylate; duplex; endovenous; incompetence; quality of life questionnaire; recanalization; saphenofemoral junction; saphenous vein.