Thoracic Aorta Abnormality, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection
Conditions
Keywords
right atrial balloon occlusion, thoracic endovascular aortic repair, stent graft repair, reduction of elimination of aortic impulse
Brief summary
Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative reduction or elimination of aortic impulse (REAI) techniques, in particular the use of right atrial occlusion, may impact patient important clinical outcomes. This study aims to provide prospective data from a large cohort of TEVAR patients to explore clinical outcomes following TEVAR procedures and, specifically, whether right atrial occlusion has significant impact on clinical outcomes, as compared to other REAI techniques. The results from this study may inform future perioperative TEVAR practices and improve TEVAR patient outcomes.
Interventions
PROCEDURERight atrial balloon occlusion
Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3
PROCEDURENon right atrial balloon occlusion
Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3
Sponsors
University of Calgary
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* age 18 years or older * thoracic endovascular aortic repair * right atrial balloon occlusion for reduction or elimination of aortic impulse * endograft deployment in landing zones 0-3
Exclusion criteria
* age 18 years or younger * non-thoracic endovascular aortic repair * reduction or elimination of aortic impulse using technique other than right atrial balloon occlusion * endograft deployment in landing zones 4 and beyond
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoleak occurrence up to hospital discharge | end of surgery to hospital discharge up to 10 days) | Endoleak occurrence prior to hospital discharge |
| Endoleak occurrence to one-year post-surgery | end of surgery to one-year post-surgery | Endoleak occurrence within one-year of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications: massive hemorrhage | within 30 days post-surgery and at 1 year | Occurrence of massive hemorrhage |
| Complications: cerebrovascular | within 30 days post-surgery and at 1 year | Occurrence of cerebrovascular accident/transient ischemic attack |
| Complications: spinal cord ischemia | within 30 days post-surgery and at 1 year | Occurrence of spinal cord ischemia |
| Complications: iliofemoral access | within 30 days post-surgery and at 1 year | Occurrence of iliofemoral access complications (bleeding/infection/thrombosis) |
| Perioperative mortality to 30 days post-surgery | post-surgery to 30 days post-surgery | 30-day perioperative mortality |
| Complications: prolonged ventilation | within 30 days post-surgery and at 1 year | Occurrence of prolonged ventilation for more than 24 hours |
| Complications: acute kidney injury | within 30 days post-surgery and at 1 year | Occurrence of acute kidney injury |
| Complications: acute kidney injury with renal replacement therapy | within 30 days post-surgery and at 1 year | Occurrence of acute kidney injury requiring renal replacement therapy |
| Complications: cardiovascular events | within 30 days post-surgery and at 1 year | Occurrence of cardiovascular events (myocardial injury after non-cardiac surgery/cardiac arrest/myocardial infarction) |
| Complications: retrograde dissection | within 30 days post-surgery and at 1 year | Occurrence of retrograde dissection |
| All-cause mortality to one-year post-surgery | post-surgery to one-year post-surgery | One-year all-cause mortality |
Contacts
Primary ContactClaire Allen, MD, FRCPC
Outcome results
None listed