Impact of Right Atrial Occlusion on TEVAR Outcomes

N/ANot Yet RecruitingNCT06786351

University of Calgary100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Thoracic Aortic Aneurysm Thoracic Aortic Dissection Thoracic Aorta Abnormality

Interventions

Non right atrial balloon occlusionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Endoleak occurrence up to hospital discharge

Endoleak occurrence prior to hospital discharge

Time frame: end of surgery to hospital discharge up to 10 days)

Endoleak occurrence to one-year post-surgery

Endoleak occurrence within one-year of surgery

Time frame: end of surgery to one-year post-surgery

Secondary Outcomes

Perioperative mortality to 30 days post-surgery

30-day perioperative mortality

Time frame: post-surgery to 30 days post-surgery

All-cause mortality to one-year post-surgery

One-year all-cause mortality

Time frame: post-surgery to one-year post-surgery

Complications: massive hemorrhage

Occurrence of massive hemorrhage