Clinical Efficacy and Safety of Using N-Butyl Cyanoacrylate in the Treatment of Perforator Vein Insufficiency

Year 2024, Volume: 77 Issue: 3, 265 - 271, 10.10.2024

Nur Dikmen Yaman

Abstract

Objectives: Venous insufficiency has traditionally been managed through various techniques, including surgical interventions and thermal ablation.
A novel technique for venous insufficiency is non-thermal ablation using a vein sealing system, involving the endovenous delivery of N-butyl
cyanoacrylate (NBCA) tissue adhesive to the vein. Despite advances in treatment options, the management of isolated perforator incompetence
remains a challenge due to its role in the pathophysiology of chronic venous insufficiency (CVI). This single-center retrospective study aimed to
evaluate the efficacy of the non-thermal, non-tumescent embolization method using NBCA for managing perforator incompetence.

Materials and Methods: We retrospectively analyzed 98 consecutive patients diagnosed with perforator vein insufficiency, treated with NBCA.
The study protocol included physical examinations, Doppler ultrasonography, venous clinical severity scoring, CEAP (Clinical-Etiology-Anatomy-
Pathophysiology) classification, and quality of life assessments before and after the procedure. The primary goal was to compare clinical, functional,
and duplex parameters in managing varicose vein diseases with isolated primary perforator incompetence using duplex-guided NBCA treatment.
Analyses were performed using SPSS software. Categorical variables were reported as frequencies, and continuous variables as means ± standard
deviations or medians with interquartile ranges. Chi-square or Fisher’s exact tests were used for categorical data, and the Mann-Whitney U test for
continuous variables. A p value less than 0.05 was considered statistically significant.

Results: Ninety-eight obliteration procedures were completed. The study evaluated occlusion rate, procedural pain, phlebitis, ecchymosis, and
paresthesia. The occlusion rate at 6 months was 96.9%, with a significant reduction in pain and other symptoms of CVI. The incidence of complications
was low. Phlebitis was observed in 3.4% of cases, ecchymosis in 2.8%, and transient paresthesia in 1.7%. There were no reports of serious adverse
events, such as deep vein thrombosis or systemic allergic reactions.

Conclusion: The interruption of perforators effectively reduces the symptoms of CVI and promotes rapid ulcer healing. This non-tumescent, nonthermal
embolization method can be safely applied with high success rates. The results of this study suggest that NBCA is a viable option for treating
perforator incompetence.

Keywords

N-butyl cyanoacrylate , perforator vein incompetence , venous ulcer

Ethical Statement

This retrospective study, conducted at a single center, received approval from the the Human Research Ethics Committee of Ankara University Faculty of Medicine (approval no.: İ06-454-24, date: 09.07.2024).

Supporting Institution

-

Project Number

-

Thanks

-

Perforatör Ven Yetmezliğinin Tedavisinde N-Butil Siyanoakrilat Kullanımının Klinik Etkinliği ve Güvenliği

Abstract

Gereç ve Yöntem: NBCA ile tedavi edilen, perforatör ven yetmezliği tanısı alan 98 ardışık hasta retrospektif olarak analiz edilmiştir. Çalışma
protokolü, işlem öncesi ve sonrası fizik muayene, doppler ultrasonografi, venöz klinik şiddet skorlaması, CEAP (Klinik-Etiyoloji-Anatomi-
Patofizyoloji) sınıflandırması ve yaşam kalitesi değerlendirmelerini içermektedir. Birincil amaç, Doppler ultrasonografi kılavuzluğunda NBCA tedavisi
kullanılarak izole primer perforatör ven yetmezliği olan damar hastalıklarının tedavisinde klinik, fonksiyonel ve Doppler ultrasonografi parametreleri
karşılaştırmaktır. Analizler SPSS yazılımı kullanılarak yapılmış olup, kategorik değişkenler frekanslar olarak ve sürekli değişkenler ortalama ± standart
sapmalar veya çeyrekler arası aralıklara sahip medyanlar olarak rapor edilmiştir. Kategorik veriler için ki-kare veya Fisher’s exact testleri, sürekli
değişkenler için Mann-Whitney U testi kullanılmıştır. 0,05’ten küçük bir p değeri istatistiksel olarak anlamlı kabul edilmiştir.

Bulgular: Doksan sekiz obliterasyon işlemi tamamlanmıştır. Çalışmada obliterasyon oranı, işlem esnasında ve sonrasında ağrı, flebit, ekimoz ve
parestezi değerlendirilmiştir. Altıncı ayda obliterasyon oranı %96,9 olup, ağrıda ve diğer kronik venöz yetmezlik semptomlarında önemli bir azalma
olmuştur. Komplikasyon görülme sıklığı düşüktür. Olguların %3,4’ünde flebit, %2,8’inde ekimoz ve %1,7’sinde geçici parestezi gözlenmiştir. Derin
ven trombozu veya sistemik alerjik reaksiyonlar gibi ciddi yan etkiler bildirilmemiştir.

Sonuç: Perforatör venlerin obliterasyonu ile kesintiye uğratılması, kronik venöz yetmezlik semptomlarını etkili bir şekilde azaltmakta ve ülserin
hızlı iyileşmesini desteklemektedir. Tümesan kullanılmayan, termal olmayan bu embolizasyon yöntemi, yüksek başarı oranlarıyla güvenle
uygulanabilmektedir. Bu çalışmanın sonuçları, NBCA’nın perforatör ven yetmezliğinin tedavisinde uygun bir seçenek olduğunu göstermekt

Keywords

N-butil siyanoakrilat , perforatör ven yetmezliği , venöz ülser

Ethical Statement

This retrospective study, conducted at a single center, received approval from the the Human Research Ethics Committee of Ankara University Faculty of Medicine (approval no.: İ06-454-24, date: 09.07.2024).

Supporting Institution

-

Project Number

-

Thanks

-

References

• 1. Lees TA, Trender H. Chronic limb swelling vascular and endovascular surgery: companion to specialist surgical practice, 5th ed. UK: Saunders Elsevier; 2014. p. 317-318.
• 2. Bergan JJ, Bundens WP. Clinical application of objective testing in venous insufficiency. In: Ascher E, editor. Haimovici’s vascular surgery, 6th ed. UK: Wiley- Blackwell, Oxford: 2012. p. 1107-1120.
• 3. Rasmussen LH, Bjoern L, Lawaetz M, et al. Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years. Eur J Vasc Endovasc Surg. 2010;39:630-635.
• 4. Proebstle TM, Alm J, Göckeritz O, et al. 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. 2011;54:146-152.
• 5. Kerver AL, van der Ham AC, Theeuwes HP, et al. The surgical anatomy of the small saphenous vein and adjacent nerves in relation to endovenous thermal ablation. J Vasc Surg. 2012;56:181-188.
• 6. Bozkurt AK, Yılmaz MF. A prospective comparison of a new cyanoacrylate glue and laser ablation for the treatment of venous insufficiency. Phlebology. 2016;31(1 Suppl):106-113.
• 7. Whiteley MS, Holdstock J. Percutaneous radiofrequency ablations of Varicose Veins (VNUS Closure). In: Greenhalgh Roger M, editor. Vascular and endovascular challenges. London: Biba Publishing; 2004. p. 361-381.
• 8. Min RJ, Almeida JI, McLean DJ, et al. Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results. Phlebology. 2012;27:398-403.
• 9. Almeida JI, Min RJ, Raabe R, et al. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results. Vasc Endovascular Surg. 2011;45:631-635.
• 10. Almeida JI, Javier JJ, Mackay EG, et al. Cyanoacrylate glue great saphenous vein ablation: preliminary 180-day followup of a first-in-man feasibility study of a no-compression no- local-anesthesia technique. J Vasc Surg. 2012;55:297.
• 11. Almeida JI, Javier JJ, Mackay E, et al. First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphat Disord. 2013;1:174-180.
• 12. Whiteley M. Glue, steam and Clarivein–Best practice techniques and evidence. Phlebology. 2015;30(2 Suppl):24-28.
• 13. Kishore R, Sankar TB, Anandi A, et al. A Prospective Study in Comparison of Ambulatory Phlebectomy and Duplex Guided Foam Sclerotherapy in the Management of Varicosities with Isolated Perforator Incompetence. Indian J Surg. 2016;78:356-363.
• 14. Labropoulos N. Current views on the management of incompetent perforator veins. Ann Phlebology. 2020;18:1-3.