Aortic Stenosis Symptomatic, Stroke, Complication, Thoracic Aortic Aneurysm
Conditions
Brief summary
Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.
Interventions
PROCEDURECarbon Dioxide and Saline Flush
The TEVAR or TAVI device will be flushed with approximately 1.2L of medical grade carbon dioxide using a 60mL syringe and connecting tubing. The reservoir will then be flushed with at least 60mL of standard saline prior to deployment to minimize bubbles in the saline.
PROCEDUREStandard Saline Flush
Standard of care flushing of the TEVAR or TAVI device with normal saline.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective TEVAR or TAVI * Over 18 years old
Exclusion criteria
* Recent acute myocardial infarction * Recent stroke or TIA * Post or pending organ transplantation * Active peptic ulcer disease * Recent gastrointestinal bleed * History of bleeding diathesis or coagulopathy or contraindications to antiplatelet or anticoagulant therapy. * Permanent pacemaker or ICD * History of atrial fibrillation * Moderate or severe allergy to iodinated contrast not amenable to predmedication * Renal failure * Unable to safely undergo MRI * Enrollment in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 30 days | Infection, bleeding, stroke, pseudoaneurysm formation, etc. |
| All cause mortality | 30 days | Post procedural death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 7 days | Physical examination and magnetic resonance imaging (MRI) brain. |
| Silent Infarction | 7 days | MRI brain. |
Countries
Canada
Contacts
Primary ContactKong Teng Tan, MD, FRCPC
Outcome results
None listed