Effectiveness and Safety of Bleomycin Sclerotherapy in Pediatric Low-Flow Vascular Malformations: A Retrospective Cross-Sectional Study

Authors

  • Rio Hermawan Department of Radiology, Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia
  • Koesbandono Koesbandono Department of Radiology, Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia
  • Raditya Utomo Department of Radiology, Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia
  • Hardini Intan S. Mahdi Department of Radiology, Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia
  • Ade Nurlina Department of Radiology, Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia
  • Ratna Sari Wijaya Department of Radiology, Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia

DOI:

https://doi.org/10.19166/med.v15i3.11227

Keywords:

Bleomycin, low-flow vascular malformation, pediatric, safety, sclerotherapy

Abstract

Background:

Low-flow vascular malformations (LFVMs) are congenital vascular anomalies commonly managed using sclerotherapy. Among available sclerosant agents, bleomycin has demonstrated favorable therapeutic efficacy and safety profiles in pediatric vascular malformations, although treatment responses remain variable across different lesion types and morphologies.

 

Methods:

This retrospective cross-sectional study evaluated pediatric patients with LFVMs who underwent bleomycin sclerotherapy at Dharmais Cancer Hospital between January 2019 and May 2025. Demographic characteristics, lesion profiles, treatment sessions, cumulative bleomycin doses, therapeutic outcomes, and treatment-related adverse events were analyzed. Therapeutic responses were categorized into Grade 0-3 outcomes.

 

Result:

A total of 41 pediatric patients with LFVMs were included in the study. Patients aged 0-5 years represented the largest age group (51.2%), while the head and neck region was the most common lesion location (41.4%). Venolymphatic malformations (51.2%) and microcystic lesions (65.8%) were the predominant lesion subtypes. Grade 2 clinical response was the most frequently observed therapeutic outcome (58.5%), whereas Grade 3 response was identified in 17.1% of patients. The mean number of treatment sessions was 5.80 +/- 2.42. Treatment-related adverse events were minimal, with pain and edema observed in one patient each (2.4%), and no cases of pulmonary injury or major systemic complications identified. No significant association was found between treatment sessions or cumulative bleomycin dose and therapeutic outcomes (p>0.05).

 

Conclusions:

Bleomycin sclerotherapy demonstrated favorable effectiveness and safety profiles in pediatric patients with LFVMs. Therapeutic outcomes appeared to be influenced more strongly by lesion characteristics than by treatment intensity or cumulative bleomycin dose.

References

1. Ahmad S. Efficacy of percutaneous sclerotherapy in low flow venous malformations: a single center series. Neurointervention. 2019;14(1):53-60. doi:10.5469/neuroint.2019.00024.

2. Bekkers VZ, Khan F, Aarts P, Zdunczyk K, Prens EP, Wolkerstorfer A, et al. Needle-free electronically controlled jet injector treatment with bleomycin and lidocaine is effective and well-tolerated in patients with recalcitrant keloids. Lasers Surg Med. 2023. doi:10.1002/lsm.23737.

3. Dave TV, Madhuri BK, Laghmisetty S, Tripathy D, Kaliki S, Rath S, et al. Long-term outcomes of transcutaneous non-image guided bleomycin sclerotherapy in orbital/adnexal lymphatic malformations: a protocol-based management in 69 eyes. Eye. 2021;36(4):789-796. doi:10.1038/s41433-021-01527-9.

4. Finitsis S, Faiz K, Linton J, Shankar J. Bleomycin for head and neck venolymphatic malformations: a systematic review. Can J Neurol Sci. 2020;48(3):365-371. doi:10.1017/cjn.2020.178.

5. Goldann C, Deleu A, Schungel MS, Loeser JH, Akinina A, Guntau M, et al. Bleomycin electrosclerotherapy (BEST) for treatment of slow-flow vascular malformations in children. Pediatr Res. 2025. doi:10.1038/s41390-025-04455-6.

6. Guo L, Wu C, Li X, Song D, Sun J, Zhang Y. Simulated angiography using a bleomycin mixture for sclerotherapy of lymphatic malformations. Front Pediatr. 2020;8:563517. doi:10.3389/fped.2020.563517.

7. Horbach SER, Van de Ven JS, Nieuwkerk PT, Spuls PI, Van der Horst CMAM, Reekers JA. Patient-reported outcomes of bleomycin sclerotherapy for low-flow vascular malformations and predictors of improvement. Cardiovasc Intervent Radiol. 2018;41(10):1494-1504. doi:10.1007/s00270-018-1999-8.

8. Ierardi AM, Colletti G, Biondetti P, Dessy M, Carrafiello G. Percutaneous sclerotherapy with gelified ethanol of low-flow vascular malformations of the head and neck region: preliminary results. Diagn Interv Radiol. 2019;25(6):459-464. doi:10.5152/dir.2019.18542.

9. Karastaneva A, Gasparella P, Tschauner S, Crazzolara R, Kropshofer G, Modl M, et al. Indications and limitations of sirolimus in the treatment of vascular anomalies-insights from a retrospective case series. Front Pediatr. 2022;10:857436. doi:10.3389/fped.2022.857436.

10. Lilje D, Wiesmann M, Hasan D, Riabikin A, Ridwan H, Holzle F, et al. Interventional therapy of extracranial arteriovenous malformations of the head and neck-a systematic review. PLoS One. 2022;17(7):e0268809. doi:10.1371/journal.pone.0268809.

11. Marchand A, Caille A, Gissot V, Giraudeau B, Lengelle C, Bourgoin H, et al. Topical sirolimus solution for lingual microcystic lymphatic malformations in children and adults (TOPGUN): study protocol for a multicenter, randomized, assessor-blinded, controlled, stepped-wedge clinical trial. Trials. 2022;23(1):557. doi:10.1186/s13063-022-06365-y.

12. Moreno MAS, Campo DLE. Diagnostico y manejo de lesiones vasculares en cabeza y cuello de pacientes pediatricos de la Fundacion Hospital de la Misericordia, periodo 2012-2019. Acta Odontol Colomb. 2020;10(2):112-126. doi:10.15446/aoc.v10n2.86650.

13. Muller-Wille R, Wildgruber M, Wohlgemuth WA. Interventionelle behandlungsoptionen bei vaskularen malformationen. Phlebologie. 2022;51(3):137-145. doi:10.1055/a-1808-2566.

14. Muller-Wille R, Wildgruber M, Sadick M, Wohlgemuth WA. Vascular anomalies (Part II): interventional therapy of peripheral vascular malformations. Rofo. 2018;190(10):927-937. doi:10.1055/s-0044-101266.

15. Nam SH, Kwon KA. Treatment of giant cervico-mediastinal lymphatic malformations: a case series. J Med Case Rep. 2018;12(1):166. doi:10.1186/s13256-018-1705-0.

16. Plettendorff L, Werner JA, Wiegand S. Vascular malformations of the head and neck in children. In Vivo. 2023;37(1):366-375. doi:10.21873/invivo.13087.

17. Poget M, Fresa M, Ezzi OE, Saliou G, Doan MT, De Roessingh AB. Lymphatic malformations in children: retrospective review of surgical and interventional management. Pediatr Surg Int. 2022;39(1):17. doi:10.1007/s00383-022-05320-x.

18. Schmidt VF, Cangir O, Meyer L, Goldann C, Hengst S, Brill R, et al. Outcome of bleomycin electrosclerotherapy of slow-flow malformations in adults and children. Eur Radiol. 2024;34(10):6425-6435. doi:10.1007/s00330-024-10723-6.

19. Scuglia M, Conforti A, Valfre L, Totonelli G, Iacusso C, Iacobelli BD, et al. Operative management of neonatal lymphatic malformations: lesson learned from 57 consecutive cases. Front Pediatr. 2021;9:709223. doi:10.3389/fped.2021.709223.

20. Sun N, Liu R, Cheng G, Wu P, Yu F, Qing L, et al. The rare complication of vascular malformations of the limb after sclerotherapy: a report of 3 cases and brief literature review. BMC Pediatr. 2023;23(1):248. doi:10.1186/s12887-023-04018-w.

21. Vollherbst DF, Gebhart P, Kargus S, Burger A, Kuhle R, Gunther P, et al. Image-guided percutaneous sclerotherapy of venous malformations of the head and neck: clinical and MR-based volumetric mid-term outcome. PLoS One. 2020;15(10):e0241347. doi:10.1371/journal.pone.0241347.

22. Wang W, Liu B, Long J, Bi J, Huo R. Sclerotherapy in lymphatic malformations with intralesional hemorrhage: a retrospective comparison with non-hemorrhagic lymphatic malformations. Clin Cosmet Investig Dermatol. 2022;15:2275-2283. doi:10.2147/CCID.S386813.

23. Wu Z, Zou Y, Fu R, Jin P, Yuan H. A nomogram for predicting sclerotherapy response for treatment of lymphatic malformations in children. Eur J Med Res. 2022;27(1):257. doi:10.1186/s40001-022-00844-3.

Downloads

Published

2026-06-22

How to Cite

Hermawan, R., Koesbandono, K., Utomo, R., Mahdi, H. I. S., Nurlina, A., & Wijaya, R. S. (2026). Effectiveness and Safety of Bleomycin Sclerotherapy in Pediatric Low-Flow Vascular Malformations: A Retrospective Cross-Sectional Study. Medicinus, 15(3), 58–67. https://doi.org/10.19166/med.v15i3.11227

Issue

Section

Clinical Research