Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

University Health Network, Toronto

Status and phase: Unknown; Phase 1

Conditions: Aortic Stenosis Symptomatic; Stroke, Complication; Thoracic Aortic Aneurysm

Treatments: Procedure: Carbon Dioxide and Saline Flush; Procedure: Standard Saline Flush

Study type: Interventional

Funder types: Other

Identifiers

NCT03998631

19-5219

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Saline Flush

Placebo Comparator group

Description:

This is the control arm. The TEVAR or TAVI device will be flushed with at least 60mL of standard saline to reduce bubbles in the reservoir prior to deployment. This is the standard of care.

Treatment:

Procedure: Standard Saline Flush

Carbon Dioxide and Saline Flush

Experimental group

Description:

Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.

Treatment:

Procedure: Carbon Dioxide and Saline Flush