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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Flush | Placebo Comparator | 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. |
|
| Carbon Dioxide and Saline Flush | Experimental | Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon Dioxide and Saline Flush | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Infection, bleeding, stroke, pseudoaneurysm formation, etc. | 30 days |
| All cause mortality | Post procedural death. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke | Physical examination and magnetic resonance imaging (MRI) brain. | 7 days |
| Silent Infarction | MRI brain. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kong Teng Tan, MD, FRCPC | Contact | 416-340-4800 | x6166 | kongteng.tan@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kong Teng Tan, MD, FRCPC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17888969 | Background | Gutsche JT, Cheung AT, McGarvey ML, Moser WG, Szeto W, Carpenter JP, Fairman RM, Pochettino A, Bavaria JE. Risk factors for perioperative stroke after thoracic endovascular aortic repair. Ann Thorac Surg. 2007 Oct;84(4):1195-200; discussion 1200. doi: 10.1016/j.athoracsur.2007.04.128. | |
| 30572774 | Background |
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No plan to share data with other researchers.
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|
|
| Standard Saline Flush | Procedure | Standard of care flushing of the TEVAR or TAVI device with normal saline. |
|
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| Bechara CF. Commentary: Eliminating Air From Stent-Grafts During Arch Endovascular Therapy: One Step Closer to Reducing Stroke. J Endovasc Ther. 2019 Feb;26(1):81-82. doi: 10.1177/1526602818819922. Epub 2018 Dec 21. No abstract available. |
| 27645761 | Background | Lansky AJ, Brown D, Pena C, Pietras CG, Parise H, Ng VG, Meller S, Abrams KJ, Cleman M, Margolis P, Petrossian G, Brickman AM, Voros S, Moses J, Forrest JK. Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial). Am J Cardiol. 2016 Nov 15;118(10):1519-1526. doi: 10.1016/j.amjcard.2016.08.013. Epub 2016 Aug 23. |
| 29431856 | Background | Perera AH, Rudarakanchana N, Monzon L, Bicknell CD, Modarai B, Kirmi O, Athanasiou T, Hamady M, Gibbs RG. Cerebral embolization, silent cerebral infarction and neurocognitive decline after thoracic endovascular aortic repair. Br J Surg. 2018 Mar;105(4):366-378. doi: 10.1002/bjs.10718. Epub 2018 Feb 12. |
| 27798380 | Background | Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kolbel T. Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment. J Endovasc Ther. 2017 Feb;24(1):84-88. doi: 10.1177/1526602816675621. Epub 2016 Oct 26. |
| 26896417 | Background | Kolbel T, Rohlffs F, Wipper S, Carpenter SW, Debus ES, Tsilimparis N. Carbon Dioxide Flushing Technique to Prevent Cerebral Arterial Air Embolism and Stroke During TEVAR. J Endovasc Ther. 2016 Apr;23(2):393-5. doi: 10.1177/1526602816633705. Epub 2016 Feb 19. |
| 20137879 | Result | Cheng D, Martin J, Shennib H, Dunning J, Muneretto C, Schueler S, Von Segesser L, Sergeant P, Turina M. Endovascular aortic repair versus open surgical repair for descending thoracic aortic disease a systematic review and meta-analysis of comparative studies. J Am Coll Cardiol. 2010 Mar 9;55(10):986-1001. doi: 10.1016/j.jacc.2009.11.047. |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002245 | Carbon Dioxide |
| ID | Term |
|---|---|
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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