Early-Term Outcomes for Treatment of Saphenous Vein Insufficiency with N-Butyl Cyanoacrylate: A Novel, Non-Thermal, and Non-Tumescent Percutaneous Embolization Technique

Authors

  • Mustafa Tok Department of Cardiovascular Surgery, Uludag University Faculty of Medicine, Bursa
  • Oktay Tüydeş Department of Cardiovascular Surgery, Bingol State Hospital, Bingol
  • Ahmet Yüksel Department of Cardiovascular Surgery, Bingol State Hospital, Bingol
  • Sefa Şenol Department of Cardiovascular Surgery, Education and Research Hospital, Elazig
  • Serkan Akarsu Department of Cardiovascular Surgery, Medical Art Izmir Hospital, Izmir

DOI:

https://doi.org/10.1532/hsf.1496

Abstract

Background: The purpose of this study was to present early-term outcomes of VariClose® Vein Sealing System, which is a novel, non-thermal, and non-tumescent percutaneous embolization technique for treatment of saphenous vein insufficiency.
Methods: Between March 2014 and July 2015, 189 saphenous veins in 141 patients were treated with Variclose Vein Sealing System containing n-butyl cyanoacrylate. Pre-, intra-, post-procedural, and follow-up data of patients were collected and retrospectively reviewed.
Results: Mean age of patients was 42.5 ± 14.0 years, of which 53% were female. Technical success rate of intervention was 98.9%. Mean procedure time was 14.3 ± 7.5 minutes. Eighty-nine percent of patients (n = 126/141) were available at mean follow-up time of 6.7 months. Mean Venous Clinical Severity Score was significantly improved from 8.3 ± 2.2 at pre-procedure period to 3.3 ± 1.8 at follow-up. No complete recanalization was observed, but 2 patients were presented with partial recanalization during follow-up. The complete occlusion rate was 98.4%. No serious adverse event related to procedure was observed.
Conclusion: Variclose Vein Sealing System appears to be safe and effective in treatment of saphenous vein insufficiency. Further randomized studies with long-term outcomes are required for determining optimal treatment modality in patients with saphenous vein insufficiency.

Author Biographies

Mustafa Tok, Department of Cardiovascular Surgery, Uludag University Faculty of Medicine, Bursa

Department of Cardiovascular Surgery

Oktay Tüydeş, Department of Cardiovascular Surgery, Bingol State Hospital, Bingol

Department of Cardiovascular Surgery

Ahmet Yüksel, Department of Cardiovascular Surgery, Bingol State Hospital, Bingol

Department of Cardiovascular Surgery

Sefa Şenol, Department of Cardiovascular Surgery, Education and Research Hospital, Elazig

Department of Cardiovascular Surgery

References

Akahoshi T, Hashizume M, Shimabukuro R, et al. 2002. Long-term results of endoscopic histoacryl injection sclerotherapy for gastric variceal bleeding: a 10-year experience. Surgery 131(1 Suppl):S176-81.

Almeida JI, Kaufman J, Göckeritz O, et al. 2009. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol 20:752-9.

Almeida JI, Min RJ, Raabe R, McLean DJ, Madsen M. 2011. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results. Vasc Endovascular Surg 45:631-5.

Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. 2015. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology 30:397-404.

Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. 2005. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol 15:175-84.

Carradice D, Mazari FA, Samuel N, Allgar V, Hatfield J, Chetter IC. 2011. Modelling the effect of venous disease on quality of life. Br J Surg 98:1089-98.

Ceulen RP, Bullens-Goessens YI, Pi-VAN DE Venne SJ, Nelemans PJ, Veraart JC, Sommer A. 2007. Outcomes and side effects of duplex-guided sclerotherapy in the treatment of great saphenous veins with 1% versus 3% polidocanol foam: results of a randomized controlled trial with 1-year follow-up. Dermatol Surg 33:276-81.

Gillet JL, Guedes JM, Guex JJ, et al. 2009. Side-effects and complications of foam sclerotherapy of the great and small saphenous veins: a controlled multicentre prospective study including 1,025 patients. Phlebology 24:131-8.

Gloviczki P, Comerota AJ, Dalsing MC, et al. 2011. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 53:2S-48S

Kerver AL, van der Ham AC, Theeuwes HP, et al. 2012. The surgical anatomy of the small saphenous vein and adjacent nerves in relation to endovenous thermal ablation. J Vasc Surg 56:181-8.

Labropoulos N, Leon M, Nicolaides AN, Giannoukas AD, Volteas N, Chan P. 1994. Superficial venous insufficiency: correlation of anatomic extent of reflux with clinical symptoms and signs. J Vasc Surg 20:953-8.

Lattimer CR, Kalodiki E, Azzam M, Makris GC, Somiayajulu S, Geroulakos G. 2013. Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foam sclerotherapy. Int Angiol 32:394-403.

Lawson J, Gauw S, van Vlijmen C, et al. 2013. Sapheon: the solution? Phlebology 28(Suppl 1):2-9.

Malgor RD, Gasparis AP, Labropoulos N. 2015. Morbidity and mortality after thermal venous ablations. Int Angiol 35:57-61.

McHugh SM, Leahy AL. 2014. What next after thermal ablation for varicose veins: non-thermal ablation? Surgeon 12:237-8.

Morrison N, Gibson K, McEnroe S, et al. 2015. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg 61:985-94.

Navarro L, Min RJ, Boné C. 2001. Endovenous laser: a new minimally invasive method of treatment for varicose veins--preliminary observations using an 810 nm diode laser. Dermatol Surg 27:117-22.

Pollak JS, White RI Jr. 2001. The use of cyanoacrylate adhesives in peripheral embolization. J Vasc Interv Radiol 12:907-13.

Proebstle TM, Alm J, Göckeritz O, et al. 2011. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg 54:146-52.

Proebstle TM, Alm J, Dimitri S, et al. 2015. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg: Venous and Lym Dis 3:2-7.

Rabe E, Otto J, Schliephake D, Pannier F. 2008. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg 35:238-45.

Van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. 2009. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg 49:230-9.

Van den Bremer J, Moll FL. 2010. Historical overview of varicose vein surgery. Ann Vasc Surg 24:426-32.

Welch HJ. 2006. Endovenous ablation of the great saphenous vein may avert phlebectomy for branch varicose veins. J Vasc Surg 44:601-5.

Published

2016-06-20

How to Cite

Tok, M., Tüydeş, O., Yüksel, A., Şenol, S., & Akarsu, S. (2016). Early-Term Outcomes for Treatment of Saphenous Vein Insufficiency with N-Butyl Cyanoacrylate: A Novel, Non-Thermal, and Non-Tumescent Percutaneous Embolization Technique. The Heart Surgery Forum, 19(3), E118-E122. https://doi.org/10.1532/hsf.1496

Issue

Section

Article