Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
| Registry | NCT03998631 |
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| Status | Unknown |
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| Phase | Phase 1 |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 20 (Estimated) |
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| Sponsor | University Health Network, Toronto (Other) |
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| Conditions | Thoracic Aortic Aneurysm, Aortic Stenosis Symptomatic, Stroke, Complication |
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| Interventions | Carbon Dioxide and Saline Flush, Standard Saline Flush (Procedure) |
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| Dates | start 2019-07-20, primary completion 2020-12-31 (estimated), completion 2021-03-31 (estimated), first posted 2019-06-26, last updated 2020-09-23 |
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| Locations | 1 site in Canada |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Saline Flush | Placebo comparator | Procedure: Standard Saline Flush | 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 | Procedure: Carbon Dioxide and Saline Flush | Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush. |
- Carbon Dioxide and Saline Flush (Procedure), also known as Cook Zenith alpha thoracic endovascular graft, Sapien Transcatheter Heart Valve, CoreValve Trascatheter Aortic Valve: 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 Flush (Procedure), also known as Cook Zenith alpha thoracic endovascular graft, Sapien Transcatheter heart valve, Core Valve Transcatheter Aortic Valve: Standard of care flushing of the TEVAR or TAVI device with normal saline.
+Outcome measures
Primary outcomes
- Complications [30 days]: Infection, bleeding, stroke, pseudoaneurysm formation, etc.
- All cause mortality [30 days]: Post procedural death.
Secondary outcomes
- Stroke [7 days]: Physical examination and magnetic resonance imaging (MRI) brain.
- Silent Infarction [7 days]: MRI brain.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| University Health Network | Toronto, Ontario | Canada | Recruiting |
+Publications
- 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. PMID 17888969
- 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. PMID 30572774
- 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. PMID 27645761
- 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. PMID 29431856
- 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. PMID 27798380
- 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. PMID 26896417
- Results publication: 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. PMID 20137879
+Investigators