Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome

Abstract

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.

What is popular may no longer be popular: Cyanoacrylate and other alternatives in surgical treatment of chronic venous insufficiency

“…Chan et al [25] published inferior results in a similar group of 29 patients and 57 legs. The 12-month occlusion rate was 78.5%.…”

Efficacy of Cyanoacrylate Glue Ablation of Primary Truncal Varicose Veins Compared to Existing Endovenous Techniques: A Systematic Review of the Literature

“…Selection bias toward bilateral varicose veins was observed in one prospective and one retrospective study. 25,26 Another reported a modification of intervention after commencement of data collection which improved the complication rate in the remaining patients. 27 Blinding of assessors was not possible.…”

“…27 The rest utilized the VenaSeal system (Medtronic, Dublin, Ireland). 12,13,21,25,26,28,[32][33][34] All procedures commenced by cannulation of the target vein with an introducer needle under ultrasound guidance at the most distal point of reflux. The position of the delivery catheter tip distal to SFJ or SPJ ranged from 3 to 5 cm.…”

“…13,32 An even broader timing interval extended from skin preparation to final bandaging, including phlebectomies (mean 64 minutes). 25,26 One operator performed the procedures under intravenous sedation, which further extended length of intervention. 13…”

Siyanoakrilat ile Safen Ven Embolizasyonunda Ortalama Trombosit Hacmi ve Trombosit Sayısının Değişimi

“…Ancak yine yapılan literatür taramasında süperfisiyal ven trombozu sıklığı %05 ile %4 arasında değiştiği tespit edilmiş ve DMWH ile tedavi edildiği belirtilmiştir(15)(16)(17)(18)(19). Yine benzer şekilde,Yiu Che Chan ve arkadaşlarının 29 hasta ve 57 bacak ile yaptıkları bir çalışmada; post-op 2 hastada derin venöz sistemde trombüs tespit edildiği ve bu hastaları bir haftalık LMWH ile tadavi ettiklerini belirtmişlerdir(20). SONUÇ:Bu çalışma serimizdeki 60 hastanın hiçbirinde venöz tromboemboli veya pulmoneremboli vakasına rastlanmadı.…”