The experimental rationale for new bleomycin-polidocanol mini-foam administration in the treatment of children with head and neck venous malformations

Relevance. Venous malformation (VM) is an abnormal development of the collecting blood vessels based on the vascular wall formation disorder, which occurs during the peripheral vascular network differentiation. According to various sources, VM prevalence ranges from 1 to 2 in 10 000 newborns. Head and neck VMs significantly reduce patients’ quality of life, causing severe functional and aesthetic impairments. Sclerotherapy is an effective treatment method for children with venous malformations. In recent years, bleomycin has been the most commonly used sclerosant. It is a glycopeptide antibiotic synthesized by Streptomyces verticillus and belongs to cytostatic medications. They successfully use it for venous malformations sclerotherapy, also in children. Purpose – the study aimed to improve the sclerotherapy method by combining the advantages of foam sclerotherapy and bleomycin.

Materials and methods. 48 samples of rats’ external femoral veins were morphologically examined. We divided the rats into 2 groups depending on the administrated agent: the first group – 3% polidocanol (lauromacrogol 400), the second group – bleomycin-polidocanol mini-foam composition. The histological assessment identified the changes in the vein endothelium, necrosis of tissue structures, cell dystrophy characteristics.

Results. The first group, which used the bleomycin-polidocanol mini-foam composition, demonstrated more pronounced irreversible changes in the venous vessel endothelium compared to the second group.

Conclusions. The experimental study revealed that the proposed method of VM sclerotherapy using new bleomycin-polidocanol mini-foam composition is more effective than the polidocanol foam sclerotherapy. The new method is highly effective, minimally invasive, safe and can be considered an independent treatment method in children with head and neck VM.

1. Blind AM, Vabres P, Carmignac V, Duffourd Y, Mahé A. Malformations veineuse liées à des mutations du gene TEK: illustration d'un continuum Clinique et génétique à partir d'un cas de syndrome de Bean. Annales de Dermatologie et de Vénérélogie. 2017;144(12):S243–4 https://doi.org/10.1016/j.annder.2017.09.395

2. De Greef C, Flandroy P., Mathurin P., et al. Low flow venous malformations in children. Phlebologie. 1992;45(4):477-481. Available from: https://pubmed.ncbi.nlm.nih.gov/1302324/

3. Dan VN, Sapelkin SV, Sharobaro VI, Timina IE, Tsygankov VN, Karmazanovskiy GG, Subbotin VV, Vafina GR. Angiodysplasias of the head and neck: present-day principles of treatment using elements of plastic surgery. Angiology and vascular surgery. 2013;19(4):136-142 (In Russ.) Available from: http://www.angiolsurgery.org/magazine/2013/4/18.htm

4. Rutherford RB. Congenital vascular malformations: diagnostic evaluation. Semin Vasc Surg. 1993;6:225-232. Available from: https://pubmed.ncbi.nlm.nih.gov/8305977/

5. Mulliken JB, Glowacki J. Hemangiomas and vascular malformations in infants and children: A classification based on endothelial characteristics. Plast. Reconst. Surg. 1982;69(3):412-420 https://doi.org/10.1097/00006534-198203000-00002

6. Wassef M, Enjolras O. Superficial vascular malformations: classification and histopathology. Ann Pathol. 1999;19:253–64. Available from: https://pubmed.ncbi.nlm.nih.gov/10456199/

7. Feied CF, Jackson JJ, Bren TS et al. Allergic reactions to polidocanol for vein sclerosis. Two case reports. J. Dermatol. Surg. Oncol. 1994;20:466-468 https://doi.org/10.1111/j.1524-4725.1994.tb03218.x

8. Roginskij VV, Ovchinnikov IA, Nadtochij AG, Ryzhov RV, Smirnov YaA. Radiofrequency thermoablation for patients with maxillo-facial blood vessels diseases. Head & neck.2015;1:31-35 (In Russ.). Available from: https://headneckfdr.ru/files/HM2015001.pdf

9. Cabrera J, Cabrera Jr J, Garcia-Olmedo MA, Redondo P. Treatment of venous malformations with sclerosant in microfoam form. Arch Dermatol. 2003;139;1409-1416 https://doi.org/10.1001/archderm.139.11.1409

10. Nerobeev AI, Bol’shakov MN. Combined treatment of vascular malformations of the head and neck.Annals of Plastic, Reconstructive and Aesthetic Surgery. 2006; 4:118 (In Russ.). Available from: https://www.elibrary.ru/item.asp?id=12964915

11. Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 Jan;27(1):58-60. Available from: https://pubmed.ncbi.nlm.nih.gov/11231246/

12. Zhukov OB, Sinitsyn VE, Rudin YuE, Romanov DV, Babushkina EV. Venous malformation of the spongy body of the urethra. Andrology and Genital Surgery. 2017;18(3):37- 43 (In Russ.) https://doi.org/10.17650/2070-9781-2017-18-3-37-43

13. De Lorimier AA. Sclerotherapy for venous malformations. J Pediatr Surg. 1995;30(2):188-194 https://doi.org/10.1016/0022-3468(95)90558-8

14. Ladapo AA. Hemangioma of the cheek. J. Or. Surg. 1981;39(10):778-779. Available from: https://pubmed.ncbi.nlm.nih.gov/6944459/