Retrospective cohort study assesses clinical improvement in vascular malformations, suggesting effective treatment options.
BACKGROUND: Vascular malformations (VMs) are congenital anomalies that often cause pain, swelling, disfigurement, and functional impairment. Conventional sclerotherapy, though widely used, typically requires multiple sessions and may yield incomplete resolution. Bleomycin-Electrosclerotherapy (BEST) and Bleomycin-Electroperfusiontherapy (BEPT) combine bleomycin with reversible electroporation to enhance endothelial uptake, potentially improving outcomes. METHODS: We conducted a retrospective cohort study (January 2024-August 2025) at Christchurch Hospital of 27 patients (40 procedures) with clinically and radiologically confirmed vascular malformations, where bleomycin had been administered percutaneously, intra-arterially or intravenously, followed by electroporation using the IGEA Cliniporator VITAE. Primary outcome was clinical improvement assessed by GAIS. Secondary outcomes included VAS pain scores, number of treatments, complication rates and subgroup analyses. This study is reported in accordance with the STROBE statement for observational studies. RESULTS: The cohort included venous (40.7%), lymphatic (18.5%), venolymphatic (7.4%) and glomovenous malformations (11.1%), intramuscular fast-flow vascular anomaly (3.7%), Klippel-Trenaunay spectrum (3.7%), FAVA (3.7%) and arteriovenous malformations (11.1%). Clinical improvement (GAIS 1-3) was observed in 24/27 patients (88.9%; 95% CI 71.9%-96.1%). Exceptional improvement or resolution (GAIS 1) was achieved in 37.0% and partial improvement (GAIS 2-3) in 51.9%, after a mean of 1.48 sessions. Mean VAS score improved from 6.3 to 2.4 (p < 0.001; Cohen's d = 1.68). Subgroup analysis demonstrated a 100% improvement rate in treatment-naïve patients (n = 7; 95% CI 64.6-100%) and in lymphatic malformations (n = 5; 95% CI 56.6%-100%); both subgroups were small and the wide confidence intervals preclude definitive conclusions. Adverse events included transient sensory nerve loss (18.5%), hyperpigmentation (44.4%) and localised necrosis in intraoral lesions (11.1%), all resolving except for 1 case of permanent hyperpigmentation. No systemic toxicity occurred. CONCLUSION: BEST and BEPT are effective adjuncts for vascular malformations, reducing treatment burden compared to conventional sclerotherapy and showing particular promise in microcystic lymphatic malformations and selected high-flow AVMs. Larger multicentre studies with extended follow-up are warranted to confirm safety, efficacy, refine patient selection and optimise dosing.
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Krauss et al. (2026) studied this question.
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