Group: Special Indications
Vascular Malformations
Vascular malformations are the only non-malignant disease area in the indication index: every other disease area in it is a tumour area, while the general principles and device headings do not name a disease at all. Non-oncological electroporation applications are kept on separate pages and do not enter this index. The approach rests on potentiating the sclerotherapeutic effect of bleomycin with electroporation and has been studied particularly in venous and lymphatic malformations.
38publication records
27clinical publication records
0preclinical publication records
7reviews
2013–2026publication span
Clinical publications: randomized, prospective and retrospective studies, case series and case reports. Preclinical publications: animal, in vitro, modelling and experimental biophysics studies.
Health Technology Assessments in This Area
This portal counts the volume of the literature; it does not assess whether a procedure is effective. The bodies below do make that assessment, and their conclusions are independent of how large the literature is: a large literature does not mean the evidence was found sufficient.
- AIHTA · 2024 · Bleomycin electrosclerotherapy (BEST) in vascular anomalies, systematic review (DSD 137)
The full set with citations is on the Regulatory Documents page. The portal does not interpret these reports on its own behalf; for the current decision consult the issuing body’s own publication.
Clinical and Technical Data Reported in the Publications
The sum of the fields reported in the full text of the 38 publications in this area. The numbers are summed, not interpreted.
Sum of the patient counts reported across publications1,114 (reported in 28 publications)
Publications relating their cohort to other publicationspossible cohort overlap (1)
Total lesions reported679 (in 15 publications)
Devices used (21 publications naming a device)Cliniporator VITAE (9) · Cliniporator (9) · Clinicporator Vitae (1) · IGEA S.p.A. (1) · IGEA S.p.A. electroporation device (1) · IGEA electroporation device (1)
Agent delivered and route (33 publications reporting an agent)bleomycin · intratumoural (20) · bleomycin · both intravenous and intratumoural (6) · bleomycin (4) · bleomycin · intraarterial (2) · bleomycin · intravenous (1)
Approach (28 publications report it)percutaneous (25) · transcutaneous surface (3)
Image guidance (30 publications report it)ultrasound (24) · fluoroscopy (16) · direct vision (4) · magnetic resonance imaging (3) · computed tomography (1)
Response criteria (27 publications report it)clinical examination (15) · other (9) · volumetric (2) · RECIST (1)
Combination therapy (18 publications report it)other combination (9) · systemic chemotherapy (5) · surgery (3) · other immunotherapy (2) · targeted therapy (2)
Publications reporting retreatment19 of 30 publications (8 do not report it)
Field strength400–1300 V/cm (13 records, median 1000)
Applied voltage400–1000 V (2 records, median 1000)
Number of pulses8–20 (11 records, median 8)
Pulse duration100–100000 µs (14 records, median 100)
The totals are not a count of unique patients: the same cohort may have been reported in more than one publication.
Literature Status by Method
Publication count, clinical and preclinical split, literature volume and publication span for each clinical method. The badges at the top of the page summarise the Electrosclerotherapy and ECT records separately; the full split by method is here.
Electrochemotherapy (ECT)
7publication records
6clinical publication records
0preclinical publication records
Exploratory / low-volume literaturethreshold 2/7 records
Clinical and preclinical split of that figure: 2 clinical, 0 preclinical.
2013–2025
Electrosclerotherapy
28publication records
19clinical publication records
0preclinical publication records
Limited clinical publication volumethreshold 12/28 records
Clinical and preclinical split of that figure: 12 clinical, 0 preclinical.
2017–2026
Other electroporation applications
2publication records
2clinical publication records
0preclinical publication records
This set does not name a single clinical method; no literature volume is assigned.
2025–2026
Records with no determined method
1publication records
0clinical publication records
0preclinical publication records
This set does not name a single clinical method; no literature volume is assigned.
2019–2019
Mechanisms Mentioned in Abstracts
The figure is the number of abstracts mentioning the mechanism. A mention does not mean it was demonstrated in that study.
Increased Intracellular Bleomycin Accumulation 34
Reversible Membrane Permeabilisation 9
Potentiation of Cytotoxic Drug Permeability 6
Electrode Geometry and Placement 5
Electric Field Distribution and Modelling 3
Muscle Contraction and Anaesthesia Requirement 2
Antivascular Effect and Vessel Disruption 2
Vascular Lock Effect 2
Necrosis and Necroptosis 2
Transmembrane Potential Change 1
Increased Intracellular Cisplatin Accumulation 1
Irreversible Pore Formation and Cell Death 1
Study Type Distribution
The percentage gives the share of the whole area.
| Study type | Publications | Share within this area |
|---|---|---|
| Randomized Clinical Trial | 2 | 5% |
| Prospective Clinical Study | 5 | 13% |
| Clinical Study | 4 | 11% |
| Retrospective Clinical Study | 7 | 18% |
| Case Series | 3 | 8% |
| Case Report | 6 | 16% |
| Systematic Review / Meta-Analysis | 3 | 8% |
| Guideline / Consensus | 1 | 3% |
| Review | 4 | 11% |
| Protocol | 3 | 8% |
Publication Table
38 publication records sorted by study design. Click a title to open the citation, mechanism and full abstract drawer.
Classifications are generated automatically and can be wrong for individual records. Methodology
| Regime | Publication | Year | Study type | Model | Mechanism | Patients / lesions | Device | Agent and route | Reported outcome | Abstract |
|---|---|---|---|---|---|---|---|---|---|---|
| Electrosclerotherapy | Horbach et al · Dermatol Surg | 2020 | Randomized Clinical Trial | Human | Increased Intracellular Bleomycin Accumulation, Transmembrane Potential Change | 5 / 15 | Cliniporator | – · intratumoural | – | Background: Bleomycin sclerotherapy is ineffective for treating capillary malformations (CMs) because bleomycin cannot adequately be injected into the small-diameter capillary lumina. Electr… |
| ECT | Zhang et al · J Oral Maxillofac Surg | 2013 | Randomized Clinical Trial | Human | Muscle Contraction and Anaesthesia Requirement | 59 | – | – | – | Purpose: Intranasal dexmedetomidine is noninvasive and has been reported as premedication for children undergoing surgery. The aim of this study was to evaluate the safety and efficacy of in… |
| Electrosclerotherapy | Colletti et al · J Craniomaxillofac Surg | 2025 | Prospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation | 10 | Cliniporator | bleomycin · intratumoural | complete response 6 count (10 patients) | Arteriovenous Malformations (AVM) can present themselves in an ample clinical spectrum. They worsen over time, creating local complications such as ulceration, destruction, infection, pain, … |
| Electrosclerotherapy | Deleu et al · CVIR Endovasc | 2025 | Prospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation | 30 / 35 | Cliniporator VITAE | bleomycin · intratumoural | overall survival 100% (35 lesions) | Background: Slow-flow vascular malformations are persistent congenital vascular lesions that progressively disrupt tissue structure and function, often causing pain, swelling, and esthetic c… |
| Electrosclerotherapy | Goldann et al · Pediatr Res | 2025 | Prospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation | 30 | Cliniporator VITAE | bleomycin · intravenous | – | Background: This prospective study evaluates the effectiveness and safety of Bleomycin electrosclerotherapy (BEST) for treating slow-flow vascular malformations in a pediatric cohort. While … |
| Electrosclerotherapy | Guida et al · – | 2025 | Prospective Clinical Study | – | Increased Intracellular Bleomycin Accumulation | 12 | IGEA electroporation device | bleomycin · intratumoural | – | Background: Vascular malformations are relatively common in children. Current therapeutic strategies include observation, pharmacological therapy, sclerotherapy, laser therapy, embolization,… |
| Other EP | Obereisenbuchner et al · Cardiovasc Intervent Radiol | 2025 | Prospective Clinical Study | Human | Reversible Membrane Permeabilisation, Increased Intracellular Bleomycin Accumulation | 21 / 21 | – | bleomycin · both intravenous and intratumoural | complete response 4 count (21 patients) | Purpose: This study aims to evaluate and compare safety and clinical outcomes of reversible electroporation with either intravenous (BEST) or intraarterial (BEET) Bleomycin application treat… |
| Other EP | Mistretta et al · Neuroradiology | 2026 | Clinical Study | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | 1 / 1 | Cliniporator | bleomycin · intraarterial | – | A rare extra- and intracranial mixed vascular malformation involving the scalp soft tissues and the dura mater, associated with skull erosion, and characterized by both a low-flow capillary-… |
| Electrosclerotherapy | Obereisenbuchner et al · Front Neurol | 2026 | Clinical Study | Human | Increased Intracellular Bleomycin Accumulation, Preservation of Nerve and Vascular Structures | 25 | Cliniporator VITAE | bleomycin · intratumoural | complete response 32% (25 patients) | Introduction: Recently, Bleomycin-Electrosclerotherapy (BEST) has emerged as a novel alternative in the treatment of slow-flow vascular malformations. Regarding the commonly affected head an… |
| Electrosclerotherapy | Haehl et al · J Pediatr Surg | 2025 | Clinical Study | Human | Increased Intracellular Bleomycin Accumulation | 45 | Cliniporator VITAE | bleomycin · both intravenous and intratumoural | overall survival 97.8% (45 patients) | Rationale and objectives: Bleomycin electrosclerotherapy (BEST) is a promising treatment for slow-flow vascular malformations (SFVMs). Due to limited paediatric data, this study aimed to ass… |
| ECT | Li et al · Chin J Integr Med | 2013 | Clinical Study | Human | – | – | – | – | – | Objective: To evaluate the efficacy and safety of electrochemotherapy in treating venous malformations. Methods: Electrochemotherapy was applied to 665 patients with venous malformations of … |
| Electrosclerotherapy | Krauss et al · J Med Imaging Radiat Oncol | 2026 | Retrospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | 27 | Cliniporator | bleomycin · intratumoural | overall survival 10 count (27 patients) | Background: Vascular malformations (VMs) are congenital anomalies that often cause pain, swelling, disfigurement, and functional impairment. Conventional sclerotherapy, though widely used, t… |
| Electrosclerotherapy | Loeser et al · Rofo | 2026 | Retrospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | – / 80 | IGEA Medical | bleomycin · both intravenous and intratumoural | disease-free survival 58.9% (56 lesions) | Purpose: Sclerotherapy remains the standard for interventional treatment of slow-flow vascular malformations. However, bleomycin electrosclerotherapy (BEST) has shown promising results in th… |
| Electrosclerotherapy | Vielsmeier et al · Biomedicines | 2025 | Retrospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation, Potentiation of Cytotoxic Drug Permeability | 20 | Cliniporator VITAE | bleomycin · intratumoural | – | Background/Objectives: Bleomycin electrosclerotherapy (BEST), which combines intralesional bleomycin administration with electroporation, enhances drug uptake and has shown efficacy in treat… |
| Electrosclerotherapy | Loeser et al · Rofo | 2025 | Retrospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | 12 / 24 | – | bleomycin · both intravenous and intratumoural | objective response 54.8% (24 lesions) | Purpose: The objective of the study was to retrospectively investigate the efficacy, technical feasibility, and patient safety of bleomycin electrosclerotherapy for lymphatic malformations a… |
| Electrosclerotherapy | Obereisenbuchner et al · Cardiovasc Intervent Radiol | 2025 | Retrospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation | 20 | – | bleomycin · intratumoural | – | Introduction: Bleomycin-electrosclerotherapy (BEST) is a novel treatment for slow-flow vascular malformations (SFVMs), most studied in venous malformations. This study specifically evaluated… |
| ECT | Liu et al · J Vasc Surg Venous Lymphat Disord | 2024 | Retrospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation | 152 | – | bleomycin · intratumoural | – | Objective: This study aims to investigate the difference in safety and efficacy between two treatments for venous malformations (VMs), electrochemotherapy combined with polidocanol foam (ECP… |
| Electrosclerotherapy | Schmidt et al · Eur Radiol | 2024 | Retrospective Clinical Study | Human | Increased Intracellular Bleomycin Accumulation | – | Cliniporator VITAE | bleomycin · both intravenous and intratumoural | – | Objectives: To evaluate the safety and clinical outcome of bleomycin electrosclerotherapy (BEST) for treating extracranial slow-flow malformations. Methods: In this retrospective investigati… |
| Electrosclerotherapy | Latini et al · J Clin Med | 2025 | Case Series | Human | Increased Intracellular Bleomycin Accumulation, Electric Field Distribution and Modelling | 2 / 2 | Cliniporator | bleomycin · intratumoural | bleeding control 2 count (2 patients) | Background : According to the ISSVA 2018 classification, arteriovenous malformations (AVMs) are high-flow vascular malformations, distinct from low-flow lesions. About 60% of extracranial AV… |
| Electrosclerotherapy | Guida et al · Children (Basel) | 2025 | Case Series | Human | Increased Intracellular Bleomycin Accumulation | 12 | IGEA S.p.A., IGEA S.p.A. electroporation device | bleomycin · both intravenous and intratumoural | objective response 2 count (12 patients) | Background: Vascular malformations are relatively common in children. Current therapeutic strategies include observation, medical therapy, sclerotherapy or embolization, laser therapy, cryoa… |
| Electrosclerotherapy | Wohlgemuth et al · J Vasc Surg Venous Lymphat Disord | 2021 | Case Series | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | 17 / 20 | Cliniporator VITAE | bleomycin · intratumoural | stable disease 0 count (17 patients) | Objective: Bleomycin is one of the most commonly used agents in sclerotherapy for slow-flow vascular malformations worldwide. However, its efficiency remains unknown. The objective of the pr… |
| Electrosclerotherapy | Downes et al · Cureus | 2026 | Case Report | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | 2 | Igea adjustable length hexagonal electrode | bleomycin | – | Bleomycin electrosclerotherapy (BEST) is a recently introduced treatment for lymphovascular malformations that combines intralesional bleomycin injection under image guidance with a precisel… |
| ECT | Huppert et al · J Dtsch Dermatol Ges | 2025 | Case Report | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | 1 / 1 | – | bleomycin | objective response 1 count (1 patients) | Dear Editors, We present a 59-year-old female patient with a venous malformation. Arising from a vasculogenetic developmental disorder, vascular malformations are rare, congenital malformati… |
| Electrosclerotherapy | Loeser et al · Cardiovasc Intervent Radiol | 2024 | Case Report | Human | Increased Intracellular Bleomycin Accumulation | 1 / 1 | Cliniporator VITAE, Clinicporator Vitae | bleomycin · intratumoural | stable disease 1 score (1 patients) | This publication has no abstract. |
| ECT | Krt et al · Front Oncol | 2022 | Case Report | Human | Increased Intracellular Bleomycin Accumulation, Electrode Geometry and Placement | 1 / 1 | Cliniporator VITAE, Cliniporator | bleomycin · intraarterial | complete response 1 count (1 patients) | Introduction: The study aims to demonstrate a combination of superselective catheterization and electrochemotherapy as a feasible and effective new technological approach in treating high-fl… |
| ECT | Dalmády et al · Pediatrics | 2020 | Case Report | Human | Increased Intracellular Bleomycin Accumulation | 1 / 1 | Cliniporator | bleomycin · intratumoural | tumour volume change 63% | The treatment of microcystic and combined lymphangiomas, especially in the head and neck region, is still a challenge because the lymphangiomas do not respond to conventional therapies and t… |
| Electrosclerotherapy | McMorrow et al · Br J Oral Maxillofac Surg | 2017 | Case Report | Human | Increased Intracellular Bleomycin Accumulation | 1 | – | bleomycin · intratumoural | – | Venous malformations are congenital anomalies of the vascular system. The injection of bleomycin (a cytotoxic, antitumour drug) into the lesion is a safe and effective treatment for low-flow… |
| Electrosclerotherapy | Gehr et al · Cardiovasc Intervent Radiol | 2026 | Systematic Review / Meta-Analysis | Human | Increased Intracellular Bleomycin Accumulation | – / 416 | – | bleomycin · intratumoural | stable disease 62% (401 patients) | Purpose: To review the available evidence on the effectiveness and safety of bleomycin electrosclerotherapy (BEST) for slow-flow vascular malformations. Materials and methods: A systematic r… |
| ECT | Michailidis et al · Clin Pract | 2025 | Systematic Review / Meta-Analysis | Literature Analysis | Increased Intracellular Bleomycin Accumulation | – | – | bleomycin | – | Background : Vascular malformations (VMs) are congenital anomalies of the vascular system-capillary, venous, lymphatic, arteriovenous, or combined-frequently associated with notable morbidit… |
| Electrosclerotherapy | Ognard et al · Eur Radiol | 2025 | Systematic Review / Meta-Analysis | Human | Increased Intracellular Bleomycin Accumulation, Potentiation of Cytotoxic Drug Permeability | 566 | – | bleomycin · intratumoural | – | Background: Vascular anomalies (VAs) require specialized multidisciplinary management. Bleomycin electrosclerotherapy (B)EST combines electroporation with intralesional bleomycin to enhance … |
| Electrosclerotherapy | Stabuc et al · J Vis Exp | 2026 | Guideline / Consensus | Human | Increased Intracellular Bleomycin Accumulation, Reversible Membrane Permeabilisation | 1 / 1 | – | bleomycin · intratumoural | tumour volume change 70% (1 lesions) | Bleomycin electrosclerotherapy (BEST) is an emerging, minimally invasive treatment for treating slow-flow vascular malformations. Following intralesional administration of bleomycin, reversi… |
| Electrosclerotherapy | Lisec et al · Radiol Oncol | 2026 | Review | Animal (In Vivo) | Increased Intracellular Bleomycin Accumulation, Potentiation of Cytotoxic Drug Permeability | – | – | bleomycin | – | Background: Bleomycin electrosclerotherapy (BEST) is an emerging treatment option for vascular malformations (VMs), predominantly slow-flow venous malformations, with increasing use in other… |
| Electrosclerotherapy | Muir et al · Radiol Oncol | 2024 | Review | Human | Increased Intracellular Bleomycin Accumulation, Antivascular Effect and Vessel Disruption | – | – | bleomycin · intratumoural | – | Background: Bleomycin ElectroScleroTherapy (BEST) is a new approach in the treatment of vascular malformations. After bleomycin is administered to the malformation, electric pulses are appli… |
| Electrosclerotherapy | Muir et al · Radiol Oncol | 2023 | Review | Human | Increased Intracellular Bleomycin Accumulation | – | – | bleomycin · intratumoural | – | Background: Biomedical applications of electroporation are expanding out of the field of oncology into vaccination, treatment of arrhythmias and now in the treatment of vascular malformation… |
| Undetermined | Horbach SER · – | 2019 | Review | Literature Analysis | – | – | – | – | – | MANAGEMENT OF VASCULAR MALFORMATIONS SOPHIE E.R. HORBACH MANAGEMENT OF UITNODIGING Voor het bijwonen van de openbare verdediging van het proefschrift MANAGEMENT OF VASCULAR MALFORMATIONS DIA… |
| Electrosclerotherapy | Anon · BMJ Open | 2018 | Protocol | – | – | – | – | – | – | This publication has no abstract. |
| Electrosclerotherapy | Horbach SER · – | 2018 | Protocol | Human | Increased Intracellular Bleomycin Accumulation | 20 | Cliniporator | bleomycin · intratumoural | – | The current state of the art treatment modality for hypertrophic capillary malformations, laser therapy, has a considerable rate of non-responders and recurrence. Intralesional bleomycin inj… |
| Electrosclerotherapy | Horbach et al · BMJ Open | 2017 | Protocol | Human | Increased Intracellular Bleomycin Accumulation | 20 / 60 | Cliniporator | bleomycin · intratumoural | – | Introduction: The current state-of-the-art treatment modality for hypertrophic capillary malformations (CMs), laser therapy, has a considerable rate of non-responders and recurrence. Intrale… |
No publication matches these filters.
Limitations
Publication volume is not clinical efficacy or evidence quality. It describes how much literature exists in the area and of what kind; it does not indicate how strongly the treatment is supported, guideline endorsement or regulatory status.
Patient totals are not a count of unique patients. The same cohort may have been reported in more than one publication; the totals are not a meta-analysis.
How the corpus was assembled, the tier thresholds, the definition of a clinical publication and why methods are counted separately: Literature Map.