Long-term Outcomes After Different Management Strategies for High-level Cerebral Arteriovenous Malformation

NCT04136860 | Unknown

• 1 other identifier: KY 2019-09-15
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Arteriovenous malformations (AVMs) are complex and rare cerebral vascular dysplasia. The main purpose of treatment is to avoid the neurological impairment caused by hemorrhagic stroke. The Spetzler-Martin (SM) grading system is widely used to estimate the risk of postoperative complication based on maximum AVM nidus diameter, pattern of venous drainage, and eloquence of location. Generally, grade I and II are amenable to surgical resection alone. Grade III is typically treated via a multimodal approach, including microsurgical resection, embolization, and radiosurgery (SRS). Grade IV and V are generally observed unless ruptured. However, some previous studies indicated that despite the high rate of poor outcomes for high-level unruptured AVMs, the mortality for high-level unruptured AVMs are likely lower than untreated patients. With the development of new embolic materials and new intervention strategies, patients with high-level AVMs may have more opportunities to underwent more aggressive interventions. The OHAVM study aims to clarify the clinical outcomes for patients with SM grade IV and V AVMs after different management strategies.

Conditions

Arteriovenous Malformation of Brain

Outcome Measures

Primary Outcomes (6)

• modified Ranking Scale score at 2 weeks after the operation

  The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead

  2 weeks after operation

• modified Ranking Scale score at 1 year after the operation

  The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead

  1 year after operation

• modified Ranking Scale score at 3 years after the operation

  The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead

  3 years after operation

• modified Ranking Scale score at 5 years after the operation

  The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead

  5 years after the operation

• modified Ranking Scale score at the last follow-up

  The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead

  up to 10 years after the operation

• Long-term hemorrhagic rate

  For conservative group, the observation period was from the diagnosis to the last follow-up. For the intervention group, to rule out the influence of transient unstable blood flow in the perioperative period, the observation period was defined as from 2 weeks after the operation to the last follow-up.

  Conservative group: from the diagnosis to the last follow-up (up to 10 years); Intervention group: from 2 weeks after the operation to the last follow-up (up to 10 years)

Secondary Outcomes (1)

• Obliteration rate

  At least 3 years, up to 10 years

Other Outcomes (5)

• Incidence of postoperative epilepsy

  2 weeks and 1 years after the operation and the last follow-up (up to 10 years)

• Incidence of perioperative hemorrhage

  2 weeks after the operation

• Incidence of perioperative infarction

  2 weeks after the operation

Study Arms (5)

Conservative management

Patients refused to accept any interventional treatment or patients were not suitable for any interventional treatment.

Microsurgical resection

All microsurgical procedures were performed with intraoperative neuronavigation, ultrasonography, indocyanine fluorescence angiography (ICG), continuous monitoring of electroencephalogram and somatosensory evoked potential.

Embolization

Embolization or radiosurgery was recommended as a priority for lesions located in deep functional locations such as brainstem and basal ganglia. Multi-stage embolization and target embolization were widely used within the embolization. Onyx was the main embolization material.

Embolization+Radiosurgery

Embolization or radiosurgery was recommended as a priority for lesions located in deep functional locations such as brainstem and basal ganglia. Radiosurgery management was recommended for the residual lesions about 3 months after the embolization if necessary.

Single-stage hybrid surgery

Hybrid surgery is a new surgical strategy defined as single-stage combined microsurgical resection and embolization in which embolization is performed firstly on the deep feeding artery, aneurysm, AVF, and meningeal arteries involved in blood supply of the nidus, and then, the microsurgical resection was performed immediately. Intraoperative angiography was performed repeatedly before the skull was closed, confirming complete occlusion of the malformation.

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Spetzler-Martin (SM) grade IV and V brain arteriovenous malformation.

You may qualify if:

• The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
• The SM grade was IV and V.

You may not qualify if:

• Patients with multiple AVMs.
• Patients with hereditary hemorrhagic telangiectasia (HHT).
• Patients with missing clinical and imaging data.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Peking University International Hospital: collaborator

Study Sites (1)

Capital medical university affiliated Beijing Tiantan hospital

Beijing, Beijing Municipality, 101100, China

RECRUITING

Related Publications (3)

• Chen Y, Li R, Ma L, Meng X, Yan D, Wang H, Ye X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-term outcomes of brainstem arteriovenous malformations after different management modalities: a single-centre experience. Stroke Vasc Neurol. 2021 Mar;6(1):65-73. doi: 10.1136/svn-2020-000407. Epub 2020 Sep 14.

  PMID: 32928999 RESULT

• Chen Y, Li R, Ma L, Zhao Y, Yu T, Wang H, Ye X, Wang R, Chen X, Zhao Y. Single-Stage Combined Embolization and Resection for Spetzler-Martin Grade III/IV/V Arteriovenous Malformations: A Single-Center Experience and Literature Review. Front Neurol. 2020 Oct 29;11:570198. doi: 10.3389/fneur.2020.570198. eCollection 2020.

  PMID: 33193013 RESULT

• Chen Y, Yan D, Li Z, Ma L, Zhao Y, Wang H, Ye X, Meng X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-Term Outcomes of Elderly Brain Arteriovenous Malformations After Different Management Modalities: A Multicenter Retrospective Study. Front Aging Neurosci. 2021 Feb 18;13:609588. doi: 10.3389/fnagi.2021.609588. eCollection 2021.

  PMID: 33679374 DERIVED

MeSH Terms

Conditions

Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yu Chen, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Chen, MD

CONTACT

8618801239327; chenyu_tiantan@126.com

Yuanli Zhao, MD

CONTACT

86-010-59978478; zhaoyuanli@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: October 23, 2019
• Study Start: April 1, 2012
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CN (1)