Mid-Term Results of Cyanoacrylate Embolization of Saphenous Veins

Close metadata

OBJECTIVE

To evaluate the results of cyanoacrylate embolization (CAE) of great (GSV) and small (SSV) saphenous veins in patients with varicose veins (VVs) of the lower limbs.

MATERIAL AND METHODS

This is an ongoing prospective observational study including patients with VVs who underwent CAE of GSV or SSV. The outcomes are assessed in a week, 1, 3, 6 and 12 months after surgery, and then every year. Efficacy criteria are technical success, no vein recanalization, absence of residual reflux along the vein and within sapheno-femoral junction, GSV stump length, vein involution, no need for additional treatment for varicose tributaries after 3 months, no need for redo intervention on the treated vein, absence of varicose vein recurrence, reduction of CEAP class and VCSS score. Safety criterion is the absence of adverse reactions (ARs) associated with CAE.

RESULTS

CAE was performed on 142 limbs in 115 patients with VVs. GSV trunk was embolized in 82% of cases, SSV trunk — in 18%. Technical success was achieved in all cases. GSV stump length varied from 0 to 45 mm (mean 16.7±9.0 mm). Sclerotherapy for varicose tributaries within 3 months was performed on 80 (56%) legs. Follow-up period was 1-24 months. Additional sclerotherapy of tributaries was required for 38 (27%) limbs. GSV involution was observed in 3 (2%) cases within 12-24 months. Trunk recanalization within 3-12 months after intervention was found on 13 out of 142 (9%) limbs with reflux at the junction and on 3 out of 117 (2%) limbs after GSV obliteration. VV recurrence occurred on 8 (6%) limbs, as reported by the investigator, and on 3 (2%) limbs, as reported by the patient. AEs included phlebitis of the trunk (n=16; 11%) and thrombophlebitis of residual tributaries (n=8; 6%), cord sensation (n=8; 6%), glue propagation out of the junction (n=3; 2%), skin sensitivity disturbance (n=5; 4%), subcutaneous granuloma (n=1; 1%), subcutaneous hematoma (n=2; 1%), deep vein thrombosis (n=1; 1%), and allergy (5 out of 115 patients; 4%).

CONCLUSION

CAE is a reliable method for saphenous vein ablation.

Keywords:

chronic venous disease

varicose veins

cyanoacrylate embolization

endovenous obliteration

Authors:

E.L. Murzina

Neftyanik Hospital

K.V. Lobastov

Pirogov Russian National Research Medical University

ORCID: 0000-0002-5358-7218

A.B. Bargandzhiya

Pirogov Russian National Research Medical University

L.A. Laberko

Pirogov Russian National Research Medical University

I.B. Popov

Tyumen State Medical University

Received:

24.05.2020

Accepted:

24.06.2020

List of references:

Onida S, Davies AH. Predicted burden of venous disease. Phlebology. 2016;31(1 Suppl):74-79. https://doi.org/10.1177/0268355516628359
Chiesa R, Marone EM, Limoni C, Volonte M, Petrini O. Chronic venous disorders: correlation between visible signs, symptoms, and presence of functional disease. J Vasc Surg. 2007;46(2):322-330. https://doi.org/10.1016/j.jvs.2007.04.030
Zolotukhin IA, Seliverstov EI, Shevtsov YN, Avakiants IP, Tatarintsev AM, Kirienko AI. Risk factors for venous symptoms in Russian patients with chronic venous disease. Curr Med Res Opin. 2019;35(9):1583-1587. https://doi.org/10.1080/03007995.2019.1605050
Chiesa R, Marone EM, Limoni C, Volonte M, Schaefer E, Petrini O. Effect of chronic venous insufficiency on activities of daily living and quality of life: correlation of demographic factors with duplex ultrasonography findings. Angiology. 2007;58(4):440-449. https://doi.org/10.1177/0003319706292012
Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids. Angiology. 2002;53(3):245-256. https://doi.org/10.1177/000331970205300301
Masuda E, Ozsvath K, Vossler J, Woo K, Kistner R, Lurie F, Monahan D, Brown W, Labropoulos N, Dalsing M, Khilnani N, Wakefield T, Gloviczki P. The 2020 appropriate use criteria for chronic lower extremity venous disease of the American Venous Forum, the Society for Vascular Surgery, the American Vein and Lymphatic Society, and the Society of Interventional Radiology. J Vasc Surg Venous Lymphat Disord. 2020;8(4):505-525. https://doi.org/10.1016/j.jvsv.2020.02.001
Bozkurt KA, Lawaetz M, Danielsson G, Lazaris AM, Pavlovic M, Olariu S, Rasmussen L. European College of Phlebology guideline for truncal ablation. Phlebology. 2020;35(2):73-83. https://doi.org/10.1177/0268355519857362
Nicolaides A, Kakkos S, Baekgaard N, Comerota A, de Maeseneer M, Eklof B, Giannoukas AD, Lugli M, Maleti O, Myers K, Nelzen O, Partsch H, Perrin M. Management of chronic venous disorders of the lower limbs. Guidelines According to Scientific Evidence. Part I. Int Angiol. 2018;7(3):181-254. https://doi.org/10.23736/S0392-9590.18.03999-8
Vos CG, Ünlü Ç, Bosma J, van Vlijmen CJ, de Nie AJ, Schreve MA. A systematic review and meta-analysis of two novel techniques of non-thermal 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
Sannikov AB, Emel’ianenkoVM. Retrospective analysis of results of using cyanoacrylate composition for varicose vein ablation. Angiol Sosud Khir. 2019;25(1):93-98. https://doi.org/10.33529/angio2019113
Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015;61(4):985-994. https://doi.org/10.1016/j.jvs.2014.11.071
Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. 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
Morrison N, Kolluri R, Vasquez M, Madsen M, Jones A, Gibson K. 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. 2019;34(6):380-390. https://doi.org/10.1177/0268355518810259
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
Parsi K, Roberts S, Kang M, Benson S, Baker L, Berman I, Bester LJ, Connor DE, Dinnen P, Grace J, Stirling A, Ibrahim N, Lekich C, Lim A, Matar L, Nadkarni S, Paraskevas P, Rogan C, Thibault PK, Thibault S, van Rij A, Yang A. Cyanoacrylate closure for peripheral veins: Consensus document of the Australasian College of Phlebology. Phlebology. 2020;35(3):153-175. https://doi.org/10.1177/0268355519864755
Rabe E, Breu F, Cavezzi A, Smith PC, Frullini A, Gillet J, Guex J, Hamel-Desnos C, Kern P, Partsch B. European guidelines for sclerotherapy in chronic venous disorders. Phlebology. 2014;29(6):338-354.
Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW. American Venous Forum International Ad Hoc Committee for Revision of the, CC, Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004;40(6): 1248-1252. https://doi.org/10.1016/j.jvs.2004.09.027
Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB. American Venous Forum Ad Hoc Outcomes Working, G., Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010; 52(5):1387-1396. https://doi.org/10.1016/j.jvs.2010.06.161
De Maeseneer M, Pichot O, Cavezzi A, Earnshaw J, van Rij A, Lurie F, Smith PC, Union Internationale. Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins — UIP consensus document. Eur J Vasc Endovasc Surg. 2011;42(1):89-102. https://doi.org/10.1016/j.ejvs.2011.03.013
Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, de Wolf M, Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M, ESVS Guidelines Committee: Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Koncar I, Lindholt J, de Ceniga MV, Vermassen F, Verzini F, Document Reviewers: De Maeseneer MG, Blomgren L, Hartung O, Kalodiki E, Korten E, Lugli M, Naylor R, Nicolini P, Rosales A. Editor’s Choice — Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2015;49(6):678-737. https://doi.org/10.1016/j.ejvs.2015.02.007
Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. 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
Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. 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
Gibson K, Minjarez R, Gunderson K, Ferris B. Need for adjunctive procedures following cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of postprocedure compression: Three-month data from a postmarket evaluation of the VenaSeal System (the WAVES Study). Phlebology. 2019;34(4):231-237. https://doi.org/10.1177/0268355518801641
Chan YC, Law Y, Cheung GC, Cheng SW. Predictors of Recanalization for Incompetent Great Saphenous Veins Treated with Cyanoacrylate Glue. J Vasc Interv Radiol. 2017;28(5):665-671. https://doi.org/10.1016/j.jvir.2017.01.011
Parsi K, Kang M, Yang A, Kossard S. Granuloma formation following cyanoacrylate glue injection in peripheral veins and arteriovenous malformation. Phlebology. 2020;35(2):115-123. https://doi.org/10.1177/0268355519856756
Almeida JI, Murray SP, Romero ME. Saphenous vein histopathology 5.5 years after cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2020;8(2):280-284. https://doi.org/10.1016/j.jvsv.2019.04.014
Gibson K, Minjarez R, Rinehardt E, Ferris B. Frequency and severity of hypersensitivity reactions in patients after VenaSeal cyanoacrylate treatment of superficial venous insufficiency. Phlebology. 2020;35(5):337-344. https://doi.org/10.1177/0268355519878618
Pillutla A, Hendrix MP, Ha J. Endovenous Glue-Induced Thrombosis in Nonthermal Glue Closure Therapy for Greater Saphenous Vein Insufficiency: A Single-Center Experience. J Vasc Interv Radiol. 2019;30(7): 1075-1080. https://doi.org/10.1016/j.jvir.2018.12.730
Langridge BJ, Onida S, Weir J, Moore H, Lane TR, Davies AH. Cyanoacrylate glue embolisation for varicose veins — A novel complication. Phlebology. 2020;35(7):520-523. https://doi.org/10.1177/0268355520901662
Zernovicky F. Fast progressive devastating granulomatic reaction after VenaSeal procedure. Int Angiol. 2018;37:S168-S169.