Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm Without Rupture
• Intervention / Treatment: Procedure: Type of aneurysm repair

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-061
    • Centro Hospitalar Universitário de São João

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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. 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovascular repair; 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; 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.
Open repair; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Sao Joao

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Aortic Diseases; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: AAArepair

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No