Silent Brain Infarction After Endovascular Arch Procedures

Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry

This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.

Study Overview

• Status: Completed
• Conditions: Aortic Arch Aneurysm
• Intervention / Treatment: Device: Endovascular Arch Procedures

Detailed Description

Introduction. Poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. The objective of this work was to quantify these lesions using the STEP registry.

Methods. This multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed to identify the location and number of new silent brain infarctions (SBI), microbleeds ans general outcome of the patients.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Marie Lannelongue Hospital (Paris, France)
• Germany
  • Hamburg, Germany
    • University Hospital Hamburg-Eppendorf (Hamburg, Germany)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients, who received routine postoperative DW-MRI within 7 days after endovascular aortic arch repair between September 2018 and January 2020 at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) and Marie Lannelongue Hospital (Paris, France) were identified.

Description

Inclusion Criteria:

• Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3

Exclusion Criteria:

• Missing preoperative computed tomography angiography (CTA) scan of the chest and any circumstances that precluded the DW-MRI to be performed in the appropriate time window, such as a medical condition or an MRI contraindication

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Silent Brain Infarction; treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure with silent brain infarction	Device: Endovascular Arch Procedures; Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)
Patients without Silent Brain Infarction; treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure without silent brain infarction	Device: Endovascular Arch Procedures; Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of silent cerebral infarcts on DW-MRI	Primary outcomes were the frequency of silent cerebral infarcts on DW-MRI after endovascular arch procedures, and to identify the number, the distribution, and predictors of these lesions.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative ischemic stroke	Secondary outcomes were perioperative ischemic stroke defined as a brain infarction of ischemic etiology which occurs during surgery or within 30 days after surgery, TIA, hemorrhagic stroke, 30-day mortality, spinal cord ischemia, length of stay and discharge disposition.	30 days

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Massachusetts General Hospital; Stanford University; Groupe Hospitalier Paris Saint Joseph; Universitätsklinikum Hamburg-Eppendorf; Vascular Surgical Research Group, Imperial College, London, UK; Sanger Heart and Vascular Institute, Charlotte, NC; Loyola University Medical Center, Maywood, IL; UAB School of Medicine, Birmingham, AL; Heidelberg University Hospital, Heidelberg, Germany; University Hospital of Freiburg, Freiburg, Germany; Baylor Research Hospital, Dallas, TX; Emory University Hospital, Atlanta, GA; University Hospital of Mainz, Mainz, Germany; Diakonie Hospital Jung-Stilling, Siegen, Germany; Mayo Clinic, Rochester, MN; Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA; Maastricht University Medical Centre, Maastricht, Netherlands; I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy; Memorial Care Long Beach Heart & Vascular Institute, Long Beach, CA

Publications and helpful links

General Publications

• Charbonneau P, Kolbel T, Rohlffs F, Eilenberg W, Planche O, Bechstein M, Ristl R, Greenhalgh R, Haulon S; STEP collaborators. Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results from the STEP Registry. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):239-245. doi: 10.1016/j.ejvs.2020.11.021. Epub 2020 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Magnetic resonance imaging; Thoracic endovascular aortic repair; DW-MRI; Silent cerebral infarction; Aortic arch disease
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Infarction; Aneurysm; Brain Infarction
• Other Study ID Numbers: INSERM UMR_S 999

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