Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.

Study Overview
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Brief Summary
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Scalp arteriovenous malformations (AVMs) are rarely encountered vascular scalp anomalies that represent 8% of all AVMs. Different terms are being used to describe the vascular anomalies of the scalp include cirsoid aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula and arteriovenous malformation. Derived from the Greek language, kirsos, the term cirsoid aneurysm is used to describe the AVM as it resembles varix. Case studies reported approximately 200 cases with increased prevalence during the last 15 years. The etiology of scalp AVMs remains controversial, it can be spontaneous or traumatic. They generally develop in the trauma background and in patients over 30-year-old while spontaneous scalp AVM may present at birth and remains asymptomatic until adulthood.

Detailed Description
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Patients with scalp AVMs are usually presented with scalp swelling, and cosmetic concerns along with other presentations including headache, pain, tinnitus, audible bruits, palpable thrills, and hemorrhage. Neuro-radiological diagnosis is the cornerstone for the surgical procedure to be performed, and cranial angiography is of great significance for diagnosis and treatment selection. MRA is also of significance for establishing a diagnosis as scalp AVMs are confused with hemangioma and cavernomas. Treatment of the cirsoid aneurysm is difficult due to the abnormal fistulous communications between the feeding arteries and veins and high shunt flow. Management protocols for scalp AVMs include various options including surgical excision, endovascular embolization, ligation, and intralesional injections. Operative blood loss, postoperative cosmetic complications are significant concerns when treating scalp AVMs, thus various methods are used pre and postoperatively in order to control these concerns. A thorough analysis of scalp AVMs regarding anatomy, feeder vessels, size, and other different variables is required for a better understanding of the problem in order to improve the outcomes.

Official Title
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Outcome and Prognostic Factors of Surgical Management of Scalp Arteriovenous Malformations

Conditions
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Cirsoid Aneurysm

Intervention / Treatment
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* Procedure: total surgical excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with scalp AVMs confirmed by various imaging techniques. AVMs of the scalp will include: cirsoid aneurysm, serpentinum aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula, high flow shunts and arteriovenous malformations. Age group: any age group. Aetiology: congenital, traumatic, or any. Exclusion Criteria: High risk patients or unfit for surgery. Patients refused surgery, or scheduled for endovascular intervention.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical excision<br>complete surgical excision of the scalp AVMs after identifying feeding arteries, vein and high flew shunts to perform a complete devascularization of the AVM. | Procedure: total surgical excision<br>* patients will be operated under general anesthesia. Pressure is applied along the incision line while staying away from the palpable margin of the AVM lesion and used Raney clips to control bleeding. Once the skin flap was raised, the lesion could be seen through the galea. The galea around the lesion is incised, and the lesion will be separated from the underlying skin using a combination of bipolar diathermy and sharp dissection. The nidus is often located in galeal aponeurosis. Dilated arteries and veins extended into subcutaneous tissue, which was separated with special care to prevent accidental nidus rupture and avoid excessive cauterization to prevent postoperative scalp necrosis. Ligation is applied on feeder arteries, then applied to veins with total excision of the lesion. After excision of the lesion, the skin flap was replaced with interrupted stitches. The wound was allowed to heal primarily along with intravenous administration of antibiotics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion of the feeding arteries and veins confirmation by imaging techniques | identifying the occluded arteries and vein of the excised AVM through the use of diagnostic radiology including CT angiography and conventional angiography to evaluate the results of a well planned surgical excision of scalp AVM. This will be monitored for a period of 6 months post operative. | This will be monitored for a period of 6 months post-operative. | 
| Cosmetic outcome according to the modified Hollandar scale | Following up the cosmetic outcome according to the modified Hollandar scale to achieve better prognosis and higher patient satisfaction. The modified Hollandar scale: 0 score represents the best score, and an overall score of 6 points represents the worst outcome. the use of the modified Hollander scale would be used for post-operative evaluation and a period of 6 month-follow-up. | This will be monitored for a period of 6 months post-operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect prognostic factors that affect the outcomes: etiology | By identifying the important factors affecting the outcome including: etiology: congenital, traumatic or idiopathic. Studying how etiology can affect the outcome of surgical excision of scalp AVMs. | This will be monitored for a period of 6 months post-operative. | 
| Detect prognostic factors that affect the outcomes: age | By identifying the important factors affecting the outcome including: age Studying how age variation can affect the outcome of surgical excision of scalp AVMs and compare different age groups to prognosis. | This will be monitored for a period of 6 months post-operative. | 
| Detect prognostic factors that affect the outcomes: site and size | By identifying the important factors affecting the outcome including: site and size: the site and size of the scalp AVM and how the site affects the prognosis post-operative. | This will be monitored for a period of 6 months post-operative. | 
| Detect prognostic factors that affect the outcomes: Primary arterial supply of the AVM, number of feeders | By identifying the important factors affecting the outcome including: Primary arterial supply of the AVM, number of feeders: through the use of imaging techniques, determine the primary feeding arteries and their numbers and hw it will affect the prognosis and recurrence rate. Studying the distribution of the AVMs and their primary arterial supply and the number of feeding arteries and how this can affect the outcome of surgical excision of scalp AVMs. based on the anatomy of arterial supply. | This will be monitored for a period of 6 months post-operative. | 
| Detect prognostic factors that affect the outcomes: clinical symptoms | By identifying the important factors affecting the outcome including: clinical symptoms: how pre-operative symptoms could be indicative for prognosis compared to post-operative symptoms in case of any residuals. Studying various symptoms compared with post-operative residuals, if any, and how they can affect the outcome of surgical excision of scalp AVMs. | This will be monitored for a period of 6 months post-operative. |