Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.

Outcome and Prognostic Factors of Surgical Management of Scalp Arteriovenous Malformations

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.

Study Overview

• Status: Recruiting
• Conditions: Cirsoid Aneurysm
• Intervention / Treatment: Procedure: total surgical excision

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof; Phone Number: 00201006071988; Email: khallaf@aun.edu.eg
• Study Contact Backup: Name: Farrag Mohammad Farrag Saad, M.D.; Phone Number: 01065652394; Email: Farragmohammad@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University Hospitals
    • Contact: Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof; Phone Number: 00201006071988; Email: khallaf@aun.edu.eg
    • Contact: Farrag Mohammad Farrag Saad, M.D; Phone Number: 00201065652394; Email: Farragmohammad@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Surgical excision; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Gurkanlar D, Gonul M, Solmaz I, Gonul E. Cirsoid aneurysms of the scalp. Neurosurg Rev. 2006 Jul;29(3):208-12. doi: 10.1007/s10143-006-0023-y. Epub 2006 Apr 6.
• Komiyama M, Nishikawa M, Kitano S, Sakamoto H, Imai K, Tsujiguchi K, Mizuno T. Non-traumatic arteriovenous fistulas of the scalp treated by a combination of embolization and surgical removal. Neurol Med Chir (Tokyo). 1996 Mar;36(3):162-5. doi: 10.2176/nmc.36.162.
• Heilman CB, Kwan ES, Klucznik RP, Cohen AR. Elimination of a cirsoid aneurysm of the scalp by direct percutaneous embolization with thrombogenic coils. Case report. J Neurosurg. 1990 Aug;73(2):296-300. doi: 10.3171/jns.1990.73.2.0296.
• Albuquerque Sousa LH, Maranha Gatto LA, Demartini Junior Z, Koppe GL. Scalp Cirsoid Aneurysm: An Updated Systematic Literature Review and an Illustrative Case Report. World Neurosurg. 2018 Nov;119:416-427. doi: 10.1016/j.wneu.2018.08.098. Epub 2018 Aug 24.
• Sofela A, Osunronbi T, Hettige S. Scalp Cirsoid Aneurysms: Case Illustration and Systematic Review of Literature. Neurosurgery. 2020 Feb 1;86(2):E98-E107. doi: 10.1093/neuros/nyz303. Erratum In: Neurosurgery. 2019 Dec 1;85(6):861.
• Furtado SV, Srinivasa R, Vala K, Mohan D. Contemporary management of scalp cirsoid aneurysm: A dual-trained neurosurgeon's perspective. Clin Neurol Neurosurg. 2021 Feb;201:106437. doi: 10.1016/j.clineuro.2020.106437. Epub 2020 Dec 15.
• Li F, Zhu S, Liu Y, Chen Y, Chi L, Chen G, Zhang J, Qu F. Traumatic arteriovenous fistula of the superficial temporal artery. J Clin Neurosci. 2007 Jun;14(6):595-600. doi: 10.1016/j.jocn.2006.04.011. Epub 2007 Mar 26.
• Mohamed WN, Abdullah NN, Muda AS. Scalp arteriovenous malformation : a case report. Malays J Med Sci. 2008 Jul;15(3):55-7.
• Khodadad G. Arteriovenous malformations of the scalp. Ann Surg. 1973 Jan;177(1):79-85. doi: 10.1097/00000658-197301000-00015. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: OPFSMSAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No