Cyanoacrylate Adhesive Closure in the Real-World Practice: 2-Year Results of Varicose Vein Treatment
https://doi.org/10.21518/1995-1477-2022-19-1-132-139
Abstract
Introduction. Over the past decade, thermal tumescent (TT) ablation became the “gold standard” treatment of varicose veins. Non-thermal non-tumescent (NTNT) methods emerged in response to minimize the interventional invasion.
Aim. To evaluate the two-year results of cyanoacrylate adhesive closure (CAC).
Methods. Between July 2019 and July 2021, CAC was performed in 457 patients (average age 57.8 ± 15.7 years), on 634 limbs and 725 saphenous veins. Patient distribution according to CEAP was: C2 – 38%; C3 – 37%; C4 – 19%; C5 – 4%; C6 – 2%. The inclusion criteria were: incompetence of sapheno-femoral/popliteal junction and axial reflux > 0.5 sec, diameter of saphenous trunk > 6 mm, presence of varicosities. CAC was performed according to the protocol of the American Vein Closure System In more than 2/3 of cases (76.2%), CAC was performed selectively without tributary treatment . The pain was assessed by visual-analogue scale (VAS). The control ultrasound was performed on the 3rd day, 1, 3, 6, and 12 months post-intervention.
Results. Anatomical success was achieved in 100%. The VAS pain score was < 3 in 93% of patients. Partial recanalization occurred in 4 (0.6%) patients. Distal deep vein thrombosis was detected in 2 (0.3%) patients, migration of glue – in 7 (1%) patients, phlebitislike skin reaction – in 50 (11%), superficial thrombophlebitis – in 20 (4.4%) and soft tissue granuloma at the access site was diagnosed in 6 (1.3%) patients.
Conclusion. CАC is a highly effective and safe treatment method with 99.4% occlusion rate in s. two-year follow-up period.
About the Authors
O. Shirinbek
Phlebology Center SM-Clinic
Russian Federation
Russian Federation
Olimi Shirinbek, Dr. Sci. (Med.), Surgeon, Deputy Chief Physician for Surgery, Head of the Cardiovascular Surgery Department at the Center for Medical and Corporate Training
7a, Bldg. 22, Staropetrovskiy Lane, Moscow, 125130
G. V. Mnatsakanyan
Phlebology Center SM-Clinic
Russian Federation
Russian Federation
Gevorg V. Mnatsakanyan, Cardiovascular Surgeon
7a, Bldg. 22, Staropetrovskiy Lane, Moscow, 125130
S. N. Odinokova
Phlebology Center SM-Clinic; Sklifosovsky Institute for Clinical Medicine of Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Saniya N. Odinokova, Assistant of Human Anatomy Department of Sklifosovsky Institute
7a, Bldg. 22, Staropetrovskiy Lane, Moscow, 125130; Bldg. 10, Mokhovaya St., Moscow, 125130
References
1. Belramman A., Bootun R., Lane T., Davies A. Endovenous Management of Varicose Veins. Angiology. 2018;70(5):388–396. https://doi.org/10.1177/0003319718780049.
2. Robertson L., Evans C., Fowkes F. Epidemiology of chronic venous disease. Phlebology: J Ven Dis. 2008;23(3):103–111. https://doi.org/10.1258/phleb.2007.007061.
3. Yang G., Parapini M., Gagnon J., Chen J. Comparison of cyanoacrylate embolization and radiofrequency ablation for the treatment of varicose veins. Phlebology: J Ven Dis. 2018;34(4): 278–283. https://doi.org/10.1177/0268355518794105.
4. Bootun R., Onida S., Lane T. Varicose veins and their management. Surgery (Oxford). 2016;34(4):165–171. https://doi.org/10.1016/j.mpsur.2016.02.002.
5. Kugler N., Brown K. An update on the currently available nonthermal ablative options in the management of superficial venous disease. J Vasc Surg Venous Lymphat Disord. 2017;5(3):422–429. https://doi.org/10.1016/j.jvsv.2017.01.014.
6. Braithwaite B., Hnatek L., Zierau U., Camci M., Akkersdijk G., Nio D. Radiofrequency-induced thermal therapy: results of a European multicentre study of resistive ablation of incompetent truncal varicose veins. Phlebology: J Ven Dis. 2012;28(1):38–46. https://doi.org/10.1258/phleb.2012.012013.
7. Lurie F., Creton D., Eklof B. Prospective randomised study of Endovenous Radiofrequency Obliteration (Closure) Versus Ligation and Vein Stripping (EVOLVeS): 2-year follow-up. J Vasc Sur. 2005;42(1):178. https://doi.org/10.1016/j.jvs.2005.04.007.
8. Rasmussen L., Lawaetz M., Bjoern L., Vennits B., Blemings A., Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Sur. 2011;98(8):1079–1087. https://doi.org/10.1002/bjs.7555.
9. Ctoiko Yu.M., Kirienko A.I., Zatevakhin I.I., Pokrovskii A.V., Karpenko A.A., Zolotukhin I.A. et al. Diagnostics and Treatment of Chronic Venous Disease: Guidelines of Russian Phlebological Association. Flebologiya. 2018;(3):188. (In Russ.) Available at: https://phlebology-sro.ru/upload/iblock/23d/rossiyskieklinicheskie-rekomendatsii-po-khzv-2018.pdf.
10. Davies A., Azzam M., Bradbury A., Brookes J., Calam J., Evans D. et al. Varicose veins: diagnosis and management. Clinical guideline [CG168]. Available at: https://www.nice.org.uk/guidance/CG168.
11. Gloviczki P., Dalsing M., Eklöf B., Lurie F., Wakefield T., Monika L., Gloviczki M. (eds.). Handbook of Venous and Lymphatic Disorders. 4th ed. NY: CRC Press; 2017. 815 p. https://doi.org/ 10.1201/9781315382449.
12. Wittens C., Davies A., Bækgaard N., Broholm R., Cavezzi A., Chastanet S. Editor’s Choice – Management of Chronic Venous Disease. Eur J Vas End Sur. 2015;49(6):678–737. https://doi.org/ 10.1016/j.ejvs.2015.02.007.
13. Nesbitt C., Bedenis R., Bhattacharya V., Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Coch Dat Syst Rev. 2014. https://doi.org/10.1002/14651858.cd005624.pub3.
14. Davies H., Popplewell M., Darvall K., Bate G., Bradbury A. A review of randomised controlled trials comparing ultrasoundguided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology: J Ven Dis. 2015;31(4):234–240. https://doi.org/ 10.1177/0268355515595194.
15. Vos C., Ünlü Ç., Bosma J., van Vlijmen C., de Nie A., Schreve M. A systematic review and meta-analysis of two novel techniques of nonthermal endovenous ablation of the great saphenous vein. J Vasc Surg Venous Lymphat Disord. 2017;5(6):880–896. https://doi.org/10.1016/j.jvsv.2017.05.022.
16. Tang T., Rathnaweera H., Kam J., Chong T., Choke E., Tan Y. Endovenous Cyanoacrylate Glue to Treat Varicose Veins and Chronic Venous Insufficiency-Experience Gained From Our First 100+ Truncal Venous Ablations in a Multi-Ethnic Asian Population Using the Medtronic VenaSeal Closure System. J Vasc Surg Venous Lymphat Disord. 2019;7(5):764. https://doi.org/10.1016/j.jvsv.2019.06.007.
17. Labenz J., Börsch G. Successful Endoscopic Hemostasis of Duodenal Variceal Bleeding with Histoacryl. Endoscopy. 1993;25(02):194–194. https://doi.org/10.1055/s-2007-1010287.
18. Teng M., Chen C., Lirng J., Chen S., Lee L., Chang T. N-butyl-2-cyanoacrylate for embolisation of carotid aneurysm. Neuroradiology. 1994;36(2):144–147. https://doi.org/10.1007/bf00588084.
19. Min R., Almeida J., Mclean D., Madsen M., Raabe R. Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results. Phlebology: J Ven Dis. 2012;27(8): 398–403. https://doi.org/10.1258/phleb.2011.011084.
20. Almeida J., Min R., Raabe R., McLean D., Madsen M. Cyanoacrylate Adhesive for the Closure of Truncal Veins. Vas Endovas Surg. 2011;45(7):631–635. https://doi.org/ 10.1177/1538574411413938.
21. Almeida J., Javier J., Mackay E., Bautista C., Proebstle T. Cyanoacrylate Glue Great Saphenous Vein Ablation: Preliminary 180-Day Follow-Up of a First-In-Man Feasibility Study of a NoCompression-No-Local-Anesthesia Technique. J Vas Sur. 2012;55(1):297. https://doi.org/10.1016/j.jvs.2011.11.008.
22. Lam Y., De Maeseneer M., Lawson J., De Borst G., Boersma D. Expert review on the VenaSeal® system for endovenous cyano-acrylate adhesive ablation of incompetent saphenous trunks in patients with varicose veins. Exp Rev Med Dev. 2017;14(10): 755–762. https://doi.org/10.1080/17434440.2017.1378093.
23. Khartman K. (ed.). Minimally Invasive Varicose Vein Treatment Moscow: GEOTAR-Media; 2018. 176 p. (In Russ.).
24. Almeida J., Javier J., Mackay E., Bautista C., Proebstle T. First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphat Disord. 2013;1(2):174–180. https://doi.org/10.1016/j.jvsv.2012.09.010.
25. Almeida J., Javier J., Mackay E., Bautista C., Cher D., Proebstle T. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology: J Ven Dis. 2014;30(6):397–404. https://doi. org/10.1177/0268355514532455.
26. Proebstle T., Alm J., Dimitri S., Rasmussen L., Whiteley M., Lawson J. et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015;3(1):2–7. https://doi. org/10.1016/j.jvsv.2014.09.001.
27. Proebstle T., Alm J., Dimitri S., Rasmussen L., Whiteley M., Lawson J. et al. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021;9(2):329–334. https://doi.org/10.1016/j.jvsv.2020.05.019.
28. Morrison N., Gibson K., McEnroe S., Goldman M., King T., Weiss R. et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vas Sur. 2015;61(4):985–994. https://doi. org/10.1016/j.jvs.2014.11.071.
29. Morrison N., Gibson K., Vasquez M., Weiss R., Cher D., Madsen M. et al. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017;5(3):321–330. https://doi.org/10.1016/j.jvsv.2016.12.005.
30. Gibson K., Morrison N., Kolluri R., Vasquez M., Weiss R., Cher D. et al. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018;6(5):606–613. https://doi.org/10.1016/j. jvsv.2018.04.009.
31. Morrison N., Kolluri R., Vasquez M., Madsen M., Jones A., GibsonK. Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial. Phlebology: J Ven Dis. 2018;34(6):380–390. https://doi.org/ 10.1177/0268355518810259.
32. Morrison N., Gibson K., Vasquez M., Weiss R., Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2020;8(6):978–989. https://doi.org/10.1016/j. jvsv.2019.12.080.
33. Belentsov S.M. VenaSeal for vertical veno-venous reflux elimination in patients with chronic venous disease. Ambulatornaya Khirurgiya. 2021;18(1):48–54. (In Russ.) https://doi.org/ 10.21518/1995-1477-2021-18-1-48-54.
Review
For citations:
Shirinbek O., Mnatsakanyan G.V., Odinokova S.N. Cyanoacrylate Adhesive Closure in the Real-World Practice: 2-Year Results of Varicose Vein Treatment. Ambulatornaya khirurgiya = Ambulatory Surgery (Russia). 2022;19(1):132-139. (In Russ.) https://doi.org/10.21518/1995-1477-2022-19-1-132-139
Views:
846
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International.
Email this article 