Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas (SUIT-SAVM)

Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas: Multicenter Prospective Cohort Study

Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex neurosurgical lesions that are very challenging to manage. Spinal vascular malformations account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our understanding of these lesions has dramatically increased thanks to neuroimaging technology (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities including conservative observation, endovascular embolization, microsurgical resection, radiation therapy, and combined therapies have been reported. The treatment for these AVMs and AVFs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. Due to the rarity of these spinal vascular lesions, reports of their management and outcomes have been limited to small series and case reports. And the rates of obliteration and outcomes are not satisfactory, especially the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for the treating neurosurgeon.The purpose of this study is to establish multimodality treatment mode and evaluate the anatomical cure rate and functional preservation rate.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Vascular Diseases

Detailed Description

This is a multicenter, prospective, observational, registration study. There are nine centers involved in the study. The investigators set up a more detailed classification system for spinal vascular malformations. In accordance with inclusion criteria and exclusion criteria, this cohort study will include 380 samples in the study period of three years. According to the spinal angiography, the correct diagnosis and treatment strategy will be made. The minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc. All the enrolled patients will be visited a total of four times, postoperative day 1 and postoperative day 7, followed up postoperative 3 months and 12 months. The anatomical cure rate and spinal cord function will be assessed objectively. All data will be recorded in the network database platform.

• Study Type: Observational
• Enrollment (Anticipated): 380

Contacts and Locations

• Study Contact: Name: Hong Tao, MD; Phone Number: 86-13810000653; Email: hongtao.edu@gmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Tao Hong
    • Contact: Hong Tao, MD.; Phone Number: 13810000653

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with spinal AVMs/AVFs

Description

Inclusion Criteria:

• patient diagnosed with spinal vascular diseases including

  • intradural arteriovenous malformation,
  • intradural arteriovenous fistula,
  • dural arteriovenous fistula,
  • extradural arteriovenous malformation,
  • paravertebral arteriovenous malformation,
  • paravertebral arteriovenous fistula,
  • cobbs' syndrome,
  • other spinal arteriovenous metameric syndromes involve the spinal cord.
• patient not received surgical or interventional treatment before
• patient with normal cardiac, renal and hepatic function
• patient capable of understanding the content of the patient information / Informed Consent Form
• patient willing and able to participate in the registry

Exclusion Criteria:

• patient received surgical treatment or interventional treatment before
• patient is pregnant
• patient allergic to iodine
• patient unable to complete follow-up
• patient with cerebral lesions
• patient with other spinal lesions
• patient with cardiac, renal or hepatic dysfunction

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the spinal cord function	American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function.Indexes (ASIA score) at baseline (1 day before operation) and 12 months follow-up will be collected, then the change from preoperative to 12 months follow-up will be assessed.	1 day before operation and 12 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of perioperative complications		1 week
Anatomic obliteration rate	the anatomic obliteration rate is determined by angiography 3 months post operation.	3 months post operation
American Spinal Injury Association(ASIA) Score		1 week, 3 months, 6 months, 12 months post operation
Modified Aminoff & Logue's Scale (mALS)		1 week, 3 months, 6 months, 12 months post operation
Modified Denis Pain and Numbness Scale (mDPNS)		1 week, 3 months, 6 months, 12 months post operation

Collaborators and Investigators

• Sponsor: Hongqi Zhang, MD
• Collaborators: General Hospital of Chinese Armed Police Forces; Beijing Tiantan Hospital; Chinese PLA General Hospital; Peking University Third Hospital; Beijing Hospital; Beijing Tsinghua Chang Gung Hospital; Tianjin Medical University General Hospital; China Rehabilitation Research Center; Beijing Haidian Hospital
• Investigators: Study Director: Zhang Hongqi, MD, Neurosurgical Department, Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• Lee YJ, Terbrugge KG, Saliou G, Krings T. Clinical features and outcomes of spinal cord arteriovenous malformations: comparison between nidus and fistulous types. Stroke. 2014 Sep;45(9):2606-12. doi: 10.1161/STROKEAHA.114.006087. Epub 2014 Jul 15.
• Rangel-Castilla L, Russin JJ, Zaidi HA, Martinez-Del-Campo E, Park MS, Albuquerque FC, McDougall CG, Nakaji P, Spetzler RF. Contemporary management of spinal AVFs and AVMs: lessons learned from 110 cases. Neurosurg Focus. 2014 Sep;37(3):E14. doi: 10.3171/2014.7.FOCUS14236.
• Gross BA, Du R. Spinal glomus (type II) arteriovenous malformations: a pooled analysis of hemorrhage risk and results of intervention. Neurosurgery. 2013 Jan;72(1):25-32; discussion 32. doi: 10.1227/NEU.0b013e318276b5d3.
• Gross BA, Du R. Spinal pial (type IV) arteriovenous fistulae: a systematic pooled analysis of demographics, hemorrhage risk, and treatment results. Neurosurgery. 2013 Jul;73(1):141-51; discussion 151. doi: 10.1227/01.neu.0000429848.91707.73.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: December 27, 2016
• First Submitted That Met QC Criteria: January 16, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 4, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Spinal Arteriovenous Malformation; Spinal Arteriovenous Fistula
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Cord Diseases; Cardiovascular Abnormalities; Vascular Malformations; Vascular Diseases; Fistula; Congenital Abnormalities; Arteriovenous Malformations; Spinal Cord Vascular Diseases
• Other Study ID Numbers: D161100003816001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided