Adverse events and complications following cyanoacrylate adhesive closure of varicose veins
AbstractBackground. Cyanoacrylate adhesive closure is currently considered to be an alternative to thermal ablation of varicose veins. It emerged as a natural step towards minimally invasive surgical treatment of incompetent saphenous veins.
Objective. The purpose of this study was to assess the safety of cyanoacrylate adhesive closure in treatment of patients with varicose veins based on two-year experience.
Patients and methods. Between July 2019 and July 2021, cyanoacrylate adhesive closure was performed in a total of 457 patients (634 limbs and 725 venous trunks). The inclusion criteria were as follows: CEAP clinical classes C2–C6, junctional and truncal valve incompetence with reflux >0.5 sec, saphenous vein diameter > 6 mm, presence of varicosities. Cyanoacrylate adhesive closure was carried out according to the standard VenaSeal protocol. In 76.2% of cases, the procedure was performed selectively without tributary treatment. Duplex ultrasound follow-up examinations were carried out on POD 3, as well as at 1, 3, 6 and 12 months following the procedure.
Results. Partial recanalization occurred in 4 (0.8%) cases between 6 and 15 months post-procedure. Glue migration and propagation into the deep vein was detected in 7 (1.5%) patients and asymptomatic sural vein thrombosis was found in 2 (0.4%) cases. Phlebitis-like skin reaction developed in 50 (11%) cases, superficial thrombophlebitis – in 20 (4.3%) patients. In 6 (1.3%) cases, the procedure was complicated by soft tissue foreign body granuloma. There were no cases of either pulmonary embolism or peripheral neuropathy.
Conclusion. The procedure of cyanoacrylate adhesive closure proved highly effective and safe in treating patients with superficial venous insufficiency and was associated with minimal incidence of adverse events during the two-year follow-up. Further studies are needed to assess the long-term safety of the method.
Keywords: cyanoacrylate adhesive closure; cyanoacrylate embolization; glue ablation; varicose veins; non-thermal non-tumescent methods
Funding. The study had no financial support.
Conflict of interest. The authors declare no conflicts of interest.
Authors’ contribution. Study conception and design – Shirinbek O.; data collection and handling – Shirinbek O., Mnatsakanyan G.V., Odinokova S.N.; draft manuscript preparation – Mnatsakanyan G.V., Odinokova S.N., Shirinbek O.; manuscript revision – Shirinbek O.
For citation: Shirinbek O., Mnatsakanyan G.V., Odinokova S.N. Adverse events and complications following cyanoacrylate adhesive closure of varicose veins. Angiology and Vascular Surgery. 2023; 29 (1): 59–66. DOI: https://doi.org/10.33029/1027-6661-2023-29-1-59-66 (in Russian)
References
1. Parsi K., Roberts S., Kang M., et al. Cyanoacrylate closure for peripheral veins: Consensus document of the Australasian College of Phlebology. Phlebology: The Journal of Venous Disease. 2019; 35 (3): 153–175. DOI: https://doi.org/10.1177/0268355519864755
2. Edwards H., Day J. Fourier transform Raman spectroscopic studies of the curing of cyanoacrylate glue. Journal of Raman Spectroscopy. 2004; 35 (7): 555–560. DOI: https://doi.org/10.1002/jrs.1184
3. Belentsov S.M. VenaSeal for vertical veno-venous reflux elimination in patients with chronic venous disease. Ambulatory Surgery. 2021; 18 (1): 48–54. DOI: https://doi.org/10.21518/1995-1477-2021-18-1-48-54 (in Russian)
4. Murzina E.L., Lobastov K.V., Bargandzhiya A.B., et al. Mid-Term Results of Cyanoacrylate Embolization of Saphenous Veins. Flebologiya. 2020; 14 (4): 311–321. DOI: https://doi.org/10.17116/flebo202014041311 (in Russian)
5. Shirinbek O., Odinokova S.N. Cyanoacrylate Adhesive Closure of Saphenous Veins. Flebologiya. 2021; 15 (4): 297–303. DOI: https://doi.org/10.17116/flebo202115041297 (in Russian)
6. Shirinbek O. Kleevaya obliteraciya magistral’nyh podkozhnyh ven: rukovodstvo dlya vrachej. Moskva: GEOTAR-Media. 2022; 48. DOI: https://doi.org/10.33029/9704-7103-6-KOV-2022-1-48 (in Russian)
7. Shirinbek O., Mnatsakanyan G.V., Odinokova S.N. Cyanoacrylate Adhesive Closure in the Real-World Practice: 2-Year Results of Varicose Vein Treatment. Ambulatory Surgery. 2022; 19 (1): 132–139. DOI: https://doi.org/10.21518/1995-1477-2022-19-1-132-139 (in Russian)
8. Kumar V., Abbas A., Aster J., Perkins J. Robbins Basic Pathology. Philadelphia: Elsevier; 2018.
9. Gibson K., Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. 2016; 25 (2): 149–156. DOI: https://doi.org/10.1177/1708538116651014
10. Park I., Jeong M., Park C., et al. Clinical Features and Management of “Phlebitis-like Abnormal Reaction” After Cyanoacrylate Closure for the Treatment of Incompetent Saphenous Veins. Annals of Vascular Surgery. 2019; 55: 239–245. DOI: https://doi.org/10.1016/j.avsg.2018.07.040
11. Yacoub M., Lemière C., Malo J. Asthma caused by cyanoacrylate used in a leisure activity. Journal of Allergy and Clinical Immunology. 2005; 116 (2): 462–462. DOI: https://doi.org/10.1016/j.jaci.2005.04.015
12. Watts T., Thursfield D., Haque R. Allergic contact dermatitis caused by VenaSeal tissue adhesive. Contact Dermatitis. 2019; 80 (6): 393–395. DOI: https://doi.org/10.1111/cod.13206
13. Montgomery R., Stocks S., Wilkinson S. Contact allergy resulting from the use of acrylate nails is increasing in both users and those who are occupationally exposed. Contact Dermatitis. 2016; 74 (2): 120–122. DOI: https://doi.org/10.1111/cod.12497
14. Andujar R., Cruz M., Villar A., et al. High eosinophil levels and poor evolution in occupational asthma due to cyanoacrylate exposure. American Journal of Industrial Medicine. 2011; 54 (9): 714–718. DOI: https://doi.org/10.1002/ajim.20953
15. Almeida J., Javier J., Mackay E., et al. Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2017; 5 (5): 658–666. DOI: https://doi.org/10.1016/j.jvsv.2017.03.016
16. Proebstle T., Alm J., Dimitri S., et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2015; 3 (1): 2–7. DOI: https://doi.org/10.1016/j.jvsv.2014.09.001
17. Morrison N., Gibson K., McEnroe S., et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery. 2015; 61 (4): 985–994. DOI: https://doi.org/10.1016/j.jvs.2014.11.071
18. Bozkurt A., Yılmaz M. A prospective comparison of a new cyanoacrylate glue and laser ablation for the treatment of venous insufficiency. Phlebology: The Journal of Venous Disease. 2016; 31 (Suppl 1): 106–113. DOI: https://doi.org/10.1177/0268355516632652
19. Koramaz İ., El Kılıç H., Gökalp F., et al. Ablation of the great saphenous vein with nontumescent n-butyl cyanoacrylate versus endovenous laser therapy. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2017; 5 (2): 210–215. DOI: https://doi.org/10.1016/j.jvsv.2016.09.007
20. Yavuz T., Acar A., Aydın H., Ekingen E. A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results. Vascular. 2018; 26 (5): 547–555. DOI: https://doi.org/10.1177/1708538118770548
21. Tekin A., Tuncer O., Memetoğlu M., et al. Nonthermal, Nontumescent Endovenous Treatment of Varicose Veins. Annals of Vascular Surgery. 2016; 36: 231–235. DOI: https://doi.org/10.1016/j.avsg.2016.03.005
22. Chan Y., Law Y., Cheung G., et al. Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome. Phlebology: The Journal of Venous Disease. 2016; 32 (2): 99–106. DOI: https://doi.org/10.1177/0268355516638200
23. Tseng Y., Ma L., Luo T., et al. Thromboembolic Events Secondary to Endoscopic Cyanoacrylate Injection: Can We Foresee Any Red Flags? Canadian Journal of Gastroenterology and Hepatology. 2018; 2018: 1–10. DOI: https://doi.org/10.1155/2018/1940592
24. Lam Y., De Maeseneer M., Lawson J., et al. Expert review on the VenaSeal® system for endovenous cyano-acrylate adhesive ablation of incompetent saphenous trunks in patients with varicose veins. Expert Review of Medical Devices. 2017; 14 (10): 755–762. DOI: https://doi.org/10.1080/17434440.2017.1378093
25. Cho S., Gibson K., Lee S.H., et al. Incidence, classification, and risk factors of endovenous glue-induced thrombosis after cyanoacrylate closure of the incompetent saphenous vein. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2020; 8 (6): 991–998. DOI: https://doi.org/10.1016/j. jvsv. 2020.01.009
26. Pillutla A., Hendrix M.P., Ha J. Endovenous Glue-Induced Thrombosis in Nonthermal Glue Closure Therapy for Greater Saphenous Vein Insufficiency: A Single-Center Experience. Journal of Vascular and Interventional Radiology. 2019; 30 (7): 1075–1080. DOI: https://doi.org/10.1016/j.jvir.2018.12.730
Местные неврологические осложнения в виде парестезий встречаются редко - не более 0-3% [17, 22]. В нашей работе подобного неврологического осложнения не наблюдалось. В этом отношении нетермическая облитерация имеет явное преимущество перед методами термооблитерации ввиду отсутствия эффекта тумесценции и термического воздействия на кожные ветви n. suralis и n. saphenus. Данное обстоятельство имеет большое значение для радикальности устранения тотального вертикального рефлюкса, а именно возможности облитерации магистральной подкожной вены на всем протяжении от соустья до области лодыжек.
По результатам выполненного исследования можно констатировать, что абсолютное большинство нежелательных явлений и осложнений после ЦКО подлежит консервативной терапии и не сопровождается существенным изменением лечебно-диагностической тактики. В зависимости от времени появления в послеоперационном периоде эти нежелательные явления и осложнения можно разделить на ближайшие - возникающие в первые сутки после вмешательства (миграция и пролабирование клея; асимптомный тромбоз суральных вен), ранние - в период первых недель (флебитическая реакция кожи, поверхностный тромбофлебит) и поздние (формирование гранулемы инородного тела мягких тканей), возникающие через несколько месяцев после ЦКО (см. таблицу).
)
Заключение
Цианоакрилатная облитерация вен сопряжена с минимальным риском развития нежелательных явлений и осложнений, наиболее частым из которых является флебитическая реакция кожи.
Целесообразно продолжение сбора и дальнейший анализ данных о тех или иных нежелательных явлениях и осложнениях клеевой технологии, а также создание официального регистра долгосрочных исходов лечения после ЦКО.
Литература
1. Parsi K., Roberts S., Kang M., et al. Cyanoacrylate closure for peripheral veins: Consensus document of the Australasian College of Phlebology. Phlebology: The Journal of Venous Disease. 2019; 35 (3): 153-175. DOI: https://doi.org/10.1177/0268355519864755
2. Edwards H., Day J. Fourier transform Raman spectroscopic studies of the curing of cyanoacrylate glue. Journal of Raman Spectroscopy. 2004; 35 (7): 555-560. DOI: https://doi.org/10.1002/jrs.1184
3. Беленцов С.М. Клеевая технология устранения патологического вено-венозного рефлюкса при хронических заболеваниях вен нижних конечностей: ближайшие и отдаленные результаты. Амбулаторная хирургия. 2021; 18 (1): 48-54. DOI: https://doi.org/10.21518/1995-1477-2021-18-1-48-54
4. Мурзина Е.Л., Лобастов К.В., Барганджия А.Б. и др. Среднесрочные результаты цианоакрилатной эмболизации магистральных подкожных вен. Флебология. 2020; 14 (4): 311-321. DOI: https://doi.org/10.17116/flebo202014041311
5. Ширинбек О., Одинокова С.Н. Цианоакрилатная клеевая облитерация подкожных вен. Флебология. 2021; 15 (4): 297-303. DOI: https://doi.org/10.17116/flebo202115041297
6. Ширинбек О. Клеевая облитерация магистральных подкожных вен: руководство для врачей. М.: ГЭОТАР-Медиа. 2022; 48. DOI: https://doi.org/10.33029/9704-7103-6-KOV-2022-1-48
7. Ширинбек О., Мнацаканян Г.В., Одинокова С.Н. Цианоакрилатная клеевая облитерация варикозных вен в реальной клинической практике: двухлетние результаты лечения. Амбулаторная хирургия. 2022; 19 (1): 132-139. DOI: https://doi.org/10.21518/1995-1477-2022-19-1-132-139
8. Kumar V., Abbas A., Aster J., Perkins J. Robbins Basic Pathology. Philadelphia: Elsevier; 2018.
9. Gibson K., Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. 2016; 25 (2): 149-156. DOI: https://doi.org/10.1177/1708538116651014
10. Park I., Jeong M., Park C., et al. Clinical Features and Management of “Phlebitis-like Abnormal Reaction” After Cyanoacrylate Closure for the Treatment of Incompetent Saphenous Veins. Annals of Vascular Surgery. 2019; 55: 239-245. DOI: https://doi.org/10.1016/j.avsg.2018.07.040
11. Yacoub M., Lemière C., Malo J. Asthma caused by cyanoacrylate used in a leisure activity. Journal of Allergy and Clinical Immunology. 2005; 116 (2): 462-462. DOI: https://doi.org/10.1016/j.jaci.2005.04.015
12. Watts T., Thursfield D., Haque R. Allergic contact dermatitis caused by VenaSeal tissue adhesive. Contact Dermatitis. 2019; 80 (6): 393-395. DOI: https://doi.org/10.1111/cod.13206
13. Montgomery R., Stocks S., Wilkinson S. Contact allergy resulting from the use of acrylate nails is increasing in both users and those who are occupationally exposed. Contact Dermatitis. 2016; 74 (2): 120-122. DOI: https://doi.org/10.1111/cod.12497
14. Andujar R., Cruz M., Villar A., et al. High eosinophil levels and poor evolution in occupational asthma due to cyanoacrylate exposure. American Journal of Industrial Medicine. 2011; 54 (9): 714-718. DOI: https://doi.org/10.1002/ajim.20953
15. Almeida J., Javier J., Mackay E., et al. Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2017; 5 (5): 658-666. DOI: https://doi.org/10.1016/j.jvsv.2017.03.016
16. Proebstle T., Alm J., Dimitri S., et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2015; 3 (1): 2-7. DOI: https://doi.org/10.1016/j.jvsv.2014.09.001
17. Morrison N., Gibson K., McEnroe S., et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery. 2015; 61 (4): 985-994. DOI: https://doi.org/10.1016/j.jvs.2014.11.071
18. Bozkurt A., Yılmaz M. A prospective comparison of a new cyanoacrylate glue and laser ablation for the treatment of venous insufficiency. Phlebology: The Journal of Venous Disease. 2016; 31 (Suppl 1): 106-113. DOI: https://doi.org/10.1177/0268355516632652
19. Koramaz İ., El Kılıç H., Gökalp F., et al. Ablation of the great saphenous vein with nontumescent n-butyl cyanoacrylate versus endovenous laser therapy. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2017; 5 (2): 210-215. DOI: https://doi.org/10.1016/j.jvsv.2016.09.007
20. Yavuz T., Acar A., Aydın H., Ekingen E. A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results. Vascular. 2018; 26 (5): 547-555. DOI: https://doi.org/10.1177/1708538118770548
21. Tekin A., Tuncer O., Memetoğlu M., et al. Nonthermal, Nontumescent Endovenous Treatment of Varicose Veins. Annals of Vascular Surgery. 2016; 36: 231-235. DOI: https://doi.org/10.1016/j.avsg.2016.03.005
22. Chan Y., Law Y., Cheung G., et al. Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome. Phlebology: The Journal of Venous Disease. 2016; 32 (2): 99-106. DOI: https://doi.org/10.1177/0268355516638200
23. Tseng Y., Ma L., Luo T., et al. Thromboembolic Events Secondary to Endoscopic Cyanoacrylate Injection: Can We Foresee Any Red Flags? Canadian Journal of Gastroenterology and Hepatology. 2018; 2018: 1-10. DOI: https://doi.org/10.1155/2018/1940592
24. Lam Y., De Maeseneer M., Lawson J., et al. Expert review on the VenaSeal® system for endovenous cyano-acrylate adhesive ablation of incompetent saphenous trunks in patients with varicose veins. Expert Review of Medical Devices. 2017; 14 (10): 755-762. DOI: https://doi.org/10.1080/17434440.2017.1378093
25. Cho S., Gibson K., Lee S.H., et al. Incidence, classification, and risk factors of endovenous glue-induced thrombosis after cyanoacrylate closure of the incompetent saphenous vein. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2020; 8 (6): 991-998. DOI: https://doi.org/10.1016/j. jvsv. 2020.01.009
26. Pillutla A., Hendrix M.P., Ha J. Endovenous Glue-Induced Thrombosis in Nonthermal Glue Closure Therapy for Greater Saphenous Vein Insufficiency: A Single-Center Experience. Journal of Vascular and Interventional Radiology. 2019; 30 (7): 1075-1080. DOI: https://doi.org/10.1016/j.jvir.2018.12.730
All articles in our journal are distributed under the CC BY-NC-ND 4.0 (Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International)
п?? GEOTAR-Media Publishing Group. The use of textual and illustrative content from this publication for the training of any artificial intelligence systems п?? including machine learning models and neural networks п?? is strictly prohibited without the prior written consent of the copyright holder.