Bleomycin Electrosclerotherapy 2.0.
The Next-Gen Technique for Vascular Malformations
Electrosclerotherapy 2.0 represents a significant advancement in the treatment of vascular malformations, offering an improved approach for patients seeking effective and less painful interventions. This innovative technique leverages cutting-edge technology to enhance therapeutic outcomes and patient experience.
Understanding Vascular Malformations
IN A NUTSHELL
Vascular Malformations are caused by mutations in a gene
Can affect capillaries, veins, arteries and lymphatics
Can be slow-flow or fast-flow
Do not regress
IN A NUTSHELL
Vascular Malformations are caused by mutations in a gene
Can affect capillaries, veins, arteries and lymphatics
Do not regress
Can be slow-flow or fast-flow
Vascular malformations are complex congenital lesions resulting from errors in vascular development (mutations in a gene), leading to abnormally formed blood vessels that can affect various parts of the body. These persistent vascular anomalies are distinct from tumors and do not typically regress, often requiring specialized treatment. Understanding the intricate nature of these malformations is crucial for determining the most appropriate and effective therapeutic strategy, such as electrosclerotherapy, to address the specific characteristics of each lesion. The careful assessment of each patient with a vascular malformation is paramount.
Types of Vascular Malformations
Vascular malformations encompass a broad spectrum of anomalies, each with distinct characteristics and clinical presentations. These can range from simple capillary malformations, often appearing as birthmarks, to more complex lymphatic malformations and venous malformations. Each type of malformation presents unique challenges for treatment, requiring a tailored approach to ensure optimal outcomes. The precise identification of the malformation type is a critical first step in planning any intervention, including advanced techniques like electrosclerotherapy.
ISSVA Classification of Vascular Malformations
The classification of vascular malformations is primarily based on the predominant vessel type involved and the rate of blood flow through the lesion. This systematic approach aids in diagnosis, prognosis, and treatment planning. The widely accepted ISSVA classification system differentiates between slow-flow and fast-flow vascular malformations, which guides clinicians in selecting appropriate interventions such as sclerotherapy or electrosclerotherapy. Accurate classification is essential for achieving the best treatment outcome for patients with vascular malformations.
Slow-flow Vascular Malformations
Slow-flow vascular malformations include venous malformations and lymphatic malformations, characterized by sluggish blood flow or impaired lymphatic drainage. These types of lesions often present with swelling, pain, and functional impairments. Effective treatment of slow-flow vascular malformations often involves strategies to induce sclerosis or reduce the size of the lesion, with approaches like bleomycin electrosclerotherapy proving highly beneficial. The protocol for treating slow-flow malformations is carefully designed to target these specific characteristics.
Fast-Flow Vascular Malformations
Fast-flow vascular malformations, in contrast to their slow-flow counterparts, are characterized by rapid blood flow and can include arteriovenous malformations. These lesions often present with more pronounced symptoms such as pulsatile masses, bruits, and even heart failure due to shunting. While electrosclerotherapy is primarily known for its efficacy in treating slow-flow vascular malformations, understanding different flow dynamics is critical in selecting the most appropriate intervention for all vascular anomalies.
Overview of
Electrosclerotherapy
IN A NUTSHELL
Electrosclerotherapy works by delivering brief pulses of electrical current
This current open "pores", holes in the membrane of the cell
Bleomycin and other drugs can penetrate the cell and increase effectiveness
IN A NUTSHELL
Electrosclerotherapy works by delivering brief pulses of electrical current
This current opens "pores", holes in the membrane of the cell
Bleomycin and other drugs can penetrate the cell and increase effectiveness
What is Electrosclerotherapy?
Electrosclerotherapy is an innovative and highly effective therapeutic approach, particularly for the treatment of vascular malformations, including venous and lymphatic malformations. This technique combines the principles of traditional sclerotherapy with the advanced process of electroporation. During electrosclerotherapy, a sclerosing agent, commonly bleomycin, is injected directly into the vascular malformation or lesion. Subsequently, a series of precisely controlled electric pulses are delivered to the targeted area via electrodes.
These electric pulses temporarily increase the permeability of the cell membranes within the malformation, a phenomenon known as reversible electroporation, allowing for enhanced uptake of the bleomycin. This synergistic action significantly improves the efficacy of the sclerosing agent, leading to better outcomes in the treatment of slow-flow vascular malformations. The procedure is designed to induce fibrosis and shrinkage of the abnormal vessels, offering a less invasive alternative to surgical intervention for many patients with vascular anomalies.
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The bleomycin electrosclerotherapy
Bleomycin plays a pivotal role as the primary sclerosing agent in electrosclerotherapy, especially in the treatment of slow-flow vascular malformations. This antineoplastic antibiotic, originally used in cancer therapy, has proven to be highly effective when delivered intralesionally. When combined with electroporation, the use of bleomycin is optimized, as the electric pulses facilitate its entry into the cells of the vascular malformation.
The bleomycin dose and bleomycin concentration are carefully determined to maximize its sclerosing effects on the abnormal vessels while minimizing potential side effects. Bleomycin in the treatment protocol induces an inflammatory response within the lesion, leading to fibrosis and ultimately the collapse and shrinkage of the malformation. This targeted approach ensures that the sclerosing agent acts directly on the affected tissues, making bleomycin electrosclerotherapy a highly effective treatment for slow-flow vascular malformations, including lymphatic and venous malformations, with a favorable safety profile.
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Comparison of Electrosclerotherapy Techniques
ELECTROSCLEROTHERAPY 1.0
The landscape of electrosclerotherapy techniques has evolved, with significant advancements leading to improved patient outcomes and reduced discomfort. Early electrosclerotherapy 1.0 systems, such as the Cliniporator from IGEA, utilized monophasic square pulses at a maximum frequency of 5KHz. It is effective but this approach was often associated with considerable pain for patients.
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ELECTROSCLEROTHERAPY 2.0
In contrast, Electrosclerotherapy 2.0, based on Mirai Medical's ePORE technology, represents a significant leap forward. This device delivers biphasic pulses at frequencies up to 333KHz (usual 250KHz), creating a fundamentally different form of electric field. This high-frequency biphasic pulse delivery system is much less painful, making the procedure far better tolerated and feasible under local anesthesia.
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My personal experience, involving 20 patients treated with monophasic (EST 1.0) and 20 with biphasic high frequency (EST 2.0) , demonstrates similar efficacy between the two systems but highlights the superior tolerability and significantly reduced pain with EST 2.0. Electrosclerotherapy 2.0 appears the best treatment option for patients with vascular malformations.
Electrosclerotherapy 2.0: The Advantages
IN A NUTSHELL
Electrosclerotherapy 2.0 uses a newer technology called High Frequency Electroporation
This allows to titrate the amount of current being delivered
It's hugely less painful and better tolerated
Can be done in Local Anesthesia, in an Outpatient Setting
IN A NUTSHELL
Electrosclerotherapy 2.0 uses a newer technology called High Frequency Electroporation
This allows to adjust the amount of current being delivered
It's hugely less painful and better tolerated
Can be done in Local Anesthesia, in an Outpatient Setting
Preliminary results show Better Safety Profiles
Technical Differences Between High Frequency and Low Frequency
Electrosclerotherapy 2.0, introduces substantial technical advancements compared to Electrosclerotherapy 1.0. The fundamental difference lies in the hardware (different energy generator) and the characteristics of the electric pulse delivered.
The new machine system generates biphasic pulses at an impressive frequency of up to 333KHz, creating a distinct electric field that optimizes the electroporation process.
In contrast, the EST 1.0 machine delivers monophasic square pulses at a maximum frequency of 5KHz. This marked difference in pulse delivery significantly impacts the modulation of the electrical current and, crucially, the patient's experience during the treatment of vascular malformations.
Pain Management and Tolerability
The disparate electric field generated by Electroporation 2.0 device, with its high-frequency biphasic pulses, dramatically enhances pain management and patient tolerance during electrosclerotherapy. Unlike the EST 1.0 device, which often necessitated more intensive pain relief due to the nature of its electric pulse, EST 2.0 technology makes the procedure much less painful and remarkably well-tolerated. This allows for the treatment of vascular malformations to be performed effectively under local anesthesia, a significant improvement for patients. This advancement not only increases patient comfort but also broadens the accessibility of electrosclerotherapy as a viable treatment for vascular malformations.
Clinical Outcomes and Efficacy
In terms of clinical outcomes and efficacy, Electrosclerotherapy 2.0 with ePORE has demonstrated comparable results to Electrosclerotherapy 1.0, while significantly improving the patient experience. My personal experience, involving an equal number of patients treated with both systems, confirms that both achieved similar efficacy in the treatment of vascular malformations. However, the EST 2.0 system consistently resulted in much less pain and superior overall tolerability.
Case Studies and Personal Experience
I have been using Electroporation, and specifically Electrosclerotherapy for years. As a procedure, it is very effective and I rely on it in almost all cases of diffused Vascular Anomalies, in those that did not respond to Sclerotherapy and in S3 AVM.
While me and the patients have been pleased by the effectiveness, it has been a procedure that carried disadvantages.
Conventional Electrosclerotherapy causes brutal muscular spasms and is extremely painful. Thus needs to be done under general anesthesia.
In the process of evolving the approach and seek better technologies I landed on the so called "High Frequency Electroporation"
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EST 2.0
Electrosclerotherapy 2.0, is exactly this. This approach also involved the precise intralesional bleomycin injection, followed by the application of electrical current to open pores on the membrane. However the energy is delivered in a very different way.
In EST the current is delivered in a high frequency, biphasic way. This has several consequences.
High Frequency Biphasic electroporation can be considered the upgrade of the technology. And EST takes full advantage of it.
Needleless Electrosclerotherapy (NEST): The Best Option for Skin and Mucosal Malformations
What is Needleless Electrosclerotherapy (NEST)?
Needleless Electrosclerotherapy (NEST) represents a groundbreaking advancement, offering a less invasive and potentially superior option for the treatment of superficial vascular malformations, particularly those affecting the skin and mucosal surfaces. Unlike traditional electrosclerotherapy which requires direct intralesional injection with a needle, NEST utilizes specialized surface electrodes to deliver the electric pulse and facilitate the uptake of the sclerosing agent, such as bleomycin, without puncturing the skin or mucosa.
This method leverages the principles of reversible electroporation to enhance the permeability of cell membranes in the targeted lesion, allowing topical application or direct contact delivery of the bleomycin. This innovation significantly reduces patient discomfort, eliminates needle-related anxiety, and minimizes the risk of scarring caused by needles, positioning NEST as a game-changer for accessible and tolerable treatment of vascular malformations.
The Plate-Based, Needleless Electrode
A key innovation enabling Needleless Electrosclerotherapy (NEST) is the development of advanced electrode technologies, such as the EndoVE. The EndoVE is an endoscopic plate-based, needleless electrode specifically designed for precise and contact-based application of electric pulses to mucosal vascular malformations, particularly in difficult-to-reach areas.
This specialized electrode allows for the controlled delivery of the electric pulse to the target lesion without the need for an invasive injection, making the process much less painful and better tolerated. The ability to perform reversible electroporation using such a device opens new avenues for treating internal mucosal vascular anomalies, ensuring effective intralesional delivery of bleomycin and significantly improving the outcome for patients, particularly those with delicate head and neck vascular malformations.
Similarly, EndoVE and NEST can be used on the skin to treat Vascular Malformations without the need to rely on needles, minimizing pain and preventing the scarring where the needle enters.
FAQ
See the most asked questions
It is an advanced bleomycin-based treatment for vascular malformations. It uses high-frequency electroporation to improve efficacy and tolerability.
All kinds of Vascular Malformations can be treated, whether they are slow-flow or fast-flow: Capillary (Port Wine Stain), Venous, Lymphatic and AVM.
Electrosclerotherapy 2.0 system is much less painful than earlier electrosclerotherapy devices.
All patients with Vascular Malformations who look for a faster, safer and more effective results.
Yes! Different from Electrosclerotherapy 1.0 which delivers longer pulses, the High Frequency EST 2.0 does not cause severe muscle contraction and pain. Thus it can be done with just local anesthesia
EST 2.0 is extremely effective for all kins of Vascular Malformations
Our preliminary results show that Electrosclerotherapy 2.0 is safer than Electrosclerotherapy 1.0
Needleless Elecro Sclero Therapy (NEST) is the Next Gen Electrosclerotherapy. Instead of needles it uses surface hi-technology plates. Hence, it is even less painful and does not leaves the marks that EST 1.0 does.
About Me
Giacomo Colletti
cranio maxillo facial surgeon
Prof. Giacomo Colletti is a maxillofacial surgeon and university professor with a specific clinical and scientific interest in angiomas and vascular malformations of the head and neck region. For decades he has been involved in the diagnosis and treatment of infantile hemangiomas, venous, lymphatic and arteriovenous malformations, with particular attention to complex lesions of the face and upper airways.
He carries out his work in multidisciplinary referral centers, where he collaborates with dermatologists, interventional radiologists, anesthesiologists and other specialists to offer patients a personalized pathway, based on the most recent international guidelines and the most modern minimally invasive techniques (laser, sclerotherapy, electrosclerotherapy, hybrid surgical-interventional procedures).
He was the first in the world to conceive and introduce innovative minimally invasive techniques such as the use of radiofrequency plasma (J-Plasma) for Venous and Lymphatic Malformations and MEST (Modified ElectroScleroTherapy) for the treatment of AVMs.
He performs the treatment of complex cases in the centers of Lyon (France) and Poznan (Poland) and also sees patients in the United States, in New York.
In addition to his clinical activity, Giacomo Colletti is the author of numerous scientific articles and book chapters on vascular anomalies.
Many of these publications are available on PubMed, the reference site for international scientific works.
You can click here to read the list of works in chronological order on the uniMORE University website.
He is frequently invited to present his techniques at major international conferences.
Giacomo Colletti is a lecturer in Cranio-Maxillo-Facial Surgery at uniMORE, University of Modena and Reggio Emilia.
Here you can find his faculty page at the University: UNI-FIND Giacomo Colletti
The goal of angioma.eu is to provide patients and families with clear, up-to-date and reliable information on angiomas and vascular malformations, to facilitate access to proper specialist evaluation and to guide each person in making informed therapeutic choices.
Prof. Giacomo Colletti
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