Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

Study Overview
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Brief Summary
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This is an observational retrospective cohort study of all patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary referral centre between 2009 and 2015. Patients were excluded if they were non-elective cases or had complex aortic aneurysms (juxta-renal, thoraco-abdominal or thoracic). Differences between both groups of repair were assessed, as well as short- and long-term complications including medical complications, duration of hospital stay, major cardiovascular events, mortality and vascular reintervention.

Official Title
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Retrospective Cohort Study of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

Conditions
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Abdominal Aortic Aneurysm Without Rupture

Intervention / Treatment
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* Procedure: Type of aneurysm repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This is an observational retrospective cohort study of all patients consecutively submitted to elective AAA surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015. Exclusion Criteria: The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular repair<br>Observational retrospective cohort of patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015 through endovascular repair. The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms. | Procedure: Type of aneurysm repair<br>* In open surgery repair group, aneurysm repair was performed by open surgery including aortobifemoral bypass, aorto-bi-iliac bypass and tubular aortic bypass. In endovascular repair (EVAR group), aneurysm correction was performed by percutaneous approach, femoral cutdowns and aorto-uni-iliac EVARs with femorofemoral bypass.<br>|
| Open repair<br>Observational retrospective cohort of patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015 through open repair. The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms. | Procedure: Type of aneurysm repair<br>* In open surgery repair group, aneurysm repair was performed by open surgery including aortobifemoral bypass, aorto-bi-iliac bypass and tubular aortic bypass. In endovascular repair (EVAR group), aneurysm correction was performed by percutaneous approach, femoral cutdowns and aorto-uni-iliac EVARs with femorofemoral bypass.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Acute myocardial infarction (with PCI, CABG or no intervention), decompensated heart failure, neurological deficit (including transient ischemic attack or stroke) or death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death of any cause | 12 months | 
| Medical complications | Including digestive complications such as intestinal obstruction or ischemia, acute myocardial infarction (with PCI, CABG or no intervention), decompensated heart failure, neurological deficit (including transient ischemic attack or stroke), respiratory failure (including pneumonia, prolongation of endotracheal intubation, need for a tracheostomy) or acute renal failure (plasma creatinine > 3 mg/dL with or without the need for dialysis). | 30 days |