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

University Health Network, Toronto20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Thoracic Aortic Aneurysm Aortic Stenosis Symptomatic Stroke, Complication

Interventions

Carbon Dioxide and Saline FlushPROCEDURE

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.

Standard Saline FlushPROCEDURE

Standard of care flushing of the TEVAR or TAVI device with normal saline.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Complications

Infection, bleeding, stroke, pseudoaneurysm formation, etc.

Time frame: 30 days

All cause mortality

Post procedural death.

Time frame: 30 days

Secondary Outcomes

Stroke

Physical examination and magnetic resonance imaging (MRI) brain.

Time frame: 7 days

Silent Infarction

MRI brain.